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

项目总结 通过对基因、环境和生活方式的个体差异的联合研究，精准医学 研究提供了发现改善人类健康的潜力。受成本下降的刺激 下一代测序，电子健康记录的广泛使用，可穿戴设备的普及， 和其他技术进步，这类研究所需的巨大规模现在是触手可及的。这些 然而，相同的特征加剧了保护研究参与者的挑战。与多个- 现场临床试验、多点精准医学研究在根本上有所不同，包括广泛使用 同意未指明的将来使用生物检疫剂和数据；长期持续时间；数量、多样性和 收集的数据的复杂性；以及信息风险的演变性质。这样的研究牵涉到国家 管理一系列主题的法律--例如人类受试者研究、基因测试以及一般和 基因隐私和歧视--这反过来可能对研究实践产生重大影响， 包括同意披露、保密考虑以及向以下人员提供个人研究结果 参与者，仅举几个例子。因此，选择适用哪个州的法律，以及在什么情况下， 可以在很大程度上改变精准医学研究中的参与者权利和保护。 传统上，“法律选择”问题是通过合同协议预先解决的，但 道达尔在道德行为方面没有可用的研究。联邦法律规定了最低标准 保护研究参与者，但许多州已经制定了额外的要求，这些要求没有先发制人 根据联邦法律，并可能直接与其他州的法律冲突。因为多点试验通常依赖于 地方IRB的审查和监督，核算和协调州法律的问题得到了相对 很少有人注意到。然而，精准医学研究的性质和规模，加上新的联邦 对单一内部审查委员会的要求，可能会使法律选择问题迅速突出。 我们这项应用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和如何 可能适用于解决这些问题。具体地说，我们将(1)探索选定利益相关者的经验和 关于多地点研究中的法律选择问题的观点；以及(2)召集著名的 法律和研究专家开始评估现有法律选择框架在多个地点的适用情况 精准医学研究。

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.