SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP Overview of Institutional Responsibility and Obligations Hortencia Hornbeak Ph D Associate Director for Scientific Re by pxx21398

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									 SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


                 Overview of
Institutional Responsibility and Obligations

          Hortencia Hornbeak, Ph.D.

Associate Director for Scientific Review and Policy
National Institute of Allergy and Infectious Diseases
            National Institutes of Health

                  March 3, 2007
 SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


               Discussion Points
 Overview
 Human Subjects
 Animal Welfare
 Costs Considerations
 Other Policy Requirements: Investigational New Drugs
 Systems for Policy Adherence Internet Resources
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP




             Overview
 SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


                 Capacity Building
 Maintaining a sustainable research portfolio
  includes:
    Securing   research funds
    Creating  an administrative infrastructure to comply
     with the policies of the awarding organization
    Each  awarding organization has their specific
     requirements
   SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP




           NIH Grants Policy Statement


 The NIH Grants Policy Statement (GPS) summarizes
  all policy requirements that serve as terms and
  conditions of NIH grant awards.
     SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


     NIH Grants Policy Statement Parts I and II
 Part I: NIH Grants - General Information
 Part II: Terms and Conditions of NIH Grant Awards
   Subpart   A: General
     Pre-Award Process               Civil Rights
     Overview of Terms and Conditions Environment Impact
     Public Policy Requirements      Availability of Information
     Ethical Conduct                 Other Policy
     Individual Rights                Requirements (IND, etc.)
     Human Subjects                  Notice of Grant Award
     Animal Welfare                  Payment
     Inclusion Requirements          Cost Considerations
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          Human Subjects
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


               Human Subjects

 NIH expects grantees to take appropriate
  action to protect privacy and ensure
  confidentiality of individuals participating in
  research projects.
 SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


               Human Subjects

 Department of Health and Human Services (DHHS)
  regulations for the protection of human subjects (45
  CFR part 46) provide a systematic means, based on
  internationally recognized ethical principles, to
  safeguard the rights and welfare of individuals who
  participate as subjects in research activities
  supported or conducted by NIH/DHHS.
  SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


                   Human Subjects

 The Office of Human Research Protections (OHRP) is the
  U.S. DHHS office that grants an Assurance of Compliance
  with HHS regulations. This Assurance is called a Federal
  Wide Assurance (also known as FWA).
 All sites that enroll human subjects or that work with
  identifiable human materials are required to have a FWA.
    Directions for obtaining a FWA, and a list of sites with
     FWAs is available at: www.hhs.gov/ohrp/assurances.
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP



   What is a Federal Wide Assurance?

 A Federal Wide Assurance (FWA) is a document
  that serves as an agreement with the OHRP that all
  human subject research conducted by the
  institution will comply with high ethical and
  procedural standards for the protection of human
  research volunteers
 SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


        The Federal Wide Assurance
          Notification of Approval

 If submitted in an electronic format, the person
  submitting the electronic file, the Human Protections
  Administrator and the Signatory Official will receive
  an automatically generated e-mail notifying them of
  FWA approval along with an FWA number that has
  been assigned to the institution.
 SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


        The Federal Wide Assurance
        Notification of Approval (cont.)

 When an institution submits an FWA in paper copy,
  the institution will need to monitor the OHRP website
  for approval:
  http://ohrp.cit.nih.gov/search/asearch.asp#ASUR
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP




          Animal Welfare
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP



                Animal Welfare

 Grantee organizations that use vertebrate animals
  in NIH supported activities must have an Animal
  Welfare Assurance on file with the NIH Office of
  Laboratory Animal Welfare (OLAW).
    The OLAW website can be accessed at:
    http://grants.nih.gov/grants/olaw/olaw.htm
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP




        Cost Considerations
    SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


       Four Principles that Indicate Allowability
1. Reasonableness: a cost is considered reasonable if the dollar
   amount is within limitations that a prudent person would pay
   for that good or service
2. Allocability: a cost is allocable if the goods or services can be
   assigned directly to the grant
3. Consistence: costs are considered consistent if they are
   routinely applied to the same category. Consistency is
   enhanced when grantees have written policies and procedures
   to account for charges for personnel, travel, supplies etc.
4. Conformance: most grant costs should conform to the
   “Allowability of Costs/Activities” section of the Grants Policy
   Statement.
 SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


                    Cost Issues

 Direct Cost: any cost that can be specifically
  identified with a project.
 Indirect Cost: any cost that cannot be allocated to
  one specific project.
    Typical indirect costs (F&A) include facilities
     operations and maintenance, depreciation and
     administrative expenses.
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP




  Systems for Policy Adherence
     SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


               Key Systems to Consider
          in the Management of NIH Grants
1. General                           10. Banking arrangements
2. Application preparation           11. Budget preparation and
3. Policies and procedures                 controls
4. Grant monitoring after            12.   Accounting system
     award                           13.   Personnel
5.   Standards of conduct            14.   Internal Controls
6.   Fiscal and scientific overlap   15.   Procurement
7.   Consortium arrangements         16.   Property/Asset
8.   Indirect costs                        Management
9.   Records management              17.   Travel
 SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


