NeuroEthics of Non-Therapeutic Invasive Human Neurophysiologic Research

联系PD/PI：Pouratian，Nader 项目总结/摘要 BRAIN Initiative在侵入性人类神经科学研究方面进行了大量投资， 独特的神经外科机会的优势，研究基本的人类神经科学，没有治疗意图。 这些非治疗性研究由于不确定性和关于何时进行的分歧而具有特殊的伦理意义。 应允许进行这类研究，特别是在风险/效益评估方面。这样的伦理问题出现了 由于（1）这些研究使参与者暴露于治疗性手术之外的额外风险，（2）这些 风险不能被任何直接治疗获益的预期所抵消，（3）神经系统后遗症可能更多 （4）侦查手段的稀有性导致了侦查手段的不确定性， 实际风险，以及（5）这种调查的好处或价值并不明显，并且考虑到快速的 随着这一领域的发展，我们可能越来越不清楚我们应该重视什么知识， 社会我们假设（i）患有致残性疾病的患者参与者具有独特的和有价值的 （二）对这种研究的风险和价值的看法，（二）这种判断可能与 研究人员和公众基于不同的生活经验，（三）理解这些不同的 判断可以推进未来研究的伦理设计，并批判性地拓宽该领域对价值评估的讨论。 个人风险与研究的社会效益。在目标1中，我们试图了解患者-参与者 对此类试验的风险、益处和可允许性的看法。这群人可能有独特的视角 基于他们的慢性神经系统疾病史，这可能会独特地影响他们的风险评估， 值我们将通过不同程度的侵入性研究采访患者，以阐明广泛的 的经验，并评估的影响，侵入性的相关观点。在目标2中，我们阐明 研究者（医生、工程师、神经科学家和其他人）的不同观点以及 公众，以评估不同的社会，生活和职业经历如何影响风险和效益评估 这些数据和目标1中的数据将提供一套广泛的比较叙述， 风险、收益及其评价。在目标3中，我们将阐明所有三个人群的观点 关于未来研究的风险、收益和社会价值的限制。未来的科学研究 在非治疗性研究中，应采用不断发展的技术来追求目标？为了实现这些目标，我们 一个由临床医生、伦理学家和心理学家组成的多学科团队一起探索不同的社会价值观。 为风险/效益评估提供信息。该提案得到了一个具有悠久历史的环境的加强， 目前在多个研究者中进行的非治疗性侵入性人类神经科学研究组合。冲击 我们的目标是描述不同的利益相关者的价值观如何能够和应该被纳入设计， 对未来非治疗性侵入性人类神经生理学研究的评估， 这些观点将导致更加一致、具有社会包容性和道德上严格的风险/效益评估。 项目摘要/摘要第6页

Contact PD/PI: Pouratian, Nader Project Summary/Abstract The BRAIN Initiative has made a significant investment in invasive human neuroscientific studies that take advantage of unique neurosurgical opportunities to study basic human neuroscience without therapeutic intent. These non-therapeutic studies are of particular ethical interest due to uncertainty and disagreement about when such studies should be allowed, particularly with respect to risk/benefit assessments. Such ethical issues arise since (1) these investigations expose participants to additional risks beyond that of therapeutic surgery, (2) these risks cannot be offset by any expectation of direct therapeutic benefit, (3) the neurological sequelae may be more consequential than harm to other organs, (4) the rarity of the investigative techniques results in uncertainty of the actual risks, and (5) the benefits or value of such investigations are not explicitly obvious, and given the rapid growth of this field, it may become increasingly unclear what knowledge we should value going forward as society. We hypothesize (i) that patient-participants living with disabling disorders have a unique and valuable perspective on the risks and worth of such research, (ii) that such judgements may contrast with those of investigators and the general public based on differing life experience, and (iii) that understanding these different judgments can advance the ethical design of future studies and critically broaden the field’s discussion of valuing the individual risks against the social benefit of the research. In Aim 1, we seek to understand patient-participant perspectives on risks, benefits, and permissibility of such trials. This population may have unique perspectives based on their history of chronic neurologic disease, which may uniquely influence their assessment of risks and value. We will interview patients across studies with varying degrees of invasiveness to elucidate a wide range of experiences and to evaluate the impact of invasiveness on the relevant perspectives. In Aim 2, we elucidate alternate perspectives from investigators (physicians, engineers, neuroscientists and others) as well as the public, to assess how differing social, life, and occupational experiences impact risk and benefit assessments This data and data from aim 1 will provide a wide-ranging set of comparative narratives about perceptions of risks, benefits, and the evaluations thereof. In Aim 3, we will elucidate perspectives from all three populations on the limits of the risks, benefits, and social worth of future research. Are there limits to what future scientific goals should be pursued with evolving technology in non-therapeutic studies? To address these aims, we bring together a multidisciplinary team of clinicians, ethicists, and psychologists to explore the diverse social values that inform risk/benefit assessments. The proposal is enhanced by an environment with a strong history and current portfolio of non-therapeutic invasive human neuroscientific studies across multiple investigators. Impact. Our goal is to characterize how different stakeholder values can and should be incorporated in the design and assessment of future non-therapeutic invasive human neurophysiological studies, with the anticipation that such perspectives will lead to more consistent, socially inclusive, and ethically rigorous risk/benefit assessments. Project Summary/Abstract Page 6