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神经外科患者作为人体研究对象:颅内电生理学研究中的伦理考虑。

Neurosurgical Patients as Human Research Subjects: Ethical Considerations in Intracranial Electrophysiology Research.

机构信息

Weill Institute for Neurosciences, Department of Neurology, Memory and Aging Center, University of California San Francisco, San Francisco, California.

Weill Institute for Neurosciences, Department of Neurosurgery, University of California San Francisco, San Francisco, California.

出版信息

Neurosurgery. 2018 Jul 1;83(1):29-37. doi: 10.1093/neuros/nyx361.

DOI:10.1093/neuros/nyx361
PMID:28973530
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5777911/
Abstract

Intracranial electrical recordings and stimulation of neurosurgical patients have been central to the advancement of human neuroscience. The use of these methods has rapidly expanded over the last decade due to theoretical and technical advances, as well as the growing number of neurosurgical patients undergoing functional procedures for indications such as epilepsy, tumor resection, and movement disorders. These methods pose the potential for ethical conflict, as they involve basic neuroscientific research utilizing invasive procedures in human patients undergoing treatment for neurological illnesses. This review addresses technical aspects, clinical contexts, and issues of ethical concern, utilizing a framework that is informed by, but also departs from, existing bioethical literature on matters in clinical research. We conclude with proposals for improving informed consent processes to address potential problems specific to intracranial electrophysiology research, a general schema for scrutinizing research-related risk associated with different methods, and a call for the development of consensus to ensure continuing scientific progress alongside crucial patient protections in this promising area of human neuroscience.

摘要

颅内电记录和神经外科患者的刺激一直是人类神经科学发展的核心。由于理论和技术的进步,以及越来越多的神经外科患者因癫痫、肿瘤切除和运动障碍等适应症而接受功能手术,这些方法的使用在过去十年中迅速扩大。这些方法带来了潜在的伦理冲突,因为它们涉及利用侵入性程序对正在接受治疗神经疾病的人类患者进行基础神经科学研究。本综述利用临床研究中现有生物伦理文献所提供的但又与之不同的框架,探讨了技术方面、临床背景和伦理关注问题。我们最后提出了一些建议,以改善知情同意程序,解决颅内电生理学研究中特定的潜在问题,提出了一个一般的方案来仔细审查与不同方法相关的研究风险,并呼吁制定共识,以确保在这一有前途的人类神经科学领域继续科学进步的同时,为患者提供关键保护。

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