药物临床试验痴呆弱势群体与权益保障伦理学问题研究

Ethics and rights protection of vulnerable group in clinical trials of drugs for dementia

临床研究阿尔茨海默病(Alzheimer's disease,AD)疾患的渐进性发展让患者与研究者备受困扰,不同程度认知障碍导致一系列不同的伦理学问题。在无AD症状但存高危风险的临床前期,主要聚焦在预防性措施、高危风险信息披露及针对受辱或歧视等受试者保护问题;在认知障碍症状显性的临床研究阶段,则主要侧重于改善患者认知功能,人体试验在纳入AD弱势受试者过程中,采取特殊保护措施以符合相关伦理学准则。此类困惑亟待采取综合权重方法,对AD研究进展涉及的伦理、法律及社会效应进行权衡评估。本文围绕上述核心问题在AD临床试验前期、临床试验阶段等层面展开论述,并就风险/受益、隐私保护、知情同意、自主决策、研究预先指示与患者偏好预测等方面进行相关性分析,以期为当前AD研究受试者保护及伦理审查实践提供参考。

As Alzheimer＇s disease（AD） is characterized by progressive development of cognitive impairment,different severities of the condition may cause a series of ethic issues. In preclinical phases with high-risk but none AD symptom,the issues mainly focus on preventive measures,disclosure of sensitive information,and subject protection against humiliation or discrimination. During clinical research when the subjects have explicit AD symptoms,attention should be given to how to improve the outcome of cognitive impairment,especially the subjects involving vulnerable groups,which call for special protective measures in accordance with conventional ethical principle. However,the issues above-mentioned to some extent can be handled by taking combinative assessment ofethical,legal and social effects into account. Based on the core problems and principles,this article attempted to discuss the controversial bioethical issues such as risk/benefit,privacy protection,informed consent,decision-making of autonomy,advance directives of research,and prediction of subjects＇ preferences. We hope these considerations can provide references to the bioethical understanding of AD research and decision-making of ethics review.