Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices: A Review

作者：S. Hendriks, C. Grady, W. Chiong, J. Fins, P. Ford, S. Goering, H. Greely, K. Hutchison, M. L. Kelly, Scott Y. H. Kim, E. Klein, S. Lisanby, H. Mayberg, H. Maslen, Franklin G. Miller, Khara M. Ramos, K. Rommelfanger, S. Sheth, Anna Wexler · 发表于：JAMA Neurology · 年份：2019 · DOI：10.1001/jamaneurol.2019.3523 · 被引用次数：92 · 研究领域：Medicine、Psychology

Importance: Developing more and better diagnostic and therapeutic tools for central nervous system disorders is an ethical imperative. Human research with neural devices is important to this effort and a critical focus of the NIH BRAIN Initiative. Despite regulations and standard practices for conducting ethical research, researchers and others seek more guidance on how to ethically conduct neural device studies. This paper draws on, reviews, specifies, and interprets existing ethical frameworks, literature, and subject matter expertise to address three specific ethical challenges in neural devices research: analysis of risk, informed consent, and post-trial responsibilities to research participants. Observations: Research with humans proceeds after careful assessment of the risks and benefits. In assessing whether risks are justified by potential benefits in both invasive and non-invasive neural device research, the following categories of potential risks should be considered- those related to surgery, hardware, stimulation, research itself, privacy and security, and financial burdens. All three of the standard pillars of informed consent – disclosure, capacity, voluntariness - raise challenges in neural device research. Among these challenges are the need to plan for appropriate disclosure of information about atypical and emerging risks, a structured evaluation of capacity when that is in doubt, and preventing patients from feeling unduly pressured to participate. Research...