DOCUMENTOS E FORMA DE SUBMISSÃO DE PROTOCOLOS DE PESQUISA AO COMITÊ DE ÉTICA EM PESQUISA DO Uni-FACEF

Prezados(as) pesquisadores(as),

Considerando o ofício carta nº 327/2011/CONEP/CNS/MS da Comissão Nacional de Ética em Pesquisa – CONEP, datado de 18/11/2011, fez-se necessária a elaboração de novos procedimentos acerca do envio e submissão das pesquisas realizadas no Uni-FACEF para análise deste Comitê de Ética em Pesquisa, sendo que, a partir de 14 de setembro de 2012, todas as pesquisas enquadradas nos quesitos das Resoluções nº 466/2012 e 510/2016, do Ministério da Saúde, Conselho Nacional de Saúde e Comissão Nacional de Ética em Pesquisa – MS/CNS/CONEP, deverão tramitar por intermédio de sistema nacional online próprio denominado PLATAFORMA BRASIL.

Para tanto, os pesquisadores deverão se cadastrar e utilizar a PLATAFORMA BRASIL, (disponível em:www.saude.gov.br/plataformabrasil) sistema desenvolvido para intermediar a tramitação dos protocolos de pesquisa entre pesquisadores, Comitês de Ética em Pesquisa e a CONEP.

Visando facilitar o uso da PLATAFORMA BRASIL, disponibilizamos o Manual Ilustrado da Plataforma Brasil para submissão de Protocolos de Pesquisa ao Comitê de Ética em Pesquisa (clique aqui) que explica o passo a passo de:

1) cadastro do pesquisador; e
2) submissão de Protocolos de pesquisa para análise do Comitê de Ética em Pesquisa.

Todos os documentos necessários para o cadastramento de Protocolos de Pesquisa na Plataforma Brasil deverão ser digitalizados (alguns precisarão ser preenchidos, impressos, assinados e depois digitalizados).

Os documentos necessários são:

  1. Carta de apresentação do projeto ao Comitê de Ética em Pesquisa do Uni-FACEF: Esta carta deve ser elaborada e assinada pelo orientador (ou pesquisador autônomo responsável), especificando nome do projeto de pesquisa, nome aluno, tipo de bolsa concedida,  e tipo de trabalho (TCC, iniciação científica, mestrado, doutorado, pesquisa independente, etc.);
  2. Folha de Rosto: Esta folha deve ser impressa direto da Plataforma Brasil, que gerará automaticamente de acordo com as informações preenchidas. A Folha de Rosto deverá ser obtida no item denominado ANEXAR FOLHA DE ROSTO, através do campo IMPRIMIR FOLHA DE ROSTO. Depois de imprimir, o responsável deverá assinar a folha e depois digitaliza-la para anexar aos documentos exigidos na Plataforma Brasil. Lembre-se que, nos casos de pesquisa de alunos de graduação, o pesquisador responsável é o ORIENTADOR e que o título do protocolo deve ser idêntico ao da capa do projeto de pesquisa.
  3. Projeto de pesquisa em português. Os projetos deverão conter os seguintes itens:
    • capa com título do projeto, nome e titulação do orientador e aluno (se houver), dados de contato (telefone, endereço e e-mail) e tipo do trabalho (TCC, IC, etc.);
    • sumário do projeto;
    • introdução e justificativa;
    • clara apresentação dos objetivos, procedimentos, metodologia, descrição e apresentação dos instrumentos a serem utilizados e trabalho dos dados da pesquisa;
    • descrição e apresentação dos instrumentos a serem utilizados na pesquisa (ex.: roteiro de entrevista, questionário, formulários, etc.);
    • referencial teórico sobre o tema trabalhado;
    • referências;
    • cronograma de execução da pesquisa (tempo de duração a partir da data de aprovação pelo Comitê de Ética em Pesquisa).
  4. Termo de Consentimento Livre e Esclarecido (TCLE): Documento devidamente elaborado para a pesquisa, ou uma justificativa do pesquisador para isenção do TCLE, se for o caso. É importante descrever, no projeto de pesquisa, o procedimento de obtenção da assinatura neste Termo. Consultar as Resoluções CNS nº 466/2012 e 510/2016, para as devidas exigências relativas a este documento, tais como:
    • É imprescindível que o TCLE seja um convite de participação ao participante da pesquisa, devendo informar o título completo da pesquisa; informar claramente quem é o responsável pela pesquisa; e conter um resumo do projeto, evitando descrições muito detalhadas de técnicas, em particular daquelas que não afetarão os participantes da pesquisa.
    • O TCLE deve descrever os riscos previsíveis, de forma clara e simples. E, se não houver riscos previsíveis, apenas dizer que não há riscos previsíveis.
    • Deve deixar clara a garantia de que os eventuais participantes da pesquisa podem se recusar a participar em qualquer momento, sem que isto acarrete qualquer penalidade e não cause represálias de qualquer natureza.
    • Deve deixar clara a garantia de sigilo de dados confidenciais ou dos que, de algum modo, possam provocar constrangimento ou prejuízos ao participante da pesquisa. Deve deixar claro que a identidade dos participantes da pesquisa será preservada.
    • Deve incluir endereço, telefone e e-mail, ou outra forma de contato, com o pesquisador responsável e o Comitê de Ética em Pesquisa do Uni-FACEF.

O TCLE é um documento único e deve ser sempre apresentado integralmente. Nunca o apresente inserido como parte de outro texto ou parte do mesmo. O TCLE deve ser emitido em duas vias e ser assinado por todos os pesquisadores e pelo participante da pesquisa, sendo que uma via deve ser entregue ao participante da pesquisa

5. Declaração assinada pelo responsável pela instituição (pelo local) onde será realizada a pesquisa: Nesta declaração, deverá constar o nome do pesquisador responsável e o título do projeto de pesquisa, afirmando que a instituição reconhece a intenção do pesquisador de realizar a pesquisa em suas dependências e a autoriza, após a análise e o parecer do Comitê de Ética em Pesquisa.

A partir do cadastramento do Protocolo de Pesquisa na PLATAFORMA BRASIL, o Comitê de Ética em Pesquisa do Uni-FACEF receberá os protocolos e iniciará a sua análise.

Atenciosamente,

Comitê de Ética em Pesquisa do Uni-FACEF

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