Abstract
ObjectiveInformation 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.Methods21 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.ResultsInformation 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% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68).ConclusionsA booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials.
Highlights
Informed consent is essential to protecting the participant in medical research. [1,2,3,4] It has two components: a verbal component, which consists of a discussion, usually between the potential participant and the investigator, and a written component, which consists of documents presented to the potential participant, and is intended to facilitate discussion with the potential participant
The result is that written informed consent forms (ICFs) have become increasingly difficult for participants to read and understand. [9,10,11,12,13,14,15,16] Many potential participants do not read the information they are given, and those who try may fail to understand what they are reading [6,10,11,12]
In addition we investigate whether simplifying the trial specific ICF with simpler language, diagrams of study design, and tables of expected visits, improves patient understanding of a clinical trial
Summary
Informed consent is essential to protecting the participant in medical research. [1,2,3,4] It has two components: a verbal component, which consists of a discussion, usually between the potential participant and the investigator, and a written component, which consists of documents presented to the potential participant, and is intended to facilitate discussion with the potential participant. Informed consent is essential to protecting the participant in medical research. Despite the potential for the written component to enhance the process, numerous problems have been identified with informed consent documents. The result is that written informed consent forms (ICFs) have become increasingly difficult for participants to read and understand. [14] Patients who do not fully understand the implications of participation in a research trial are more likely to regret their decision and to withdraw from the study later. The assessment process undertaken by Institutional Review Boards (IRBs) may worsen rather than improve these problems. In an evaluation of ICFs for clinical trials assessed by IRBs in Veteran’s Administration Medical Centers, most changes made to the ICFs increased their length and made them harder to read. In an evaluation of ICFs for clinical trials assessed by IRBs in Veteran’s Administration Medical Centers, most changes made to the ICFs increased their length and made them harder to read. [19] For large clinical trials this process may be repeated across tens or hundreds of sites
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