How proxies make decisions about research for patients with Alzheimer's disease

We examined the proxy decision-making and informed consent processes for cl inical research involving 49 patient-subjects with dementia in an outpatien t setting by performing serial in-depth, structured, open-ended telephone i nterviews. Interviews were tape recorded and transcribed. Transcripts were then coded and analyzed. Although in all cases proxy consent was obtained f or research from a legally authorized representative, proxies reported cons iderable ambiguity regarding who made the decision to participate in resear ch, or to what degree the decision was that of the proxy or of the patient. Reasons proxies gave for participating in research included: hope of direc t or indirect benefits to the patient, caregiver, or patient's descendents; desperation; trust in the investigator; belief in the goodness of research ; and altruism. These reasons varied according to the type of research. For instance, in drug trials hope of direct benefit prevailed; in studies not evaluating a potential therapy more altruistic concerns predominated. Being a proxy decision maker for research can be burdensome. The degree of burde n related to making a decision to participate in research seems influenced by a number of intersecting factors, most importantly, the risk and nature of the study, the extent to which patients were able to participate in the decision, and the duration and severity of dementia. Proxy decisionmaking c oncerning participation in research for patients with dementia can be a dif ficult task. The process might be improved by emphasizing that proxy consen t is being sought because the nature of the patient's underlying medical co ndition can preclude the ability to make meaningful decisions. In addition, clinical researchers should recognize that giving proxy consent might plac e additional burdens on caregivers and discuss this explicitly when proxy c onsent is solicited.