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IRBs: Contributors and Resolvers of Problems

IRBs: Contributors and Resolvers of Problems. Presented by Bernard A Schwetz, D.V.M., Ph.D. Director Office for Human Research Protections 3 rd Annual NPTEC IRB Conference Rapid City, SD July 11, 2005. Topics. Regulatory Update

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IRBs: Contributors and Resolvers of Problems

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  1. IRBs: Contributors and Resolvers of Problems Presented by Bernard A Schwetz, D.V.M., Ph.D. Director Office for Human Research Protections 3rd Annual NPTEC IRB Conference Rapid City, SD July 11, 2005

  2. Topics • Regulatory Update • Secretary’s Advisory Committee on Human Research Protections (SACHRP) • Current Issues

  3. Regulatory Update • Department of Homeland Security • IOM committee – research involving prisoners • Workshops – alternatives to local IRBs • AE reporting • Regulatory actions • Equivalent protections • FDA central IRB draft guidance • IRB registration

  4. SACHRP • Subcommittees • Subpart C • Research Involving Children • Subpart A • Other topics • Role of Institutional Officials • Training of research investigators • AE reporting • Alternatives to local IRBs (central IRB)

  5. Other Current Issues Vulnerabilities of the enterprise • Burdens on the enterprise • Public trust • Can we prevent the next tragedy?

  6. 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

  7. Risks Created By Gaps In The Regulations/Guidances • Protection of the decisionally impaired • Protection of non-english speaking subjects • Institutional and professional conflicts of interest • Inadequate consent process, no measure of understanding • Requirement for training

  8. Dilemma • IRBs and investigators want • Guidance, and • Flexibility • Hard to have both

  9. Lack of Trust • Minority populations • Non-minorities

  10. Lack Of Trust Depends On The Community, The Population • Minorities • Distrust of researchers • Distrust of government • Lack of helpful information • They’ve been victimized & abused • High background of medical problems • Not enough help from the government

  11. Lack Of Trust Depends On The Community, The Population • Non – minorities • Indifference • Fear of harm • Inconvenience, expense, time • Lack of helpful information

  12. Trust Depends On Credibility!

  13. Things Have Undermined Our Credibility • Tragedies – may have been preventable • Heavy media attention • Conflicts of interest • Abuses of the past • Unethical behaviors • Intentional confusion – treatment & research

  14. How Do We Build Trust?How Do We Enhance Our Credibility? • Be honest with ourselves & the public • Comply with ethical & legal standards • Transparent & timely processes • Stronger emphasis on ethics • Sensitivity to public interests and needs • Cultural differences • Local conditions • Provide useful information to the public & others • Conferences on public trust • Outreach to the public

  15. Can We Prevent the Next Tragedy? Learn from our mistakes! Accident Precursor Analysis and Management National Academy of Engineering, 2004

  16. Impact of the Next Tragedy? • Erosion of public trust • Disincentive for young investigators • Congressional responses • Mandatory accreditation, certification, education? • Pay cost of harm to subjects? • More strict regulations – conflicts of interest, etc.? • Registration of studies and trials? • All research covered by Federal Regs

  17. Closing Thoughts • The enterprise is vulnerable • Must have ownership of burdens • Human subject protection is highest priority • Public trust is essential

  18. How to Contact OHRP? Address: Office for Human Research Protections 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Phone: Office: (240) 453-6900 Toll-Free within the U.S. (866) 447-4777 Fax: (240) 453-6909 Email: ohrp@osophs.dhhs.gov Website: http://www.hhs.gov/ohrp/

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