title: 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.
authors.affiliation: Institute for Genome Sciences and Policy, Duke University, Durham, North Carolina, United States of America.
authors.forename: Laura M
authors.initials: LM
authors.lastname: Beskow
authors.forename: Devon K
authors.initials: DK
authors.lastname: Check
authors.forename: Emily E
authors.initials: EE
authors.lastname: Namey
authors.forename: Lauren A
authors.initials: LA
authors.lastname: Dame
authors.forename: Li
authors.initials: L
authors.lastname: Lin
authors.forename: Alexandra
authors.initials: A
authors.lastname: Cooper
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Weinfurt
authors.forename: Leslie E
authors.initials: LE
authors.lastname: Wolf
mesh_terms: D003219:Confidentiality / Q000941:ethics* / Q000523:psychology; D003625:Data Collection; D030881:Disclosure; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018907:Privacy; D012106:Research; D012108:Research Personnel / Q000941:ethics* / Q000523:psychology; D014481:United States