Constance F. Citro, Daniel R. Iglen and Cora B. Marrett (Eds.), Protecting Participants and Facilitating Social and Behavioral Sciences Research.
Protecting Participants represents the findings of the Panel on Institutional Review Boards, Surveys, and Social Science Research, which was established in 2001 by the National Academies' National Research Council. The Panel was charged with examining the structure, function, and performance of the Institutional Review Board system as it relates to social, behavioral, and economic sciences (SBES). Researchers have long complained about problems in obtaining "human subjects approval" for their projects in the SBES. This work highlights the inadequacies of the various systems and makes specific recommendations for improvement.
After reviewing the history and research literature of SBES-related human subjects protection, examining IRB guidelines of major research universities and federal agencies, and hearing from witnesses from various SBES professional organizations, the Panel produced fifteen recommendations. After an Executive Summary, an explanation of the context for the Panel, and a discussion of basic concepts in protecting human subjects, the book presents a history of regulatory activity spanning 1945 to the present. The Panel's recommendations are organized within four areas: (1) enhancing Informed Consent; (2) enhancing confidentiality protection; (3) enhancing the effectiveness of IRBs in handling "minimal risk" research; (4) and general system improvement issues. Helpful appendices include comparisons of changes in legislative language over the years, information about selected relevant organizations, a literature review of research related to IRB operations, and a commissioned chapter on data confidentiality issues.
Among the major points made by the Panel is that IRBs are not being as flexible as allowed by federal regulations in approving human subjects applications. The Panel found that IRBs, even though overworked, spend too much time revising wording of Informed Consent forms without understanding the full context of Informed Consent processes for the types of populations typically studied by SBES research (e.g. ethnic and language minorities and vulnerable populations). The Panel also maintains that IRBs apply higher than necessary protection standards for research that poses little or no risks to participants.
The Panel recommends that the federal Office for Human Rights Protection (OHRP) develop procedures and guidelines for Informed Consent that are suitable for alternative populations (including ethnic and language minorities). OHRP should also provide more specific direction about the conditions under which Informed Consent can and should be waived. To better protect confidentiality, OHRP and IRBs should develop and implement "best practice" techniques to protect privacy and confidentiality. Flexibility should be allowed when researchers use microdata that already incorporate such techniques. Both OHRP and IRBs should better tailor waived and expedited reviews according to minimal risk involved with SBES research participants.
The book's strength is in its systematic and clear presentation of the findings and recommendations, and the comprehensiveness of scope. One issue that should concern social work researchers is the lack of social work involvement in any of the committees, hearings, and Panel membership. In order to represent the unique perspective of social work research, social work leadership and research organizations must find ways to become actively involved in future development of policies regarding the protection of research participants in SBES research.
Ed Cohen, University of California, Berkeley
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|Publication:||Journal of Sociology & Social Welfare|
|Article Type:||Book Review|
|Date:||Sep 1, 2004|
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