Impact of Data Access Policies on Biobank Participation

The NIH data access policy for genetic research provides enormous opportunities for genetic investigators but also raises a number of challenges for educating and recruiting participants into large-scale genetic research studies. The NIH released a final data access and sharing policy for genome-wide association studies (GWAS) in August, 2007. The policy requires specific phenotypic and genetic data from GWAS be deposited into a government controlled, limited access database. The goal of this study is to examine how NIH data access policies will impact participation in large-scale genetic research. In parallel with the emergence of GWAS, medical centers and research institutions worldwide are developing biobanks that house large numbers of participant DNA samples and data. Large scale participant recruitment initiatives are required to sustain and grow these resources that will increasingly be "tapped" to support GWAS. Challenges for the investigators establishing these and similar collections include: the most appropriate manner to educate potential research participants about genetic research and the data sharing policy, how to inform them about known and potential risks, and how to do this in an efficient and scaleable manner. These challenges make it increasingly difficult to individually consent research participants as well as consent for each future use. Broad consent, one in which the participants consent to uses of their biospecimen and data for unspecified future research of prospectively collected cohorts, is generally accepted in the US and more so in Europe. However, controversy exists over how much control to offer participants regarding future access to and uses of samples and data. An opt-out model, one in which participants may indicate that they do not wish for leftover de-identified clinical samples or medical record data to be used for research is being incorporated into biobanks. Although the practice is controversial, its use may become more common as US investigators seek more efficient means of amassing large scale collections necessary for GWAS and other genome wide analytic approaches. Potential participants' understanding of both broad consent and opt-out models must be assessed in the context of genetic research and existing data access policies. To date, participant knowledge about data access policies and practices and their potential impact on participation, or their participation preferences, has not been assessed. We will ascertain novel educational strategies needed to help a patient population consisting of patients from a metropolitan Chicago hospital clearly understand the data access policy for genetic research, the role of the government as the holder of the data, the privacy protections included in the policy and the known and potential risks to privacy. Specifically, we propose to: (1) Investigate whether data access policies affect the willingness of patients to participate in a prospective hospital-based biobank, (2) Assess whether wide-spread data sharing policies for genetic research impacts participants' preferences for two consent models: broad consent and opt-out approaches, and (3) Develop recommendations to help future patients to better understand GWAS and data access policies. To address these aims, we will conduct semi-structured interviews on a random sample of patients ascertained from Northwestern Memorial Hospital and affiliated outpatient clinics. The interviews will address in greater depth preliminary data obtained from focus groups on data sharing and genetic research and will be analyzed according to qualitative research methods. Interview results will inform development of a survey to test educational messages on data sharing and to address patients' interest in participating in genetic research based on a presentation of the two consent models. The results of the survey will provide a basis for recommendations of educational messages and consent models for participants involved in studies in which data will be shared.