The elderly patient and informed consent. Empirical findings

Abstract

Informed consent with the elderly patient and the competency of this patient population have been neglected issues in medicine and law. Particularly, the competency of the elderly patient has received little empirical investigation. The present study examines the capacity of geriatric patients to consent to research participation. Competency is investigated through the use of hypothetical consent information on three dimensions: comprehension of consent material, quality of reasoning about the decision to participate or not participate in research, and reasonable choice regarding participation. The results indicate that elderly patients' choices about those projects in which participation is "reasonable" do not differ, by and large, from younger patients. However, the elderly show significantly poorer comprehension of consent information. Thus, screening for competency and providing special instructions may become an important part of the research process when the elderly are participants.

KIE: This study examines the competence of the elderly to give informed consent to participate in research by assessing and comparing the willingness of elderly and young medical patients to participate in six hypothetical experiments of various risk-benefit ratios. Competence was determined by a three-part analysis of the consent--comprehension of consent material, quality of reasoning about the decision whether or not to participate, and reasonableness of choice. The elderly subjects showed significantly poorer understanding of consent material but only insignificantly poorer scores in the other two dimensions. The authors cautiously generalize to treatment situations and suggest screening for competence, developing aids to comprehension, enlisting family members' help, and seeking proxy consent if necessary.