Evaluation of legal legislation compliance and readability of clinical trial informed consent forms

Aim: Before enrolment study, volunteers who are planning to participate in a clinical trial should be given detailed and understandable information about the study by via of informed consent (ICF). In this study, we evaluated clinical trial files submitted to Turkish Medicines and Medical Devices Agency (TITCK) to investigate the compliance to legal legislation and readability of ICFs as well as the factors affecting them. Method: This is descriptive, cross-sectional study. ICFs in the Phase II-III-IV and observational clinical trials files first submitted to TITCK in 2016 has been evaluated. Compliance to legislation was calculated according to minimum requirements of ICFs. Each criterion receives a score of 2 if it is totally met, 1 if partially met, and 0 if not met. Scoring is based on point range of 0 to 100. Readability of ICFs were evaluated using Ateşman Formula. ICFs were also evaluated in terms of written format (font size, line spacing, section headings) and page count. The data analyzed by using descriptive statistics, chi-square test, t-tests, ANOVA, Mann-Whitney U, and Kruskal Wallis analysis. Results: It was found that the average score of compliance to legislation of ICFs is 86.5 ± 13.9 (n=194) and readability of ICFs is 36.9±10.6 (n=180). Compliance to legislation scores for sponsor-supported studies and researcher initiated studies were found to be 94.1±6.9 (n=131) and 70.8±11.6 (n=63) (p<0.001), respectively; number of pages were 18.8±7.4 and 3.4±2.8 (p<0.001) respectively, and readability was found HARD. ICFs of sponsor supported studies was found statistically higher than others in the terms of 12 font text type and more (p<0.001), 1.5 and more line spacing (p=0.001), and section headings (p<0.001). Conclusion: Results showed that researchers need easy-to-read ICF writing training that fits legal regulations. It also showed that the members of the ethics committee, especially the civilian members, should evaluate the ICFs more carefully.