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Emerging Issues and the Role of OHRP

Emerging Issues and the Role of OHRP. Presented by Bernard A Schwetz, D.V.M., Ph.D. Director Office for Human Research Protections Medical Research Summit Baltimore, MD April 23, 2004. Topics. Focus on the enterprise Burden vs. Protection Effectiveness/efficiency of IRBs

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Emerging Issues and the Role of OHRP

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  1. Emerging Issues and the Role of OHRP Presented by Bernard A Schwetz, D.V.M., Ph.D. Director Office for Human Research Protections Medical Research Summit Baltimore, MD April 23, 2004

  2. Topics • Focus on the enterprise • Burden vs. Protection • Effectiveness/efficiency of IRBs • Accreditation of institutions • Preventing another HSP tragedy

  3. 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

  4. The Enterprise • Where are risks to subjects? • Risks to subjects determine risks to the enterprise

  5. Burden To The Enterprise Vs. Risks To Subject Burdens represent protection of • Research subjects • Institutions, sponsors • Both • Neither

  6. Burdens That Protect • Research subjects • informed consent focused on HSP • Institutions, sponsors • informed consent focused on limiting liability

  7. Burdens (con’t) • Both • Well trained investigators • Neither • Most AE reports in multi-site studies

  8. Burdens (con’t) Let’s be more clear about • What’s being protected • Sources of burden

  9. Sources of Burden • Regulations – Federal, State • Over-interpretation of regs • Fear of litigation • Duplicative requirements of sponsors

  10. Effectiveness of IRBs • Overall very good, but not consistently so • Diversity greater than local needs dictate • What is the role of IRBs today? • interface with partners • Reluctance to serve • workload, liability (public member) • Institutional culture of indifference

  11. Efficiency of IRBs • Moving the freight vs. doing well • Range is disturbing • 10 min to days/ protocol • inadequate IT support • Excessive behaviors • Lack of training, understanding • Inadequate resources • Lack of info on best practices

  12. Accreditation of Institutions • OHRP supports the concept • Potentially very beneficial • We must be patient!

  13. Preventing Another HSP Tragedy • Not likely a simple cause • Two elements • permissive infrastructure • last opportunity to prevent • The enterprise is fragile!

  14. Permissive Infrastructure • Error of IRB approval • Indifference to regulations • Poor quality management • Lack of accountability • Studies by-passed the IRB • Focus is on IRBs

  15. Last Opportunity To Present • Somebody fell asleep at the wheel! • No redundant step to detect a problem in time • Fear of being caught, hope beyond reason • May not be the person originally at fault • “blinded” by C of I • Focus is on investigators

  16. Closing Thoughts • Focus on the whole enterprise • Balance burden & protection • Need to review function of IRBs • Accreditation would be progress • How do we prevent another HSP tragedy? • Public trust is essential

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