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.

Keywords: Comprehension; Confidentiality; Consent forms; Informed consent; Research subjects; Risk.

Figure 1

Do consent from descriptions of Certificates influence hypothetical willingness to participate in research? ^{^}