Thought Leader Comparisons of Risks in Precision Medicine Research

Abstract

Biomedical research is increasingly capitalizing on an array of data to illuminate the interplay between "omics, " lifestyle, and health. Leveraging this information presents opportunities to advance knowledge but also poses risks to research participants. In interviews with thought leaders, we asked which data type associated with a hypothetical precision medicine research endeavor was riskiest: 42% chose ongoing access to electronic health records, 17% chose genomic analyses of biospecimens, and 15% chose streaming data from mobile devices. Other responses included "It depends" (15%), the three types are equally risky (8%), and the combination of data types together is riskiest (3%). When asked to consider the hypothetical study overall, 60% rated the likelihood of the risks materializing as low, but 20% rated the potential consequences as severe. These results have implications for study design and informed consent, including placing appropriate emphasis on the risks and protections for the full range of data. KEYWORDS research ethics, informed consent, genomic research, electronic health records, big data

Federated Analysis for Privacy-Preserving Data Sharing: A Technical and Legal Primer

“…This could lead to actors performing subpar data protection compliance because they lack sufficient resources to ensure appropriate compliance. It could also lead to actors reducing their data sharing due to the potential for GDPR noncompliance, even in circumstances where the data sharing offers large benefits to society or the individual and poses privacy risks that are limited or nonexistent ( 7 ).…”