Confronting real time ethical, legal, and social issues in the Electronic Medical Records and Genomics (eMERGE) Consortium

Genetics in Medicine

Volumn 12, Issue 10, 2010, Pages 616-620

  Clayton, Ellen Wright ^a   Smith, Maureen ^b   Fullerton, Stephanie M ^c   Burke, Wylie ^c   McCarty, Catherine A ^d   Koenig, Barbara A ^e   McGuire, Amy L ^f   Beskow, Laura M ^g   Dressler, Lynn ^h   Lemke, Amy A ^b   Ramos, Erin M ⁱ   Rodriguez, Laura Lyman ⁱ  

^a VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

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

^d MARSHFIELD CLINIC   (United States)

^e Mayo Clinic   (United States)

^f BAYLOR COLLEGE OF MEDICINE   (United States)

^g DUKE UNIVERSITY   (United States)

^h University of North Carolina   (United States)

ⁱ NATIONAL HUMAN GENOME RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ELECTRONIC MEDICAL RECORD; GENOMICS; LEGAL ASPECT; MEDICAL ETHICS; NOTE; SOCIAL ASPECT;

COMMUNITY-BASED PARTICIPATORY RESEARCH; CONFIDENTIALITY; ELECTRONIC HEALTH RECORDS; ETHICS COMMITTEES, RESEARCH; ETHICS, MEDICAL; GENETIC RESEARCH; GENOME-WIDE ASSOCIATION STUDY; GENOMICS; HUMANS; INFORMATION DISSEMINATION; INFORMED CONSENT; INTERINSTITUTIONAL RELATIONS; NATIONAL HUMAN GENOME RESEARCH INSTITUTE (U.S.); NATIONAL INSTITUTES OF HEALTH (U.S.); PHYSICIAN-PATIENT RELATIONS; RESEARCH DESIGN; UNITED STATES;

EID: 77958607891     PISSN: 10983600     EISSN: None     Source Type: Journal    
DOI: 10.1097/GIM.0b013e3181efdbd0     Document Type: Note

References (43)

