ELSIcon2022 • Paper • May 31, 2022
Laura Beskow, Leslie Wolf
Our previous research demonstrated that precision medicine research implicates numerous state laws, including human subjects research, genetic testing, and both general and genetic privacy and discrimination, that are not preempted by federal law and can substantially alter participant rights and protections in precision medicine research. Thus, the choice of which state’s laws apply, and under what circumstances, can have significant impact on research design and human subjects protections.
However, the traditional route for addressing choice of law issues—contractual agreement—is not available in the context of research, and there has been little attention to how to reconcile state laws in research oversight. The evolving research context, including the federal requirements for single-IRB review, is likely to bring choice of law issues to rapid prominence.
In our NIH-funded exploratory research project, we conducted qualitative interviews with key informants regarding their experiences and opinions regarding choice of law questions in the precision medicine context. We also held workshops with choice of law experts and research law and ethics experts together to identify the factors, including the places associated with precision medicine research, characteristics of participant’ rights and protections, and elements of choice of law frameworks, that are most crucial to account for in a future choice of law precision medicine research framework.
We present the findings from both aims of our research and the implications of that research for future research and development of a framework for addressing choice of law questions in precision medicine research design and consent processes.