Abstracts

Rationale: The many existing and emerging DNA databases contain valuable information used to study the complex relationship between genetic variation and human health. The current research policy calls for widespread data sharing and public release of all sequenced data into online databases with unrestricted access. As technology advances it will be increasingly easy to identify an individual from a relatively small amount of genotypic data. The development of responsible research policies must achieve an appropriate balance between protecting privacy and promoting research and should be informed by the concerns, needs, and preferences of individuals who donate tissue for genetic research.Methods: We approached 100 cases and 100 healthy controls who signed traditional research consent forms approved by Baylor Institutional Review Board (IRB) for participation in the Baylor Epilepsy Channelopathy Project. Subjects were interviewed in two rounds of focus groups with regards to the following; (1) their attitudes towards public DNA data release, (2) their desire for control about sharing their genetic data, and (3) their assessment of three models of informed consent: traditional, binary, and tiered consent. Their responses were verbatim recorded, coded and analyzed.Results: The preliminary data yielded the following; (1) the participants expressed general desire for greater control over public release of their genetic data although they were at large not interested in micromanaging the flow of their genetic information. (2) We found variation in their judgments about providing their genetic information for “greater good”. (3) There was an overwhelming preference for the tiered consent; although (4) the participants were uniformly concerned about increasing the complexity of the consent process and form. Conclusions: Our preliminary results indicate that research subjects are willing to provide their genetic material for “greater good”; however they wish to exercise control about the level of public visibility of their genetic information and they rely on the consent process to provide them with an opportunity to do so. Further systematic collection and analysis of this valuable information can lead to the development of an ethically justified, empirically-driven model consent process and form for genomic sequencing research. Supported by: The Greenwall Foundation Faculty Scholars Program in Bioethics; Baylor College of Medicine Basic and Clinical Collaborative Research Grant; NINDS 5K08NS47304-3 and NS049130