Ogbogu Ubaka, Burningham Sarah, Ollenberger Adam, Calder Kathryn, Du Li, El Emam Khaled, Hyde-Lay Robyn, Isasi Rosario, Joly Yann, Kerr Ian, Malin Bradley, McDonald Michael, Penney Steven, Piat Gayle, Roy Denis-Claude, Sugarman Jeremy, Vercauteren Suzanne, Verhenneman Griet, West Lori, Caulfield Timothy
Faculties of Law and Pharmacy & Pharmaceutical Sciences, University of Alberta, 116 Street and 85 Avenue, Edmonton T6G 2R3, Canada.
BMC Med Ethics. 2014 Feb 3;15:7. doi: 10.1186/1472-6939-15-7.
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.
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.
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.
用于基于细胞的研究和临床干预的人类生物材料使用的增加给患者和捐赠者的隐私带来了风险，包括从匿名细胞系和相关遗传数据中重新识别个人的可能性。随着用于重新识别的技术和数据库变得价格合理且更加精密复杂，这些风险将会增加。出于研究和监管目的要求将细胞系与捐赠者的临床信息持续关联的政策，以及限制研究参与者控制其遗传数据使用方式能力的现有做法，加剧了隐私方面的担忧。
迄今为止，与基于细胞的研究和干预相关的隐私问题在学术和政策制定背景下并未受到太多关注。本文源自一个多学科研讨会，旨在通过概述问题、提出新颖的治理策略和政策建议，以及确定做出合理政策决策所需进一步证据的领域来纠正这一情况。本文作者认为，现有规则和规范可以合理扩展以应对这种情况下的隐私风险，同时不损害研究环境中的新发展，并且此类规则的例外情况应采用逐案处理的方式进行论证。在制定新政策时，必须考虑到管理基于细胞的研究及相关领域的更广泛监管框架，以及受影响群体的观点，包括科学家、研究参与者和公众。
本文概述了一次政策制定研讨会的审议情况，该研讨会聚焦于与基于细胞的研究和干预相关的隐私挑战。本文首先概述了这些挑战，随后讨论了研讨会讨论中出现的关键主题和建议。本文得出结论，与基于细胞的研究和干预相关的隐私风险应通过基于证据的政策改革来应对，这些改革既要考虑既定的法律和道德规范，也要考虑有关实际或预期危害的当前知识。作者们还呼吁开展研究，以识别和解决在隐私风险理解方面的差距。
