The Informed Consent and the disputes identified in ethics examination by CEP-FHEMIG

The Informed Consent Form (ICF) is a fundamental piece on the elaboration of research with human beings and it contains all the ethics safeties and guaranties for the voluntaries chosen to participate in the project. Because of its importance, the informed consent is given a special attention by the Research Ethics Committee (REC) and is required for the approval of the project. Objectives: raise all causes search projects pending at FHEMIG’s REC in recent 30 months, highlighting the flaws related to the ICF. Methods: This is a retrospective study in which the research projects in FHEMIG’s REC were evaluated from February 2012 to July 2014. Results: 280 projects are assessed with the following opinion: Approved 239 (85.4%), Pending 37 (13.2%), and Not Approved 03 (1.1%), Withdrawn 01 (0.4 percent). Among the 37 Pending Studies were accounted 126 pending. These pending were grouped into 03 categories: 08 (6.3%) of Document Pending, Pending on the Project 55 (43.7%) and Pending on the ICF 63 (50.0%). Conclusion: Errors in the preparation of ICF are still the main causes of pending in the ethical assessment of a research project by CEP-FHEMIG.