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					    NIH Update – Spring 2008
Office of Policy for Extramural Research Administration

                    Marcia Hahn, Director
                  Division of Grants Policy
  Office of Policy for Extramural Research Administration


                                                     OPERA
NIH Budget News
    and Priorities


              OPERA
                  Final NIH Appropriations
                           FY 2008
    • NIH received a total of
      $29.457 billion
      • Increase of $329 million from
        FY2007
    • Average competing award
      expected to increase by 1%
    • Average noncompeting
      award also increases by 1%
      but implementation will vary
      by IC.
    • No change to NRSA stipend
      levels or funding policies

3       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-036.html
                       FY2008 NIH Budget
                         $29.457 Billion
                                                     10%
                                                                 11%
       53%
    $15.61 B

                                                                  6%
                                                                 3%
                                                           10%
                                         2%   5%

         Research Project Grants (53%)   Research Centers (10%)
         R&D Contracts (11%)             Other Research (6%)
         Training (3%)                   Intramural Research (10%)
         Research Mgmt & Support (5%)    All Other (2%)
4
             Quick and Easy Search:
         New Tools to Search NIH Funding
    • Prototype reports, data and analyses website now
      available at: http://report.nih.gov/
    • Will replace the current Award Information and Data
      web page and will provide:
      – Quick access to “Frequently Requested Reports”
      – FAQs on how success rates are computed and questions
        on the NIH budget
      – Search tools for locating data and reports quickly and
        easily
      – Links to funding estimates for certain research areas,
        conditions, and diseases.
    • Foundation for broader NIH-wide Research Portfolio
      Online Reporting Tool (RePORT)

5
         President’s Budget Request for
                     FY 2009
    • Requested a total of
      $29.457 billion for NIH
      • Same as FY2008
    • Estimated 9,757 new
      and competing renewal
      Research Project
      Grants
      • Approximately 14 less
        than FY2008 and 566
        less than FY2007
6                               More at: http://officeofbudget.od.nih.gov
            President’s Budget Request
                      FY 2009
    Areas of Focus:
      – Bolster funding to new investigators especially in
        novel and recently emerging areas of opportunity – Goal
        of sustaining 1,500 new investigators each year achieved
        in FY 2007.
      – Encourage established investigators through
        investigator-initiated research projects, which remain the
        workhorse of NIH research.
      – Roadmap/Common Fund – Incubator for new ideas and
        initiatives that accelerate the pace of discovery
      – Global Fund for HIV/AIDS, Tuberculosis and Malaria
      – NRSA Funding Policy – Proposed 1% stipend increase
7                   More at: http://officeofbudget.od.nih.gov/ui/HomePage.htm
              NIH Priority: Roadmap for
                  Medical Research
    • “Version 1.5” Builds on Success of Original
      Roadmap
    • NIH is Focusing on Three Roadmap “Themes”:
       – Research Teams of the Future
       – Re-engineering the Clinical Research Enterprise
       – New Pathways to Discovery
         • Includes two recently added pathway areas, the
           Human Microbiome Project and New Initiative in
           Epigenomics.
    • New Roadmap programs to be selected in Spring,
      2008 – Stay Tuned!
8                                    More at: http://nihroadmap.nih.gov
                NIH Priority: Blueprint for
                 Neuroscience Research
    • Cooperative effort among 16 ICs to accelerate
      Neuroscience research.
    • RFAs in 2007-2009 will focus on three themes,
      respectively:
       – Neurodegeneration during disease and aging;
       – Neurodevelopment throughout the lifespan; and
       – Neuroplasticity, from molecular to behavioral levels.
    • Available neuroscience resources include: animal
      models; imaging tools; neuroinformatics
      (computational biology); core facilities; cells, tissue,
      and DNA; gene and protein expression; and
      training.
9                               More at: http://neuroscienceblueprint.nih.gov
     NIH Priority: Continued Focus
         on New Investigators




10   Available at: http://grants.nih.gov/grants/new_investigators/index.htm
                      Updated Definition of
                       “New Investigator”
     • Definition updated to provide more detailed guidance
     • “New” investigators cannot have successfully competed as a
       PD/PI for most research grants.
        – R03, R13/U13, R15, R21, R25, R34, R36, R41, R43 R55,
           or R66 grants
        – F05, F03, F31, F32, F34, F37, or F38 grants
        – K01, K08, K22, K23, K25, or K99/R00 grants
        – G07, G08, G11, G13, G20, S10, S15, X01, X02, C06, or
           UC6 grants.
     • PD/PI’s who did not initially compete for a major research
       grant but were later designated as PD/PI are still considered
       “new”.
     • All PD/PIs must meet the new investigator definition to receive
       special consideration on multi/PI grants.

11       Available at: http://grants.nih.gov/grants/new_investigators/resources.htm
             NIH/CSR Shortens Review
               for New Investigators
• New investigators unsuccessful in a R01 grant submission who
  are readily able to address the concerns and issues identified
  in the Summary Statement may shorten the time to the next
  review.
• Available for all CSR study sections reviewing new investigator
  R01 applications submitted for standard receipt dates (not
  including RFAs and PARs with special dates).
• Policies and practices include:
   – Resubmission applications to be considered at the next
     cycle must be submitted by March 20, July 20, or November
     20.
   – New Investigators who do not choose this option may use
     the standard resubmission dates for subsequent
     submissions (March 5, July 5, or November 5).

