Seeking To Improve Human Research Protections through Accreditation John H' Mather MD Director, ORCR

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Seeking To ImproveHuman ResearchProtections
throughAccreditationJohn H. Mather
MDDirector, ORCR, OVPR
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What will be discussed?

• The Universitys commitment to accreditation of
  its Human Research Participant Protection Program
  (HRPPP)
• Present information on the current status of
  development and the present schedule.
• Provide an opportunity for questions.

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What has been the impetus for accreditation of
human subject (participant) protection programs?

• Increased vigilance of adherence to regulatory
  compliance at OHRP and FDA since 1998.
• Shut-downs of human subject research at several
  major academic institutions by OHRP through
  summer 2001. e.g. University of Pennsylvania,
  Duke, Johns Hopkins etc.
• Development of a Plan for Insuring Adequate
  Protection of Participants in Clinical Trials.
• Issued Spring 2002. University of Michigan.

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What is thePlan for Insuring Adequate Protection
of Participants in Clinical Trials?

• Human Research Coordinating Council
• Significant enhancements of IRBs
• Optimization of CACR
• Organization of PEERRS Program
• Establishment of ORCR
• Development of M-PRIME
• Seek Accreditation for the HRPPP

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Who will accredit?Association for Accreditation
of Human Research Protection Programs (AAHRPP)

• AAHRPP works to protect the rights and welfare of
  research participants by fostering and advancing
  the ethical and professional conduct of persons
  and organizations that engage in research with
  human participants. AAHRPP achieves its mission
  by using an accreditation process based on self
  assessment, peer review, and education.

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What are the origins of AAHRPP?

• Initiated by Public Responsibility in Medicine
  and Research PRIMR
• PRIMR and AAMC partner with five other Founding
  Members.
• Founding and Incorporated April 2001
• Number Accredited Institutions May 2004
• For More Information http//aahrpp.org/index.htm
  l

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Who are the founding organizations?

• Association of American Medical Colleges
• Association of American Universities
• Consortium of Social Science Organizations
• Federation of American Societies for Experimental
  Biology
• National Association of State Universities and
  Land-Grant Colleges
• National Health Council
• Public Responsibility in Medicine and Research

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What are some Accreditation Principles?

• Research participants protection is foremost
• Compliance is the minimum requirement
• The whole institution, not just the IRBs
• Coverage of all disciplines under FWA
• Educational and collegial
• Peer Driven Expert Review
• Performance based Not an audit
• Confidential and Voluntary
• No reports to Regulatory Agencies
• (AAHRPP modeled on AAALAC)

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Human Subjects Protection is a Shared
Responsibility
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What are the accreditation standards?

• Based on U.S. federal regulations for
  conducting human research
• - Department of Health and Human Services
• 45 CFR 46
• - Food and Drug Administration
• 21 CFR 50, 56 and 11,312,812, as
  appropriate
• ICH Good Clinical Practice Guidelines
• Common Sense and Best Practices

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What do the Standards evaluate?

• Structure
• - What we have
• Process
• - What we do
• Outcome
• - What we achieve

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What are the Five Domains for accreditation by
AAHRPP?

• Domain I The Organization
• Domain II Review Bodies (not just the IRB)
• Domain III Investigators
• Domain IV Sponsors
• Domain V Participants

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What is involved in Each Domain?

• Domains Divided into STANDARDS
• STANDARDS Divided into ELEMENTS
• For each STANDARD and each ELEMENT
• AAHRPP needs a written statement attached
• to a policy/procedure/item to demonstrate
• HRPP meets standard/element.

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What is the process sequence?

• Self-assessment
• On-site evaluation
• Council on Accreditation

• Self Evaluation
• Program Description
• Expert site visitors
• Tailored to organizational
• setting
• Determines
• Accreditation category

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What is going on Now?

• Complete initial Self Assessment in 2004
• (18 month process of review, evaluation,
  surveys, improvements, reallocation of resources,
  etc.)
• Continue to make HRPPP improvements
• Submit written application to AAHRPP
• Provide additional input and documents
• AAHRPP Site visit

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What happens on a Site Visit?

• Site visit (week long/system wide)
• Interviews with
• - Officials
• - Administrators various units
• - Staff RSPP and allied units
• - IRB members
• - Researchers
• - Allied research support e.g. Pharmacy
• - and other committees e.g. COI, IBC

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What do IRB members need to know?Examples

• Basic principles of human subjects protection
• Regulations/Policies/Assurance what they
  mean, where to find them, how to apply them
• Process of review meeting protocol
• How to read minutes/expedited review reports
• Where to go for more information

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How do investigators prepare? Examples

• (Re-) Read Belmont Report
• (Re-) Read UM Human Subjects Guide
• Fully comprehend the IRB processes
• Familiarity with M-PRIME system
• Complete on-line training modules e.g. PEERRS
  and document completion

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What happens after that?

• Exit Interview with Officials
• Receipt of written report
• Thirty day response period to address
• questions or gaps
• Site Visit Team Report and UM response
  submitted to AAHRPP Council on Accreditation
• AAHRPP Council renders a decision

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Summary of Timetable for InitialAccreditation

• Self Assessment ?
  UNDERWAY
• Necessary system adjustments ?
  ONGOING
• Preparation of application and program
  description
• Submission of application ?
  AIMING FOR JAN 2005
• Preparation for on-site evaluation
• Hosting of on-site evaluation-preliminary
  feedback ?(Est) MARCH 2005
• Notification and negotiation on accreditation
  ? (Est) JUNE 2005
• Receipt of Accreditation ?
  (Est) JULY 2005

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What are the potential Benefits of accreditation?

• Improves protection program (HRPPP)
• Assists in achieving compliance
• Facilitates research integrity
• Improves research quality
• Instills confidence in sponsors
• Builds public trust
• Protection not Perfection is the Focus

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Audience Question

• You said that they are going to randomly select
  investigators to interview during this process.
  Were off to a good start with you beginning to
  do these road shows and this session today. How
  do we get the word out and let our many hundreds
  of investigators on this campus know about the
  potential of them being interviewed during this
  process?

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Audience Question

• Do you see a need to come back and give updates
  to faculty when you have a better idea of what
  they need to know? I think I share Erichs
  concern that unless we have a very targeted
  message and we know exactly who to target to we
  are not going to get a lot of interest from the
  faculty.