Navigating data sharing in research.

Abstract

Sharing biomedical research data can accelerate scientific discovery, leading funders and journals to increasingly mandate sharing. However, data openness must be balanced with protecting research participants from harm in an evolving legal and social landscape. Drawing on experiences from the Electronic Medical Records and Genomics (eMERGE-IV) Network-a US-based, multi-site consortium gathering genomic and medical data focused on underrepresented groups to refine disease risk prediction-we examine challenges in implementing data sharing that are "as open as possible, as closed as necessary." Recent US legal developments, including the Dobbs decision and gender-affirming care bans, highlight the urgency of considering data-sharing risks and required the Network to rethink strategies to prevent individual- and group-level harms from genomic analyses. eMERGE-IV implemented several strategies to mitigate concerns, including cell suppression for race/ethnicity data and not extracting certain diagnostic codes from participants' electronic health records. These decisions balanced immediate protection and long-term scientific benefits for relevant populations. Participant agreement to broad data sharing in informed consent is often required for research participation to make data as open as possible. No consent form, however, can define the terms of "as closed as necessary"-a construct that is subject to sociolegal changes across the life cycle of research studies. Providing protection requires robust data governance, including engagement with prospective and actual participants. The research enterprise must reconsider its consenting approach and develop transparent, inclusive governance structures responsive to evolving vulnerabilities while maintaining scientific progress. Public trust depends on the research enterprise successfully navigating these competing demands.