Dealing With the Long-Term Social Implications of Research
Hammerschmidt, Dale E
The American journal of bioethics : AJOB 2011 May; 11(5): 5-9
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 (IRBs) 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.
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Emanuel, Ezekiel J.; Wood, Anne; Fleischman, Alan; Bowen, Angela; Getz, Kenneth A.; Grady, Christine; Levine, Carol; Hammerschmidt, Dale E.; Faden, Ruth; Eckenwiler, Lisa; Muse, Carianne Tucker; Sugarman, Jeremy (2004-08-17)The oversight of research involving human participants is widely believed to be inadequate. The U.S. Congress, national commissions, the Department of Health and Human Services, the Institute of Medicine, numerous professional ...
Levine, Carol; Faden, Ruth; Grady, Christine; Hammerschmidt, Dale; Eckenwiler, Lisa; Sugarman, Jeremy (Consortium to Examine Clinical Research Ethics, 2004-02-03)Research participants require ongoing protection of the kind already established in law and regulation. However, "special scrutiny" for certain types of research is also needed. Three criteria for special scrutiny are 1) ...