Trial reportBMJ open2020
Self-directed multimedia process for delivering participant informed consent.
Trial report in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.
What it found
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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
9 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023Pooled it
- Digital tools in the informed consent process: a systematic review.BMC medical ethics · 2021Pooled it
- Short-Form Video Informed Consent Compared With Written Consent for Adolescents and Young Adults: Randomized Experiment.JMIR formative research · 2024Trial
- eConsent vs traditional consent among prospective biobank participants: a randomized study within a study trial.npj digital public health · 2026Article
- eConsent vs. Traditional Consent Among Prospective Biobank Participants: A Randomized Trial.medRxiv : the preprint server for health sciences · 2025Article
- An asynchronous electronic consent for improving consent in research among patients with cancer.The oncologist · 2025Article
- Digital Informed Consent/Assent in Clinical Trials Among Pregnant Women, Minors, and Adults: Multicountry Cross-Sectional Evaluation of Comprehension and Satisfaction.JMIR human factors · 2025Article
- Keys to improving the informed consent process in research: Highlights of the i-CONSENT project.Health expectations : an international journal of public participation in health care and health policy · 2022Article
- Perspectives of Information Access in the Informed Consent Process for Clinical Research Participation in Australia.Ethics & human researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveObtaining informed consent is a cornerstone requirement of conducting ethical research. Traditional paper-based consent is often excessively lengthy and may fail to achieve the desired participant understanding of study requirements. Multimedia tools including video and audio may be a useful alternative. This study aimed to determine the efficacy, usability and acceptability of self-directed multimedia delivery of participant consent.
designIt is a single-centre, randomised, prospective study to determine the efficacy, usability and acceptability of a self-directed multimedia consent process (intervention) compared with the traditional paper-based approach (control). The intervention was free of research staff, with computer-based finger-signed consent.
settingPathology blood collection services in Tasmania, Australia.
participants298 participants (63±8 years; 51% female individuals) referred from general practice were randomised to intervention (n=146) and control (n=152). OUTCOME MEASURES: Efficacy, usability and acceptability of the allocated consent process were assessed by a questionnaire.
resultsAll participants successfully completed the allocated interventions. Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p<0.05 all). Intervention participants were more likely to engage with the study information and spend more time on the consent process (p=<0.001 and p=0.006, respectively). Both groups reported similar levels of acceptability, although more control participants reported that the study information was too long (24% vs 14%; p=0.020).
conclusionA self-directed multimedia consent process is effective for achieving participant understanding and obtaining consent free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs and achieve informed consent in clinical 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.