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					Research Administration
   Training Seminar
      Reference Material
          May 2008
                                                                               Introduction


Research administration training becomes more important as research funding
increases, compliance remains a top issue, and improvement opportunities exist



   fiscal year 2006, Northwestern received $383.8 million in research
 In
 funding
 Proposalvolume increased 10.6% between fiscal year 2004 and fiscal
 year 2006
 Northwestern           is highly ranked in terms of total federal research
 funding
 Ensuringcompliance with rules and regulations governing research
 remains a Federal priority




 Source: Office for Research Annual Report. (2006): Northwestern University.
                                                                                              2
                                                                       Introduction


Research administration training helps Northwestern decrease compliance risk,
administer grants more consistently, and improve support for administrators



 Decrease   the University‘s exposure to Federal compliance risk
 Provide a foundation of support and a reference tool for research
 faculty and staff
        government has expectations for proper compliance
 Federal
 programs, including training and communication




                                                                                      3
                                                                          Introduction


During this seminar, we will discuss topics including the research administration
process, roles & responsibilities, and compliance implications



 Roles   and responsibilities of faculty and staff
 Overview  of research administration processes that link the different
 aspects of research administration
 Regulatory fundamentals which form the foundation of research
 administration
 Specificresearch administration topics, including effort reporting and
 cost sharing, and expectations related to fiscal administration
 Dialogue  about gaps in the understanding of research compliance at
 the institutional and individual levels



                                                                                         4
                                                                                                                                                                                                                                                                       Roles and Resp.


From a global perspective, each individual and office has a significant role throughout the
research administration process.

Research Administration Process
                                        Pre-Proposal                                                                                         Proposal Development and Budgeting

                                                                                                                                          (6) Complete             (7) Review
                              (2) Conduct             (2A)                                                                                                       and Approve                  (8)              (9) Info
          (1) Identify                                                      (3) Review                                                      OSR form,                                     Proposal/
                                  pre-               Limited                                               (4) Proposal                                           by Schools/                                  entered                    A
            funding                                                 Yes          by                                                        conduct QA,                                   budget sent
                                proposal           Submission                                                 written                                                 Deans                                      into
         opportunities                                                      Committee                                                       obtain dept                                    to OSR
                                activities             s?                                                                                                        (if applicable)                              NUORISN
                                                                                                                                             approval

                                                                                     No

                                                                                                           (4A) Budget                     (5) Obtain
                                                                                                             prepared                    safety approval




           Proposal / Protocol Review, Approval and Processing                                                                                             Award Acceptance and Account Establishment

                                                                                                                        (16) Preaward                                                                        (21)                                             (25) Project       (26) Project
                                                                                              (15) Is                                         (17) Notice of                                (20)                                 (22) Info entered
                                                                                                                          accounts                                                                         Contract/                                             folder              folder
              (10)             (11) Meets           (12) Proposal                                                                             grant award or                                                                   into NUORISN and
                                                                          (14) JIT           preaward                    approved &                                (19) A                Review &
 A          Proposal            terms and            submitted to                                                 Yes established for                                              Yes                       grant                project account             established         information   B
                                                                           Phase            account(s)                                           contract         Contract?              negotiate                                 established in
            reviewed           conditions?             sponsor                                                         grants and sub-                                                                     accepted                                           and sent to        reviewed by
                                                                                            necessary?                                           received                                 contract                                     CUFS
                                                                                                                          contracts                                                                         by NU                                               ASRSP               ASRSP

                                                                                                                                                                                           No
                                                                                                                                               (18) Notice of
                                                                                                                                             Grant Award sent
                             (11A) Proposal         (13) Proposal                                                                             to PI/co-PI(s) &
                              sent back for          logged into                                                                                                                                                       (23) PI and unit
                                                                                                                             No                    all dept                                                                                    (24) Co-PI(s) &
                                                                                                                                                                                                                        administration
                                revision              NUORISN                                                                                  administration                                                                                 their unit admin.
                                                                                                                                                                                                                       notified to post
                                                                                                                                                                                                                                               notified to post
                                                                                                                                                  involved                                                              transactions to
                                                                                                                                                                                                                                                 transactions
                                                                                                                                                                                                                            account




                                                   Management and Monitoring of Projects                                                                                                                     Award Close-Out

                 (27) PI/Dept./                                                            (31A) Is more work                      (33) Submit                             (35) PI prepares             (38) PI submits          (39) ASRSP                     (40) ASRSP
                Center Admin.                                                             required to complete         Yes          request for                              final technical           technical report/          closes out                    submits final
               provide oversight                                                                project?                                                                                                                                                                              End
                                                                                                                                   supplement                               report and NIH               deliverable to          award (deficit               financial report
                 (fin, scientific,                                    (31) PI
                    HR, effort)                                                                                                                                          invention statement               sponsor               and surplus)                    to sponsor
                                                                     continue                      No
     B                                                                to work
                                              (29) OPRS and
                                               ORS monitor               on                                                        (34) No cost                             (36) ASRSP
                                                                                           (31B) Is more time
                  (28) ASRSP                 technical aspect         project                needed without             Yes       extension given                         reviews financial
               conducts fin rptg,              (if applicable)                             additional funding?                                                              status w/Unit
                                                                                                                                      by OSR
                 A/P (approve
                 $500+), A/R &
                   compliance                                                                      No
                                              (30) OSR and                                                                  Yes                                               (37) OSR
                                             ASRSP monitor                                                                (Renew         Go to (4)                         prepares, signs
                                             financial aspect                             (31C) Does the area
                                                                                          of research require a
                                                                                                                           and/or        proposal                         patent reports and
                                                                                           renewal proposal?               bridge         written                          submits (DOD)
                                                                                                                          funding)

                                                                                                 No
                                                                                               (32)
                                                                                             Complete
                                                                                              current                                                                                                                                                                                               5
                                                                                                                                                                                                                                                                                                    6
                                                                                              project
                                                                                                     Roles and Resp.


     A good understanding of the roles and responsibilities will help to make the
     research administration process more efficient and effective

     Research Administration Roles


           Central                                Central
 SVP Business   and Finance
 Office for Research                               Unit                                    Unit
 OSR         ORD
                                                                              Administrators,such as:
 OPRS        TTP                                                              — Business/ Research
 ASRSP       Cost Studies                                                       Administrators
                                                     PI                         — Program Assistants
 ORS         Internal Audit

 ORI                                                                         Department   Chairs
                                                                              Dean‘s   Office




                          PIs are the primary grant manager with Unit and Central
                      Administrators providing additional levels of administrative support

                                                                                                                       6
                                                                                  Roles and Resp.


Principal Investigators (PIs) are specifically responsible for the technical,
administrative, and fiscal management of a project, including subcontracts


Selected PI Responsibilities
   Understand and apply rules and regulations
   Reflect accurate University-sanctioned costs and rates in proposal budgets
   Ensure costs are compliant with OMB Circular A-21
   Provide sufficient lead time to process and submit proposals
   Disclose and manage actual or potential conflicts of interest or commitment
   Manage award and comply with grant terms and conditions




                  Grants are awarded to institutions not PIs —
                        PIs are NU’s project managers


                                                                                                    7
                                                                                                    8
                                                                               Roles and Resp.


Unit administrators have an interdependent relationship with PIs, providing
administrative support on sponsored projects


Selected Unit Administrator Responsibilities
   Support PIs, such as:
     — Completing appropriate forms
     — Developing budgets
     — Conducting quality assurance on total proposal and sub-contracts
     — Submitting proposal to sponsor, when appropriate

   Knowledge of rules and regulations
   Other specific responsibilities, including monitoring financial and compliance
    controls for grants



             Unit administrators have a stewardship responsibility
              to funding agencies and Northwestern University


                                                                                                 8
                                                                                                 9
                                                                              Roles and Resp.


Department Chairs/ Center Directors are primarily responsible for supporting
research and monitoring the research administration process


Selected Department Chair/ Center Director Responsibilities
 Support and monitor research and research administration, including:

    — Absorbing overdrafts when a PI‘s non-sponsored funding sources are
       insufficient
          PI non-sponsored funds can include such accounts as discretionary and start-
           up funds, released funds, designated gift accounts
    — Providing adequate departmental resources to administer the project

    — Monitoring appropriate use of students

    — Allocating space and other resources to meet project needs

    — Ensuring consistency between the proposed project goals and the objectives of
       the Department, School, and Northwestern




                                                                                                 9
                                                                                                10
                                                                                         Roles and Resp.


Research Roles & Responsibilities: New Online Resource for Research Community

What Is It?
 A web-based tool that communicates and clarifies roles and responsibilities related to the
  research administration process at Northwestern University

Who Should Use It?
 Anyone involved in the research administration process – school/unit and central
  administrators, faculty, etc.

Why Should I Use It?
 To better understand the various roles and responsibilities involved in the research process,
  with ability to generate and print customized reports

How Was It Created?
 Faculty, school/unit and central administrators participated in workgroups that created a
  comprehensive list of research related tasks along with the corresponding roles and
  responsibilities
Where Can I Find It?
 Link to the website can be found in The Guide for Research Information, as well as ORI‘s
  Training & Education web page (http://www.research.northwestern.edu/guide/)


               New online tool to serve the research community!
                                                                                                           10
                                                                                                           11
                                                                           Roles and Resp.


Research Roles & Responsibilities


   Web-based resource to help Northwestern‘s research community better understand
    the various roles and responsibilities in the research process.




                                                                                             11
                                                                                             12
                                                                       Roles and Resp.


Research Roles & Responsibilities



   Describes levels of responsibility for each role
   Filters information by role, process, or level of responsibility
   Display results in a table or list format
   Generates filtered reports
   Links to offices involved in NU's research processes




                http://www.researchroles.northwestern.edu/




                                                                                         12
                                                                                         13
                                    Roles and Resp.


Research Roles & Responsibilities




                                                      13
                                                      14
                                                                                                                 Roles and Resp.


The Office for Research consists of several units dedicated to facilitating the
various aspects of research administration for NU’s research faculty and staff


                                                    Office for Research
                                                Vice President for Research




                        Assoc VP/ Office                  Assoc VP for           Office for Research
   Assoc VPs for                                                                                        Office for Research
                         for Research                       Research             Planning, Finance &
     Research                                                                                              Development
                           Integrity                       Operations              Communications




    Center for               Office for                    Office for               Office for the
                                                                                                          Office for Research
   Comparative               Sponsored                     Research                 Protection of
                                                                                                         Information Systems
    Medicine                 Research                       Safety                Research Subjects



                                                                         Institutional           Institutional
              Chicago Unit                Evanston Unit                 Review Boards           Review Board
                                                                          (Chicago)               (Evanston)


                                                                                    Animal Care
                                               Other Related                          and Use
                                                NU Offices                           Committee
                                                                                                                                   14
                                                                                                                                   15
                                                                                                                Roles and Resp.


The Associate Vice Presidents work with the Vice President for Research to guide
the strategic direction of research conducted at Northwestern and improve the
Office for Research’s customer service orientation

                                                   Office for Research
                                               Vice President for Research




                       Assoc VP/ Office                  Assoc VP for           Office for Research         Office for
  Assoc VPs for
                        for Research                       Research             Planning, Finance &         Research
    Research
                          Integrity                       Operations              Communications           Development




   Center for               Office for                    Office for               Office for the
                                                                                                         Office for Research
  Comparative               Sponsored                     Research                 Protection of
                                                                                                        Information Systems
   Medicine                 Research                       Safety                Research Subjects



                                                                        Institutional           Institutional
             Chicago Unit                Evanston Unit                 Review Boards           Review Board
                                                                         (Chicago)               (Evanston)


                                                                                   Animal Care
                                               Other Related                         and Use
                                                NU Offices                          Committee
                                                                                                                                  15
                                                                                                                                  16
                                                                                                                 Roles and Resp.


The Associate Vice President for Research Integrity reports directly to the Vice
President for Research and…


                                                    Office for Research
                                                Vice President for Research




                        Assoc VP/ Office                  Assoc VP for           Office for Research         Office for
   Assoc VPs for
                         for Research                       Research             Planning, Finance &         Research
     Research
                           Integrity                       Operations              Communications           Development




   Center for                Office for                    Office for               Office for the
                                                                                                          Office for Research
  Comparative                Sponsored                     Research                 Protection of
                                                                                                         Information Systems
   Medicine                  Research                       Safety                Research Subjects



                                                                         Institutional           Institutional
              Chicago Unit                Evanston Unit                 Review Boards           Review Board
                                                                          (Chicago)               (Evanston)


                                                                                    Animal Care
                                                Other Related                         and Use
                                                 NU Offices                          Committee
                                                                                                                                   16
                                                                                                                                   17
                                                                           Roles and Resp.


…ORI is dedicated to serving and safeguarding Northwestern’s research
enterprise through the encouragement of responsible and ethical research


Selected ORI Responsibilities
 Serve and safeguard Northwestern‘s research community

 Coordinate training, education and communication

 Support and partner with the research community

 Monitor and correct non-compliance in accordance with University and federal
  guidelines




                                                                                             17
                                                                                             18
                                                                                                                Roles and Resp.


The AVP for Research Operations and Office for Research Planning, Finance and
Communications work together to plan for and manage Office for Research daily
activities

                                                   Office for Research
                                               Vice President for Research




                       Assoc VP/ Office                  Assoc VP for           Office for Research         Office for
  Assoc VPs for
                        for Research                       Research             Planning, Finance &         Research
    Research
                          Integrity                       Operations              Communications           Development




   Center for               Office for                    Office for               Office for the
                                                                                                         Office for Research
  Comparative               Sponsored                     Research                 Protection of
                                                                                                        Information Systems
   Medicine                 Research                       Safety                Research Subjects



                                                                        Institutional           Institutional
             Chicago Unit                Evanston Unit                 Review Boards           Review Board
                                                                         (Chicago)               (Evanston)


                                                                                   Animal Care
                                              Other Related                          and Use
                                               NU Offices                           Committee
                                                                                                                                  18
                                                                                                                                  19
                                                                       Roles and Resp.


The Associate Vice President for Research Operations provides operational
management and oversight for all OR units supporting the research enterprise


Selected AVP for Research Operations Responsibilities
 Efficient Operations

 Compliance

 OR Management

 OR Project Management and Representation




                                                                                         19
                                                                                         20
                                                                                  Roles and Resp.


The Office for Research Planning, Finance and Communications (ORPFC)
provides direct services to the research enterprise and reports both to the VPR
and AVP – Research Operations

Selected ORPFC Responsibilities
   Overseeing strategic planning and performing financial analyses to define
    programmatic alternatives for determination of the optimal use of resources
   Developing human resources practices and operational processes that lead to
    enhanced effectiveness
   Advocating on behalf of the Research community
   Managing communications and publications to foster the flow of information between
    the Office for Research and its many constituents
   Facilitating publication of faculty research accomplishments to the internal and
    external communities
   Promoting fiscal responsibility and compliance with internal and external policies and
    regulations
   Serving as a consulting and training resource for management and staff in the Office
    for Research
                                                                                                    20
                                                                                                    21
                                                                                                                Roles and Resp.


The Office for Research Development (ORD) reports to the VPR and…



                                                   Office for Research
                                               Vice President for Research




                       Assoc VP/ Office                  Assoc VP for           Office for Research         Office for
  Assoc VPs for
                        for Research                       Research             Planning, Finance &         Research
    Research
                          Integrity                       Operations              Communications           Development




   Center for               Office for                    Office for               Office for the
                                                                                                         Office for Research
  Comparative               Sponsored                     Research                 Protection of
                                                                                                        Information Systems
   Medicine                 Research                       Safety                Research Subjects



                                                                        Institutional           Institutional
             Chicago Unit                Evanston Unit                 Review Boards           Review Board
                                                                         (Chicago)               (Evanston)


                                                                                   Animal Care
                                              Other Related                          and Use
                                               NU Offices                           Committee
                                                                                                                                  21
                                                                                                                                  22
…provides strategic support to faculty and research teams


Selected ORD Responsibilities
   Identify and procure external research support
   Research program and grant proposal development
   Identify and secure appropriate partners and collaborators
   Identify appropriate funding opportunities
   Grantsmanship training and grant process overview
   Research administration support for large and/or complex grants (earlier stages than
    interactions with OSR)
   Provide assistance obtaining institutional commitments and cost-sharing for proposals
   Provide assistance establishing external partnerships and affiliated subcontracts or
    consortium agreements, including those in the outreach and K-12 arena
   Provide assistance developing budgets for large and/or complex grants.


                                                                                           22
                                                                                           23
                                                                                                                Roles and Resp.


The Center for Comparative Medicine (CCM) reports to the Associate Vice
President for Research Operations and…


                                                   Office for Research
                                               Vice President for Research




                       Assoc VP/ Office                  Assoc VP for           Office for Research         Office for
  Assoc VPs for
                        for Research                       Research             Planning, Finance &         Research
    Research
                          Integrity                       Operations              Communications           Development




   Center for               Office for                    Office for               Office for the
                                                                                                         Office for Research
  Comparative               Sponsored                     Research                 Protection of
                                                                                                        Information Systems
   Medicine                 Research                       Safety                Research Subjects



                                                                        Institutional           Institutional
             Chicago Unit                Evanston Unit                 Review Boards           Review Board
                                                                         (Chicago)               (Evanston)


                                                                                   Animal Care
                                                Other Related                        and Use
                                                 NU Offices                         Committee
                                                                                                                                  23
                                                                                                                                  24
                                                                              Roles and Resp.


…is a service and teaching unit for all of the animals used in research, testing, and
education at Northwestern University


Selected CCM Responsibilities
   Supports the research and teaching activities of faculty using animals
   Provides and oversees the humane care and use of animals
   Houses research animals and maintains support space and services for the use of
    animals
   Provides training in the care and use of animals
   Supports the activities of the ACUC




                                                                                                24
                                                                                                25
                                                                                                                 Roles and Resp.


The Office for Sponsored Research (OSR) is comprised of two units and facilitates
the research administration process — from pre-award through award close-out


                                                    Office for Research
                                                Vice President for Research




                        Assoc VP/ Office                  Assoc VP for           Office for Research         Office for
   Assoc VPs for
                         for Research                       Research             Planning, Finance &         Research
     Research
                           Integrity                       Operations              Communications           Development




   Center for                Office for                    Office for               Office for the
                                                                                                          Office for Research
  Comparative                Sponsored                     Research                 Protection of
                                                                                                         Information Systems
   Medicine                  Research                       Safety                Research Subjects



                                                                         Institutional           Institutional
              Chicago Unit                Evanston Unit                 Review Boards           Review Board
                                                                          (Chicago)               (Evanston)


                                                                                    Animal Care
                                                  Other Related                       and Use
                                                   NU Offices                        Committee
                                                                                                                                   25
                                                                                                                                   26
                                                                            Roles and Resp.


OSR provides administrative support over the life of a sponsored project and has
offices on both campuses


Selected OSR Responsibilities
   Proposal validation and submission
   Negotiate, execute, and accept contract and grant awards
   Award notification
   Account establishment
   Issue sub-awards
   Award terms and conditions interpretation
   Provide other administrative support over the life cycle of a grant
   Take action, as necessary, to protect the interests of the University
   Information dissemination



                                                                                              26
                                                                                              27
                                                                                                                 Roles and Resp.


The Office for Research Safety (ORS) reports to the Associate Vice President for
Research Operations and…


                                                    Office for Research
                                                Vice President for Research




                        Assoc VP/ Office                  Assoc VP for           Office for Research         Office for
   Assoc VPs for
                         for Research                       Research             Planning, Finance &         Research
     Research
                           Integrity                       Operations              Communications           Development




   Center for                Office for                    Office for               Office for the
                                                                                                          Office for Research
  Comparative                Sponsored                     Research                 Protection of
                                                                                                         Information Systems
   Medicine                  Research                       Safety                Research Subjects



                                                                         Institutional           Institutional
              Chicago Unit                Evanston Unit                 Review Boards           Review Board
                                                                          (Chicago)               (Evanston)


                                                                                    Animal Care
                                                 Other Related                        and Use
                                                  NU Offices                         Committee
                                                                                                                                   27
                                                                                                                                   28
                                                                                Roles and Resp.


…is responsible for safety and compliance programs across the University
involving hazardous materials and processes


Selected ORS Responsibilities
   Chemical, biological, radiation, and general laboratory safety
   Compliance oversight (all of the above) — interactions with multiple state and federal
    agencies
   Hazardous waste disposal ($300K/yr)
   Emergency response (―spills ‗n thrills‖)
   Security oversight (materials of national security interest)
   Safety committee administration
     — Recombinant DNA Safety Committee
     — Radiation Safety Committee
     — Laser Safety Committee
     — Chemical and Biological Safety Committee




                                                                                                  28
                                                                                                  29
                                                                                                                 Roles and Resp.


The Office for the Protection of Research Subjects (OPRS) reports to the
Associate Vice President for Research Operations and…


                                                    Office for Research
                                                Vice President for Research




                        Assoc VP/ Office                  Assoc VP for           Office for Research         Office for
   Assoc VPs for
                         for Research                       Research             Planning, Finance &         Research
     Research
                           Integrity                       Operations              Communications           Development




   Center for                Office for                    Office for               Office for the
                                                                                                          Office for Research
  Comparative                Sponsored                     Research                 Protection of
                                                                                                         Information Systems
   Medicine                  Research                       Safety                Research Subjects



                                                                         Institutional           Institutional
              Chicago Unit                Evanston Unit                 Review Boards           Review Board
                                                                          (Chicago)               (Evanston)


                                                                                    Animal Care
                                                Other Related                         and Use
                                                 NU Offices                          Committee
                                                                                                                                   29
                                                                                                                                   30
                                                                                       Roles and Resp.


…coordinates the activities of the IRBs and the ACUC to ensure that research
involving human or animal subjects meets ethical research standards




       Institutional Review Board (IRB)               Animal Care and Use Committee (ACUC)
    IRB panels review and approve or                    Ensures the humane care and use of
     disapprove research involving human                  animals in research by working with the
     subjects or materials and data obtained              animal facility (CCM) to protect the
     from human subjects                                  welfare of animal subjects
    The staff are trained to:                           Assists the research community by
      — Ensure the rights and welfare of                  ensuring compliance with federal, state
        human research subjects are            OPRS       and institutional regulations
        adequately safeguarded in the
        proposal
      — Assist investigators and the NU
        research community to minimize risk
        to the human research subject
      — Achieve compliance with all federal,
        state and institutional regulations




                                                                                                         30
                                                                                                         31
                                                                                                                Roles and Resp.


Office for Research Information Systems (ORIS) to the Associate Vice President
for Research Operations and…


                                                   Office for Research
                                               Vice President for Research




                       Assoc VP/ Office                  Assoc VP for           Office for Research         Office for
  Assoc VPs for
                        for Research                       Research             Planning, Finance &         Research
    Research
                          Integrity                       Operations              Communications           Development




   Center for               Office for                    Office for               Office for the
                                                                                                         Office for Research
  Comparative               Sponsored                     Research                 Protection of
                                                                                                        Information Systems
   Medicine                 Research                       Safety                Research Subjects



                                                                        Institutional           Institutional
             Chicago Unit                Evanston Unit                 Review Boards           Review Board
                                                                         (Chicago)               (Evanston)


                                                                                   Animal Care
                                                  Other Related                      and Use
                                                   NU Offices                       Committee
                                                                                                                                  31
                                                                                                                                  32
                                                                              Roles and Resp.


…provides leadership and strategic direction in the design, creation and
deployment of technical solutions to address cross-functional business issues


Selected ORIS Responsibilities
   Identification and implementation of technical solutions
   Champion the application of IS solutions and technologies to the Northwestern
    research enterprise
   Provide technical support and application/ systems implementation
   Provide the technical infrastructure




                                                                                                32
                                                                                                33
                                                                                   Roles and Resp.


There are other offices related to Northwestern’s research enterprise including
ASRSP, Effort Reporting and Cost Studies

                               Northwestern
                                University
                                President



            Northwestern                      Sr VP for Business
          University Provost                     and Finance



                                              Office of Financial
            VP Research
                                                 Operations


                                                 Assoc VP of
                                                  Financial
                                                 Operations




                                              Effort Reporting
                                  ASRSP                             Cost Studies
                                                  Project




                                                                                                     33
                                                                                                     34
                                                                                  Roles and Resp.


Accounting Services for Research and Sponsored Programs (ASRSP) reports to
the Controller’s Office and…

                              Northwestern
                               University
                               President



           Northwestern                      Sr VP for Business
         University Provost                     and Finance



                                             Office of Financial
           VP Research
                                                Operations


                                                Assoc VP of
                                                 Financial
                                                Operations




                                             Effort Reporting
                                 ASRSP                             Cost Studies
                                                 Project




                                                                                                    34
                                                                                                    35
                                                                                Roles and Resp.


…is responsible for administrating and facilitating the financial administration of
sponsored research grants


Selected ASRSP Responsibilities
   Prepare and submit financial status reports and invoices to sponsors
   Collect sponsor reimbursements; deposit checks and process wire transfers
   Process Letter of Credit draws for expenditures
   Review and process select sponsored project transactions
   Approve transactions over 90 days
   Coordinate sponsor and annual A-133 audits
   Inventory government-titled equipment
   Administer the quarterly effort certification process
   Process subcontract invoices
   Assist in interpretation and promote compliance with sponsor and University policies


                                                                                                  35
                                                                                                  36
                                                                                   Roles and Resp.


