ArticleFrontiers in digital health2025
The benefits of fully electronic consent management and consent collection via a tablet PC in supporting time-critical pandemic research-an example from a NAPKON COVID-19 project.
Article in Frontiers in digital health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Implementing informed consent in federated medical research: a blueprint designed to safeguard data subject rights in Germany.Journal of translational medicine · 2026Article
- Design, implementation and analysis of a quality assurance process for Informed Consents using the DZHK registry TORCH-DZHK1 as an example.PLOS digital health · 2026Article
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Authors and funding
9 authors.
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Abstract
Objective: A study participant's informed consent, based on study information and expressed using a consent form (CF), is the ethical and legal basis for research with humans. Timely automatic access to a participant's consent status in different systems is crucial for knowing which medical data, images, and biological samples can be collected for research. To support time-critical (pandemic) research, this article evaluates a fully electronic consent management system and a consent collection process using a tablet PC in comparison to traditional paper-and-pencil-based approaches and assesses their impact on patient recruitment. Materials and methods: The evaluation is based on a COVID-19 study [the Results: The initial CF validity increased significantly from 67.38% for paper-and-pencil-based CFs to 99.46% for tablet-based CFs. This quality increase also reduced the number of invalid CFs or CFs requiring corrections, which can lead to study exclusion and, consequently, lower recruitment rates and lost research data. The time lag between recruitment and the availability of data decreased significantly when using tablet-based CFs, supporting time-critical research while protecting participants' privacy. Overall, the participants' and study staff's feedback on tablet-based CF collection was positive and highlighted the benefits of tablet-based CF collection in reducing the documentational burden on study staff and enabling participants to adjust the CF's appearance, for example, by choosing a bigger font size. Discussion: Although tablet-based CF collection has measurable positive effects, especially on patient recruitment rates due to an increase in initially valid CFs, the majority of the National Pandemic Cohort Network (German: Conclusion: Fully electronic informed consent collection is the "best practice" approach to ensure valid CFs and increase initial patient inclusion rates in studies. Due to the additional benefits, including shorter time-to-research, electronic consent form collection should be integrated into pandemic response schemes and other time-critical research.
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