        Benchmark of Good Systems
 General
   Good    organizational charts
   Responsible   persons are identified
     Clearly delegated authority

 Policies and Procedures
   Written   and well documented
   Formulated by institution
   All staff are trained in them
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


   Benchmark of Good Systems (cont.)
 Grant monitoring after award
    Periodic programmatic reviews
    Financial review of actual vs. budget

 Standards of conduct
    Conflict   of interest
 Fiscal and Scientific Overlap
    Avoid duplication of payment   for
      Same research
      Same equipment
      Time of researchers
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


  Benchmark of Good Systems (cont.)

 Consortium Arrangements
    Standardagreement
    Performance and cost is monitored

 Indirect Costs
    Clearlyidentified
    Properly used
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


   Benchmark of Good Systems (cont.)

 Records Management
   Covers scientific and administrative records
     Written policies and procedures
     Where and for how long are they stored
     How disposed

 Banking arrangements
   Separate  bank account for the grant
   Maintain account into which funds can be
    transferred electronically
   Authorized signatories (preferably 2)
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


   Benchmark of Good Systems (cont.)
 Budget preparation and controls
   Reviewed by accounting for accuracy
   Source (cost) information is documented
   Once approved
     Changed by authorized person(s)
     Monitored monthly/quarterly
         Actuals vs. Budget
 Accounting system
   Accounting  personnel are knowledgeable in NIH
    terms and conditions
   Double entry accrual accounting used
   Project/job cost ledger for the specific grant
  SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


      Benchmark of Good Systems (cont.)
 Personnel
    Written   policy manual
      Job descriptions
      Annual evaluations
      Time and attendance is recorded

 Payroll
      Prepared based on attendance records
      Verified by a second person
      Distributed by PI/accounting/direct deposit
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


    Benchmark of Good Systems (cont.)
 Internal Controls
    Accounts    audited annually
      by independent accountant
      OMB A133 requirement
      by internal/government auditors
    Financialsystems comply with NIH standards
    Separation of duties
    Blank checks management
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


   Benchmark of Good Systems (cont.)
 Procurement
   Written policies
   Purchases approved by authorized manager
   Three quotations for large purchases
   Blanket purchase orders for supplies

 Property/Asset Management
   Capital expenditure is defined
   Items are recorded in register and managed
      property tags
      annual inventory
      Disposal is authorized and recorded
 SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


    Benchmark of Good Systems (cont.)
 Travel
     Written policies
     How is travel approved
     How are expense claims verified
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP




             Questions?
     SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


                   Contact Information
                Hortencia Hornbeak, Ph.D.
           Associate Director for Review and Policy
National Institute of Allergy and Infectious Diseases/NIH/DHHS
                    6700-B Rockledge Drive
                        Rm. 3142, MSC
                   Bethesda, MD 20892-7616
                     Phone:(301) 496-8208
                      Fax: (301) 435-9368
                    HHornbeak@niaid.nih.gov
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP




        Internet Resources
 SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


                  DHHS Websites
 Office for Human Research Protections (OHRP):
  http://www.hhs.gov/ohrp/
 OHRP Institutional Review Board (IRB) or Independent Ethics
  Committee (IEC):
  http://www.hhs.gov/ohrp/assurances/
 OHRP Assurance:
  http://www.hhs.gov/ohrp/assurances/assurances_index.html
   SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP



                       NIH Websites
 National Institutes of Health:
  http://www.nih.gov
 Fogarty International Center:
  http://www.fic.nih.gov/
 Notice of Grant Award:
  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part5.ht
  m#_Toc54600106/
 NIH Grants Policy Statement:
  http://grants2.nih.gov/grants/policy/nihgps_2003/index.htm
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP


                 NIH Websites
 NIH Grants and Funding Opportunities:
  http://grants1.nih.gov/grants/index.cfmI
 NIH Guide to Grants and Contracts:
  http://grants1.nih.gov/grants/guide/index.html
 NIH Extramural Programs:
  http://grants.nih.gov/grants/funding/funding.htm
 Office of Laboratory Animal Welfare (OLAW):
  http://grants.nih.gov/grants/olaw/olaw.htm
SUCCESSFUL PROPOSAL DEVELOPMENT WORKSHOP



                     NIAID Websites
 National Institute of Allergy and Infectious Diseases:
    http://www.niaid.nih.gov/
 NIAID Funding Page:
    http://www.niaid.nih.gov/ncn/
 Grant Application Basics:
    http://www.niaid.nih.gov/ncn/grants/basics/index.htm\
   Checklists for Applications:
    http://www.niaid.nih.gov/ncn/grants/charts/checklists.htm
 “All About Grants” Tutorials:
    http://www.niaid.nih.gov/ncn/grants

								
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