Factors Influencing Informed Consent Preferences in Digital Health Research: Survey Study of Prospective Participants

• Published in: Journal of medical Internet research 2025-01, Vol.27, p.e63349
• Main Authors: McInnis, Brian J, Pindus, Ramona, Kareem, Daniah, Vital, Daniela G, Hekler, Eric B, Nebeker, Camille
• Format: Article
• Language: English
• Subjects: Adult; Aged; Comprehension; Digital Health; Female; Humans; Informed Consent; Male; Middle Aged; Patient Preference; Prospective Studies; Surveys and Questionnaires
• ISSN: 1438-8871; 1438-8871
• DOI: 10.2196/63349

Readability is important to consider when developing informed consent communications for prospective research participants, but not the most important consideration. Other factors to consider relate to learning preferences and literacy needs of people recruited to participate in research, as these factors can influence understanding of consent communications. To promote understanding among prospective participants, researchers should take a human-centered approach to develop consent communications. This study aims to explore how factors related to readability, topic, and participant demographic characteristics play into preferences for digital health research consent material. These factors are important to consider as not attending to some details that matter to a specific subgroup of prospective participants may systematically exclude people from research. People eligible to participate in a digital health study were recruited to review 31 paragraph length sections of a consent form, referred to as "text snippets," for an existing institutional review board-approved digital health study. Participants (N=79) were surveyed and asked to choose between 2 variations of the text snippets, either indicating a preference for the institutional review board-approved original or a version that was modified to improve readability. A slim majority of participants provided feedback about the snippets (n=44; 55%). Our qualitative analysis of the feedback found that participants preferred shorter snippets, in general, but the snippets also elicited new questions not addressed by the original consent material. This observation is supported by our quantitative analysis, which found that when the character length of the original was longer, participants were less likely to prefer the original (P