Informed Consent and Psychiatric Patients

To the Editor: The article by Donna A. Wirshing, M.D., and colleagues (1) and the related editorial by Paul S. Appelbaum, M.D. (2), underscore the salience of the informed consent process in research involving psychiatric patients. Dr. Wirshing et al. provide new data on the ability of 49 patients with schizophrenia at a Veterans Administration Medical Center to learn and remember information about proffered medication research studies. It is indeed reassuring that these patients felt informed and performed well on a test of the relevant material presented to them.

This article and its companion editorial address only the informational component of informed consent; there remains another critical component about which empirical data are still lacking. The term “voluntary,” as applied to informed consent, refers to the capacity to act without undue influence or coercion (3). The importance of choice in this context has historical roots dating to the seventeenth-century concept of free will as essential to our status as human beings. That citizens, patients, and prisoners have at various times been commandeered as unwilling subjects in medical research is well documented (4–6).

The challenge for our profession today is to validate the informed consent process by protecting potential subjects from the possibility of unwitting exploitation by well-intended but overzealous research clinicians. To do so, principal investigators and institutional research boards should consider explicitly the following factors influencing volition: who is responsible for subject recruitment (reflecting an awareness of the transference effect of the treating psychiatrist as researcher), what special status and benefits are offered uniquely to subjects (including monetary compensation, free care, and prolonged hospitalization), and who will supervise and intervene on behalf of the patient in the event that the patient’s competence erodes during the course of the study.

The articles in the November 1998 issue are a timely reminder that the 50 years of progress in the scientific conduct of controlled drug trials for schizophrenia (7) should be matched by comparable advances in research ethics.