日本针对涉及精神疾病患者的神经科学研究的伦理准则制定
Ethics Guideline Development for Neuroscience Research involving Patients with Mental Illness in Japan.
作者信息
Takimoto Yoshiyuki, Shimanouchi Akifumi
机构信息
Department of Biomedical Ethics, The University of Tokyo, Tokyo, Japan.
Department of Philosophy, Hoshi University, Tokyo, Japan.
出版信息
Asian Bioeth Rev. 2023 Feb 10;15(4):365-375. doi: 10.1007/s41649-023-00240-x. eCollection 2023 Oct.
UNLABELLED
This study aims to develop guidelines of key concepts and specific considerations to make the research more ethical when conducting neurological examinations and treatment interventions in mentally ill patients. We analyzed guideline development theory and literature, previous issues, and discussions with specialists of philosophy, medicine, sociology, and bioethics. The selection of research participants, drafting of intervention plans, and informed consent process were examined with reference to the dual burden; the minimal risk as a general rule of ethical allowance levels, assent and dissent to assess the individual's judgment capacity for consent, relational autonomy for personal consent with assistance by the proxy, and risk/benefit assessments. When conducting studies, this guideline requires that these three processes be set up appropriately on a case-by-case basis.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1007/s41649-023-00240-x.
未标注
本研究旨在制定关键概念和具体考量的指南，以便在对精神病患者进行神经学检查和治疗干预时使研究更符合伦理道德。我们分析了指南制定理论和文献、先前存在的问题，并与哲学、医学、社会学和生物伦理学专家进行了讨论。参照双重负担、作为伦理允许水平一般规则的最低风险、用于评估个体同意判断能力的同意和不同意、代理协助下个人同意的关系自主性以及风险/收益评估，对研究参与者的选择、干预计划的起草和知情同意过程进行了审查。在开展研究时，本指南要求根据具体情况适当设置这三个过程。
补充信息
在线版本包含可在10.1007/s41649-023-00240-x获取的补充材料。
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