| 168
| <![CDATA[<i class="fa fa-times" aria-hidden="true" style="display:none"></i>]]>
|
| 368
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Os protocolos de pesquisa deverão seguir a RDC Nº 466 de 12 de dezembro de 2012/MS, que trata das diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos, com as seguintes obrigatoriedades:</span>]]>
|
| 369
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>Projeto Básico:</strong></span>]]>
|
| 371
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Página de Rosto (capa);</span>]]>
|
| 372
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Introdução;</span>]]>
|
| 373
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Objetivo;</span>]]>
|
| 374
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Material e Método (ou casuística e método, caso se trate de experimentação com seres humanos);</span>]]>
|
| 375
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Análise do Risco;</span>]]>
|
| 376
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Cronograma;</span>]]>
|
| 377
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Termo de Consentimento Livre e Esclarecido – TCLE; (em pesquisa com seres humanos);</span>]]>
|
| 378
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Termo de Assentimento Livre e Esclarecido – TALE e Termo de Compromisso de Utilização de Dados – TCUD (quando houver necessidade);</span>]]>
|
| 379
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Origem dos recursos financeiros;</span>]]>
|
| 380
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Referências Bibliográficas.</span>]]>
|
| 382
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>Documentos:</strong></span>]]>
|
| 384
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Folha de Rosto devidamente assinada pela autoridade máxima da instituição e pelo pesquisador responsável;</span>]]>
|
| 385
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Termos de Anuência dos departamentos/instituições envolvidos na pesquisa;</span>]]>
|
| 386
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Cadastro do currículo dos Pesquisadores Responsável e Executante na Plataforma Lattes – CNPq.</span></span>]]>
|
| 386
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Cadastro do currículo dos Pesquisadores Responsável e Executante na Plataforma Lattes – CNPq.</span>]]>
|
| 390
| <![CDATA[<p style="text-align: center;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>CADASTRO NA PLATAFORMA BRASIL</strong></span></p>]]>
|
| 390
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>CADASTRO NA PLATAFORMA BRASIL</strong></span>]]>
|
| 391
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>Procedimento:</strong></span>]]>
|
| 393
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Para Cadastro de <em>currículo lattes</em> do pesquisador na Plataforma Lattes, acessar página <a style="color: #000000;" href="http://lattes.cnpq.br/"><span style="text-decoration: underline;">http://lattes.cnpq.br/</span></a>, ir para Acesso Direto, escolher o item <strong><em>“Cadastrar novo currículo”</em></strong> e preencher os dados solicitados;</span>]]>
|
| 393
| <![CDATA[<a style="color: #000000;" href="http://lattes.cnpq.br/"><span style="text-decoration: underline;">http://lattes.cnpq.br/</span></a>]]>
|
| 393
| <![CDATA[<span style="text-decoration: underline;">http://lattes.cnpq.br/</span>]]>
|
| 394
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Para Cadastro do pesquisador na Plataforma Brasil (pesquisa em humanos), acessar página <a style="color: #000000;" href="http://plataformabrasil.saude.gov.br/login.jsf"><span style="text-decoration: underline;">http://plataformabrasil.saude.gov.br/login.jsf</span></a> escolher o item <strong><em>“Cadastrar-se”</em></strong> e preencher os dados solicitados;</span>]]>
|
| 394
| <![CDATA[<a style="color: #000000;" href="http://plataformabrasil.saude.gov.br/login.jsf"><span style="text-decoration: underline;">http://plataformabrasil.saude.gov.br/login.jsf</span></a>]]>
|
| 394
| <![CDATA[<span style="text-decoration: underline;">http://plataformabrasil.saude.gov.br/login.jsf</span>]]>
|
| 395
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Para cadastrar uma nova Pesquisa o usuário deve ter concluído o seu cadastro de pessoa física. O pesquisador deverá realizar o <em>login</em> na Plataforma Brasil e deverá em seguida clicar no botão “<strong><em>Nova submissão”</em></strong>. Todos os campos com um asterisco vermelho (*) são de preenchimento obrigatório;</span>]]>
|
| 396
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">No momento do cadastro é imprescindível informar todos os pesquisadores envolvidos;</span>]]>
|
| 397
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Todos os termos de apresentação obrigatória deverão ser anexados:</span>]]>
|
| 400
| <![CDATA[<li style="list-style-type: none;">
<ul>
