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.

项目概要 通过基因、环境、生活方式等个体差异的综合研究，精准医疗 在成本下降的推动下，研究提供了改善人类健康的潜力。 下一代测序、电子健康记录的广泛使用、可穿戴设备的激增、 和其他技术进步一样，此类研究所需的巨大规模现在已经可以实现。 然而，与多方相比，相同的特征加剧了保护研究参与者的挑战。 站点临床试验、多站点精准医学研究在根本上有所不同，包括广泛使用 同意未来对生物样本和数据的长期使用； 所收集数据的复杂性；以及信息风险的不断变化的性质。 管辖一系列主题的法律，例如人类受试者研究、基因测试以及一般和 遗传隐私和歧视——反过来又会对研究实践产生重大影响， 包括同意披露、保密考虑以及向他人提供个人研究结果 仅举几例，因此，选择适用哪个州的法律以及在什么情况下， 可以极大地改变精准医学研究中参与者的权利和保护。 传统上，“法律选择”问题是通过合同协议提前解决的，但是 联邦法律没有规定研究的道德行为的最低标准。 保护研究参与者，但许多州已经制定了不可抢占的额外要求 因为多地点试验通常依赖于联邦法律，并且可能与其他州的法律直接冲突。 地方IRB审查和监督，解释和协调州法律的问题相对受到关注 然而，精准医学研究的性质和规模，加上新的联邦却很少受到关注。 单一 IRB 审查的要求可能会使法律选择问题迅速凸显出来。 我们此应用程序的目标是开始探索利益相关者的经验和意见 研究背景下的法律选择问题，以及现有的法律选择框架是否存在以及如何存在 具体来说，我们将（1）探索选定的利益相关者的经验和 关于多地点研究中法律问题选择的观点；(2) 召集一组知名人士 法律和研究专家开始评估现有法律选择框架在多地点的应用 精准医学研究。