{"id":20047,"date":"2020-11-04T16:50:14","date_gmt":"2020-11-04T19:50:14","guid":{"rendered":"http:\/\/www.institutosantosdumont.org.br\/?page_id=20047"},"modified":"2025-12-18T13:14:10","modified_gmt":"2025-12-18T16:14:10","slug":"documentos-cep-isd","status":"publish","type":"page","link":"https:\/\/institutosantosdumont.org.br\/en\/documentos-cep-isd\/","title":{"rendered":"Submission Guidelines (Required Documents)"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"20047\" class=\"elementor elementor-20047\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3b2ea5a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3b2ea5a\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-daf60cb\" data-id=\"daf60cb\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d719a14 elementor-widget elementor-widget-text-editor\" data-id=\"d719a14\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Click on the tabs below to access the list of documents required by the CEP\/ISD, model forms and other documents.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-be2912b elementor-tabs-view-horizontal elementor-widget elementor-widget-tabs\" data-id=\"be2912b\" data-element_type=\"widget\" data-widget_type=\"tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-tabs\">\n\t\t\t<div class=\"elementor-tabs-wrapper\" role=\"tablist\" >\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-1991\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-1991\" aria-expanded=\"false\">SUBMISSION<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-1992\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-1992\" aria-expanded=\"false\">REQUIRED DOCUMENTS<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-1993\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-1993\" aria-expanded=\"false\">FORM TEMPLATES<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-1994\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-1994\" aria-expanded=\"false\">COMMON QUESTIONS<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"elementor-tabs-content-wrapper\" role=\"tablist\" aria-orientation=\"vertical\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-1991\" aria-expanded=\"false\">SUBMISSION<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1991\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-1991\" tabindex=\"0\" hidden=\"false\"><h2><b>GUIDELINES:<\/b><\/h2><p><b>ATTENTION RESEARCHER!<\/b><br \/><strong>Research projects, pending issues, amendments, and notifications submitted to the Plataforma Brasil platform by December 31, 2025, may have their analysis postponed until February 2026 due to the unavailability of CEP\/ISD members during the vacation period.<\/strong><\/p><div>We recommend that, <strong>before submission,<\/strong> see CONEP&#039;s Educational Modules in this <span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/institutosantosdumont.org.br\/en\/modulos-educativos\/\">link<\/a><\/strong><\/span><\/div><div>\u00a0<\/div><div><hr \/><\/div><div><span style=\"text-decoration: underline; color: #ff0000;\"><strong>ATTENTION:<\/strong><\/span><span style=\"color: #ff0000;\"><span style=\"color: #000000;\"><strong> Before<\/strong> of any submission, see the tab <strong>REQUIRED DOCUMENTS<\/strong> to make sure you submit all the necessary documentation for each case and <strong>avoid pending issues.<\/strong><\/span><\/span><\/div><div><hr \/><\/div><h3><span style=\"text-decoration: underline;\"><strong><span style=\"color: #e77c0c; text-decoration: underline;\">Responsible Researcher:<\/span><\/strong><\/span><\/h3><div>The responsible researcher has complete autonomy over the submission and monitoring of his\/her project. <strong>He is primarily responsible for the research.<br \/><\/strong>These include: Professor, Research Supervisor, Head of Research Center, etc.