ArticleBMC medical ethics2025
Bridging ethical gaps in digital health research: a framework for informed consent aligned with NIH guidance.
Article in BMC medical ethics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Governing Ethical Tensions in Youth Digital Mental Health Research.JMIR mental health · 2026Article
- Redefining cardiometabolic biomarkers in the big data era: toward a personalized medicine-centered reconstruction of risk prediction models.Frontiers in cardiovascular medicine · 2026Article
- Connecting biospecimens and data: a scoping review-informed conceptual framework for digital infrastructure in biobanking and genomic research in low- and middle-income countries.Frontiers in public health · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundDigital health technologies, including mobile applications, wearable devices, and sensors, are rapidly transforming clinical research. However, current informed consent practices often fall short of addressing the unique ethical risks introduced by these technologies. This study aims to develop and assess a comprehensive ethical consent framework to improve transparency, equity, and participant protection in digital health research.
methodsWe developed a consent framework aligned with national research ethics guidance, including 63 attributes and 93 subattributes across four domains: Consent, Grantee (Researcher) Permissions, Grantee (Researcher) Obligations, and Technology. We conducted thematic analysis under guidance and then reviewed 25 informed consent forms from real-world digital health studies to expand the guidance and assess each form's alignment with the framework. We used descriptive statistics to measure attribute completeness and to identify missing ethical elements.
resultsNone of the consent forms fully adhered to all the required or recommended ethical elements, especially those related to technology-specific risks. The highest completeness for the required attributes reached only 73.5%. We also identified four ethically salient consent elements not present in the current national guidance: commercial profit sharing, study information disclosure, during-study result sharing, and data removal requests.
conclusionsThese findings reveal persistent ethical gaps in participant protection and highlight the need for more comprehensive, equity-oriented consent practices. Our framework offers a practical tool to strengthen transparency, autonomy, and justice in digital health research.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.