Sharing Patient Data with Industry: A qualitative exploration of approaches and ethical considerations among academic medical centers

Abstract: Academic Medical Centers (AMC) are increasingly partnering with industry to share patient data and biospecimens in order to improve diagnostic knowledge and therapeutic options for patients. Hospitals are generally legally permitted to share identified data for research without patient consent, provided that the risk involved is minimal and they have secured a waiver from a review board. While law regulating patient data sharing between hospitals and industry is limited, hospitals can offer patients more protection than legally required. However, little is known about actual policies and practices of AMCs with regard to sharing patient data and biospecimens with industry.
In this qualitative study, which involved interviews with United States AMC stakeholders in charge of patient data sharing (n=35), we examined the conditions and criteria under which they share patient data and biospecimens with industry. We found that, while the same federal legal framework governs the sharing of patient data and biospecimens across AMCs, they take a wide range of approaches for selecting with whom and under what conditions they will share patient data with industry. These approaches vary from complete non-participation in data sharing to the establishment of specialized policies and committees to review data sharing proposals. In our presentation, we will explore both the variety of approaches as well as the broader ethical principles such as public benefit and autonomy enabled by these different approaches.

J. Denard Thomas – University of Michigan; Kerry Ryan – University of Michigan; Jodyn Platt – University of Michigan; Melissa Creary – University of Michigan; Alexandra Vinson – University of Michigan; Camille Giacobone – University of Michigan; Skyler Pearse – University of Michigan; Kayte Spector-Bagdady – University of Michigan