Informed consent by proxy. An issue in research with elderly patients

The New England Journal of Medicine
J W WarrenH L Muncie

Abstract

The need for clinical study of patients in nursing homes is growing as this population grows; yet many of these patients are mentally incompetent to give informed consent for such research, and the decision must therefore be left to family members or other proxies. We studied the decisions by the proxies for 168 patients in nursing homes about whether to permit the patients' participation in a study involving minimal risk. The proxies were family members in all but one case, and 78 of 168 (46 percent) refused consent. Refusal was significantly associated (P less than 0.001) with the views that research should not be done in nursing homes, that the study would disturb the patient, that the patient, if able, would refuse to participate in the study, and that the proxy would refuse to participate in such a study if asked. Of the 55 proxies who believed that the patient would refuse consent, however, 17 (31 percent) gave consent, in apparent opposition to the patient's wishes. We conclude that refusal by family members to allow incompetent elderly patients to participate in studies may be an important obstacle to research among the elderly. Both the selection of proxies and the bases for their decisions require further study and de...Continue Reading

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