Proposed regulations for research involving those institutionalized as mentally infirm: A consideration of their relevance in 1995

Research ethics and clinical trials: Fostering collaboration with research participants

“…For example, in placebo-controlled trials with individuals lacking in decisionmaking capacity, proxies evaluate the risk/benefit for the patient and may be permitted to determine enrollment, though whether their decision is based on what the patient would have wanted and the risks the patient would have been willing to take, is rarely a part of the discussion between proxy and researcher. The ethical issues inherent in running clinical trials with persons incapable of participating in the research endeavor, unfortunately, go beyond the scope of this article; the reader is referred to the many excellent discussions that focus specifically on patients with questionable capacity (Candilis, 1993;De Renzo, 1994;Appelbaum, 1995;Elliot, 1995;Keyserling, 1995;Kopelman, 1995;Berg, 1996;Levine, 1996;Hoppe, 1996;Bonnie, 1997;Muncie, 1997; Committee on Care at End of Life, 1997; Karlawish, 1997;Shamoo, 1997).…”