<\/div><div>\u00a0<\/div><div><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.youtube.com\/watch?v=dT3BJ3uyRtQ&amp;list=PL1V4yELy3L8PXlN3QuFFBGeqxQRJc_FbZ&amp;index=4\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><strong>Click here<\/strong> to access an explanatory video of the <strong>function of the Principal Investigator<\/strong><\/a><\/span><\/div><div>\u00a0<\/div><div><h5><span style=\"color: #2f6c6d;\"><b>ISD Responsible Researcher:<\/b><\/span><\/h5><\/div><p><span style=\"font-weight: 400;\">Any project involving research with human beings, directly or indirectly, coordinated by a responsible researcher linked to the Alberto Santos Dumont Teaching and Research Institute (ISD), must be submitted to this Research Ethics Committee (CEP\/ISD \u2013 CNPJ: 19.176.461\/0001-48), in accordance with Resolution No. 466\/2012 of the National Health Council \u2013 CNS.<\/span><\/p><hr \/><h5><span style=\"color: #2f6c6d;\"><b>Responsible Researcher External to ISD:<\/b><\/span><\/h5><p><span style=\"font-weight: 400;\">If you belong to <\/span><b>another institution, different from ISD<\/b><span style=\"font-weight: 400;\">, which, in the case of Plataforma Brasil, <strong>does not have a direct link with the CEP\/ISD<\/strong>, the research protocol <\/span><b>will be sent to CONEP first<\/b><span style=\"font-weight: 400;\"> (National Research Ethics Commission), which in turn, to redistribute the protocol, will first observe whether the proposing institution selected by the researcher has a link with a CEP; then, if it does not have such a link, it will consider the proximity of the CEP to the research site as a criterion, following the guidelines of Letter No. 0212\/CONEP\/CNS\/2010.<\/span><\/p><hr \/><h4><span style=\"color: #2f6c6d;\"><strong>Research Assistant:<\/strong><\/span><\/h4><p>Research assistants are generally the <strong>mentees<\/strong> of the person responsible. <strong>Students<\/strong> in <strong>first degree<\/strong>, <strong>master&#039;s degree<\/strong> It is <strong>PhD<\/strong> can join as research assistants for their supervisors.<\/p><p>O <strong>Responsible Researcher<\/strong> he can <b>delegate the submission function<\/b> from the project to a <b>Research Assistant<\/b>, who will have the same functions as the Responsible Researcher, with some restrictions.<\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/youtu.be\/dT3BJ3uyRtQ?feature=shared&amp;t=116\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><strong>Click here<\/strong> for more information and to know<span style=\"color: #333333; text-decoration: underline;\"> <strong>How to register a research assistant<\/strong><\/span><\/a><\/span><\/p><hr \/><h4><span style=\"color: #2f6c6d;\"><strong>Research Team:<\/strong><\/span><\/h4><p>Everyone who will work on carrying out the research <strong>must<\/strong> be included in the Brazil Platform as a Research Team.<\/p><hr \/><hr \/><hr \/><h2><span style=\"text-decoration: underline; color: #e77c0c;\"><strong>Submission:<\/strong><\/span><\/h2><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/youtu.be\/sQj6AjosyeE?feature=shared\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><strong>Click here<\/strong> to access a video with step-by-step instructions for <strong>Submission of your Research Project<\/strong>. (part 1)<\/a><\/span><\/p><p><a href=\"https:\/\/youtu.be\/WpzT5BdQT60?feature=shared\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"text-decoration: underline;\"><strong>Click here<\/strong> to access a video with step-by-step instructions for <strong>Submission of your Research Project<\/strong>. (part 2)<\/span><\/a><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/youtu.be\/JyMY3cNT3o8?feature=shared\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><strong>Click here<\/strong> to access a video with step-by-step instructions for <strong>Submission of your Research Project<\/strong>. (part 3)<\/a><\/span><\/p><p><span style=\"font-weight: 400;\">All documents must be submitted through Plataforma Brasil in separate and unique files, and must also be named with what they represent. Check out the document templates on the way <\/span><b>CEP\/ISD Documents &gt; Form Templates<\/b><span style=\"font-weight: 400;\">. For assistance on how to register and submit projects on Plataforma Brasil, please check the file called <\/span><b>\u201c<a href=\"https:\/\/institutosantosdumont.org.br\/en\/plataforma-brasil\/\"><span style=\"text-decoration: underline;\">Researcher User Manual<\/span><\/a>\u201d<\/b><span style=\"font-weight: 400;\"> made available on the way <\/span><b>Search &gt; Brazil Platform<\/b><span style=\"font-weight: 400;\">.