“Choice of law” in precision medicine research

• Published in: American journal of human genetics Vol. 109; no. 8; pp. 1347 - 1352
• Main Authors: Beskow, Laura M., Wolf, Leslie E.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 04.08.2022; Elsevier
• Subjects: choice of law; Confidentiality; human subjects protections; Humans; informed consent; legal rights; Precision Medicine; precision medicine research; research ethics; United States; United States; human subjects protections; legal rights; precision medicine research; choice of law; informed consent; research ethics
• ISSN: 0002-9297; 1537-6605; 1537-6605
• DOI: 10.1016/j.ajhg.2022.06.009

Large-scale precision medicine research requires massive amounts of data representing people from all walks of life; thus, in the US, it is often multistate research. Significant legal and ethical quandaries arise as a result of the patchwork of laws states have enacted that may apply to research, are not preempted by federal law, and may impose requirements or provide participant rights and protections that differ from other states. Determining which state’s laws apply, and under what circumstances, is not solved by the transition to a single-IRB model and researchers cannot simply choose one state’s laws to apply uniformly. At a minimum, the current process of meeting each state’s requirements could be made more reliable and efficient. To fundamentally change this status quo, however, requires action at multiple levels. Federally, well-known gaps in the Genetic Information Nondiscrimination Act should be closed, and a coherent system of compensation for research injury—including non-physical injuries—should be developed. States should clarify which of their laws are intended to apply to research and work collaboratively to harmonize them. At the level of individual research projects, numerous policies and procedures could be standardized through authoritative guidelines. Examples include clarifying the scope of broad consent, understanding and upholding Certificates of Confidentiality, offering individual research results responsibly, and consistently disseminating aggregate results to participants and the public. Overall, development of a choice of law framework specific to the research context could significantly promote clarity and consistency. In the US, legal and ethical quandaries arise in large-scale precision medicine research because of the patchwork of laws states have enacted that may impose requirements or provide participant rights and protections that differ from other states. We propose solutions to this predicament at federal, state, and research project levels.