Human Genetics

, Volume 130, Issue 3, pp 441–449 | Cite as

Genomic databases access agreements: legal validity and possible sanctions

Review Paper

Abstract

Large-scale, public genomic databases have greatly improved the capacity of researchers to do genomic research. In order to ensure that the scientific community uses data from these public resources properly, data access agreements have been developed to complement already existing legal and ethical norms. Sanctions to address cases of data misuse constitute an essential part of this compliance framework meant to protect stakeholders in genomic research. Yet very little research and community debate has been done on this most important topic. This paper presents a review of different sanctions that could be invoked in cases of non-compliance from data users. They have been identified through comprehensive research and analysis of over 450 documents (journal articles, policy, guidelines, access policies, etc.) related to this topic. Given the considerable impact on users of even the milder sanctions considered in our paper, it is essential that stakeholders strive to achieve the highest degree of standardization and transparency when designing controlled-access agreements. It is only fair, after all, that users be able to expect that the border between acceptable and unacceptable conduct is clearly delineated and predictable in controlled-access policies. This suggests the importance for researchers to undertake additional empirical studies on the clarity and accessibility of existing database access agreements and related policies in the near future.

Notes

Ackniowledgments

The authors are grateful for the financial assistance of the International Cancer Genome Consortium and would like to acknowledge the contribution of all members of the EPC. We are particularly grateful to Prof. Martin Bobrow for his wise words of advice on the importance of not over-sanctioning users and to Mr. Francis Hemmings for his research assistance on the overview of available sanctions.

References

  1. Australian Government (2007) Monitoring and Compliance Framework in Accordance with the Gene Technology Act 2000Google Scholar
  2. Burke-Robertson J (2008) Natural Justice, Members, and the Not-For-Profit Organization. Philantropist 21(4)Google Scholar
  3. Council of Science Editors (2009) White paper on promoting integrity in scientific journal publications. http://www.councilscienceeditors.org/files/public/entire_whitepaper.pdf
  4. Fortin SPS, Grintuch R, Deschênes M (2011) Access arrangements for biobanks: a fine line between facilitating and hindering collaboration. Public Health Genomics 14:104–114Google Scholar
  5. Genome Canada (2008) Data release and resource sharing. http://www.genomecanada.ca/medias/PDF/EN/DataReleaseandResourceSharingPolicy.pdf
  6. Holden C (2009) Scientific publishing-paper retracted following genome data breach. Science 325(5947):1486–1487PubMedCrossRefGoogle Scholar
  7. HUGO Ethics Committee (2002) Statement on Human Genomic Databases http://www.hugo-international.org/hugo/HEC_Dec02.html
  8. Jobin P-G, Vézina N, Baudouin JL (2005) Les obligations. 6e éd. Éditions Y. Blais, Cowansville, QuébecGoogle Scholar
  9. Joint Statement by Research Funders (2011) Global funding agencies commit to enhancing access to research data to improve public health. http://www.wellcome.ac.uk/News/Media-office/Press-releases/2011/WTX064132.htm
  10. Kaye J et al (2009) Data Sharing in Genomics-re-shaping scientific practice. Nat Rev Genet 10:331–335PubMedCrossRefGoogle Scholar
  11. Knoppers BM, Abdul-Rahman M, Bédard K (2007) Genomic databases and international collaboration. King’s Law J 18:291Google Scholar
  12. Koffman L, Macdonald E (2007) The law of contract, 7th edn. Oxford University Press, OxfordGoogle Scholar
  13. Lang T (2011) Advancing global health research through digital technology and sharing data. Science 331(6018):714–717. doi:10.1126 PubMedCrossRefGoogle Scholar
  14. Lowrance WW (2006) Access to collections of data and materials for health research. A report to the Medical Research Council and the Wellcome TrustGoogle Scholar
  15. Miles MB, Huberman AM (1994) Qualitative data analysis: an expanded sourcebook. Sage Publications, LondonGoogle Scholar
  16. National Institutes of Health (2003) Final NIH statement on sharing research data. NOT-OD-03-032. http://grants.nih.gov/grants/guide/notice-files/NOTOD-03-032.html
  17. National Institutes of Health (2007) Points to consider forIRBs 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). http://gwas.nih.gov/pdf/GWAS_points_to_consider_A.pdf
  18. Organization for Economic Cooperation and Development (2006) Guidelines for the licensing of genetic inventions. http://www.oecd.org/dataoecd/39/38/36198812.pdf
  19. Rodriguez LL (2010) Sharing of genomic—early experiences implementing the NIH GWAS policy. Paper presented at the International Data Sharing Conference, OxfordGoogle Scholar
  20. Singapore Statement on Research Integrity (2010) Paper presented at the 2nd World Conference on Research Integrity, SingaporeGoogle Scholar
  21. Steneck NH, Bulger RE (2007) The history, purpose, and future of instruction in the responsible conduct of research. Acad Med 82(9):829–834PubMedCrossRefGoogle Scholar
  22. Swan J (2006) Canadian contract law. LexisNexis Butterworths, MarkhamGoogle Scholar
  23. The Federation of American Societies for Experimental Biology (2006) Shared responsability, individual integrity: scientists addressing conflicts of interest in biomedical research. http://www.faseb.org/portals/0/pdfs/opa/FASEB_COI_paper.pdf
  24. Toronto International Data Release Workshop Authors (2009) Prepublication data sharing. Nature 461(7261):168–170CrossRefGoogle Scholar
  25. UNESCO (1997) Universal Declaration on the Human Genome and Human RightsGoogle Scholar
  26. Waddams SM (2010) The law of contracts, 6th edn. Canada Law Book, AuroraGoogle Scholar
  27. Wellcome Trust (2003) Sharing data from large-scale biological research projects: a system of tripartite responsibility. http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtd003207.pdf
  28. World Association of Medical Editors (2011) Publication Ethics Policies for Medical Journals. http://www.wame.org/resources/publication-ethics-policies-for-medical-journals

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  1. 1.Deptartment of Human Genetics, Faculty of Medicine, Centre of Genomics and PolicyMcGill UniversityMontrealCanada
  2. 2.Deptartment of Human Genetics, Faculty of Medicine, Centre of Genomics and PolicyMcGill UniversityMontrealCanada
  3. 3.St John of God PathologySubiacoWestern Australia
  4. 4.School of SurgeryThe University of Western AustraliaCRAWLEYAustralia

Personalised recommendations