Navigating data sharing in research

Area of Science:

• Biomedical research
• Genomics
• Data science

Background:

• Funders and journals increasingly mandate biomedical research data sharing to accelerate discovery.
• Data openness must be balanced with protecting research participants from harm, especially in sensitive areas like genomics.
• Evolving legal and social landscapes necessitate adaptive strategies for responsible data sharing.

Purpose of the Study:

• To examine challenges in implementing "as open as possible, as closed as necessary" data sharing.
• To analyze the impact of recent US legal developments on genomic data sharing practices.
• To identify strategies for mitigating individual- and group-level harms from genomic data analyses.

Main Methods:

• Drawing on experiences from the Electronic Medical Records and Genomics (eMERGE-IV) Network.
• Implementing strategies such as cell suppression for race/ethnicity data.
• Revising data extraction protocols for electronic health records.

Main Results:

• Recent legal changes (e.g., Dobbs decision) highlighted risks in genomic data sharing.
• eMERGE-IV adapted strategies, including data suppression and selective data extraction, to mitigate harms.
• These adaptations balanced immediate participant protection with long-term scientific benefits for underrepresented groups.

Conclusions:

• Informed consent alone cannot fully address the "as closed as necessary" construct due to sociolegal changes.
• Robust data governance and participant engagement are essential for protecting research participants.
• The research enterprise must develop transparent, inclusive governance structures to maintain public trust while advancing science.