Ethical Considerations in Clinical Trials for Disorders of Consciousness.
Ethical Considerations in Clinical Trials for Disorders of Consciousness.
复制标题
意识障碍的临床试验中的道德考虑。
DOI：
10.3390/brainsci12020211
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发表时间：
2022-02-02
期刊：
影响因子：
3.3
通讯作者：
Edlow BL
中科院分区：
文献类型：
--
作者：
Young MJ;Bodien YG;Edlow BL
随着意识障碍（DoC）患者临床试验范围的扩大，考虑相关的伦理挑战和机遇越来越重要。在DoC患者的弱势人群中进行负责任的研究，包括昏迷，植物人状态/无反应觉醒综合征（VS/UWS），最低意识状态（MCS），隐蔽皮层处理（CCP）和认知运动分离（CMD），需要积极主动地考虑可能出现的独特伦理问题，并采取强有力的保护措施来保护患者，代理人和其他关键利益相关者。在此，我们确定并批判性地评估了涉及DoC参与者的临床试验中伦理考虑的四个核心类别：（1）自主性，尊重个人和具有阈意识的个人的知情同意;（2）平衡未知的利益和风险，特别是考虑到行为和意识之间的认识论差距，使主观状态的普通归属复杂化;（3）向代理人和临床团队披露与意识有关的研究结果;（4）公正考虑，包括公平获得跨社区和地理区域的临床试验招募。我们概述了临床医生，神经伦理学家和从事DoC临床试验的研究人员的指导原则和研究机会，以推进这一复杂而关键的研究领域的伦理研究设计和部署。
As the clinical trial landscape for patients with disorders of consciousness (DoC) expands, consideration of associated ethical challenges and opportunities is of ever-increasing importance. Responsible conduct of research in the vulnerable population of persons with DoC, including those with coma, vegetative state/unresponsive wakefulness syndrome (VS/UWS), minimally conscious state (MCS), covert cortical processing (CCP), and cognitive motor dissociation (CMD), demands proactive deliberation of unique ethical issues that may arise and the adoption of robust protections to safeguard patients, surrogates, and other key stakeholders. Here we identify and critically evaluate four central categories of ethical considerations in clinical trials involving participants with DoC: (1) autonomy, respect for persons and informed consent of individuals with liminal consciousness; (2) balancing unknown benefits and risks, especially considering the epistemological gap between behavior and consciousness that complicates ordinary ascription of subjective states; (3) disclosure to surrogates and clinical teams of investigational results pertaining to consciousness; and (4) justice considerations, including equitable access to clinical trial enrollment across communities and geographies. We outline guiding principles and research opportunities for clinicians, neuroethicists, and researchers engaged in DoC clinical trials to advance ethical study design and deployment in this complex yet crucial area of investigation.
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影响因子：
1.6
作者：
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通讯作者：
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Matthews, Alicia K
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通讯作者：
Sauaia A