ArticleClinical and translational science2015
Reading Level and Length of Written Research Consent Forms.
Article in Clinical and translational science, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 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
25 citing papers in PubMed.
- Video-Assisted Informed Consent in a Clinical Trial of Resuscitation of Extremely Preterm Infants: Lessons Learned.American journal of perinatology · 2024Trial
- Optimised patient information materials and recruitment to a study of behavioural activation in older adults: an embedded study within a trial.F1000Research · 2020Trial
- Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting.Patient education and counseling · 2019Trial
- Permission form synopses to improve parents' understanding of research: a randomized trial.Journal of perinatology : official journal of the California Perinatal Association · 2017Trial
- Videos for informed consent enable task shifting while enhancing patient safety and satisfaction: a retrospective study.BMC anesthesiology · 2025Article
- Readability of health research informed consent forms: case of the National Health Research Ethics Committee in Tanzania.BMC medical ethics · 2025Article
- Transforming Informed Consent Generation Using Large Language Models: Mixed Methods Study.JMIR medical informatics · 2025Article
- Article
- Development of a New Tool for Writing Research Key Information in Plain Language.Health literacy research and practice · 2024Review
- A taxing problem: The impacts of research payment practices on participants and inclusive research.PloS one · 2024Article
- A comprehensive analysis of the readability of consent forms for blood transfusion in Spain.Blood transfusion = Trasfusione del sangue · 2023Article
- Factors Influencing Successful Recruitment of Racial and Ethnic Minority Patients for an Observational HIV Cohort Study in Washington, DC.Journal of racial and ethnic health disparities · 2022Observational
- Multicomponent Informed Consent with Marshallese Participants.Journal of empirical research on human research ethics : JERHRE · 2021Article
- Any progress in informed consenting for cancer treatment? Results from a cross sectional analysis at a comprehensive cancer center.Journal of cancer research and clinical oncology · 2021Article
- Too Dense and Too Detailed: Evaluation of the Health Literacy Attributes of an Informed Consent Document.Journal of racial and ethnic health disparities · 2020Article
- Developing informed consent materials for non-English-speaking participants: An analysis of four professional firm translations from English to Spanish.Clinical trials (London, England) · 2018Article
- An Observational Study of the Association of Video- Versus Text-Based Informed Consent With Multicenter Trial Enrollment: Lessons From the PALM Study (Patient and Provider Assessment of Lipid Management).Circulation. Cardiovascular quality and outcomes · 2018Observational
- An Assessment of a Shortened Consent Form for the Storage and Research Use of Residual Newborn Screening Blood Spots.Journal of empirical research on human research ethics : JERHRE · 2017Article
- Standard Versus Simplified Consent Materials for Biobank Participation: Differences in Patient Knowledge and Trial Accrual.Journal of empirical research on human research ethics : JERHRE · 2017Article
- Improving readability of informed consents for research at an academic medical institution.Journal of clinical and translational science · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In 100 Institutional Review Board approved consent forms (CFs), we assessed pages, reading levels, and whether they included essential elements. CF page numbers ranged from 3 to 28 (mean, 10.3) and readability ranged from grades 5.6 to 28.9 (mean, 11.6). The CF mean score for including essential elements was 90.8% (range: 63.5-100%). There were no significant differences by specialty in number of pages (p = 0.053), but surgical specialties had the highest readability (mean, 13.1), and pediatrics the lowest (10.5), p = 0.008. While approved CFs generally included the Office for Human Research Protections recommended essential elements, they were very long, and even pediatric forms, which had the lowest reading levels, were written on average at a tenth grade level. Researchers need guidance to resolve pressure between regulatory mandates and guidelines and "keeping it simple and clear."
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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.