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

项目摘要 通过对基因、环境和生活方式的个体差异的综合研究， 研究提供了发现改善人类健康的可能性。受成本下降的刺激， 下一代测序，电子健康记录的广泛使用，可穿戴设备的激增， 和其他技术进步，这种研究所需的巨大规模现在是可以实现的。这些 然而，同样的特点也增加了保护研究参与者的挑战。相比之下，多 现场临床试验，多地点精准医学研究在根本上不同，包括使用广泛的 同意未指明的未来使用生物标本和数据;长期持续时间;数量，多样性， 所积累数据的复杂性;以及信息风险不断演变的性质。这样的研究表明， 这些法律管辖着一系列主题，如人类受试者研究、基因检测，以及一般和 遗传隐私和歧视，这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，并提供个人研究结果， 参与者，仅举几例。因此，选择适用哪个州的法律，以及在什么情况下， 可能会大大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"问题通过合同协议提前解决，但 在研究的道德行为中，没有途径。联邦法律规定了 保护研究参与者，但许多州已经制定了额外的要求， 联邦法律，并可能直接与其他州的法律冲突。因为多中心试验通常依赖于 地方IRB审查和监督，会计和协调国家法律的问题已经收到相对 很少注意。然而，精准医学研究的性质和规模，加上新的联邦 单一IRB审查的要求，可能会使法律选择问题迅速突出。 我们这个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以及如何 可以用来解决这些问题。具体而言，我们将（1）探讨选定的持份者的经验， （2）就多地点研究中的法律选择问题， 法律的和研究专家开始评估现有法律选择框架在多地点 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.