Metadata language
Title:
Optimization of Informed Consent Forms for clinical trials participants
Author:
Subject:
informed consent form ; clinical trials ; ethics committees ; readability ; good clinical practice
Abstract:
An Informed Consent Form documents participants’ acceptance of participation in a clinical trial. The aim of the research was to examine how the current format of informed consent forms impacts readability of the documents and patient understanding of the critical elements. Subsequent to that analysis, improvements to the format were proposed for implementation by ethics committees, regulatory authorities, and sponsor companies that prepare clinical trials. The research consisted of 3 parts. Part 1 of the research analyzed the length of the informed consent forms and their growth over time, the use of visual aids in the forms, and how these factors varied based on the intended reader of the document. Part 2 of the research involved 9 ethics committees in Poland. EC members were asked to grade the importance of ICF elements and to ask about EC members’ opinions regarding currently used ICFs. The aim of Part 3 of the research was to conduct a readability assessment comparing a standard version ICF and a modified (shortened and illustrated) and to propose solution optimizing the design of the informed consent forms. Based on the information retention observed in this study, significant improvements in readability and design are needed for informed con-sent forms to fulfill their intended purpose. Patient representation in the ethical review process is advisable, and it is recommen ; ded that standards for readability assessments of ICFs be developed that can be applied consistently on a global scale given the international nature of clinical research today.