Dr Carol Somkin
Carol Somkin, PhD, Julie Harris PhD, Petra Liljestrand PhD, Cathy Schaefer, PhD
Multiple Stakeholder Views on Data Sharing: Implications for Biobank Governance
Kaiser Permanente Northern California (KPNC) is assembling a large biobank, known as the Research Program on Genes, Environment, and Health (RPGEH) that will link data from 500,000 participants’ electronic medical records to DNA samples and environmental data and share these data with qualified researchers in an effort to improve health and healthcare broadly. The purposes of this study were to 1) examine the values of different stakeholder groups regarding data sharing policies (KPNC and federal policies); 2) examine stakeholders’ attitudes regarding potential social and individual benefits and harms resulting from sharing RPGEH data; and 3) synthesize these attitudes and values in order to identify promising ethical strategies for RPGEH data access, benefits sharing, and governance policies. To date, we have conducted 40 semi-structured interviews with representatives from five stakeholder groups (including internal and external scientists, Human Research Protection Program staff and institutional review board members, RPGEH participants, and individuals who declined participation in the RPGEH). We also conducted two focus groups with members the RPGEH Community Advisory Panel. We developed a codebook through a reflexive, iterative process and three qualitative researchers coded transcripts and analyzed the data. Overall, participants and members of the community advisory panel had more concerns about group harms than other stakeholder groups. Several different stakeholders raised concerns and suggested methods for dealing with benefit sharing and/or report-back of RPGEH results. We provide preliminary suggestions for governance structure and access policies based on this subsample of stakeholder interviews.
Carol Somkin, PhD, is a senior research scientist at the Kaiser Permanente Division of research. She received her PhD in Sociology from Columbia University. She leads the Ethical Social Implications Core for the Kaiser Permanente Research Program on Genes, Environment and Health (RPGEH). The aim of the RPGEH is to create a comprehensive resource for research on the genetic and environmental determinants of health and disease and response to treatment that brings together clinical data from electronic medical records, biospecimens, and information on behavioral and environmental factors. The RPGEH plans to enroll 500,000 participants by 2013. Dr. Somkin also has a special interest in intervention studies in multiethnic populations and in community-based participatory research, as well as in the effect of race/ethnicity and culture on health and health services use. She is currently conducting a NCI-funded cluster randomized trial to evaluate the effectiveness of a telephone intervention, which is tailored to the health literacy of participants, to increase the participation in cancer clinical trials.