Deferred consent. A new approach for resuscitation research on comatose patients.
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.
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NS
Abramson
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A
Meisel
P
P
Safar
D001927:Brain Diseases; D002986:Clinical Trials as Topic; D003128:Coma / Q000628:therapy*; D004630:Emergencies; D004992:Ethics, Medical; D035082:Federal Government; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D035842:Research Subjects; D012151:Resuscitation; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation; D014481:United States; D014483:United States Dept. of Health and Human Services; D014486:United States Food and Drug Administration