Institutional review boards' use and understanding of certificates of confidentiality.
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Certificates of Confidentiality, issued by agencies of the U.S. government, are regarded as an important tool for meeting ethical and legal obligations to safeguard research participants' privacy and confidentiality. By shielding against forced disclosure of identifying data, Certificates are intended to facilitate research on sensitive topics critical to the public's health. Although Certificates are potentially applicable to an extensive array of research, their full legal effect is unclear, and little is known about stakeholders' views of the protections they provide. To begin addressing this challenge, we conducted a national survey of institutional review board (IRB) chairs, followed by telephone interviews with selected chairs, to learn more about their familiarity with and opinions about Certificates; their institutions' use of Certificates; policies and practices concerning when Certificates are required or recommended; and the role Certificates play in assessments of research risk. Overall, our results suggest uncertainty about Certificates among IRB chairs. On most objective knowledge questions, most respondents chose the incorrect answer or 'unsure'. Among chairs who reported more familiarity with Certificates, composite opinion scores calculated based on five survey questions were evenly distributed among positive, neutral/middle, and negative views. Further, respondents expressed a variety of ideas about the appropriate use of Certificates, what they are intended to protect, and their effect on research risk. Nevertheless, chairs who participated in our study commonly viewed Certificates as a potentially valuable tool, frequently describing them as an 'extra layer' of protection. These findings lead to several practical observations concerning the need for more stakeholder education about Certificates, consideration of Certificates for a broader range of studies, the importance of remaining vigilant and using all tools available to protect participants' confidentiality, and the need for further empirical investigation of Certificates' effect on researchers and research participants.
Ethics Committees, Research
Published Version (Please cite this version)10.1371/journal.pone.0044050
Publication InfoBeskow, Laura M; Check, Devon K; Namey, Emily E; Dame, Lauren A; Lin, Li; Cooper, Alexandra; ... Wolf, Leslie E (2012). Institutional review boards' use and understanding of certificates of confidentiality. PloS one, 7(9). pp. e44050. 10.1371/journal.pone.0044050. Retrieved from https://hdl.handle.net/10161/21077.
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Professor in Medicine
Assistant Professor in Population Health Sciences
Devon Check, PhD is a health services researcher focused on understanding and overcoming barriers to the delivery of equitable, high-quality care for patients with cancer and other potentially life-limiting conditions.Dr. Check received her PhD in Health Policy and Management from the Gillings School of Global Public Health at UNC-Chapel Hill. Prior to joining the Department of Population Health Sciences at Duke, she completed a postdoctoral fellowship in Delivery Science at Kaiser P
Manager, Program Assessment
Alexandra Cooper serves as Associate Director for Education and Training at Duke's Social Science Research Institute and as Associate Director for the Duke Initiative on Survey Methodology. She is committed to serving Duke scholars across all levels – from undergraduates through senior faculty – by ensuring they have access to the training and support they need to learn and apply the tools and methods of the social sciences. She guides and directs a wide range of col
Professor in Population Health Sciences
Kevin P. Weinfurt, PhD, is Professor and Vice Chair of Research in the Department of Population Health Sciences at Duke University Medical Center and a faculty member of the Duke Clinical Research Institute. He holds secondary appointment as a Professor of Psychology and Neuroscience, Professor of Psychiatry and Behavioral Sciences, Professor of Biostatistics and Bioinformatics, and a Faculty Associate of the Trent Center for the Study of Medical Humanities and Bioethics. Dr. Weinf
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