Highly Portable and Cloud-Enabled Neuroimaging Research: Confronting Ethics Challenges in Field Research with New Populations

项目总结/摘要 这4年的神经伦理学R 01总部设在明尼苏达大学（UMN）将召开全国 由顶尖神经伦理学、神经法学和神经科学专家组成的工作组，进行实证研究， 为人口研究的道德行为提出基于证据的共识建议 在现场环境中的新的和不同的人群中使用高度便携的云支持MRI。NIH是 支持高场便携式MRI（3U 01 EB 025153 - 02 S2，PI：Garwood）和超 低场MRI（P41 EB 015896，PI：罗森）。随着便携式MRI的快速发展，迫切需要指导 未解决的伦理、法律的和社会问题。这个R 01项目建立在两个NIH行政 初步查明最紧迫的未解决的电子和信息社会问题的补充材料： 同意;（2）数据安全和隐私;（3）建立当地解释和沟通能力 神经成像数据;（4）广泛依赖基于云的人工智能（AI）进行数据分析;（5） 解释算法在不同人群中的潜在偏差;（6）研究结果的返回和偶然（或 次要的）研究结果给研究参与者;（7）响应参与者访问其数据的请求。 在这一初步工作的基础上，目标1将利用调查研究为系统的工作提供信息。 目标2中描述的工作组（WG）过程。在目标1a中，我们将调查美国公众，包括超过- 农村、老年人、非西班牙裔非洲裔美国人、西班牙裔/拉丁裔和经济上 弱势受访者，探讨可能的研究用例，他们提出的问题，潜在的解决方案， 愿意参与研究。在目标1b中，我们将调查专家利益相关者， 当前/未来的研究用例以及如何应对ELSI挑战。专家利益攸关方将来自5个 主要群体：（1）利用脑MRI的研究人员和开发新MRI技术的科学家;（2）神经伦理学 和法律的学者;（3）行业利益相关者;（4）监管机构和标准制定的领导者 （5）患者维权组织的领导者。目标2建立在目标1的基础上， 关于该领域研究道德行为的循证共识指导， 便携式云端神经成像在目标2a中，我们将使用一种改进的德尔菲方法来获得初始工作组 关于问题优先级、研究用例和潜在建议的意见，并将制定一份注释 参考书目。在目标2b中，工作组将采取一种结构化的分析和建立共识的进程， 在生物伦理学和法律方面有着良好基础，以便确定最佳做法并提出建议 目标1的工作。在目标2c中，我们将征求专家读者对我们建议的反馈意见 并通过一个重要的公开会议。项目产品将包括：一个在线注释书目， 协商一致的建议、个别有针对性的文章、已发表的经验分析、网播公众 会议，同行评审期刊的专题讨论会问题，在线访问我们的工作，并广泛传播。

Project Summary / Abstract This 4-year Neuroethics R01 based at the University of Minnesota (UMN) will convene a national Working Group of top neuroethics, neurolaw, and neuroscience experts to conduct empirical research and generate evidence-based consensus recommendations for the ethical conduct of population research using highly portable, cloud-enabled MRI in new and diverse populations in field settings. NIH is supporting the development of both high-field portable MRI (3U01EB025153-02S2, PI: Garwood), and ultra- low field MRI (P41EB015896, PI: Rosen). As portable MRI develops quickly, guidance is urgently needed on unresolved ethical, legal, and social issues (ELSI). This R01 project builds on two NIH Administrative Supplements that have preliminarily identified the most pressing unresolved ELSI issues: (1) informed consent; (2) data security and privacy; (3) establishing local capacity to interpret and communicate neuroimaging data; (4) extensive reliance on cloud-based artificial intelligence (AI) for data analysis; (5) potential bias of interpretive algorithms in diverse populations; (6) return of research results and incidental (or secondary) findings to research participants; and (7) responding to participant requests for access to their data. Building on this preliminary work, Aim 1 will utilize survey research to inform a systematic Working Group (WG) process described in Aim 2. In Aim 1a, we will survey the U.S. general public, including over- sampling of rural, older adult, non-Hispanic African American, Hispanic/Latino, and economically disadvantaged respondents, to probe likely research use cases, issues they raise, potential solutions, and willingness to participate in research. In Aim 1b, we will survey expert stakeholders to elicit views on current/future research use cases and how to address the ELSI challenges. Expert stakeholders will be from 5 key groups: (1) researchers utilizing brain MRI and scientists developing new MRI technology; (2) neuroethics and legal scholars; (3) industry stakeholders; (4) leaders in regulatory agencies and standard-setting organizations; and (5) leaders in patient advocacy organizations. Aim 2 builds on Aim 1 to generate evidence-based consensus guidance on the ethical conduct of research in the field using highly portable, cloud-enabled neuroimaging. In Aim 2a, we will use a modified Delphi method to elicit initial WG views on issue priorities, research use cases, and potential recommendations, and will develop an Annotated Bibliography. In Aim 2b, the WG will pursue a structured process of analysis and consensus building that is well-established in bioethics and law, in order to identify best practices and formulate recommendations informed by the Aim 1 work. In Aim 2c, we will solicit feedback on our recommendations from expert readers and through a major public conference. Project products will include: an online Annotated Bibliography, WG consensus recommendations, individual targeted articles, published empirical analyses, a webcast public conference, a symposium issue of a peer-reviewed journal, online access to our work, and wide dissemination.