Terms of Consent submitted to an Ethics Committee: Analysing the wording: is the information in the Consent Form understood by the research participant?

The aim of this study was to analyse the Terms of Free and Informed Consent (TCLE) of the research projects submitted to the Research Ethics Committee of the Faculty of Health (CEP/FS) of the University of Brasília between January and October 2013, in order to check whether the requirements of CNS Resolutions 196/96 (until July/13) and 466/12 (July to October/13) were being met.This study is justified by the need for the scientific community to draw up consent forms in clear language that is accessible to potential research participants so that they can exercise their autonomy in a truly free and informed manner. For autonomy to be fully achieved, this must be reflected in the drafting of the ICF. With this in mind, 190 ICFs submitted to the CEP/FS were analysed according to four categories of parameters: 1) structure; 2) details of the research; 3) analysis of the wording and 4) information about the researcher. The comparative result shows that there were no significant differences in the preparation of the ICFs submitted to the CEP/FS with the change in the Resolution. This analysis showed that the ICFs analysed partially complied with the rules.