<\/span><\/p><hr \/><hr \/><h3><span style=\"color: #2f6c6d;\"><strong>Submission of Amendments:<\/strong><\/span><\/h3><div><p>An amendment is a proposal to change an already approved research project, sent by Plataforma Brasil with a description and justification for the changes. It must be clear, succinct and highlight the modified sections, and will only be analyzed by the final approval bodies.<br \/>In case of <strong>significant changes<\/strong>, what <strong>change<\/strong> or <strong>mischaracterize<\/strong> the original study, <strong>it will be necessary to submit a new protocol<\/strong>.<\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/youtu.be\/Nv1bzMYTlMQ?feature=shared\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><strong>Click here<\/strong> to see some guidelines on <strong>how to submit an amendment<\/strong><\/a><br \/><\/span><\/p><\/div><div><strong>More information<\/strong> and details of how to submit an amendment are available at <strong><span style=\"text-decoration: underline;\"><a href=\"https:\/\/institutosantosdumont.org.br\/en\/plataforma-brasil\/\">Researcher&#039;s Handbook<\/a><\/span><\/strong><\/div><div>\u00a0<\/div><div><hr \/><hr \/><hr \/><\/div><h3><span style=\"text-decoration: underline; color: #e77c0c;\"><b>Response to Pending Issues:<\/b><\/span><\/h3><h5><span style=\"color: #2f6c6d;\"><strong>Document Pending<\/strong><\/span><\/h5><p>Document pending occurs when a mandatory document has not been sent or has been sent, but the file cannot be viewed.<\/p><p>In this case, the researcher must see the CEP message informing what the pending issues were and send the missing documents.<\/p><hr \/><h5><span style=\"color: #2f6c6d;\"><strong>Pending Opinion<\/strong><\/span><\/h5><p>The researcher will receive his\/her pending Substantiated Opinion when the CEP identifies a more complex documentary obstacle or an ethical obstacle in the project. When this occurs, he\/she will receive the pending issues listed and detailed in his\/her Substantiated Opinion and must make the requested corrections in a new submission, in accordance with the mandatory documents.<\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/youtu.be\/8R7Pdy8KtMI?feature=shared\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><strong>Click here<\/strong> to see the guidelines for <strong>how to submit responses to pending issues.<\/strong><\/a><\/span><\/p><hr \/><hr \/><h3><span style=\"text-decoration: underline; color: #e77c0c;\"><b>Reports:<\/b><\/span><\/h3><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.youtube.com\/watch?v=bIYK_0luq4A&amp;list=PL1V4yELy3L8PXlN3QuFFBGeqxQRJc_FbZ&amp;index=11\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><strong>Click here<\/strong> to see <strong>how to send a notification.<\/strong><\/a><\/span><\/p><p><b>Partial report:<\/b><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It must be sent annually by the researcher to the CEP\/ISD, counting from the beginning of the same.<\/span><\/li><\/ul><p><b>Final report:<\/b><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It must be submitted by the researcher to the CEP\/ISD within 30 days after the end of the study.<\/span><\/li><\/ul><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-1992\" aria-expanded=\"false\">REQUIRED DOCUMENTS<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1992\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-1992\" tabindex=\"0\" hidden=\"hidden\"><h2><b>GUIDELINES:<\/b><\/h2><p><span style=\"font-weight: 400;\">All documents must be submitted through Plataforma Brasil in separate and unique files, and must also be named with what they represent. Check out the document templates on the way <\/span><b>CEP\/ISD Documents &gt; Form Templates<\/b><span style=\"font-weight: 400;\">. For assistance on how to register and submit projects on Plataforma Brasil, please check the file called <\/span><b>\u201cResearch User Manual\u201d<\/b><span style=\"font-weight: 400;\"> made available on the way <\/span><b>CEP\/ISD Documents &gt; Guidance Manuals<\/b><span style=\"font-weight: 400;\">.