12   More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html
               Pathway to Independence
                     (K99/R00)
     • Facilitates timely transition from mentored postdoctoral
       research to independent research position at earlier stage.
     • Primary, long-term goal is to increase and maintain strong
       cohort of new and talented, NIH-supported independent
       investigators.
     • Provides up to 5 years of support consisting of two phases:
        – Initial phase (K99): 1-2 years of mentored support for
          highly promising, postdoctoral research scientists.
        – 2nd Phase (R00): Up to 3 years of independent support
          contingent on securing an independent research position.
     • Standard K Submission Dates (February 12, June 12,
       October 12)
     • Program Announcement PA-07-297
13       Qs and As at: http://grants.nih.gov/grants/new_investigators/QsandAs.htm
                NIH Director’s
          New Innovator Award (DP2)


     • Stimulates highly innovative research and supports
       promising new investigators.
     • Awards provide up to $1.5 million in direct costs for
       (up to) a 5 year project period.
     • Highly Popular: NIH received nearly 2,200
       applications in FY2007 and funded 29.

     • Program continues with applications due March 31,
       2008 (RFA-RM-08-114).
14       More at: http://grants.nih.gov/grants/new_investigators/innovator_award
          NIH Director’s Bridge Award (R56)
               Updated and Expanded
     • Continued, limited funding for new and established PIs who
       have submitted a competing renewal, who just miss the
       nominal funding payline for the IC.
     • Additional funded time for PIs to strengthen a resubmission.
     • Selectees will receive one-year of funding up to $500,000
       DC + applicable F&A (increased from $333,000)

     • Cannot apply, cannot self-nominate! Criteria:
        – Must have < $400,000 in other support (total costs) from
          all sources to fund research (increased from $200,000)
        – A1s and only the most meritorious A2s are now eligible
        – Applications submitted in FY2007 that are still being
          considered for funding & FY2008 submissions

15       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-037.html
New Scientific and Grants
   Management Policies


                     OPERA
           Enhancing Peer Review at NIH
      The Charge: “Fund the best science, by the
      best scientists, with the least administrative
      burden…”
     • Initial Public Consultation Period
        – RFI for public comment period in Summer, 2007
        – Regional Consultation Meetings held Fall, 2007
     • Final Draft Report submitted to Dr. Zerhouni in
       February 28, 2008 and available for public comment
       until March 17, 2008.
     • NIH will formally announce the new initiatives it
       plans to implement in Spring, 2008.
17                          More at: http://enhancing-peer-review.nih.gov
        Enhancing Peer Review: Selections
           from the Draft Final Report
     • Challenges identified in 7 broad areas:
       – Reducing administrative burden on applicants,
         reviewers, and NIH staff
       – Enhancing the rating system
       – Optimizing support at different career stages
       – Optimizing support for different types of science
       – Reducing stress on the support system of science
       – Meeting the need for continuous review of NIH
         peer review

18                         More at: http://enhancing-peer-review.nih.gov
          Enhancing Peer Review: Select
         Challenges and Recommendations
     • Recommendations under consideration for pilot
       testing and community feedback include:
       – Shortening the length of applications
       – Providing unambiguous feedback by scoring all
         applications and including a “Not Recommended for
         Resubmission” option
       – Eliminating “Special Status” of amended applications by
         considering all applications as “New”
       – Linking potential review service to most prestigious NIH
         awards
       – Employing an editorial board model for review of
         interdisciplinary research
       – Instituting a minimum effort requirement for investigators
         on RPGs
       – Pilot ranking early-career investigators against each other
19                              More at: http://enhancing-peer-review.nih.gov
            Continuous Submission Process
            for NIH Study Section Members
     Appointed members of chartered Study Sections may
      submit applications as they are developed and NIH
             will review within 120 days of receipt.
     • Chartered Study Section member must be the
       PD/PI. Multi-PI applications are eligible if one or
       more PD/PI is an appointed Study Section member.
     • Limited to R01, R21 and R34 (including AIDS-
       related) applications submitted for standard due
       dates.
     • Not available for temporary or ad hoc reviewers, or
       reviewers for other Federal agencies.
20       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-26.html
            Clarification of NIH Policy on Late
                  Application Submission
         NIH expects grant applications to be submitted
                            on time.
     • Late applications
        – Generally are not accepted, except in rare instances. Unaccepted
          late applications will be returned without review
        – Permission is not granted in advance
        – Must be accompanied by a cover letter with compelling reasons for
          the delay (including timing and nature of the cause of the delay)
        – Regular Standing Submission dates – Late applications must be
          received within two weeks of standing submission date
        – Expedited Standing Submission dates – Late applications must be
          received within one week of standing submission date.
     • NIH will not consider accepting late applications for the
       Special Receipt Dates for RFAs and PARs
21       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-027.html
                 Centralized NIH Database
                  of Human Genome Data
     •   Facilitates rapid and broad access to Genome-Wide
         Association Study (GWAS) datasets
     •   Policy addresses:
         –   Principles governing the repository
         –   Data sharing procedures and requirements
         –   Research participant protection and privacy
         –   Data Access Committees
         –   Intellectual property and publication rights
         –   Oversight and governance of repository
     •   Implementation guidance now available at:
         http://grants.nih.gov/grants/guide/notice-files/NOT-
         OD-08-013.html
22                           GWAS Website: http://grants.nih.gov/grants/gwas
            FY 2008 Legislative Mandates
     • Most provisions identical to existing requirements in
       Appropriations from FY 2005-2007
     • Ban on False and Deliberately Misleading Scientific
       Information
        – Similar to existing research integrity, fraud and false
          claims restrictions
        – No significant changes expected for grantees.
     • Restriction on Employment of Unauthorized Alien Workers
        – Similar to existing Immigration and Nationality Act
          requirements
        – No significant changes expected for grantees
     • NIH Public Access Policy
        – No longer optional – compliance mandated by law
23       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-041.html
             Revised Public Access Policy
        All investigators funded by NIH must submit to PubMed
        Central an electronic version of their final, peer-reviewed
              manuscripts upon acceptance for publication.
     • Applicable to peer-reviewed articles accepted for publication
       on or after 4/7/08, and arising from direct or indirect grant or
       contract funds active in FY 2008, and beyond.
     • Starting May 25, 2008, all applications and progress reports
       must include the PMC or Manuscript Submission reference
       number when citing NIH-funded articles
     • Compliance mandated by Public Law 110-161
     • Full-text articles to be made publicly available on NLM’s
       PubMed Central no later than 12 months after date of
       publication
24       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html
                       How to Comply
     • Address copyright issue: Institutions and
       investigators are responsible for ensuring that
       publishing/copyright agreements allow submission.
     • Submission of articles to NIH: Upon acceptance
       for publication, deposit final manuscript in NIH
       Manuscript Submission (NIHMS) system. Many
       journals will submit articles on behalf of author.
     • Citing Articles in Applications & Progress
       Reports: Beginning with 5/25/08 submission date,
       when citing articles authored or co-authored by the
       applicant(s) that fall under the Policy, include the
       PubMed Central ID or NIH MS ID number for each
       article.

