NIH Public Access Author Manuscript IRB. Author manuscript; available in PMC 2014 July 01.
NIH-PA Author Manuscript
Published in final edited form as: IRB. 2014 ; 36(1): 1–8.
Certificates of confidentiality and informed consent: perspectives of IRB chairs and institutional legal counsel Devon K. Check1, Leslie E. Wolf2, Lauren A. Dame3, and Laura M. Beskow3 1Duke
Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA
2Center
for Law, Health & Society, Georgia State University College of Law, Atlanta, GA, USA
3Institute
for Genome Sciences and Policy, Duke University, Durham, NC USA
Introduction NIH-PA Author Manuscript
Certificates of Confidentiality are an important tool for safeguarding research participants' privacy and the confidentiality of their data. According to federal law,1 researchers who obtain a Certificate cannot be forced to disclose the names or other identifying characteristics of research participants in any legal proceeding. By shielding researchers and institutions from compelled disclosure, Certificates are intended to facilitate research on sensitive topics by reassuring participants about the security of their information.
NIH-PA Author Manuscript
When a Certificate has been obtained for a study, prospective participants must be informed about it. On its Web-based “kiosk”2 the National Institutes of Health (NIH) provides sample language (Box 1) for use in consent forms to describe Certificates' protections and the limitations of those protections. However, little is known about professionals' use of and opinions about this language, nor institutional guidance about how Certificates should be described to participants as part of the consent process. These data are important because NIH's sample language is complex and potentially difficult to understand.3-5 In addition, despite the strong assertion in NIH's language that, “With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena”, 6 there is uncertainty about whether Certificates can provide such absolute protection in all circumstances.7-11 These factors threaten the validity of informed consent, but the opinions of institutional leaders involved in development of appropriate consent language, as well as information about institutional guidance concerning Certificates, help inform potential solutions. As part of a larger study assessing use and understanding of Certificates of Confidentiality, we conducted interviews with Institutional Review Board (IRB) chairs7 and institutional legal counsel.8 Here we focus on themes that emerged from those interviews about Certificates' effects on consent forms and processes. We also conducted a search of research institutions' websites to determine what kind of guidance they provide about how to describe Certificates as part of the consent process.
Corresponding author: Dr. Laura M. Beskow, Duke Institute for Genome Sciences & Policy, 240 North Building, Duke University, Campus Box 90141, Durham, NC 27708 USA; Tel: 919-668-2293; FAX: 919-668-0799; [email protected].
Check et al.
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Methods NIH-PA Author Manuscript
We gathered data from IRB chairs and institutional legal counsel, as well as from a web search of institutional policies. Below is a brief summary of the methods used for each source; more details are available in the Appendix. IRB Chairs
NIH-PA Author Manuscript
We conducted an online survey of IRB chairs to examine their use and understanding of Certificates.7 To explore survey responses in more depth, we conducted follow-up interviews with selected chairs whose responses indicated a particularly positive or negative view of Certificates, or whose institutions had experienced a legal demand for research data. We computed composite opinion scores based on five survey questions about the extent to which Certificates achieve their intended purposes, with scores ranging from 5 to 25. Lower scores indicated a less favorable view of Certificates and higher scores a more favorable view. For the analysis presented here, we focus on the interview responses related to informed consent. We used qualitative analysis software to generate from the interview transcripts a report containing (1) any text from the section of the interview on informed consent, and (2) any text that included the word ‘consent.’ One author (D.K.C.) identified themes that emerged within the report, and organized these themes into a codebook. Another author (L.M.B.) independently analyzed the report, applying codes per the codebook. These two authors then reconciled any discrepancies. Institutional Legal Counsel We also conducted interviews about Certificates with institutional legal counsel.8 Although we did not ask specific questions about Certificates' effects on informed consent, counsel spontaneously commented on these issues. In this secondary analysis, we used qualitative analysis software to generate a report containing any text from the transcripts that referred to consent forms and processes. Two authors (L.E.W. and D.K.C.) independently analyzed the report based on the themes identified from the IRB chair transcripts. Search of Institutional Websites
NIH-PA Author Manuscript
One author (L.A.D.) led a search of the websites of the 39 U.S. institutions that have both an American Association of Medical Colleges-accredited medical school12 and an Association of Schools of Public Health-accredited school of public health13 to locate their policies on Certificates. Initially, we searched for the term “Certificate of Confidentiality” using the search function on each school's home page. If that failed to produce results, we looked for links to research-related information, and then reviewed those pages for relevant categories. We collected and analyzed the portions of the websites that discussed Certificates, including suggested or required consent language.
Results Characteristics of Information Sources Our sample of IRB chair interviewees (n=21) consisted of 7 with a high (18+; “favorable” view of Certificates) composite opinion score (4 of whom had experience with legal
IRB. Author manuscript; available in PMC 2014 July 01.
Check et al.
