From the Comprehensive Epilepsy Center, Department of Neurology (B.T.), Yale University School of Medicine, New Haven, CT; Epilepsy Center of Excellence, Neurology Service (B.T.), VA Connecticut Healthcare System, West Haven; Division of Clinical Research (R.C.), National Institute of Neurological Disorders and Stroke, NIH, Bethesda, MD; Division of Neurology, Department of Pediatrics (L.G.E.), Northwestern University Feinberg School of Medicine, Chicago; Stanley Manne Children's Research Institute (L.G.E.), Ann & Robert H. Lurie Children's Hospital of Chicago, IL; and Division of Neurology (J.A.R.), Lahey Hospital and Medical Center, Burlington, MA.
Neurology. 2020 Apr 14;94(15):661-669. doi: 10.1212/WNL.0000000000009241. Epub 2020 Mar 16.
This update to the American Academy of Neurology's 1998 position statement endeavors to provide guidance for the consistent ethical conduct and review of neurologic research involving human participants. It does so by outlining a widely used ethical framework of 7 principles derived from the foundational documents of modern bioethics, including the Nuremberg Code, the World Medical Association's Declaration of Helsinki, the Belmont Report, and the US Department of Health and Human Service's Common Rule. The position statement then applies this principle-based framework to analyze and produce recommendations for the management of common and important ethical issues encountered in neurologic clinical research. These include institutional review board oversight, equitable research participant inclusion, cognitive impairment in research participants, international studies, the replication crisis, and genetic testing and modification.
本项对美国神经病学学会 1998 年立场声明的更新旨在为涉及人类参与者的神经科学研究的一致伦理行为和审查提供指导。它通过概述一个广泛使用的伦理框架来实现这一目标,该框架源自现代生物伦理学的基础文件,包括纽伦堡法典、世界医学协会赫尔辛基宣言、贝尔蒙报告和美国卫生与公众服务部的通用规则。该立场声明然后应用基于原则的框架来分析和提出建议,以管理神经科临床研究中常见和重要的伦理问题。这些问题包括机构审查委员会监督、公平的研究参与者纳入、研究参与者的认知障碍、国际研究、复制危机以及基因检测和修饰。