Viewpoint: IRBs, hospital ethics committees, and the need for "translational informed consent".
In this paper, the authors contrast the model of informed consent oversight employed by most IRBs with that most commonly employed by hospital ethics committees at academic medical centers. The challenge of developing adequate consent forms is complicated by competing aims that are difficult to reconcile. "Completeness" in conveying highly technical information is often at odds with comprehensibility for lay audiences. The authors argue that the problems posed by consent are tied to the fact that in clinical research, consent documents are perceived as the primary mechanism for securing informed consent, as opposed to viewing the consent process and conversation as the primary mechanism. Concerns for informed consent should be refocused to the consent process rather than IRB review of documents, using teams of consent monitors, and this new emphasis should be piloted through the National Institute of Health's recent turn toward clinical and translational science awards.
May
Thomas
T
Center for the Study of Bioethics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA. tmay@mcw.edu
Craig
J M
JM
Spellecy
Ryan
R
D028741:Ethics Committees, Clinical; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D014481:United States