Dove Edward S
Ph.D. candidate in the School of Law at the University of Edinburgh. Previously, he was an Academic Associate at the Centre of Genomics and Policy at McGill University in Montreal. He received his LL.M. degree from Columbia University.
J Law Med Ethics. 2015 Winter;43(4):675-89. doi: 10.1111/jlme.12311.
Biobanks are a key emerging biomedical research infrastructure. They manifest the turn towards greater global sharing of genomic and health-related data, which is considered by many to be an ethical and scientific imperative. Our collective interests lie in improving the health and welfare of individuals, communities, and populations; improving health and welfare requires access to, and use of, widely dispersed quality data. But sharing these individual and familial data requires in turn that due thought be given to the ethical and legal interests at stake. Most critically, data sharing must occur in an environment whereby privacy interests are safeguarded throughout the lifecycle of biobank initiatives, and regardless of the locations where the data are stored, to which they are sent, and where they are ultimately processed. In this article, I outline the complex dimensions of data privacy regulation that challenge data sharing within the biobanking context. I discuss how harmonization may be a remedy for the gaps and marked differences of approach in data privacy regulation. Finally, I encourage the development of foundational responsible data sharing principles set within an overarching governance framework that provides assurance that reasonable expectations of privacy will be met.
生物样本库是一种关键的新兴生物医学研究基础设施。它们体现了向更大范围全球共享基因组和健康相关数据的转变，许多人认为这在伦理和科学上是必要的。我们的共同利益在于改善个人、社区和人群的健康与福祉；而改善健康与福祉需要获取并使用广泛分散的高质量数据。但共享这些个人和家族数据反过来要求我们充分考虑其中涉及的伦理和法律利益。最关键的是，数据共享必须在这样一种环境中进行，即在生物样本库计划的整个生命周期内，无论数据存储在何处、发送到何处以及最终在何处进行处理，隐私利益都能得到保护。在本文中，我概述了数据隐私监管的复杂层面，这些层面在生物样本库背景下对数据共享构成了挑战。我讨论了协调如何可能弥补数据隐私监管中方法上的差距和显著差异。最后，我鼓励制定在总体治理框架内设定的基础性负责任数据共享原则，该框架能确保满足对隐私的合理期望。
