Deferred consent. A new approach for resuscitation research on comatose patients
Abramson, N.S.; Meisel, A.; Safar, P.
JAMA 255(18): 2466-2471
1986
ISSN/ISBN: 0098-7484 PMID: 3701965 Document Number: 268947
Federal regulations require researchers conducting clinical trials to obtain consent to experimentation from their intended subjects or, if the latter are incompetent, from next of kin. This requirement places constraints on researchers who are working with comatose patients in need of immediate treatment after resuscitation under conditions where prior consent is not practical. The authors, participants in the NIH-funded Brain Resuscitation Clinical Trial (BRCT), propose two new concepts to be applied to resuscitation research to satisfy federal consent law: "minimal differential risk," and "deferred consent." The first concept allows consent requirements to be waived when there is a negligible difference in risks between standard and experimental therapies. The second permits researchers to initiate experimental therapy under emergency conditions, and then to obtain consent to continue from the subjects' next of kin.