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Policy recommendations for addressing privacy challenges associated with cell-based research and interventions

Ubaka Ogbogu12*, Sarah Burningham2, Adam Ollenberger2, Kathryn Calder3, Li Du2, Khaled El Emam4, Robyn Hyde-Lay2, Rosario Isasi5, Yann Joly6, Ian Kerr7, Bradley Malin8, Michael McDonald9, Steven Penney102, Gayle Piat11, Denis-Claude Roy12, Jeremy Sugarman13, Suzanne Vercauteren14, Griet Verhenneman15, Lori West16 and Timothy Caulfield172

Author Affiliations

1 Faculties of Law and Pharmacy & Pharmaceutical Sciences, University of Alberta, 116 Street and 85 Avenue, Edmonton T6G 2R3, Canada

2 Health Law Institute, Faculty of Law, University of Alberta, 116 Street and 85 Avenue, Edmonton T6G 2R3, Canada

3 cbcf Tumor Bank/Alberta Cancer Research Biorepository, Cross Cancer Institute, Rm 2312, 11560 University Avenue, Edmonton T6G 1Z2, Canada

4 Faculty of Medicine, University of Ottawa, CPCR, 401 Smyth Road, Ottawa K1H 8 L1, Canada

5 Centre of Genomics and Policy, Faculty of Medicine, and Department of Human Genetics, McGill University, 740, avenue Dr. Penfield, suite 5206, Montreal H3A 0G1, Canada

6 Centre of Genomics and Policy, Department of Human Genetics, McGill University, 740, avenue Dr. Penfield, suite 5206, Montreal H3A 0G1, Canada

7 Faculties of Law and Medicine, Department of Philosophy and School of Information Studies, University of Ottawa, 75 Laurier Avenue East, Ottawa K1N 6 N5, Canada

8 Schools of Medicine and Engineering, Vanderbilt University, 2525 West End Avenue, Nashville 37203, USA

9 W. Maurice Young Center for Applied Ethics, University of British Columbia, 2329 West Mall, Vancouver V6T 1Z4, Canada

10 Faculty of Law, University of Alberta, 116 Street and 85 Avenue, Edmonton T6G 2R3, Canada

11 Cell and Tissue Innovative Research Centre, University of Alberta, 116 Street and 85 Avenue, Edmonton T6G 2R3, Canada

12 Centre de recherche Hôpital Maisonneuve-Rosemont, and Faculty of Medicine, University of Montreal, 5415 L’Assomption blvd, Montreal Quebec H1T 2M4, Canada

13 Berman Institute of Bioethics and Department of Medicine, John Hopkins University, Baltimore Maryland 21205, USA

14 Faculty of Medicine, University of British Columbia, 2329 West Mall, Vancouver V6T 1Z4, Canada

15 University of Leuven, Oude Markt 13, Leuven 3000, Belgium

16 Alberta Transplant Institute, Faculty of Medicine, University of Alberta, 116 Street and 85 Avenue, Edmonton T6G 2R3, Canada

17 Faculty of Law and School of Public Health, University of Alberta, 116 Street and 85 Avenue, Edmonton T6G 2R3, Canada

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BMC Medical Ethics 2014, 15:7  doi:10.1186/1472-6939-15-7

Published: 3 February 2014

Abstract

Background

The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors’ clinical information for research and regulatory purposes, and existing practices that limit research participants’ ability to control what is done with their genetic data, amplify the privacy concerns.

Discussion

To date, the privacy issues associated with cell-based research and interventions have not received much attention in the academic and policymaking contexts. This paper, arising out of a multi-disciplinary workshop, aims to rectify this by outlining the issues, proposing novel governance strategies and policy recommendations, and identifying areas where further evidence is required to make sound policy decisions. The authors of this paper take the position that existing rules and norms can be reasonably extended to address privacy risks in this context without compromising emerging developments in the research environment, and that exceptions from such rules should be justified using a case-by-case approach. In developing new policies, the broader framework of regulations governing cell-based research and related areas must be taken into account, as well as the views of impacted groups, including scientists, research participants and the general public.

Summary

This paper outlines deliberations at a policy development workshop focusing on privacy challenges associated with cell-based research and interventions. The paper provides an overview of these challenges, followed by a discussion of key themes and recommendations that emerged from discussions at the workshop. The paper concludes that privacy risks associated with cell-based research and interventions should be addressed through evidence-based policy reforms that account for both well-established legal and ethical norms and current knowledge about actual or anticipated harms. The authors also call for research studies that identify and address gaps in understanding of privacy risks.