Selecting an Institutional Review Board & other related topics by HC111126174151

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									  Selecting an Institutional
Review Board & other related
           topics
Region/ORD Training Workshop on Protection of
 Human Subjects in EPA's Research and Non-
             Research Studies

               September 2005

   Rebecca L. Calderon, Ph.D, M.P.H.
               Director
       Human Studies Division
         What is a Federal Wide
          Assurance (FWA)?
•   The Federal Wide Assurance (FWA) is the only type of new assurance of
    compliance accepted and approved by OHRP for institutions engaged in
    non-exempt human subjects research conducted or supported by HHS.
    Under an FWA, an institution commits to HHS that it will comply with the
    requirements set forth in 45 CFR part 46, as well as the Terms of
    Assurance.
•   FWAs also are approved by OHRP for federal wide use, which means that
    other federal departments and agencies that have adopted the Federal
    Policy for the Protection of Human Subjects (also known as the Common
    Rule) may rely on the FWA for the research that they conduct or support.
    Institutions engaging in research conducted or supported by non-HHS
    federal departments or agencies should consult with the sponsoring
    department or agency for guidance regarding whether the FWA is
    appropriate for the research in question. There are two versions of the
    FWA and the Terms of Assurance, one of each for domestic (U.S.)
    institutions and for international (non-U.S.) institutions.
               Terms of Federal wide
                    Assurance
•   Human Subjects Research must be guided by Ethical Principles
     All of the Institution’s HSR regardless of funding is subject to ethical principles
•   Applicability – all HSR conducted or supported by any federal department or
    Agency that has adopted the Common Rule
•   Compliance with Federal Policy for the Protection of Human Subjects and Other
    Applicable Federal State, Local or Institutional Laws, Regulations and policies
    EPA 40 CFR part 26
•   Written Procedures –
•   Scope of IRBs Responsibilities
•   Informed Consent Requirements
•   Requirements for assurances for collaborating Institutions
•   Written Agreements with Independent Investigators Who are not Otherwise
    Affiliated with the Institution
•   Institutions Support for the IRB
•   Educational training
•   Renewal of Assurance (every 3 years)
            Where to look?

• http://www.hhs.gov/ohrp/assurances/
          Voluntary accreditation
• The Association for the Accreditation of Human
  Research Protection Programs, Inc. (AAHRPP), is a
  nonprofit organization that works with organizations that
  conduct human research to raise the level of protection
  for research participants. AAHRPP accredits
  organizations that can demonstrate they provide
  participant safeguards that surpass the threshold of
  state and federal requirements. The accreditation
  program utilizes a voluntary, peer-driven, educational
  model. For organizations interested in learning more
  about AAHRPP accreditation, visit www.aahrpp.org.
           Commercial IRBs

• Specified service – contractual service
• Western Institutional Review Board
  (WIRB)
• Schulman Associates Institutional
  Review, Inc
• Sterling Institutional Review Board
• Independent Review Consulting, Inc
            Considerations

•  FWA – IRB listed (HSD – UNC)
• Collaborators
• State/local requirements
• Special populations (Indian Health
  Service)
• International Studies
• Multiple IRB – Primary then concurring
• Fed >> State >> Local
                  EPA IRB
• Recommendation to HSD to establish
  IRB - HSPPO
• ORD moving to harmonize
• ORD IRB?
• EPA IRB?
• Uniform and flexible
• HSSRO
  the protection of participants in research
    should be our primary priority

                                               8
                 Miscellaneous


• Messing up?
    •   Administrative
    •   Adverse Events
    •   IRB but no EPA approval
    •   No approval at all (surveys)

    Reporting requirements IRB and/or HSSRO
              Miscellaneous

• EPA employee on IPA
• Paper Reduction Act
• Communication
  – Individual Consent Form
  – Community (Report or Presentation)
  – Officials
• Ownership of data
• Protection of confidentiality

								
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