Abstract
This chapter describes five key areas in which clinical bioinformatics activities are regulated by law and policy. These are, namely, open-data requirements, consent practices, anonymization strategies, restrictions on cross-border data transfer, and prohibitions on genetic discrimination. The discussion draws on examples of norms that are currently in effect in North America, Europe, Asia, and Oceania in order to illustrate the ways in which positions on various specific questions can either mutually converge or deviate from one another around the globe. The tension that animates virtually all of the debates throughout this area, whether explicitly or through proxy issues, this chapter argues, is between the promotion of the interests of research participants—particularly in ensuring data privacy—on the one hand, and in establishing a landscape optimized to best promote medical research discoveries, on the other.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
Each of these laws have been significantly amended since they were initially enacted.
- 2.
In the common law and civil law traditions, respectively.
- 3.
Namely, the Canadian Institutes of Health Research (CIHR); the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC).
- 4.
Or any of various synonyms used, such as ‘identifying data’.
References
British Columbia. Freedom of information and protection of privacy act. Revised Statutes of British Columbia, chapter 165. Queen’s Printer BC; 1996.
Cai R, Hao Z, Winslett M, Xiao X, Yang Y, Zhang Z, Zhou S. Deterministic identification of specific individuals from GWAS results. Bioinformatics. 2015;31(11):1701.
Canada. Personal information protection and electronic documents act. Statutes of Canada, chapter 5. Queen’s Printer for Canada; 2000.
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-council policy statement: ethical conduct for research involving humans. Ottawa: Secretariat on Responsible Conduct of Research; 2014.
Contreras JL. NIH’s genomic data sharing policy: timing and tradeoffs. Trends Genet. 2015;31(2):55.
Council of Europe. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine. Strasbourg: Council of Europe; 1997.
Dwork C, Roth A. The algorithmic foundations of differential privacy. Found Trends Theor Comp Sci. 2014;9(3–4):211.
Edwards J. Privacy and big data: presentation by privacy commissioner John Edwards. New Zealand Privacy Commissioner; 2014.
El Emam K, Arbuckle L. Anonymizing health data: case studies and methods to get you started. Beijing: O’Reilly; 2013.
Erlich Y, Williams JB, Glazer D, Yocum K, Farahany N, Olson M, et al. Redefining genomic privacy: trust and empowerment. PLoS Biol. 2014;12(11):e1001983. doi:10.1371/journal.pbio.1001983.
Expert Advisory Group on Data Access. Governance of data access. 2015. http://www.wellcome.ac.uk/stellent/groups/corporatesite/@msh_peda/documents/web_document/wtp059343.pdf
Expert Advisory Group on Data Access. Statement for EAGDA funders on re-identification. 2013. http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/web_document/wtp055972.pdf
Government of Canada. Tri-agency open access policy on publications. 2015. http://www.science.gc.ca/default.asp?lang=En&n=F6765465-1
Homer N, Szelinger S, Redman M, Duggan D, Tembe W, Muehling J, et al. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genet. 2008;4(8):1000167.
Horvitz E, Mulligan D. Data, privacy, and the greater good. Science. 2015;349(6245):253.
Hunter v. Southam. 11 Dominion Law Reports, 4th Series, 641. 1984.
Kamm L, Bogdanov D, Laur S, Vilo J. A new way to protect privacy in large-scale genome-wide association studies. Bioinformatics. 2013;29(7):886.
Katz v. United States. 389 US 347. 1967.
Kaye J, Whitley EA, Lund D, Morrison M, Teare H, Melham K. Dynamic consent: a patient interface for twenty-first century research networks. Eu J Hum Gen. 2015;23:141.
Lauter K, López-Alt A, Naehrig M. Private computation on encrypted genomic data. 2014. http://research.microsoft.com/pubs/219979/genomics.pdf
Liddell K. Just genetic discrimination? The ethics of Australian law reform proposals. Univ NSW Law J. 2002;25(1):160.
Lu W, Yamada Y, Sakuma J. Efficient secure outsourcing of genome-wide association studies. IEEE CS Security and Privacy Workshops. 2015.
Manson NC, O’Neill O. Rethinking informed consent in bioethics. Cambridge: Cambridge University Press; 2007.
Marshall E. Bermuda rules: community spirit, with teeth. Science. 2001;291(5507):1192.
McCarthy MI, Abecasis GR, Cardon LR, Goldstein DB, Little J, Ioannidis JP, et al. Genome-wide association studies for complex traits: consensus, uncertainty and challenges. Nat Rev Genet. 2008;9(5):356.
National Institutes of Health. Modifications to genome-wide association studies (GWAS) data access. 2008. http://gds.nih.gov/pdf/Data%20Sharing%20Policy%20Modifications.pdf
National Institutes of Health. NIH genomic data sharing policy. 2014c. http://gds.nih.gov/PDF/NIH_GDS_Policy.pdf
National Institutes of Health. Notice number: NOT-OD-14-124. 2014a, 27 August. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html
National Institutes of Health. Supplemental information to the National Institutes of Health genomic data sharing policy. 2014b. http://gds.nih.gov/PDF/Supplemental_Info_GDS_Policy.pdf
Office for Civil Rights. Guidance regarding methods for de-identification of protected health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) privacy rule. 2012. http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html
Office of the Information & Privacy Commissioner for British Columbia. Updated guidance on the storage of information outside of Canada by public bodies. 2014, 16 June. https://www.oipc.bc.ca/public-comments/1649
Personal Data Protection Commission (Singapore). Advisory guidelines for the healthcare sector. 2014, 11 September.
Philippine National Health Research System. National ethical guidelines for health research. 2011. http://www.ethics.healthresearch.ph/index.php/phoca-downloads/category/4-neg?download=9:pub-ethics-guidelines-2011
Rothstein MA. Currents in contemporary ethics: GINA, the ADA, and genetic discrimination in employment. J Law Med Ethics. 2008;36(4):837.
Tobin SL, Lee SSJ, Greely HT, Ormond KE, Cho MK. Not a loophole: commercial exploitation of an IRB error. Comment on: Gibson G, Copenhaver GP. Consent and internet-enabled human genomics. PLoS Genet. 2010;6(6):e1000965.
United States Agency for Healthcare Research and Quality. Registries for evaluating patient outcomes: a user’s guide. Rockville: US Department of Health and Human Services; 2007.
Wolfson M, Wallace SE, Masca N, Rowe G, Sheehan NA, Ferretti V, et al. DataSHIELD: resolving a conflict in contemporary bioscience—performing a pooled analysis of individual-level data without sharing the data. Int J Epidemiol. 2010;39(5):1372.
Disclosure Statement
Funding for this work was provided by the Canada Research Chair in Law and Medicine.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2016 Springer Science+Business Media Dordrecht
About this chapter
Cite this chapter
Phillips, M. (2016). Key Law and Policy Considerations for Clinical Bioinformaticians. In: Wang, X., Baumgartner, C., Shields, D., Deng, HW., Beckmann, J. (eds) Application of Clinical Bioinformatics. Translational Bioinformatics, vol 11. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-7543-4_14
Download citation
DOI: https://doi.org/10.1007/978-94-017-7543-4_14
Published:
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-017-7541-0
Online ISBN: 978-94-017-7543-4
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)