ArticleBMC medical ethics2023
Developing a digital informed consent app: opportunities and challenges of a new format to inform and obtain consent in public health research.
Article in BMC medical ethics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Unique ecology of co-occurring functionally and phylogenetically undescribed species in the infant oral microbiome.PLoS computational biology · 2026Article
- Development of a Framework for the Enrollment of Children and Families in Emergency Department Research.Journal of the American College of Emergency Physicians open · 2025Article
- Shifting from Traditional to Pragmatic Randomized Controlled Trials: Insights and Lessons Learned from the Toddler Oral Health Intervention.Pragmatic and observational research · 2025Article
- Risk, Revelation, and Reflection: A Personal Journey Through Ethics, Risk Literacy, and Informed Consent.Circulation. Cardiovascular quality and outcomes · 2024Article
- Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital.BMC health services research · 2024Article
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformed consent procedures for large population-based cohort studies should be comprehensive and easy-to-use. This is particularly challenging when participants from different socio-economic groups and multicultural ethnic backgrounds are involved. Recently, more and more studies have tried to use multimedia in informed consent procedures. We describe the development and testing of a digital informed consent app and elaborate on whether this may contribute to a comprehensive and practical procedure to obtain informed consent for public health research.
methodsIn a sample of parents with young children, we used a mixed method approach to study the user experience of an informed consent app and evaluate whether it can be used to adequately inform people and register their consent. Through semi-structured interviews we investigated participants' experiences with and opinions about the app, with a special focus on comprehensibility of the content and the usability of the app. Information retention questions were asked to evaluate to what extent participants could recall key aspects of the provided study information.
resultsThe 30 participants in this study used the app between 4 and 15 min to give their consent. Overall, they found the app well-designed, informative and easy to use. To learn more about the study for which informed consent is asked, most of the participants chose to watch the animated film, which was generally found to convey information in a clear manner. The identification process was met with mixed reactions, with some feeling it as a secure way to give consent, while for others it contradicted their view of using data anonymously. Information retention questions showed that while all participants remembered various aspects of the study, fewer than half answered all four questions satisfactorily.
conclusionOur study shows that a well-designed informed consent app can be an effective tool to inform eligible participants and to record consents. Still, some issues remain, including trust barriers towards the identification procedure and lack of information retention in some participants. When implementing consent procedures that incorporate digital formats, it may be beneficial to also invest in a complementary face-to-face recruitment approach.
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