NeuroEthics of Non-Therapeutic Invasive Human Neurophysiologic Research

联系PD/PI：Pouratian，Nader 项目摘要/摘要 大脑倡议在侵入性的人类神经科学研究上做出了重大投资，这些研究需要 利用独特的神经外科机会，在没有治疗意图的情况下研究基础人类神经科学。 这些非治疗性研究具有特别的伦理意义，因为对何时进行研究存在不确定性和分歧。 应允许进行此类研究，特别是在风险/效益评估方面。这样的伦理问题就产生了。 由于(1)这些调查将参与者暴露在治疗手术之外的额外风险中，(2)这些 任何对直接治疗益处的期望都不能抵消风险，(3)神经后遗症可能更多 (4)侦查手段的稀缺性导致了对 实际风险，以及(5)此类调查的好处或价值并不明显，而且考虑到 随着这一领域的发展，我们未来应该重视哪些知识可能会变得越来越不清楚 社会。我们假设(I)患有致残障碍的患者-参与者有独特的和有价值的 关于这类研究的风险和价值的观点，(2)这种判断可能与 侦查人员和普通公众基于不同的生活经历，以及(三)对这些不同的理解 判断可以推进未来研究的伦理设计，并批判性地扩大该领域对价值的讨论 个人风险对社会效益的影响研究。在目标1中，我们试图理解患者-参与者 对此类试验的风险、收益和允许性的看法。这群人可能有独特的观点 基于他们的慢性神经疾病病史，这可能独特地影响他们对风险的评估和 价值。我们将在不同侵袭性程度的研究中采访患者，以阐明广泛的范围 评估经验，并评估侵入性对相关观点的影响。在目标2中，我们阐明了 来自调查人员(医生、工程师、神经科学家和其他人)以及 公众，评估不同的社会、生活和职业经历如何影响风险和收益评估 这些数据和来自目标1的数据将提供一组广泛的关于 风险、收益及其评价。在目标3中，我们将阐明这三个群体的观点。 关于未来研究的风险、收益和社会价值的限度。未来的科学研究有没有极限 在非治疗性研究中，应该利用不断发展的技术来追求目标？为了实现这些目标，我们带来了 一个由临床医生、伦理学家和心理学家组成的多学科团队共同探索不同的社会价值观 为风险/收益评估提供信息。这项提议得到了一个有着深厚历史和 目前多名研究人员的非治疗性侵入性人类神经科学研究组合。冲击力。 我们的目标是描述不同的利益相关者价值观如何能够并且应该被纳入设计和 对未来非治疗性侵入性人类神经生理学研究的评估，预计 观点将导致更一致的、社会包容的和道德上更严格的风险/收益评估。 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