Research ethics committee: experience of Brazilian researchers in the sexual and reproductive health area

• Grant number: 12/20924-0
• Support Opportunities: Regular Research Grants
• Start date: May 01, 2013
• End date: April 30, 2015
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Maria José Martins Duarte Osis
• Grantee: Maria José Martins Duarte Osis
• Host Institution: Centro de Pesquisas em Saúde Reprodutiva de Campinas (CEMICAMP). Campinas , SP, Brazil

Abstract

In Brazil, every research project involving human subjects must be evaluated by a Research Ethics Committee and, depending on the subject area that will be developed, should also be submitted to the evaluation of the National Ethical Research Committee(CONEP). CEP/CONEP is the Brazilian System of Ethical Review of Research in the country, known as CEP/CONEP System. Despite the great expansion of the CEP/CONEP System and many efforts to improve it, there are comments from researchers - the main users, who are not always satisfied with the functioning of this system. Objective: To know the opinion and experience of researchers in the field of sexual and reproductive health of the Brazilian Ethical Review System - CEP/CONEP System. Subjects and Methods: A double, quantitative and qualitative approach, will be used in this study. All investigators working on research in sexual and reproductive health (according to the Lattes / CNPq Platform) and who sent a project to be evaluated by CEP in the last 36 months will be invited to participate in the quantitative part of the study. A sample of 20 researchers who have participated in the quantitative stage from the five geographic regions of Brazil will be purposively selected and invited to be part of the qualitative component of the study. In each region, two researchers who reported to have had difficulties with CEP/CONEP and two researchers who mentioned they did not have any problem with this institution will be invited. In both approaches, the interviews with the researchers will be done by telephone. In the first step, the interviews will be recorded and typed simultaneously. The semi-structured interviews will be recorded and then transcribed. (AU)