title: 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.
authors.affiliation: Division of Genomic Medicine, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD 20892, USA. ramoser@mail.nih.gov
authors.forename: Erin M
authors.initials: EM
authors.lastname: Ramos
authors.forename: Corina
authors.initials: C
authors.lastname: Din-Lovinescu
authors.forename: Ebony B
authors.initials: EB
authors.lastname: Bookman
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: McNeil
authors.forename: Carl C
authors.initials: CC
authors.lastname: Baker
authors.forename: Georgy
authors.initials: G
authors.lastname: Godynskiy
authors.forename: Emily L
authors.initials: EL
authors.lastname: Harris
authors.forename: Thomas
authors.initials: T
authors.lastname: Lehner
authors.forename: Catherine
authors.initials: C
authors.lastname: McKeon
authors.forename: Joel
authors.initials: J
authors.lastname: Moss
authors.forename: Vaurice L
authors.initials: VL
authors.lastname: Starks
authors.forename: Stephen T
authors.initials: ST
authors.lastname: Sherry
authors.forename: Teri A
authors.initials: TA
authors.lastname: Manolio
authors.forename: Laura Lyman
authors.initials: LL
authors.lastname: Rodriguez
mesh_terms: D022126:Access to Information; D035843:Biomedical Research; D016208:Databases, Factual; D055106:Genome-Wide Association Study; D006801:Humans; D007255:Information Services; D012108:Research Personnel
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