The Effort Reporting Project reports to the Controller’s Office and…


                               Northwestern
                                University
                                President



            Northwestern                      Sr VP for Business
          University Provost                     and Finance



                                              Office of Financial
            VP Research
                                                 Operations


                                                 Assoc VP of
                                                  Financial
                                                 Operations




                                              Effort Reporting
                                  ASRSP                             Cost Studies
                                                  Project




                                                                                                     36
                                                                                                     37
                                                                                Roles and Resp.


…is charged with assisting other entities to enable effort reporting compliance


Selected Effort Reporting Project Manager Responsibilities
   Work with ASRSP Effort Coordinators to enable compliant quarterly effort
    certification at Northwestern
   Maintain Effort Reporting System/Committed Effort Management (ERS/CEM)
   Provide training to faculty and staff on effort reporting policies and ERS/CEM
   Work with OSR and departments to resolve effort reporting issues and answer
    questions related to effort commitments, charging and cost sharing of salary to
    sponsored projects
   Coordinate communications to sponsors regarding changes in effort, personnel status,
    and significant salary changes
   Monitor federal agency and other university communications for regulations,
    investigations, and policies related to effort reporting
   Work with individual faculty members and administrators to complete effort reports
    or other documentation in cases with high commitments of effort or other unique
    effort-related situations
                                                                                                  37
                                                                                                  38
                                                                                   Roles and Resp.


Cost Studies reports to the Controller’s Office and…


                               Northwestern
                                University
                                President



            Northwestern                      Sr VP for Business
          University Provost                     and Finance



                                              Office of Financial
            VP Research
                                                 Operations


                                                 Assoc VP of
                                                  Financial
                                                 Operations




                                              Effort Reporting
                                  ASRSP                             Cost Studies
                                                  Project




                                                                                                     38
                                                                                                     39
                                                                                    Roles and Resp.


…is charged with managing the Facilities & Administration Rate and related
activities/ reporting


Selected Cost Studies Responsibilities
   Development and negotiation of the university F&A Rate
   Data driven analysis relating to F&A cost allocation and recovery, fringe benefit
    costs, space, and other direct and indirect cost allocations
   Oversight and analysis of internal sales (recharge) activities, including rate
    development/documentation, monitoring of financial activity, policy development,
    and overall compliance
   Monitoring university compliance with A-21 cost accounting practices
   Distribution of the Monthly Indirect Cost Report
   Determination of cost transfer policies and review of selected cost transfers
   Review of selected sponsored project expenditures



                                                                                                      39
                                                                                                      40
                                                                             Roles and Resp.


Research Centers either report directly to the Vice President for Research or the
Dean of the School with which they are associated

                                             Northwestern
                                          University President



                                            Northwestern
                                          University Provost




                             Office for                      Respective
                             Research                       School Dean



                             University                    School Based
                          Research Centers                Research Centers




          All University and School-Based Research Centers are listed at:
                     http://www.research.northwestern.edu/centers/

                                                                                               40
                                                                                               41
                                                                                          Roles and Resp.


Understanding and citing rules and regulations governing research
administration, such as A-21, can help facilitate PI/ administrator discussions
                                                                                     Case Study



             Situation                            Problem                  Resolution and Outcomes
 On  occasion, PIs may direct an     The charges are not directly       Requestpre-spending authority
  administrator to temporarily        allocable to the award to which     on sponsored project
  charge a Federal award for          they are charged
                                                                          With respect to Federal awards
  expenses, which do not benefit        — Direct violation of the key
                                                                          not involving approved, pre-
  that award                              OMB A-21 principles,
                                                                          spending authority, RACs:
                                          including allocability
 The  expectation exists that                                              — Are to be used to correct
  those charges will only be          ―Parking Charges‖ is a red flag        legitimate mistakes
  ―temporarily‖ charged to that       for auditors often highlighted        — Should reflect actual
  award until it becomes              by:                                     circumstances leading to
  possible to transfer the charges      — Shear number of RACs                the mistake
  to the appropriate account            — Boilerplate explanations          — Involving pre-spending
                                          including, ―To move to              must be submitted within
 Referred   to as ―parking               correct account‖                    90 days of a sponsored
  charges‖                                                                    account opening




                                                                                                            41
                                                                                                            42
                                                                                           Policy & Procedure


Policies governing the research administration process can be viewed as a
regulatory pyramid with each policy level building upon and more specific than
those below




                                                  Individual        Award-specific NIH or NSF
                                                 Contract or         Grant/ Contract Terms

                                                 Grant Terms

                                          University Policies and             Northwestern University
                                               Procedures                            Policies

                                                                                          NIH GPS1/
                                          Sponsor Specific Policy
                                                                                      NSF GPM2 & FDP3

                                                                                                  A-21 and
                                                Federal Policies                                   A-110




 Notes: (1) NIH Grants Policy Statement
        (2) NSF Grants Policy Manual                                                                       42
                                                                                                           43
        (3) Federal Demonstration Partnership
Federal Policies, such as the Office of Management and Budget Circulars A-21
and A-110, form the process and financial framework for research administration



 OMB Circular A-21
  —   Establishes principles for determining costs applicable to grants, contracts, and other
      agreements with educational institutions

 Cost   Accounting Standards (CAS)1
  —   Provides guidance and parameters for higher educational institutions when accounting for
      costs associated with sponsored projects

 OMB Circular A-110
  —   Establishes uniform administrative requirements for federal grants and agreements to
      universities, hospitals and other non-profits

 OMB Circular A-133
  —   Establishes the standards for obtaining consistency and uniformity among Federal agencies
      for the audit of non-profit organizations expending Federal awards




 Note: (1) Contained within OMB Circular A-21                                                     43
                                                                                                  44
Federal Policies, such as the Office of Management and Budget Circulars A-21
and A-110, form the process and financial framework for research administration

   Policy                            Purpose                                               Subject Matter
 OMB           Defines  the financial framework for administering     Direct  Costs                  General Provision for
 Circular       federally-sponsored research                           Facilities and                  Selected Items of Cost
 A-21          Describes the basis for calculating facilities and      Administrative Costs (i.e.,    ―Effort Reporting‖ as
                administrative (indirect) costs                         indirect costs)                 described under
               Provides a reference section for determining how to    Identification and              Compensation for
                charge specific, common costs                           Assignment of F&A Costs         personal services

 Cost          Providesguidance and parameters for Higher             501 — Estimating, accumulating and reporting costs
 Accounting    Educational institutions when accounting for costs      502 — Allocating costs incurred for the same purpose
 Standards     associated with sponsored projects                      505 — Accounting for unallowable costs

                                                                       506 — Cost accounting period

 OMB           Establishesuniform administrative requirements for     Pre-award   requirements — e.g., forms for application,
 Circular      federal grants and agreements to universities,           special award conditions, etc.
 A-110         hospitals and other non-profits                         Post-award requirements — e.g., financial
                                                                        management, cost sharing, allowable costs, period of
                                                                        availability of funds, etc.
                                                                       Property Standards — e.g., federally-owned property,
                                                                        equipment, etc.
 OMB           Establishesthe standards for obtaining consistency     Audit parameters
 Circular      and uniformity among Federal agencies for the audit     Auditor and Auditee responsibilities
 A-133         of non-profit organizations expending Federal awards    Federal Agency responsibilities




        Please see http://www.whitehouse.gov/omb/circulars/.com and The Guide for more information
                                                                                                                                  45
                                                                                                                                   44
Specific agencies and governmental entities, such as the National Science
Foundation, clarify Federal regulations applicable directly to the agency’s awards

For Example:
   The NIH Grants Policy Statement (GPS) provides specific guidelines for its grantees,
    such as the section on Research Patient Care Costs beginning on page 246 which:
     — Provides a definition of Research Patient Care Costs
     — Charges Northwestern as the grantee with responsibility for establishing rates for
        patient care costs with our clinical affiliates
     — Exempts costs of ancillary tests performed by external organizations from research
        patient care costs definition
     — May require a discussion with OSR to determine applicability to a particular award

   The National Science Foundation Grants Policy Manual (GPM) provides specific
    guidelines for its grantees, such as Section 618 which:
     — Provides NSF‘s unique definition of Participant Support Costs
     — Exempts these costs from F&A
     — Prohibits rebudgeting out of this cost category
     — Prohibits federal employees from receiving such support


                    NIH Grants Policy Statement can be located at
                      http://grants.nih.gov/grants/policy/nihgps/
        National Science Foundation Grants Policy Manual can be located at
            http://www.nsf.gov/pubs/manuals/gpm05_131/gpm05_131.pdf                         45
                                                                                            46
Federal Demonstration Partnership gives designated universities more freedom to
manage Federal awards by streamlining/ eliminating certain requirements

Federal Demonstration Partnership (FDP) Highlights:
A cooperative initiative among federal agencies and institutional recipients of
 federal funds
 Established toincrease research productivity by streamlining the
 administrative process and minimizing the administrative burden on principal
 investigators while maintaining effective stewardship of federal funds
 NSF serves as the official host of participating agency documents relating to
 the FDP
 http://www.nsf.gov/awards/managing/fed_dem_part.jsp

For Example:
 FDP waives/eliminates the need for prior sponsor approval to purchase
 capital equipment

                                                                                  46
                                                                                  47
Federal Demonstration Partnership gives designated universities more freedom to
manage Federal awards by streamlining/ eliminating certain requirements



                                                                                  Select Agencies
          FDP General Requirements
                                                    ARO       DOE       EPA      NASA       NIH         NSF   ONR    USDA
 Pre-award costs (90 Days)
                                                                              Prior approval waived

 Purchase of Equipment not in the approved
                                                                              Prior approval waived1
 budget
 Subsequent no-cost extension or extension of
                                                                              Prior approval required
 more than 12 months
 Inclusion of unrecovered F&A costs as cost
                                                                                     Permitted
 sharing
 Rebudgeting among budget categories
                                                                              Prior approval waived2

 Use of electronic records to meet record
                                                                                     Permitted
 retention requirements




        The full text of the FDP terms and conditions are located at http://www.nsf.gov/home/grants/grants_fdp.htm


 Notes: (1) Army requires approval
        (2) NIH approval needed is change in scope of greater than 25% total costs                                      47
                                                                                                                        48
University policies and procedures are generally focused on establishing how NU
complies with Federal guidelines



For example:
   A-21 establishes the need for the system that we generally refer to as effort
    reporting and…
   …NIH GPS and NSF GPM further define expectations, but…
   …Northwestern has the responsibility for determining exactly how it will
    meet those guidelines and expectations via its Key Effort Reporting
    Policies
     — Issued June 2004




                                                                                    48
                                                                                    49
University policies and procedures are generally focused on establishing how NU
complies with Federal guidelines
                                                 Effort Reporting at Northwestern University
             A-21 Base Guidelines                         NIH Grants Policy Statement                        Example of How NU Complies
    Principles located under Section J.10,           Discusses more specific effort reporting           100% effort at Northwestern University is
     Compensation for Personal Services                issues, such as the definition of base salary       equal to activities related to the
                                                       when:                                               Northwestern appointment
    Guidelines discuss:
                                                                                                             — Includes: teaching, research, clinical
      — General principles, such as after-the-           —   Clinical practice compensation is
                                                                                                                care and administration
         fact confirmation                                   guaranteed by the university
                                                                                                             — Excludes consulting and other outside
      — Criteria for acceptable methods                  —   Clinical practice effort is shown on               professional activities
      — Examples of acceptable methods,
                                                             the university appointment form is
         such as:                                            paid through the university                  Northwestern University has an effort
            Plan Confirmation                                                                             reporting system in place to assist the
            After the Fact Activity Records
                                                         —   Clinical practice effort is included          effort reporting process
            Multiple Confirmation Records
                                                             and accounted for on the university‘s
                                                             effort report


                                                 Effort Reporting at Northwestern University
             A-21 Base Guidelines                            NSF Grants Policy Manual                        Example of How NU Complies
    Principles located under Section J, number       Discusses more specific effort reporting           100% effort at Northwestern University is
     10 — Compensation for Personal Services           issues, such as:                                    equal to activities related to the
                                                         —   Changes in PI or person-months                Northwestern appointment
    Guidelines discuss:
                                                                                                             — Includes: teaching, research and
      — General principles, such as after-the-               devoted to an NSF project
                                                                                                                administration/ service
         fact confirmation                               —   Contracting or transferring the NSF             — Excludes consulting and other outside
      — Criteria for acceptable Methods                      project effort                                     professional activities
      — Examples of acceptable methods,
                                                         —   How to account for NSF project
         such as:                                                                                         Northwestern University has an effort
            Plan Confirmation
                                                             effort related to meetings and                reporting system in place to assist the
            After the Fact Activity Records
                                                             conferences                                   effort reporting process
            Multiple Confirmation Records
                                                                                                                                                        49
In some cases, the terms of a grant will specify even more detailed terms,
conditions, and research administration procedures



For example:
 Northwestern  will not allow human subjects research to be performed
 until those involved have been properly trained
  — A specific grant, however, might require Northwestern to furnish
    proof of training to the NIH




                                                                             50
                                                                             51
In some cases, the terms of a grant will specify even more detailed terms,
conditions, and research administration procedures



                         Sample Variations Between Normal Procedures and Specific Grant Terms and Conditions
     Topic
                               General NU Procedure                                 Specific Grant Scenario
 Carry Forward     UnderFDP guidelines, NU does not need specific      May require approval prior to carrying forward
 Balance           approval to carry forward unobligated balances       any unobligated balances
 Human Subjects    NU requires and will not allow research to begin    May  require Northwestern to submit actual human
 Training          until those conducting and administering research    subjects training certifications of all individuals
                   involving humans have completed research             involved in performing and/or administering a
                   administration training                              particular grant, such as OSR personnel




                                                                                                                          51
                                                                                                                          52
                                                                     Policy & Procedure


For more information on Federal, agency, or University policies and procedures,
visit The Guide for Research Information — www.northwestern.edu/research/guide




                                                                                     52
                                                                                     53
                                                                                                                           Process


          OMB Circular A-110 establishes the regulatory and process basis for the research
          administration process — from the pre-award through the award close-out stage
                       Grants Administration Process Stages and Topics as defined by OMB Circular A-110
                               ―Uniform Administrative Requirements for Grants and Agreements With Institutions of
                                          Higher Education, Hospitals, and Other Non-Profit Organizations‖

               Pre-Award                                   Post-Award Administration
              Administration                                                                                     Award Close-out



          Purpose                   Standards  for financial           Purpose of Procurement             Purpose
Topics    Pre-award   policies       management systems                  Standards                          Close-out procedures
          Forms for applying        Payment                            Recipient responsibilities         Subsequent adjustments
           for Federal assistance    Cost-sharing or matching           Codes of conduct                    and continuing
          Debarment and             Program income                     Procurement records                 responsibilities
           suspension                Revision of budget and program     Contract administration            Collections of amounts
          Special award              plans                              Contract provisions                 due
           conditions                Allowable costs                    Monitoring and reporting
          Certifications and        Period of availability of funds     program performance
           representations           Insurance coverage                 Financial reporting
                                     Federally-owned and exempt         Retention and access
                                      property                            requirements for records
                                     Supplies and other expendable      Purpose of termination and
                                      properties                          performance
                                                                         Termination
                                                                         Enforcement




                                                                                                                                       53
                                                                                                                                       54
                                                                                                                   Process


Pre-Award Administration begins when an Investigator decides to develop a
proposal and concludes with a proposal is officially awarded or rejected
                    Grants Administration Process Stages and Topics as defined by OMB Circular A-110


      Pre-Award
     Administration                                Post-Award Administration                          Award Close-out




                            Six to Nine Months
 Development                  Agency Review



                   JIT

Submit Proposal    Revised Budget              Award
                               Pre-Award Costs
       Submit Proposal     Just-in-Time (JIT)    Revised Budget                 Pre-Award Costs             Award
      PI/Dept. prepare        At agency request,      PIrevises and then     PIsubmits OSR-2     OSR establishes
      proposal and obtain       PI submits:             submits budget to       form to OSR          account
      official unit               — IRB and ACUC        OSR
                                                                                OSR  establishes    Department
      approval                      approval letters
                                                        Aims may need to       pre-spending         encumbers correct
                                  — Documentation
        submits proposal
      PI                                               be revised              account              salary amounts to
                                    of human
      packet to OSR                                                                                  be charged to
                                    subject             Only   required if:
                                                                                                     account
      OSR   endorses               education
                                                       Original proposal not
                                  — Other support
      Proposalsubmitted                                fully funded and
      to sponsor                                        Requested by
                                                        sponsor
                                                                                                                             54
                                                                                                                    Process


Post-Award Administration can involve multiple budget periods covering
additional proposals, reports, and renewal submissions


    Pre-Award
   Administration                                  Post-Award Administration                            Award Close-out




                              1st Budget Period           2nd Budget Period       3rd Budget Period      No Cost Extension




                                       Progress Report                             Supplement          Competing Renewal
                    Verify   if required by sponsor                           Usuallyagreed upon     Submittedthrough
                                                                               by PI and sponsor       OSR as if were a new
                    PI/Dept. ensure OPRS approvals are current and
                                                                                                       proposal
                    submitted to OSR with Continuation Proposal                Submitsupplemental
                                                                               proposal to OSR         PIneeds new OPRS
                    OSR-100     if required by sponsor
                                                                                                       protocol regardless of
                                                                                                       original expiration
                                                                                                       date

                                                                                                                                55
                                                                                                                     Process


Award Close-out involves the submission of several reports detailing the results
and outcomes of an award


     Pre-Award
    Administration                              Post-Award Administration                                Award Close-out




                                                                                                         Close-out Process



                                                                                                  Final Reports:
                                                                                                   Progress
                                                                                                   Financial
                                                                                                   Invention
                                                                                                   Equipment


                            Progress                 Financial                   Invention                   Equipment
                                                        Sponsor Requirements Differ

                      PIsubmits directly to    Completed   by ASRSP      Submitted to OSR,           Completed   by ASRSP
                      sponsor                                               which verifies with
                                                                            TTP
                                                                           OSR submits directly
                                                                            to Sponsor

                                                                                                                                56
                                                                                                                                                Process


The research administration process can be further broken down into a life cycle
composed of five stages, each of which contains sub-stages and several topics


         Pre-Award
        Administration                                       Post-Award Administration                                               Award Close-out



                                                         Roles and Responsibilities Related to Research Projects


          Grant                                     Proposal/ Protocol
                                                                               Award Acceptance and              Managing and
 Administration Proposal Development and Budget    Review, Approval and                                                                Award Close-Out
Life Cycle Stage                                                                 Establish Account             Monitoring Projects
                                                        Processing




                                                  Grant Administration Life Cycle Stages
                         One                        Two                              Three                             Four                  Five
                Proposal    Proposal                                      Award                                    Managing            Award
                Development Review,                                       Acceptance                               and                 Close-out
                and Budget  Approval                                      and Account                              Monitoring
                            and                                           Establishment                            Projects
                            Processing

                                                                                                                                                          58
                                                                                                                                                      Process — Stage I


  The Proposal Development and Budget Stage discusses how to prepare a proposal
  consistent with sponsor policies and regulations


                                                                    Roles and Responsibilities Related to Research Projects


             Grant                                             Proposal/ Protocol
                                                                                          Award Acceptance and              Managing and
    Administration Proposal Development and Budget            Review, Approval and                                                              Award Close-Out
   Life Cycle Stage                                                                         Establish Account             Monitoring Projects
                                                                   Processing




             Grant                                                    Initial
                          Research Idea          Proposal
Administration Life                                                 Compliance
  Cycle Sub-Stage         Formulation            Creation
                                                                      Review


          Selected • Funding Resources    • Proposal             • Federal
           Topics
                       – External           Preparation and        Demonstration
                         Funding            Submission             Partnership                                    Specific Training Discussion Topics
                         Resources        • Facilities and         (FDP) Terms
                       – Key Dates/
                         Forms for
                                            Administration/        and Conditions                                  Use of Human Subjects
                                            Indirect Cost        • US Export
                         External
                                            Rate                   Control Laws
                         Agencies
                                          • Award Staffing         Information and                                 Use of Animals
                       – Internal
                         Funding          • Use of Human           Guidelines
                         Resources          Subjects             • External Agency                                 Export Control Laws
                      • Grant Writing     • Use of Animals         Policies and
                        Resources                                  Guidelines
                                          • Clinical Trials                                                        Working with Industry
                                          • Social/
                                            Behavioral
                                            Research




                                                                                                                                                                      58
                                                                                                                                              Process — Stage II


The Proposal Review, Processing, and Approval Stages ensure proposals meet
sponsor requirements thereby increasing competitiveness


                                                               Roles and Responsibilities Related to Research Projects


          Grant                                           Proposal/ Protocol
                                                                                     Award Acceptance and              Managing and
 Administration Proposal Development and Budget          Review, Approval and                                                              Award Close-Out
Life Cycle Stage                                                                       Establish Account             Monitoring Projects
                                                              Processing




                                     Grant          Research
                                                                            Proposal
                        Administration Life     Administration Unit
                          Cycle Sub-Stage                                  Submission
                                                     Review


                                  Selected • Preproposal              • Completed
                                   Topics Review, Proposal              Proposals                          Specific Training Discussion Topics
                                                Review and            • Useful Data for
                                                Endorsement             Proposal                            Proposal Submission
                                              • Safety                  Submission
                                                Enforcement           • Electronic
                                                Policy                  Proposal
                                                                                                            Principle of Endorsement
                                              • Conflicts of            Submission
                                                Interest and                                                Safety Enforcement
                                                Conflicts of
                                                Commitment
                                                                                                            Conflicts of Interest/ Commitment




                                                                                                                                                               59
                                                                                                                                         Process — Stage III


The Award Acceptance and Establish Account Stage discusses how an award is
established and when work can begin on an award


                                                           Roles and Responsibilities Related to Research Projects


          Grant                                     Proposal/ Protocol
                                                                                 Award Acceptance and              Managing and
 Administration Proposal Development and Budget    Review, Approval and                                                                Award Close-Out
Life Cycle Stage                                                                   Establish Account             Monitoring Projects
                                                        Processing




                                                               Grant                                  Account
                                                  Administration Life     Award Acceptance
                                                    Cycle Sub-Stage                                   Creation


                                                             Selected • Negotiating and       • Object Codes
                                                              Topics Accepting                  and Account
                                                                          Agreements            Related
                                                                        • General Award       • Pre-Spending on
                                                                          Administration        Sponsored
                                                                          Procedures            Accounts
                                                                        • Establishing        • Criteria for
                                                                          Sponsored Project     Defining
                                                                          Accounts              Sponsored
                                                                                                Projects Versus
                                                                                                Gifts




                                                         Specific Training Discussion Topics
                                                          Pre-spending
                                                          Gifts versus Grants
                                                                                                                                                          61
                                                                                                                                                Process — Stage IV


The Managing and Monitoring Projects Stage includes the on-going management
of an award, including how to account for cost sharing and other topics


                                                        Roles and Responsibilities Related to Research Projects


          Grant                                    Proposal/ Protocol
                                                                              Award Acceptance and              Managing and
 Administration Proposal Development and Budget   Review, Approval and                                                                        Award Close-Out
Life Cycle Stage                                                                Establish Account             Monitoring Projects
                                                       Processing




                                                                                           Grant           Award Financial Management
                                                                              Administration Life
                                                                                Cycle Sub-Stage                   Award Management

            Specific Topic Highlights                                                    Selected • General Award Administration Policies
                                                                                          Topics and Procedures
     Cost Sharing
                                                                                                    • Revised Proposal     • Equipment
                                                                                                      Budgets                Policies/
     Effort Reporting                                                                              • Fiscal Obligations     Fabricated
                                                                                                      and Costing            Equipment
                                                                                                                             Policy
     Independent Contractors/                                                                        Principles
                                                                                                    • Cost Sharing/        • Component
      Consultants                                                                                     Matching Policy        System Policy
                                                                                                    • Effort Reporting     • Travel
                                                                                                                             Requirements
     Travel Requirements                                                                           • Independent
                                                                                                      Contractors/         • Released Funds
                                                                                                      Consultants            Policy
     Released Funds



                                                                                                                                                                61
                                                                                                                                                                62
                                                                                                                                               Process — Stage V


The Award Close-Out Stage discusses what to do when an award is completed or
relinquished


                                                        Roles and Responsibilities Related to Research Projects


          Grant                                    Proposal/ Protocol
                                                                              Award Acceptance and              Managing and
 Administration Proposal Development and Budget   Review, Approval and                                                                      Award Close-Out
Life Cycle Stage                                                                Establish Account             Monitoring Projects
                                                       Processing



                                                                                                                          Selected   • Award Transfer and
                                                                                                                           Topics      Relinquishment by
                                                                                                                                       Northwestern




                                                                                                             Specific Topic Highlights
                                                                                                     Award Close-out Process
                                                                                                     Equipment Inventory




                                                                                                                                                              62
                                                                                                                                                              63
                                                                                           Process


OSR utilizes several forms spanning the research administration process



                      Key Research Administration Forms Utilized by OSR
     Form                                              Description
OSR-1          Proposal Submission Form
OSR-CT         Submission Form for Clinical Trials
               Request For Review and Approval of Proposed Action Related to a Pending Proposal Or
OSR-2
               Sponsored Project
OSR-3          Proposed Internal Budget for a Sponsored Project
OSR-4          Award Transfer or Relinquishment
OSR-6          Request to Issue a New Subagreement
OSR-7          Request to Modify a Subagreement
OSR-100        Significant Financial Interest Disclosure
VA MOU         University V.A. Joint Appointment Memorandum of Understanding




            OSR Forms page: http://www.research.northwestern.edu/osr/forms.html

                                                                                                     63
                                                                                                     64
                                                                                                     Safety Enforcement