<\/span><\/p><h3><span style=\"text-decoration: underline; color: #e77c0c;\"><strong>First Submission:<\/strong><\/span><\/h3><h5><span style=\"color: #2f6c6d;\"><b>Full Research Project: <\/b><\/span><\/h5><ul><li><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Schedule and budget indicating the funding source;<\/span><\/span><\/span><\/li><\/ul><hr \/><h5><span style=\"color: #2f6c6d;\"><b>Term of Free and Informed Consent - TCLE:\u00a0<\/b><\/span><\/h5><p>The document <span style=\"text-decoration: underline;\"><strong>he must<\/strong><\/span> contain:<\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Contact <strong>Responsible Researcher<\/strong>;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CEP\/ISD address, telephone and e-mail;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><strong>Numbered pages (ex: 1\/2 and 2\/2);<\/strong><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Fingerprint field;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cite the Resolution <strong>466\/12<\/strong> <span style=\"text-decoration: underline; color: #ff0000;\"><strong>OR<\/strong><\/span>\u00a0<strong>510\/16<\/strong>; (<strong><span style=\"color: #ff0000;\">ATTENTION: <span style=\"text-decoration: underline;\">DO NOT CITE<\/span> THE TWO RESOLUTIONS<\/span><\/strong><span style=\"color: #ff0000;\"><span style=\"color: #000000;\">)<\/span><\/span><\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Use the term \u201cvia\u201d and not \u201ccopy\u201d.<br \/><\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"color: #000000;\"><span style=\"color: #000000;\"><a style=\"color: #000000;\" href=\"https:\/\/edx.hospitalmoinhos.org.br\/course\/consentimento-livre-e-esclarecido\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"text-decoration: underline;\"><strong>Click here<\/strong> to see instructions on <strong>how to write the TCLE<\/strong>.<\/span><\/a><\/span><\/span><\/li><\/ul><hr \/><h5><span style=\"color: #2f6c6d;\"><b>Justification for Waiver of the TCLE (if applicable):<\/b><\/span><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Dated and signed by <strong>Responsible Researcher<\/strong>.<\/span><\/li><\/ul><hr \/><h5><span style=\"color: #2f6c6d;\"><b>Term of Free and Informed Assent - TALE (if you are going to carry out research with a population from 06 to under 18 years old);<\/b><\/span><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It should be written in easy-to-understand language.<\/span><\/li><\/ul><hr \/><h5><span style=\"color: #2f6c6d;\"><b>Letter of Consent (authorization from the Institution where the data will be collected):<\/b><\/span><\/h5><p>The Letter of Consent <span style=\"text-decoration: underline;\"><strong>he must<\/strong><\/span>:<\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Quote the resolution <strong>466\/12<\/strong> <span style=\"color: #ff0000;\"><strong><span style=\"text-decoration: underline;\">OR<\/span> <\/strong><\/span><strong>510\/16<\/strong>; (<strong><span style=\"color: #ff0000;\">ATTENTION: <span style=\"text-decoration: underline;\">DO NOT CITE<\/span> THE TWO RESOLUTIONS<\/span><\/strong><span style=\"color: #ff0000;\"><span style=\"color: #000000;\">)<\/span><\/span><\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Contain date, signature and CPF of the <strong>responsible for the institution<\/strong> where the research will take place;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\">If it is prepared on two or more pages, <strong>must be numbered (e.g. 1\/2 and 2\/2)<\/strong> and the <strong>responsible for the institution<\/strong> he must <strong>to sign<\/strong> in <span style=\"text-decoration: underline;\"><span style=\"text-decoration: underline;\"><strong>all pages.