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Issues Before IRBs: OHRP Views

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

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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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