title: Practical barriers and ethical challenges in genetic data sharing.
abstract: The underlying ethos of dbGaP is that access to these data by secondary data analysts facilitates advancement of science. NIH has required that genome-wide association study data be deposited in the Database of Genotypes and Phenotypes (dbGaP) since 2003. In 2013, a proposed updated policy extended this requirement to next-generation sequencing data. However, recent literature and anecdotal reports suggest lingering logistical and ethical concerns about subject identifiability, informed consent, publication embargo enforcement, and difficulty in accessing dbGaP data. We surveyed the International Genetic Epidemiology Society (IGES) membership about their experiences. One hundred and seventy five (175) individuals completed the survey, a response rate of 27%. Of respondents who received data from dbGaP (43%), only 32% perceived the application process as easy but most (75%) received data within five months. Remaining challenges include difficulty in identifying an institutional signing official and an overlong application process. Only 24% of respondents had contributed data to dbGaP. Of these, 31% reported local IRB restrictions on data release; an additional 15% had to reconsent study participants before depositing data. The majority of respondents (56%) disagreed that the publication embargo period was sufficient. In response, we recommend longer embargo periods and use of varied data-sharing models rather than a one-size-fits-all approach.
authors.affiliation: Computational and Statistical Genomics Branch, National Human Genome Research Institute, Baltimore, MD 21224, USA. claire.simpson@nih.gov.
authors.forename: Claire L
authors.initials: CL
authors.lastname: Simpson
authors.affiliation: Department of Bioethics, Case Western Reserve University, Cleveland, OH 44106, USA. aaron.goldenberg@case.edu.
authors.forename: Aaron J
authors.initials: AJ
authors.lastname: Goldenberg
authors.affiliation: Department of Internal Medicine, Washington University in St. Louis, St. Louis, MO 63110, USA. rculverh@dom.wustl.edu.
authors.forename: Rob
authors.initials: R
authors.lastname: Culverhouse
authors.affiliation: Department of Medicine, University of British Columbia, Vancouver, BC V6Z 1Y6, Canada. denise.daley@hli.ubc.ca.
authors.forename: Denise
authors.initials: D
authors.lastname: Daley
authors.affiliation: Computational and Statistical Genomics Branch, National Human Genome Research Institute, Baltimore, MD 21224, USA. rpi@case.edu.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Igo
authors.affiliation: Departments of Medicine (Medical Genetics) and Genome Sciences, University of Washington, Seattle, WA 98195, USA. gjarvik@medicine.washington.edu.
authors.forename: Gail P
authors.initials: GP
authors.lastname: Jarvik
authors.affiliation: Department of Genetics, Louisiana State University Health Sciences Center, New Orleans, LA 70112, USA. dmanda@lsuhsc.edu.
authors.forename: Diptasri M
authors.initials: DM
authors.lastname: Mandal
authors.affiliation: EURAC Institute of Genetic Medicine, Bolzano 39100, Italy. deborah.mascalzoni@eurac.edu.
authors.forename: Deborah
authors.initials: D
authors.lastname: Mascalzoni
authors.affiliation: Oklahoma Medical Research Foundation, Oklahoma City, OK 73104, USA. courtney-montgomery@omrf.org.
authors.forename: Courtney Gray
authors.initials: CG
authors.lastname: Montgomery
authors.affiliation: Computational and Statistical Genomics Branch, National Human Genome Research Institute, Baltimore, MD 21224, USA. bpierce@health.bsd.uchicago.edu.
authors.forename: Brandon
authors.initials: B
authors.lastname: Pierce
authors.affiliation: Computational and Statistical Genomics Branch, National Human Genome Research Institute, Baltimore, MD 21224, USA. rplaetke@alaska.edu.
authors.forename: Rosemarie
authors.initials: R
authors.lastname: Plaetke
authors.affiliation: Computational and Statistical Genomics Branch, National Human Genome Research Institute, Baltimore, MD 21224, USA. aaron.goldenberg@case.edu.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Shete
authors.affiliation: Computational and Statistical Genomics Branch, National Human Genome Research Institute, Baltimore, MD 21224, USA. rculverh@dom.wustl.edu.
authors.forename: Katrina A B
authors.initials: KA
authors.lastname: Goddard
authors.affiliation: Department of Epidemiology & Biostatistics, Case Western Reserve University, Cleveland, OH 44106, USA. cmj7@case.edu.
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Stein
mesh_terms: D001290:Attitude; D019992:Databases as Topic; D055106:Genome-Wide Association Study; D006801:Humans; D033181:Information Dissemination / Q000941:ethics*; D007258:Informed Consent; D010465:Perception; D011795:Surveys and Questionnaires