25                           More at: http://publicaccess.nih.gov/FAQ.htm
              Registration of Clinical Trials
       The FDA Amendments Act (P.L. 110-85) mandates
      registration and results reporting at ClinicalTrials.gov
             by sponsors of applicable clinical trials.
     • Expansion of existing ClinicalTrials.gov registry.
     • Includes Phase II-IV clinical trials of drugs and devices
       subject to FDA regulation.
     • Increased number of data elements that must be submitted.
     • Not limited to trials for serious or life threatening diseases.
     • Competing applications and progress reports grants with NIH-
       funded trials must include a certification of submission.
     • NIH encourages registration in ClinicalTrials.gov of ALL
       clinical research trials funded by NIH, whether required under
       the law or not.

26       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html
                Registration of Clinical Trials
                        (continued)
     Detailed Requirements:
     • Effective December 26, 2007, all ongoing trials of drugs and
       devices for serious or life-threatening diseases are to be
       registered in ClinicalTrials.gov database
     • All other trials are to be registered within 1 year
     • New trials are to be registered within 21 days after the first
       patient is enrolled
     • Registration information must be posted publicly within 30
       days of submission for drug trials, or 30 days of FDA
       approval for device trials
     • Civil penalties to be levied for noncompliance if trials are not
       properly registered.
     • NIH will verify registration before funds are released. See
       requirements for competing applications and noncompeting
       progress reports at NIH Guide Notice NOT-OD-08-023.
27
               FY 2008 NIH Salary Cap
      Effective January 1, 2008, salary and wages on
      NIH grants limited to an annual rate of $191,300
                (equal to Executive Level I).
     • An individual's base salary is NOT constrained by the
       legislative provision for a limitation of salary. An
       institution may pay an individual's salary amount in
       excess of the salary cap with non-federal funds.
     • Grantees should provide information on full salary needs
       (if more than the cap) so NIH can adjust based on future
       limits.
     • Salary Cap Summary (Historical Information):
       http://grants.nih.gov/grants/policy/salcap_summary.htm

28     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-035.html
            Multiple Principal Investigators
              Supporting Team Science
     Goal: Encourage collaboration among equals when
      that is the most appropriate way to address a
      scientific problem, a “Team Science” approach.

     • NIH Implementation Plans for Recognition of Multiple PIs on
       Federally-Funded Research Projects
        – http://rbm.nih.gov/NIH_Multi_PIs.doc

     • Multiple Principal Investigator website and FAQs:
       – http://grants.nih.gov/grants/multi_pi/index.htm


29
          Elimination of Paper Notification of
                Award Letters (NoAs)
     • As of January 1, 2008, NIH is no longer
       providing paper notification of NoA letters.
     • NoAs are sent solely by e-mail and award
       letters are accessible through the eRA
       Commons.
     • All award recipients must be e-mail enabled!
       – Edit your institutional profile in the eRA
         Commons.
       – If already enabled, confirm that the address is
         correct.
30      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-002.html
                       Electronic FSR
                     Submission Required
     • As of October 1, 2007, NIH requires all
       Financial Status Reports (FSRs) to be
       submitted using the electronic FSR
       system in the eRA Commons.
     • Applies to both domestic and foreign
       grantees.
     • Does not apply to other Federal
       agencies.
31     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-078.html
            Federal Funding Accountability
            and Transparency Act (FFATA)
     Public Law 109-282 requires information on every
     grant, including 1) the amount, 2) descriptive purpose
     of the grant, and 3) name and location of recipient of
     primary performance location. This includes data on
     all subawards over $25,000.
     • Prepare for potential increased attention and scrutiny when
       data is made publicly available.
     • NIH is actively involved with a variety of Federal-wide
       committees to implement the act and is tailoring processes to
       meet its requirements.
     • FFATA may require form changes in the 424 (R&R) and PHS
       398 to capture performance site information. - Stay Tuned

32                                      More at: www.FederalSpending.gov
       Highlights of New and
Existing Grant Requirements


                        OPERA
               Financial Conflict of Interest
                    (FCOI) Activities
     NIH continues to enhance and promote compliance with
       the FCOI Regulation (42 CFR Part 50, Subpart F)
     • NIH system-wide review of FCOI policies, procedures, and
       guidance
     • eRA Commons FCOI module/reporting tool for grantees
       (implementation expected 10/08)
     • Updated FAQs and an online tutorial
        – For grants, cooperative agreements, and contracts
     • Articles in NIH Extramural Nexus
     • Web based reporting and tracking tool for NIH staff
     • Pilot Compliance Program on FCOI
     • NIH Targeted Site Reviews
     • FCOI mailbox (FCOICompliance@mail.nih.gov)
     • NIH Guide Notices
34      Web Postings and Resources at: grants.nih.gov/grants/policy/coi/index.htm
         Pilot FCOI Compliance Program
• NIH selected a number of institutions for review
  of their FCOI policy and related information.
     – Assess compliance with 42 CFR Part 50 Subpart F
     – An outgrowth of the NIH Targeted Site Reviews
     – Desk reviews, not site visits
• Results of the pilot program will be shared with
  the grantee community for educational
  purposes to enhance and improve FCOI
  compliance.

