TY - JOUR
T1 - Policy recommendations for addressing privacy challenges associated with cell-based research and interventions
AU - Ogbogu, Ubaka
AU - Burningham, Sarah
AU - Ollenberger, Adam
AU - Calder, Kathryn
AU - Du, Li
AU - El Emam, Khaled
AU - Hyde-Lay, Robyn
AU - Isasi, Rosario
AU - Joly, Yann
AU - Kerr, Ian
AU - Malin, Bradley
AU - McDonald, Michael
AU - Penney, Steven
AU - Piat, Gayle
AU - Roy, Denis Claude
AU - Sugarman, Jeremy
AU - Vercauteren, Suzanne
AU - Verhenneman, Griet
AU - West, Lori
AU - Caulfield, Timothy
N1 - Funding Information:
Funding for this paper and authors’ participation in the workshop was provided by the Office of the Privacy Commissioner of Canada’s Contributions Program, the Canadian Stem Cell Network, the Cancer Stem Cell Consortium, cbcf Tumor Bank, and the PACE-Omics Project funded by Genome Canada, Genome Alberta, the Canadian Institutes for Health Research, and Alberta Health and Wellness. The authors would like to thank Kalina Kamenova for comments on an earlier draft of the paper, Maeghan Toews for editorial support, and members of the Health Law Institute team, particularly Robyn Hyde-Lay, for administrative support.
PY - 2014/2/3
Y1 - 2014/2/3
N2 - 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.
AB - 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.
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U2 - 10.1186/1472-6939-15-7
DO - 10.1186/1472-6939-15-7
M3 - Article
C2 - 24485220
AN - SCOPUS:84893195211
SN - 1472-6939
VL - 15
JO - BMC Medical Ethics
JF - BMC Medical Ethics
IS - 1
M1 - 7
ER -