Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003) / Chapter Skim
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7 System Issues
7 System Issues
Pages 165-182
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From page 165... ...
the development of national policy for human research participant protection. With limited time and resources, our discussion of these topics is lim165
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GUIDANCE AND SUPPORT FOR IRBS Developing OHRP Guidance for IRBs Throughout our report we stress the need for the Office for Human Research Protections (OHRP) to develop authoritative guidance for IRBs in several areas: appropriate ways to obtain and document informed consent for different types of SBES research (Chapter 4)
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From page 167... ...
Both the IOM committee and NBAC make strong recommendations 2 participant groups should also be involved in the development of guidance on minimal-risk and other pertinent issues, although participant involvement may be difficult to obtain because SBES research covers a wide range of populations as distinct from a group of patients with a specific disease as is characteristic of much clinical research. 3 Currently, SBES professional association guidelines on human research participant protection are addressed to researchers, not to IRBs.
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From page 168... ...
, professional associations, individual IRBs, and individual researchers, there are now some materials available to help SBES researchers understand their responsibilities for human research participant protection and to learn how to navigate the maze of relevant regulations and procedures for project approval (see Appendix B; see also Oakes, 20021. There is much less guidance for IRBs or for researchers in other fields on how to handle different types of SEES research methods and populations studied.
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IRBs need in-depth discussions and analysis of the varieties of SBES research, issues that different types of research raise for human research participant protection, and effective ways to address those issues. The development of appropriate training materials for IRBs will require the joint efforts of OHRP, relevant SBES professional associations, and IRBs that are experienced in reviewing SBES research.4 Second, in the short term, training for SBES researchers of necessit~r must involve short courses at professional association meetings, on-line self-study modules, and the like.
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The Office for Human Research Protections, with input from a variety of scholars in science and ethics, should coordinate the development and dissemination of core education elements and practices for human research ethics among those conducting and overseeing research. Accreditation One response to heightened concern about the adequacy of the IRB system for protecting human research participants has been a call for greater oversight of IRBs by the federal government (see, e.g., Once of Inspector General, 1 998b; legislation introduced by Senator Kennedy)
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disciplines and take cognizance of appropriate review practices for different types of SBES research methods and populations studied. In this regard, it is encouraging to note that the Association for the Accreditation of Human Research Protection Programs added seats to its board for SBES researchers and has pilot-tested accreditation procedures at research institutions that conduct SBES research.
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suggests that IRBs sometimes require technical changes to SBES research designs that are not necessary for human participant protection and that go beyond the expertise of the IRB members. For example, an IRB may require a change in wording of a survey question without fully understanding the purpose of the question or the research that went into testing the proposed wording; the IRB may also overestimate the risk that the question poses to human participants.
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Nevertheless, to minimize both the reality and the perception, we urge IRBs to clearly identif y and justify changes that the IRB requires on behalf of human participant protection and to offer other suggestions on a purely adviso~r basis.6 Involvement of Investigators The Common Rule does not specify how IRBs should communicate with investigators except to require an IRB to inform the investigatorks) "in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity" (45 CFR 46.109d)
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Clear Guidance from IRBs to Researchers To facilitate better communication of IRB expectations, so that researchers submit research protocols for review that fully address human participant protection issues, we believe that IRBs should provide clear guidance about what constitutes an acceptable protocol. A useful practice in this regard could be to post on websites outstanding examples of approved research protocols that meet high standards for participant protection in such areas as confidentiality protection and informed consent.
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These members hope that implementation of Recommendation 7.1 to improve IRB-research interaction and other steps such as clearer guidance from IRBs to researchers and more explicit guidance from OHRP to IRBs—could go a long way to alleviate the possible need for a formal appeals process. ORGANIZATION OF AND AMONG IRBS Organization and Staffing of IRBs The Common Rule requires that IRBs have at least five members with varying backgrounds, including at least one scientist and one nonscientist, and at least one member not affiliated with the research institution, but it does not otherwise specify IRB composition, size, staffing, or other organizational features.
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recently sponsored research to develop "optimal" staffing costs for operating human research participant protection programs at VA medical centers. From interviews with participant protection experts, data from the 1995 Bell survey (Bell, Whiton, and Connelly, 1998)
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There are no easy answers to how best to protect human participants in multisite studies. The IRB system was established in part to permit local community input the Common Rule requires that IRB membership be diverse in terms "of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes" (45 CFR 46.107a)
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Experience gained from these IRBs may, over time, be helpful in determining effective structures and procedures for review of multisite research. DEVELOPING hL\TIONAL POLICY FOR HUMAN RESEARCH PARTICIPANT PROTECTION Leadership for National Policy Development Leadership in developing national policy and providing adequate oversight of human research participant protection is a fundamental obligation of the federal government given its role as a major research sponsor and its obligation under the Constitution to promote the general welfare of the population.
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Properly funded and organized, such an agency should be well positioned to provide leadership, involve experts from the full range of research disciplines, bring the views of research participants to bear, and protect federal policy in this area from partisan concerns. Involvement of SBES Researchers in National Policy Setting Recommendation 7.2: Any committee or commission that is established to provide advice to the federal government on human research participant protection policy should represent the full spectrum of disciplines that conduct research involving human participants.
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The benefits of such involvement would include not only increased support for and understanding of human participant protection policies among SBES researchers, but also useful cross-fertilization of ideas and knowledge between SBES and biomedical researchers about such topics as confidentiality protection and effective informed consent. Such cross-fertilization is increasingly important given the growing interdisciplinary nature of much research today.
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will be needed in the future. To help guide the human research participant protection system as it moves forward and to enable IRBs and others to cope constructively with change, we see two critical needs.
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offer additional recommendations in a few areas that are particularly important for human participant protection in SBES research. GUIDANCE AND SUPPORT FOR IRBS Developing OHRP Guidance for IRBs .;; Throughout our report we stress the need for the Office for Human Research Protections (OHRP)
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