ArticleScientific reports2024
Simplifying informed consent as a universal precaution.
Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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
8 citing papers in PubMed.
- Understanding Informed Consent: A Cross-Sectional Study of Objective and Self-Perceived Comprehension in Romania.Healthcare (Basel, Switzerland) · 2026Article
- Evaluating large language models for simplifying non-English medical consent with clinician involvement.NPJ digital medicine · 2026Article
- Emergency consent pathways in acute ischemic stroke trials: determinants, consequences, and stakeholder attitudes-an evidence-mapping study.BMC medical ethics · 2026Article
- The ESMO/SIOG Cancer in the Elderly Working Group pragmatic strategies for clinical trial designs and endpoints in older adults with cancer.ESMO open · 2026Review
- Digital mental health needs a purpose-driven approach.Nature human behaviour · 2026Review
- Readability of informed consent forms from ClinicalTrials.gov in ketamine clinical trials for mental health conditions: a cross-sectional analysis.Therapeutic advances in psychopharmacology · 2026Article
- Impact of video -based incentive on patient willingness to read the informed consent form with comprehension before minimally-invasive surgery: a randomized controlled trial.Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques · 2025Article
- 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
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
One barrier to participating in clinical research is that patients with low literacy skills (1 in 5 US adults) may struggle to understand the informed consent document (ICD). Writing consents using health literacy and plain language guidelines including simplified syntax and semantics can increase understandability and facilitate inclusivity of research populations with literacy challenges. Our study aim was to evaluate a simplified ICD for understandability while considering factors known to relate to comprehension (reading skills and working memory). We performed an on-line survey of 192 adults ages 18-77 in Georgia. Participants performed significantly better on the simplified ICD test. We built an additional model with all version x measure interactions (i.e., age, sex, race, urbanicity, GMVT, WM). This model did not significantly improve model fit, F < 1.00, suggesting that individual differences did not moderate the effect of simplification. Our findings suggest that using plain language and simplified syntax and semantics in ICD as a universal precaution may reduce cognitive reading burden for adults regardless of differences in reading skill or working memory. Increasing understandability in ICD may help improve targets for clinical trial enrollment.
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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.