35     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-010.html
           FCOI Targeted Site Reviews
     • Targeted Site Reviews are an initiative to determine
       whether grantee institutions have:
        – Fully implemented the FCOI regulations as they pertain to
          grants and cooperative agreements (42 CFR Part 50
          Subpart F), and;
        – Complied with reporting requirements.
     • Eighteen site reviews completed in FY 2006
        – “Observations from NIH’s FY 2006 Targeted Site Reviews
          on Financial Conflict of Interest” have been posted on the
          OER Conflict of Interest page:
          http://grants.nih.gov/grants/policy/coi/index.htm
        – Guide Notice: http://grants.nih.gov/grants/guide/notice-
          files/NOT-OD-07-048.html

36                     FCOI questions for NIH?   FCOIcompliance@mail.nih.gov
                      AAMC-AAU Report
     • Protecting Patients, Preserving Integrity, Advancing Health:
       Accelerating the Implementation of COI Policies in Human
       Subjects Research (February 2008)
     • Calls on medical schools and major research universities to
       develop and implement institutional FCOI policies within the
       next two years and to refine individual FCOI standards
        – Policies on individual FCOI in human subjects research
        – Policies on institutional FCOI in human subjects research
        – Implementation of COI policies
     • Report includes practical resource information in its
       Appendices
                            Entire report available at:
37           http://www.aamc.org/newsroom/pressrel/2008/080228.htm
                       FCOI
             Definition of Investigator
 Investigator – Principal Investigator (PI) and any
 other person who is responsible for the design,
 conduct, or reporting of research funded by PHS, or
 proposed for such funding. The term “Investigator”
 includes the Investigator’s spouse and dependent
 children.
• An Investigator is not just the Principal Investigator or
  Senior/Key Personnel conducting the PHS-sponsored
  research.
• Recipient institutions are encouraged to broadly
  consider an individual’s role, rather than title, and their
  degree of independence when applying the definition.
38
                    FCOI Summary of
                 Reporting Requirements
     1. At the time of application: Investigators must
        submit known significant financial interests to
        the institution.
     2. Prior to the expenditure of funds: The
        institution must report a financial conflict of
        interest to the NIH and assure that it has been
        managed, reduced, or eliminated.
     3. FCOI identified after the initial report: The
        institution must report within 60 days of
        identification and assure that it has been
        managed, reduced, or eliminated.

39     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-013.html
                   FCOI - Subrecipients
     • If the grantee institution performs NIH-funded
       research through “subgrantees, contractors, or
       collaborators,” the grantee institution must take
       reasonable steps to ensure compliance by
       requiring either:
       – Subrecipient Investigators to comply with the grantee
         institution’s policy OR
       – Subrecipient institutions to provide assurances to the
         grantee institution that will enable it to comply

      Subrecipients should report identified FCOIs to grantee
          institution. Grantee institution reports to NIH.
40
                         FCOI
              Information to be Reported
     • All FCOI reports should include the
       following information:

       – Grant number;
       – Name of Principal Investigator (PI) or contact PI if
         multiple PI award;
       – Name of Investigator with the FCOI; and
       – Distinguish which method was used to protect the
         research from bias (e.g., managed, reduced, or
         eliminated).



41
             OIG Report - NIH: Conflict of
           Interest in Extramural Research
     • Recommendations in January 2008 report
       – Increase oversight of grantee institutions to ensure their
         compliance with Federal FCOI regulations.
       – Require grantee institutions to routinely provide details
         regarding the nature of FCOI and how they are
         managed, reduced or eliminated.
       – Require Institutes to forward to the Office of Extramural
         Research (OER), NIH, all FCOI reports received from
         grantee institutions and ensure OER’s database includes
         all FCOI reports provided by grantee institutions.


42     Full report available at: http://oig.hhs.gov/oei/reports/oei-03-06-00460.pdf
          FY 2008 OIG Audit Work Plan
              Selected Highlights
• Colleges’ and Universities’ Compliance with Cost Principles
   – Cost transfers, effort reporting, and other areas
• University Administrative and Clerical Salaries
   • Are salary costs appropriately charged?
• Use of Data and Safety Monitoring Boards in Clinical Trials
• NIH Monitoring of Extramural Conflicts of Interest
   – How NIH monitors extramural grantees’ FCOI and the
     effectiveness of NIH’s oversight
• Grantee Management of Financial Conflicts of Interest in
  Research Funded by the NIH
   – Monitoring of FCOIs, nature of FCOIs, and how FCOIs
     managed (for FCOIs reported to NIH in FY 2006)

43           FY 08 Work Plan: http://oig.hhs.gov/publications/workplan.html#1
                    Audit Requirements

        All NIH Grantees that expend $500,000 or
        more within a year in Federal awards are
              subject to an audit requirement.
     • Audits are due within the earlier of 30 days after
       receipt of the auditor’s report(s) or 9 months after
       the end of the grantee’s audit period.
     • Grantees delinquent in submitting audits risk the
       imposition of sanctions and potential loss of
       Federal funds.


