title: Ethical and practical challenges of sharing data from genome-wide association studies: the eMERGE Consortium experience.
abstract: In 2007, the National Human Genome Research Institute (NHGRI) established the Electronic MEdical Records and GEnomics (eMERGE) Consortium (www.gwas.net) to develop, disseminate, and apply approaches to research that combine DNA biorepositories with electronic medical record (EMR) systems for large-scale, high-throughput genetic research. One of the major ethical and administrative challenges for the eMERGE Consortium has been complying with existing data-sharing policies. This paper discusses the challenges of sharing genomic data linked to health information in the electronic medical record (EMR) and explores the issues as they relate to sharing both within a large consortium and in compliance with the National Institutes of Health (NIH) data-sharing policy. We use the eMERGE Consortium experience to explore data-sharing challenges from the perspective of multiple stakeholders (i.e., research participants, investigators, and research institutions), provide recommendations for researchers and institutions, and call for clearer guidance from the NIH regarding ethical implementation of its data-sharing policy.
authors.affiliation: Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX 77030, USA. amcguire@bcm.edu
authors.forename: Amy L
authors.initials: AL
authors.lastname: McGuire
authors.forename: Melissa
authors.initials: M
authors.lastname: Basford
authors.forename: Lynn G
authors.initials: LG
authors.lastname: Dressler
authors.forename: Stephanie M
authors.initials: SM
authors.lastname: Fullerton
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Koenig
authors.forename: Rongling
authors.initials: R
authors.lastname: Li
authors.forename: Cathy A
authors.initials: CA
authors.lastname: McCarty
authors.forename: Erin
authors.initials: E
authors.lastname: Ramos
authors.forename: Maureen E
authors.initials: ME
authors.lastname: Smith
authors.forename: Carol P
authors.initials: CP
authors.lastname: Somkin
authors.forename: Carol
authors.initials: C
authors.lastname: Waudby
authors.forename: Wendy A
authors.initials: WA
authors.lastname: Wolf
authors.forename: Ellen Wright
authors.initials: EW
authors.lastname: Clayton
mesh_terms: D003299:Cooperative Behavior; D030541:Databases, Genetic; D057286:Electronic Health Records / Q000941:ethics*; D055106:Genome-Wide Association Study / Q000379:methods*; D023281:Genomics / Q000941:ethics*; D006801:Humans; D033181:Information Dissemination / Q000941:ethics*; D020407:Internet; D054560:National Human Genome Research Institute (U.S.); D009316:National Institutes of Health (U.S.); D011640:Public Policy; D014481:United States