Deferred consent. A new approach for resuscitation research on comatose patients

Abstract

Methodological constraints inherent in the rapidly growing field of resuscitation research have created an apparent conflict with newly promulgated federal regulations, especially those concerning informed consent requirements. We propose that two new concepts be applied to resuscitation research to satisfy the current federal regulations governing biomedical research. The first of these concepts is "minimal differential risk," ie, in resuscitation medicine, the difference between the risk of an undesirable outcome when standard, commonly accepted therapy may be used and the risk of an undesirable outcome with experimental therapy is minimal. The second concept is "deferred consent," ie, obtaining consent to continue with an experimental therapy after administration of that therapy has already begun. We believe that the emergency exception to informed consent applies to resuscitation research. Recognition of the applicability of these concepts to resuscitation research should allow compliance with federal and state regulations that otherwise might inhibit or preclude such research endeavors.

KIE: 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.