The proposed project seeks to identify concrete policies and practices that can better serve both people and institutions in building local, state, and national health information systems necessary to maximize the potential of data throughout its life cycle. We will focus on 5 intertwined and endemic issues to the life cycle of data that arise in precision oncology: (1) informed consent, (2) duration of specimen storage; (3) storage of germline DNA sequence data (4) disclosed commercialization; and (5) data sharing at local, state, and national levels. Our proposed research will identify public preferences for specific policies and practices governing these issues thus addressing a major gap in understanding how the public views data as it flows across functional boundaries ? clinical care, quality improvement, research and public health - and across local, state, and national levels. Our interdisciplinary research team with expertise in policy, learning health systems, ethics, precision oncology, and public health genomics has partnered with an expert advisory team that spans these levels and boundaries. Specifically, at the local level we are engaging the University of Michigan Health Systems Institutional Review Board (IRB), Comprehensive Cancer Center, Central Biorepository, Compliance Office, and precision oncology researchers (MI-ONCOSEQ). At the state level, we are interacting with the Michigan Health Information Network (MiHIN) that coordinates 10 health exchanges with the Michigan Department of Health and Human Services. At the national level, we are engaging with the multi-state PCORI-funded LHSnet, the American Society of Clinical Oncology?s CancerLINQ, which will combine data across practices for quality improvement. Using an explanatory sequential design, we will investigate the public?s knowledge, attitudes, and acceptance of data policies and practices using case studies that illustrate the life cycle of data in precision oncology (n=3,500) (Aim 1) and conduct deliberative sessions to identify recommendations for changes in institutional practices/policies (n=225) (Aim 2). We will then quantitatively assess whether these recommendations ameliorate concerns and identify optimal policies through conjoint analysis using a longitudinal follow-up survey conducted at the state and national scale (n=2,500) (Aim 3).
The proposed project seeks to identify concrete policies and practices that can better serve both people and institutions in building local, state, and national health information systems necessary to maximize the potential of data throughout its life cycle. We will focus on 5 interwined and endemic issues to the life cycle of data that arise in precision oncology: (1) informed consent, (2) duration of specimen storage; (3) storage of germline DNA sequence data (4) disclosed commercialization; and (5) data sharing at local, state, and national levels. This research will inform policy and will have benefits for both the diverse U.S. public and the nation?s health information infrastructure.
| Spector-Bagdady, Kayte; De Vries, Raymond G; Gornick, Michele G et al. (2018) Encouraging Participation And Transparency In Biobank Research. Health Aff (Millwood) 37:1313-1320 |
