Institutional review boards' use and understanding of certificates of confidentiality.

Abstract

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.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1371/journal.pone.0044050

Publication Info

Beskow, Laura M, Devon K Check, Emily E Namey, Lauren A Dame, Li Lin, Alexandra Cooper, Kevin P Weinfurt, Leslie E Wolf, et al. (2012). Institutional review boards' use and understanding of certificates of confidentiality. PloS one, 7(9). p. e44050. 10.1371/journal.pone.0044050 Retrieved from https://hdl.handle.net/10161/21077.

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Scholars@Duke

Check

Devon Karnes Check

Assistant Professor in Population Health Sciences

Devon Check, PhD is a health services and implementation researcher whose primary research interests include quality of care and the implementation of evidence-based and guideline-recommended practices in oncology. Her projects use large secondary data analysis as well as qualitative and mixed methods to investigate variation and inequities in cancer care, the experiences of patients and clinicians, and multi-level factors that impact cancer treatment and outcomes. She has a specific interest in supportive cancer care, and within that area, she has a growing portfolio of research projects focused on pain and symptom management in cancer. 

Dr. Check also has methodological expertise in implementation science. She has served as the implementation research methods expert on several behavioral intervention trials that use a hybrid effectiveness-implementation design. She also co-leads the Implementation Science Core Working Group as part of the Coordinating Center for the NIH Pragmatic Trials Collaboratory and the NIH HEAL Collaboratory. 

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 Permanente Northern California's Division of Research. 

Areas of Expertise: Implementation Science and Health Services Research

Cooper

Alexandra Cooper

Manager, Program Assessment

Alexandra Cooper serves as Associate Director for Evaluation and Assessment within the Purpose Project in the Kenan Institute for Ethics.  She supports the Project in making question of character, purpose and meaning signature features of the Duke community by gathering evidence about the Project's programs and their effects and by working with Project team members to examine and understand what that evidence shows us about what the Project does and can accomplish.

Prior to joining the Purpose Project she worked at Duke's Social Science Research Institute, first as its Administrative Director and subsequently as its Associate Director for Education and Training.  She has guided and directed a wide range of collaborative educational programming and services and devoted  effort to a wide range of research projects, supporting both quantitative and qualitative data collection, management, analysis, and reporting.  Prior to coming to Duke, she held faculty positions at Lafayette College and the University of North Carolina - Charlotte.  She holds a B.A. in Political and Social Thought and in French from the University of Virginia and a Ph.D. in Political Science from the University of North Carolina - Chapel Hill.


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