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- Final Accreditation Subcommittee Report
- March 29, 2004
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- Thomas L. Adams*, Association of Clinical Research Professionals
- David Ceryak, Eli Lilly &
Company
- Tora L. Bikson, RAND Corporation
- Gary L. Chadwick, Associate
Provost
- Robert DeVita, Ministry Health
Care
- Nigel Harris, Morehouse School of
Medicine
- Robert G. Hauser, Abbott
Northwestern Hospital
- Felix A. Khin-Maung-Gyi*, Chesapeake
Research Review, Inc.
- Douglas Peddicord, Association of
Clinical Research Organizations
- Mary L. Polan, Stanford
University School of Medicine
- Co-Chair*
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- The HRPP Accreditation Working Group should consider the following:
- Certification of HRPP
accreditation organizations
- Incentives that could / should
be in place to motivate organizations to achieve HRPP accreditation
and
- Potential impact of
accreditation
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- Testimony from:
- Bernard Schwetz, DVM, PhD, Acting Director, OHRP
- Donald Marlow, PhD., FDA
- Institutions that have gained HRPP Accreditation:
- David Wynes, Ph.D., University of
Iowa
- Angela Bowen, M.D., Western
Institutional Review Board
- Organizations that have Accreditation Programs:
- Elma Heidemann, Canadian Council
on Health Services Accreditation
- Rogert Eaglen, Ph.D., Association
of American Medical Colleges
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- Testimony from:
- Accrediting Bodies
- Jessica Briefer-French, MHSA, Partnership for Human Research Protection,
Inc (PHRP)
- Marjorie Speers, Ph.D., Association for the Accreditation of Human
Research Protection Programs, Inc (AAHRPP)
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- The subcommittee is encouraged that a number of organizations committed
to high quality clinical research came together and formed two entities
to begin the voluntary accreditation of clinical research institutions.
- The subcommittee recognizes that AAHRPP and PHRP are in the early stages
of existence and are continuing to evolve.
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- The subcommittee recognizes and commends the seven institutions that
have achieved accredited status.
- Three independent IRBs
- Patient Advocacy Council Inc., Mobile, Alabama
- Western Institutional Review Board, Olympia, Washington
- New England Review Board, Wellesley, Massachusetts
- One VA medical Center (23 under NCQA)
- Hunter Holmes McGuire Veteran’s Affairs Medical Center, Richmond,
Virginia
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- Institutions that have achieved accredited status, cont.
- One community hospital
- Catholic Medical Center, Manchester, New Hampshire
- One health care system research arm
- Baylor Research Institute, Dallas, Texas
- one university based medical center
- The University of Iowa, Iowa City, Iowa
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- The subcommittee is, however, concerned that the scope and cost of the
accreditation process may be impediments for some institutions to seek
accreditation.
- Given the voluntary nature of accreditation, there is concern that an
institution conducting research which is perhaps the furthest from being
in full compliance with applicable regulations, will be least likely to
seek accreditation.
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- The Subcommittee, however, believes that accreditation is important and
that patience will be needed for the assessment of the impact of
accreditation on the human research enterprise.
- Natural market pressures should push institutions toward seeking
accreditation, if research sponsors gravitate to placement of research
in those institutions that have achieved accreditation.
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- Reaffirmation of Interim Report
- “In the absence of additional experience and concrete information, the
Subcommittee supports the concept of accreditation of Human Research
Protection Programs (HRPP’s) for the protection of human subjects in
research. Accreditation promises to be a useful mechanism for all
organizations involved in human research that, like education and
certification for individuals, can lead to self improvement of systems
and outcomes.”
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- Further, the subcommittee finds:
- Existing data does not allow a valid review and conclusion as to the
efficiency of HRPP accreditation of research institutions as a guarantor
of quality research and subject safety. HRPP is not just limited to
“clinical” research.
- It is premature for government agencies to offer incentives to research
institutions to seek accreditation.
- Building on the CDC grant, there should be a systematic evaluation of
accreditation as an assurance of quality research and subject
protections.
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- Further, the subcommittee finds:
- Current practices used by regulatory agencies to collect data on IRBs
and institutions could be further developed to measure the impact
accreditation has on accredited institutions.
- After the assessment of the impact of accreditation occurs (assuming a
positive outcome), Agencies should develop a list of incentives for
research institutions that seek accreditation.
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- Further, the subcommittee finds:
- The government should have no role in endorsing one accrediting
organization over another. However, there may be value in evaluating the
process and procedures used by accrediting bodies, in accredited
institutions.
- Any accrediting body should have a strong self-assessment for
institutions undergoing the accreditation process.
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- Further, the subcommittee finds:
- The subcommittee has suggested that a conference, organized by HHS be
held to include all of the major stakeholders to offer an opportunity to
examine a wide range of self-regulatory initiatives that have been
undertaken by responsible parties over the last four years, of which
certification is the most structured and furthest along.
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- All individuals who presented testimony to the subcommittee
- Bernard Schwetz, DVM, PhD, OHRP
- Cathy Slatinshek, OHRP
- Yvonne Higgins, OHRP
- Katherine Madigan – Association
of Clinical Research Professionals
- Cheryl Stevens – Chesapeake
Research IRB
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Notes