1. National Institutes of Health. Policy for sharing of data obtained in NIH supported or conducted Genome-Wide Association Studies (GWAS). Available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html. Accessed July 31, 2009.
2. National Institutes of Health. Human microbiome project. Available at: http://nihroadmap.nih.gov/hmp/. Accessed July, 19, 2010.
3. NHLBI. NHLBI large-scale DNA sequencing project population studies., 2009., Available at:, http://www.nhlbi.nih.gov/recovery/media/NHLBI-DNA-cohorts. htm. Accessed April, 21, 2010.
4. International HapMap Consortium. Integrating ethics and science in the International HapMap Project. Nat Rev Genet 2004;5:467-475.
5. Foster MW, Eisenbraun AJ, Carter TH. Communal discourse as a supplement to informed consent for genetic research. Nat Genet 1997;17:277-279.
6. Foster MW, Sharp RR, Freeman WL, Chino M, Bernsten D, Carter TH. The role of community review in evaluating the risks of human genetic variation research. Am J Hum Genet 1999;64:1719-1727.
7. Sharp RR, Foster MW. Involving study populations in the review of genetic research. J Law Med Ethics 2000;28:41-51, 3.
8. Sharp RR, Foster MW. Community involvement in the ethical review of genetic research: lessons from American Indian and Alaska Native populations. Environ Health Perspect 2002;110(Suppl 2):145-148.
9. Sharp RR, Foster MW. Grappling with groups: protecting collective interests in biomedical research. J Med Philos 2007;32:321-337.
10. Godard B, Marshall J, Laberge C. Community engagement in genetic research: results of the first public consultation for the Quebec CARTaGENE project. Community Genet 2007;10:147-158.
11. Rotimi C, Leppert M, Matsuda I, et al; International HapMap Consortium. Community engagement and informed consent in the International HapMap project. Community Genet 2007;10:186-198.
12. McCarty CA, Chapman-Stone D, Derfus T, Giampietro PF, Fost N; Marsh-field Clinic PMRP Community Advisory Group. Community consultation and communication for a population-based DNA biobank: the Marshfield clinic personalized medicine research project. Am J Med Genet A 2008; 146A:3026-3033.
13. Collins FS, Morgan M, Patrinos A. The Human Genome Project: lessons from large-scale biology. Science 2003;300:286-290.
14. Common consent. Nature 2009;460:933.
15. Lemke AA, Wolf W, Hebert-Beirne J, Smith M. Public and biobank attitudes toward genetic research participation and data sharing. Public Health Genomics 2010;13:368-377.
16. Brownstein JS, Cassa CA, Mandl KD. No place to hide\-reverse identification of patients from published maps. N Engl J Med 2006;355:1741-1742.
17. Homer N, Szelinger S, Redman M, et al. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genet 2008;4:e1000167.
18. Jacobs KB, Yeager M, Wacholder S, et al. A new statistic and its power to infer membership in a genome-wide association study using genotype frequencies Nat Genet 2009;41:1253-1257.
19. Loukides G, Denny J, Malin B. Do clinical profiles constitute privacy risks for research participants? Paper presented at 2009 American Medical Informatics Association Annual Symposium, San Francisco, California.
20. Malin B. Re-identification of familial database records. Paper presented at Proceedings of the 2006 American Medical Informatics Association Annual Symposium, Washington, D.C.
21. Malin B, Sweeney L. How (not) to protect genomic data privacy in a distributed network: using trail re-identification to evaluate and design anonymity protection systems. J Biomed Inform 2004;37:179-192.
22. Beskow LM, Dean E. Informed consent for biorepositories: assessing prospective participants' understanding and opinions. Cancer Epidemiol Bi-omarkers Prev 2008;17:1440-1451.
23. Ormond KE, Cirino AL, Helenowski IB, Chisholm RL, Wolf WA. Assessing the understanding of biobank participants. Am J Med Genet A 2009; 149A:188-198.
24. McCarty CA, Nair A, Austin DM, Giampietro PF. Informed consent and subject motivation to participate in a large, population-based genomics study: the Marshfield Clinic Personalized Medicine Research Project. Community Genet 2007;10:2-9.
25. National Cancer Institute, Office of Biorepositories and Biospecimen Research. Best practices for biospecimen resources. Available at: http:// biospecimens.cancer.gov/global/pdfs/NCI-Best-Practices-060507.pdf. Accessed October 7, 2009.
26. National Institutes of Health. NIH points to consider for IRBs and Institutions in their review of data submission plans for Institutional Certifications under NIH's policy for sharing of data obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS). 2007. Available at: http://grants.nih.gov/grants/gwas/gwas-ptc.pdf. Accessed July 19, 2010.
27. National Human Genome Research Institute. NHGRI points to consider for IRBs and Institutions in their review of data submission plans for Institutional Certifications under NIH's policy for sharing of data obtained in NHGRI-supported or conducted Medical Sequencing Studies (NHGRI MSP).2008. Available at: http://www.genome.gov/Pages/Research/Sequence MapsBAC/ MedicalSequencing/MSPPtstoConsider03.12.08.pdf. Accessed July 19, 2010.
28. Lemke AA, Trinidad SB, Edwards KL, Starks H, Wiesner GL; GRIPP Consortium. Attitudes toward genetic research review: results from a national survey of professionals involved in human subjects protection. J Empir Res Hum Res Ethics 2010;5:83-91.
29. Knoppers BM, Joly Y, Simard J, Durocher F. The emergence of an ethical duty to disclose genetic research results: international perspectives. Eur J Hum Genet 2006;14:1170-1178.
30. National Bioethics Advisory Commission. Research involving human biological materials: ethical issues and policy guidance, Vol. 1. Rockville, MD: National Bioethics Advisory Commission, 1999.
31. Quaid KA, Jessup NM, Meslin EM. Disclosure of genetic information obtained through research. Genet Test 2004;8:347-355.
32. Clayton EW. Informed consent and biobanks. J Law Med Ethics 2005;33: 15-21.
33. Kohane IS, Mandl KD, Taylor PL, Holm IA, Nigrin DJ, Kunkel LM. Medicine. Reestablishing the researcher-patient compact. Science. 2007; 316:836-837.
34. Wolf SM, Lawrenz FP, Nelson CA, et al. Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics 2008;36:219-248, 211.
35. Bookman EB, Langehorne AA, Eckfeldt JH, et al; NHLBI Working Group. Reporting genetic results in research studies: summary and recommendations of an NHLBI working group. Am J Med Genet A 2006; 140:1033-1040.
36. Fernandez CV, Kodish E, Weijer C. Informing study participants of research results: an ethical imperative. IRB 2003;25:12-19.
37. Miller FA, Christensen R, Giacomini M, Robert JS. Duty to disclose what? Querying the putative obligation to return research results to participants. J Med Ethics 2008;34:210-213.
38. Parker LS. Rethinking respect for persons enrolled in research. ASBH Exch 2006;9:6-7.
39. Murphy J, Scott J, Kaufman D, Geller G, LeRoy L, Hudson K. Public expectations for return of results from large-cohort genetic research. Am J Bioeth 2008;8:36-43.
40. Kaufman D, Murphy J, Scott J, Hudson K. Subjects matter: a survey of public opinions about a large genetic cohort study. Genet Med 2008;10:831-839.
41. Fernandez CV, Taweel S, Kodish ED, Weijer C. Disclosure of research results to research participants: a pilot study of needs and attitudes of adolescents and parents. Paediatr Child Health 2005;10:332-334.
42. Shalowitz DI, Miller FG. Disclosing individual results of clinical research: implications of respect for participants. JAMA 2005;294:737-740.
43. Office of Population Genomics, National Human Genome Research Institute, Research programs, 2009. http://www.genome.gov/ 27530162. Accessed October 19, 2009.