Title

"Choice of Law" in Precision Medicine Research.

Publication Title

American Journal of Human Genetics

Document Type

Article

Publication Date

8-4-2022

Abstract

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.

Comments

External Links

PubMed

Georgia State University Library

Recommended Citation

Laura M. Beskow & Leslie E. Wolf,“Choice of law” in precision medicine research. American Journal of Human Genetics, 109(8) Am. J. of Human Genetics 1347–1352 (2022).

DOI

10.1016/j.ajhg.2022.06.009

Volume

109

Issue

8

First Page

1347

Last Page

1352

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