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Issues Before IRBs: OHRP Views

This presentation by Bernard A. Schwetz, D.V.M., Ph.D., Acting Director of the Office for Human Research Protections, delves into the complexities surrounding human research, the burdens faced by Institutional Review Boards (IRBs), and the significant challenges in the Human Research Protection (HSP) landscape. Key topics include defining research, issues of participant recruitment, the importance of public trust, and the potential for the VA to set a standard for HSP best practices. This session underscored the need for rigorous ethical oversight while balancing research advancement.

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Issues Before IRBs: OHRP Views

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  1. Issues Before IRBs: OHRP Views Presented by Bernard A Schwetz, D.V.M., Ph.D. Acting Director Office for Human Research Protections Washington, D.C. April 8, 2004

  2. Topics • what is research? • burdens on IRBS • greatest challenges to HSP • challenge to the VA

  3. What is Research? How do I avoid going to the IRB? • surveys • public health surveillance • quality improvement programs • self exemption is a problem • differentiating criteria not agreed upon

  4. Research or Not? • …”a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” • involves living human subjects or their identifiable data

  5. Criteria: Research or Not? • intent • generalizable results • publication • source of funding • legal authorization SACHRP asked to consider

  6. Burdens on IRBs – unnecessary ones? • adverse event reports • over-interpretation of regulations • no expedited review • excessive records • excessive informed consent documents • review of the scientific details? • fear of litigation • central vs. local IRBs • lack of standard format for protocols • protocol vs. grant application

  7. Greatest Challenges to HSP • recruitment of subjects • therapeutic misconception • divergence of IRBs • institutional culture of indifference • relocation of research: AHC to community • burden vs. protection

  8. Greatest Challenges to HSP (con’t) • lack of detailed knowledge of the enterprise • hard to detect problems • can’t follow trends • research enterprise is fragile

  9. Human Research Enterprise SPONSORS Industry, Government agencies, others RESEARCH INSTITUTIONS IRB’s committees: protocol, COI, radiation, biosafety, etc. PAYERS, INSURERS CRO SMO EDUCATORS RESEARCH TEAMS Investigators Collaborators Team members REGULATORY OVERSIGHT FDA, Common Rule Agencies state and local government DSMB • RECIPIENTS • the public – • products • knowledge STUDY SUBJECTS ACCREDITING ORGANIZATIONS AAHRPP PHRP Patient Representatives Advocacy Groups

  10. Challenge to the VA Research Community How could the VA become the model for HSP? • accreditation • compliance • consistent procedures • best practices • measured impact of accreditation

  11. Closing Thoughts • public trust is the key • credibility! credibility! • need for a role model

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