Abstract
BackgroundThe aim was to evaluate the readability of research information leaflets (RIL) for minors asked to participate in biomedical research studies and to assess the factors influencing this readability.Methods and FindingsAll the pediatric protocols from three French pediatric clinical research units were included (N = 104). Three criteria were used to evaluate readability: length of the text, Flesch's readability score and presence of illustrations. We compared the readability of RIL to texts specifically written for children (school textbooks, school exams or extracts from literary works). We assessed the effect of protocol characteristics on readability. The RIL had a median length of 608 words [350 words, 25th percentile; 1005 words, 75th percentile], corresponding to two pages. The readability of the RIL, with a median Flesch score of 40 [30; 47], was much poorer than that of pediatric reference texts, with a Flesch score of 67 [60; 73]. A small proportion of RIL (13/91; 14%) were illustrated. The RIL were longer (p<0.001), more readable (p<0.001) and more likely to be illustrated (p<0.009) for industrial than for institutional sponsors.ConclusionResearchers should routinely compute the reading ease of study information sheets and make greater efforts to improve the readability of written documents for potential participants.
Highlights
The participation of minors in clinical research protocols requires authorization from their legal guardians
Researchers should routinely compute the reading ease of study information sheets and make greater efforts to improve the readability of written documents for potential participants
The way in which information is delivered to a child for possible inclusion in a research protocol must be approved by the institutional review board
Summary
The participation of minors in clinical research protocols requires authorization from their legal guardians. This authorization cannot override the refusal of the child [1,2]. European regulations require pediatric patients to be provided with information about studies in which they are asked to participate, including their risks and benefits, in a language that the child is likely to understand [4]. There is no consensus regarding the use of a separate assent document for research, many institutional review boards require their use when presenting study information for children [5]. The aim was to evaluate the readability of research information leaflets (RIL) for minors asked to participate in biomedical research studies and to assess the factors influencing this readability
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