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.

Research Participants’ Understanding of and Reactions to Certificates of Confidentiality

“…In crafting our simplified language, we attempted to remain faithful to the substance of NIH’s version, which states: “With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena.” Despite this strong assertion, it is unclear whether Certificates can provide such absolute protection in all circumstances (Beskow et al 2012; Beskow, Dame, and Costello 2008, 2009; Wolf et al 2012). Thus, developing consent descriptions of Certificates that are both simple and accurate is critically important.…”

“…The research enterprise depends on public confidence that participants’ confidentiality will be vigorously protected (Beskow et al 2012). Authorized by federal law (Public Health Service Act §301(d), 42USC §241(d)), Certificates of Confidentiality are an important tool for meeting this ethical and legal obligation.…”

Behavioral Genetics in Criminal and Civil Courts

“…146 As a result, the certificate mechanism has been significantly under-utilized by biobanks (a 2003 study found that only 1 of 12 major biobanks in the U.S. had obtained a certificate, and only about quarter of IRBs would require or recommend it). 146,149 We have yet to see whether the NIH will endorse—and implement—the recommendation of the planners of the All of Us Research Program that all users of identifiable data be required to secure a certificate. 143 In the meantime, concern remains for all biobanks and genetic research settings, and significantly, for clinical testing laboratories, a domain not covered by a certificate.…”

The Moral and Legal Need to Disclose Despite a Certificate of Confidentiality

“…Study investigators, research subjects, IRBs, and legal counsel differ in their knowledge level and familiarity with COCs (Coffey and Ross 2004; Catania et al 2007; Beskow 2012; Wolf et al 2012). In part, differences arise because only one court has spoken directly to the issue of the Certificate’s validity, upholding the COC, and promoting a widespread belief of absolute protection of confidentiality under COCs (Beskow, Dame, and Costello 2008).…”