A mechanism for controlled access to GWAS data: experience of the GAIN Data Access Committee

Abstract

The Genetic Association Information Network (GAIN) Data Access Committee was established in June 2007 to provide prompt and fair access to data from six genome-wide association studies through the database of Genotypes and Phenotypes (dbGaP). Of 945 project requests received through 2011, 749 (79%) have been approved; median receipt-to-approval time decreased from 14 days in 2007 to 8 days in 2011. Over half (54%) of the proposed research uses were for GAIN-specific phenotypes; other uses were for method development (26%) and adding controls to other studies (17%). Eight data-management incidents, defined as compromises of any of the data-use conditions, occurred among nine approved users; most were procedural violations, and none violated participant confidentiality. Over 5 years of experience with GAIN data access has demonstrated substantial use of GAIN data by investigators from academic, nonprofit, and for-profit institutions with relatively few and contained policy violations. The availability of GAIN data has allowed for advances in both the understanding of the genetic underpinnings of mental-health disorders, diabetes, and psoriasis and the development and refinement of statistical methods for identifying genetic and environmental factors related to complex common diseases.

Figure 1

Overview of the GAIN Data-Access Review Process After a researcher (requestor) submits a PR via dbGaP, the PR is reviewed and signed by the signing official at the requestor’s institution. The PR undergoes a preliminary review by the GAIN DAC staff before being sent to the GAIN DAC for a vote. If the PR is approved, the requestor (approved user) can access data sets from dbGaP. If the PR is disapproved or a revision to the PR is requested, the requestor can revise and resubmit the PR to begin the evaluation process again.

Figure 2

Summary of Key Aspects of Governance for Controlled Access to GAIN Data Sets through dbGaP Prior to the implementation of the GWAS policy, both the GAIN Steering Committee and the Advisory Committee to the Director (ACD) Working Group on Participant and Data Protection (ACD PDP) provide oversight and input on policy questions related to GAIN data use, privacy concerns, and other topics, as appropriate. Once the governance structure for the GWAS policy is operational, oversight of GAIN is integrated with the other NIH DACs (only 5 of the 13 other DACs are shown here).