Evaluation of Legal Legislation Compliance and Readability of Clinical Trial Informed Consent Forms

Ther Innov Regul Sci. 2020 Mar;54(2):468-475. doi: 10.1007/s43441-019-00078-2. Epub 2020 Jan 8.


Background: The volunteers approached for participation in a clinical trial should be given detailed and understandable information about the study through an informed consent form (ICF) before enrollment. In this study, we evaluated clinical trial files submitted to the 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.

Methods: This is a descriptive, cross-sectional study. We evaluated 160 ICFs in the phase II-IV clinical trial files submitted to TITCK in 2016 to determine their compliance to legislation (n = 160) and to assess their readability (n = 152) using Atesman formula. Overall compliance score was calculated. ICFs were also evaluated in terms of written format (font size, line spacing, section headings) and page count. Statistical analysis was performed with chi-square, Student's t test, analysis of variance, Mann-Whitney U, and Kruskal Wallis analysis.

Results: Compliance to legislation and suitability of written format of international trial ICFs were significantly higher than those of national trial ICFs. Most of the national trials were investigator initiated. Readability was low in both national and international trial ICFs where the text was longer in the latter.

Conclusion: Results showed that researchers need easy-to-read ICF writing training that fits legal regulations.

Keywords: Atesman formula; consent document; ethics committee; health literacy; human subjects.

MeSH terms

  • Comprehension*
  • Consent Forms*
  • Cross-Sectional Studies
  • Humans
  • Research Design