44
               Summary of Audit Requirements
     Grantee Type      Source of Audit       Where to Submit Audit Reports
                        Requirement
     State & Local    OMB Circular A-133          Federal Audit Clearinghouse
     Governments                                  1201 E. 10th Street
     Colleges &                                   Jeffersonville, IN 47132
     Universities                                 Questions:
     Non-Profits                                  1-800-253-0696
     Hospitals
                                             National External Audit Review Center
     For-Profits                             HHS Office of Inspector General
                     45 CFR Part 74.26 (d)   HHS Office of Audit Services
                                             1100 Walnut Street, Suite 850
                                             Kansas City, MO 64106-2197
                                             Phone: 800-732-0679/816-426-7725

     Foreign         NIH Grants Policy
                     Statement (same as          (same as For-Profits)
45
                     For-Profits)
                   Closeout Final Reports

        Grantees are strongly encouraged to submit
     closeout documents electronically through the eRA
                         Commons!
• Documents are due within 90 days of
  project period end date
     – Final Financial Status Report (now required
       electronically)
     – Final Inventions Statement & Certification
     – Final Progress Report
• Failure to submit timely reports may
  affect future funding to the organization!
46     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-051.html
           NIH Centralized Processing Center
     • Announced in NIH Guide 4/2/2008:
       http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-
       061.html
     • NIH strongly encourages electronic submission of closeout
       documents through the eRA Commons.
     • Centralized office accepts receipt of all non-financial, paper-
       based closeout documents
        – Final Progress Report
        – Final Invention Statement and Certification
     • Mail to the Central NIH unit at:
        NIH Centralized Processing Center
        6705 Rockledge Drive, Room 2207, MSC 7987
        Bethesda, MD 20892-7987 (for regular or US Postal Service Express
          mail)
        Bethesda, MD 20817 (for other courier/express mail delivery only)


47
               NIH Policy on Data Sharing
          Investigators submitting a research application
       requesting $500,000 or more of direct costs, in any
       single budget period to NIH, must include a plan for
      sharing final research data for research purposes, or
              state why data sharing is not possible.

     Applicant Resources:
     • Data Sharing Chart: Quick guide for identifying data sharing
       regulation/policy/guidance documents applicable to NIH
       funding http://grants.nih.gov/grants/policy/data_sharing/data_sharing_chart.doc
     • Data Sharing Main Page: http://grants.nih.gov/grants/policy/data_sharing

48        More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
               NIH Policy on Sharing of Model
                         Organisms
     Investigators submitting an NIH application/proposal
      are expected to include a specific plan for sharing
       and distributing unique model organism research
         resources generated using NIH funding in the
      application/proposal OR state appropriate reasons
       for why such sharing is restricted or not possible.

     Applicant Resources:
     • Data Sharing Main Page available at:
       http://grants.nih.gov/grants/policy/model_organism/index.html
        – Frequently Asked Questions
        – Sample Sharing Plans
49       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html
Requirements and Compliance
 Assistance for OHRP / OLAW



                       OPERA
                       OLAW
                Compliance Assistance
 • “What Investigators Need to Know About the Care and Use of
   Laboratory Animals”
     – Brochure explains the requirements for using animals in
       PHS-supported research
    – Contact OLAW to request multiple copies
 • FAQs on “PHS Policy on Humane Care and Use of
   Vertebrate Animals” available on the OLAW website
 • IACUC 101 is a series of workshops on the roles and
   responsibilities of IACUCs, including federal policies and
   regulations regarding animal welfare.
     – March 26, 2008: Atlanta, GA
     – April 15, 2008: Galveston, TX
51                                           More at: http://olaw.nih.gov
           Policy on UnAllowable Costs for
             Activities Involving Animals
        Institutions are not permitted to charge grants or
         contracts for animal activities when terms and
                     conditions are not upheld.
     • Absence/suspension of valid Assurance filed with OLAW
     • Absence/suspension of valid IACUC approval of the animal
       activity:
        – Failure to obtain IACUC approval for animal activity.
        – Continuing animal activities after IACUC approval has expired.
        – Continuing animal activities after suspension of IACUC approval.
     • Institutions must report noncompliant situations to:
        – OLAW (olawdco@mail.nih.gov or 301-594-2061)
        – Institute/Center (IC) supporting the award
52                           More at: Notice NOT-OD-07-044 at http://olaw.nih.gov
             Consortium Agreements:
           Subawards and Animals (Cont.)
     • Prime grantee is accountable to NIH and must confirm
       Assurance and IACUC approval (dated within 3 years)
     • Animal welfare requirements apply to all consortium
       participants and sub-projects
        – Inter-Institutional Assurance is needed:
            • Prime grantee has no animal program; animal work is
              being conducted at an Assured performance site
        – Foreign Assurance is needed:
            • Direct support to a foreign institution
            • Domestic prime grantee with a foreign performance
              site using animals (Domestic grantee’s IACUC
              approves animal activities performed at foreign site)
53       GPS Page 224 at: http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
            Public Outreach Materials from
                        OHRP
     • Informational
       pamphlets on
       becoming a
       research volunteer.
     • Call OHRP at
       (800) 447-477 for
       up to 50 free
       copies.
     • Now available in
       Spanish!

54                           More at: http://www.hhs.gov/ohrp/outreach/
           New Online Tutorial on Protecting
            Human Research Participants
     • Free, on-line tutorial now available that satisfies the
       NIH human subjects training requirement
     • Designed for those involved in the design and/or
       conduct of research involving human participants.
     • Replaces the NCI Human Participant Protections
       Education for Research Teams Course previously
       available for this requirement.
     • Available at:
        – http://phrp.nihtraining.com/users/login.php

55      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-054.html
Application Forms and
Electronic Submission


                 OPERA
         Changes to NIH Application Forms
• New PHS 398 forms approved for optional use until
  May 24, 2008. Use will be mandatory for submission
  dates after May 25.
     – Changes will also be incorporated into PHS 398 components
       used in the SF424 (R&R) form set. Grants.gov development
       of these forms is pending.
     – The new PHS 2271 form is currently available and must be
       used for appointments made on/after May 1, 2008.
     – The PHS 3734 and HHS 568 forms have also been renewed
       and are now available.
• New PHS 2590 forms available and required for all
  progress reports.

