To the Editor:-I read with great interest the recent editorial by Pearson [1] with its thoughtful and provocative analysis of the problems of obtaining informed consent when a potential subject's condition precludes this action. Pearson correctly details the Food and Drug Administration's criteria for exempting a clinical investigation from the requirement for obtaining informed consent. Although I agree with his analysis, I do not believe that the study [2] that formed the basis for his editorial satisfied the requirements for "deferred consent" or came within the aegis of the Food and Drug Administration's exemption.
I refer specifically to Pearson's fourth prerequisite for permitting emergency research without a patient's consent: "the investigation could not be performed without the waiver." This stipulation implies that the condition being studied will be sudden and unanticipated and will mandate immediate action. The first sentence of the abstract in the article by Balser et al. [2] clearly demonstrates that the pathology being investigated was neither sudden nor unaticipated. Rather, it was predictable and reasonably foreseeable: "Postoperative supraventricular tachyarrhythmia is a common complication of [cardiac] surgery."
Accordingly, each patient should have been enrolled in this study before surgery, at which time informed consent easily could have been obtained in a nonemergent setting. Thereafter, if the arrhythmia developed in a patient who satisfied the other requirements for entrance into the randomization procedure, there would have been no ethical problems in conducting the investigation.
I am concerned that an unduly low threshold for waiving requirements for informed consent risks impairing the role of institutional review boards in the implementation of this important provision of federal regulations. This very well may result in imposing inflexible requirements for informed consent in a truly emergent setting, thereby interfering with the acquisition of important knowledge.
Peter J. Cohen, M.D., J.D.
Member, Institutional Review Board; Intramural Research Program; National Institute on Drug Abuse; National Institutes of Health; Baltimore, Maryland 21224
(Accepted for publication March 15, 1999.)
The views and opinions expressed herein are those of the author and do not necessarily reflect those of the National Institute on Drug Abuse (NIDA), NIDA's Intramural Research Program, or its institutional review board.
