Supporting high-quality enrollment decision-making in clinical research: development of a novel informed consent communication framework and curriculum

In clinical trials, the process of informed consent is intended to support prospective participants in making enrollment decisions that are well informed and aligned with their values and preferences. Despite the importance of relationship building during the consent process, there is little structured guidance for researchers on how to effectively facilitate informed consent conversations with prospective participants. This project aimed to develop and implement a relationship-based communication framework for clinical researchers, with the ultimate goal of supporting prospective participants in making values-aligned decisions.

The ENgaging with Values to Inform research enrollment deciSIONs (ENVISION) study was launched to improve the process of research enrollment decision-making within the context of a multisite cystic fibrosis clinical trial. The ENVISION team sought input from individuals with cystic fibrosis, researchers, institutional review board leaders, and clinical research leaders to understand key issues in consent communication in the context of cystic fibrosis trials. A working group of the ENVISION team incorporated these viewpoints into the development of a consent communication framework, which was guided by consideration of elements of the Ottawa Decision Support Framework and incorporated established communication strategies. The communication framework and an accompanying training curriculum were finalized through iterative review with the working group and the full team.

The development process resulted in a four-component, values-oriented communication framework, the RIVER framework: Relationship (forming a connection with the prospective participant), Information (sharing about the study), Values Exploration (eliciting and examining relevant values), and Resolution (confirming a values-aligned decision). Each component includes considerations to support prospective participants in making values-aligned decisions. RIVER is implemented through a training curriculum designed for research coordinators. The training curriculum consists of two 2-hour sessions that include didactic teaching, group discussion, and role-play scenarios, which provide an opportunity to practice real-world clinical research enrollment conversations.

The RIVER framework offers a structured approach to communication during clinical research consent conversations that is designed to enhance voluntary, informed decisions. Ongoing evaluation of the framework and training curriculum will inform opportunities for future revisions, adaptations, and broader dissemination.