The growth and gaps of genetic data sharing policies in the United States

Journal of Law and the Biosciences

Volumn 2, Issue 3, 2016, Pages 56-68

  Arias, Jalayne J ^a   Pham Kanter, Genevieve ^b,c   Campbell, Eric G ^d,e  

^a LERNER RESEARCH INSTITUTE   (United States)

^b DREXEL UNIVERSITY   (United States)

^c HARVARD UNIVERSITY   (United States)

^d MASSACHUSETTS GENERAL HOSPITAL   (United States)

^e HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Data sharing; Genetic; Genomic; Policy; Research; Scientific norms

Indexed keywords

EID: 84975788577     PISSN: None     EISSN: 20539711     Source Type: Journal    
DOI: 10.1093/jlb/lsu032     Document Type: Article

References (25)

1. EliotMarshall, Bermuda Rules: Community Spirit with Teeth, 291 SCIENCE 1192 (2001)
2. Final NIH Genomic Data Sharing Policy, 79 Fed. Reg. 51,345 (Aug. 28, 2014)
3. Dina N. Paltoo et al., Data UseUnder theNIHGWASData Sharing Policy and Future Directions, 46NAT.GENET. 9, 934-938 (2014)
4. National Science Foundation, Award and Administration Guide: Other Post Award Requirements and Considerations, http://www.nsf.gov/pubs/policydocs/pappguide/nsf13001/aag?6.jsp#VID4 (accessedOct. 20, 2014)
5. HumanGenome Project Information Archive, Policies on Release ofHuman Genomic SequenceData Bermuda-Quality Sequence, http://www.ornl.gov/sci/techresources/Human?Genome/research/bermuda.shtml (accessed July 20, 2014)
6. National Human Genome Research Institute, Current NHGRI Policy for Release and Database Deposition of Sequence Data 1997, http://www.genome.gov/10000910 (accessed July 20, 2014)
7. Final NIH Statement on Sharing Research Data, NOT-OD-03-032 (Feb. 26, 2003), https://www.genome. gov/EdKit/pdfs/1992b.pdf (accessed Dec. 4, 2014)
8. DOE-NIH Joint Subcommittee on the Human Genome, NIH, DOE Guidelines Encourage Sharing of Data, Resources, 4 Human Genome News (1993)
9. COMMITTEE ON RESPONSIBILITIES OF AUTHORSHIP IN THE BIOLOGICAL SCIENCES, NATIONAL RESEARCH COUNCIL, SHARING PUBLICATION-RELATED DATA AND MATERIALS: RESPONSIBILITIES OF AUTHORSHIP IN THE LIFE SCIENCES 3 (The National Academies 2003)
10. Jorge L.Contreras, Bermuda's Legacy: Policy, Patents, and theDesign of the Genome Commons, 12MINN. J. L. SCI. TECH. 61 (2011)
11. The Wellcome Trust, Sharing Data from Large-Scale Biological Researcher Projects 1, 4 (2003), http://www. genome.gov/pages/research/wellcomereport0303.pdf (accessed Dec. 4, 2014)
12. William W. Lowrance & Francis S. Collins, Identifiably in Genomic Research, 3 SCIENCE 600 (2007)
13. Jane Kaye et al., Data Sharing in Genomics-Re-Shaping Scientific Practice, 10NAT. REV. GENET. 331 (2009)
14. Nils Homer et al., Resolving Individuals Contributing Trace Amounts of DNA to Highly Complex Mixtures Using High-Density SNP GenotypingMicroarrays, 4 PLOSGENET. e1000167 (2008)
15. P3G Consortium et al., Public Access to Genome-Wide Data: Five Views on Balancing Research with Privacy and Protection, 5 PLOSGENET. e1000665 (2009)
16. National Human Genome Research Institute, Genetic Information Nondiscrimination Act (GINA) of 2008, http://www.genome.gov/24519851 (accessed July 21, 2014)
17. Michelle M. Mello & Leslie E. Wolf, The Havasupai Indian Tribe Case-Lessons for Research Involving Stored Biologic Samples, 363 NEJM 204 (2010)
18. National Institutes of Health, Lacks Family Reach Understanding to Share Genomic Data of HeLa Cells (Aug. 7, 2013), http://www.nih.gov/news/health/aug2013/nih-07.htm (accessed July 21, 2014)
19. Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, 76 Fed. Reg. 44512 (July 26, 2011)
20. Genevieve Pham-Kanter, Darren Zinner & Eric G. Campbell, Codifying Collegiality: Recent Developments in Data Sharing Policy in the Life Sciences, 9 PLOS One e108451 (2014)
21. Department of Health and Human Services, Regulatory Changes in ANPRM, http://www.hhs.gov/ohrp/ humansubjects/anprmchangetable.html (accessed Feb. 11, 2014)
22. AmyMcGuire et al., To Share orNot Share:ARandomized Trial of Consent forData Sharing inGenome Research, 13 GENET. MED. 948 (2011)
23. Susan B. Trinidad et al., Genomic Research and Wide Data Sharing: Views of Prospective Participants, 12GENET. MED. 8, 486-495 (2010)
24. Jill O. Robinson et al., Participants' Recall and Understanding ofGenomic Research and Large-Scale Data Sharing, 8 J. EMPIR. RES. HUM. RES. ETHICS 4, 42-52 (2013)
25. Rosalina James et al., Exploring Pathways to Trust: A Tribal Perspective on Data Sharing, 16 GENET. MED. 820, 826 (2014), http://www.nature.com/gim/journal/vaop/ncurrent/full/gim201447a.html (accessedOct. 20, 2014)