Supporting high-quality enrollment decision-making in clinical research: development of a novel informed consent communication framework and curriculum.
12 affiliations
- 1Department of Bioethics and Decision Sciences, Geisinger College of Health Sciences, 100 N. Academy Ave, Danville, PA, 17822, USA. [email protected].
- 2Treuman Katz Center for Pediatric Bioethics and Palliative Care, Seattle Children's Research Institute, Seattle, WA, USA.
- 3Department of Bioethics and Decision Sciences, Geisinger College of Health Sciences, 100 N. Academy Ave, Danville, PA, 17822, USA.
- 4Community member, Carrollton, TX, USA.
- 5Department of Bioethics, Clinical Center National Institutes of Health, Bethesda, MD, USA.
- 6Advarra IRB, Columbia, MD, USA.
- 7Cystic Fibrosis Foundation, Bethesda, MD, USA.
- 8Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
- 9Department of Family Medicine and Public Health Sciences, Wayne State University, Detroit, MI, USA.
- 10Division of Translational Medicine and Human Genetics, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
- 11Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA, USA.
- 12Department of Pediatrics, University of Washington, Seattle, WA, USA.
Abstract
Background
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.Methods
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.Results
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.Conclusion
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.
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BibTeX
@article{kraft2026supporting,
title = {{Supporting high-quality enrollment decision-making in clinical research: development of a novel informed consent communication framework and curriculum.}},
author = {Stephanie A Kraft and Kathryn M Porter and Abigail Brickler and Sylvia Mazuera and Holly A Taylor and Luke Gelinas and Devan M Duenas and Jennifer C Tsing and Cynthia George and Tamar Krishnamurti and Aisha T Langford and Rebecca Mueller and Kathleen J Ramos and Holly H Võ and Elliott M Weiss and Benjamin S Wilfond and ENVISION Study Team},
journal = {BMC medical research methodology},
year = {2026},
month = jul,
doi = {10.1186/s12874-026-02885-2},
url = {https://europepmc.org/article/MED/42958486},
note = {CC BY},
}
RIS
TY - JOUR
TI - Supporting high-quality enrollment decision-making in clinical research: development of a novel informed consent communication framework and curriculum.
AU - Stephanie A Kraft
AU - Kathryn M Porter
AU - Abigail Brickler
AU - Sylvia Mazuera
AU - Holly A Taylor
AU - Luke Gelinas
AU - Devan M Duenas
AU - Jennifer C Tsing
AU - Cynthia George
AU - Tamar Krishnamurti
AU - Aisha T Langford
AU - Rebecca Mueller
AU - Kathleen J Ramos
AU - Holly H Võ
AU - Elliott M Weiss
AU - Benjamin S Wilfond
AU - ENVISION Study Team
PY - 2026
DA - 2026/07/25
JO - BMC medical research methodology
DO - 10.1186/s12874-026-02885-2
UR - https://europepmc.org/article/MED/42958486
AB - Background 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.Methods 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.Results 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.Conclusion 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.
SN - 1471-2288
ER -