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Editor's Correspondence |

Waiving Informed Consent for Research on Spiritual Matters?

Julie Goldstein, MD
Arch Intern Med. 2000;160(12):1870-1871. doi:.
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When I first picked up the article by Harris et al,1 I read with open-minded interest: Would such prayer have any effect on the course of illness of the subjects studied? If so, or even if not, how could it hurt? Even for the agnostic, when critically ill, wouldn't most be of the opinion that anything that might help is worth trying, particularly if there is no harm done in the trying?

As I read the study, however, it was not the findings that intrigued me, but the method of study—specifically, the rationale, approved by the institutional review board, to bypass the informed consent of prospective subjects. The authors made a point of elaborating on this choice, anticipating that there would be some reader concern. They offered or implied a number of reasons to support circumventing the informed consent process and justify proceeding with the study: (1) that there is "no known risk" associated with the procedure, (2) that the informed consent discussion with prospective subjects would be likely to bias the study toward inclusion of a propensity of "prayer-receptive" subjects, and (3) that the informed consent inquiry itself could cause distress for the patient, in that the patient would be forced to think about issues of faith at a time when it may not have been that patient's desire to do so.

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