NU’s safety enforcement policy helps ensure compliance with safety regulations,
maintain NU eligibility for Federal funding, and promote a safe workplace

                 Office for Research Safety — Safety Enforcement Policy Highlights
            ISIS                   Enforcement                    Punishment                  Responsibility
   The Principal               Non-compliant                Flagrant disregard of       Department chairs,
    Investigator is              laboratories may be           the University safety        center directors, and
    responsible for              closed until                  policies may result in       directors of other
    completing ISIS and          compliance can be             the permanent loss of        facilities are
    may assign a ―Safety         confirmed                     laboratory privileges        responsible for
    Designate‖                                                                              ensuring compliance
                                Personnel representing
                                                                                            with University
   Laboratory annual            the Office for Research
                                                                                            policies
    review is initiated          may enter non-
    through ISIS                 compliant laboratories                                    Departments may be
                                 to remove any                                              held liable for
   Registrations for
                                 hazardous materials                                         — The financial cost
    RDNA use, Lasers,
                                                                                                of removing
    Radioactive Materials,
                                                                                                hazardous
    and Select Agents are
                                                                                                materials
    submitted using ISIS
                                                                                             — Any damages
                                                                                                caused by failure to
                                                                                                comply with safety
                                                                                                policies

               Please contact the Office for Research Safety for further detail
                                                                                                                     64
                                                                                                                    122
                                                                                          Safety Enforcement


The Integrated Safety Information System (ISIS)


               Office for Research Safety — Safety Enforcement Policy Highlights
               ISIS                        Reviewers                            Process
   Principal Investigator‘s       Laboratory Safety               PI submits ISIS information
    Basic Information               Specialist (LSS)
                                                                    ORS staff reviews
   Safety Evaluation Wizard       Laser Safety Officer (LSO)
                                                                    Committee reviews
   Safety Forms and               Radiation Safety Officer         registrations (as applicable)
    Registrations                   (RSO)
                                                                    Laboratory Worker reviews
   Registration Review            Biological Safety
                                                                    Laboratory Annual Review
                                    Professional (BSP)
   Laboratory Worker Review                                         scheduled
                                   Radiation Safety
   Laboratory Annual Review
                                    Committee (RSC)
                                   Recombinant DNA Safety
                                    Committee (RDNASC)



      Contact ORS for access to ISIS: http://www.isis.northwestern.edu/
                                                                                                          65
                                                                                                         123
                                                                                    OPRS/IRB/ACUC


OPRS, the IRB and the ACUC participate with researchers in the shared
responsibility for ensuring the protection and/or welfare of research subjects



                  Responsibility for Ensuring the Protection
                    and/or Welfare of Research Subjects
                                      Office for the Protection of Research Subjects
                                                          (OPRS)
                                   OPRS ensures ethical and humane research practices,
                                    protects subjects from unnecessary discomfort or
                                    harm, and protects the researcher and the University
       Principal                        Administrative                  Administrative
      Investigator                        Support                         Support

                                    Institutional Review           Animal Care and Use
                                        Board (IRB)                Committee (ACUC)
                                   Provides oversight of         Provides oversight of
                                    human subject research         animal research and use




                                                                                                66
                                                                                               112
                                                                                OPRS/ IRB


Principal investigators need to have approval to conduct research that involves
human subjects


                                        IF                                   THEN
                     Performing                   Involving Human        File Application
                                        AND
                      Research                        Subjects             with OPRS


                 Research is a                  Human subjects
Definitions       systematic                      means living
                  investigation                   individual(s) about
                  designed to develop             whom a researcher
                  or contribute to                obtains:
                  general body of                   — Data through
                  knowledge                           intervention or
                                                      interaction with
                                                      the individual
                                                             OR
                                                    — Identifiable
                                                      private
                                                      information

                                                                                             67
                                                                                            113
                                                                                                     OPRS/ IRB


There are three types of review for human subjects research — Exempt,
Expedited and Convened IRB

                                           Types of IRB Reviews
 Review Type                          Description                                         Example
Exempt            Briefer application, ensuring compliance with              Existing data
                   Belmont principles usually approved by OPRS staff
                                                                              Program evaluation
                                                                              Publicly available data



Expedited         One or more IRB panel members reviews and makes            Noninvasive collection of
                   the required determination rather than requiring            biological specimens
                   review by full Committee
                                                                              Research on group characteristics
                  Used for minimal risk projects when research is in an       or behavior
                   approved category
                                                                              Survey interviews (when not
                                                                               exempt)
Convened          Minimal risk research not in pre-approval categories       Survey regarding unlawful
IRB                                                                            behavior
                  Research that is more than minimal risk
                                                                              ―Flooding‖ experiments
                                                                              Medical drug and device studies


                                                                                                                  68
                                                                                                                 114
                                                                                          OPRS/ IRB


The IRB’s shared responsibility for research involving human subjects involves
ensuring research plans have adequate safeguards
Shared Responsibilities for Research Involving Human Subjects

                                            Institutional


                                IRB Responsibility PI/ Research Team
                                                    Responsibility
                          Review and approve
                                                     Ensures approved protocol
                      Require modification of, or
                                                      is followed consistently
                          Disapprove research
                                                     Direct Responsibility for
                           involving humans or        safeguarding subjects
                           identifiable information
                           obtained from them        Prompt reporting of
                                                      UPIRSOS


                                           Responsibility
Specific IRB Responsibilities
   Protect the rights and welfare of human research subjects
     — Risks are reasonable in light of potential benefit
     — Ensures equitable selection of subjects
     — Ensures the consent process is adequate to preserve autonomous decision-making
   Assist investigators and the NU research community to minimize risk to the subjects
   Achieve compliance with federal, state and institutional regulations
                                                                                                       69
                                                                                                      115
                                                                                                                     OPRS/ IRB


The OPRS/ IRB review and approval process encompasses five main stages from
application submission to approval
 OPRS/ IRB Submission Process



                                                                                      Determination
    PI submits new                      Distribution routing                         whether research            Study
                      OPRS pre-review        for review                                                        approved
      application                                                                    meets criteria for
                                                                                        approval




                                                               Major Modifications
                                                                   Required
          Bubble Color Legend                                                                  Minor Modifications
                                                                                                   Required


                                                                                       Modification
    PI Action is        OPRS/ IRB                                                                         Review of required
                                                                                       required for
     Required             Action                                                                          minor modifications
                                                                                         approval




                                                                                                                                  70
                                                                                                                                 116
                                                                                                      OPRS/ ACUC


The ACUC’s shared responsibility for research involving animals involves
ensuring Northwestern faculty and staff use animals in a humane manner
Shared Responsibilities for Research Involving Animals
                                                  Institutional


                                  ACUC Responsibility PI/ Research Team
                              Ensures research plan has Responsibility
                               adequate safeguards        Ensures protocol is
                                                           followed consistently
                               CCM Responsibility         Direct responsibility for
                                    Ensures animals       treatment of animals
                                     receive proper care

                                                 Responsibility
 Specific ACUC Responsibilities
    Review, require modification of, and approve all research and other activities involving animals
    Confirm assessment of alternative methods which:
      — Replaces animals
      — Refines procedures, and/or
      — Reduces animal numbers or animal distress

    Ensure that investigators, research technicians, animal care personnel, and others are adequately trained to
     conduct research with animals in a proper and humane manner
    Review the institution’s animal care and use program, central and satellite facilities, and PI
     laboratories, at least once every six months                                                                    71
                                                                                                                    117
                                                                                  OPRS/ ACUC


The ACUC has formal committee structure, which incorporates key stakeholders
and viewpoints into the approval process




       ACUC Committee Structure


         Chairman                         ACUC Committee Members and Backgrounds

                                          16   full-time faculty members
                                         3   Non-affiliated Community members
           Vice-
         Chairman                        3   voting Veterinary members
                                         4   alternate Veterinary members
                       4 Alternate       1Ex-officio member from the Office for
        20 Committee   Committee
          Members       Members           Research
                                         3   IACUC Consultant specialists:
                                                   Office for Research Safety
                                                   Primate Specialist
                                                   Breeding – Transgenic specialist


                                                                                                72
                                                                                               118
                                                                                                                                            OPRS/ ACUC


 The OPRS/ ACUC review and approval process encompasses five main stages
 from application submission to approval
     OPRS/ ACUC Review and Approval Process1



                                         Application                  Application is               Application may
        PI submits the                                                                                                               Application
                                     reviewed by OPRS/                  assigned to
       study application                                                                         require clarification
                                     ACUC coordinator               Designated2 or Full                                              is approved
         to the ACUC                                                Committee3 review
                                                                                                   or modification
                                      for completeness



                                                                                                                    If Necessary

                                                                                                     Application is
                                                                                                                               Revised application is
                                                                                                   returned to the PI
                 Bubble Color Legend                                                                for revisions and
                                                                                                                               returned to the ACUC
                                                                                                                                    for re-review
                                                                                                      resubmission

                                                                                                                  Process continues until
          PI Action is                  OPRS/ ACUC                                                                Reviewers are satisfied
           Required                       Action




Notes: (1) The ACUC Review and Approval Process can only begin after all personnel listed on the protocol have completed the necessary basic training and are
           enrolled in the Occupational Health and Safety Program..
       (2) Designated Review is a standard, non-deadline review involving two panel members (one faculty member and a veterinarian). Any committee member
           may request full committee review if deemed necessary.
       (3) Full Committee review is automatically conducted when primates are involved, certain food and water restrictions, or special review items are planned.
           The review involves a primary and secondary reviewer presenting the protocol to the full committee at a convened ACUC meeting.                    73
                                                                                                          OPRS/ ACUC


The normal and competing renewal approval process for research involving
animals has a few complexities, which requires added administrative vigilance
                                                                                                  Case Study

             Situation                                    Problem                      Resolution and Outcomes
  Sponsored project funding                  An ACUC        protocol                  Forthe fourth and fifth
  approval period is for five                     ―approval‖ gap exists for             years, submit:
  years                                           the fourth and fifth years             — A new protocol for
                                                  of the funding period                     review by the ACUC
        pursue a competing
  PI will
                                                                                            toward the end of the
  renewal to extend project                   How    to deal with:
                                                                                            third funding period
                                                   — Different approval
         involves vertebrate
  Project                                                                               — Include a copy of the
                                                     cycles
  animals                                                                                   third year progress
                                                   — Different approval
  ACUC   protocol is                                process                                report with submission
  approved for the standard                                                             For any competing
  three year period                                                                     renewal, follow the same
                                                                                        process except submit
                                                                                        protocol prior to initiation
                                                                                        of funding

                               Funding Approval                    5 yrs                          5 yrs


                         ACUC Approvals 1 and 2            3 yrs               2 yrs


                         ACUC Approvals 3 and 4                                            3yrs               2 yrs
                                                                                                                       74
                                                                               OPRS/ ACUC


Activities and responsibilities of the ACUC



Annually the ACUC reviews approximately:
          175-200 new protocols
          190- 220 de Novo protocols
          360-400 Addenda
          350-395 Personnel modifications
Semi-annually, the ACUC schedules teams and inspects approximately:
          Central Facility site:        Evanston 92                    Chicago 125
          Investigator Laboratories:    Evanston 60                    Chicago 204
          Approved Satellites:          Evanston: 7 satellites for 3 PIs
                                        Chicago: 25 satellites for 20 PIs
The IACUC is also responsible for reviewing, semi-annually, the training and
education records of every individual associated with the care and use of animals.
                                                                                             75
                                                                                            121
                                                                             CCM


Center for Comparative Medicine


Centrally administered animal resource:


   Provides housing and care for laboratory animals in CCM facilities (CH
    & EV), or in facilities administered by academic departments (with
    CCM providing primary care and oversight)


   Provides training to research staff in the care & use of animals




                                                                                   76
                                                                                CCM


Center for Comparative Medicine - Monthly Protocol Bill


Monthly bill composed of three categories of charges:


   Animal orders


   Per diem charges - standard daily animal care that includes housing, feed
    & bedding


   Special services – separation due to overcrowding, vet/drug supplies,
    surgical services, Animal Care Technician or Animal Health Technician
    assistance, van transportation, etc.




                                                                                      77
                                                                                     CCM


Center for Comparative Medicine - New Billing Format



Added & enhanced features:


   Billing Summary on last page


   Graphs showing daily census counts for entire billing month


   Capability to send bills via email to multiple individuals; i.e., PI, Business
    Administrator, Lab Manager, Financial Assistant, etc.




                                                                                           78
                                                                  CCM


Center for Comparative Medicine - Sample Census Graph



                                                        PI Name


                     2008-0123




                                                                        79
                                                                                    A-21


OMB Circular A-21 establishes the cost principles for universities and governs the
direct and indirect charging of costs to sponsored awards


OMB Circular A-21 Content Highlights
   Defines direct versus indirect (i.e., F&A) costs
   Defines guiding principles of reasonableness, allowability, allocability, and
    consistency
   Identifies the allowability of specific types of costs — i.e., Section J
   Includes Cost Accounting Standards (―CAS‖)
   Establishes the F&A rate development methodology
   Drives NU policies




                                                                                           80
                                                                                           65
                                                                          Cost Principles


OMB Circular A-21 states that sponsored project costs are comprised of allowable
direct costs plus the allocable portion of allowable indirect costs

Total Sponsored Project Cost Formula



           DIRECT                          INDIRECT                    TOTAL
           COSTS                             COSTS                     COSTS



             Direct Costs                      Indirect Costs
       Costs that can be                 Costs incurred for
        identified specifically            common or joint
        with a particular                  objectives that cannot be
        sponsored activity and             identified readily and
        with a high degree of              specifically with a
        accuracy                           particular sponsored
                                           project




                                                                                            81
                                                                                            66
                                                                                              Cost Principles


Direct and indirect costs allocable to sponsored agreements are comprised of
many different kinds of costs from many different areas of the University



                    Subcontracts                                Secretary
               (both direct and F&A)                             Salary          OSR
            PI                            Lab      Scientific       Office        Cost
          Salary                        Supplies   Journals         Phone        Studies
                     Specialized
                     Equipment
                                                    Office         ASRSP            Library
          Fringe
          Benefits                                 Computer
                                      Post-doc
                                      Salaries                                   Building
                   Animals                         Dept. Chair       Custodial
                             Travel                  Time            Services




                      DIRECT                                       F&A
                      COSTS                                       COSTS
                                                                                                                82
                                                                                                                67
                                                                        Cost Principles


Four key principles help determine whether direct and indirect costs can be
charged to a sponsored agreement


 OMB Circular A-21 Charging Guiding Principles




                      Reasonable                 Allocable



                       Allowable                 Consistent




                                                                                          83
                                                                                          68
                                                                         Cost Principles


Reasonableness is determined by the prudent person test — i.e., are the nature and
charge amount not excessive and within the bounds of common sense



 OMB   Circular A-21:
  — A cost may be considered reasonable if the nature of the goods or
    services acquired or applied, and the amount involved therefore,
    reflect the action that a prudent person would have taken under the
    circumstances prevailing at the time the decision to incur the cost
    was made (Section C.3)




                                                                                           84
                                                                                           69
                                                                                                    Cost Principles


Reasonableness is determined by the prudent person test — i.e., are the nature and
charge amount not excessive and within the bounds of common sense (cont’d)

 OMB Circular A-21 Definition                   Test                  Reasonableness Test Questions
A cost may be considered                    Common            Is the cost generally recognized as necessary for
reasonable if the nature of the             Practice           the operation of the institution or the
goods or services acquired or                                  performance of the agreement?
applied, and the amount involved
                                                              Did the individuals involved act with due
therefore, reflect the action that a
                                                               prudence under the circumstances?
prudent person would have taken
under the circumstances                     Rules,            Is the cost consistent with the requirements
prevailing at the time the decision         Regulations        imposed by arms-length bargaining, federal or
to incur the cost was made                  and Terms          state laws and regulations, and the agreement‘s
(Section C.3)                                                  terms and conditions?
                                                              Are the actions consistent with established
                                                               institutional policies and practices?
                                            Perception        How would it look if published in the Tribune?
                                                              Is it consistent with ethical business practices
                                                               and applicable laws?



 If a charge fails any one of these tests, it is probably not a a reasonable charge for a sponsored agreement

                                                                                                                      85
                                                                                                                      70
                                                                          Cost Principles


Allocability is determined by whether or not a cost benefits a particular sponsored
agreement



 OMB     Circular A-21:
   —   A cost is allocable to a particular cost objective if the goods or
       services involved are chargeable or assignable to such cost
       objective in accordance with relative benefits received or other
       equitable relationship (Section C.4.a)




                                                                                            86
                                                                                            71
                                                                                                         Cost Principles


Allocability is determined by whether or not a cost benefits a particular sponsored
agreement (cont’d)


           OMB Circular A-21 Definition                                      Determinants of Allocability
 A cost is allocable to a particular cost objective if            Cost incurred solely to advance the work under
 the goods or services involved are chargeable or                  a sponsored agreement
 assignable to such cost objective in accordance
                                                                  Benefits both the sponsored agreement and
 with relative benefits received or other equitable
                                                                   other work of the institution, in proportions that
 relationship (Section C.4.a)
                                                                   can be approximated through use of reasonable
                                                                   methods
                                                                  Necessary to overall operation of the institution,
                                                                   and is assignable, in part, to sponsored projects




   Key Point
                        An appropriate method should be used to allocate the costs of bulk
                        purchases to individual projects

                                      Appropriate                              Inappropriate
                             Allocate based on a reasonable          Allocate based on the number of
                              estimate of actual consumption           grants in the department

                                                                                                                           87
                                                                                                                           72
                                                                         Cost Principles


Allowability of direct and indirect costs is determined by OMB Circular A-21 as
well as sponsor, University, and award-specific policies



 Certaintypes of costs are deemed unallowable, as either direct or
 indirect costs of sponsored projects.
 Allowability:
  — A-21 Section J.1-50 (General provisions for selected items of cost)
  — Agency-specific policy (e.g., NIH Grants Policy Statement)
  — University policy (e.g., Travel & Entertainment Policy)
  — Terms & conditions of individual awards




                                                                                           88
                                                                                           73
                                                                         Cost Principles


Allowability of direct and indirect costs is determined by OMB Circular A-21 as
well as sponsor, University, and award-specific policies (cont’d)


Examples
   A-21 Section J:
     — Most advertising costs
     — Alcohol
     — Fundraising activity
     — First class airfare

   Agency-specific policy:
     — NIH salary limitation

   University policy:
     — Employee morale costs

   Award-specific terms & conditions:
     — Some grants prohibit foreign travel


                                                                                           89
                                                                                           74
                                                                         Cost Principles


Consistency is determined by how costs are treated in similar circumstances — i.e.,
like costs cannot be direct charged in one case and indirectly in another



 OMB Circular A-21:
  —   All costs incurred for the same purpose, in like circumstances, are either
      direct costs only or F&A costs only . . . but cannot be both (Section
      C.11.a)

  —   Purpose of the standard (Appendix A, CAS 9905.502):
        to ensure that ―each type of cost is allocated only once and on only one
         basis to any sponsored agreement or other cost objective.‖
        ―…necessary to guard against the overcharging of some cost objectives
         and to prevent double counting (which occurs most commonly when
         cost items are allocated directly to a cost objective without eliminating
         like cost items from indirect cost pools which are allocated to that cost
         objective).‖



                                                                                           90
                                                                                           75
                                                                                                 Cost Principles


Using a case study can help illustrate when costs must be considered a part of the
institution’s indirect cost recovery vs. when they can be directly charged to a grant


                   Background             Activity Type        Appropriate Action               Lesson
                Paperfor a             Routine                NOT OK    to          Costsare not:
                Research Grant —        administrative task     directly charge per      — An unusual
                must print final                                CAS & University           circumstance
 Scenario I     technical report and                            direct charge            — Greater in
                other general                                   policy; charge to          amount than
                correspondence                                  non-sponsored              usual
                                                                account
                                                                                       Are recovered
                                                                                       through the F&A
                                                                                       rate

                   Background             Activity Type        Appropriate Action               Lesson
                Paper for a            Unique to nature of    OK to directly        Costsare:
                Research Grant —        project (greater in     charge per CAS &         — An unusual
                develop and print       amount or different     University direct          circumstance
 Scenario II    mass number of          in purpose than is      charge policy            — Substantively
                surveys to evaluate     typical)                                           greater amount
                clinical outcomes                                                          than usual
                                                                                       Canbe direct
                                                                                       charged
                                                                                                                   91
                                                                                Charging


To determine whether to charge an award for a particular cost, faculty and staff
can follow a simple decision process


   Decision Process for Direct Charging an Award



                                                                        Charge the
    Reasonable?          YES         Direct or              DIRECT      cost to the
    Allowable?                        F&A?                           award using the
     Allocable?                    (consistency)                       appropriate
          NO                              F&A                         expense object
                           Charge a non-sponsored account
                              (dept operating account)




                                                                                           92
                                                                                           77
                                                                                         Charging


There are four cost accounting standards (CAS) applicable to universities, as well
as a requirement to submit and maintain a Disclosure Statement (DS-2)



              Historic Perspective                        Cost Accounting Standards
    Historically, CAS were applied to           Number                Subject Matter
     commercial government contractors and
                                                  501        Consistency in estimating,
     focused on issues of consistency
                                                              accumulating and reporting costs
    19 standards apply in the commercial
     environment                                  502        Consistency in allocating costs
    Four adopted for universities, which have                incurred for the same purpose
     been incorporated into A-21
                                                  505        Accounting for unallowable costs



                                                  506        Cost accounting period




                                                                                                    93
                                                                                                    78
                                                                        Charging


The Disclosure Statement — i.e., DS-2 — describes how the University accounts
for its costs including its indirect cost allocation methodology



DS-2 Highlights
   Describes University‘s cost accounting practices
   Is reviewed and approved by DHHS, the University‘s cognizant agency
   Must be updated and resubmitted to DHHS whenever practices change
    — NU‘s original submission was in December 1996
    — Two revisions since December 1996 (latest in January 2006)




                                                                                   94
                                                                                   79
                                                                        Charging


OMB Circular A-21 outlines the methodology for developing the Facilities and
Administrative (F&A) rate



Facilities & Administrative (F&A) Rate Calculation Formula


                       Indirect Costs Supporting
                         Organized Research
                                                   =      51.0% 1
                       Direct Costs of Organized
                               Research




 Note: (1) Current negotiated rate
                                                                                   95
                                                                                   80
                                                                           Cost Sharing


Cost sharing occurs when a cost specifically benefits a sponsored project but is not
charged to that project


   The University or some other entity bears the cost
     — Normally in the form of a direct cost, such as salary or capital equipment
     — With sponsor approval, may take the form of F&A costs where reimbursement is
       waived or reduced
     — Cost sharing = ―matching‖




                                                                                          96
                                                                                          81
                                                                                  Cost Sharing


There are three types of cost sharing, with the differences between the types
affecting how we account for cost sharing


Mandatory:
 Cost sharing that is required by sponsors as a matter of statute, regulation or policy, or
  is indicated in individual solicitations

Voluntary Committed:
 Cost sharing that is not required by sponsors, but is offered by PIs in proposals
   — If included in proposals, becomes a commitment that must be met upon award


Voluntary Uncommitted:
 Cost sharing that is not required by a sponsor, nor offered in a proposal but which
  occurs in the course of executing the project, primarily in the form of actual effort
  greater than committed effort
   — January 2001 OMB clarification: voluntary uncommitted cost sharing does not
      have to be included in F&A rate base




                                                                                                 97
                                                                                                 82
                                                                                           Cost Sharing


We must both track and be able to verify cost sharing in University records,
regardless of the form it takes


 Any form of cost sharing represented in a proposal‘s budget/ budget justification becomes a
 commitment upon award that must be met and tracked for sponsor verification in the
 University‘s records

                           Cost Sharing Requirements                  Cost Sharing Calculation

                      Salary cost sharing tracked through:
                        — Effort reports
  Salary Costs
                        — In some cases, salary charges on
                           designated cost sharing accounts
                      A PI with mandatory or voluntary        Effort         Effort   Effort Not
                       committed salary cost sharing                     =           +
                                                              Reported       Charged    Charged
                       MUST report cost sharing on their
                       effort report
                         — Includes cost sharing due to NIH
                           salary cap

                                                                                            i.e., Cost
                      Non-salary cost sharing tracked                                      Shared
Non-Salary Costs
                       through ―Grants-Matching‖ expense
                       object (8799) or, charges on
                       designated cost sharing accounts


                                                                                                          98
                                                                                                          83
                                                                       Cost Sharing


OMB Circular A-110 describes certain requirements to which we must adhere
when managing cost sharing

Cost Sharing Requirements
   Verifiable from the recipient‘s records
   Not included as contributions for any other Federally-assisted project or
    program. (In other words, you cannot count institutional cost sharing more
    than once against a Federally funded sponsored project)
   Necessary and reasonable for proper and efficient accomplishment of
    project or program objectives
   Allowable under applicable cost principles
   Not paid by the Federal Government under another award, except where
    authorized by Federal statute to be used for cost sharing or matching
   Provided for in the approved budget when required by the Federal awarding
    agency
   Conform to other provisions of OMB Circular A-110, as applicable
                                                                                      99
                                                                                      84
                                                                                Cost Sharing


There are specific, unacceptable forms of cost sharing




Unacceptable Forms of Cost Sharing
   Costs funded by other sponsored projects
   Costs pledged as cost sharing for another funded project
   Otherwise unfunded salary for effort beyond the contractual appointment period —
    e.g., nine months
   Costs reimbursed through the F&A rate, including cost of construction or renovation
    of University buildings, except in rare circumstances and with express approval
   Salary dollars above a regulatory cap (e.g. NIH salary cap)
   Any costs not deemed to be necessary and reasonable for the proper and efficient
    accomplishment of project or program objectives




