Ethical and practical challenges of sharing data from genome-wide association studies: The eMERGE Consortium experience (original) (raw)

  1. Melissa Basford2,
  2. Lynn G. Dressler3,
  3. Stephanie M. Fullerton4,
  4. Barbara A. Koenig5,
  5. Rongling Li6,
  6. Cathy A. McCarty7,
  7. Erin Ramos6,
  8. Maureen E. Smith8,
  9. Carol P. Somkin9,
  10. Carol Waudby7,
  11. Wendy A. Wolf10 and
  12. Ellen Wright Clayton2
  13. 1Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas 77030, USA;
  14. 2Vanderbilt University Medical Center, Nashville, Tennessee 37232, USA;
  15. 3University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina 27599, USA;
  16. 4University of Washington School of Medicine, Seattle, Washington 98195, USA;
  17. 5Mayo Clinic, Rochester, Minnesota 55905, USA;
  18. 6National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland 20892, USA;
  19. 7Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, USA;
  20. 8Center for Genetic Medicine, Northwestern University, Chicago, Illinois 60611, USA;
  21. 9Kaiser Permanente, Oakland, California 94611, USA;
  22. 10Division of Genetics, Children's Hospital Boston, Boston, Massachusetts 02115, USA

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.

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