The purpose of this article is to heighten awareness and provide information on issues that have affected and continue to affect the mentally ill who participate in research studies. Three of the major controversies surrounding medical research (placebo and washout studies, challenge studies, and informed consent), ethical concerns related to these issues, and proposed strategies to protect and safeguard mentally ill participants are examined. The role of the nurse as patient advocate and educator, in accordance with the American Nurses Association's ethical code for nurses, is discussed.J Am Psychiatr Nurses Assoc, 2007; 13(4), 221-229.
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