Kayte Spector-Bagdady et al at the New England Journal of Medicine: “The advent of standardized electronic health records, sustainable biobanks, consumer-wellness applications, and advanced diagnostics has resulted in new health information repositories. As highlighted by the Covid-19 pandemic, these repositories create an opportunity for advancing health research by means of secondary use of data and biospecimens. Current regulations in this space give substantial discretion to individual organizations when it comes to sharing deidentified data and specimens. But some recent examples of health care institutions sharing individual-level data and specimens with companies have generated controversy. Academic medical centers are therefore both practically and ethically compelled to establish best practices for governing the sharing of such contributions with outside entities.1 We believe that the approach we have taken at Michigan Medicine could help inform the national conversation on this issue.
The Federal Policy for the Protection of Human Subjects offers some safeguards for research participants from whom data and specimens have been collected. For example, researchers must notify participants if commercial use of their specimens is a possibility. These regulations generally cover only federally funded work, however, and they don’t apply to deidentified data or specimens. Because participants value transparency regarding industry access to their data and biospecimens, our institution set out to create standards that would better reflect participants’ expectations and honor their trust. Using a principlist approach that balances beneficence and nonmaleficence, respect for persons, and justice, buttressed by recent analyses and findings regarding contributors’ preferences, Michigan Medicine established a formal process to guide our approach….(More)”.