Exploring Challenges, Progress, and New Models for Engaging the Public in the Clinical Research Enterprise Clinical Research Roundtable Workshop Summary (2003) / Chapter Skim
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3. Increasing the Role of the Public in Research Oversight
3. Increasing the Role of the Public in Research Oversight
Pages 24-35
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From page 24... ...
issued 40 Determination Letters (NBAC, 2001~; from July 2000 to November 2002, OHRP issued 335 such letters.3 During this session of the workshop, Daniel Federman described the recent IOM report about the system for protecting research participants, and Nancy Dubler discussed a project to train public members of IRBs. Angela Bowen talked about recruiting and retaining independent members of IRBs, Marjorie Speers discussed the role of the public in formulating accreditation standards as well as the potential for accreditation to foster greater public input into the research process, and Greg Koski offered alternative models for the review of research.
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25 20 15 10 o Failure to Falsification Informed Follow Consent Protocol Adverse Qualifications Records Event Reporting FIGURE 3.2 Formal Complaints to FDA Regarding IRB Deficiencies This chart was redrawn from a presentation given by Stan Woolen of the FDA Office of Medical Policy, Division of Scientific Investigations, to the IOM Committee on Assessing the System for Protecting Human Research Participants in May 2001. workshop, Daniel Federman, M.D., Dean for Alumni Relations and Clinical Teaching at Harvard University and Chair of the IOM committee that wrote the report, presented a selection of the committee's findings that were most relevant to the public's role in the ethical oversight of research.
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The financial conflict of interest review mechanism would employ relevant expertise on that issue. "Participants and community representatives have a great Deal to contribute to the Design, review, and conduct of projects and should be energetically recruited." Daniel Federman These review bodies should inform the Research Ethics Review Board (Research ERB, the term the committee adopted to replace IRB in order to reflect the mission of the board)
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"No one currently knows those suffering harm from current investigation, for] everyone currently a participant in a research protocol." Daniel Federman 27 ISSUES REGARDING INDEPENDENT MEMBERS OF IRBS Meeting the Need for Inclepenclent Members of Research ERBs Nancy Neveloff Dubler, J.D., Director of the Division of Bioethics at Montefiore Medical Center and Professor of Epidemiology and Social Medicine at Albert Einstein College of Medicine, began the Certificate Program in Research Ethics intending to fill the need for training unaffiliated, nonscientist IRB members.
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Dubler also is developing guidelines for participation for independent Research ERB members, based on the principles that research is a collaborative enterprise that involves scientists, members of Research Ethics Review Boards, and research participants in a collaborative process and that the goal of therapeutic and non-therapeutic research is to develop new knowledge and protect participants (see Box 3.1~. Attracting and Retaining Unaffiliatecl MembersAn Inclepenclent IRB Perspective Western IRB (WIRB)
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PUBLIC INVOLVEMENT IN THE ACCREDITATION PROCESS The method of involving the public in oversight of research should be tailored to meet specific goals, commented Executive Director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) Marjorie Speers.
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NEW MODELS OF ETHICAL REVIEW Greg Koski, Ph.D., M.D., Director of OHRP,8 offered new models of review to improve the efficiency and effectiveness of the system for responsible conduct of human research. For the past 20 years, the twin pillars of informed consent and IRB review have formed the base of the protection system.
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Research Site B FIGURE 3.4 Centralized Consortium Research Site D The National Cancer Institute' s (NCI' s) central review pilot program is one example of the tandem model, in which an expert central board with public, ethics, and scientific and clinical representation carries out a high-level review and then, under a set of carefully-defined delegations of authorities and responsibilities, works with local boards that can address the issues at the local sites (Figure 3.5~.
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i2 See ohrp.osophs.&hs.gov/humansubjects/qip/qip.htm for more information about the quality improvement program. ENGAGING THE PUBLIC IN THE CLINICAL RESEARCH ENTERPRISE Central Review Board Terms of Participation and Responsibilities ~~\ W;~K ~~d jV~.: ~ ~ ~ ~ Multicenter Clinical Trial FIGURE 3.5 Tandem Model Practice ~ ~ Practice HRPP )
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GUIDANCE ON INTERPRETATION OF THE REGULATIONS David Rimoin, M.D., Ph.D., Chairman of Pediatrics at Cedars-Sinai Medical Center commented that one of the problems with individual IRBs has been the tremendous variability in their interpretation of what is regulation, what is guideline, and what is hearsay. He also noted that sometimes institutions focus on protecting themselves rather than protecting research participants and that there should be some appeals process to address this issue.
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Dubler described her pilot program to recruit and train public Research ERB members, Dr. Bowen shared the WIRE experience, Dr.
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