TY - JOUR
T1 - Dealing with the long-term social implications of research
AU - Fleischman, Alan
AU - Levine, Carol
AU - Eckenwiler, Lisa
AU - Grady, Christine
AU - Hammerschmidt, Dale E.
AU - Sugarman, Jeremy
N1 - Funding Information:
Alan Fleischman, March of Dimes Foundation Carol Levine, United Hospital Fund Lisa Eckenwiler, George Mason University Christine Grady, National Institutes of Health Dale E. Hammerschmidt, University of Minnesota Jeremy Sugarman, Berman Institute of Bioethics
PY - 2011/5
Y1 - 2011/5
N2 - 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.
AB - 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.
KW - Human subjects research
KW - IRB (institutional review board)
KW - Research ethics
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U2 - 10.1080/15265161.2011.560337
DO - 10.1080/15265161.2011.560337
M3 - Review article
C2 - 21534138
AN - SCOPUS:79957878624
SN - 1526-5161
VL - 11
SP - 5
EP - 9
JO - American Journal of Bioethics
JF - American Journal of Bioethics
IS - 5
ER -