Abstract
In this paper we briefly review the history of human clinical research in the United States, and describe the role that Institutional Review Boards (IRBs) have played. In particular, we describe the role of the IRB in clinical research involving the cognitively impaired. We emphasize the importance of further empirical research to elucidate the process of informed consent, surrogate decision-making, advance directives, and the role of the IRB, and suggest directions for future investigation.
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