To the Editor:—
The editorial by Drs. Truog and Robinson was both interesting and thought-provoking. 1Among the many salient issues discussed, obstacles to effective informed consent was a particularly poignant topic. Truog and Robinson clearly outlined how mandates for informed consent in emergency medical situations nearly stifled important clinical research in this crucial medical venue. Most physicians would agree that some modifications are necessary to ensure patient protection while still allowing investigation in situations in which obtaining consent is difficult or impossible.
However, we must take issue with the example used whereby Truog and Robinson propose bypassing informed consent, ostensibly because “it won’t matter to the patient.” To review, the authors site an example of comparing two long-used disinfecting surgical preparation soaps to see which has the lowest infection rate. Because they believe that it would be difficult to understand how a patient would have an objection to participating in such a trial, they find it “… difficult to see the value of obtaining specific informed consent…” Furthermore, they think that obtaining informed consent would “… significantly increase the logistical difficulties of performing the trial…” However, it is exactly this situation that should require informed consent. The scope of the investigation is clear. The outcome of the study is clearly defined. This does not significantly increase logical difficulties, rather, informed consent is even easier to obtain than in many other trials because of the straightforward nature of the study.
The work of Dr. Beecher would be for naught if we subjectively decide which information the patient does or does not need to know. When the ability to obtain informed consent is not compromised because of a life-threatening emergency, patient autonomy should always be respected and consent obtained.
Drs. Truog and Robinson spark an interesting debate on the future of informed consent. They point out specific areas in which dialogue and investigation are needed. However, we should not forsake our ethical or professional obligation to our patients to simplify our research protocols. As Dr. Beecher has shown us, informed consent is an important and inalienable patient right.