What Happens After a Neural Implant Study? Neuroethics Expert Workshop on Post-Trial Obligations

IF 2.6 4区 哲学 Q1 ETHICS
Ishan Dasgupta, Eran Klein, Laura Y. Cabrera, Winston Chiong, Ashley Feinsinger, Joseph J. Fins, Tobias Haeusermann, Saskia Hendriks, Gabriel Lázaro-Muñoz, Cynthia Kubu, Helen Mayberg, Khara Ramos, Adina Roskies, Lauren Sankary, Ashley Walton, Alik S. Widge, Sara Goering
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Abstract

What happens at the end of a clinical trial for an investigational neural implant? It may be surprising to learn how difficult it is to answer this question. While new trials are initiated with increasing regularity, relatively little consensus exists on how best to conduct them, and even less on how to ethically end them. The landscape of recent neural implant trials demonstrates wide variability of what happens to research participants after an neural implant trial ends. Some former research participants continue to receive support for their devices (e.g., battery and component replacements, software updates, etc.). Others, when safe, have their neural implants removed through surgical explantation. Still others continue to live with a deactivated neural implant embedded in their body. In the United States, there are no uniform requirements to provide services, of any kind, after an neural implant study ends, and other nations are similarly facing this challenge. The existence of a post-trial gap in an expanding neural implant research ecosystem invites obvious questions: What is owed to neural implant research participants post-trial, and why has providing it been so difficult to accomplish in practice? To take a step forward on this difficult issue, we assembled one group of stakeholders – researchers funded for neuroethics grants by the National Institutes of Health – to explore possible starting points on one topic: ethical guidance for post-trial care of research participants in neural implant trials. Based on shared concerns discussed in the expert workshop the current paper is a call to action. It reports the key areas of convergence from the meeting and highlights important next steps towards developing much needed guidance.

神经植入研究之后会发生什么?审后义务神经伦理学专家研讨会
研究性神经植入临床试验结束后会发生什么?要回答这个问题有多难,可能会令人吃惊。虽然新试验越来越频繁地启动,但对于如何以最佳方式开展试验却鲜有共识,而对于如何以合乎道德的方式结束试验更是鲜有共识。近期神经植入试验的情况表明,神经植入试验结束后,研究参与者的情况千差万别。一些前研究参与者会继续获得设备支持(如电池和组件更换、软件更新等)。还有一些人在安全的情况下通过手术取出神经植入物。还有一些人则继续带着体内已停用的神经植入体生活。在美国,神经植入研究结束后没有统一的服务要求,其他国家也同样面临这一挑战。在不断扩大的神经植入研究生态系统中,试验后缺口的存在引发了显而易见的问题:神经植入研究参与者在试验后应该得到什么,为什么在实践中很难做到?为了在这一难题上向前迈出一步,我们召集了一组利益相关者--获得美国国立卫生研究院神经伦理学基金资助的研究人员--探讨一个话题的可能出发点:神经植入试验参与者试验后护理的伦理指导。根据专家研讨会讨论的共同关注点,本文件是一份行动呼吁书。它报告了会议达成共识的关键领域,并强调了制定急需的指导意见的重要后续步骤。
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来源期刊
Neuroethics
Neuroethics MEDICAL ETHICS-
CiteScore
5.50
自引率
7.10%
发文量
31
审稿时长
>12 weeks
期刊介绍: Neuroethics is an international, peer-reviewed journal dedicated to academic articles on the ethical, legal, political, social and philosophical questions provoked by research in the contemporary sciences of the mind and brain; especially, but not only, neuroscience, psychiatry and psychology. The journal publishes articles on questions raised by the sciences of the brain and mind, and on the ways in which the sciences of the brain and mind illuminate longstanding debates in ethics and philosophy.
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