The appropriateness of language found in research consent form templates: a computational linguistic analysis

Background: To 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.
Methods: We 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...