Ivan Brown Andrew, MacDuffie Katherine E, Goering Sara, Klein Eran
University of Washington, Philosophy, Seattle, Washington.
Seattle Children's Research Institute, Treuman Katz Center for Pediatric Bioethics and Palliative Care, Seattle, Washington.
Neuroethics. 2025 Apr;18(1). doi: 10.1007/s12152-025-09593-6. Epub 2025 Mar 26.
Research participants in long-term, first-in-human trials of implantable neural devices (i.e., brain pioneers) are critical to the success of the emerging field of neurotechnology. How these participants fare in studies can make or break a research program. Yet, their ability to enroll, participate, and seamlessly exit studies relies on both the support of family/caregivers and care from researchers that is often hidden from view. The present study offers an initial exploration of the different kinds of support that play a role in neural device trials from the perspectives of brain pioneers and their support partners (spouses, paid caregivers, parents, etc.). Using a mixed methods approach (semi-structured, open-ended interviews and a survey) with interpretive grounded theory, we present narratives from a study of six pioneers -- four in brain-computer interface (BCI) trials, and two in deep brain stimulation (DBS) trials -- and five support partners, about their experiences of being supported and supporting participants in implantable neural device studies. Our findings indicate the substantial amount of work involved on the part of pioneers - and some support partners - to make these studies successful. A central finding of the study is that non-logistical forms of support - social, emotional, and epistemic support - play a role, alongside more widely acknowledged forms of support, such as transportation and physical and clinical care. We argue that developing a better understanding of the kinds of support that enable neurotechnology studies to go well can help bridge the gap between abstract ethical principles of caring for subjects and on-the-ground practice.
参与植入式神经装置长期首次人体试验的研究参与者（即脑部先驱者）对于神经技术这一新兴领域的成功至关重要。这些参与者在研究中的表现可能决定一个研究项目的成败。然而，他们参与登记、参与研究以及顺利退出研究的能力既依赖于家庭/照顾者的支持，也依赖于研究人员的关怀，而这种关怀往往不为人所见。本研究从脑部先驱者及其支持伙伴（配偶、付费照顾者、父母等）的角度，初步探讨了在神经装置试验中发挥作用的不同类型的支持。我们采用混合方法（半结构化、开放式访谈和一项调查）并运用解释性扎根理论，呈现了对六位先驱者（四位参与脑机接口[BCI]试验，两位参与深部脑刺激[DBS]试验）和五位支持伙伴的研究叙述，内容涉及他们在植入式神经装置研究中获得支持以及支持参与者的经历。我们的研究结果表明，先驱者以及一些支持伙伴为使这些研究取得成功付出了大量努力。该研究的一个核心发现是，除了交通、身体和临床护理等更广泛认可的支持形式外，非后勤形式的支持——社会、情感和认知支持——也发挥了作用。我们认为，更好地理解有助于神经技术研究顺利开展的支持类型，有助于弥合关爱受试者的抽象伦理原则与实际操作之间的差距。
