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

Vanderson Assis Romualdo,Ledna Bettcher,Francisco José Machado Viana,Roberta Mendonça Bosque

doi:10.5935/2238-3182.20140076

Abstract

Introduction: 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projects are assessed with the following opinion: Approved 239 (85.4%), Pending 37 (13.2%), and Not Approved 03 (1.1%), Withdrawn 01 (0.4 percent).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.

Highlights

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
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

Summary

EDUCAÇÃO MÉDICA

O Termo de Consentimento e as pendências identificadas na apreciação ética pelo CEP-FHEMIG. Introdução: O Termo de Consentimento Livre e Esclarecido (TCLE) é peça fundamental na elaboração de uma pesquisa envolvendo seres humanos e expressa todas as garantias éticas e humanas do pesquisador frente ao voluntário. Objetivo: Levantar todas as causas de pendências de projetos de pesquisa apreciados no CEP-FHEMIG, nos últimos 30 meses, ressaltando as falhas relacionadas ao TCLE. Resultados: Foram apreciados 280 projetos, com o seguinte Parecer: Aprovados 239 (85,4%), Pendentes 37 (13,2%), Não aprovados 03 (1,1%), Retirado 01 (0,4%). Dentre os 37 estudos com Parecer Pendente foram contabilizadas 126 pendências. Conclusão: Erros na elaboração do TCLE ainda são as principais causas de pendências na apreciação ética de um projeto de pesquisa pelo CEP-FHEMIG. Palavras-chave: Bioética; Ética em Pesquisa; Consentimento Livre e Esclarecido; Termos de Consentimento

MATERIAIS E MÉTODOS

Não aprovado

Findings

Sem a descrição das formas de contato com o pesquisador