de Medeiros Kate, Girling Laura M, Berlinger Nancy
Department of Sociology and Gerontology, 6403Miami University, Oxford, OH, USA.
Center for Aging Studies, 14701The University of Maryland, Baltimore County, Baltimore, MD, USA.
Dementia (London). 2022 May;21(4):1200-1218. doi: 10.1177/14713012211072501. Epub 2022 Mar 1.
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.
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.
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.
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.
由于在几乎所有临床研究中，使用研究伙伴（代理决策者）代表阿尔茨海默病或相关痴呆症（ADRD）患者给予知情同意是常见做法，因此缺乏研究伙伴的ADRD患者经常被排除在参与研究之外。社会研究与临床研究呈现出不同的机遇和风险。我们认为，为临床研究制定的指导方针可能对社会研究过度限制，而且，自动排除ADRD患者会带来单独的伦理挑战，因为这既无法支持现有的决策能力，也会导致研究中代表性不足。
本研究的目的是确定与在社会研究中纳入缺乏研究伙伴的认知脆弱参与者相关的关键要素。
研究设计/研究样本：我们对49篇涉及潜在认知受损个体（包括缺乏研究伙伴的ADRD患者）的能力和研究同意的文章进行了适应性定性证据综合（QES）及后续内容分析。
我们确定了四个主要主题领域：定义能力、资格和同意；知情同意的各个方面；评估对社会研究相关风险理解的策略；以及风险与益处。
基于研究结果，我们提出了新的且符合伦理的方法，以确定同意参与社会研究的能力，使认知有挑战的人群能够参与同意过程，并考虑将越来越多可能从能使数百万人受益的研究中被排除的人群所带来的风险。
