Preservation of the Capacity to Appoint a Proxy Decision Maker Implications for Dementia Research
Preservation of the Capacity to Appoint a Proxy Decision Maker Implications for Dementia Research
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DOI：
10.1001/archgenpsychiatry.2010.191
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发表时间：
2011-02-01
影响因子：
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通讯作者：
Appelbaum, Paul S.
中科院分区：
文献类型：
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作者：
Kim, Scott Y. H.;Karlawish, Jason H.;Appelbaum, Paul S.
内容：涉及决策能力受损的人（如阿尔茨海默病[AD]患者）的研究仍然具有伦理挑战性，特别是当研究涉及重大风险时。如果不能同意研究的个人能够指定研究代理人，则允许指定代理人（而不是事实上的代理人）来代表受试者。目的：评估AD患者在多大程度上保留了指定研究代理人的能力。设计：访谈研究。设置：学术研究。参与者：对188名AD患者进行了访谈，以了解他们是否有能力指定研究代理人并同意2种假设的研究方案，一项风险较低的测试新药的随机临床试验（药物RCT）和一项风险较高的测试神经外科细胞植入物的随机临床试验（神经外科RCT）。每个受试者的分类能力状态由5名有经验的精神病学家通过独立的能力访谈录像审查确定。主要结果测量：指定研究代理人的能力、同意药物RCT的能力和同意神经外科RCT的能力的分类能力确定。数据显示，37.7%（40/106）被认为无法同意药物RCT的患者和54.8%（86/157）被认为无法同意神经外科RCT的患者能够指定研究代理人。只有7的186（3.8%）被认为是能够同意的神经外科RCT的所有5 psychiatrist.Conclusions：一个相当大的比例的人与AD谁被认为是无法同意低风险或高风险的研究保留了任命一个研究代理的能力。因为很少有人被发现是明确能够提供独立的同意，以高风险的AD研究，提供指定的代理人，即使在AD发病后，这可能是最好的，在疾病的早期阶段，可能有助于解决关键的伦理挑战AD研究。
Context: Research involving persons with impaired decision-making capacity (such as persons with Alzheimer disease [AD]) remains ethically challenging, especially when the research involves significant risk. If individuals incapable of consenting to research studies were able to appoint a research proxy, it would allow for an appointed surrogate (rather than a de facto surrogate) to represent the subject.Objective: To assess the extent to which persons with AD retain their capacity to appoint a research proxy.Design: Interview study.Setting: Academic research.Participants: One hundred eighty-eight persons with AD were interviewed for their capacity to appoint a proxy for research and to provide consent to 2 hypothetical research scenarios, a lower-risk randomized clinical trial testing a new drug (drug RCT) and a higher-risk randomized clinical trial testing neurosurgical cell implants using a sham control condition (neurosurgical RCT). Categorical capacity status for each subject was determined by independent videotaped reviews of capacity interviews by 5 experienced psychiatrists.Main Outcome Measures: Categorical capacity determinations for the capacity to appoint a research proxy, capacity to consent to a drug RCT, and capacity to consent to a neurosurgical RCT.Results: Data showed that 37.7% (40 of 106) of those deemed incapable of consenting to the drug RCT and 54.8% (86 of 157) of those deemed incapable of consenting to the neurosurgical RCT were found capable of appointing a research proxy. Only 7 of 186 (3.8%) were deemed capable of consenting to the neurosurgical RCT by all 5 psychiatrists.Conclusions: A substantial proportion of persons with AD who were thought incapable of consenting to lower-risk or higher-risk studies have preserved capacity for appointing a research proxy. Because few persons are found to be unequivocally capable of providing independent consent to higher-risk AD research, providing for an appointed surrogate even after the onset of AD, which might best be done in the early stages of the illness, may help address key ethical challenges to AD research.