Transcript Seeking To Improve Human Research Protections through

Seeking To Improve
Human Research
Protections through
Accreditation
6/7/04
John H. Mather MD
Director, ORCR, OVPR
1
What will be discussed?
 The
University’s commitment to
accreditation of its Human Research
Participant Protection Program (HRPPP)
 Present
information on the current status
of development and the present schedule.
 Provide
6/7/04
an opportunity for questions.
2
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 the“Plan for Insuring
Adequate Protection of
Participants in Clinical Trials”?
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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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4
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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5
What are the origins of AAHRPP?
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Initiated by Public Responsibility in Medicine and
Research [PRIM&R]
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PRIM&R and AAMC partner with five other
Founding Members.
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Founding and Incorporated April 2001
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Number Accredited Institutions May 2004
For More Information: http://aahrpp.org/index.html
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Who are the founding
organizations?
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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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7
What are some Accreditation
Principles?
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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
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(AAHRPP modeled on AAALAC)
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Human Subjects Protection is a
Shared Responsibility
Investigator/
Researcher
IRB
Institution
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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10
What do the Standards evaluate?
• Structure
- What we have
• Process
- What we do
• Outcome
- What we achieve
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11
What are the Five Domains for
accreditation by AAHRPP?
 Domain
I
 Domain II
 Domain III
 Domain IV
 Domain V
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The Organization
Review Bodies (not just the IRB)
Investigators
Sponsors
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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13
What is the process sequence?
Self-assessment
On-site evaluation
Council on Accreditation
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Self Evaluation
Program Description
Expert site visitors
Tailored to organizational
setting
Determines
Accreditation category
14
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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15
What happens on a Site Visit?
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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
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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
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(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 Initial
Accreditation
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
Notification and “negotiation” on accreditation
Receipt of Accreditation
6/7/04
→
→(Est) MARCH 2005
→
(Est) JUNE 2005
(Est) JULY 2005
20
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.
We’re 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 Erich’s 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.”
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