Assessing Patient and Community Engagement in Data Governance

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ABSTRACT The University of California, San Francisco (UCSF) Clinical and Translational Science Institute (CTSI) has a strong track record of building infrastructure, securing resources, and fostering and supporting a diverse, transdisciplinary workforce who share a vision and mission to accelerate research to improve health. Now in the first year of its most recent renewal, CTSI is working toward the related goals of (a) fully incorporating community stakeholders into clinical and translational research and (b) creating a responsible, community- informed regulatory framework for guiding the use of personal health information for research. These efforts are informed by recent calls for data oversight mechanisms that address the limitations of focusing exclusively on individual consent and risk disclosure as strategies for protecting patients and research participants. New approaches include shared governance models in which multiple stakeholders – including patients and community representatives – contribute to decisions about the sharing and use of clinical and patient data. Shared governance promises greater accountability and transparency, but little is known about attempts to put it into practice including how institutional factors enable and/or limit meaningful patient and community participation. This bioethics supplement will extend CTSI's aims by closely examining UCSF's culture of data sharing. A culture of data sharing is a dynamic system of stakeholder groups, their interests, and the rules, norms and tools guiding how patient data are produced, maintained and used. The objectives of this project are to (a) elucidate the culture of data sharing and how it influences patient and community involvement in data policy decisions, and (b) help guide UCSF and other health sciences institutions toward shared governance. We will accomplish these objectives through a rigorous combination of empirical and normative aims. First, a qualitative study will examine institutional values, priorities and practices pertaining to patient data, and the extent and quality of patient and community involvement in data governance. Then, findings from the study will be used to develop a framework that details the specific commitments, actions and relationships that foster public engagement and a more inclusive and trustworthy culture of data sharing. The framework will augment UCSF CTSI's efforts to enact shared data governance and will help institutions engaged in translational science research and learning health system development incorporate significant and meaningful public involvement in data policy decisions.