Inclusion of people living with Alzheimer’s disease or related dementias who lack a study partner in social research: Ethical considerations from a qualitative evidence synthesis

Abstract

Background Because use of a study partner (proxy decision-maker) to give informed consent on behalf of someone living with Alzheimer’s disease or related dementias (ADRD) is common in nearly all clinical research, people living with ADRD who lack a study partner are regularly excluded from participation. Social research presents different opportunities and risks than clinical research. We argue that guidelines developed for the latter may be unduly restrictive for social research and, further, that the automatic exclusion of people living with ADRD presents separate ethical challenges by failing to support extant decision-making capacity and by contributing to underrepresentation in research. Purpose The study objective was to identify key components related to including cognitively vulnerable participants who lack a study partner in social research. Research design/Study sample We conducted an adaptive qualitative evidence synthesis (QES) and subsequent content analysis on 49 articles addressing capacity and research consent for potentially cognitively compromised individuals, to include people living with ADRD, who lack a study partner. Results We identified four major topic areas: defining competency, capacity, and consent; aspects of informed consent; strategies to assess comprehension of risks associated with social research; and risks versus benefits. Conclusions Based on findings, we suggest new and ethically appropriate ways to determine capacity to consent to social research, make consent processes accessible to a population experiencing cognitive challenges, and consider the risks of excluding a growing population from research that could benefit millions.