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

Abstract

BackgroundThe 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.DiscussionTo 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.SummaryThis 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.

Individualized medicine enabled by genomics in Saudi Arabia

“…However, there remains an urgent need in Saudi Arabia for up to date policies that comply with international standards, which implement strict control and protection of privacy and public release of bio-specimens and data [ 166 - 168 ]. CEGMR will also continue to develop and implement new algorithms and databases enabling iterative dynamic interpretations of data in personalized health decision making [ 169 - 171 ].…”

“…(C) The percentage of CYP2C9*2 and CYP2C9*3 polymorphisms identified in Oman, Egypt, Lebanon, as well as in Al-Ahsa, Riyadh and Jeddah regions of the KSA. The incidence of CYP2C9 polymorphisms in Saudi population was similar to Caucasians; but, it was more than Asians and Africans [ 169 ] and adverse bleeding episodes are not uncommon in Saudi patients with CYP2C9*2 and CYP2C*3 alleles and may require 40% less Warfarin dose to induce effective anti-coagulation [ 169 ].…”

The European General Data Protection Regulation: Challenges and Considerations for iPSC Researchers and Biobanks

“…It is therefore advisable to seek explicit consent for the collection and processing of genetic or biometric data, and researchers should avoid giving tissue donors a guarantee of absolute anonymity or privacy. To promise that the donor cannot and will never be identified is to encourage an unrealistic expectation, and could expose researchers to liability if a data subject is identified (e.g., through a data breach) [ 11 , 25 ]. Academic studies that generate iPSC should also consider the consent requirements associated with making these cell lines available to the wider research community.…”

The risk of re-identification versus the need to identify individuals in rare disease research

“…15 Arguments like these have been used in order to substantiate calls for regulatory changes and policy recommendations. 3, 16, 17 However, as was shown in a recent systematic review of re-identification attacks (see below) on health data, there are reasons to proceed with caution and to wait for more nuanced accounts before changing policies and regulatory frameworks. It should be remembered, as argued above, that too strict legal regulatory requirements to maintain anonymity may be detrimental to research where maximum benefit from data may only be achieved by distinguishing individuals within the data set.…”