Caring for BRAIN pioneers: Understanding and enhancing family and researcher support in neural device trials

关爱 BRAIN 先驱：了解并加强家庭和研究人员对神经设备试验的支持

• 批准号: 10655638
• 负责人: Sara Goering
• 金额: $ 34.16万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10655638
• 关键词: Accounting; Address; Affect; Articulation; Attention; Brain; Caregivers; Caring; Clinical; Consent; Deep Brain Stimulation; Development; Devices; Enrollment; Ethicists; Ethics; Ethnography; Family; Family member; Feedback; Feeling; Frustration; Funding; Future; Individual; Interview; Investments; Modeling; Motivation; Nature; Operative Surgical Procedures; Participant; Personal Satisfaction; Persons; Process; Qualitative Research; Recommendation; Recovery; Relationship-Building; Research; Research Assistant; Research Design; Research Ethics; Research Personnel; Risk; Role; Science; Shapes; Structure; Study Subject; Technology; Time; Time Study; Translations; Work; brain computer interface; experience; experimental study; family support; first-in-human; instrument; meetings; member; neural; neural implant; neuroethics; neurotechnology; participant safety; programs; psychosocial; recruit; research study; side effect; success; willingness

Project abstract BRAIN pioneers are people who take on significant risk as participants in first-in-human or early neurotechnology studies for the sake of helping to further science. Their willingness to try invasive and non- medically necessary devices, their investments of significant time and energy, and their close relationships with study teams, typically built over 3-5 years of intensive experiments, make them relatively unique as research participants. Their well-being is integral to the continued development of the field of neural technology, yet relatively little neuroethical attention has been focused on the structures of support, from researchers and from family members, that enable BRAIN pioneers to successfully participate in neural device trials. In this study, we: 1) Utilize an embedded ethicist to observe interactions between participants in long-term, implantable neural device trials, their family partners, and the research team to identify modes of care and support provided in the experimental setting; 2) Use qualitative interviewing to explore how participants, family members and researchers articulate the role, benefits, and limitations of family and researcher care and support before, during, and after a trial; and 3) Develop recommendations for best practices for a more inclusive support structure in research design and practice.

项目摘要 BRAIN 先驱者是那些作为首次人体或早期研究的参与者而承担重大风险的人 神经技术研究是为了帮助进一步发展科学。他们愿意尝试侵入性和非侵入性的 医疗必需的设备、他们投入的大量时间和精力以及他们与 研究团队通常经过 3-5 年的密集实验而建立，这使得它们作为研究相对独特 参与者。他们的福祉是神经技术领域持续发展不可或缺的一部分，但 研究人员和研究人员对支持结构的神经伦理关注相对较少 家庭成员，使 BRAIN 先驱者能够成功参与神经设备试验。在这项研究中， 我们：1）利用嵌入式伦理学家来观察参与者之间的长期、可植入的相互作用 神经装置试验、他们的家庭伙伴和研究团队确定提供的护理和支持模式 在实验环境中； 2) 使用定性访谈来探索参与者、家庭成员和 研究人员在之前阐明家庭和研究人员关怀和支持的作用、好处和局限性， 审判期间和之后； 3) 制定最佳实践建议，以提供更具包容性的支持 研究设计和实践的结构。