57                    All Forms Available at: grants.nih.gov/grants/forms.htm
                    Upcoming eSubmission
                       Form Changes
     Transition to Adobe-based 424(R&R) forms continues
       but no firm dates set yet.

     Things we are trying to coordinate into a single
       transition:
     • Transition of current PureEdge-based 424 (R&R) applications
     • FFATA will require form changes in the 424 (R&R) to capture
       performance site information
     • Other 424 (R&R) changes also possible during OMB renewal
     • A few OMB-approved changes to the PHS 398 components

     • F, T, and K transition still on hold
     • Transition of Complex Mechanisms still on hold.

58                            Stay Tuned!
                  Helpful Hint:
          Read & Follow All Instructions!
     • Avoid having to submit corrected
       applications – read and follow all
       application guide and
       announcement instructions
       – Look for the HHS logo in the
         application guide for any special
         instructions or fields not marked as
         mandatory on the federal-wide
         form that are required by NIH
59               More at: http://grants.nih.gov/grants/funding/424/index.htm
                     Helpful Hint:
                 Avoid Common Errors
     NIH-specific requirements:
     • Use PDF format for text attachments
     • R&R Senior/Key Person Profile(s) form
       – Include eRA Commons Username in the
         “Credential, e.g. agency login” field for all
         individuals assigned a PD/PI role.
       – Include the Organization Name for all Senior/Key
         Persons listed
     • R&R Budget form - Senior/Key Person effort
       must be greater than zero
60            More at: http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm
                      Helpful Hint:
                 Track Your Application
     • Clicking “Submit” is NOT the last step!
       – It is the applicant’s responsibility to track the
         application through the submission process
       – Use eRA Commons to check for submission
         errors/warnings and to view your assembled
         application

     • If you can’t view your application in eRA
       Commons – we can’t review it!

61                             More at: http://era.nih.gov/ElectronicReceipt/
                     Recent Changes

     • Responded to applicant
       feedback…
       – Reduction of correction window
         in eRA Commons from 5 days
         to 2 days.
       – Enhanced application guide
         instructions
       – Extended application viewing
         times through Federal holidays

62                         More at: http://era.nih.gov/ElectronicReceipt/
eRA Commons



        OPERA
             Servicing Other Agencies

• Continuing to service HHS partners
     – Agency for Healthcare Research & Quality (AHRQ)
     – Centers for Disease Control and Prevention (CDC)
     – Food & Drug Administration (FDA)
     – Substance Abuse & Mental Health Services
       Administration (SAMHSA)
     – Veteran’s Health Administration (VA)



64
                 Enhanced eRA Commons
                    Features – 10/2007
     • Electronic Streamlined Non-competing Award
       Process (eSNAP)
       – Changes to Institutional Profile
         Assurances/Certifications
       – Updated to include changes to multi-PI Leadership
         Plan and research with Select Agents
     • Delegation of PI status to assistant for
       reviewing electronic applications
     • Ability to monitor the electronic submission of
       reference letters
65      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-064.html
                  Enhanced eRA Commons
                      Features (cont.)
• Updated Status screens.
     – Added ability to search and track applications by
       Grants.gov tracking number.
     – Reorganized application/grant data to separate
       applications requiring further action in the
       submission process from all others.


• While the screens may look different, all the
  information you’re used to seeing is still
  available (plus more!)
66     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-007.html
                  Coming Soon: X-Train

     • X-Train is a new system to improve the
       administration of NIH Training Grants.
       – Allows PIs and staff to electronically submit
         appointment forms and termination notices
       – Allows institutional staff to track status and timing
         of appointment actions
       – Will be available through eRA Commons
     • Pilot begun December 2007 with over 90
       training grants at 9 universities.
     • Full production release expected Spring 2008
67
                       Reminder:
                  Profile Maintenance
     • PIs have an obligation to keep information in
       their Personal Profile current and need to
       update it regularly
     • Profile data used in other electronic
       processes (e.g., Summary Statements,
       eNotifications)
       – Degrees
       – Position Titles
       – Addresses - e-mail & postal

68
Technical Assistance and
     Training Resources


                    OPERA
                       SBIR/STTR
                Pipeline to Partnerships
     • Showcase of SBIR/STTR grantee technology
       available to potential strategic partners and
       investors for development opportunities.
     • Searchable index organized by technology and
       stage of development.




70                More at: http://www.ott.nih.gov/p2p/p2p_writeup.html/
              Redesigned OER Web Site

     • Office of Extramural Research home page
       – Links to funding opportunities, grants policy,
         application and forms, awarded grant data
     • Redesign based on focus groups and visitor
       feedback
       – New search tools
       – Comprehensive glossary and acronyms list
       – New content walks through the NIH grant-
         making process
     • Also improved & updated eRA web site
71                         Visit at: http://grants.nih.gov/grants/oer.htm
72   OER web site located at http://grants.nih.gov/grants/oer.htm
               Redesigned eRA Web Site

     • Services for Applicants - 'plain language' fact
       sheets on eRA services
     • Commons - overview, quick link to system,
       user guides, release notes, FAQs and other
       resources
     • NIH & Grantor Agencies - highlights services
       and system modules available for NIH staff and
       other Federal agencies
     • News & Events - eRA updates and info on
       upcoming workshops/seminars
73                                         Visit at: http://era.nih.gov/
                       Summary of
                  Helpful NIH Web Pages
     • NIH Searchable Database of RFAs, PAs, and Guide Notices
        http://grants.nih.gov/grants/guide/index.html
     • NIH Grants Policy Statement (Rev. 12/03)
       http://grants.nih.gov/grants/policy/nihgps_2003/index.htm