                                                                                               100
                                                                                                85
                                                                                 Cost Sharing


Accounting for cost sharing fulfills several important objectives




Importance of Accounting for Cost Sharing
   Ensures NU can provide documentation/ verification that mandatory and voluntary
    committed cost sharing obligations have been met
   Ensures proper classification of costs in F&A rate calculation (mandatory and
    voluntary committed cost sharing must be included in the base [denominator])
   Provides valuable management information in the form of accurate financial
    accounting (reporting of full research costs)




                                                                                                101
                                                                                                 86
                                                                                            F&A Rate


There are four major functions of a higher education institution of which
organized research is one


                                          Higher Education Activities
                                                           Other Sponsored    Other Institutional
          Instruction           Organized Research
                                                           Activities (OSA)    Activities (OIA)



                       All research and development
                        activities of an institution that are
                        separately budgeted and accounted
 Today’s Focus
                        for including:
                         — Sponsored   Research
                         — ―University‖   Research

                   Definitions
                       Sponsored Research — ―all research and development activities that are
                        sponsored by Federal and non-Federal agencies and organizations”
                       ―University‖ Research — ―all research and development activities that are
                        separately budgeted and accounted for by the institution under an internal
                        application of institutional funds”
                                                                                                       102
                                                                                                        87
                                                                                   F&A Rate


Through the Facilities and Administrative (F&A) rate, the federal government
reimburses the University for indirect costs supporting organized research



Facilities & Administrative (F&A) Rate Calculation Formula

                           Indirect Costs Supporting
                              Organized Research
                                                          =        51.0% 1
                           Direct Costs of Organized
                                   Research


Facilities & Administrative (F&A) Rate Highlights
      Provides the reimbursement basis for NU‘s indirect expenses — i.e., those costs that
       cannot be identified specifically with a sponsored project or other major function
      Based on a periodic calculation and submission of a rate proposal, which is then
       negotiated with Northwestern‘s cognizant agency (DHHS)


    Note: (1) Current negotiated rate
                                                                                              103
                                                                                               88
                                                                         F&A Rate


A-21’s F&A rate development methodology involves the assignment and allocation
of NU’s direct and indirect costs to the University’s major functions
                                                                   Illustration

F&A Rate Development Methodology per OMB Circular A-21

                          Indirect Cost Assignment
                               and Allocation



                                            Other         Other
                            Organized
            Instruction                   Sponsored    Institutional
                            Research
                                          Activities    Activities

                            Direct Cost Buckets


                                                                                    104
                                                                                     89
                                                                                 F&A Rate


The F&A Rate calculation formula has two major components with the resulting
rate expressed in the form of a ratio


              The ―Pool‖
               Comprised of individual indirect

  Component
                cost components
    Detail       — Facilities costs
                 — Administrative costs
               Based on allocations of actual costs
                                                                   The Ratio
                                                                    For every $1.00
                   Indirect Cost ―Pool‖                              recovered in direct
                                                       =   51.0%     research costs, NU
                    Direct Cost ―Base‖                               is eligible to recover
                                                                     another $0.51 in
                                                                     indirect costs
              The Base
               Typically expressed as modified
  Component     total direct costs (MTDC), but may
    Detail      be TDC or salaries & wages
               Based on actual costs charged to
                research accounts


                                                                                            105
                                                                                             90
                                                                                 F&A Rate


As its name would suggest, the F&A cost pool is comprised of two types of costs:
Facilities related and Administrative related costs

               Facilities Related Costs              Administrative Related Costs
   Building Depreciation/ Use Allowance        General Administration (GA)
                                                  — e.g., President, HR, Budget Planning
   Equipment Depreciation/ Use Allowance
                                                    and Accounting Services
   Interest
                                                Department Administration (DA)
   Operations & Maintenance                      — e.g., Deans offices and departmental
                                                    offices
   Library
                                                Sponsored Projects Administration (SPA)
                                                  — e.g., VP Research, OSR, Cost Studies,
                                                    ASRSP, and Research Safety
                                                Student Services




                                                                                            106
                                                                                             91
                                                                                          F&A Rate


There are four primary steps involved in the F&A rate calculation…


 F&A Rate Calculation Process Steps

                                                                                Divide:
       Assign                           Remove             Allocate
  expenditures to                  unallowable costs   allowable pool                 F&A costs
 pools and bases by               from pools (See A-   costs to major             allocated to OR1
   function code                     21 Section J )       functions
                                                                                   MTDC of OR1



                                                            Modified Total Direct Costs (MTDC)
                                                         Equal to total direct costs, less:
                                                            — Capital equipment
                                                            — Patient care
                                                            — Graduate student tuition remission
                                                            — Rent
                                                            — Scholarships & fellowships
                                                            — Telecom & Networking Charges
                                                            — Subcontract amounts > $25,000




 Note: (1) Refers to Organized Research
                                                                                                     107
                                                                                                      92
                                                                                                                      F&A Rate


…with step three being the most complicated


 F&A Rate Calculation Process Steps

                                                                                                          Divide:
       Assign                             Remove                             Allocate
  expenditures to                    unallowable costs                   allowable pool                        F&A costs
 pools and bases by                 from pools (See A-                   costs to major                    allocated to OR1
   function code                       21 Section J )                       functions
                                                                                                            MTDC of OR1




                                            Indirect Cost Pool Allocation Detail
 Indirect Cost Pool      Allocation Basis                                    Allocation Basis Detail
Facilities             Square   Feet            Allocation Statistic is equal to Sq Ft used for each Major Function divided
                                                  by Total Assignable Sq Ft
Administration         ModifiedTotal Cost of               Major Function                               Allocation
                       each major function
                                                 General   Administration                 University-wide   MTC
                                                 Department    Administration             School/   Department MTC
                                                 Sponsored    Projects Administration     Sponsored   project MTC

                                                 Student   Services                       Allocated   100% to Instruction


                                                                                                                                 108
                                                                                                                                  93
                                                                                    F&A Rate


F&A costs are distributed to the major University activities using space and MTC
allocation metrics


                      Allowable                                Allowable
                  Facilities Related                        Administrative
                Indirect Costs $150M                      Indirect Costs $50M

                       Space                                MTC & Other
                    Allocations                              Allocations



         $30M                                                                     $6.25M
                    $21M   $52.5M      $21.5M   $22.5M        $1.25M   $45M




          $51.0M               $74.0M                    $23.75M              $51.25M

        Organized                                Other Sponsored       Other Institutional
        Research            Instruction             Activities             Activities
      $100M MTDC           $200M MTDC
                                                  $10M MTDC              $90M MTDC

                                                                                               109
                                                                                                94
                                                                          F&A Rate


In this example, the calculated F&A rate for organized research grants is 51.0%,
resulting from $51.0M divided by $100M MTDC organized research base



                   Allowable                        Allowable
               Facilities Related                Administrative
             Indirect Costs $150M              Indirect Costs $50M

                Space                   MTC & Other
             Allocations                 Allocations
           20% to Research             42% to Research

      $30M
                  $21M



     $51.0M F&A
                      = 51.0% Research F&A Cost Rate
       Organized
       Research
     $100M MTDC
                                                                                     110
                                                                                      95
                                                                                  F&A Rate


Generally, NU requires sponsored projects to carry the applicable negotiated F&A
rate because of the financial impact of recovering those costs


Reality of F&A Rates (and the negotiation process)
   Negotiated rate is almost always less than the actual calculated rate
     — Even if all sponsors paid the applicable negotiated rate, NU isn‘t fully recovering
       its actual F&A costs

Importance of Maximizing F&A Recovery
   Assessing the F&A rate represents recovery of costs already incurred by the
    University, which benefited the sponsors
   F&A recovery is a critical component of the University‘s budget and necessary to
    support a sustained investment in the research enterprise




                                                                                             111
                                                                                              96
                                                                            Cost Transfers


A cost transfer is the act of moving a charge from one account to another

                                                                     Illustrative




             Account 1                            Account 2
                          Charge




                                                                                         112
                                                                                          97
                                                                                                        Cost Transfers


The need for a cost transfer must reflect adherence to federal cost principles and
must be well-documented

          Cost Transfer Guiding Principles                       Cost Transfer Documentation Standards
   Cost transfers are for correcting ERRORS                  Transfers must be supported by full explanation
                                                               and justification, as well as a certification of the
   Cost transfers should NOT be used as a means of
                                                               propriety of the transfer
    managing available cash balances
                                                                — Principal Investigators must sign off on all
   Project funds are NOT interchangeable                          transfers over 90 days
     — The integrity of each grant account must be
                                                              Explanations such as ―to correct error‖ or ―to
        maintained
                                                               transfer to correct project‖ are not sufficient
   Fundamental reasonableness, allowability,                    — Generally, you need to answer the question
    allocability, and consistency of costs must still be           ―WHY‖ you are making the transfer rather
    established                                                    than merely explaining ―WHAT‖ you are
                                                                   doing
   Costs allocable to several projects CANNOT be
                                                                 — ASRSP may call you for further details and/or
    charged solely to a single project
                                                                   return the RAC to you to address an
   Costs not allocable to a project CANNOT be                     insufficient explanation
    charged to that project, even temporarily
                                                              Documentation submitted with the transfer should
                                                               include documentation of the original charge such
                                                               as the ledger sheet or purchase order
                                                              Transfers from one object code to another should
                                                               only be made in order to accurately reflect the
                                                               nature of the expenditure

                                                                                                                      113
                                                                                                                       98
                                                                                    Cost Transfers


Cost transfers must be performed within a reasonable amount of time from the
initial charge — the NIH and the University have set standards



               NIH                           Northwestern




   Must be made within          Must be made within 90 days of the
    90 days after the error       original charge using a Request for
    is discovered                 Accounting Correction (RAC) form
                                 Transfers of salary charges should
                                  take place prior to certifying effort*    Recertification
                                                                           of effort reports
                                 90-day Exception Letter needed for        is an audit flag
                                  cost transfer requests submitted after   and may require
                                  90 days                                      additional
                                                                               approvals
                                 ASRSP must review and approve
                                  transfers greater than 90 days
                                 Requests to transfer costs onto
                                  sponsored accounts greater than 12
                                  months from the original date of
                                  incurrence will generally not be
                                  approved
    Note: (*) In most cases                                                                      114
                                                                                                  99
                                                                                          Cost Transfers


There are four key steps to follow when requesting a cost transfer


    Cost Transfer Justification and Documentation Steps

                                                           Draw a correlation         Document and
        Provide a                   Explain the            between the initial         maintain all
        reason for                   purpose of              charge and the               relevant
       the transfer                 the transfer          account to which it      information related
                                                          is being transferred        to the transfer

    Key Data to Consider:
   State why the               State what the              Establish a direct
    transfer needs to            entry is intended to         benefit to the
    be made                      accomplish                   account (project)
                                                              to be charged
   Detail an
    explanation of
    how the error
    occurred




                                                                                                       115
                                                                                                       100
                                                                                 Cost Transfers


Cost transfer justifications should include four components, which together
provide a complete and accurate explanation and rationale to a reviewer


   Why the entry is being made
     — Lab supplies (test tubes) that were charged 100% to sponsored project X should
       have been split 50/50 between sponsored projects X and Y
   Explanation of how the error occurred
     — A data entry error caused the lab supplies in question to inadvertently be charged
       to only one account
     — The error was discovered during a regular review of the charges on the award
       (sponsored project X)
   What the entry is intended to accomplish
     — This cost transfer entry is intended to correct the error by moving exactly 50% of
       the charges from sponsored project X to sponsored project Y
   Establishment of direct benefit to new project
     — As the test tubes were used in equal proportions between the projects, the transfer
       of 50% of the charges will align the costs with the benefits for each project


                                                                                              116
                                                                                              101
                                                                            Cost Transfers


There are several cost transfer practices, which will raise ―red flags‖ to auditors



 Transfers   made in excess of 90 days after the original charge
 Transfers  without a full explanation or ―cookie cutter‖ explanations
 (e.g., ―to correct error‖)
 High   volume of transfers
         in timing (i.e., near end of project period) and ―route‖ (mostly
 Patterns
 onto, and rarely off of sponsored accounts) of transfers
 Transfers   among ―closely related‖ projects




                                                                                         117
                                                                                         102
                                                                        Cost Transfers


Establishing pre-award accounts, when appropriate, can prevent the necessity of
making cost transfers


 Pre-award accounts allow  the PI to begin work and record charges against the
 proper account related to a project before the start of the award
 Costs are   incurred at the institution‘s or department‘s risk
 The PIrequests account from OSR and submits an OSR-2 form, explaining
 the need and supplying a detailed budget




                                                                                     118
                                                                                     103
                                                                                  Program Income


Program income is gross income earned that was directly generated by the grant-
supported activity or earned as a result of the award


     Examples of Program Income
    Fees for services performed,
     such as laboratory tests
    Money from the use, sale, or
     rental of equipment purchased
     with project funds
    Sale of supplies or equipment
     purchased or fabricated with                      Recipient organizations to account
     project funds                        Federal      for program income related to
                                        Expectations   projects funded in whole or in part
    Sale of software, tapes or
     publications                                      with Federal funds
    Sale of research materials, such
     as animal models, vectors, or
     reagents
    Fees from participants at
     conferences or symposia
    Royalties from patents and
     copyrights

                                                                                              119
                                                                                              104
                                                                                  Program Income


Program income is generally used in one of two primary ways with management
responsibilities falling to PIs and the Controller’s Office


                Usage Guidelines                       Management Responsibilities
   Additive: Added to grant funds to further      Position                  Detail
    project objectives unless otherwise         PI/                Monitor and report
    stipulated by the awarding agency           Administrator       program income
      — Use before requesting additional cash
        payments                                                   Deposit into project
                                                                    account
   Used to finance the non-Federal share of
    the project — i.e., Overdraft
   Subtractive: Decreases the Federal share    Controller’s       Help determine whether
    of costs contributed to the project         Office              income constitutes
                                                                    program income
   No obligation to the Federal government
    for income earned after the project‘s end                      Help educate with respect
    unless indicated in the award                                   to reporting requirements




                                                                                              120
                                                                                              105
                                                                           Program Income


Now that you know what program income is, we need to distinguish it from cost
sharing


          Program Income                               Cost Sharing



       Gross income earned                         Cost sharing occurs
       that was directly                           when a cost
       generated by the grant-                     specifically benefits
       supported activity or          VS.          a sponsored project
       earned as a result of the                   but is not charged to
       award                                       that project




                                                                                       121
                                                                                       106
                                                                                         Recharge Centers


Recharge centers refers to the recurring activities of an NU unit for which that
unit receives a fee in exchange for providing specialized goods and/ or services


Recharge Center Highlights
   Definition
     —   Activities of a unit that provides goods and/ or services of a specialized nature to
         Northwestern users on a recurring basis and charges a fee for those goods and/ or services
         that is borne by either sponsored or non-sponsored CUFS accounts

   Purpose
     —   Increase procurement efficiency or convenience
     —   Good and/ or service may not otherwise available

   Customers
     —   Primarily Northwestern faculty, staff, and students
     —   External customers are allowed on an incidental basis only

   Identification Criteria
     —   Good and/ or service is being provided on a recurring basis primarily to NU users
     —   Costs of providing the good and/ or service are recovered through fees to users
     —   Typically, but not always, there is value added by personnel in providing the good and/ or
         service
                                                                                                       122
                                                                                                       107
                                                                                 Recharge Centers


Recharge center management requires specific accounting and administrative
activities


Required Recharge Center Accounting and Administrative Activities
   Document/calculate cost-based rate(s) and publish price(s)
   Adhere to the federal cost accounting requirements in determining rate(s) and price(s)
    and seek review/ approval by Cost Studies
   Establish and maintain a separate Fund 0024 CUFS account to capture expense and
    revenue activity
   Establish and maintain a separate Capital Reserve Account, if equipment depreciation
    is reflected in the prices charged to users
   Have an acceptable method/ system for tracking actual usage
   Bill customers on a timely basis
   At least annually, analyze surplus/ deficit position (actual expenses versus actual
    revenues)
   Retain records to support charges (7 years)
                                                                                               123
                                                                                               108
                                                                                                Recharge Centers


Recharge service center rates are based on the A-21 costing principles and must
adhere to key rate development and process guidelines
Recharge Service Center Rate Development Overview

              Costs                               Rate Development                          Review
    Service center costs must              Rates must be designed to              Surplus/ deficit analysis
     be appropriate as direct                recover no more than the total          must be prepared and, if
     costs and meet the                      cost of the service over a long-        necessary, rates adjusted
     guidelines of                           term period                             annually for consistency
     allowability, allocability,                                                     with a long-term cost
                                            Charges to users must be based
     reasonableness and                                                              recovery plan and goal of
                                             on the actual use of the services
     consistency to be                                                               breaking even
     charged to sponsored                   Charges to users must be
     projects                                equitable, with no internal user
                                             subsidizing another University
                                             user



                                        Residuals (Surpluses) and Deficits
                                      Should be carried forward into the next
                                       year‘s rate calculation
                                        — 60 days‘ working capital does not
                                           need to be carried forward for
                                           surpluses
                                                                                                              124
                                                                                                              109
                                                                              Recharge Centers


Service Center Directors have primary recharge service center management
responsibility with other University offices and units in support



                                                    Office of Financial
                   Service Center
    Role                                            Ops/ Cost Studies
                      Director




    Resp.
                  Manages routine                Assists in development
                   operations
                                                  Reconciles capital
                  Prepares rates and              equipment information
                   tracks financial
                   performance                    Reviews and approves
                                                   rate calculations
                  Administers
                   billing and                    Monitors billings and
                   collection                      rates for reasonableness
                   activities                      and timeliness
                                                  Helps correct non-
                                                   compliant practices
                                                  Establishes/ monitors
                                                   adherence to policy                      125
                                                                                            110
                                                                        Recharge Centers


Recharge center policies, step-by-step procedures, and reference material can be
found on the Cost Studies website


     http://www.northwestern.edu/coststudies/recharge.html


   Recharge center and Pass-Through Activity Guidelines
   Calculation of Recharge Center Rates
   Recharge centers A to Z (seminar slides and reference material)
   FY08 Standard Templates




                                                                                      126
                                                                                      111
                                                                                                                    Budgeting


PIs need to submit three forms and several pieces of documentation to OSR in
order for the NIH grant application review process to begin

                                                                                                                    Initial
                                                                          Other Support
   Completed                           Support                                                                    Application
 Internal Forms          +          Documentation              +          Documentation              =             for OSR
                                                                          (If Necessary)
                                                                                                                    Review



 Internal Forms                         Support Documentation1                       Other Support Documentation
 OSR-1              If not Grants.gov:                  If Grants.gov                Collaboration     and Consultant
                     Hard copy proposal                  SFR424 (R&R)                 Letters
 OSR-100            Form PHS398:                        Grant Application Package
                       Face page/Signature Page         Administrative Shell         Subcontract    documents
 OSR-3  (at time      Abstract page                      Site Performance               —   Budget
  of award)            Budget: initial and total year      Locations                      —   Budget justification
                        or modular budget page             Other Project
 OSR-CT    (for                                                                           —   Statement of Work
                          If non-modular budget—           Information
  non-NIH                  provide full budget             Senior/Key Personnel           —   Consortium letter from
  clinical trials)         justification                   PHS398 Cover Page                  other Institution‘s
                          If modular budget                Supplement                         research office
                           required — utilize              PHS398 Checklist
                           modular budget tabulator        PHS398 Modular or
                     Biosketches                            R&R Budget
                       Resources                          Subaward Budget
                       Checklist                           Attachment
                       Agency Guidelines
                          If RFA/PA




Note: (1) For NIH Grants.gov submission, completed Pure Edge application package must be submitted to OSR using Depot,
        along with all other required forms                                                                                     127
                                                                                                                                149
                                                                                           Budgeting


There are two types of NIH budgets —Modular and Detailed



                  Category                                      Detail
                 Purpose        Details project costs based on number of modules of $25,000
                                Used when direct costs (less consortium F&A) are less than
                                 $250,000 per year
 NIH Modular
   Budget        Download       Part of NIH Form 398 and SF424 (R&R) application
                                http://www.research.northwestern.edu/osr/forms.html#NIH




                  Category                                      Detail
                 Purpose        Details project costs and personnel roles for non-modular awards
                                Used when
 NIH Detailed                     —   NU is the subcontractee
   Budget
                                  —   Direct costs exceed $250,000 in a single year
                 Download       Part of NIH Form 398 and SF424 (R&R) application
                                http://www.research.northwestern.edu/osr/forms.html#NIH

                                                                                                       128
                                                                                                       150
                                                                                              Budgeting


  The NU Modular Budget Tabulator is an internal form that provides OSR with
  additional budget detail for NIH Modular Budgets




                     Category                                     Detail
                   Purpose         Assist PI in determining number of modules to request for modular
                                    awards
  NU Modular                       Computes F&A costs for NIH checklist
Budget Tabulator   Campus          On-campus
                   Selection       Off-campus
                   Process         Submit to OSR — not NIH
                   Download        http://www.research.northwestern.edu/osr/forms.html#NIH




                                                                                                          129
                                                                                                          151
                                                                       Budgeting


The NU Modular Budget Tabulator’s top portion details costs exempt from the
F&A rate and subcontracts…




     Costs
   Exempt
  from the
 F&A Rate




Subcontracts




                                                                                   130
                                                                                   152
                                                                             Budgeting


…while the bottom portion details costs subject to the F&A rate as well as
information for the NIH checklist


Costs Subject
  to the F&A
         Rate




      Information
      for the NIH
         Checklist




                                                                                         131
                                                                                         153
                                                                            Budgeting


The NIH Modular Budget page has two basic parts — the top portion for
requested direct costs and the bottom portion for limited budget justification




   Requested Direct
          Costs and
   Personnel Details




     Limited Budget
       Justification is
limited to personnel,
   subcontracts, and
      explanation for
 variance in modules
            requested
                          PHS 398 (Rev. 04/06)


                                                                                        132
                                                                          Budgeting


The NIH Detailed Budget provides details on the first year budget, with the top
section detailing personnel, consultant and equipment costs…




   Personnel




  Consultants
  Equipment




                                                                                      133
                                                                                      155
                                                                              Budgeting


  …and the bottom section detailing other costs including supplies, travel, patient
  care, alterations/ renovations, other, and consortium/ contractual costs



          Supplies


            Travel
     Patient Care
            Costs
    Alterations &
     Renovations

  Other Expenses
        Consortium/
        Contractual
(i.e., subcontracts)




                                                                                          134
                                                                                          156
                                                                                        Budgeting


Grants.gov provides a single interface for all Federal grant-making agencies to
announce and receive applications for grant opportunities
                                 Grants.gov Submission Process
 Step                                          Description
  I     Notify your OSR Grant and Contract Officer of your intent to submit an application via
         Grants.gov
  II    Download   the PureEdge Application Viewer
           —Free software package that will allow you to complete and submit applications
           electronically and securely on Grants.gov
 III    Findand Download the appropriate Funding Opportunity Announcement (FOA) in
         Grants.gov
 IV     Submit   the OSR-1 and OSR-100 to OSR
  V     Complete   the Application package
 VI     Upload   your application to the NUIT Depot WebFile server, using instructions provided
         by OSR
           —Depot is a Northwestern web-based file sharing tool. Due to technical constraints,
           applications should not be forwarded to OSR via e-mail.
 VII    OSR   reviews application package and requests any necessary revisions. PI confirms
         final application version. OSR submits to Grants.gov before deadline.

