Precision medicine research implicates numerous state laws that may affect participants' rights and protections and are not preempted by federal law. The choice of which state's laws apply, and under what circumstances, can have significant impact on research design and oversight. But neither of the traditional approaches to choice of law issues-contractual agreement or determination by a court after a dispute arises-fit the research context well. We hosted a series of workshops with choice of law experts and research law and ethics experts to identify factors that are most crucial to account for in a future choice of law precision medicine research framework. Our workshops focused on precision medicine 'places' and choice of law factors; there was consensus that 'place where the harm occurred' was relevant and best represented by where the participant resides and/or where the research/institution is located. Our experts identified factors that need to be accounted for in a future choice of law framework. They also identified potential approaches, including a federal law or model state law as ways of achieving more uniformity of protections and a comprehensive database of laws, which merit further consideration to provide IRBs and researchers the guidance they require.

中文翻译：

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解决多州精准医学研究中的法律选择挑战：专家对关键因素的评估。

精准医学研究涉及许多可能影响参与者权利和保护且不受联邦法律优先的州法律。选择适用哪个州的法律以及在什么情况下适用，会对研究设计和监督产生重大影响。但是，选择法律问题的传统方法——合同协议或纠纷发生后法院的裁决——都不能很好地适应研究背景。我们与选择的法律专家以及研究法律和伦理专家一起举办了一系列研讨会，以确定在未来选择法律精准医学研究框架中最关键的因素。我们的研讨会侧重于精准医学“场所”和法律因素的选择；一致认为“伤害发生的地方” 参与者居住的地方和/或研究/机构所在的地方是相关的并且最能代表。我们的专家确定了在未来选择法律框架时需要考虑的因素。他们还确定了潜在的方法，包括联邦法律或示范州法律作为实现更统一保护的方法和全面的法律数据库，值得进一步考虑为 IRB 和研究人员提供他们需要的指导。