Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...) considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency. (shrink)

: National bioethics commissions have been critiqued for a variety of structural, procedural, and political aspects of their work. A more recent critique published by Dzur and Levin uses political philosophy to constructively critique the work of national bioethics commissions as public deliberative forums. However, this public forum critique of bioethics commissions ignores empirical research in political science and normative claims that suggest that advisory commissions can and should have diverse of functions beyond that of being public forums. The present (...) paper argues that the public forum critique too narrowly considers the roles that bioethics commissions can play in public bioethics and ignores the moral obligation of commissions to fulfill their mandates. Evaluations of commissions must consider that these institutions can serve in capacities other than those of a public deliberative forum and use additional measures to evaluate the multiple roles and successes of bioethics commissions in public policy. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.