                                                                                                    135
                                                                                                    157
                                                                                                   Budgeting




NIH is making the transition to the SF424 (R&R) form and electronic submission
through Grants.gov




                                                                        Dates below are now TBA…




                                                        R01
                                                        (Feb 5, 2007)




       Available at: http://era.nih.gov/ElectronicReceipt/files/Electronic_receipt_timeline_Ext.pdf


                                                                                                               136
                                                                                                               158
                                               Budgeting




NSF FastLane vs. Grants.gov




   Solicitation will specify whether to use
    Grants.gov or FastLane
   No collaborative proposals or any with
    subawards through Grants.gov




                                                           137
                                                           159
                                                                                                                     Budgeting


Depending on PI salary and effort commitment, salary costs can be a major
component of cost sharing…
                                     NU Effort Commitment/ Cost Sharing Guidelines
                 NU requires PI effort on all applications1
                 If effort is not charged to the project, the department must agree to pay the amount of
                  salary proportional to the amount of effort contributed to the project (voluntary
                  committed cost sharing)
                 If any personnel on an application are paid a salary rate that exceeds any salary cap, the
                  department must cost-share salary that is above the cap

                                             NIH Salary Cap Details
    The salary cap is based on a 12-month appointment, so if an investigator‘s appointment is less than 12
     months, a proportionately lower cap applies


        NIH Salary Cap Details                                        NIH Salary Cap Calculation Example
     Appointment Length        Cap                    Cap Calculation
                                                                                        Cap Calculation                 Result
                                                   Necessary Information
         12 Months          $191,300
                                                     12 Month Cap —
         11 Months          $175,358                  $191,300
                                                                                = ($191.3/12 Months) x 9 Months      = $143,475
                                                     PI Appointment
         9 Months           $143,475                  Length — 9 Months



Note: (1) Exceptions include equipment and instrumentation grants, doctoral dissertation grants, student augmentation grants,
         and institutional/individual training grants (for faculty mentors)                                                      138
                                                                                                                                 160
                                                                                         Budgeting


…with some NIH K awards having special effort / cost sharing considerations




     K Award          At least 75% effort
   Requirements       Generally maximum of $75,000 for PI salary



    Overlapping       If the K award recipient is working on other projects that have
      Goals            overlapping goals with the K award, effort may overlap




                                                                                                     139
                                                                                                     161
                                                                                             Budgeting


Effort for all personnel must be included in all proposals, NIH now uses a
different measurement methodology from past proposal submissions




Previous Method:
Include the
percentage of effort
each project
member will devote
to the project




Current Method:
Include the number
of months of effort
each project
member will devote
to the project


                    NIH created a Percent Effort to Person Months Calculator located at:
                   http://grants1.nih.gov/grants/policy/person_months_conversion_chart.xls
                                                                                                         140
                                                                                                         162
                                                                                                  Budgeting


Fringe benefit information must also be included in the Budget Justification for all
budgets except for modular NIH budgets


                    Fringe Costs Statements to Add to All Proposal Budget Justifications
                     Federal Awards                                   Non-Federal Awards
       Employee benefits have been calculated based      Employee benefits have been calculated based
        on the following DHHS approved rates:              on the following DHHS approved rates:
         — 09/01/07 – 8/31/08 .... 22.4%                    — 09/01/07 – 8/31/08 .... 24.0%
         — 09/01/08 – 8/31/09 .... 21.9%                    — 09/01/08 – 8/31/09 .... 24.1%
         — 09/01/09 – 8/31/10 .... 23.5% (projected)        — 09/01/09 – 8/31/10 .... 25.3% (projected)
         — 09/01/10 – 8/31/11 .... 24.3% (projected)        — 09/01/10 – 8/31/11 .... 26.2% (projected)
         — 09/01/11 – 8/31/12 .... 24.9% (projected)        — 09/01/11 – 8/31/12 ….26.9% (projected)




                            DHHS Approved Exceptions to Fringe Costs Above
                      Graduate Students                               Statutory Rate
                    Time Period               Rate                 Time Period                Rate
          09/01/07 – 08/31/08                 1.7%     09/01/07 – 08/31/08                    6.7%
          09/01/08 – 08/31/09                 1.7%     09/01/08 – 08/31/09                    6.6%
          09/01/09 – 08/31/10 (projected)     1.7%     09/01/09 – 08/31/10 (projected)        6.7%
          09/01/10 – 08/31/11 (projected)     1.7%     09/01/10 – 08/31/11 (projected)        6.8%
          09/01/11 – 08/31/12 (projected)     1.7%     09/01/11 – 08/31/12 (projected)        6.8%
                                                                                                              141
                                                                                                              163
                                                                                                      Budgeting


Follow three steps when determining fringe benefit costs for sponsored research
projects…

             Action 1                                Action 2                                 Action 3
            Identify the                           Identify the
            Appropriate                                                                       Multiply
                                                  Start Date &                             Fringe Rate by
            Fringe Rate
             Based on                            Corresponding                               Applicable
            Employment                           Composite Rate                            Salary Amount
               Type


                                            The Composite Rate is the rate used      Fringe Cost = Fringe Rate x
                                             in Calculations.                           Applicable Salary Dollars
   Review the OSR web site for the         Review the OSR web site for the
    appropriate rate:                        Benefit Rate Composite table:
    http://www.research.northwestern.        http://www.research.northwestern.ed
    edu/osr/docs/FY08_Fringe_FA_me           u/osr/docs/fringe_composite.xls
    mo.pdf
     — Federal vs. Non-Federal
     — Full vs. Statutory vs. Graduate
        School Student




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                                                                                                                  164
                                                                                                        Budgeting


…while paying close attention to the third step

                                                          Action 3
                                                       Multiply
                                                    Fringe Rate by
                                                      Applicable
                                                    Salary Amount



                                    Group One                        Group Two                 Group Three
                                   Full Rate                     Statutory Rate        Graduate School Student Rate
 Fringe Benefit Cost   =                x                   +           x          +                x
                           Full Benefit Eligible Salary         Temporary Salary         Graduate School Salary


                              Full Benefit Eligible
                               Salary includes
                                — Faculty
                                — Postdocs
                                — Technicians
                                — Other professionals




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                                                                                                                    165
                                                                                                 Budgeting


Consultants have special budgeting considerations and cannot be another
Northwestern University faculty or staff

    Consultant     A consultant or independent contractor is an individual hired to give professional
    Definition     advice or services for a fee but not as an employee of the University



   Include regardless of whether or not paid
   List names, institutional affiliations
     — Include consulting physicians and those serving on external advisory committees

   Describe services to be performed in the budget justification
   Include:
      — Number of days
      — Rate of compensation
      — Travel
      — Per diem
      — Other related costs

   Note: For NSF awards made after March 15, 2006, there is no maximum daily consultant rate so
    long as rate is reasonable
      — If award terms and conditions are dated prior to March 15, 2006, then NSF maximum daily
        consultant rate of pay is $537.00
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                                                                                                             166
                                                                                              Budgeting


Other direct costs used in budgets include equipment, computer charges, rental/
lease charges and other expenses


   Equipment
     — Individual cost of $5,000 or more & a useful life of at least one year

   Other Expenses should be itemized by category and unit cost
     — Animal care
          Per diem and number of days
     — Patient travel
     — Human subjects payments
     — Publication costs
     — Computer charges
     — Rental and leases of, for example, equipment and space
     — Equipment maintenance and service contracts
     — Tuition



                               See sponsor guidelines to determine allowability of certain
        Important               types of expenses
       Consideration           There are often restrictions on the amount of funding for
                                equipment and travel

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                                                                                                          167
                                                                                                Budgeting


Research Assistant Scholarship (RAS) allows graduate student RAs supported by
sponsored projects to have a portion of their tuition charged directly to projects
                      The Graduate School covers the balance of tuition via an RAS only if the
                       sponsored project carries full F&A rate
                      Minimum stipend level to receive the RAS is $1,686/month for 2007-08
                      Tuition is not charged F&A
                      The maximum amount awarded by the NIH for the support of a graduate
                       student on a research grant or a cooperative agreement is equal to the zero
   Important
 Considerations        level National Research Service Award (NRSA) Postdoctoral Fellow
                       stipend in effect at the time the grant award is issued
                         — Currently $36,996 (Current stipend amounts can be found at
                           http://grants2.nih.gov/training/nrsa.htm)
                         — The amount provided for compensation includes salary or wages,
                           fringe benefits, and tuition remission


                                      Academic year 2007-08 Tuition Charges to
                                    Sponsored Projects Carrying the Full F&A Rate
                                             Student Type               Cost per Quarter
                                   Full-registration                          $3,156
                                   588, 598, and 599 Registrations            $3,117
                                   503 Registrations                          $1,104
                                   See http://www.tgs.northwestern.edu/docs/RAS_Form_0708.doc
                                                                                                            146
                                                                                                            168
                                                                                 Budgeting


Consortium / contractual — i.e., subcontracts — require additional paperwork
when included in a proposal

   Subcontractor organization must be identified in budget justification
   Work to be performed by the subcontractor must be described in a Statement of Work
   Subcontractor organization‘s OSR office must provide an approved detailed and
    multi-year budget
     — Budget must include both direct and indirect costs

   Subcontracts from NU-affiliated organizations must also be detailed in this manner
    and include:
     — Northwestern Medical Faculty Foundation (NMFF)
     — Northwestern Memorial Hospital (NMH)
     — Evanston Northwestern Healthcare (ENH)
     — Children‘s Memorial Hospital (CMH)
     — Rehabilitation Institute of Chicago (RIC)
     — Veteran‘s Administration (VA)

   Subcontract F&A is not included in the NIH direct cost limits — i.e., $250,000
    Modular & $500,000 non-Modular — but is included in the NU MTDC calculations

                                                                                             147
                                                                                             169
                                                                                                   Budgeting


The F&A rate must be included in the Budget Justification for all proposal
budgets — except NIH — or the checklist page for NIH proposals


          F&A Rate Statements to Add to All Proposal Budget Justifications or NIH Checklist page
                    Federal Awards*                                    Non-Federal Awards
      F&A has been calculated based on the following      F&A has been calculated based on the following
       DHHS approved rates:                                 rates:
        — 51.0% MTDC….09/01/07 – 8/31/08                      — 55.2% MTDC….09/01/07 – 8/31/08
        — 51.0% MTDC….09/01/08 and thereafter                 — 55.2% MTDC….09/01/08 and thereafter
          (provisional)                                         (provisional)



   *Note: The F&A rate for DOD contracts is 52.0% MTDC. This rate applies whether the funds are
       received directly from the federal sponsor or through a subcontract).


                                        On the NIH checklist page, check the following boxes:

      Special                            DHHS Agreement Dated: 03/24/08
   Considerations                        Modified total direct cost base

                                         Add above language to Explanation section


                                                                                                               148
                                                                                                               170
                                                                                                                Budgeting


Exclusions from the MTDC calculation include several object codes



                                                 Exclusions include:
                     Object Code                                 Description
                           5335           Fabricated equipment
                           5490           Space rental
                           5720           Hospital medical expenses
                       6910-6960          Telecom/ network expenses1
                       7510-7599          Capital equipment
                       8010-8080          Tuition and stipends
                           8510           Amortization
                           8650           Subcontracts in excess of the first $25,000




Note: (1) For object code 6950, only international and off-campus calling cards are allowed per Converged Communication
         Policy found at http://www.it.northwestern.edu/telephone/converge/index.html
                                                                                                                            149
                                                                                                                            171
                                                                                                        Budgeting


Follow a few guiding principles when determining facilities and administrative
costs for sponsored research projects
               Action 1                                 Action 2                             Action 3
              Calculate
              Modified                                Identify the                         Multiply
             Total Direct                             Appropriate                        MTDC by F&A
                Costs                                  F&A Rate                             Rate
              (MTDC)


   MTDC = Direct Costs - Exclusions          Review the OSR web site for         F&A Cost = MTDC x F&A Rate
                                               the appropriate rate:
                                               http://www.research.northwest
                                               ern.edu/osr/p_fa1.html
                                              Use composite rate if
                                               necessary for calculation only



                               Any agency written policies or statements limiting F&A recovery should
                                be used as part of the F&A cost calculation and included in the proposal
                               Unless specified by sponsor, the F&A base for budgets with a lower F&A
  Important                     rate should be the Total Direct Costs
Considerations                 Limitations:
                                 — Can be agency-wide or program-specific
                                 — Are most common for private foundations



                                                                                                                    150
                                                                                                                    172
                                                                                          Budgeting


As you recall, similar costs should be treated the same in like circumstances as
described in OMB Circular A-21 except for…


     Normally Unallowable Direct Costs
 Object Code             Description
    0100       Professional exempt salary
    0102       Clerical wages                                These costs are included in costs
                                                 Point One
    0112       Premium overtime wages                        reimbursed as part of NU’s F&A
    3010       Paper and office supplies
    3910       Books, periodicals and journals
                                                             If these costs were included as direct
    5030       Professional memberships          Point Two   costs, NU would then recover them
                                                             once as direct and again as F&A
    5110       Department photocopying
 5510 & 5520   Postage and shipping for other
               than technical materials
    6725       Food and entertainment




                                                                                                      151
                                                                                                      173
                                                                                              Budgeting


…unlike circumstances where the funding agency approves, the costs are
allocable, and appropriate documentation can be provided

                    Normally Unallowable Costs
                 Direct Charging Criteria                       Done
   Included in the sponsor approved budget or sponsor
    guidelines                                                  
                                                                         Costs can be direct charged
   Appropriate documentation can demonstrate a direct                   only if all criteria are met
    relationship of such charges to the scientific activities   
    of the grant and an unusual circumstance exists                                        ―Unlike
   All costs can be easily and accurately identified with                            Circumstances‖
    the particular project                                                             is the key to
                                                                                      being allowed to
                                                                                       direct charge




    Example One          Program projects and center grants and similar large, complex programs



    Example Two
                         Projects that involve extensive database accumulation, survey tabulation,
                         and/or graphics or manuscript preparation.


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                                                                                                          174
                                                                                                    Proposal Sub


There are four basic elements of the proposal submission process, which span
proposal preparation through proposal transmission…



  Proposal Submission Process


   Investigator and                                              OSR reviews
 Department prepare               Investigator                 proposal, verifies            OSR endorses and
                                submits proposal                                           transmits proposal to
 proposal and obtain                                         budget and validates
                               packet to OSR and                                           sponsor/ returns it to
     official unit                                            work scope against
       approval                   Dean‘s office                    policies                  the PI for mailing




Note: Proposals should be submitted to OSR at least FIVE business days prior to a sponsor's designated
      deadline to allow for (1) adequate review, (2) necessary corrections to be made, and (3) institutional
      endorsement




                                                                                                                   153
                                                                                                                   130
                                                                                                           Proposal Sub


…and have special considerations to keep in mind when submitting a proposal
electronically



     Items Due to OSR 5 Days Prior to Electronic Submission Deadline*
    Signed OSR-1 form and OSR-100 forms (if applicable)
    Electronic access provided to OSR for all completed sponsor forms
     except for Technical Sections, which can be in progress
    Letters of consortium, budgets and work scopes signed by institutions'
     Office for Research, if subcontracts are involved
    Letters of endorsement or any other evidence of official approvals of
     cost sharing commitments (as applicable)                            All newer electronic
                                                                                              processes, including
                                                                                              Grants.gov, require
                                                                                              five days processing
                                                                                                      time



*The research plan and associated sections may be submitted to OSR 2 days prior to the deadline.




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                                                                                                                          131
                                                                                                          Proposal Sub


OSR reviews proposals to ensure the University’s commitment to perform the
work is reasonable and maximizes the proposal’s competitiveness
             Forms                                      Format                                     Budget
   Appropriate for program/                  Correct margins, fonts, etc.              Components include:
    agency                                     are used                                    — Salary rates
   Complete, according to                    Proposal components are in                  — Fringe benefits
    guidelines                                 correct order                               — Equipment
                                              Page limitations are                        — Subcontracts
                                               followed
                                                                                           — Animal rates

                                                                                           — Travel

                                                                                           — Tuition

                                                                                           — Patient care

                                                                                           — F&A Costs

                                                                                         Appropriateness of costs
                                                                                         Math

                             Commitments of                              Compliance with
                        Cost sharing                               Sponsor policies
                        External resources (e.g.,                  Northwestern policies
                         subcontractor‘s                            The law
                         commitments)
                        PI time (effort)
                        Space
                                                                                                                         155
                                                                                                                         132
                                                                                                   Proposal Sub


Limited Submissions competitions are those that limit the number of applications
Northwestern can put forward in either a pre- or full proposal stage
                                         Limited Submissions Process
 Number           Stage                                           Highlights
    I       Announcements         Components:
                                    — Opportunity identification
                                    — Brief description
                                    — Funding agency's web site link
                                    — Internal and external deadlines
                                  Faculty must adhere to all posted deadlines
                                  Office for Research approval necessary prior to proceeding with an
                                   application
   II       Nomination            Done by responding to the announcement and sending the required
                                   information by the internal deadline to committee
                                  Two types:
                                       —Individual investigator awards
                                       —Equipment/instrumentation and multi-investigator awards

   III      Review                Performed by Faculty Standing Advisory Committee
                                  Evaluate applications against the program guidelines and review criteria
                                  Makes a recommendation regarding a nominee(s) to the Vice President for
                                   Research
   IV       Outcome               Final approval made by Vice President for Research
                                  Notification to all applicants and OSR

          The Office for Research has authority for all Limited Submissions funding opportunities
                       http://www.research.northwestern.edu/osr/funding_limited.html
                                                                                                                  156
                                                                                    Proposal Sub


Because PIs are responsible for the technical, administrative, and fiscal
management of awards, only certain people may be the PI on an award
                                              Automatically Eligible
                               Tenure-track faculty

 Includes full, associate      Nontenure-track research faculty
 and assistant professors      Nontenure-track clinical faculty
                               Instructors
                               Adjunct faculty
                               Senior research investigators (normally emeritus)
                               Librarians & curators


                                Categories of Eligibility Requiring VPR/FSM Dean
                                                      Approval
                               Visiting Scholars on case-by-case basis
                               Visiting Faculty on case-by-case basis
                               Research Associates may seek special approval
                            _______________________________
                               Postdocs not eligible
                               Research Assistants not eligible
                                                                                                   157
                                                                                                   134
                                                                                      Proposal Sub


OSR captures useful information for grants administration on their web page,
including key addresses, dates, contact names and official NU numbers
                                                                                 Illustrative




                       Visit — http://www.research.northwestern.edu/osr/useful.html



                                      On the OSR home page, users can locate
                                      useful grants administration data by
                                      clicking ―Useful data for forms‖




                                                                                                     158
                                                                                                     135
                                                                                                      Proposal Sub


OSR captures useful information for grants administration on their web page,
including key addresses, dates, contact names and official NU numbers (cont'd)
                                                                                                Examples

 Animal Assurance Number                              DUNS#                                    FEIN
   A 3283-01                               Dun and Bradstreet #                    Federal Employer
                                             (DUNS#)                                  Identification Number
   USDA Registration
    Certification 33-R-0129              Evanston Campus – 160079455                 36-2167817
                                         Chicago Campus – 005436803




                                  FWA                         Fiscal Agent/Notice of Award
                        Federal-wide Assurance                  Susan G. Ross
                         Identification Number                    Director, Evanston Campus
                                                                  Office for Sponsored
                        FWA 00001549
                                                                  Research (OSR)
                                                                  633 Clark Street
                                                                  Evanston, IL 60208-1110
                                                                  phone: 847.491.3003
                                                                  fax: 847.491.4800
                                                                  e-mail: OSR-Evanston
                                                                  @northwestern.edu                                  159
                                                                                                                     136
                                                                                                     Endorsement


Correspondence to external funding agencies requires University endorsement to
ensure the NU’s interests are protected and positions are accurately portrayed

                                            Correspondence Policy
                        Correspondence to funding agencies concerning the administration
                         of sponsored projects is reviewed by OSR grant and contract
                         officers and requires University endorsement prior to transmittal




     Endorsement Process

      PI creates                 OSR reviews                                                    OSR forwards
 correspondence,                OSR-2 form and                                                correspondence to
                                correspondence                   OSR endorses                the Funding Agency
completes an OSR-                                               correspondence
  2, and forwards               and modifies as                                              and provides a copy
    both to OSR                   appropriate                                                      to the PI




Note: If the nature of the request involves rebudgeting or an extension of time, action will be taken only after
      receipt of agency approval


                                                                                                                   160
                                                                                                                   137
                                                                                Effort Reporting


 Effort Reporting


As a recipient of federal research funding, NU is required to abide by OMB
Circular A-21 (Cost Principles for Educational Institutions)

Effort Reporting is the method by which institutions ensure salary costs, generally the
largest cost component of any grant, are charged appropriately


Effort Reporting Is Verification That:

   Appropriate salary and wage expenses were charged to sponsored programs
     — Labor represents ~ 75% of direct research costs

   Cost sharing was performed as promised
   Sponsored activity was appropriately classified in the indirect cost rate
     — Charged and Mandatory/Voluntary Committed Cost Shared effort




                                                                                              161
                                                                                              175
                                                                                           Effort Reporting




                              A-21 Effort Reporting Requirements
After-the-Fact        ―Must recognize the principle of after-the-fact confirmation or
Confirmation           determination so that costs distributed represent actual costs‖ – A21,
                       Section J. 10
                      Effort must be reported at the end of a designated time period after the
                       work is performed
Certification         Must encompass all employee activities on an integrated basis
                        — ―Reports will reflect an after-the-fact reporting of the percentage
                          distribution of activity of employees‖
                      Performed by someone using suitable means of verification that the work
                       was performed
Based on Actual       Must be of effort expended — not just salary charged (although ideally
Time Working           these are consistent)



   Charge salary based on estimate of how effort will be expended – must then verify
    how effort was actually expended and appropriateness of salary charges
   Other recipients of federal funds have more stringent methods of verifying salary
    expense (e.g., daily timecards)

                                                                                                         162
                                                                                                         176
                                                                          Effort Reporting


OIG Audit Work Plan and Findings


Compliance Reinforced by OIG:
   Certification
     — Lack of and/or incorrect reporting of effort
     — Timely reporting
     — Is labor charged consistent with effort devoted?
     — Was the certifier appropriate?
     — Account for all activities

   Commitments
     — Was the proposed effort, including Mandatory and Voluntary Committed Cost
       Share, met?
     — Are faculty over-committed?

   Other
     — Excessive and inappropriate labor cost transfers




                                                                                        163
                                                                                        177
                                             Effort Reporting


Effort Reporting - Risk of Non-compliance…




                                                           164
                                                           178
                                                                                  Effort Reporting




      Effort reporting encompasses more than just certifying effort

    Effort Reporting is how NU manages the time and salary/ wage costs associated
    with faculty and staff commitments to and on sponsored activities


                       Pre-award                              Post-award

Appointing              Preparing
Faculty &              the Proposal             Charging                   Certifying
  Staff                  Budget                  Salary                     Effort

 Employment               Effort is          Salary is charged           Effort is
    terms are              proposed, a            or cost-shared,           attested to,
   established,         commitment is             consistent with          after activity
   including #             made to the             activity either         has occurred
months (contract             sponsor            directly to grant
 period), % full         If there is a           budget or cost
time, salary base      choice, we should         sharing account
                          not volunteer
                         effort and cost
                             sharing


                                                                                                165
                                                                                                179
                                                                       Effort Reporting


Key Principle of Effort Reporting



             Principle                          Principle Detail

In a given quarter, the certified %    If salary charges are greater than
of effort must be equal to or more      effort expended, salary must be
than the % of salary charged and        adjusted
cost-shared to the grant               Adjustments to salary charges
                                        must be made before Effort
                                        Report is completed
                                       Effort commitments should be
                                        met during the budget period




                                                                                     166
                                                                                     180
                                                                                               Effort Reporting


Effort Reporting – Key Topics
   100% Effort ≠ 40 ≠ 60 ≠ 80 hours per week
     — No fixed work week
     — 100% Effort = Estimated total number of hours worked on University compensated
       activities

   Full Workload/Institutional Base Salary (IBS)
     — IBS is the annual compensation paid by an organization for an employee‘s appointment,
         whether that individual‘s time is spent on research, teaching, patient care, or other
         activities. Base salary excludes any income that an individual is permitted to earn outside
         of duties for the applicant/grantee organization (NIH Grants Policy Statement, December
         2003)
     — Effort Includes
               teaching, research and administration, and NMFF activity, if applicable
               appointments as chair, dean, and/or center director (e.g. object code 0060)
     — Effort Excludes
               outside consulting activities, activities associated with affiliated entities other than
                  NMFF
               VA compensated effort

   Faculty must certify their own effort certifications, in addition to those of their research staff;
    inappropriate for BAs/RAs to certify effort for the department
   NIH salary cap limitation


                                                                                                             167
                                                                                                             181
                                                                                   Effort Reporting


Effort Reporting – Key Topics

   Cost Transfers
     — Retroactive salary adjustments are highly discouraged for periods for which
       effort has already been certified
     — Charges to the sponsored accounts should not be higher than the certified
       Effort
   Commitment
     — Most faculty responsibilities would preclude one being paid 100% from
       sponsored projects
     — Commitment threshold
     — Special care in determining if research faculty can be charged 100%:
         Competitive proposal writing (new or renewal) and regular
          administrative duties cannot be allocated to sponsored awards
         Non-competitive, continuation award proposals (progress reports) – can
          be included as part of sponsored projects effort

   Faculty members and senior researchers must commit some effort to the
    sponsored project within the fiscal year unless specifically exempted by the
    sponsor (e.g., equipment grants)


                                                                                                 168
                                                                                                 182
                                                                                    Effort Reporting


Effort Reporting – Key Topics


   Summer effort (9-month faculty only)
     — Certification will most likely only be for sponsored activities related to
       summer salary received from sponsors
   Agency prior approvals are required if:
     — 25% reduction in time devoted to the project per budget period
       Example: 35% charged and 5% committed cost share (CCS) effort
       Reduction to 30% effort requires agency approval:
       (5% CCS and 25% charged effort)
     — Absence of 3 months or more

   Change in key personnel should be communicated to the agency and OSR
   Consistency of reporting effort: Progress reports, current pending & support
    pages, effort reports and financial status reports




                                                                                                  169
                                                                                                  183
                                                                                  Effort Reporting


Effort Reporting at NU



   At NU we report effort each academic period within federal guidelines, which
    translates to each quarter
   NU‘s policies require that effort reports be certified within 4 weeks after they
    are available for certification (usually ready 3 weeks after each quarter end)
   Refer to the FY07 effort reporting timeline for more clarification
   The interim HRIS system used in FY04 and FY05 is still active and should be
    used to complete reports for those time periods




                                                                                                170
                                                                                                184
Effort Reporting at NU


   Starting 1st quarter of FY09, PeopleSoft Chartstring will replace CUF Chartstring
    on the effort form
     — Q1 of FY09 effort forms will be generated around mid December



   PeopleSoft:
     — Mandatory Cost Share: Fund 191
     — Over-the-Cap: Fund 192



   Example:
     — An NIH award that has 5% Mandatory Cost Share and 20% Paid Effort
       Chartstring display in Effort Reporting:




                                                                                        171
                                                                                      Effort Reporting


Ten detailed effort reporting policies which can be categorized consistent with the
life cycle of the grant and supported by training

                                 10. Faculty and Administrator Training


     Preparing
                                              Charging                          Certifying
    the Proposal
                                               Salary                            Effort
      Budget
1. Basis for estimating effort          6. Prospective                    [1.Basis for estimating
   percentages and                         establishment of salary           effort percentages and
   calculating salary requests             on sponsored project (or          calculating salary
   in proposals                            cost sharing) accounts            requests in proposals]
2. Expectations regarding               7. Summer effort and              [7.Summer effort and
   faculty effort in proposals             salary for faculty with           salary for faculty with
3. Institutional stance on                 9- and 11-month                   9- and 11-month
   voluntary cost sharing                  appointments                      appointments]
4. Expectations regarding               8. Retroactive salary             9. Faculty (personal)
   extramural funding of                   adjustments                       certification of effort
   faculty academic year                                                     reports
   salary
5. Reduction of effort
   commitments when
   awarded budget is reduced
   from proposed

    Document available on http://www.northwestern.edu/asrsp/effort.html (password needed)
                                                                                                       172
                                                                                       Effort Reporting


Policy Area #1: Discusses the basis for estimating effort percentages and
calculating salary requests

For most NU faculty (i.e., those who do not hold NMFF appointments), the basis for
effort percentages indicated in proposals is the effort which relates to and is required
by an individual's NU appointment(s), including research, teaching and
administration activities
The basis for salary request calculations in proposals is that salary which
corresponds to the basis for the effort percentage estimate

                     Basis for                Activities related to
                                         =
                    100% effort                NU appointment
                                             Activities Include:
                                                Teaching
                                                Research
                                                Administration
                                                Where applicable, clinical activity

                     Consulting and outside, professional activities, are
                         excluded from the basis for 100% effort
                                                                                                      173
                                                                                Effort Reporting


Policy Area #2: Expectation for Faculty Effort in Proposals

Faculty are expected to commit some level of effort (>0%) on proposals on
which they are listed as principal investigator (PI) or key personnel, with
exceptions for certain types of proposals.


