Alternative Decision-Makers' Perspectives on Assent and Dissent for Dementia Research

Objectives: Investigators generally address the ethical dilemma of patients' decisional impairment in Alzheimer disease (AD) research by obtaining consent from alternative or surrogate decision makers (" proxies") as well as assent from patients. How these proxies conceptualize patient assent, or lack of objection, to participate may influence decisions made of the patients' behalf, but has been little studied. This report examines statements of proxies relevant to how they conceptualized assent and dissent to research. Design: Surveys and in-depth interviews of proxies presented with hypothetical scenario related to enrolling relatives with AD in a clinical trial of an investigational drug for AD. Participants: Proxies (n = 25) for people with AD. Measurements: Open-ended and rating-scaled items assessing perspectives on enrollment in research, influences on decision-making, and willingness to override a relative's preferences regarding research participation. Statements with relevance to assent or dissent were coded. Results: Proxies described looking for consistent behavioral or verbal indications of assent versus objection when trying to determine patients' preferences. However, proxies sometimes expressed willingness to override patients' desires in favor of patients' presumed best interests. The amnestic nature of the disorder led some proxies to justify overriding temporary dissent or discomfort in the interest of promoting patients' values. Patients' dependence on their caregivers for decision-making, and caregivers' awareness of their ability to persuade their relatives, also emerged in descriptions of the decision-making process. Conclusions: Proxies' statements regarding a hypothetical research enrollment decision revealed several themes with implications for the concepts of assent and dissent. Proxies may persuade or influence patients to promote the patient's best interests or values. Further work, particularly examining actual decision-making, is warranted to determine how best to operationalize the concepts of assent and dissent in the context of research involving decisionally impaired adults.