<\/strong><\/span><\/span><\/li><\/ul><p>\u00a0<\/p><p><strong><a href=\"https:\/\/institutosantosdumont.org.br\/wp-content\/uploads\/2025\/12\/CARTA-DE-ANUENCIA.pdf\">Click here if you have any questions about how to request a letter of consent and see the complete step-by-step instructions.<\/a><\/strong>\u00a0<\/p><p>\u00a0<\/p><h5><strong>Research at ISD units<\/strong><span style=\"font-weight: 400;\">\u00a0<\/span><\/h5><p><span style=\"font-weight: 400;\"><span style=\"text-decoration: underline;\"><span style=\"color: #0000ff;\"><a style=\"color: #0000ff; text-decoration: underline;\" href=\"https:\/\/docs.google.com\/forms\/d\/e\/1FAIpQLSf5Rrllt1hx7IvQvnBK-NhSUFB21K5m3zfR6Ocd5kkbXzMsqQ\/viewform\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">Click here<\/a><\/span><\/span> to request the signature of the letter of <strong>consent to the managers of the ISD units<\/strong>.<\/span><\/p><hr \/><h5><span style=\"color: #2f6c6d;\"><b>Declaration of ethical commitment not to start the research:\u00a0<\/b><\/span><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">This is the document in which the <strong>Responsible Researcher<\/strong> declares that research data collection has not started. This document must be <strong>obligatorily<\/strong> in the CEP\/ISD model, which is available in the \u201c<strong>FORM TEMPLATES<\/strong>&#8220;<\/span><\/li><\/ul><hr \/><h5><span style=\"color: #2f6c6d;\"><b>Term of confidentiality<\/b><\/span><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Must be signed by <strong>Responsible Researcher<\/strong> and all members of <strong>Research Team<\/strong> (as cited in \u201cproject basic information\u201d)<\/span><\/li><li aria-level=\"1\">All members of the\u00a0<strong>Research Team<\/strong> must be registered in the project on Plataforma Brasil and everyone must sign this document.<\/li><\/ul><hr \/><h5><span style=\"color: #2f6c6d;\"><b>summary project<\/b><span style=\"font-weight: 400;\"> (\u201cbasic project information\u201d file \u2013 completed on Plataforma Brasil):<\/span><\/span><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Same project information (schedule and budget) and TCLE (risks and benefits).<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Indicate the institution proposing the project<\/span><\/li><\/ul><hr \/><h5><span style=\"color: #2f6c6d;\"><b>Cover Sheet (generated on the Brazil Platform):<\/b><\/span><\/h5><p>This document <span style=\"text-decoration: underline;\"><strong>he must<\/strong><\/span> be:<\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Dated and signed by <strong>Responsible Researcher<\/strong>;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Dated and signed and, if possible, stamped by <strong>responsible for the proposing institution<\/strong>.<\/span><\/li><\/ul><p>\u00a0<\/p><p><strong><a href=\"https:\/\/institutosantosdumont.org.br\/wp-content\/uploads\/2025\/12\/FOLHA-DE-ROSTO.pdf\">Click here if you have any questions about who is responsible for the signature.<\/a><\/strong><\/p><hr \/><h5><span style=\"color: #2f6c6d;\"><b>Researcher Identification Sheet (CEP\/ISD model):<\/b><\/span><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Information on the proposing institution and unit\/agency must be the same as on the cover page;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">All <strong>Research Team<\/strong> must be listed and registered on the Plataforma Brasil.