   Mentors on training grants typically do not require specific effort commitments (their
    effort will relate to their own sponsored projects)
   Faculty effort may be during the academic year, summer, or both
   The latest effort commitment continues during no-cost extensions, unless otherwise
    communicated to the sponsor
   Effort commitments may not exceed 100%, including all applicable activities. Effort
    commitments on sponsored programs typically should not equal 100%, taking into
    consideration all administration and proposal development effort
   Effort commitments to sponsors may be reduced (typically up to 25%) without prior
    notification to sponsors


                                                                                              174
                                                                                              187
                                                                            Effort Reporting


Policy Areas #3 & #4: Voluntary Cost Sharing/ Expectations for Extramural
Funding of Faculty Academic Year Salary


Northwestern University does not typically cost share on a voluntary basis.
Voluntary cost sharing commitments are to be made only where the competitive
forces and perceived institutional benefit of receiving the award are deemed to be
sufficiently strong to warrant it


If faculty expect to expend effort on sponsored projects during the academic year, a
proportionate amount of academic year faculty salary should be requested from
sponsors (to the extent that this is consistent with agency practice)




                                                                                          175
                                                                                          188
                                                                               Effort Reporting


Policy Area #5: Reduction of effort when award reduced from proposal




When an awarded budget reflects a reduction from the proposed budget, an
evaluation by the PI must occur to determine the effect on the effort commitments


   Budget cuts are becoming more common, especially with federal agencies, so it is
    increasingly important to determine how the project will be accomplished with the
    reduced funding
   In some instances, the sponsor requests a revised scope, which should include a re-
    evaluation of the proposed effort




                                                                                             176
                                                                                             189
                                                                           Effort Reporting


Policy Area #6: Prospective Establishment of Salary on Sponsored Project/ Cost
Sharing Accounts


Salary distribution should begin on sponsored projects and/ or cost sharing accounts
as soon as the project is awarded, and concurrently with actual project effort


   Use prespending accounts (easy to establish with OSR), if needed




                                                                                         177
                                                                                         190
                                                                         Effort Reporting


Policy Area #7: Summer Effort and Salary




To the extent it is required, effort certification for the period beyond the
appointment should only reflect the activity for which the faculty member is
responsible and earning salary in that period. For most faculty, summer/ research
quarter activity represents effort and salary on sponsored projects only

Faculty who receive summer salary from sponsored projects must be prepared to
certify that effort was expended on those projects during the summer in at least
the same proportion as the summer salary charged to those projects. Effort
expended during the academic year does not satisfy a commitment related to the
receipt of summer salary




                                                                                       178
                                                                                       191
                                                                            Effort Reporting


Policy Area #8: Retroactive Salary Adjustments


(closely related to policy #6)
Retroactive salary adjustments are highly discouraged for periods for which effort
has already been certified
Charges to the sponsored accounts should not be higher than the certified Effort
Journal applicable dates (“from” and “through” dates in HRIS) must correspond to
the intended original transaction
Retroactive adjustments more than 90 days past the date of the initial charge require
a detailed explanation by the PI
Retroactive salary adjustments seeking to place costs onto sponsored projects will not
be processed if the requested adjustment is more than one year after the date of the
initial charge




                                                                                          179
                                                                                          192
                                                                              Effort Reporting


Policy Area #9: Faculty Certification of Effort Reports




Faculty are required to certify (sign) their own effort reports, and also are required to
certify the effort reports of the research staff working on their sponsored projects
(graduate students, post doctoral fellows, and other similar persons)




                                                                                            180
                                                                                            193
                                                                              Effort Reporting


Policy Area #10: Training for faculty and administrators on effort reporting




All faculty and staff involved in effort reporting are expected to receive appropriate
levels of effort reporting training




                                                                                            181
                                                                                            194
                                                                                        Effort Reporting




             Central Administrator (CA)
   Initializes new Effort Reporting cycle quarterly                          Effort
   Sends notification to Departments                                         Certification
                                                                              Process in ERS
              Pre Reviewer (Business Administrator)
    •   Pre Reviews commitment and payroll distribution; makes
        adjustments (CT or CS) as needed
    •   When complete, automatic e-mail notification is sent to Certifier
        via bulk e-mail

                                     Certifier (Faculty)
              •   Certifies actual effort by award in terms of percentages of total
                  effort expended
              •   If percentages were updated, an automatic e-mail is sent to the
                  Post Reviewer

                                  Post Reviewer (Business Administrator)
                         •   Administrator Post Reviews the effort forms if the Certifier
                             made changes to the effort percentages reflected in Pre Review

                                                                                                      182
                                                                                                      195
                                                       Effort Reporting


ERS log-in screen

URL: https://ersweb.itcs.northwestern.edu/GenericERS




                                                                     183
                                                                     196
                                                     Effort Reporting


CERT (Effort Certification) main page




          CERT Tab




                                        Open work list for effort
                                        forms for which you are
                                            directly responsible

Completion status of
the department(s) you
are managing



                                                                   184
                                                                   197
                                                               Effort Reporting


Sample effort report in pre-review status (sponsored effort)




                                                                             185
                                                                             198
                                                                   Effort Reporting


Sample effort report in pre-review status (non-sponsored effort)




                                                                                 186
                                                                                 199
                          Effort Reporting


CEM options




―Manage by Individual‖
is the most common task




                                        187
                                        200
                               Effort Reporting


Sample Individual's CEM plan




                                             188
                                             201
                                                Effort Reporting


Effort Reporting Contact Information

http://www.northwestern.edu/asrsp/effort.html




                  Helpdesk Contacts:




                                                              189
                                                              202
                                                                                                     Released Funds


―Released funds‖ provide some budget flexibility and can be used to support
Northwestern’s research enterprise

               The salary portion of university-budgeted faculty academic year compensation
Released Funds remaining unobligated at fiscal year-end as the result of partial/full support
  Definition   from a sponsored award providing full University on- or off-campus indirect
               costs and fringe benefits
                                                                                                     Highlights

            Requirements for Funds Release                                     Use Expectations
   Funds to support the salary must have been included        Non-recurring costs, for example:
    in the University appropriated budget                        —   Bridging support for graduate students,
   The sponsored award must provide full University                 postdoctoral fellows, etc., when there is a
    on- or off-campus indirect costs and fringe benefits             temporary hiatus in sponsored project
                                                                     funding
   Salaries of research faculty, visiting faculty, post-
    doctoral fellows, etc., as well as exempt and non-           —   Stipend supplement with no work
    exempt staff, are not available for release                      requirement for an NRSA pre or
                                                                     postdoctoral fellow
   All of the funds to be released must be available at
                                                                 —   Fringe benefits for postdoctoral fellows
    the time of release
                                                                     supported on sponsored projects that do not
                                                                     provide fringe benefits




                                                                                                                   190
                                                                                                                   203
                                                                                     Pre-Spending


Pre-award spending allows spending on anticipated awards prior to NU actually
receiving the award with PIs/ departments bearing the financial risk


Conditions Under Which to Request the Establishment of a Pre-spending Account
   Get a head start on a federal project that is subject to Federal Demonstration
    Partnership (FDP) terms and conditions
   Begin a project on the designated start date, but prior to receiving an actual award
    notice from the sponsor




                                                                                                    191
                                                                                                    138
                                                                              Pre-Spending


Pre-award spending allows spending on anticipated awards prior to NU actually
receiving the award with PIs/ departments bearing the financial risk (cont’d)


      Pre-Spending Process


                 Obtain account number in                Use an OSR-2 Form
                advance of arrival of award

               Available 90 days in advance        Turnaround time varies — allow
 Details        of a project start date              a week
               In certain circumstances, a         Awards with human subjects must
                Guarantee Account number             furnish evidence of IRB approval
                may be required
                                                    Awards with animal subjects must
               PI/ Department assumes the           furnish evidence of ACUC
                financial risk in the event an       approval before animal objects
                award is not funded or the           will be opened
                prespending period exceeds
                sponsor guidelines                  If ACUC or IRB is not approved,
                                                     OSR will restrict




                                                                                             192
                                                                                             139
                                                                                                Gift vs. Grant


Gifts and grants have different characteristics, which help faculty and staff to
properly categorize funding sources
    Category          Gift          Grant                     Examples
 Contractual and      None           Yes               Perform specific research
 Reporting                                             Abide by applicable requirements and guidelines
 Requirements                                          Specific deliverable(s)

 Specific Start       None           Yes
 and Stop Dates

                                                       Adherence to a line item budget
 Formal, Fiscal      Limited         Yes               Delineation of costs into direct and F&A costs
 Accountability                                        Project audit by the sponsor or a third party
                                                       Payment contingent upon satisfactory programmatic
                                                        progress
 Terms and            None           Yes
 Conditions                                            Disposition of tangible and intangible property
                                                        resulting from the project


 Administrative    Development    Office for
 Management of        Office      Research/
 the Gift or                     Controller‘s
 Grant                             Office

                     If ANY of the above criteria are met,
                    then the funding is a Sponsored Project                                                      193
                                                                                                                 140
                                                                                  Gift vs. Grant


Gifts and grants have different characteristics, which help faculty and staff to
properly categorize funding sources (cont’d)
                                                                            Case Study


          Situation                       Problem               Resolution and Outcomes
  Microsoft Corporation                     indicates "All
                                 Solicitation                  Is   a sponsored project
  puts out a Request for         awards will be made as
                                                                Proposalshould go
  Proposal (RFP)                 unrestricted gifts."
                                                                through OSR
  NU PI submits a proposal      Recipientsare expected to
                                                                Rationale:
  by the RFP‘s stated due        provide Microsoft
                                                                  — Formal proposal
  date                           Research with brief
                                                                    required by sponsor in
                                 progress reports at least
                                                                    response to
                                 twice yearly
                                                                    solicitation
                                                                  — Progress report is a
                                                                    deliverable




                                                                                                   194
                                                                                                   141
                                                                                        Working w/ Indus


NU must balance its pursuit of research to expand the body of knowledge with
industry's search for knowledge for application in products, processes and services


                        Northwestern Versus Industry Goal Comparison
     Goal                      Northwestern                                 Industry
 Overall            Expand the body of knowledge              Develop a product, process and/or
 Objective                                                      service
 Knowledge          Ability to publish with only limited      Keep information proprietary and
 Dissemination       time delay for review of patent            away from competitors
                     rights
 Knowledge          Ownership of intellectual property        Ownership and control of
 Ownership           developed by NU                            intellectual property developed by
                      — Company may negotiate for               NU
                        rights
 Funding            Full F&A recovery                         Reduce costs wherever possible
                    Reasonable payment terms, such as
                     timing and payment frequency




                                                                                                      195
                                                                                                      142
                                                                                                   Working w/ Indus


Investigators and Administrators should together carefully manage six key risk
areas on industry projects

                           Management Tips for Key Industry Award Risk Areas
  Risk Area                    Management Tip                                       Rationale
 Prespending       Do not prespend                                 Uncertainty as to whether and when NU
                                                                     and company will reach an agreement
 Payment           Check with ASRSP to ensure payments are         Some companies are slow to or do not
                    on schedule                                      make payments
                   Do not allow spending to exceed revenue         Overdrafts resulting from company non-
                    received                                         payment must be covered by the
                                                                     department
 Budgets           Rebudgeting is generally flexible               Sponsors generally do not impose
                                                                     restrictions
 Unallowable       Cannot charge administrative support and        ―Double dipping‖ — full F&A already
 Costs              office supplies, if full F&A is assessed         reimburses the University for those costs

 Final Report      Must be submitted in a timely manner            Final report may trigger the final payment
 Fixed Price       Unspent funds will be transferred to non-       Some companies will pay the same amount
 Projects           sponsored account upon acceptance of final       for completion of a project, regardless of
                    report                                           costs incurred by PI
                      — Overdrafts are covered by Department/
                        Center
                                                                                                                  196
                                                                                                                  143
                                                                     Working w/ Indus


A summary of the broad principles applicable to research agreements between the
University and industrial and commercial organizations is on the web



Research Agreements with Northwestern University - Guide for Industry
 http://www.research.northwestern.edu/osr/industry.html




                                                                                   197
                                                                                   144
                                                                                    Export Controls


For reasons of national security and competitiveness, Federal regulations extend
to the export of goods and technology, which present special challenges for NU



            Export Regulation Rationale
    Category                    Details
 National            Prevent  contributing to the
 Security             military potential of U.S.
                      international adversaries
                                                                    Balancing national security
                     Prevent  proliferation of                     and U.S. economic vitality
                      weapons of mass                               with academic freedom and
                                                     Key Research
                                                      Challenge     the publication of research
                      destruction                                   results — regardless of the
                                                                    activity and whether the
                     Advance  U.S. foreign                         activity is sponsored
                      policy goals
 Competitiveness     Protectthe U.S. economy
                      and promote trade goals




                                                                                                  198
                                                                                                  145
                                                                                                            Export Controls


Regulations governing export controls are centered around three Federal
departments and are a key emphasis of OIGs when reviewing universities

                                               Export Control Regulation Highlights
        Regulation     Department of Commerce                 Department of State              Department of Treasury
        Name          Export Administration              International Traffic in Arms           of Foreign Assets
                                                                                             Office
                      Regulations (EAR — trade             Regulations (ITAR —               Control (OFAC — trade
                      protection)                          national security)                embargoes)
        Basic         Protectsitems developed            Protects items developed          Prohibits transfer of U.S.
        Concept       that provide U.S. with an            specifically for military use     assets to targeted countries,
 Key                  economic advantage                                                     terrorists, narcotics
                                                                                             traffickers, and WMD
                                                                                             proliferators
        Specific      Commerce     Control List          United States Munitions List               include Cuba; Iran;
                                                                                             Countries
        Highlights    (CCL)                                (8-9 pages)                       Libya; Myanmar (Burma);
                                                                                             North Korea; Sudan
                      Commercial  nonmilitary sales      Some   listings are very broad
                      to foreign corporation or                                              Groups/ Individuals: The
                      foreign government                                                     Taliban; Terrorists; Milosevic
                                                                                             Associates; Narcotics
                      Ten   General Prohibitions
                                                                                             Traffickers
                      Denied   Persons List
                                                                                                      Designated Persons
                                                                                             Specially
                      Dual Use                                                              (SDNs) and Blocked Persons




                                  Violations can result in significant penalties,
                                     including $1M plus fines and jail time
                                                                                                                          199
                                                                                                                          146
                                                                                                                      Export Controls


There are four primary ways to violate export control regulations and three
methods Universities can employ to minimize their violation risk

    Ways Export Control Regulations Can be Violated
       Violation1                            Details
 Government                   Contracts  may include ―specific
 sponsored research            national security controls‖
 (EAR734.11)
                              Contracts containing                                      Violation Minimization Techniques
                               prepublication reviews                                     Obtain licenses and limit access to
 Release of                   Lab   tours                                                 research
 technology through
                              Hosting   foreign scientists                               Perform work with U.S. citizens or
 ―visual inspection‖
                                                                                           permanent residents in a controlled
 ―Use‖ of equipment           Foreign national2 employees/                                setting
                               students access to controlled
                                                                                          Perform   work under exemptions
                               technology
 Lab technology               In-house open discussion of
 leaving the U.S.              controlled technology
                                                                                                  NU emphasizes this
                                                                                                 technique in order to
                              Release of technology both in the                                maintain highest level of
                               U.S. and abroad                                                     academic freedom


Notes: (1) Making technology or software available to foreign nationals, visually orally, or by practice or application
     under guidance of persons with knowledge of the technology
      (2) Any person who is not a U.S. citizen or permanent resident; and foreigners who possess temporary visas                    200
                                                                                                                                    147
                                                                                        Export Controls




See OSR’s Export Control Web Site for Additional Information



                   See: http://www.research.northwestern.edu/osr/export_controls.html




                                                                                                      201
                                                                                                      148
                                                                                  Consultants


A consultant or independent contractor is an individual hired to give professional
advice or services for a fee


Subcontract vs. consultant or independent contractor
   Subcontracted work is usually conducted at another institution or company, and
    generally has a budget for salary, fringe, supplies, etc. The sponsor requirements and
    terms and conditions have to be passed down with the subcontract via written
    agreements.
   A consulting agreement is generally to an individual who is not using institutional
    facilities and is working independently without detailed supervision.




                                                                                                202
                                                                                                204
                                                                                   Consultants


Consultants are different from employees and, consequently, require written
agreements prior to commencing any work



          Consultant versus Employee                   Consultant Agreement Terms
       Twenty characteristics — Common               Define the work scope and
        Law Classification Factors:                    deliverables
                                                      Indicate the payment terms and
        http://www.northwestern.edu/hr/policies/
        ch3pol.pdf
                                                       require timely, itemized invoices
                                                       from consultant
       Distinction important for
        withholding income taxes,
        providing employee benefits, and
        complying with other legal
        requirements




                                                                                                 203
                                                                                                 205
                                                                           Consultants


Administrators should follow ASRSP processing guidelines in order for consultant
related expenses to be processed properly




                CUFS
                                    ―Grant Consult‖ commodity code used in CUFS
                Related
                                    Object code 5010




                                    Contracted Services Form — unless payee is a
               Forms and             company
                Invoices
                                    Invoice from consultant




                                                                                         204
                                                                                         206
                                                                                 Consultants


Speaker fees require special attention for compliance with rules and regulations




         The Rule                                          The Exception
    Speaker Fees are           Except:             May be allowable on conference
    not normally                                    grants, training grants or where
    allowable on                                    specifically included in the
                                                    approved budget
    sponsored projects
                                                   Presentation should relate to
                                                    project and only individuals
                                                    involved in project should attend




                                                                                               205
                                                                                               207
                                                                                   Consultants


When managing contractor/ consultant related expenses, just remember to keep a
few important things in mind


Things to Remember
   Providing a detailed description of services provided will speed processing.
   Remember the approval process requires Department, School, OSR, and ASRSP
    approvals before AP generates a check.
   Original signature of the Principal Investigator is required on the Contracted Services
    Form.
   Requests for payment made 90 days or later after service is provided are highly
    suspect and a large audit flag.
   All NSF funds awarded prior to 3/15/06 are subject to the daily consultant rate of pay
    limit of $537. This constraint has been eliminated for FY06 appropriated funds.
   Payment cannot be approved before service is completed.
   Two ways to process:
     — Resident through Account Payable
     — Non-resident through Payroll
                                                                                                 206
                                                                                                 208
                                                                                                      Travel Req.


There are specific regulations governing travel related expenses charged to
Federally sponsored awards


                                                                                   Specific Regulations
                                                                               All travel must be completed
                                                                                within the beginning and end
                                                                                dates of the award
                        Travel Defined                                         US Flag Air Carriers must be
Domestic         Travel within   USTC1                                         used on Federal awards with
Travel                                                                          certain, limited exceptions
                                                                               Reimbursement to individuals
Foreign          Travel between                  Travel between               must not be made prior to
                  USTC and any          OR         points outside               completion of travel
                  other country                    USTC
                                                                               $65 limit on per person dinner
                                                                                expense, including tax and tip
                                                                               No alcohol is allowable
                                                                               Original receipts required




  Note: (1) USTC refers to The United States, U.S. Territories and Canada
                                                                                                                    207
                                                                                                                    209
                                                                                 Travel Req.


In order to speed processing and stay in compliance with applicable rules, ensure
you always keep a few points in mind when administering travel related expenses


Administering Travel — Helpful Hints
   Include original detailed receipts
   All trips must be made within the beginning and end dates of the award
   Before charging travel to an award, make sure the terms do not require pre-trip
    approval or contain spending limitations by the sponsor
   Working lunches are not allowable
   Subtract any alcohol off meal bills
   Lodging: travelers will be reimbursed for the reasonable and actual cost
   Exclude movies and health club charges from hotel expenses
   Reimbursements cannot be approved before travel is completed




                                                                                               208
                                                                                               210
                                                                               Travel Req.


   Fees for Visas are allowable when foreign travel is authorized as part of the
   budget, and a visa is necessary for travel. The following categories are allowable:

                                                         Allowable on Sponsored
Description                 Fee Amount
                                                         Projects?
Department of Homeland      $320                         Yes
Security (DHS) Visa Fee

Fraud Fee                   $500                         Yes

International Office Fee    $346                         Yes

DHS Fee for Beneficiaries   $300                         No
and Dependents
World Education Services    $100                         No

Premium Processing Fee      $1,000                       No



                                                                                             209
                                                                                             211
                                                                                      Equip. Inventory


Northwestern University maintains its equipment inventory to track capital
equipment that costs $5,000 and over and has a minimum life of one year



                                          Equipment Inventory Coordinator Responsibilities
                                             Updating the inventory database
 The inventory includes capital              Tagging new capital equipment
 equipment in many of NU's buildings
 as well as some off-site locations          Reinventorying old capital equipment
                                             Training departments to set-up their own non-capital
                                              equipment inventories to track equipment that costs
                                              under $5,000


                                                  Elements of Equipment Inventory Policy
                                             Introduction                  Fabricated Equipment
                                             Disposal Procedures           Forms
 http://www.northwestern.edu/equipment-      Equipment Disposal            Useful Lives
                   inventory/index.html       Form
                                                                            FAQs
                                             Request Inventory List
                                                                            Contact Information
                                             Do-It-Yourself-
                                              Inventory
                                                                                                     210
                                                                                  Establish/ Monitor


OSR’s award and acceptance process helps ensure accuracy, protects NU and
establishes management infrastructure

                                OSR Award Review and Acceptance Process
   Complex
   Process     Step                                    Action
                 1       Verify that the award matches an endorsed proposal
                 2       Verify correct agency terms are included
                         Negotiate terms with agency, conferring with PI/ Dept as needed
                           — Period of Performance, Budget, Statement of Work, Intellectual
                              Property, Payment, Termination, Indemnification, Informed
                              Consent, flow-down terms (if applicable), etc.
                         Endorse award on behalf of NU and obtain agency counter-signature
                 3       Verify the existence of IRB and ACUC approvals
                 4       Confer with PI/ Department in the case of unusual terms or
                          atypically deep budget cut
                 5       Establish award in InfoEd and CUFS (PeopleSoft after 9/1/08)
                           — Appropriate funds into standard objects based on approved
                             budget, internal budget, or award type — such as modular & FDP
                 6       Create and distribute Project Account Summary and award
                          documents to PI, Department, and ASRSP
                 7       Set-up Award File
                                                                                                  211
                                                                                                Establish/ Monitor


OSR will establish the CUFS account after review and approval of the award


                      CUFS Number                                       Example Fund Numbers
                  XXXX-XXX-XXXX                               Number                Sponsor Type
                                                                 0600       NIH
  CUFS
              Fund Number:                                       0830       NSF
               First four digits of the
                CUFS account number                              0965       Foundations
               Indicates the sponsor type                       0980       Other Educational Institutions



                  Actions for Departments to Take Once CUFS Account Is Established
              Basic              Obtain access to the account across all NU business systems
                                 Establish salaries
              Additional         Request any additional object codes be opened
                                 Set up tickler for important dates, such as reports, compliance
 Actions
                                  protocol reviews
                                 Create departmental file
              If Necessary       Move PI effort from NMFF to NU
                                 Meet with PI to review terms
                                 Initiate OSR forms 6 or 7 for any subcontracts
                                                                                                               212
                                                                                                               215
                                                                  Establish/ Monitor


The Project Account Summary (PAS) serves as an award summary, which details
the budget, CUFS numbers, and other details for the award’s records




  Award Details, such as PI
     name, CUFS number,
        Budget Dates, etc.




