Beskow Laura M, Dame Lauren, Costello E Jane
Duke Translational Medicine Institute, Duke University, Durham, NC 27710, USA.
Science. 2008 Nov 14;322(5904):1054-5. doi: 10.1126/science.1164100.
Certificates of Confidentiality have gained prominence in the context of efforts to build large-scale research platforms and new requirements for an unprecedented degree of data sharing. There is, however, a remarkable paucity of evidence upon which to base conclusions about the strength, applicability, and durability of the legal protections a Certificate affords. Here we describe a recent legal challenge in which a research participant’s data, collected under a Certificate, were subpoenaed as part of a criminal case that reached the North Carolina Court of Appeals. We show how, despite the legal protections ostensibly afforded by the Certificate and the vigorous objections of the Principal Investigator and institutional counsel, the research subject’s confidentiality was ultimately compromised in the course of the legal proceedings; further, we discuss the broader implications of this case for the research enterprise as a whole.
在构建大规模研究平台的努力以及前所未有的数据共享新要求的背景下，保密证书已变得越发重要。然而，关于保密证书所提供的法律保护的力度、适用性和持久性，可供得出结论的证据却极为匮乏。在此，我们描述了最近一起法律挑战事件，在该事件中，作为一桩刑事案件的一部分，依据保密证书收集的一名研究参与者的数据被传唤，该案件上诉至北卡罗来纳州上诉法院。我们展示了尽管保密证书表面上提供了法律保护，且首席研究员和机构法律顾问也强烈反对，但在法律程序过程中，研究对象的保密性最终还是遭到了侵犯；此外，我们还讨论了该案件对整个研究事业更广泛的影响。
