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

Genome Research

Volumn 21, Issue 7, 2011, Pages 1001-1007

  McGuire, Amy L ^a   Basford, Melissa ^b   Dressler, Lynn G ^c   Fullerton, Stephanie M ^d   Koenig, Barbara A ^e   Li, Rongling ^f   McCarty, Cathy A ^g   Ramos, Erin ^f   Smith, Maureen E ^h   Somkin, Carol P ⁱ   Waudby, Carol ^g   Wolf, Wendy A ^j   Clayton, Ellen Wright ^b  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^c UNIVERSITY OF NORTH CAROLINA   (United States)

^d UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^e MAYO CLINIC   (United States)

^f NATIONAL HUMAN GENOME RESEARCH INSTITUTE   (United States)

^g MARSHFIELD CLINIC   (United States)

^h NORTHWESTERN UNIVERSITY   (United States)

ⁱ KAISER PERMANENTE   (United States)

^j BOSTON CHILDREN S HOSPITAL   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DATA BASE; DATA EXTRACTION; DATA SHARING; ELECTRONIC MEDICAL RECORD; GENETIC ASSOCIATION; GENETICS; GENOME ANALYSIS; GENOMICS; HEALTH CARE POLICY; MEDICAL ETHICS; MEDICAL INFORMATION; MEDICAL PRACTICE; NATIONAL HEALTH ORGANIZATION; PRIORITY JOURNAL;

COOPERATIVE BEHAVIOR; DATABASES, GENETIC; ELECTRONIC HEALTH RECORDS; GENOME-WIDE ASSOCIATION STUDY; GENOMICS; HUMANS; INFORMATION DISSEMINATION; INTERNET; NATIONAL HUMAN GENOME RESEARCH INSTITUTE (U.S.); NATIONAL INSTITUTES OF HEALTH (U.S.); PUBLIC POLICY; UNITED STATES;

EID: 79959882088     PISSN: 10889051     EISSN: 15495469     Source Type: Journal    
DOI: 10.1101/gr.120329.111     Document Type: Article

References (24)

1. Benitez K, Malin B. 2010. Evaluating re-identification risks with respect to the HIPAA privacy rule. J Am Med Inform Assoc 17: 169-177.
2. Clayton EW, Smith M, Fullerton SM, Burke W, McCarty CA, Koenig BA, McGuire AL, Beskow LM, Dressler L, Lemke AA, et al. 2010. Confronting real time ethical, legal, and social issues in the Electronic Medical Records and Genomics (eMERGE) Consortium. Genet Med 12: 616-620.
3. Homer N, Szelinger S, Redman M, Duggan D, Tembe W, Muehling J, Pearson JV, Stephan DA, Nelson SF, Craig DW. 2008. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genet 4: e1000167. doi: 10.1371/journal.pgen. 1000167.
4. Kohane IS, Altman RB. 2005. Health-information altruists: A potentially critical resource. N Engl J Med 353: 2074-2077. (Pubitemid 41609103)
5. Kukull WA, Higdon R, Bowen JD, McCormick WC, Teri L, Schellenberg GD, van Belle G, Jolley L, Larson EB. 2002. Dementia and Alzheimer disease incidence: A prospective cohort study. Arch Neurol 59: 1737-1746. (Pubitemid 35340484)
6. Kullo IJ, Fan J, Pathak J, Savova GK, Ali Z, Chute CG. 2010. Leveraging informatics for genetic studies: Use of the electronic medical record to enable a genome-wide association study of peripheral arterial disease. J Am Med Inform Assoc 17: 568-574.
7. Lemke AA, Wolf WA, Hebert-Beirne J, Smith ME. 2010. Public and biobank participant attitudes toward genetic research participation and data sharing. Public Health Genomics 13: 368-377.
8. Lin Z, Owen AB, Altman RB. 2004. Genomic research and human subject privacy. Science 205: 183. (Pubitemid 38886715)
9. Ludman EJ, Fullerton SM, Spangler L, Trinidad SB, Fujii MM, Jarvik GP, Larson EB, Burke W. 2010. Glad you asked: Participants' opinions of re-consent for dbGaP data submission. J Empir Res Hum Res Ethics 5: 9-16.
10. Mailman MD, Feolo M, Jin Y, Kimura M, Tryka K, Bagoutdinov R, Hao L, Kiang A, Paschall J, Phan L, et al. 2007. The NCBI dbGaP database of genotypes and phenotypes. Nat Genet 39: 1181-1186. (Pubitemid 47482671)
11. Malin B, Karp D, Scheuermann RH. 2010. Technical and policy approaches to balancing patient privacy and data sharing in clinical and translational research. J Investig Med 58: 11-18.
12. Malin B, Benitez K, Masys D. 2011. Never too old for anonymity: A statistical standard for demographic data sharing via the HIPAA privacy rule. J Am Med Inform Assoc 18: 3-10.
13. McCarty CA, Wilke RA, Giampietro PF, Wesbrook SD, Caldwell MD. 2005. Marshfield Clinic Personalized Medicine Research Project (PMRP): Design, methods, and recruitment for a large population-based biobank. Per Med 2: 49-79.
14. McCarty CA, Chisholm RL, Chute CG, Kullo IJ, Jarvik GP, Larson EB, Li R, Masys DR, Ritchie MD, Roden DM, et al. 2011a. The eMERGE Network: A consortiumof biorepositories linked to electronicmedical records data for conducting genomic studies. BMC Med Genomics 4:13. doi: 10.1186/1755-8794-4-13.
15. McCarty CA, Garber A, Reeser JC, Fost NC. 2011b. Study newsletters, community and advisory board input, and focus groups discussions provide ongoing consultation for a large biobank. Am J Med Genet A (in press).
16. McGuire AL, Gibbs RA. 2006. No longer de-identified. Science 312: 370-371.
17. Menikoff J. 2010. The paradoxical problem with multiple-IRB review. N Engl J Med 363: 1591-1593.
18. National Institutes of Health. 2007. Implementation guidance and instructions for applicants: Policy for sharing of data obtained in NIH-supported or conducted genome-wide association studies (GWAS). http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-013.html
19. Office of Human Research Protections. 2008. Guidance on research involving coded private information or biological specimens. U.S. Department of Health and Human Services (HHS), Washington, DC. http://www.hhs.gov/ohrp/policy/ cdebiol.html
20. Roden DM, Pulley JM, Basford MA, Bernard GR, Clayton EW, Balser JR, Masys DR. 2008. Development of a large-scale de-identified DNA biobank to enable personalized medicine. Clin Pharmacol Ther 84: 362-369.
21. Trinidad SB, Fullerton SM, Bares JM, Jarvik GP, Larson EB, Burke W. 2010. Genomic research and wide data sharing: Views of prospective participants. Genet Med 12: 486-495.
22. Trinidad SB, Fullerton SM, Ludman EJ, Jarvik GP, Larson EB, Burke W. 2011. Research practice and participant preferences: The growing gulf. Science 331: 287-288.
23. U.S. Dept. of Health and Human Services. 2009. Protection of human subjects. In Code of federal regulations, Title 45, Part 46. U.S. Government Printing Office, Washington, DC.
24. Wolf WA, Doyle MJ, Aufox SA, Frezzo TF, Smith ME, Kibbe KE, Chisholm RL. 2003. DNA banking study in an ethnically diverse urban university hospital. Am J Hum Genet 73: 423.