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Abstract

Part I relates several stories of involuntarily committed patients who were recruited into studies posing serious risks. Part II draws on these cases to argue that the involuntary commitment of these patients leaves them vulnerable to unethical treatment by researchers. Their inherently coercive circumstances present an overwhelming obstacle to voluntary consent, and their captive status makes them attractive targets for research that could be performed using less vulnerable subjects.

Part III argues that most research on this patient population is improper under generally applicable principles of informed consent and fair subject selection. However, existing protections have proved insufficient to prevent unethical recruitment of these patients. Accordingly, Part IV builds on the Institute of Medicine's call for expanding the definition of "prisoner" in federal regulations, arguing that civilly committed patients should be included within its ambit and that the Common Rule's protections should be applied to all research involving involuntarily confined subjects.

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