     • NIH Extramural Nexus – Bimonthly newsletter for the extramural
       community
       http://grants.nih.gov/grants/nexus.htm

     • Electronic Submission of Grant Applications Homepage
       http://era.nih.gov/ElectronicReceipt/index.htm

     • CRISP database - Search to analyze an Institute’s portfolio of
       funded projects, research areas, and more
       http://crisp.cit.nih.gov/crisp/crisp_querty.generate_screen

     • Grant Application Basics
       http://grants.nih.gov/grants/grant_basics.htm
74
           New OER Outreach Webpage
              New OER Outreach Webpage
     • NIH Regional Seminars on Program Funding and Grants
       Administration
        – Funding Opportunities for New Investigators
        – Application Preparation and the Review Process
        – Grant Administration Issues, Hot Topics, and More…
     • National Animal Welfare Workshops
     • Office of Human Research Protections Workshops
     • NIH Small Business Research Workshops
     • Office of Research Integrity Workshops and Conferences

75                     Visit at: http://grants.nih.gov/grants/outreach.htm
           NIH Regional Seminars on Program
           Funding and Grants Administration

                          2008 Regional Seminars:
                      March 25-26, 2008 in San Antonio, TX
                         June 19-20, 2008 in Chicago, IL
                    NIH electronic research administration labs
                 offered in conjunction with the two-day seminar.
     • Yearly seminars to educate research administrators,
       investigators new to NIH, and trainees.
     • Due to the popularity of these seminars and availability
       of space - Early Registration is Highly
       Recommended!                               Interested in hosting?
     • Seminar and Registration Information:                          Contact us!
       http://grants.nih.gov/grants/seminars.htm
76       More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-076.html
                NIH OER Listserv Addresses
                     and Instructions
     •   Office of Biotechnology Activities (OBA):
         – https://list.nih.gov/archives/oba_news.html
     • Office of Human Research Protections (OHRP):
         – http://www.hhs.gov/ohrp/news/distributionlist.html
     • Office of Laboratory Animal Welfare (OLAW):
         – http://grants.nih.gov/grants/olaw/references/list.htm
     • eSubmission:
         – http://era.nih.gov/ElectronicReceipt/listserv.htm
         – Separate listservs available for scientists and administrators
     • NIH Guide for Grants and Contracts:
         – http://grants.nih.gov/grants/guide/listserv.htm
         – The official publication for NIH medical and behavioral research
           Grant Policies, Guidelines and Funding Opportunities

77
                    Grants Information:
                     Who to Contact!
     • Institutional Resources – First, utilize the
       expertise of your organization’s Office of
       Sponsored Programs

     Application Specific Questions
     • Administrative - Contact the Grants Management
       Specialist at the awarding Institute/Center
     • Scientific/Programmatic - Contact the designated
       Program Official/Director at awarding
       Institute/Center
     • Review Questions - Contact the assigned
       Scientific Review Officer
78
                     Grants Information:
                      Who to Contact!
     • Grants Administration individuals at all NIH ICs:
       – http://grants.nih.gov/grants/staff_list_grants_admin.htm
     • NIH Chief Grants Management Officers:
       – http://grants.nih.gov/grants/stafflist_gmos.htm


     • Grants Policy Interpretation & Consultation:
       – E-Mail: GrantsPolicy@mail.nih.gov
       – Phone: 301-435-0949
     • Compliance Issues:
       – E-Mail: GrantsCompliance@mail.nih.gov
       – Phone: 301-435-0949

79
                   Grants Information:
                    Who to Contact!
 • General Application Questions: (e-Submission guidelines,
   resources & referrals, application review & award process,
   etc.)
     – E-Mail:   GrantsInfo@nih.gov
     – Phone:    301-435-0714
 • Customer Support for Grants.gov: (navigating forms, aspects
   of submitting through the system, resources available, etc.)
     – E-Mail: support@grants.gov
     – Webpage: http://grants.gov/
     – Phone: 1-800-518-4726
 • eRA Commons Help Desk: (Commons registration help,
   application verification, Commons functionality questions, etc.)
     – Webpage: http://ithelpdesk.nih.gov/era/         Enter your own
     – Phone: 301-402-7469 (Toll Free: 866-504-9552)     help ticket!

80
           Thank You!


Any Questions?
                  OPERA
Frequently Asked
      Questions


            OPERA
                        #1 – How do I prepare for
                                  eSubmission?
     • Grants.gov requires a three-step registration
       process for the organization to submit electronically
     • eRA Commons registration is also required for both
       the organization and the PI
        – These are separate processes that can be done
          simultaneously.
     • All registrations must be completed prior to
       application submission.

     It is critical for institutions to begin these registrations
         at least 2 – 4 weeks before applications are due!
83                   More at: http://era.nih.gov/ElectronicReceipt/preparing.htm
                                  #2 – How do I submit a
                                 multiple-PI application?
     • Applications
        – NIH Grant Applications Forms (PHS 398 and SF424 R&R) accommodate
          more than one PI
        – Leadership Plan required describing roles, responsibilities, and the working
          relationship of the identified PIs.
     • Principal Investigators
        – The Contact PI will be responsible for communication between the NIH and
          the leadership team (and will be listed first on the application)
        – All PIs share the responsibility and authority for leading and directing the
          project.
     • New Investigator Policies
        – New Investigator box on the application may only be checked when all PIs
          are classified as New Investigators.
     • Review Criteria
        – Standard NIH review criteria have been modified accordingly.
     • Awards Involving More than One Institution
        – PIs from different institutions will be managed though subcontracts for now.

