Project Overview
The 2018 Common Rule revision intended to improve informed consent by recommending a concise key information (KI) section, yet it provided little guidance about how to describe KI. We developed innovative, visual KI templates with attention to health literacy and visual design principles. We explored end users’ attitudes, beliefs, and institutional policies that could affect implementing visual KI pages. Participants discussed potential benefits including improving information processing and understanding of study procedures, diversity in research, trust in research, and study workflow. They also described potential challenges to consider before widespread implementation: IRBs’ interpretations of federal guidelines, possible impact on the IRB submission processes, the effort/skill required to develop visuals, and difficulty succinctly communicating study risks. There was no consensus about when to use visual KI during consent, and some wondered if they were feasible for all study types. Visual KI offers a promising solution to long-standing informed consent challenges. Future work can explore resources and training to address challenges and promote widespread use.
Data and Data Collection Overview
From October 2023-April 2024, we conducted semi-structured interviews with principal investigators, research staff, institutional review board (IRB) personnel, including those in oversight/management, and community partners. 40 participants from three U.S. academic institutions (in the Midwest, Southeast, and Mountain West) viewed example KI pages and completed interviews. The visuals interviewees were responding to are published in the accompanying article. We coded written transcripts inductively and deductively based on the capability, opportunity, and motivation to change behavior (COM-B) framework. Data were analyzed using content analysis and organized thematically.
Selection and Organization of Shared Data
The data files shared here encompass the 40 de-identified interview transcripts with principal investigators, research staff, institutional review board (IRB) personnel, including those in oversight/management, and community partners.
The documentation files shared consist of the informed consent used in the study, a basic demographic questionnaire and the interview guide used with all participants, as well as this Data Narrative and an administrative README file. |
