{"id":1007,"date":"2020-05-21T16:26:36","date_gmt":"2020-05-21T19:26:36","guid":{"rendered":"https:\/\/cep.pecege.com\/apresentacao\/"},"modified":"2023-07-04T16:37:22","modified_gmt":"2023-07-04T19:37:22","slug":"presentation","status":"publish","type":"page","link":"https:\/\/cep.pecege.com\/en\/","title":{"rendered":"Presentation"},"content":{"rendered":"\t\t
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1. Presentation<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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.<\/span><\/p>

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).<\/span><\/p>

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.<\/span><\/p>

Its main task is to ensure that scientific research is performed in accordance with the current national ethical guidelines<\/span>, protecting the rights and interests of the research participants in their integrity and dignity.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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1.1. CEP\/Conep System<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The CEP\/Conep System was created in October of 1996, with the issue of Resolution 196 of the National Council of Health, known as <\/span>CNS Resolution 196\/96<\/span><\/a> This Resolution created the <\/span>National Committee of Ethics in Research<\/span><\/a> (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<\/span><\/p>

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 \u2013 System CEP\/Conep.<\/span><\/p>

It is Conep’s jurisdiction to evaluate ethical quality and follow the Research Protocols of <\/span>the so-called Special Thematic Areas<\/b>. 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.<\/span><\/p>

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.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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1.1.1. Human Subject Research Ethics Committee (CEP)<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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CEPs are installed and maintained by institutions that perform research involving human beings, regardless of the area of knowledge.<\/span><\/p>

In the menu “Instructions for submission”<\/strong><\/a> on this website, the researcher can obtain more information on which researches should be submitted to the evaluation of CEP \u2013 PECEGE and how to perform this submission.<\/span><\/p>

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.<\/span><\/p>

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, <\/span>CEP should require the researcher to know and apply the national ethical guidelines in the elaboration and development of their research project<\/b>.<\/span><\/p>

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.<\/span><\/p>

In practice, CEPs are the gateway of scientific research involving humans in the CEP\/Conep System. They receive from researchers, through <\/span>Plataforma Brasil<\/b>, the documents known as Research Protocol, that is, the set formed by the research project, alongside other documents necessary for CEP’s evaluation.<\/span><\/p>

Although CEP is responsible for applying ethical guidelines and evaluating research projects, <\/span>it is a non transferable responsibility of the researcher to know and adopt these guidelines during the execution of the research work.<\/b><\/p>

Currently, with the repeal of Resolution CNS n\u00ba 196\/96, the main ethical guidelines for research with humans in Brazil are available in Resolutions <\/span>CNS n\u00ba 466\/2012<\/span><\/a> and <\/span>CNS n\u00ba 510\/2016<\/span><\/a>.<\/span><\/p>

In total, the normative <\/span>corpus<\/span><\/i> of the CEP\/Conep System is formed by:<\/span><\/p>