Addressing choice of law challenges in multi-state precision medicine research: experts’ assessment of key factors

• Published in: Journal of law and the biosciences Vol. 9; no. 1; p. lsac013
• Main Authors: Wolf, Leslie E, Brown, Erin Fuse, Greeson, Roxanne, Hammack-Aviran, Catherine, Hazel, James W, Rencher, William, Beskow, Laura M
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01.01.2022
• Subjects: Bioethics; Clinical trials; Conflict of laws; Ethical aspects; Evaluation; Human experimentation in medicine; Laws, regulations and rules; Original; Self-experimentation in medicine; human subjects protections; law; precision medicine research; choice of law; research ethics
• ISSN: 2053-9711; 2053-9711
• DOI: 10.1093/jlb/lsac013

Abstract 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.