Assessing the Use and Understanding of Certificates of Confidentiality

描述(由申请人提供)：研究人员和机构在道德和法律上有义务保护研究参与者的隐私及其数据的机密性。事实上，研究企业的成功取决于公众对私人信息将得到大力保护的信心。联邦法律授权的保密证书是满足这一期望的重要工具。通过保护研究人员和机构免受在任何法律程序中被迫披露身份数据的影响，证书旨在通过向潜在参与者保证其信息的安全性来促进参与，从而允许就对公众健康至关重要的敏感话题进行研究。事实上，人们普遍认为证书提供了近乎绝对的隐私保护。最近，随着建立大规模研究平台的努力和对数据共享程度前所未有的新要求的兴起，它们的使用得到了促进。然而，关于证书所提供的保护的力度，缺乏明显的证据来得出结论。最近提交给北卡罗来纳州上诉法院的一起案件表明，证书的全部法律效力尚不清楚。需要关于何时、为什么和如何使用证书的经验数据，包括利益攸关方对证书提供的保护的理解，以及这如何影响他们对研究风险的评估。机构利益攸关方，包括IRB主席和机构法律顾问，鉴于他们在制定和执行建议或要求获得证书的政策和做法方面发挥的核心作用，他们的看法尤其重要。这项研究的目的是检查研究机构如何理解和使用证书来保护研究参与者，以及它们在风险评估中所发挥的作用。具体地说，目标是：评估IRBs对证书的使用和理解，以及证书在风险评估中的作用，探索机构法律顾问对证书提供的保护及其机构对可识别研究数据的法律要求的经验，分析证书和类似保密保护的法律基础。我们将组成一个多学科咨询小组，在我们的研究生命周期内提供专家指导。在研究结束时，我们将与事务委员会举行面对面会议，以检讨我们的研究结果；找出可加强证书所提供的保障、加深持份者对证书的理解及促进证书的适当使用的政策优先次序；以及阐明所需的额外研究，以优化证书在保障研究参与者方面的角色。 公共卫生相关性：保密证书是履行研究人员和机构保护研究参与者隐私及其数据保密性的道德和法律义务的重要工具。然而，关于证书所提供的保护的力度，缺乏明显的证据来得出结论。我们的研究结果将提供有关何时、为什么和如何使用证书的经验数据，包括机构利益相关者对证书提供的保护的理解，以及这如何影响他们对研究风险的评估。这些数据将有助于确定当前的政策优先事项，以加强所有利益攸关方对证书的了解，并促进证书的适当使用。它们还将为未来的研究提供基础，以帮助制定更长期的政策，优化证书在保护研究参与者方面的作用。

DESCRIPTION (provided by applicant): Researchers and institutions are ethically and legally obligated to safeguard research participants' privacy and the confidentiality of their data. Indeed, the success of the research enterprise depends on the public's confidence that private information will be vigorously protected. Certificates of Confidentiality, authorized by federal law, are an important tool for meeting this expectation. By shielding researchers and institutions from forced disclosure of identifying data in any legal proceeding, Certificates are intended to facilitate participation by reassuring prospective participants about the security of their information and thus allow research to proceed on sensitive topics critical to the public's health. In fact, Certificates are commonly believed to offer near absolute privacy protection. Their use has recently been promoted in the context of burgeoning 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 of the protection Certificates afford. A recent case that reached the North Carolina Court of Appeals suggests that the full legal effect of a Certificate is unclear. Empirical data are needed concerning when, why, and how Certificates are used, including stakeholders' understanding of the protection they provide and how that affects their assessment of research risk. The perceptions of Institutional stakeholders, including IRB chairs and institutional legal counsel, are particularly important given the central role they play in developing and implementing policies and practices for recommending or requiring that a Certificate be obtained. The purpose of this study is to examine how research institutions understand and use Certificates in protecting research participants and the role they play in assessments of risk. Specifically, the aims are to: Assess IRBs' use and understanding of Certificates and the role of Certificates in risk assessments Explore institutional legal counsel perceptions of the protections Certificates provide and their institution's experiences with legal demands for identifiable research data Analyze the legal foundations for Certificates and comparable confidentiality protections We will form a multidisciplinary Advisory Panel to provide expert guidance throughout the life of our study. At the conclusion of our research, we will hold an in-person meeting with the Panel to review our findings; identify policy priorities that could strengthen the protection Certificates afford, enhance stakeholders' understanding of Certificates, and promote the appropriate use of Certificates; and elucidate additional research needed to optimize the role of Certificates in protecting research participants. PUBLIC HEALTH RELEVANCE: Certificates of Confidentiality are an important tool for meeting researchers' and institutions' ethical and legal obligations to safeguard research participants' privacy and the confidentiality of their data. There is, however, a remarkable paucity of evidence upon which to base conclusions about the strength of the protection Certificates afford. The results of our study will provide empirical data concerning when, why, and how Certificates are used, including institutional stakeholders' understanding of the protection they provide and how that affects their assessment of research risk. These data will help identify immediate policy priorities that could enhance all stakeholders' understanding of Certificates and promote the appropriate use of Certificates. They will also provide a foundation for future research to aid longer term policy development that optimizes the role of Certificates in protecting research participants.