ArticleJournal of clinical and translational science2017
Improving readability of informed consents for research at an academic medical institution.
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 21 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
21 citing papers in PubMed.
- Analysis of compliance and language use in broad informed consent forms in international multicenter clinical trials after the implementation of the 2018 common rule.BMC medical ethics · 2026Article
- Meaningful and Successful Ethical Enactments: A Proposal from Deliberative Wisdom Theory.Journal of bioethical inquiry · 2025Article
- Informed Consent in Shoulder and Elbow Surgery.Cureus · 2025Review
- Readability of health research informed consent forms: case of the National Health Research Ethics Committee in Tanzania.BMC medical ethics · 2025Article
- The use of large language models to enhance cancer clinical trial educational materials.JNCI cancer spectrum · 2025Article
- Transforming Informed Consent Generation Using Large Language Models: Mixed Methods Study.JMIR medical informatics · 2025Article
- Factors Influencing Informed Consent Preferences in Digital Health Research: Survey Study of Prospective Participants.Journal of medical Internet research · 2025Article
- What research participants say about their research experiences in Empowering the Participant Voice: Outcomes and actionable data.Journal of clinical and translational science · 2025Article
- Simplifying informed consent as a universal precaution.Scientific reports · 2024Article
- Readability of Online Materials in Spanish and English for Breast Reduction Insurance Coverage.Aesthetic plastic surgery · 2024Article
- Assessment of Consent Comprehension Among Kenyan Adolescents, Young Adults, and Parents: Comparison of Enhanced and Standard Consenting Procedures.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2024Article
- Development of a New Tool for Writing Research Key Information in Plain Language.Health literacy research and practice · 2024Review
- Evaluating visual imagery for participant understanding of research concepts in genomics research.Journal of community genetics · 2023Article
- The informed consent form navigator: a tool for producing readable and compliant consent documents.Journal of clinical and translational science · 2023Article
- Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov.Journal of clinical and translational science · 2023Article
- Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues.Frontiers in medicine · 2021Review
- Applying a Digital Health Checklist and Readability Tools to Improve Informed Consent for Digital Health Research.Frontiers in digital health · 2021Article
- Institutional improvements in readability of written informed consent forms sustained post-revised Common Rule.Journal of clinical and translational science · 2021Article
- Study protocol for a multilevel diabetes prevention program for Marshallese Pacific Islanders in faith-based organizations.Contemporary clinical trials communications · 2020Article
- Feasibility and Acceptability of a Culturally Tailored Website to Increase Fruit and Vegetable Intake and Physical Activity Levels in African American Mother-Child Dyads: Observational Study.JMIR pediatrics and parenting · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
introductionThe final rule for the protection of human subjects requires that informed consent be "in language understandable to the subject" and mandates that "the informed consent must be organized in such a way that facilitates comprehension." This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.
methodsReadability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.
resultsThe mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.
conclusionsProviding investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.
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.