84                                       More at: http://grants.nih.gov/grants/multi_pi/
             #3 – Are there any fellowship programs for
            individuals from minority or disadvantaged
                                               groups?
                                 Yes.

     However, note that a revised FOA includes
     the following changes:
 •   Effective January 1, 2007: Now 3 submission dates--April
     13, August 13, and December 13.
 •   Added new bullet in “Content and Form of Application
     Submission” section to require information that must be
     submitted by applicant Institution in a letter certifying the
     applicant’s eligibility (See FOA for further details.)
 •   Updates information on Tuition/Fees and Institutional
     Allowance, published in the NIH Guide: NOT-OD-06-093.

85           FOA at: http://grants.nih.gov/grants/guide/pa-files/PA-07-106.html
                  #4 - Does NIH still accept
            unsolicited grant applications?
      Yes. Use Parent Announcements (available on
      Grants.gov and NIH web pages) for “unsolicited”
      or “investigator-initiated” applications.

       Other funding opportunity announcements include:
     • Program Announcements
       – Statement of new or ongoing NIH interest in a certain
         research area.
     • Requests for Applications (RFAs)
       – Statement soliciting applications in a well-defined
         scientific area to accomplish specific program objectives.

86                 All Available at: http://grants.nih.gov/grants/guide/index.html
                     #5 – Can foreign applicants
                      submit modular budgets?
                                     No.

     • Receiving detailed budgets from foreign
       applications allows NIH staff to assist applicant
       community with applicable regulatory and policy
       requirements for grant funding expenditure.

     • However, domestic (U.S.) institutions with
       subawards to foreign (non-U.S.) institutions may
       use modular budgets.

87     More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-096.html
                   #6 – Are fellowship candidates
           required to register in eRA Commons?
      Yes. Applicant organizations should
      register any individual fellows submitting
      applications to NIH and AHRQ

     • PI Role in the Commons does not provide special
       status – only a record in the system that provides
       administrative authority to see pertinent application
       documents (e.g. summary statements, scores,
       submission status, etc.)
     • Individual Fellows registered by any organization
       other than the sponsoring organization should not
       have more than one eRA Commons account.
88      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-003.html
           #7- Are consortium F&A costs included
             as part of an applicant’s direct costs?
       No. Applicants are to exclude the facilities and
       administrative (F&A) costs requested by
       consortium participants when determining if the
       budget exceeds a direct cost limit.
     • This policy applies to:
        – $250K direct cost calculation for modular budgets
        – $500K direct cost calculation for NIH data sharing
          policy and requirement to contact IC staff for
          unsolicited applications requesting over $500K
     • This policy does not apply to:
        – Small Business Innovation Research (SBIR) grants
        – Small Business Technology Transfer (STTR) grants
89      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html
                  #8 – May I reduce my level of
                          effort on a K award?
       Yes. Recipients may reduce their commitment of
       total professional effort in some circumstances.
     Requirements:
     • Individual has a full-time appointment with their institution.
     • The minimum percentage of effort commitment required
         for the K award is covered by that appointment.
     Alternatively:
     • In the last two years of support individuals may reduce the
         level of effort on most K awards and replace with an NIH
         research grant or subproject.
        –      Awardee must serve as a PI or subproject Director
        –      Effort may be reduced to no less than 50% and be
               replaced by effort from the research award so total
               effort commitment remains at or above 75%.
90      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html
              #9 – How do I calculate person-
          months in a 9-month academic year?
     • Person months are the metric expressing
       amount of effort faculty and other
       senior/key personnel devote to a project
     • How are person-months calculated?
       – Multiply the percentage of effort by the number
         of months of the appointment. For example:
         • 10% of a 9 month academic year appointment
           equals .9 person months (9 x .1 = .9 person
           months)
         • 10% of a 12 month calendar appointment equals
           1.2 months (12 x .10 = 1.2 person months)
91        More at: http://grants.nih.gov/grants/policy/person_months_faqs.htm
             #10- What are the requirements
            for recombinant DNA research?
     • Institutional Biosafety Committees must review and
       certify proposed recombinant DNA research.
     • Serious adverse events in human gene transfer
       research must be reported promptly!
        – Usually within 15 days, but
        – Within 7 days if life threatening or fatal.
        – Annual reporting is also required.
     • Full text of the guidelines are available:
        – http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.
        – Site also includes available training opportunities.

92      More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-067.html
               #11 – Does NIH have a cap on
                           consultant fees?
       No. There is no cap on consultant fees and the
       NIH salary cap does not apply.
     HOWEVER,
     • Grantees must have written policies for paying
       consultants that:
       – Are consistently applied regardless of fund source.
       – Include conditions for paying consultant fees.
     • Consultants must be properly classified.
       – Consultants are defined as individuals who provide
         professional services or advice for a fee, but normally are
         not employees of the organization. This also includes
         firms that provide advice or services.
93
           #12 – How different does a “new
                  application” have to be?
      “New applications” are expected to be
      substantially different in content and scope
     • More significant differences than normally
       encountered in resubmission applications.
       – Rewording the Title and Specific Aims is not sufficient.
       – Incorporating minor changes in response to reviewer
         comments is not sufficient
     • Research Plan changes should produce a
       significant change in direction and approach. All
       research plan sections should have substantial
       changes, particularly the Specific Aims and
       Research Design and Methods sections.
94
              #13 – As PI, what happens if I
             change institutions mid-grant?
      Prior, written approval is required for transferring
      legal and administrative authority for a grant to a
      different organization.
     • Transfer approval is not automatic and requires
       approval from both NIH and the original grantee
       organization.
     • Contact your GMO before moving to initiate the
       transfer process.
     • Grants to individuals may not be transferred but
       individual fellowships may transfer to a new
       sponsoring institution.

95

				
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