title: Dealing with the long-term social implications of research.
abstract: 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.
authors.affiliation: March of Dimes Foundation, 1275 Mamaroneck Avenue, White Plains, NY 10605, USA. afleischman@marchofdimes.com
authors.forename: Alan
authors.initials: A
authors.lastname: Fleischman
authors.forename: Carol
authors.initials: C
authors.lastname: Levine
authors.forename: Lisa
authors.initials: L
authors.lastname: Eckenwiler
authors.forename: Christine
authors.initials: C
authors.lastname: Grady
authors.forename: Dale E
authors.initials: DE
authors.lastname: Hammerschmidt
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior; D026683:Advisory Committees; D000437:Alcoholism / Q000628:therapy; D000987:Antisocial Personality Disorder / Q000628:therapy; D002986:Clinical Trials as Topic / Q000941:ethics*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D024861:Genetic Enhancement / Q000941:ethics; D005824:Genetics, Behavioral / Q000941:ethics; D040261:Harm Reduction / Q000941:ethics; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D001523:Mental Disorders / Q000628:therapy; D011639:Public Opinion; D011640:Public Policy / Q000639:trends; D012945:Social Values; D014481:United States; D014754:Violence / Q000517:prevention & control