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和数据的机密性。事实上，研究事业的成功取决于公众对私人信息将得到有力保护的信心。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于在任何法律诉讼中被迫披露身份数据，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，从而允许对公众健康至关重要的敏感主题进行研究。事实上，证书通常被认为提供了近乎绝对的隐私保护。在建立大规模研究平台的迅速努力和对空前程度的数据共享的新要求的背景下，它们的使用最近得到了促进。但是，关于证书所提供的保护力度的结论所依据的证据明显缺乏。北卡罗来纳州上诉法院最近审理的一个案件表明，证书的全部法律效力尚不明确。需要关于何时、为何以及如何使用证书的经验数据，包括利益相关者对证书所提供的保护的理解，以及这如何影响他们对研究风险的评估。机构利益相关者（包括内部审查委员会主席和机构法律顾问）的看法尤其重要，因为他们在制定和实施建议或要求获得证书的政策和做法方面发挥着核心作用。本研究的目的是考察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起的作用。具体而言，目标是：评估内部审查委员会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的看法以及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建一个多学科咨询小组，在研究的整个生命周期中提供专家指导。在研究结束后，我们会与事务委员会举行面对面会议，检讨研究结果；确定可以加强证书保护的政策重点，提高利益相关者对证书的理解，并促进证书的适当使用；并阐明需要进一步的研究，以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.