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NIH-PA Author Manuscript
demands), 4 with a middle (15-17) score (2 of whom had experience with legal demands), and 10 with a low (
NIH-PA Author Manuscript
Published in final edited form as: IRB. 2014 ; 36(1): 1–8.
Certificates of confidentiality and informed consent: perspectives of IRB chairs and institutional legal counsel Devon K. Check1, Leslie E. Wolf2, Lauren A. Dame3, and Laura M. Beskow3 1Duke
Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA
2Center
for Law, Health & Society, Georgia State University College of Law, Atlanta, GA, USA
3Institute
for Genome Sciences and Policy, Duke University, Durham, NC USA
Introduction NIH-PA Author Manuscript
Certificates of Confidentiality are an important tool for safeguarding research participants' privacy and the confidentiality of their data. According to federal law,1 researchers who obtain a Certificate cannot be forced to disclose the names or other identifying characteristics of research participants in any legal proceeding. By shielding researchers and institutions from compelled disclosure, Certificates are intended to facilitate research on sensitive topics by reassuring participants about the security of their information.
NIH-PA Author Manuscript
When a Certificate has been obtained for a study, prospective participants must be informed about it. On its Web-based “kiosk”2 the National Institutes of Health (NIH) provides sample language (Box 1) for use in consent forms to describe Certificates' protections and the limitations of those protections. However, little is known about professionals' use of and opinions about this language, nor institutional guidance about how Certificates should be described to participants as part of the consent process. These data are important because NIH's sample language is complex and potentially difficult to understand.3-5 In addition, despite the strong assertion in NIH's language that, “With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena”, 6 there is uncertainty about whether Certificates can provide such absolute protection in all circumstances.7-11 These factors threaten the validity of informed consent, but the opinions of institutional leaders involved in development of appropriate consent language, as well as information about institutional guidance concerning Certificates, help inform potential solutions. As part of a larger study assessing use and understanding of Certificates of Confidentiality, we conducted interviews with Institutional Review Board (IRB) chairs7 and institutional legal counsel.8 Here we focus on themes that emerged from those interviews about Certificates' effects on consent forms and processes. We also conducted a search of research institutions' websites to determine what kind of guidance they provide about how to describe Certificates as part of the consent process.
Corresponding author: Dr. Laura M. Beskow, Duke Institute for Genome Sciences & Policy, 240 North Building, Duke University, Campus Box 90141, Durham, NC 27708 USA; Tel: 919-668-2293; FAX: 919-668-0799; [email protected].
Check et al.
Page 2
Methods NIH-PA Author Manuscript
We gathered data from IRB chairs and institutional legal counsel, as well as from a web search of institutional policies. Below is a brief summary of the methods used for each source; more details are available in the Appendix. IRB Chairs
NIH-PA Author Manuscript
We conducted an online survey of IRB chairs to examine their use and understanding of Certificates.7 To explore survey responses in more depth, we conducted follow-up interviews with selected chairs whose responses indicated a particularly positive or negative view of Certificates, or whose institutions had experienced a legal demand for research data. We computed composite opinion scores based on five survey questions about the extent to which Certificates achieve their intended purposes, with scores ranging from 5 to 25. Lower scores indicated a less favorable view of Certificates and higher scores a more favorable view. For the analysis presented here, we focus on the interview responses related to informed consent. We used qualitative analysis software to generate from the interview transcripts a report containing (1) any text from the section of the interview on informed consent, and (2) any text that included the word ‘consent.’ One author (D.K.C.) identified themes that emerged within the report, and organized these themes into a codebook. Another author (L.M.B.) independently analyzed the report, applying codes per the codebook. These two authors then reconciled any discrepancies. Institutional Legal Counsel We also conducted interviews about Certificates with institutional legal counsel.8 Although we did not ask specific questions about Certificates' effects on informed consent, counsel spontaneously commented on these issues. In this secondary analysis, we used qualitative analysis software to generate a report containing any text from the transcripts that referred to consent forms and processes. Two authors (L.E.W. and D.K.C.) independently analyzed the report based on the themes identified from the IRB chair transcripts. Search of Institutional Websites
NIH-PA Author Manuscript
One author (L.A.D.) led a search of the websites of the 39 U.S. institutions that have both an American Association of Medical Colleges-accredited medical school12 and an Association of Schools of Public Health-accredited school of public health13 to locate their policies on Certificates. Initially, we searched for the term “Certificate of Confidentiality” using the search function on each school's home page. If that failed to produce results, we looked for links to research-related information, and then reviewed those pages for relevant categories. We collected and analyzed the portions of the websites that discussed Certificates, including suggested or required consent language.
Results Characteristics of Information Sources Our sample of IRB chair interviewees (n=21) consisted of 7 with a high (18+; “favorable” view of Certificates) composite opinion score (4 of whom had experience with legal
IRB. Author manuscript; available in PMC 2014 July 01.
Check et al.
Page 3
NIH-PA Author Manuscript
demands), 4 with a middle (15-17) score (2 of whom had experience with legal demands), and 10 with a low (
