Letter Report: Protecting Participants in Behavioral and Social Science Research (2002) / Chapter Skim
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Contents of Letter Report
Contents of Letter Report
Pages 1-9
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~ The other is unnecessary burdens that may result from applying review standards for high-risk research to low-risk studies burdens on institutional review boards (~Bs) , which are the primary bodies for reviewing and monitoring research with human participants; on researchers; and sometimes on participants themselves.2 In a climate of heightened scrutiny of TRB procedures, the Institute of Medicine (IOM)
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In the letter we primarily address field, laboratory, and archival research conducted by such typical SBES methods as mail, telephone, and in-person surveys, structured interviews, participant observation, laboratory research, arid other methods that ordinarily pose low risk to participants. By "low risk" we refer to the definition in federal regulations, namely, that a study has a low probability of causing physical, psychological, or economic harm to participants and that the nature of the harm is minimal and no more than is normally encountered in daily life (see the Common Rule, Title 45, Code of Federal Regulations (CFR)
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OHRP can usefully provide guidance to IRBs by documenting and promulgating good practices for maintaining confidentiality at every stage of the research process and for informing research participants about the scope and limits of confidentiality protection that is offered them. For some sensitive studies, such as those in which a participant may report illegal behavior, it is particularly important that researchers understand their responsibilities and limits with regard to confidentiality protection and that IRBs review carefully the proposed procedures for preventing disclosure.
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that permit research access to data for which widespread public dissemination is deemed too risky (see National Research Council, 1993~. Recommendation I: The Office for Human Research Protections and other relevant federal agencies, working with professional associations in the social, behavioral, and economic sciences, should document and promulgate good practices for using state-ofthe-art computer science and statistical methods to protect the confidentiality of SBES data that are made available for secondary analysis.
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One reason involves the organizational setting of most IRBs, which are usually nested within larger institutions faced with pressures to have verifiable evidence for informed consent. Consequently, TRBs may require signed consent forms for all research, even when other consent processes or a waiver of consent would be more appropriate, in order to obtain documentation that is easily archived and retrieved for defending the procedure.
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At' In response to tragic incidents in biomedical research and increased scrutiny of {RB operations, IRBs appear to be increasingly applying review procedures that are appropn ate for high-risk research to studies that are low risk, thereby placing unnecessary burdens on researchers, TRBs, and, sometimes, human participants. A recent survey of IRBs found that onehalf or fewer research protocols eligible for exemption are in fact exempted from review and that Fill IRBs convene to review anywhere from ~ 5 to 83 percent of low-risk protocols that are eligible for expedited review (Bell, Whiton, and Connelly, 1998:Figs.
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We believe it is important to add specific SBES procedures to the list to encourage TRBs to use expedited review procedures for low-risk SBES research. Examples of specific SBES procedures that could be added to the existing list for using the expedited review procedure are experiments that test responses to noninvasive auditory or visual stimuli of competent adult participants; experiments that study decision-making with competent adult participants; and surveys of competent adults that include standard demographic and socioeconomic questions and other questions (e.g., attitudes)
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In our final report, we plan to analyze farther the data from existing studies of IRBs and to provide details on the requirements for a useful data system. Recommendation 9: OHRP and other relevant agencies, working with professional associations in the social, behavioral, and economic sciences, should develop an ongoing survey of IRB composition and practices, as an informational resource that can help assess strengths and weaknesses of the system for protecting human participants in SBES research.
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Recommendation 11: Academic institutions, working with scientific and professional associations in the social, behavioral, and economic sciences, should develop in-depth training curricula and materials that are customized for social, behavioral, and economic scientists regarding the ethical involvement of human research participants. OHRP should similarly develop for IRBs customized training materials that focus on review of SBES research.
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