<li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Folha de Rosto (devidamente assinada pela autoridade máxima da instituição e pelo pesquisador responsável);</span></li>
<li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Projeto Básico;</span></li>
<li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Termo de Compromisso Livre e Esclarecido – TCLE (em pesquisa com seres humanos), conforme define a Resolução CNS nº 466/12;</span></li>
<li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><span style="color: #000000;">Cartas de Anuência</span> das Instituições envolvidas na pesquisa;</span></li>
</ul>
</li>]]>
|
| 402
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Folha de Rosto (devidamente assinada pela autoridade máxima da instituição e pelo pesquisador responsável);</span>]]>
|
| 403
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Projeto Básico;</span>]]>
|
| 404
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Termo de Compromisso Livre e Esclarecido – TCLE (em pesquisa com seres humanos), conforme define a Resolução CNS nº 466/12;</span>]]>
|
| 405
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><span style="color: #000000;">Cartas de Anuência</span> das Instituições envolvidas na pesquisa;</span>]]>
|
| 405
| <![CDATA[<span style="color: #000000;">Cartas de Anuência</span>]]>
|
| 409
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong> </strong></span>]]>
|
| 409
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>Avaliação do Projeto:</strong></span>]]>
|
| 410
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">A avaliação pelo CEP/FCECON obedecerá ao <span style="text-decoration: underline;"><a style="color: #000000; text-decoration: underline;" href="http://www.fcecon.am.gov.br/wp-content/uploads/2023/06/Roteiro-de-Checagem.docx" target="_blank" rel="noopener">Roteiro de Checagem</a></span> podendo resultar em:</span>]]>
|
| 410
| <![CDATA[<span style="text-decoration: underline;"><a style="color: #000000; text-decoration: underline;" href="http://www.fcecon.am.gov.br/wp-content/uploads/2023/06/Roteiro-de-Checagem.docx" target="_blank" rel="noopener">Roteiro de Checagem</a></span>]]>
|
| 410
| <![CDATA[<a style="color: #000000; text-decoration: underline;" href="http://www.fcecon.am.gov.br/wp-content/uploads/2023/06/Roteiro-de-Checagem.docx" target="_blank" rel="noopener">Roteiro de Checagem</a>]]>
|
| 412
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>Aprovado</strong><strong> –</strong> Quando o protocolo se encontra totalmente adequado para execução;</span>]]>
|
| 413
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>Com pendência</strong><strong> –</strong> Quando a decisão é pela necessidade de correção, hipótese em que serão solicitadas alterações ou complementações do protocolo de pesquisa. Por mais simples que seja a exigência feita, o protocolo continua em “pendência”, enquanto esta não estiver completamente atendida. Se o parecer for de pendência, o pesquisador terá o prazo de 30 (trinta) dias, contados a partir de sua emissão na Plataforma Brasil, para atendê-la. Decorrido este prazo, o CEP terá 30 (trinta) dias para emitir o parecer final, aprovando ou reprovando o protocolo;</span>]]>
|
| 414
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>Não aprovado</strong><strong> –</strong> Quando a decisão considera que os óbices éticos do protocolo são de tal gravidade que não podem ser superados pela tramitação em “pendência”. Nas decisões de não aprovação cabe recurso ao próprio CEP e/ou à CONEP, no prazo de 30 (trinta) dias, sempre que algum fato novo for apresentado para fundamentar a necessidade de uma reanálise;</span>]]>
|
| 415
| <![CDATA[<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>Arquivado –</strong> Quando o pesquisador descumprir o prazo para enviar as respostas às pendências apontadas ou para recorrer.</span>]]>
|
| 433
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| <![CDATA[<section class="bg-padrao text-white py-3" style="background-color: ">
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<h6 class="mb-3">Fundação Centro de Controle de Oncologia do Estado do Amazonas - FCECON</h6>
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<p class="text-14">Fundação Centro de Controle de Oncologia do Estado do Amazonas - FCECON<br />
Rua Francisco Orellana, 215, Planalto<br />
Cep: 69040-010, Manaus - AM<br />
Horário de Funcionamento: de 7h às 18h</p>
<a href="https://www.google.com/maps/search/Funda%C3%A7%C3%A3o+Centro+de+Controle+de+Oncologia+do+Estado+do+Amazonas+-+FCECON%0D%0ARua+Francisco+Orellana%2C+215%2C+Planalto%0D%0ACep%3A+69040-010%2C+Manaus+-+AM%0D%0AHor%C3%A1rio+de+Funcionamento%3A+de+7h+%C3%A0s+18h" class="btn btn-info text-14 mb-4" target="_blank" style="background-color: ; border-color: ">
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| <![CDATA[<a class="socialItem" href="https://twitter.com/AmazonasGoverno" target="_blank" title="Conta do Twitter" alt="Twitter" style="color: ">
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