The British Journal of Psychology has published an article that looks at the readability and impact of participant information sheets for research studies.
Informed consent in research is partly achieved through the use of information sheets. There is a perception however that these information sheets are long and complex.
The study aimed to investigate whether the readability of participant information sheets has changed over time, whether particular study characteristics are related to poorer readability and whether readability and other study characteristics are related to successful study recruitment.
The researchers obtained 522 information sheets from the UK National Institute for Health Research Clinical Research Network: Mental Health portfolio database and study principal investigators. Readability was assessed with the Flesch reading index and the Grade level test.
The study found that information sheets increased in length over the study period. The mean grade level for readability across all information sheets was 15–16 years old, as compared to the recommended reading level for patient information, quoted in the study, as being 11–12 years old.
A high level of patient involvement was associated with more recruitment success and studies involving pharmaceutical or device interventions were the least successful.
The complexity of information sheets had little bearing on successful recruitment.
The researchers conclude that information sheets are far more complex than the recommended reading level and that the disparity may be exacerbated by an increasing focus on legal content.
The article recommends that researchers would benefit from clear guidance from ethics committees on writing succinctly and accessibly and how to balance the competing legal issues with the ability of participants to understand what a study entails.
The article can be accessed here.