1. Presentation
Since the publication of Resolution 196 of the National Council of Health in October 1996, a system for the regulation of researches conducted with human subjects was established in Brazil.
This system is known as CEP/Conep, since it is formed by the National Committee of Ethics in Research (Conep) and by the Research Ethics Committee (CEP).
As part of this system, CEP – PECEGE is responsible for the reception, evaluation, approval and monitoring of all research involving human subjects developed by its students and researchers.
Its main task is to ensure that scientific research is performed in accordance with the current national ethical guidelines, protecting the rights and interests of the research participants in their integrity and dignity.
1.1. CEP/Conep System
The CEP/Conep System was created in October of 1996, with the issue of Resolution 196 of the National Council of Health, known as CNS Resolution 196/96 This Resolution created the National Committee of Ethics in Research (Conep), whose main attribution is, alongside the Research Ethics Committees, to perform the evaluation of the ethical aspects of research that involve human beings in Brazil, directly or indirectly
Conep is responsible for developing and updating guidelines and standards for the protection of research participants and coordinate the network of Research Ethics Committees (CEP), of Institutions – System CEP/Conep.
It is Conep’s jurisdiction to evaluate ethical quality and follow the Research Protocols of the so-called Special Thematic Areas. Classified in this group are, research on genetics and human reproduction, on new equipment and devices for human health, new procedures, indigenous population, projects related to biosecurity, among others.
In addition to Conep, the System has a network of approximately 840 Research Ethics Committees distributed throughout the national territory. The researcher may have access to updated data on the National Council of Health website.
1.1.1. Human Subject Research Ethics Committee (CEP)
CEPs are installed and maintained by institutions that perform research involving human beings, regardless of the area of knowledge.
In the menu “Instructions for submission” on this website, the researcher can obtain more information on which researches should be submitted to the evaluation of CEP – PECEGE and how to perform this submission.
The Human Subject Research Ethics Committee is formed by professionals and researchers from different areas of knowledge, therefore, (it is an interdisciplinary collegiate). Collectively, members of the Research Ethics Committee have the task of evaluating the ethical quality of research developed by researchers, professors and students in a given institution.
CEP’s role is to ensure the protection of research participants, that is, people who provide information and data that the researcher needs to obtain their results. To do so, CEP should require the researcher to know and apply the national ethical guidelines in the elaboration and development of their research project.
Moreover, CEP is responsible for organizing activities of dissemination of ethics in research and for promoting training and qualification of the academic community in this area.
In practice, CEPs are the gateway of scientific research involving humans in the CEP/Conep System. They receive from researchers, through Plataforma Brasil, the documents known as Research Protocol, that is, the set formed by the research project, alongside other documents necessary for CEP’s evaluation.
Although CEP is responsible for applying ethical guidelines and evaluating research projects, it is a non transferable responsibility of the researcher to know and adopt these guidelines during the execution of the research work.
Currently, with the repeal of Resolution CNS nº 196/96, the main ethical guidelines for research with humans in Brazil are available in Resolutions CNS nº 466/2012 and CNS nº 510/2016.
In total, the normative corpus of the CEP/Conep System is formed by:
- 15 Resolutions
- 02 Operating standards
- 41 Circular letters (including notices)
These documents can be obtained from the Normative menu on the Conep website.Os CEPs são instalados e mantidos por instituições que realizam pesquisas envolvendo seres humanos, independentemente da área do conhecimento.
1.1.2. Plataforma Brasil
Plataforma Brasil is the digital working platform of the CEP/Conep System It brings together researchers and institutions, CEPs and Conep itself, in a virtual environment that offers all the tools necessary to perform the evaluation and monitoring of research involving human beings in the country.
To submit a research project to CEP – PECEGE, it is necessary for the researcher to register in Plataforma Brasil according to the guidelines offered in the menu “Instructions for submission”, on this website.
The entire analysis process performed by CEP – PECEGE will be registered in Plataforma Brasil and the researcher will be able to follow the progress of the processes of reception, evaluation, approval and monitoring of the research project on the platform itself. In addition, all communication between the researcher and CEP – PECEGE will also be through the platform. Therefore, it is essential for the researcher to know the functionalities that Plataforma Brasil offers and use the teaching materials available to understand how this system works.
Again, it is important for the researcher to follow the guidelines contained in the menu “Instructions for submission” of this website. In this menu, the researcher will also find the link to access the platform.
If the researcher wants to know the CEP/Conep System better, the ethical guidelines, functioning and Plataforma Brasil, it is recommended that the researcher take the distance education course offered free of charge by Conep, in partnership with Hospital Moinhos de Vento (Porto Alegre/RS).
1.2. CEP - Pecege
PECEGE’s Human Subject Research Ethics Committee (CEP-PECEGE) is an interdisciplinary collegiate that performs the ethical evaluation of research projects developed by students and researchers linked to Pecege.
CEP-PECEGE was created in 2019 to meet the resolutions of the National Council of Health of the Ministry of Health, specifically number 466, October 10, 1996, and 510 of April 7, 2016, which establish the guidelines for research involving human beings, following the global trend of protecting research participants.
PECEGE’s Research Ethics Committee (CEP-PECEGE) had its Founding Assembly on October 3, 2019, the beginning date of the effective existence of CEP-PECEGE. From this framework, some arrangements were adapted, such as: activities, meetings, new planning, reporting and adequacy of specific standards to meet the requirements of the National Committee of Ethics in Research (Conep), which is the grantor of the operating authorization to the associated CEPs.
The Internal Regulation of CEP-PECEGE defines the nature, constitution of the collegiate, competences, functioning, as well as general and transitional provisions.
The collegiate of CEP-PECEGE consists of 13 (thirteen) members, including in this total, the User Representative, respecting the deliberations of the ethical guidelines of Conep/CNS/MS, including the participation of professionals in the areas of health, mathematics, social and human sciences and members of society.
Ethical evaluation of research projects of CEP-PECEGE is based on the current resolutions of the Ministry of Health (Resolution CNS nº 466/2012 and Resolution CNS nº 510/2016) and in the Operational Standard of the National Council of Health (Operational Standard CNS nº 001/2013).
The approval of the initial registration of CEP-PECEGE was published in Letter No. 43/2020-CONEP/SECNS/MS.