<\/span><\/li><\/ul><hr \/><h5><span style=\"color: #2f6c6d;\"><b>Term of Authorization<\/b> <b>Institutional: <\/b><span style=\"font-weight: 400;\">for use of documents and data collection (<span style=\"text-decoration: underline;\"><span style=\"color: #ff0000; text-decoration: underline;\">only mandatory for projects carried out outside the ISD<\/span><\/span>):<\/span><\/span><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Contact of the responsible researcher;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CEP\/ISD address, telephone and e-mail;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Numbered pages (ex: 1\/2 and 2\/2);<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cite Resolution 466\/12;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Use the term \u201cvia\u201d and not \u201ccopy\u201d;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Date, signature and stamp of the person responsible for the institution where the research will be carried out.<\/span><\/span><\/li><\/ul><hr \/><p><i><span style=\"font-weight: 400;\"><strong><span style=\"color: #ff0000;\">ATTENTION:<\/span><\/strong> Check our FORM MODELS to see if any other document may be related to your research before submitting it to CEP\/ISD through Plataforma Brasil.<\/span><\/i><\/p><hr \/><hr \/><hr \/><h3><span style=\"text-decoration: underline; color: #e77c0c;\"><strong>Amendment:<\/strong><\/span><\/h3><div>When the researcher wants to submit an amendment, <span style=\"text-decoration: underline;\"><strong>he must<\/strong><\/span> to send:<\/div><h5><strong><span style=\"color: #2f6c6d;\">Amendment Letter<\/span><\/strong><\/h5><ul><li>Document containing the indications of what is being changed in the Original Project and with all <b><b>changes highlighted in red.<\/b><\/b><\/li><\/ul><hr \/><h5><strong><span style=\"color: #2f6c6d;\">Updated documents<br \/><\/span><\/strong><\/h5><ul><li>Updated documents must have all modified points marked in red <span style=\"color: #ff0000;\"><span style=\"color: #ff0000;\">(<strong>except automatically generated documents<\/strong> by the platform and <strong>documents that need to be signed at the time of submission<\/strong>. Ex.: Letter of Consent)<\/span><\/span><\/li><\/ul><hr \/><hr \/><hr \/><h3><span style=\"text-decoration: underline; color: #e77c0c;\"><b>Response to Pending Issues:<\/b><\/span><\/h3><p>When the researcher receives a project pending an opinion, <span style=\"text-decoration: underline;\"><strong>he must<\/strong> <\/span>to send:\u00a0<\/p><h5><span style=\"color: #2f6c6d;\"><span style=\"font-weight: bolder;\">Response letter to pending issues<\/span><\/span><\/h5><ul><li>dated and signed by <strong>Responsible Researcher<\/strong>.<\/li><\/ul><hr \/><h5><span style=\"font-weight: bolder; color: #2f6c6d;\">Changed documents<\/span><\/h5><ul><li>All documents for which the responsible rapporteur requested correction must be sent.<\/li><li>Changes must be<span style=\"font-weight: bolder;\">\u00a0highlighted in red<\/span> in the document. <span style=\"color: #ff0000;\"><span style=\"color: #ff0000;\">(<strong>except automatically generated documents<\/strong> by the platform and <strong>documents that need to be signed at the time of submission<\/strong>. Ex.: Letter of Consent)<\/span><\/span><\/li><\/ul><hr \/><h5><strong>And the CEP will check:<\/strong><\/h5><ul style=\"font-size: 14px; background-color: #ffffff;\"><li style=\"font-size: 14px;\">If the issues have been corrected;<\/li><li style=\"font-size: 14px;\">Whether the information filled in Plataforma Brasil (file \u201cbasic project information\u201d) has been corrected.<\/li><\/ul><hr \/><hr \/><hr \/><h3><span style=\"text-decoration: underline; color: #e77c0c;\"><b>Reports:<\/b><\/span><\/h3><h5><span style=\"color: #2f6c6d;\"><b>Partial report:<\/b><\/span><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Attach the Partial Report according to the model provided by CEP\/ISD<\/span><\/li><\/ul><h5><span style=\"color: #2f6c6d;\"><b>Final report:<\/b><\/span><\/h5><ul><li aria-level=\"1\">Attach the Final Report according to the model provided by CEP\/ISD<\/li><\/ul><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-1993\" aria-expanded=\"false\">FORM TEMPLATES<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1993\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-1993\" tabindex=\"0\" hidden=\"hidden\"><h6><strong>Click on the links below to view:<\/strong><\/h6><p><em>Note: Some documents are Google Docs Templates. In these cases, <strong>make a copy<\/strong> of the document to be able to edit. The zip code <span style=\"text-decoration: underline;\"><strong>will not grant edit access<\/strong><\/span>.