Hostname: page-component-586b7cd67f-rcrh6 Total loading time: 0 Render date: 2024-11-28T17:08:48.146Z Has data issue: false hasContentIssue false
  • English
  • Français

Comparative Approaches to Biobanks and Privacy

Published online by Cambridge University Press:  01 January 2021

Mark A. Rothstein ,
Bartha Maria Knoppers  and
Heather L. Harrell
Get access Rights & Permissions [Opens in a new window]

Abstract

Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 44 , Issue 1: Part II: Harmonizing Privacy Laws to Enable International Biobank Research , Spring 2016 , pp. 161 - 172
Copyright
Copyright © American Society of Law, Medicine & Ethics 2016

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Green, E. D., Watson, J. D. and Collins, F. S., “Human Genome Project: Twenty-five Years of Big Biology,” Nature 526, no. 7571 (2015): 29–31.CrossRefGoogle Scholar
See Dove, E. S., “Biobanks, Data Sharing, and the Drive for a Global Privacy Governance Framework,” Journal of Law, Medicine & Ethics 43, no. 4 (2015): 675-689 (discussing several large-scale research projects).Google Scholar
Kaiser, J., “Who Has Your DNA – or Wants It,” Science 349, no. 6255 (2015): 1475.CrossRefGoogle Scholar
Knoppers, B. M., “Biobanking: International Norms,” Journal of Law, Medicine & Ethics, 33, no. 1 (2007): 7–14.CrossRefGoogle Scholar
See Thorogood, A. and Zawati, M. H., “International Guidelines for Privacy in Genomic Biobanking,” Journal of Law, Medicine & Ethics 43, no. 4 (2015) (discussing UN, UNESCO, EU, and other statements and guidelines).Google Scholar
For a further discussion, see Dove, supra note 2.Google Scholar
Id.Google Scholar
U.S. Department of Homeland Security et al., Federal Policy for the Protection of Human Subjects; Proposed Rules, 80 Federal Register 53,933, 53,944 (2015).Google Scholar
Schofield, P.N., Eppig, J. and Huala, E. et al., “Research Funding: Sustaining the Data and Bioresource Commons,” Science 330, no. 6004 (2010): 592–593.CrossRefGoogle Scholar
A challenge for some countries, especially in Africa, is that the local languages “may not have words for concepts like ‘privacy,’ ‘confidentiality,’ ‘data,’ ‘research,’ or ‘genomics’ ….” Human Heredity & Health in Africa, H3Africa Guidelines for Informed Consent (2013), at 8, available at <http:/h3africa.org/ethics/17-ethics/71-informedconsent> (last visited February 19, 2016).+(last+visited+February+19,+2016).>Google Scholar
Tiered consent, in which research participants select from a menu of acceptable research topics (e.g., HIV/AIDS, mental health, genetics), is not widely used in international biobanking because biobank sponsors and researchers prefer to have specimens and health records available for all uses. Therefore, it was not one of the issues we included on the template for use by our international colleagues. Nevertheless, new health information technology and changing perceptions of participant involvement in research could lead to increase in popularity and wider use of tiered consent in biobanking.Google Scholar
NIH Genomic Data Sharing Policy, “Notice N. NOTOD-14-124,” available at <http://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html> (last visited February 19, 2016).+(last+visited+February+19,+2016).>Google Scholar
See U.S. Department of Homeland Security et al., supra note 8.Google Scholar
Knoppers, B. M. and Saginur, M., “The Babel of Genetic Data Terminology,” Nature Biotechnology 23, no. 8 (2005): 925–927.CrossRefGoogle Scholar
Global Alliance for Genomics and Health, Privacy and Security Policy Version 26 (May 2005), available at <https://genomicsandhealth.org/files/public/Privacy%20and%20Security%20Policy%20(Final%20-%2026%20May%202015).pdf> (last visited November 2, 2015).+(last+visited+November+2,+2015).>Google Scholar
Health and Social Care Act 2008.Google Scholar
Kosseim, P., Dove, E. S. and Baggaley, C. et al., “Building a Data Sharing Model for Global Genomic Research,” Genome Biology 15, no. 8 (2014): 430.CrossRefGoogle Scholar
See Harrell, H. L. and Rothstein, M. A., “Biobanking Research and Privacy Laws in the United States,” Journal of Law, Medicine & Ethics 44, no. 1 (2016): 106–127.Google Scholar
Maximillian Schrems v. Data Protection Commissioner, C-362/14, EU:2015:650 (Eur. Ct. Just. 2015). See Scott, M., “Data Transfer Pact between U.S. and Europe Is Ruled Invalid,” New York Times, October 6, 2015, available at <http://nyti.ms/1OhKvgl> (last visited February 19, 2016).+(last+visited+February+19,+2016).>Google Scholar
Eligibility for Self-Certification, available at <http:www.export.gov/safeharbor> (last visited February 19, 2016).+(last+visited+February+19,+2016).>Google Scholar
Id.Google Scholar
Statement by US Secretary of Commerce Penny Pritzker on European Court of Justice Safe Harbor Framework Decision, Press Release, October 6, 2015, available at <https://www.commerce.gov/news/press-releases/2015/10/statement-us-secretary-commerce-penny-pritzker-european-court-justice> (last visited October 6, 2015).+(last+visited+October+6,+2015).>Google Scholar
See Kaiser, , supra note 3.Google Scholar
See U.S. Department of Homeland Security et al., supra note 8.Google Scholar
See Dove, supra note 2, discussing several large-scale research projects.Google Scholar
OECD, Health Data Governance: Privacy, Monitoring and Research (2015) (the additional countries: Czech Republic, Iceland, Italy, Japan, Korea, New Zealand, Norway, Sweden, and Switzerland).Google Scholar
Bartha Maria Knoppers is a member of the Steering Committee and Mark A. Rothstein is a member of the Regulatory and Ethics Working Group of the Global Alliance for Genomics and Health.Google Scholar
Stoddart, J., Chan, B. and Joly, Y., “The European Union’s Adequacy Approach to Privacy and Data Sharing in Health Research,” Journal of Law, Medicine & Ethics 44, no. 1 (2016): 143–155.CrossRefGoogle Scholar
See Tass, A. M., “From ICH to IBH in Biobanking? A Legal Perspective on Harmonization, Standardization and Unification,” Studies in Ethics, Law and Technology 7, no. 1 (2013): 1–18.Google Scholar
See <p3g.org> (last visited February 19, 2016). Bartha Maria Knoppers is the Founder and Chair of P3G.+(last+visited+February+19,+2016).+Bartha+Maria+Knoppers+is+the+Founder+and+Chair+of+P3G.>Google Scholar
See <Genomicsandhealth.org> (last visited February 19, 2016).+(last+visited+February+19,+2016).>Google Scholar
See Schofield, et al., supra note 9.Google Scholar