  Award Budgetary Details




       Notes Section, which
        includes important
          award terms and
                 conditions




                                                                                  213
                                                                           Establish/ Monitor


OSR automatically opens object codes corresponding to the approved budget and
additional object codes by official request




  Object Codes Opened Automatically
      Those corresponding with the
       approved budget
      Standard object codes for FDP
                                                  Standard FDP Object Codes
       award
                                             Most NSF and NIH awards are FDP
                                             Including NIH Modular
                                             http://www.research.northwestern.edu/os
                                              r/objfdp.html




                                                                                          214
                                                                                          217
                                                                                       Establish/ Monitor


When charging expenditures and requesting object codes, departments should
keep a few key actions in mind


             Charging Expenditures                              Object Codes Requests
   Review Project Account Summary and                Review terms and conditions of award to
    budget to ensure the that correct object           see if Object Code is Allowable
    code is used                                      Email requests for additional object codes
   Review budget for line items that should           not included in the Project Account
    not be charged F&A                                 Summary to the Grant and Contract
     —   Marked with an asterisk on the series         Officer (GCO) or Department Assistant in
         number in the PAS and in the CUFS             OSR
         monthly budget statement (NG32)                —   Requests must have a justification that
   When processing expenditures, make sure                 indicates why the object code is
    items are charged to the budgeted object                needed and how it relates to the
    code to ensure proper charging of F&A                   project
   Assure charged account will receive some          The GCO will then determine whether or
    benefit from expense                               not these expenses are allowable or if
                                                       permission from the sponsor is needed


                   OSR has created a list of common object codes requested for
                                      sponsored projects at
                     http://www.research.northwestern.edu/osr/objorsp.html
                                                                                                      215
                                                                                                      218
                                                                           Establish/ Monitor


Object code requests should include the code to open as well as a complete and
specific rationale


           Insufficient Request                      Appropriate Request
    ―Please open object code 3100 on        ―Please open object code 3100 on
     0830-300-F500 to purchase                0830-300-F500 to purchase the
     software. PD pending.‖                   software program Engineering X.
                                              This software is needed in order to
                                              complete the data analysis
                                              proposed as part of this grant.‖



                                                             Key
                                                          Difference




                                                                                          216
                                                                                          219
                                                                                      Establish/ Monitor


Significant reallocations or other changes to the award’s terms and conditions
may require additional review and approval by OSR and/ or the sponsor




       Guidelines for Award Changes
    FDP rebudgeting privileges waive many
     restrictions
                     BUT
    Award changes which alter the project’s        Sample Changes Requiring Sponsor
     purposes will require sponsor approval
                                                               Approval
                                                  Reductions in PI effort of 25% or more
                                                  Significant absence of a PI from a project —
                                                   usually more than three months
                                                  Addition of key personnel
                                                  Increases of 25% or more of the total budget in
                                                   any budget line item generally requires OSR and
                                                   sponsor approval




                                                                                                     217
                                                                                                     220
                                                                                  Establish/ Monitor


Subcontracts are awards that involve collaboration with other institutions




    Subcontract Object Codes         Subcontract Reporting and Deliverable Highlights
 Code            Description            PI is responsible for collecting technical reports
 8640      Subcontracts up to the       and keeping a file for a retention period of usually
            first $25,000 of the         three years, but can vary by sponsors
            project period              PI must ensure receipt of final technical report
 8650      Subcontracts in excess       before approving final invoice for payment
            of $25,000 per
            subcontractor
                                                                       Area of
                                                                     emphasis for
                                                                       auditors




                                                                                                 218
                                                                                                 221
                                                                                                              Establish/ Monitor


Establishing subcontracts involves six basic steps with OSR serving as the
facilitator and primary contact point for faculty and subcontractees

   Process for Establishing a Subcontract


  Send OSR-6 or                          OSR drafts                  OSR signs and mails                 Negotiation occurs
OSR-7 form1 to OSR                      subcontract2                  to subcontractee                     (if necessary)




          Subcontractee                  OSR sends copy of                  ASRSP reviews terms
        signs subcontract                subcontract to dept.                and notifies dept. of
        and returns fully                 and ASRSP with                     dates, amounts and
            executed                    cover letter requesting                object codes for
       subcontract to OSR                   PD be created                      establishing PD




Notes: (1) OSR-6 forms are for new subcontracts while OSR-7 form are for modifications to subcontracts
        (2) FDP versus non-FDP                                                                                               219
                                                                                                                             222
                                                                         Establish/ Monitor


The subcontract payment process involves four basic steps from CUFS account
creation through invoice processing

  Subcontract Payment Process

    Department          ASRSP receives          Invoices are
   creates PD in         and forwards        certified by PI that      Department
      CUFS +            invoices to the       costs charged are     approves receiver
     Receiver             Department        acceptable and work      required field in
   Required (Y)                             has been performed            CUFS


Invoices returned to                          ASRSP reviews
   ASRSP from           AP sends check to      and then mails
  Department for             ASRSP            check to vendor
  processing with                            along with a copy
 Accounts Payable                              of the invoice




                                                                                         220
                                                                                         223
                                                                                         Establish/ Monitor


Although NIH grants are usually awarded for four to five years, each year a non-
competing renewal application must be submitted

   If the project is subject to Streamlined Noncompeting Award Process (SNAP), the
    noncompeting application can be submitted via NIH Commons

   To submit NIH non-competing renewal applications, OSR requires the following
    internal documents for both electronic and paper submissions:
                    Forms Required for NIH Non-competing Renewal Applications
       Document             Circumstances                           Special Considerations
OSR-1                   No significant changes          Photocopy of previous year‘s OSR-1 with
                         from previous year               edits may be used
                                                         Only the PI needs to sign
                        Significant changes             Submit a new OSR-1
                         from previous year
                                                         Significant changes include:
                                                           — Key personnel
                                                           — Key personnel effort
                                                           — Human or animal subject usage

OSR-100                 For any new key
                         personnel
Current IRB             If applicable
&ACUC approvals
NIH PI Compliance       PI signature required                                                          221
                                                                                                        224
                                                                              Establish/ Monitor


NSF and other sponsors also require annual progress reports




   The PI usually submits the progress report directly to the sponsor
     — For NSF, this is submitted via NSF FastLane 90 days prior to budget end date

   Submission of a progress report usually triggers the next year funding
   A progress report is required even when NSF awards all funding up front
   OSR endorsement is usually not required




                                                                                             222
                                                                                             225
                                                                              Establish/ Monitor


No-Cost Extensions (NCEs) allow work to continue on a grant without additional
funding from the sponsor




                  Effort during an extension period is assumed to be the same as the
                   last year of the grant
  Important       Sponsor must be notified if the level of effort for key personnel will
Considerations     decrease by 25% or more
                  Under FDP terms and conditions for most sponsors, OSR can grant
                   a no-cost extension of up to one year on behalf of the sponsor
                     — Note: DOD requires sponsor approval




                                                                                             223
                                                                                             226
                                                                                         Establish/ Monitor


There are two ways to request a No-Cost Extension (NCE), which will depend on
whether the award is FDP or not


                                         Requesting No-Cost Extensions
    How To                 Most FDP Awards                  Non-FDP and Second NCE request
                   PI submits an OSR-2 form                   PI submits an OSR-2 form
                    requesting a no-cost extension to           requesting a no-cost extension to
                    GCO:                                        GCO:
                      — The length of extension                   — The length of extension
                        requested                                   requested
                      — Confirm effort                            — Confirm effort
                      — Provide justification of need for         — Provide justification of the need
                        the extension (cannot be                    for the extension (cannot be
                        because funds remain)                       because funds remain)
                   Provide the most recent IRB or             Provide the most recent IRB or
                    ACUC approval letter to the GCO             ACUC approval letter to the GCO
                    (if necessary)                              (if necessary)
                                                               Submit letter to OSR for
                          Key Difference
                                                                signature (if necessary)


                                                                                                        224
                                                                                                        227
                                                                                  Establish/ Monitor


Overdrafts is another area, which can be scrutinized by both internal and external
reviewers and auditors


   Expenditures exceeding the awarded amount may be considered a type of
    uncollectable cost
   Allocable, allowable and reasonable overdrafts constitute part of the total costs of the
    project
   Department is typically responsible for funding these costs
   When resolving overdrafts, ASRSP:
     — Requires agreement among the PI, and/ or the department chair, dean, or center
       director
     — If no account has been provided within a timely manner, the excess expenditures
       will be transferred to a department/ center account




                                                                                                 225
                                                                                                 229
                                                                                                Award Close-out


Complete an OSR-4 form for any active grant, cooperative agreement, or contract
a PI wishes to relinquish or transfer prior to the project period end date


                          Award Transfer/ Relinquishment Highlights
          Category                                              Detail
      Timing               Prepare   relinquishing statement
                           Agencies  generally need at least 90 days to complete the process and
                           will not transfer an award within the last six months of a project period
      Project Personnel    PIsshould ensure appropriate arrangements have been made for
                           personnel working on their projects

      Intellectual         PIs   should consult with TTP if any IP is involved
      Property

      Transfer of          Sponsors generally expect equipment purchased under an award will
      Equipment            be transferred

      Final                ASRSP is responsible for preparing and submitting final financial
      Expenditures and     information to the funding agency
      Financial Reports
      Resource             http://www.research.northwestern.edu/osr/OSR_4.html




                                                                                                             226
                                                                                                             230
                                                                                                         Award Close-out


The award close-out process involves ensuring all project work has been
completed, required reports filed and financial matters resolved


   An electronic account close-out notification is e-mailed by ASRSP and OSR to PIs
    and Business Administrators approximately 90 days prior to the award end date

   Sponsored Account Close-out Procedures for PIs and Administrators can be found at
    http://www.northwestern.edu/asrsp/closeout.html
     — Verify that all costs charged to the account are appropriate

     — Delete invalid or obsolete encumbrances in CUFS
     — Once account has ended, identify and notify ASRSP of late charges that have not
        posted1
     — Notify University Services and CCM of the IACUC approved change to the
        account number when an award ends
            — Change of account numbers cannot take place without IACUC approval
              which is done via an IACUC protocol addendum




Note: (1) Charges which were incurred before end date but not paid until after end date — e.g., animal
     costs and tank rentals                                                                                           227
                                                                                                                      231
                                                                                                                   Award Close-out


The award close-out process involves ensuring all project work has been
completed, required reports filed and financial matters resolved (cont'd)


                                           Award Close-out Actions
            Responsibility                                   Action                             Complete
           PI/Dept/ASRSP            Review award expenditures                                      
                   PI               Review and certify final project budget statement              
                ASRSP               File final Financial Status Report (FSR)                       
                ASRSP               File final invoice and payment                                 
                ASRSP               File property reports                                          
                   PI               File effort report                                             
                   PI               File technical report                                          
             PI/OSR/TTP             File patent report1                                            
                   PI               Ensure all deliverables have been completed                    




 Note: (1) For NIH awards, the patent report should be completed by the PI and then sent to OSR for approval and
            subsequent submission to NIH
                                                                                                                                228
                                                                                                                                232
                                                                                        Close-out


Think about utilizing a Check-Out List for research when a PI leaves NU



                                    PI Check-Out List - Considerations
                            Issue                               Institutional Contact   Complete
Transferring research projects; relinquishing statement   OSR                               
Expenditures certified                                    ASRSP                             
Effort reports completed & certified                      ASRSP                             
Equipment accounted for, transferred, disposed of, etc.   Accounting Services               
Protocols closed appropriately                            OPRS – IRB & ACUC                 
Laboratory supplies handled appropriately                 ORS                               
Laboratory closing surveys conducted as appropriate       ORS                               
Original research data maintained by department           ORI                               

           PI CHECK-OUT LIST TEMPLATE AVAILABLE ON ORI’S WEB SITE:
   http://www.research.northwestern.edu/ori/best-practices/ORIPICheckOutTemplate.doc

                                                                                                    229
                                                                                                    233
                                                                                                        COI/ COC


Conflicts of Interest and Commitment refer to relationships that create the
perception that the relationship might interfere with the ability of personnel to
adequately and appropriately meet their NU obligations

       Conflicts of Interest                                              Conflicts of Commitment
                                        Inability to act in the
    When private financial              best interest of NU             When the time devoted to
     interests and NU                                                     external activities
     professional obligations            Inability to devote              potentially has an adverse
     potentially diverge                adequate time to NU               affect on capacity to meet
                                           responsibilities               University responsibilities
 Examples:
    External financial interests                                     Examples:

    Consulting and other                                                Non-compensated
     compensated professional/                                            professional activities
     commercial activities                                               Consulting and other
    Use of students/ support staff                                       compensated professional/
     on outside activities                                                commercial activities

    Use of University resources
    University dealings with
     entities with which faculty
     members have a relationship



          Northwestern’s obligation is to manage, reduce or eliminate these real or apparent conflicts
                                                                                                                   230
                                                                                                                   124
                                                                                 COI/ COC


Are these conflicts of interest?




   Clinical researcher holds equity in a company that sponsors his research?
   Clinical researcher holds equity in a company that competes with the sponsor of her
    research?
   Clinical researcher serves as COO of a software development company?
   Clinical department invites vendors to provide educational materials and
    presentations?




                                                                                            231
                                                                                            125
                                                                                     COI/ COC


Why are we concerned about conflicts?




   Protect the objectivity, credibility, and trustworthiness of academic research
   Protect the research community (i.e. YOU)
   Protect the institution

 Regulatory    requirement




                                                                                                232
                                                                                                126
                                                                                                COI/ COC


Northwestern has Conflict of Interest and Conflict of Commitment policies that
apply to both faculty and staff

                                    Faculty                                             Staff
                   http://www.research.northwestern.edu/            http://www.northwestern.edu/hr/polic
 Policy Links      policies/faculty-conflict-of-                     ies/conflict.pdf
                   interest.html

                          part-time academic appointees
                   Full or                                          Regular nonexempt and exempt staff
  Definitions        — Includes faculty-level research               in research, academic, or
                       appointees                                    administrative positions
                     — Excludes adjunct and contributed
                       service faculty
                                                      Policy Highlights
  Primary
Responsibility     TheIndividual — Each University faculty, staff and employee must exercise good
                   judgment and fully disclose potential conflicts

                   Must file when applying for: Initial funding, funding renewal or changes in financial
   OSR-100
                   interests with respect to NIH, NSF, American Cancer Society and AHA sponsored
                   projects
                   Required to   comply with federal regulations


                                                                                                           233
                                                                                                           127
                                                                                                                     COI/ COC


Management plans can help to minimize faculty conflicts of interest…

                                                                                                             Case Study

 John     Doe, a faculty member
 Principal investigatoron a NASA grant to study human motion to develop
  more effective exercise equipment for use in space-based physical
  conditioning
 University        licensed the technology to Doe‘s company, TreadTech
 TreadTech wants  to sponsor a research grant to demonstrate in a ―university
  study‖ that TreadTech‘s home exercise equipment is more effective than
  existing equipment




Adapted from: Fournier, T. (2006). Protecting the foundation, building the future: Perceptions and expectations for managing
    conflicts in academic research: University of Pennsylvania.
                                                                                                                                234
                                                                                                                                128
                                                                                                    Sci. Misconduct


Scientific misconduct involves intentional fabrication, falsification, or plagiarism
when proposing, conducting and reporting on research

                                              Scientific Misconduct
       Type                                                       Detail
Falsification/            Reporting experiments, measurements or other statistical analysis never performed
Fabrication of            Manipulating or altering data or other manifestations of the research to achieve a
Data                       desired result
                          Falsifying or misrepresenting background information, including biographical data,
                           citation of publications, or status of manuscripts
                          Selective reporting, including deliberate suppressions of conflicting or unwanted data
Plagiarism                Representing another's work as one's own




Abuse of                  Access to privileged information through the opportunity for editorial review of
Confidentiality            manuscripts submitted to journals, and
                          The opportunity for peer review of proposals being considered for funding by agency
                           panels or by internal committees, such as the Institutional Review Board (IRB) and
                           the Animal Care and Use Committee (ACUC)

Facilitation      The Office for Research Integrity facilitates the Scientific Misconduct Review process
 Process
                                                                                                                  235
                                                                                                                  129
                                                                                                  Compliance


Research compliance is not just following the rules, but conducting research with
integrity and in an ethical manner, which some would call ―doing the right thing‖

   Compliance Subject                                              Detail
Fiscal Fiduciary Duty       Northwestern University and it‘s faculty and staff are stewards of the research
                            funding with a fiduciary duty to ensure the money is spent carefully and as
                            intended
                            Oversight arms of granting entities have to rely on institutional and personal
                            integrity because they cannot monitor every dollar all the time
Purpose of the Rules and    Rulesand regulations generally reflect the will of the people funding the
Regulations                 research, such as the public and specific donors — We need to respect their
                            wishes
                            For   example:
                              —    Animal care and use regulations are intended to ensure that animals
                                   involved in research are treated humanely and used only when necessary
Marketplace Determines      Through funding decisions made by the funders, the ―marketplace‖ determines
What Research is            what research should be funded and what goals are worth pursuing
Necessary and Important     Is   the most efficient way to allocate money
Fact of Life                          is and will always be a part of research, so we need to learn to
                            Regulation
                            embrace regulation and manage it better




                                                                                                               236
                                                                                                               234
                                                                                                    Compliance


However, when we don’t do the right thing, there are several institutional and
personal consequences of non-compliance with rules and regulations
   Entity            Consequences                                        Details
Institutional   Fines and Penalties       Fines and   penalties can range well into the millions



                Exceptional Status        Institution is placed on a watch list, with additional oversight and
                                           monitoring by the Federal government
                                          Institution can lose its expanded authorities and participation in
                                           FDP
                Funding Reduction         Lose  funding with current projects redistributed to other
                                           institutions
                                          Decrease the chance a particular grant will be awarded to a
                                           particular institution
                Letter of Credit                     will no longer be able to ―draw down‖ funds, thereby:
                                          Institution
                Funding Authorization       — Increasing administrative complexity for grants, such as
                Revoked                       funding delays and purchase order processing
                                            — Increasing research faculty and staff frustration

Personal        Suspension and            Research personnel may not be allowed to conduct research in a
                Debarment                 certain area and/or overall

                Professional Integrity    Increased   perception as a person who has questionable ethics and
                Compromised                morals
                                          Decrease likelihood future proposals will be accepted

                                                                                                                 237
                                                                                 Compliance


The False Claims Act (FCA) imposes civil liability on any person or entity who
submits a false or fraudulent claim for payment or approval to the US government


Specific Violations of FCA1
 Knowingly  makes, uses or causes to be made or used or present a false or
 fraudulent claim to the government for payment of approval
 Conspiring to        have a false or fraudulent claim allowed or paid by the
 government
 Withholdingproperty of the government with the intent to defraud the
 government or to willfully conceal it from the government
 Authorizing   to make or deliver a receipt for the government's property which
 is false or fraudulent
 Knowingly  buys or receives as a pledge of an obligation or debt, public
 property from someone who lawfully may not sell or pledge the property
 Making a false statement to avoid or deceive an obligation to pay money or
 property to the government
Source: (1) False Claims Act: US Code: Title 31, Section 3729                                 238
                                                                                              236
                                                                                  Compliance


Stiff penalties make the False Claims Act one of the government's favorite tools to
combat fraud and abuse in government-funded programs


 Penalties: Treble Damages                      Qui Tam: ―Whistleblower‖
   Violators must repay:           Purpose            Allows whistleblowers to:
     — Three times the amount                            — bring a suit on behalf of the
       of damages suffered by                              government
       the government plus                               — Share in the damages
     — a mandatory civil                                   recovered as a result of the suit
       penalty of at least          Whistleblower      Person(s) who brings an FCA case
       $5,000 and no more                               is called the ―Qui Tam Relator‖
       than $10,000 per claim



                                    Award to Qui       Shall receive at least 15% but not
                                    Tam Plaintiff       more than 25% of the proceeds of
                                                        the action of settlement of the
                                                        claim




                                                                                               239
                                                                                               237
                                                                                                                      Compliance


Compliance with rules and regulations remains a hot-button issue for Federal
agencies and can result in significant fines and negative publicity to institutions

                              Select, Recent Examples of the Impact of Non-compliance1
           Institution           Time Frame                                          Details
       Florida A&M             July 2005             $1.5 million penalty for being unable to account for how $1.4
       University                                     million of a $5.3 million grant was spent
       Mayo Clinic             May 2005              $6.5 million   penalty for misusing federal grant funds

       Northeastern            February 2005         OIG audit finds inappropriate cost allocations
       University                                    Audit identified:

                                                       — $194,890 in unallowable, unallocable and unreasonable
                                                         costs
                                                        —   Internal control weaknesses relating to the monitoring of
                                                            costs and submission of reports
       Harvard                 June 2004             $2.4 millionpenalty for billing government for salaries and
       University                                     expenses unrelated to federal research
       Johns Hopkins           February 2004         $2.6 million penalty for overstating faculty time and effort on
       University                                     federal grants
       Northwestern            February              $5.5 millionpenalty for overstating effort reporting on
       University              2003                   federal sponsored projects

Source: (1) Bernard Wysocki, J. (2005, August 16). As universities get billions in grants, some see abuses: Cornell
          doctor blows whistle over use of federal funds, alleging phantom studies. The Wall Street Journal.                       240
                                                                                                                                   238
                                                                                       Compliance


In addition to the institutions themselves, institutional personnel are also held
accountable for non-compliance and can even include jail time

  Institution Type                        Penalty to Institutional Personnel
 Academic            Key   personnel suspended from any kind of research
 Medical Center
 Midwest             PIheld personally responsible – had to pay approximately $650,000 for
 University           misappropriating grant funds
 Large Research      ―Exceptional‖   designation followed by significant drop in federal funding
 University
 Large Research      Overstatedresearch support when applying for research grants
                       — Researcher was fined and JAILED
 University
 Large Private       Long-term    Federal presence
 Research
 University
 Medium-Sized        Federal   investigator presence
 Public Research
 University




                                                                                                    241
                                                                                                    239
Appendix




           242
                                                                                    NUCATS


    Northwestern University Clinical & Translational Sciences Institute (NUCATS)
                   Education, Training, & Career Development


Training Opportunities for Clinical Research Professionals
   Clinical Research Coordinator (CRC) Basic Training
     — Three day introduction to the CRC Role

   Essentials of Initiating Clinical Research Course
     — Ten week introduction to clinical research process and careers

   NUCATS Annual Clinical Research Educational Conference
     — Annual conference with 400+ attendees (May 16, 2008)
     — Nationally renowned speakers from NIH, FDA, industry and academia

   Navigating the Clinical Research Maze
     — Overview of clinical research processes

   Advisory Council for Clinical Research Lecture Series
     — Lunch-time research-related lecture the 3rd Friday of every month
     — Schedule posted on NUCATS website



    Contact NUCATS: http://www.nucats.northwestern.edu/index.html or 312-503-7952

                                                                                             243
                                                                                             240
                                                                                                                   Introduction


Research administration training will help Northwestern decrease compliance
risk, administer grants consistently, and improve support for its administrators
         Benefit of Training                                                  Rationale
 Decrease the University’s exposure     Training helps to increase the NU research communities of extensive and complex
 to Federal compliance risk              Federal rules and regulations
                                        Helps ensure administration consistency across the research enterprise
                                        Enables individual faculty and administrators to identify and minimize compliance
                                         risks
 Provide a foundation of support and    Help increase understanding of the rationale for process stages, requirements and
 a reference tool for Research           procedures
 Administrators                         Training materials can be used as reference tools in everyday situations, including
                                         contact numbers and data sources
 Federal government has                 Federal government spends billions of dollars on research and has a fiduciary duty to
 expectations for proper compliance      tax payers to ensure the funds are spent appropriately and effectively
 programs, including training and       Components of a research compliance program as required by the Federal
 communication                           government include:
                                           — Implement procedures to train and help ensure employee integrity
                                           — Utilize communication tools to promote compliance
                                           — Adopt and communicate compliance standards
                                           — Implement systems and procedures to detect and monitor instances of non-
                                              compliance
                                           — Consistently enforce policies for non-compliance
                                           — Document that appropriate actions were taken to respond to, deter and correct
                                              non-compliance
                                           — Appoint a compliance officer in a key position




                                                                                                                                  244
                                                                                                                                  241
                                                                                                                                                                                        Roles and Resp.


From a global perspective, each individual and office has a significant role
through out the research administration process and…

                                                                                                Proposal/Protocol Review, Approval and Processing
                      Proposal Development and Budget
                                                                                                     Human & Animal Subjects, Conflicts of Interest, & Safety


                                                                                                                                           JIT Stage – NU                       NU
Need for                                          OSR approves                 Sponsor            Human &
              PI writes       Cost sharing                                                                                                  runs protocol/                   Committees
Proposal/                                         and signs off on          receives and           Animals               YES                                                                                 A
              proposal         activities                                                                                                 safety consid. via                  approve
  Grant                                              proposal             reviews proposal        involved?
                                                                                                                                             committees                       protocol
                                                                                                                NO, Safety
                                                                                                              considerations                            NO




                                                           Award Acceptance and Account Establishment


                                  Sponsor approves
                                                                                               OSR obtains                 OSR issues sub-
                                   & sends award          If            Negotiate
                          A                                                                    agreement &                 contracts (depts                      B
                                  notice (grants and   Contract          contract
                                                                                              sets up account                  initiate)
                                      contracts)

                                                                     If Grant




                                                           Management and Monitoring of Projects                                                                        Award Close-Out


                                    PI/Dept./Center
                                    Admin. provide
                                       oversight
                                                              OPRS, ORS & PI
                          B
                                                              monitor technical
                                    ASRSP conducts                  aspect                                                                             ASRSP closes
                                     financial rptg,           (if applicable)              PI continue        Are additional
                                                                                                                                      Complete           out award                  Provide final                End
                                     A/P (approve                                           to work on         funds or time
                                                                                                                                       Project          (deficit and                team report
                                   purchases $500+),                                          project            needed?
                                                              OSR and ASRSP                                                                               surplus)
                                   A/R & compliance
                                                              monitor financial
                                                                  aspect



                                                                      No (Cost Extension)                                                                  Key:
       Yes (Renew and/or Supplement Funding)                                                                                                                    Input     Process    Decision       Output



                                                                                                                                                                                                                  245
                                                                                                                                                                                                                  242
                                                                                                          Roles and Resp.


