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Who Ultimately Protects Human Research Subjects?

Who Ultimately Protects Human Research Subjects?. Presented by Bernard A Schwetz, D.V.M., Ph.D. Director Office for Human Research Protections Town Meeting Columbia University Medical Center October 12, 2004. Topics. The research enterprise Does compliance protect subjects?

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Who Ultimately Protects Human Research Subjects?

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  1. Who Ultimately Protects Human Research Subjects? Presented by Bernard A Schwetz, D.V.M., Ph.D. Director Office for Human Research Protections Town Meeting Columbia University Medical Center October 12, 2004

  2. Topics • The research enterprise • Does compliance protect subjects? • Adjuncts to compliance • Compliance based on trust • How do we prevent the next tragedy? • Threats to the enterprise

  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. Does Compliance Protect Subjects? Yes, But… • How much? • From what?

  5. Adjuncts to Compliance • Common sense • Institutional attitude • Adequate resources • Accreditation of HRPPs • Certification of investigators, IRB members

  6. Compliance Based on Trust Compliance Models • On-site inspectors, full time • Self audit, government inspected • Trust (HSP programs) Guidance versus flexibility

  7. Who is Responsible for Protection? IRB Sponsor Investigator FDA or OHRP Subject Where is compliance critical?

  8. How Can We Prevent The Next Tragedy? Risks to subjects • Background around a threshold • Tragedies • Un anticipated, accidents • Preventable

  9. Sources of Risks • Inadequate training • Conflicting, completing interests • Non-compliance • Inadequate or poorly used HRPP resources • Error in judgment, flawed procedure • Clinical vs. research decisions • Non-credentialed professionals, institutions • Institutional indifference • Gaps in regulations

  10. How Can We Anticipate The Next Tragedy? • Failure analysis models • Near-miss evaluations

  11. Potential Consequences of the Next Tragedy • Mandatory certification of investigators • Mandatory accreditation of HRPPs • Regulations apply to all research • Injury to subjects covered by sponsor • Single federal office for HSP

  12. Threats to the Enterprise • Burdens to the enterprise • People unwilling to be research subjects • Fear of harm • Distrust of researchers • Cost • Inconvenience • Others

  13. Burdens on the Enterprise • Burdens created by regulations • Burdens of non-regulatory origin • Doing what’s right • Over-interpretation of regulations • Treating guidances as regulations • Fear of litigation • Gaps in the regulations/guidance's

  14. Does Compliance Protect Subjects? Yes, but not completely. Minimum standard May not prevent another tragedy

  15. Final Thoughts • Protection of human subjects is primary concern • Compliance by itself is not enough • Success of the research enterprise depends on public trust

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