Digital Informed Consent/Assent in Clinical Trials Among Pregnant Women, Minors, and Adults: Multicountry Cross-Sectional Evaluation of Comprehension and Satisfaction
Abstract BackgroundInformed consent (IC) is a cornerstone of ethical clinical research, yet comprehension gaps persist. The i-CONSENT guidelines aim to improve IC materials by enhancing clarity, accessibility, and tailoring them to the needs of diverse populations. This study...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2025-08-01
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| Series: | JMIR Human Factors |
| Online Access: | https://humanfactors.jmir.org/2025/1/e65569 |
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| Summary: | Abstract
BackgroundInformed consent (IC) is a cornerstone of ethical clinical research, yet comprehension gaps persist. The i-CONSENT guidelines aim to improve IC materials by enhancing clarity, accessibility, and tailoring them to the needs of diverse populations. This study evaluates the effectiveness of electronic IC (eIC) materials developed under these guidelines for 3 target populations—minors, pregnant women, and adults—across Spain, the United Kingdom, and Romania.
ObjectiveThe primary aim of this study is to assess participants’ comprehension of and satisfaction with eIC materials tailored to their specific needs. The secondary objectives are to identify demographic predictors of comprehension, evaluate the cross-cultural applicability of materials, and explore format preferences.
MethodsA cross-sectional study was conducted with 1757 participants (620 minors, 312 pregnant women, and 825 adults), who reviewed eIC materials through a digital platform offering layered web content, narrative videos, printable documents, and infographics. Materials were co-designed using participatory methods, including design thinking sessions with minors and pregnant women, and online surveys with adults. Comprehension was assessed using an adapted version of the Quality of the Informed Consent questionnaire. Objective comprehension (part A) was categorized as low (<70%), moderate (70%‐80%), adequate (80%‐90%), or high (≥90%). Subjective comprehension (part B) was measured using a 5-point Likert scale. Satisfaction was evaluated through Likert scales and usability questions, with scores ≥80% considered acceptable. Multivariable regression models were applied to identify predictors of comprehension.
ResultsObjective comprehension exceeded 80% across all groups: minors (mean 83.3, SD 13.5), pregnant women (mean 82.2, SD 11.0), and adults (mean 84.8, SD 10.8). Women/girls outperformed men/boys (β=+.16 to +.36). Generation X adults scored higher than millennials (β=+.26, PPPPPP
ConclusionseIC materials developed following the i-CONSENT guidelines achieved high levels of comprehension and satisfaction across diverse populations, demonstrating scalability for multinational trials. Cocreation and multimodal design effectively addressed participant preferences; however, cultural adaptation remained crucial for optimizing outcomes. The negative impact of prior trial participation highlights the need for tailored engagement strategies for returning participants. Future research should explore regional disparities, evaluate interventions for overconfident returning participants, and validate these tools across broader cultural contexts. |
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| ISSN: | 2292-9495 |