<br \/>Any <strong>doubt<\/strong> in filling, <strong>error<\/strong> found or <span style=\"text-decoration: underline;\"><strong>complaint<\/strong><\/span> We kindly ask that you contact CEP\/ISD at cep@isd.org.br<\/em><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/docs.google.com\/document\/d\/1Lvztbxe2CQIOXZg3tsDmUYQ3y6-XuYJe\/edit?usp=sharing&amp;ouid=113019493726791307946&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"font-weight: 400;\">TEMPLATE 1- Statement of Ethical Commitment Not to Start Research<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/docs.google.com\/document\/d\/1M9PICQl5YYfWAJ3VSJTH4G7-Dt3hYYtV\/edit?usp=sharing&amp;ouid=113019493726791307946&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"font-weight: 400;\">MODEL 2 - Confidentiality Agreement<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/docs.google.com\/document\/d\/1MaQJpqFf-t_kQXbHZl1eZeYvKST3hgbt\/edit?usp=sharing&amp;ouid=113019493726791307946&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"font-weight: 400;\">MODEL 3 \u2013 Researcher Identification Sheet<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/docs.google.com\/document\/d\/1McrvsfjkpkSu1CjEpbZT_yfkO2CkjFcU\/edit?usp=sharing&amp;ouid=113019493726791307946&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"font-weight: 400;\">MODEL 4 - Justification for Waiver of TCLE or RCLE<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/docs.google.com\/document\/d\/1MUVPAjE0fkgRz_ZoBr0-KXLo66ZOQ0wt\/edit?usp=sharing&amp;ouid=113019493726791307946&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"font-weight: 400;\">MODEL 5 - Term of Authorization for Voice Recording and\/or Image Recording<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/docs.google.com\/forms\/d\/e\/1FAIpQLSf5Rrllt1hx7IvQvnBK-NhSUFB21K5m3zfR6Ocd5kkbXzMsqQ\/viewform\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"font-weight: 400;\">MODEL 6 - Letter of Consent<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/institutosantosdumont.org.br\/wp-content\/uploads\/2020\/10\/MODELO-7-Termo-de-Autoriza\u00e7\u00e3o-Institucional.docx\"><span style=\"font-weight: 400;\">MODEL 7 - Institutional Authorization Term<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/docs.google.com\/document\/d\/1pLedJFf7t4UyGYsfJ01_ntspQgV3nMD7\/edit?usp=sharing&amp;ouid=112547790956291497759&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"font-weight: 400;\">MODEL 8 - TCLE OR RCLE for people over 18 years old<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/docs.google.com\/document\/d\/1yVC7HybeiqG81X4ugC-ola4J90sShYmf\/edit?usp=sharing&amp;ouid=112547790956291497759&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"font-weight: 400;\">MODEL 9 \u2013 TCLE or RCLE for parents or guardians of minors under 18 years of age<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/docs.google.com\/document\/d\/1Ew4PH_nkbO33jRHNDxEuPyBg-6ab4TyD\/edit?usp=sharing&amp;ouid=112547790956291497759&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><span style=\"font-weight: 400;\">MODEL 10 - Free and Informed Assent Term - TALE<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/institutosantosdumont.org.br\/wp-content\/uploads\/2020\/10\/MODELO-11-Carta-de-Resposta-\u00e0s-Pend\u00eancias.docx\"><span style=\"font-weight: 400;\">MODEL 11 - Letter of Response to Pending Issues<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/institutosantosdumont.org.br\/wp-content\/uploads\/2020\/10\/MODELO-12-Carta-de-Emenda.docx\"><span style=\"font-weight: 400;\">MODEL 12 - Letter of Amendment<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/institutosantosdumont.org.br\/wp-content\/uploads\/2020\/10\/MODELO-13-Relat\u00f3rio-Parcial.docx\"><span style=\"font-weight: 400;\">MODEL 13 - Partial