…a good understanding of those roles and responsibilities will help to make the
research administration process more efficient and effective
                                                                                                      Illustrative

                                 Hi
   Process Management/ Grants
   Administration Support Role




                                                                                            For example, while PIs
                                              Office for
                                                                                            and BAs/DAs are
                                            Research Units
                                                                                            focused primarily on
                                                                                            management of specific
                                                           Dean                             grants, Office for
                                                                                            Research units are more
                                         Business                                           focused on process
                                       Administrators                                       management
                                                                 Departments

                                                 Department
                                                Administrators
                                           PI                         Controller
                         Low
                                      Hi                                              Low
                                                Active, Day-to-Day Award Management


                                                                                                                        246
                                                                                                                        243
                                                                                                                      Roles and Resp.


Principal Investigators (PIs) are specifically responsible for the technical,
administrative, and fiscal management of a project, including subcontracts

 Selected Responsibilities                                                  Highlights
 Knowledge of rules and          Know, understand and comply with applicable agency and University guidelines and
 regulations                      restrictions relative to the conduct of research, training, and public service programs
 Proposal costs reflect          Ensure that the costs reflected in a proposal budget are based on University sanctioned costs
 University sanctioned            and rates
 costs and rates                 Ensure costs represent full recovery to the University for the costs of the project, unless there
                                  is an expressed, written agreement to the contrary
 Sufficient proposal lead        Prepare and submit proposals with sufficient lead time to permit a meaningful review by the
 time                             appropriate University officials prior to submission to the sponsoring agency
 No conflict of interest or      Ensure any conflicts of interest or commitment between the project work and any personal
 conflict of commitment           holdings or positions within other organizations are appropriately disclosed and managed
 Costs are compliant with        Certify that all costs charged to each contract or grant specifically and proportionately benefit
 OMB Circular A-21                the project and are allowable, allocable, reasonable and treated consistently
 Compliance with grant           Comply with:
 terms and conditions              — The specific terms and conditions of each award as stated in the contract or grant
                                     documents
                                   — All administrative requirements as set forth in various sponsoring agency and campus
                                     policy statements




              Grants are awarded to institutions not PIs — PIs are the institution’s grant manager

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                                                                                                                    Roles and Resp.


Unit Administrators have an interdependent relationship with PIs by providing
administrative support on sponsored projects


  Selected Responsibilities                                                Highlights
 Support PIs                     Compliments the PI‘s scientific expertise with an understanding of the administrative mechanics
                                  necessary to advance the research operations
                                 Coordinate project planning, operation and close-out
 Knowledge of rules and          Keep PIs informed of the account status and grant administration/ compliance issues
 regulations
 Specific Responsibilities       Read and follow requirements specified in the NOGA
                                 Establish budget in FRS and plan grant activity and close-out with PI
                                 Perform financial functions related to research operations such as charging accounts for supplies
                                 Monitor financial and compliance controls for grants
                                    — e.g., ensure unallowable costs are not charged to grants

                                 Maintain awareness of current Federal and agency rules and regulations (with help)
                                 Prepare/ submit/ approve financial reports in a timely manner




    Administrators have a stewardship responsibility to funding agencies and Northwestern University



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                                                                                                                Roles and Resp.


Department Chairs/ Center Directors are primarily responsible for supporting
research and monitoring the research administration process


 Selected Responsibilities                                               Highlights
Support and Monitor             Adequate departmental resources to administer the project
Research and Research           Cost-sharing/ matching (if applicable)
Administration                  Monitor appropriate use of students
                                Absorb overdrafts or financial liabilities associated with research projects
                                Space
                                PI Eligibility
                                Appropriateness of proposed project to the goals and objectives of the department and NU




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                                                                                                                   Roles and Resp.


ORI is dedicated to serving and safeguarding Northwestern’s research enterprise
through the encouragement of responsible and ethical research
 Selected Responsibilities                                                  Highlights
 Manage and support                   minimize, manage and communicate compliance risks to the University's research
                              Identify,
 research compliance           community
                              Respond     to, coordinate and conduct scientific misconduct investigations
                              Work with University personnel to promote and implement new guidelines related to research
                               administration while minimizing additional administrative burden
                              Monitor     and correct non-compliance in accordance with University and federal guidelines
 Coordinate training,         ORI  will coordinate and help conduct research and research administration training, education
 education and                 and communication activities
 communication
 Support and partner with     Partnerwith the research community to help identify and promote innovative methods to
 the research community        improve Northwestern's research administrative processes
                              Assist the research community in understanding and complying with laws, regulations and
                               policies
                              Emphasize  a culture of ethical conduct and integrity in research, including the establishment of
                               research misconduct principles
                              Promote     trust and accountability in the research community
 Promote excellence           ORI   will strive to improve research at Northwestern through innovation and participation




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                                                                                                                                   247
                                                                                                    Roles and Resp.


The Associate Vice President for Research Operations provides operational
management and oversight for all OR units supporting the research enterprise

 Selected Responsibilities                                        Highlights
 Efficient Operations           Ensures Office for Research units operate effectively

 Compliance                     Ensures all operations are in compliance with regulations, policies, and laws
                                 governing externally sponsored research activities
 OR Management                  Manages client service, strategic planning, work process review and
                                 enhancement, development of supporting information systems, human
                                 resources, budget and finance, and infrastructure for the Office for Research
 OR Project Management          Manages Office for Research participation in the Roles and Responsibilities,
 and Representation              Research Data Integration and Access, Financial Management System
                                 Replacement (including grants management system replacement) and Data
                                 Warehouse initiatives




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                                                                                      Roles and Resp.


Office for Sponsored Research (OSR) provides administrative support over the
life of a sponsored project and has offices on both campuses


                                 Selected OSR Responsibilities
             Proposal validation and submission
             Negotiate, execute, and accept contract and grant awards
             Award notification
             Account establishment
             Award terms and conditions interpretation
             Provide other administrative support over the life cycle of a grant
             Take action, as necessary, to protect the interests of the University
             Information dissemination




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                                                                                                                     Roles and Resp.


Office for Sponsored Research (OSR) provides administrative support over the
life of a sponsored project
 Selected Responsibilities                                                 Highlights
 Information                    Disseminateinformation about funding opportunities and significant changes in sponsor policies
 dissemination                  and procedures
 Proposal validation and        Review,  endorse on behalf of the institution, and submit all proposals for sponsored research,
 submission                     training, clinical trials, equipment acquisition, construction, public service, and other programs at
                                the University
 Negotiate, execute, and        Ensure that grants and contracts are consistent with University policy and contain terms and
 accept contract and grant      conditions that minimize unnecessary administrative burdens and exposure to compliance
 awards                         problems
 Award notification             Informappropriate campus personnel of incoming awards and provides them with a copy of the
                                requirements and obligations imposed by the grant or contract
 Account establishment                   accounts in the University financial system, appropriate funds, and provide project
                                Establish
                                account summaries to PIs and account folders to ASRSP
 Award terms and                OSR staff will interpret award terms and conditions to assist principal investigators and their
 conditions interpretation      departments in the proper administration of awards
 Provide other                     example:
                                For
 administrative support           — Draft, negotiate and endorse subcontracts following receipt of a request from the PI
 over the life cycle of a         — Review and approve certain financial or administrative transactions
 grant                            — Manage the PHS and NSF conflict of interest policy
                                  — Develop policies and processes to comply with new or changes in regulations

 Take action, as necessary,       —    Notify sponsors and ASRSP of expired protocol status
 to protect the interests of      —    Notify PIs and ASRSP of changes in PI effort
 the University

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                                                                                                                   Roles and Resp.


ORIS provides leadership and strategic direction in the design, creation and
deployment of technical solutions to address cross-functional business issues


 Selected Responsibilities                                                 Highlights
Identification and              Solutions help:
Implementation of                 — Streamline business processes
Technical Solutions               — Improve efficiency
                                  — Simplify the administrative process for faculty and staff users

Office for Research IS          Drive IS solutions and technologies within the Northwestern research enterprise
Champion
Service Provider                Network and workstation technical support, including help desk functions
                                Application and systems implementation, which includes make/buy scenarios
Provide Office for              Infrastructure enables ORIS to the Office for Research with, including:
Research Technology                — Organizational structure
Infrastructure                     — Personnel
                                   — Budget
                                   — Software development tools
                                   — Hardware
                                   — Documentation
                                   — Policies
                                   — Training opportunities




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                                                                                                                                                   Process


The research administration process can be further broken down into a life cycle
composed of five stages, each of which contains sub-stages and several topics
                          Grants Administration Process Stages and Topics as defined by OMB Circular A-110


         Pre-Award
        Administration                                          Post-Award Administration                                               Award Close-out



                                                            Roles and Responsibilities Related to Research Projects


          Grant                                        Proposal/ Protocol
                                                                                  Award Acceptance and              Managing and
 Administration Proposal Development and Budget       Review, Approval and                                                                Award Close-Out
Life Cycle Stage                                                                    Establish Account             Monitoring Projects
                                                           Processing




                                                                                                    Highlights
                 Stage
                                                      Begins:                                                         Discusses:
  Proposal Development and                   When  a PI decides to             How   to prepare a funding award consistent with applicable
  Budget                                      pursue funding                     policies and regulations
  Proposal/ Protocol Review,                 Aftera funding                    The  proposal review and submission process, which helps ensure
  Approval and Processing                     proposal is developed              the proposal has the greatest chance of success
  Award Acceptance and                       With  the acceptance              How an award is established and when work can begin on an
  Establish Account                           of a research award                award
  Managing and Monitoring                    Once work on an                   The on-going management — i.e., generally and financially — of
  Projects                                    award has begun                    an award, including how to account for cost sharing
  Award Close-out                            Once  an award                    What    to do when an award is completed
                                              expires
                                                                                                                                                             255
                                                                                                     Cost Principles


Allowability of direct and indirect costs is determined by OMB Circular A-21,
University, sponsor and other applicable policies


         Allowability Determinants               Policy/ Regulation           Unallowable Cost Examples
   Costs must be:                             A-21 Section J.1-50 —       Most advertising costs
     — Reasonable                              General provisions for
                                                                           Alcohol
     — Allocable to sponsored agreements       selected items of cost
     — Given consistent treatment through                                  Fundraising activity
       application of the generally accepted
                                                                           First class airfare
       accounting principles appropriate to
       the circumstances                       Agency-specific             NIH salary limitation
                                               policies
   Costs must conform to any limitations or
    exclusions set forth in A-21, the          University policies         Employee morale (party/ outing)
    sponsored agreement or other policies as                                costs greater than $27/person
    to types or amounts of cost items          Terms & conditions of       Some grants prohibit foreign travel
                                               individual awards




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                                                                                                                   253
                                                                                         Cost Principles


Consistency is determined by how costs are treated in similar circumstances —
e.g., like costs cannot be direct charged in one case and indirectly in another



  OMB Circular A-21 Definition                         Determinants of Consistency
All costs incurred for the same          Key to            Key: understanding distinction between a
purpose, in like circumstances, are      Consistency        DIRECT and INDIRECT cost
either direct costs only or F&A costs
only . . . but cannot be both (Section   Applicable        A-21 provisions (Section F.6.b.,
C.11.a)                                  Rules and          Appendix A)
                                         Regulations
                                                           University policy on what constitutes a
                                                            direct cost




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                                                                                                                       Cost Sharing


According to OMB Circular A-110, cost sharing occurs when a cost specifically
benefits a sponsored project, but is not charged to that project

                                            Occurs when the University or some other entity
                                             bears the cost
                                            Is normally in the form of a direct cost, such as
   Cost Sharing                              salary or capital equipment
   Parameters:
                                            With sponsor approval, it may take the form of F&A
                                             costs where reimbursement is waived or reduced
                                            Cost sharing is basically equivalent to ―matching‖

                                                       Types of Cost Sharing
   Type                     Definition                                             Special Considerations
Mandatory      Required   by sponsors as a matter         N/A
                of statute, regulation or policy; or
               Is indicated in individual
                solicitations
Voluntary —    Not required by sponsors                   Becomes   a commitment that must be met if the proposal is accepted
Committed      Offered by PIs in proposals

Voluntary —    Not required by a sponsor                  Occurs  when actual effort toward a project is greater than the effort
Uncommitted    Not offered in a proposal                   commitment in the proposal
                                                           Does not have to be tracked on activity reports or included in F&A
                                                            rate base
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                                                                                                    F&A Rate


The Facilities and Administrative (F&A) rate provides the reimbursement basis
for NU expenses that cannot be identified specifically with a major function



                                           F&A Rate Highlights
         Establishment       Established thru periodic negotiation with Northwestern‘s cognizant
                              agency (DHHS)
                             Based on periodic calculation, submission and negotiation process
         Interpretation      For every dollar received in direct sponsored research dollars,
                              Northwestern receives an additional amount as recovery of the
                              indirect costs of the sponsored research that are incurred by the
                              University
                             Example
                               — Northwestern‘s FY08 on-campus Federal F&A rate is 51.0%
                               — Northwestern can charge the sponsor $0.51 for every $1.00 of
                                 salary, fringe, and other direct cost




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                                                                                                               256
                                                                                F&A Rate


Understanding the purpose of funding is not only important to proper research
administration but also to the overall University


The Function Code
   Indicates the type of activity that is supported by the account
   Cost Studies Usage:
     — Determine how accounts are treated in the research Facilities & Administrative
       (F&A) or indirect cost rate calculation
   Accounting Services Usage:
     — Determine how accounts are treated in the preparation of the annual Financial
       Report




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                                                                                           257
                                                                                                                     F&A Rate


There are four major functions of an institution of higher education of which
Organized Research is one

                  Institutional Activity                                         Definition
                  Instruction               Teaching   and training activities of an institution except for research training
                                            Departmental    and University research are also considered part of this major
                                            function
                  Organized Research           research and development activities of an institution that are separately
                                            All

  Today’s Focus                             budgeted and accounted for, including:
                                              — Sponsored research
                                              — ―University‖ research

                  Other Sponsored           Programs and projects financed by Federal and non-Federal agencies and
                  Activities (OSA)          organizations, which involve the performance of work other than instruction
                                            and organized research
                                            Examples    include health service projects and community service programs
                  Other Institutional       Other   institutional activities means all activities of an institution except:
                  Activities (OIA)            —    Instruction, departmental research, organized research, and other
                                                   sponsored activities
                                              —    F&A cost activities
                                              —    Specialized service facilities
                                            Examples  include operation of residence halls, intercollegiate athletics, and
                                            other similar auxiliary enterprises




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                                                                                                                                 258
                                                                          F&A Rate


F&A (Indirect) Costs are expenses incurred for common objectives and cannot be
identified specifically with a major function of the institution


                    Costs                 Cost Pools            Formula



               Facilities Costs
                                          Instruction
  Building    (depreciation)
  Equipment     (depreciation)
                                                               F&A Costs
                                                              Supporting
  Interest
                                                           Organized Research
  Operations    & Maintenance            Organized
  Library                                Research
                                                             Direct Costs of
                                                           Organized Research
                                                                (MTDC)
                                             Other
                                           Sponsored
          Administrative Costs
                                           Activities
  General    Administration
  Department    Administration
                                             Other
  Sponsored    Projects Administration   Institutional
  Student    Services                     Activities


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                                                                                     259
                                                                                      F&A Rate


Generally, NU requires applicable sponsored projects to carry the full F&A rate
because of the financial and other impacts of recovering those costs


Impact
   Recovery of costs already incurred by the University, which benefited the sponsors
   Negotiated rate is almost always at a rate less than the actual calculated rate
   F&A recovery is a critical component of the University‘s budget and necessary to
    support a sustained investment in the research enterprise




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                                                                            Cost Transfers


A variety of actions can result in potentially problematic cost transfers, including
those which are done to circumvent cost transfer rules and regulations


 ―Parking   charges‖ until funding available
   —   Funds not available at a particular time, so costs charged to a
       different account until funds are available
 Circumvent    90 day pre-award spending limitations
 Charging    based on fund availability
   —   If funds are depleted in one account, use a different account to
       absorb charges




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                                                                                    Recharge Centers


Recharge service centers are operating units providing goods and services to
University users and external users on an incidental basis



                                     Recharge Service Centers
                  Type                                             Example
                                                   Printing and copy centers
      Recharge Center/Service
                                                   Computing services
      Facility
                                                   Machine and instrumentation shops
                                                   Center for Comparative Medicine (CCM)
      Specialized Service Facility                 Northwestern University Information
                                                    Technology (NUIT)




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                                                                                                    Recharge Centers


Differences between Recharge Center/ Service Facilities and Specialized Service
Facilities are generally based on the following factors

                                  Recharge Service Center Differences
                                                              Type
  Category
                   Recharge Center/ Service Facility                       Specialized Service Facility
Purpose         Provide goods and/ or services not                 Provide highly complex and technical
                 representing the major purpose of the               services, not usually available from outside
                 generating department as a convenience              vendors
Customers       May be available to a select group of users        Typically applies to a select group of users
                 or to the University in general
Rate Basis      Based on direct costs — i.e., the internal         Based on direct and indirect costs — i.e.,
                 service center support costs                        the internal service center support costs &
                                                                     NU F&A costs




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                                                                                                                   263
                                                                                                                      OPRS/ IRB


Regulations governing research involving humans are an outgrowth of the WWII
war crimes trials and use respect, beneficence, and justice as guiding principles
                                              Hallmark Regulations Related to
                                                Human Subjects Over Time
  1946                                                                                                                        1981


 1946 —                   1953 —                 1966 —                       1974 —                1979 —            1981 —
 Nuremberg                NIH adopts             PHS                          National              Belmont           Common
 Code created             review by              requires                     Research Act          Report            Rule issued
                          scientist              independent                  created               issued
                          panels                 review and
                                                 informed
                                                 consent


 Key Human Subjects Regulation                                                  Details
 Nuremberg Code created                  US code outlining basic ethical requirements for research involving human subjects
                                    First
                                    Resulting from the World War II Nuremberg war crimes trials

 NIH adopts review by scientist     Ensure    that proposed research is reviewed by peer scientists for scientific necessity and
 panels                                potential affects on human subjects
 PHS requires independent           Ensurepatients are aware of and agree to anticipated risks related to the research
 review and informed consent        Manage conflicts of interests for research reviewers

 National Research Act created      Requires  the use of IRB panels by institutions performing federally funded research using
                                     humans subjects
                                    Establishes a federal office charged with oversight of IRB process

 Belmont Report issued              Articulates  the principles of ―respect, beneficence, and justice‖ when planning for and
                                       conducting research involving human subjects
 Common Rule issued                 Assigns   institutional responsibility for IRB processes to ensure human subject research
                                       proposals and conduct are consistent with the Belmont Principles
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                                                                                                                         OPRS/ ACUC


Regulations governing the use of animals in research stem from the public’s desire
for animals to be treated humanely and have been strengthened over time
                                                Hallmark Regulations Related to
                                                 Research Animals Over Time
 1966                                                                                                                                1991


 1966 —Laboratory                 1973 — PHS              1979 — PHS             1985 — Federal                      1991 — USDA
 Animal Welfare Act               Policy on Humane        Policy on Humane       Principles for the                  creates Part 3
 (PL 89-544)                      Care and Use of         Care and Use of        Utilization and                     Standards and
                                  Laboratory              Laboratory             Care of Vertebrate                  amends Part 2
                                  Animals                 Animals Amended        Animals Used in
                                                                                 Testing, Research
                                                                                 and Training


        Key Animal Regulation                                                      Details
Laboratory Animal Welfare Act            regulations created to protect animals in research
                                     First
(PL 89-544)                                    did not extent to animals, such as mice, rats and fish
                                     Protection
                                     Names USDA as the responsible agency

Public Health Service Policy on      PHS  issued guidelines — not regulations
Humane Care and Use of               Created standards for the treatment of animals not explicitly covered under Animal
Laboratory Animals                    Welfare Act, such as mice, rats and fish
PHS Policy on Humane Care            Mandated     the creation and maintenance of an Animal Care and Use Committee to:
and Use of Laboratory Animals           —     Ensure animals are used only when scientifically necessary
Amended                                 —     Minimize stress to any one particular animal
Federal Principles for the           Provided  greater detail and guidance for complying with animal related rules and
Utilization and Care of               regulations, such as:
Vertebrate Animals Used in              — How animals may be transported
Testing, Research and Training          — Under what conditions can multiple surgeries be performed

USDA Creates Part 3 Standards        Requires    all institutions to have an on-site, qualified veterinarian to properly care for
and Amends Part 2                     animals
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                                                                               OPRS/ ACUC


OPRS/ ACUC Submission Helpful Hints



 Application must be approved before any animal activity may begin, including
  opening animal object codes
 Application sometimes must be approved, or at least submitted, before proposal can
  be submitted
 For NIH:

   — Approval by the ACUC can happen after the submission of a proposal to NIH

   — Best time to submit a protocol is at the time the PI is informed of their NIH Score

   — PI has 90 days to supply JIT information to NIH




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                                                                                                       Travel Req.


There are specific regulations governing travel related expenses charged to
Federally sponsored awards

Note:   The United States, U.S. Territories and Canada (USTC) are considered Domestic Travel


                                                   Travel Defined
                              Domestic                            Foreign
                            Travel within      Travel between     OR      Travel between
                             USTC                USTC and any                points outside
                                                 other country               USTC



                          Specific Requirements                                   Special Considerations
           All travel must be completed within the beginning and               Rental vehicles
            end dates of the award
                                                                                Field expenses
           US Flag Air Carriers must be used on Federal awards
                                                                                Registration Fees
           Reimbursement to individuals must not be made prior
                                                                                Local Travel
            to completion of travel
           $65 limit on per person dinner expense, no Alcohol
           Original receipts required


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                                                                                                                        Direct Charging


To determine whether or not a cost can be directly charged to a grant, review the
set of key criteria before making the decision

  Direct Charging Key Criteria                                                   Implication
 Does the cost make sense for         An  answer of no indicates that the cost is probably unreasonable and should not be charged
 the project?                          to the grant
 Is the cost too much to pay?         An  answer of yes may indicate that the cost is unreasonable and should not be charged to
                                       the grant
 Is the cost allowable?               Check  OMB Circular A-21, Section J as well as agency policies, university policies and
                                       the grant‘s terms and conditions
                                      Costs listed as unallowable cannot be charged directly to a grant

 Did the cost directly benefit the    If   the answer is yes, the cost must still be allowable, reasonable and allocable
 project?
 How much benefit?                    Costs that do not benefit a particular grant to any great degree should not be directly
                                       charged to a grant
                                      Costs greatly benefiting a grant, still must be allowable, reasonable and allocable

 Does the University direct           Regulations    require that like costs be treated the same in like circumstances
 charge other costs like this?              — For example, if similar costs are included in the indirect cost recovery, they cannot be
                                              directly charged to a grant




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                                                                                                                                     270
                                                                                   Direct Charging


To determine whether or not a cost can be directly charged to a grant, review the
set of key criteria before making the decision



               Direct Charging Key Criteria
 The cost makes sense for the project
                                                       
 The cost is not too much to pay
                                                       
 The cost is allowable
                                                          Cost may be charged to the
                                                           award if all criteria are met
 The cost directly benefited the project
                                                       
 There is significant benefit to the project
                                                       
 The University direct charges other costs like this
                                                       




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                                                                                                     Direct Charging


To determine whether to charge an award for a particular cost, faculty and staff
can follow a simple review process
   Decision Process for Direct Charging an Award

                                                                                        Charge the
       Reasonable?            YES          Direct or             DIRECT                 cost to the
       Allowable?                           F&A?                                     award using the
        Allocable?                       (consistency)                                 appropriate
             NO                                  F&A                                  expense object
                                Charge a non-sponsored account
                                   (dept. operating account)

                                                    Allowability
                       OMB Circular A-21 Section J                                       Key Criteria
      Discusses the allowability of certain types of common F&A and           Must be allowable under sponsor
       sponsored projects direct costs, such as alcohol and entertainment       policy
      Should be used as a reference tool                                                   AND
      If a type of cost is not specifically listed, assess the basic          Allowable under NU policy
       considerations of A-21:
                                                                                            AND
         — Allowability under other applicable policies and guidelines
         — Allocability                                                        Allowable under individual award
         — Reasonableness                                                       terms
         — Consistency
                                                                                                                   273
                                                                                                        Direct Charging


Direct Charging: Supplies Example

                                                                                                     Example

   PI — I’m new here. I need to talk with you about how to charge my lab supplies. I’m certain I can charge
    them to my grants like at my last university.
   A — Well, I’ll need to know a little about the types of grant funds you have. Also, what are the supplies, and
    how will they be used?
   PI — Well, all my grants require general supplies. I even put it in my proposal on my R01 and the sponsor
    approved it.
   A — I understand…but if the supply expenses aren’t consistent with our direct cost guidelines here, they can’t
    be charged to the grant. Federal regulations require us to treat costs consistently across the entire institution.
    An individual sponsor can’t know our policies, they expect us to be consistent.
   PI — OK, I’m familiar with the charging guidelines. But what about the paper costs for my survey responses
    from 500 study participants?
   A — You can charge that cost because it’s necessary, unusual in circumstance, greater in amount than usual,
    and directly related to the goals of the research. Let’s just make sure we clearly document the purchase.




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