Genomic research data: Open vs. restricted access

IRB Ethics and Human Research

Volumn 32, Issue 1, 2010, Pages 1-6

  Resnki, David B ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOLOGY; ETHICS; GENETIC PRIVACY; GENETICS; HUMAN; HUMAN GENOME; INFORMATION DISSEMINATION; INFORMED CONSENT; LEGAL ASPECT; PUBLIC RELATIONS; STANDARD; UNITED STATES;

COMPUTATIONAL BIOLOGY; GENETIC PRIVACY; GENETIC RESEARCH; GENOME, HUMAN; HUMANS; INFORMATION DISSEMINATION; INFORMED CONSENT; INTERINSTITUTIONAL RELATIONS; UNITED STATES;

EID: 76749144121     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (41)

1. Resnik D. Openness vs. secrecy in scientific research. Episteme 2006; 2: 135-147.
2. National Institutes of Health. Data sharing policy and implementation guidance. http://grants.nih.gov/grants/policy/data-sharing/data-sharing- guidance.htm.
3. Science. General information for authors, http://www.sciencemag.org/ about/authors/prep/gen-info.dtl;
4. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. http://www.icmje.org/
5. Marshall E. Bermuda rules: Community spirit, with teeth. Science 2001; 291: 1192.
6. World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Humans Subjects. http://www.wma.net/e/policy/b3. htm;
7. Council of the International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. http://www.cioms.ch/frame-guidelines-nov-2002.htm;
8. American Medical Association. Code of Ethics. http://www.ama-assn.org/ ama/pub/physician-resources/medical-ethics/code-medical-ethics.shtml;
9. Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46.111a7.
10. Toronto International Data Release Workshop. Prepublication data sharing. Nature 2009;491: 168-170.
11. Genetic Information Nondiscrimination Act of 2008 (P.L. 110-233, 122. Stat. 881).
12. Hudson K, Holohan M, Collins F. Keeping pace with the times -the Genetic Information Nondiscrimination Act of 2008. NEJM 2008; 358 : 2661-2663.
13. Framingham Heart Study. Proposal application and distribution agreements. http://www.framinghamheartstudy.org/research/proposal.html.
14. Framingham Heart Study. Research application overview. http://www.framing-hamheartstudy.org/research/overview.html.
15. Weir R, Olick R, Murray J. The Stored Tissue Issue: Biomedical Research, Ethics and Law in the Era of Genomic Medicine. New York: Oxford University Press, 2004.
16. Human Genome Project. About the Human Genome Project. Available at: http://www.ornl.gov/sci/techresources/Human-Genome/project/about.shtml.
17. Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46.101b4;
18. Department of Health and Human Services, Office for Human Research Protections, Guidance on Research Involving Coded Private Information or Biological Specimens, October 2008. http://www.hhs.gov/ohrp/humansubjects/ guidance/cdebiol.htm.
19. State Cancer Profiles. Data use agreement. http://statecancerprofiles. cancer.gov/datause.html.
20. See ref. 11, Weir et al. 2004.
21. National Institutes of Health. Genome-wide association studies (GWAS). http://grants.nih.gov/grants/gwas/.
22. National Institutes of Health. 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-07-088.html.
23. Couzin J. Whole-genome data not anonymous, challenging assumptions. Science 2008; 321: 1278.
24. McGuire A, Gibbs R. No longer de-identified. Science 2006;312: 370-371.
25. Lin Z, Owen A, Altman R. Genomic research and human subject privacy. Science 2004; 305: 183.
26. Homer N, Szelinger S, Redman M, et al. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microar-rays. PLOS Genetics 2008; 4(8): e1000167: 1-9.
27. Lowrance W, Collins F. Identifiability in genomic research. Science 2007; 317: 600-602.
28. See ref. 20, Lin et al. 2004.
29. National Institutes of Health. Modifications to genome-wide association studies (GWAS) access. http://grants.nih.gov/grants/gwas/data-sharing-policy- modifications-20080828.pdf.
30. See ref. 22, Lowrance and Collins 2007.
31. See ref. 22, Lowrance and Collins 2007.
32. See ref. 22, Lowrance and Collins 2007.
33. Lunshof J, Chadwick R, Vorhaus D, Church G. From genetic privacy to open consent. Nature Reviews Genetics 2008; 9: 406-411.
34. Church G. The personal genome project. Molecular Systems Biology December 13, 2005. http://www.nature.com/msb/journal/vi/m/full/msb4100040.html.
35. Harmon A. Taking a peek at the experts' genetic secrets. New York Times, October 19, 2008;
36. Marshall E. Sequencers of a famous genome confront privacy issues. Science 2007; 315: 1780.
37. McGuire A, Cho M, McGuire S, Caulfield T. The future of personal genomics. Science 2007; 317: 687.
38. Resnik D, Sharp R. Protecting third parties in human subjects research. IRB: Ethics & Human Research 2006; 28(4): 1-7.
39. See ref. 28, Lunshof et al. 2008.
40. See ref. 29, Church 2005.
41. Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46.110b1.