Thought Leader Comparisons of Risks in Precision Medicine Research.
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.
['Beskow|Laura M|LM|', 'Hammack-Aviran|Catherine M|CM|', 'Brelsford|Kathleen M|KM|']
D035843:Biomedical Research D057286:Electronic Health Records D006801:Humans D007258:Informed Consent D007857:Leadership D057285:Precision Medicine D012107:Research Design D018570:Risk Assessment
electronic health records informed consent big data genomic research research ethics