Exploring Choice of Law Challenges in Multi-Site Precision Medicine Research

探索多中心精准医学研究中法律选择的挑战

• 批准号: 10022512
• 负责人: LAURA M. BESKOW
• 金额: $ 23.25万
• 依托单位: GEORGIA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-23 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10022512
• 关键词: Academic Medical Centers; Accounting; Address; Agreement; Attention; Biomedical Research; Characteristics; Clinical Research; Conflict (Psychology); Consent; Consent Forms; Counseling; Coupled; Data; Development; Disclosure; Educational workshop; Electronic Health Record; Environment; Ethics; Foundations; Future; Genes; Genetic Privacy; Genome; Goals; Group Structure; Growth; Health; Human; Human Subject Research; Individual; Institution; Institutional Review Boards; Internet; Interview; Laws; Legal; Life Style; Multi-Institutional Clinical Trial; Names; Nature; Outcome; Participant; Process; Research; Research Design; Research Proposals; Research Support; Rights; Risk; Site; Structure; United States National Institutes of Health; Work; cost; evidence base; experience; genetic discrimination; genetic testing; improved; individual variation; interest; meetings; multi-site trial; next generation sequencing; precision medicine; recruit; success; tool; wearable device

PROJECT SUMMARY Through the combined study of individual variation in genes, environment, and lifestyle, precision medicine research offers the potential for discoveries that will improve human health. Spurred by the declining cost of next-generation sequencing, widespread use of electronic health records, proliferation of wearable devices, and other technological advances, the immense scale required for such research is now within reach. These same characteristics, however, escalate the challenge of protecting research participants. Compared to multi- site clinical trials, multi-site precision medicine research differs in fundamental ways, including the use of broad consent to unspecified future use of biospecimens and data; long-term duration; the volume, diversity, and complexity of data amassed; and the evolving nature of the informational risks. Such research implicates state laws that govern an array of topics—such as human subjects research, genetic testing, and both general and genetic privacy and discrimination—which, in turn, can have a significant impact on research practices, including consent disclosures, confidentiality considerations, and offering individual research results to participants, to name just a few. Thus, the choice of which state’s laws apply, and under what circumstances, can substantially alter participant rights and protections in precision medicine research. Traditionally, “choice of law” questions are addressed in advance through contractual agreement, but that avenue is not available in the ethical conduct of research. Federal law establishes minimum standards for protecting research participants, but many states have enacted additional requirements that are not preempted by federal law and may directly conflict with other states’ laws. Because multi-site trials have typically relied on local IRB review and oversight, the problem of accounting for and reconciling state laws has received relatively little attention. However, the nature and scale of precision medicine research, coupled with the new federal requirements for single-IRB review, are likely to bring choice of law issues to rapid prominence. Our objectives for this application are to begin exploring stakeholders’ experiences and opinions regarding choice of law questions in the research context, as well as whether and how existing choice of law frameworks might be applied in resolving them. Specifically, we will (1) explore selected stakeholders’ experiences and perspectives concerning choice of law questions in multi-site research; and (2) convene a group of renowned legal and research experts to begin evaluating the application of existing choice of law frameworks to multi-site precision medicine research.

项目摘要 通过对基因，环境和生活方式中个体变异的联合研究，精密医学 研究提供了可以改善人类健康的发现的潜力。由成本下降的刺激 下一代测序，电子健康记录的宽度使用，可穿戴设备的扩散， 以及其他技术进步，此类研究所需的巨大量表现在已经触及。这些 但是，相同的特征升级了保护研究参与者的挑战。与多 现场临床试验，多站点精密医学研究以基本方式不同，包括使用广泛 同意未指定的生物测量和数据使用；长期持续时间；数量，多样性和 数据的复杂性；以及信息风险的不断发展的性质。这样的研究暗示了国家 管理一系列主题的法律，例如人类主题研究，基因检测以及一般和一般和 遗传隐私和歧视，反过来可能对研究实践产生重大影响， 包括同意披露，信心考虑以及为个人研究结果提供 参加者，仅举几例。这是哪个州法律适用的选择，在什么情况下 可以实质地改变参与者的权利和精密医学研究中的保护。 传统上，“法律选择”问题是通过合同协议事先提前解决的，但是 道德研究的道德行为不可用。联邦法律建立了最低标准 保护研究参与者，但许多州已经制定了未抢占的其他要求 根据联邦法律，可能与其他州的法律直接冲突。因为多站点试验通常已退休 当地的IRB审查和监督，会计和核对州法律的问题已相对接受 很少关注。但是，精密医学研究的性质和规模，再加上新的联邦 单人IRB审查的要求可能会使法律问题的选择迅速突出。 我们针对此应用的目标是开始探索利益相关者的经验和意见 在研究环境中选择法律问题，以及是否现有法律框架的现有选择 可能应用于解决它们。具体而言，我们将（1）探讨选定的利益相关者的经验和 关于多站点研究中法律问题的选择的观点； （2）召集一群著名的 法律和研究专家开始评估现有的法律选择在多站点中的应用 精密医学研究。