Overview of AAHRPP Accreditation: What IRB members should know

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Overview of AAHRPP Accreditation What IRB
members should know

• Leslie I. Katzel, MD, Ph.D.
• UMSOM, Department of Medicine, Division of
  Gerontology.
• BVAMC GRECC

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History of Association for the Accreditation of
Human Research Protection Programs

• In 2001 in response to the Hopkins shutdown and
  problems in the oversight of research at other
  institutions, Public Responsibility in Medicine
  and Research (PRIMR) recognized the need for a
  new level of professionalism in the area of human
  subject protections that could be achieved by
  developing an accreditation process.

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History of Association for the Accreditation of
Human Research Protection Programs (2)

• AAHRPP is a nonprofit organization founded in
  2001 under the auspices of PRIMR, the
  Association of American Medical Colleges (AAMC),
  FASEB, and several other national organizations.
  
• AAHRPP seeks not only to ensure compliance, but
  to raise the bar in human research protection by
  helping institutions reach performance standards
  that surpass the threshold of state and federal
  requirements (from AAHRPP website www.aahrpp.org
  )

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• The voluntary accreditation process is based on
  self assessment, peer review (site visit), and
  education
• To date, 24 institutions have been accredited
  http//www.aahrpp.org/www.aspx?PageID111100

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Why become accredited?

• Protect research participants
• Improve research quality
• Achieve compliance
• Restore public trust
• Instill confidence in sponsors (in the future may
  be economic/competitive advantage)
• Prevent government intervention

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Accreditation process

• Voluntary
• Peer driven
• Educational
• Confidential

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How does accreditation work?
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• AHRPP accreditation procedures http//www.aahrpp.o
  rg/Documents/D000041.PDF

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Typical site visit

• 4-5 site visitors (one serves as the team leader)
• 3-4 days
• Site visit agenda is developed after the AAHRPP
  pre-review of application and supporting
  documents
• Exit briefing with point by point summary
• Written report provided to host institution
• Host has 30 days to respond to AAHRPP report
• Presentation to AAHRPP council

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AAHRPP philosophy of site visits

• Accreditation, not auditing
• Outcomes-based
• Focus is on process
• Validation of self-assessment instrument
• Collaborative
• Learning experiences for HRPP and AAHRPP

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Categories of Accreditation

• Full Accreditation
• Qualified Accreditation
• Provisional Status
• Accreditation Withheld

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AAHRPP Evaluation Instrument

• 5 Main domains
• Organization
• Research Review Unit (IRB)
• Investigator
• Sponsored Research
• Participant Outreach
• AAHRPP accreditation standards http//www.aahrpp.o
  rg/Documents/D000067.PDF

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What should IRB members expect?

• Probably 4 hours of site visit devoted to
  interviews of IRB members (10 of site-visit)
• Non-scientists/community representatives will
  probably be interviewed separate from scientists
• Probably all non-scientists/representatives from
  the committees will be invited, 2-3 scientists
  from each committee will be invited
• IRB chair and vice-chairs will be interviewed
  separately from regular committee members

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Sample questions IRB members may be asked by
site-visitors

• Describe your training/ orientation to the IRB
• What are some of the difficult issues that your
  committees deal with?
• What materials do you review for the meeting?
• How do you determine the level of risk?
• How does the IRB handle conflict of interest by
  IRB members?
• Is your work on the IRB appreciated by the
  institution?

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• What is the quality of the pre-submission
  scientific review?
• Are the consent forms too complex?
• In general, what can be done to improve the IRB?

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• Non-scientists and community representatives may
  also be asked
• Do the scientists on the committee respect your
  opinions?
• Are you ever asked to review protocols that you
  do not feel that you are qualified to review?

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• It is unlikely that IRB members will be asked
  specific questions about Federal code of
  regulations, FDA regulations, etc, but be
  prepared to answer questions about vulnerable
  populations and review of SAEs and unanticipated
  problems
• You may be asked idiosyncratic questions based on
  the background of the site-visitors

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Final points to consider

• This is not an audit
• Interviews with IRB members are only a small
  portion of the overall assessment of the HRPP
• Become familiar with the newly revised IRB SOPs
• AAHRPP recognizes that the HRPP at our
  institution is continuing to evolve and grow, and
  that we are committed to protecting human subjects