ArticleResearch involvement and engagement2021
Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference.
Article in Research involvement and engagement, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.
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
30 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Towards a more patient-centered clinical trial process: A systematic review of interventions incorporating health literacy best practices.Contemporary clinical trials · 2022Pooled it
- Digital animation as a tool to enhance informed consent when recruiting infants with biliary atresia to a clinical trial.Journal of pediatric gastroenterology and nutrition · 2025Trial
- The Function of Non-invasive Prenatal Testing (NIPT) Request Forms in the Australian Context.Health care analysis : HCA : journal of health philosophy and policy · 2026Article
- A Pilot Study to Explore Length and Readability Characteristics of Subject Information Sheets/Informed Consent Forms of Clinical Trial Applications in the EU.Clinical and translational science · 2026Article
- Enhancing Understanding and Acceptance of Equipment Localization: Mixed Methods Study With Clinic Staff and Potential Patients.JMIR human factors · 2026Article
- Not all information is equally important: informed consent to genetic testing for hereditary cancer.Journal of cancer research and clinical oncology · 2026Article
- Co-designing accessible trial information: lessons from designing an inclusive patient information leaflet in the RaCeR2 study.Research involvement and engagement · 2026Article
- Clinical trial participant information leaflets overstate the harms/risks of participation and understate the benefits.PloS one · 2026Article
- Advancing Equity and Patient Partnership in Clinical Trials for Inflammatory Bowel Disease: A Model for Inclusive Trial Design.Clinical and experimental gastroenterology · 2026Article
- Patient involvement in the design of ALIDHE: a study of ivosidenib + azacitidine in newly diagnosedFuture oncology (London, England) · 2025Article
- Article
- Article
- Factors Influencing Informed Consent Preferences in Digital Health Research: Survey Study of Prospective Participants.Journal of medical Internet research · 2025Article
- Jargon and Readability in Plain Language Summaries of Health Research: Cross-Sectional Observational Study.Journal of medical Internet research · 2025Observational
- Informed consent: Navigating the bioethical complexities of clinical research.Bioinformation · 2025Article
- Examining equity-related eligibility criteria in clinical trials supporting 2022 US drug approvals.PloS one · 2025Article
- Using technology to increase reach and optimize consent experience for a large-scale research program.Journal of clinical and translational science · 2025Article
- Review
- Article
- When describing harms and benefits to potential trial participants, participant information leaflets are inadequate.Trials · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
backgroundIn line with Good Clinical Practice and the Declaration of Helsinki, it is the investigator's responsibility to ensure that research participants are sufficiently informed, to enable the provision of informed consent. The Participant Information Leaflet/Informed Consent Form is key to facilitating this communication process. Although studies have indicated that clinical research Participant Information Leaflets/Informed Consent Forms are not optimal in terms of accessibility, there is little or no specific guidance available. The aim of this research was to propose and agree a set of guidelines for academic researchers and sponsors for preparing accessible and understandable Participant Information Leaflets/Informed Consent Forms.
methodsA literature review identified guidance for the preparation of patient-facing documents. Following critical appraisal, key recommendations were extracted and a set of recommendations which can be applied to clinical research Participant Information Leaflets/Informed Consent Forms were prepared. These recommendations were evaluated and amended by an Expert Consensus Conference consisting of a group of key stakeholders. The stakeholders included members of a Research Ethics Committee (both lay and expert), a patient advocate, experienced clinical researchers, a plain English editor and a Data Protection Officer. Consensus was reached regarding a final set of recommendations.
results44 recommendations were agreed upon and grouped into five categories: Layout, Formatting, Content, Language and Confirming Readability. These recommendations aimed to maximize accessibility for lay participants, including readers with dyslexia, literacy or numeracy challenges, thereby improving the quality of the consent process.
conclusionsMore empirical research is needed to further improve the informed consent process for research participants. However, these recommendations are informed by the current literature and have been ratified by expert stakeholders. It is hoped that these recommendations will help investigators and sponsors to consistently and efficiently produce more accessible clinical research Participant Information Leaflets/Informed Consent Forms.
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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.