A Booklet on Participants ’ Rights to Improve Consent for Clinical Research: A Randomized Trial

Objective: Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. Methods: 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants ’ rights. A booklet designed to provide information on participants ’ rights which used simple language was developed to replace this information in current ICF’s Readability of each component of ICF’s and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant’s rights was assessed by questionnaire. Results: Information related to participants ’ rights contributed an average of 44 % of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95