ArticleJournal of clinical and translational science2017
Assessing usefulness and researcher satisfaction with consent form templates.
Article in Journal of clinical and translational science, 2017. 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.
- Facilitating Informed Permission/Assent/Consent in Pediatric Clinical Trials.Paediatric drugs · 2019Article
- Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials.Journal of empirical research on human research ethics : JERHREArticle
- Mandating Evidence-Based Informed Consent Practices: A Critical Engagement with IRB Leader Focus Group Findings.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
5 authors.
Funding
Abstract
introductionWe aimed to improve the research consenting process by developing and evaluating simplified consent forms.
methodsFour templates written at the eighth-tenth grade reading level were developed and trialed by a group of experts in clinical research, health literacy, national regulatory requirements, and end users. Researchers from protocols which had received expedited review were surveyed at 2 time points regarding their use and assessment of the templates.
resultsAt baseline 18/86 (20.9%) responding researchers had heard of the templates and 5 (5.8%) reported that they had used them; 2 years later, 54.2% (32/59) had heard of the templates and 87.5% (28/32) had used them (
conclusionsConsent form templates may be one mechanism to improve patient comprehension of research protocols as well as efficiency of the review process, but require considerable time for development and implementation, and one key to their success is involvement and support from the IRB and technical staff.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.