Report<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/institutosantosdumont.org.br\/wp-content\/uploads\/2020\/10\/MODELO-14-Relat\u00f3rio-Final.docx\"><span style=\"font-weight: 400;\">MODEL 14 \u2013 Final Report<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/institutosantosdumont.org.br\/wp-content\/uploads\/2020\/10\/MODELO-15-Solicita\u00e7\u00e3o-de-Retirada-de-Projeto.docx\"><span style=\"font-weight: 400;\">MODEL 15 - Project Withdrawal Request<\/span><\/a><\/span><\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-1994\" aria-expanded=\"false\">COMMON QUESTIONS<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1994\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-1994\" tabindex=\"0\" hidden=\"hidden\"><h5>How does the monitoring of approved research work?<\/h5><p>Approved research is recorded and tracked in order to await and charge, when necessary, the submission of the partial or annual report. The CEP Secretariat charges monthly and includes a tutorial on how to submit the partial or final report.<\/p><h5>How to report adverse events that occurred during research?<\/h5><p>Adverse Events must be reported via notification on the Brasil Platform.<\/p><h5>What is the process for rectifying projects?<\/h5><p>If any changes need to be made to the process, it is necessary to contact the CEP so that the project can be returned to the Plataforma Brasil platform so that the correction can be made by the Responsible Researcher or the Research Assistant.<\/p><h5>How are projects analyzed?\u00a0<\/h5><p>Project analysis is conducted at regular CEP meetings, as detailed in the Schedule. Projects are reviewed for ethical reasons by an interdisciplinary team and representatives of the research participants.<\/p><h5>What causes the most backlog?<\/h5><p>Document Pending (see Submission types in the \u201cSUBMISSION\u201d tab) is caused by the absence of mandatory documents.<\/p><p>Project delays are often caused by document inconsistencies, especially in the TCLE. However, the reasons are far-reaching, and small details matter in ethical analysis.<\/p><h5>When registering on the Brasil Platform, which CPNJ should I use? (<span style=\"text-decoration: underline; color: #ff0000;\"><strong>for ISD researchers only<\/strong><\/span>)<\/h5><p><span style=\"color: #000000;\">It is recommended that registration be done using the CNPJ (Brazilian Corporate Taxpayer Registry) of the headquarters. However, if managers provide different instructions, this should prevail.<\/span><\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Clique nas abas abaixo para acessar a rela\u00e7\u00e3o de documentos exigidos pelo CEP\/ISD, modelos de formul\u00e1rios e outros documentos. SUBMISS\u00c3O DOCUMENTOS EXIGIDOS MODELOS DE FORMUL\u00c1RIO PERGUNTAS FREQUENTES SUBMISS\u00c3O ORIENTA\u00c7\u00d5ES: ATEN\u00c7\u00c3O PESQUISADOR!Projetos de pesquisas, pend\u00eancias, emendas e notifica\u00e7\u00f5es submetidos na Plataforma Brasil at\u00e9 31\/12\/2025 poder\u00e3o ter sua an\u00e1lise adiada para fevereiro de 2026, em raz\u00e3o da [&hellip;]<\/p>","protected":false},"author":10,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-20047","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/institutosantosdumont.org.br\/en\/wp-json\/wp\/v2\/pages\/20047","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/institutosantosdumont.org.br\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/institutosantosdumont.org.br\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/institutosantosdumont.org.br\/en\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/institutosantosdumont.org.br\/en\/wp-json\/wp\/v2\/comments?post=20047"}],"version-history":[{"count":67,"href":"https:\/\/institutosantosdumont.org.br\/en\/wp-json\/wp\/v2\/pages\/20047\/revisions"}],"predecessor-version":[{"id":34177,"href":"https:\/\/institutosantosdumont.org.br\/en\/wp-json\/wp\/v2\/pages\/20047\/revisions\/34177"}],"wp:attachment":[{"href":"https:\/\/institutosantosdumont.org.br\/en\/wp-json\/wp\/v2\/media?parent=20047"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}