Content and readability of informed consents: a comparative study of biomedical sciences and social sciences

This quasi-experimental study had as objective to compare the comprehensibility of a corpus of informed consent forms from research in biomedical sciences and social sciences. The methodology involved to contrast qualitatively and quantitatively the consents in terms of their content, readability and conceptual density. The results revealed that none of the pieces of information as prescribed by law (e.g., information about objectives of the study or procedures) was included in the entirety of consents analyzed. A cluster analysis based on indices of readability and conceptual density ratios identified four types of audiences to which the consents are addressed: popular science, specialist audience, general audience, and persistent readers. These audiences suggest variation in how researchers anticipate their potential participants and how consent forms are written. There was an association between the type of audience anticipated by the researchers and the discipline to which corresponds research: the difficulty of the forms from biomedical sciences was the result of the inclusion of technical terms, while the difficulty in formats from social sciences is a function of the variation in readability.