On April 5, FASEB summited comments in response to a National Institutes of Health (NIH) Request for Information (RFI) on “Processes for dbGaP Data Submission, Access, and Management” (NOT-OD-17-044). The dbGaP Database of Genotypes and Phenotypes was developed to store and share data from human studies.
FASEB’s comments focused on balancing the risks and benefits of expanded access to genomic summary statistics. Currently these valuable data products are maintained in the controlled-access portion of dbGaP, requiring annual application and approval to utilize them. FASEB offered cautious support for making many genomic summary statistics available through a registration system that includes an educational module for first time users. This approach could increase access and promote rigorous and robust use of these statistics. However, specific risks remain for research participants in studies that involve sensitive phenotypes, vulnerable populations, children, or smaller sample sizes. For these select studies, FASEB recommended NIH keep the summary statistics available only through the controlled-access system.
NIH is accepting responses to this RFI through April 7, 2017.