ArticlePloS one2017
The Appropriateness of Language Found in Research Consent Form Templates: A Computational Linguistic Analysis.
Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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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.
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Who cites it
6 citing papers in PubMed.
- Acceptability and effectiveness of a study information video in improving the research consent process for youth: a non-inferiority trial.BMJ global health · 2025Trial
- Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial.BMJ open · 2019Trial
- Article
- Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review.BMC medical ethics · 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
- An integrated conceptual framework for evaluating and improving 'understanding' in informed consent.Trials · 2017Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo facilitate informed consent, consent forms should use language below the grade eight level. Research Ethics Boards (REBs) provide consent form templates to facilitate this goal. Templates with inappropriate language could promote consent forms that participants find difficult to understand. However, a linguistic analysis of templates is lacking.
methodsWe reviewed the websites of 124 REBs for their templates. These included English language medical school REBs in Australia/New Zealand (n = 23), Canada (n = 14), South Africa (n = 8), the United Kingdom (n = 34), and a geographically-stratified sample from the United States (n = 45). Template language was analyzed using Coh-Metrix linguistic software (v.3.0, Memphis, USA). We evaluated the proportion of REBs with five key linguistic outcomes at or below grade eight. Additionally, we compared quantitative readability to the REBs' own readability standards. To determine if the template's country of origin or the presence of a local REB readability standard influenced the linguistic variables, we used a MANOVA model.
resultsOf the REBs who provided templates, 0/94 (0%, 95% CI = 0-3.9%) provided templates with all linguistic variables at or below the grade eight level. Relaxing the standard to a grade 12 level did not increase this proportion. Further, only 2/22 (9.1%, 95% CI = 2.5-27.8) REBs met their own readability standard. The country of origin (DF = 20, 177.5, F = 1.97, p = 0.01), but not the presence of an REB-specific standard (DF = 5, 84, F = 0.73, p = 0.60), influenced the linguistic variables.
conclusionsInappropriate language in templates is an international problem. Templates use words that are long, abstract, and unfamiliar. This could undermine the validity of participant informed consent. REBs should set a policy of screening templates with linguistic software.
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