SynthesisJournal of medical Internet research2020
Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review.
Synthesis in Journal of medical Internet research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 3 of them syntheses that pooled it.
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
49 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Improving Participant Recruitment in Clinical Trials: Comparative Analysis of Innovative Digital Platforms.Journal of medical Internet research · 2024Pooled it
- Opt-In and Opt-Out Consent Procedures for the Reuse of Routinely Recorded Health Data in Scientific Research and Their Consequences for Consent Rate and Consent Bias: Systematic Review.Journal of medical Internet research · 2023Pooled it
- Pooled it
- Comparing in-person and remote consent of people with dementia into a primary care-based cluster randomised controlled trial: lessons from the Dementia PersonAlised Care Team (D-PACT) feasibility study.BMC medical research methodology · 2025Trial
- Trial
- Multimodal Wearable Biosensing Meets Multidomain AI: A Pathway to Decentralized Healthcare.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Quality of Informed Consent and Interface Usability in Primary Care e-Consultation: Cross-Sectional Study.JMIR human factors · 2026Article
- Kauro, a graph-based chatbot for high-fidelity information transmission conversations.medRxiv : the preprint server for health sciences · 2026Article
- Article
- eConsent vs traditional consent among prospective biobank participants: a randomized study within a study trial.npj digital public health · 2026Article
- When genomics companies act as biobanks: governance challenges in an era of genomic assetization.Frontiers in genetics · 2026Article
- eConsent vs. Traditional Consent Among Prospective Biobank Participants: A Randomized Trial.medRxiv : the preprint server for health sciences · 2025Article
- Article
- Monitoring oral health remotely: ethical considerations when using AI among vulnerable populations.Frontiers in oral health · 2025Article
- Insights From the Development of a Dynamic Consent Platform for the Australians Together Health Initiative (ATHENA) Program: Interview and Survey Study.JMIR formative research · 2024Article
- Opportunities and challenges of a dynamic consent-based application: personalized options for personal health data sharing and utilization.BMC medical ethics · 2024Article
- Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study.Journal of medical Internet research · 2024Observational
- Digital consent in gynecology: an evaluation of patient experience.Archives of gynecology and obstetrics · 2024Article
- Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study.Pilot and feasibility studies · 2024Article
- Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants.Frontiers in medicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers.
objectiveWe aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research.
methodsWe conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials.
resultsA total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies' populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants.
conclusionsElectronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent.
trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979.
Indexed as
Identifiers
What Socratic holds
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 Socratic graph.