Research Participants’ Understanding of and Reactions to Certificates of Confidentiality

Abstract

Background Certificates of Confidentiality are intended to facilitate participation in critical public health research by protecting against forced disclosure of identifying data in legal proceedings, but little is known about the effect of Certificate descriptions in consent forms. Methods To gain preliminary insights, we conducted qualitative interviews with 50 HIV-positive individuals in Durham, North Carolina to explore their subjective understanding of Certificate descriptions and whether their reactions differed based on receiving a standard versus simplified description. Results Most interviewees were neither reassured nor alarmed by Certificate information, and most said it would not influence their willingness to participate or provide truthful information. However, compared with those receiving the simplified description, more who read the standard description said it raised new concerns, that their likelihood of participating would be lower, and that they might be less forthcoming. Most interviewees said they found the Certificate description clear, but standard-group participants often found particular words and phrases confusing, while simplified-group participants more often questioned the information’s substance. Conclusions Valid informed consent requires comprehension and voluntariness. Our findings highlight the importance of developing consent descriptions of Certificates and other confidentiality protections that are simple and accurate. These qualitative results provide rich detail to inform a larger, quantitative study that would permit further rigorous comparisons.

Informed consent for biobanking: consensus-based guidelines for adequate comprehension

“…We conducted 3 online surveys to define “adequate comprehension” for biobanking consent. The surveys were structured around model consent language ( Appendix S1 ), adapted from established sources 19 – 21 and purposely containing ample detail to accommodate a range of opinions about comprehension.…”

Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice

“…While most interviewees were neither reassured nor alarmed by information about Certificates, a higher proportion who read the NIH INDEPENDENT standard description said that it raised new concerns compared to those who read our simplified version. 140 In addition, a higher proportion of those who read the NIH standard description reported sections of the description were unclear. NIH should develop revised consent language to convey the protections afforded by Certificates more clearly to research participants.…”