Framing a Consent Form to Improve Consent Understanding and Determine How This Affects Willingness to Participate in HIV Cure Research: An Experimental Survey Study

Framing a Consent Form to Improve Consent Understanding and Determine How This Affects Willingness to Participate in HIV Cure Research: An Experimental Survey Study
Research Article
John A. Sauceda, Karine Dubé, Brandon Brown, Ashley E. Pérez, Catherine E. Rivas, David Evans, Celia B. Fisher
Journal of Empirical Research on Human Research Ethics, 14 December 2020
Abstract
HIV cure research carries serious risks and negligible benefits. We investigated how participants understand these risks and what influences their willingness to participate. Through internet-based and in-person convenience sampling, 86 HIV+ participants completed an experimental survey. Participants were randomized to read a standard consent form describing a hypothetical HIV cure study or one adapted using Fuzzy Trace Theory—a decision-making model to facilitate complex information processing. We measured consent understanding and cognitive (e.g., safe/harmful) and affective (e.g., concerning, satisfying) evaluations of HIV cure research. Participants who read the adapted consent form had improved consent understanding, but only positive affective evaluations were associated with a willingness to participate. Consent processes can use decision-making theories to facilitate comprehension of study information.

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