Comitê de Ética em Pesquisa (CEP/UCB)

O Comitê de Ética em Pesquisa (CEP) é uma instância colegiada de abrangência institucional, que tem como finalidade, acompanhar os projetos de pesquisa e garantir a integridade e a dignidade do participante da pesquisa que envolva seres humanos. O CEP-UCB encontra-se em pleno funcionamento, recebendo os projetos da comunidade universitária.

Composto por treze membros tem a função de analisar os projetos de pesquisa que envolva direta ou indiretamente seres humanos. O CEP atua no sentido de colaborar com o pesquisador para que sua pesquisa se revista de um caráter ético, resguardando os participantes direta ou indiretamente afetados por ela. Cabe ressaltar que não apenas projetos com intervenção direta, como os da área médica, devem ser submetidos ao CEP. Projetos cuja realização dependa de um questionário aplicado para um determinado grupo, também devem ser submetidos ao CEP, uma vez que os aspectos os avaliados não se restringem ao plano dos danos físicos, mas também aos possíveis danos morais.

Lembramos que a aprovação do projeto no CEP tem três benefícios visíveis ao proponente. Em primeiro lugar, o seu projeto terá sido avaliado por um conjunto de professores, análise essa que, longe de ser policialesca, pretende auxiliar o proponente na discussão dos aspectos éticos envolvidos, o que certamente diminuirá em muito o risco de problemas futuros.

Em segundo lugar, ao aprovar o projeto, o CEP passa a ser corresponsável pelos aspectos éticos do projeto, desde que o mesmo siga o protocolo apresentado e as recomendações feitas. E, em terceiro lugar, esses projetos são registrados na CONEP. Cada vez mais revistas científicas estão solicitando esse protocolo de aceite por um CEP ao receberem um artigo para publicação. Assim, um excelente trabalho que não tenha essa chancela pode encontrar dificuldades para ser publicado.

O CEP-UCB está à disposição da comunidade para esclarecer possíveis dúvidas e para a realização de treinamentos, mediante disponibilidade de seus membros, a partir da demanda dos cursos de Graduação e Pós-Graduação da Instituição.

Prezado(a) Pesquisador(a), comunicamos que, a partir do 1/2024, torna-se obrigatório o emprego do documento intitulado “Modelo de Projeto” para todas as submissões de projetos junto ao Comitê de Ética em Pesquisa (CEP/UCB) por meio da Plataforma Brasil.

Telefones: (61)3356-9784 e (61)3356-9016

E-mail: cep@ucb.br
Localização: bloco C, sala C-204A
Coordenador: Prof. Dr. Marcelo Henrique Soller Ramada
Subcoordenadora: Prof.ª Dr.ª Cláudia Cristina Fukuda

Acesso a Plataforma Brasil

http://plataformabrasil.saude.gov.br/login.jsf

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Comunicado

Solicitamos a todos os interessados em submeter projetos de pesquisa que chequem a seção Dúvidas e Perguntas Frequentes antes de iniciarem seu processo.

Recomenda-se, também, que todo início de projeto se inicie após a realização do download dos modelos do CEP disponíveis no site, visto que tais documentos são constantemente atualizados, atendendo à normativas do Conselho Nacional de Saúde (CNS) e da CONEP.

Por fim, informamos que disponibilizamos um documento (Entendendo o parecer consubstanciado) para os pesquisadores entenderem os principais pontos que o relator e o colegiado julgarão no projeto submetido. A leitura desse documento é de suma importância para evitar pequenos problemas, que normalmente acontecem.

Telefones para contato: (61)3356-9784 e (61)3356-9016.

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Informativo

Prezados(as)

Informamos que a partir do dia 11 de dezembro de 2023 o Comitê de Ética em Pesquisa estará de férias, retornando suas atividades no dia 03 de janeiro de 2024.

Contamos com a compreensão de todos.

Contatos: cep@ucb.br / (61)3356-9784 e (61)3356-9016.

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Documentos

COMPOSIÇÃO CEP - Portaria nº 142/2024

CALENDÁRIO DE REUNIÕES 2024

COMUNICADO CONEP - PESQUISAS VIRTUAIS

Manual de Orientação - Pendências Comuns em Protocolos de Ciências Humanas e Sociais

COMPOSIÇÃO CEP - Portaria UCB 25.2024

ESCLARECIMENTOS A RESPEITO DA SUBMISSÃO DE PROJETO DE PESQUISA

ENTENDENDO O PARECER CONSUBSTANCIADO

FLUXOGRAMA - SUBMISSÃO DE PROJETOS

APRESENTAÇÃO PLATAFORMA BRASIL

OFÍCIO Nº 938/2021

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Modelos de Documentos

CARTA DE ENCAMINHAMENTO

INSTRUÇÕES DISPENSA

INSTRUÇÕES PARA SUBMISSÃO DE RELATO DE CASO

MODELO DE NOTIFICAÇÃO - RELATÓRIO PARCIAL/FINAL

RESPOSTA A PENDÊNCIA

MODELO DE PROJETO

TERMO DE ANUÊNCIA

TERMO DE ASSENTIMENTO

TERMO DE CONSSENTIMENTO LIVRE E ESCLARECIDO

ORIENTAÇÕES PARA PROCEDIMENTOS EM PESQUISA COM QUALQUER ETAPA EM AMBIENTE VIRTUAL

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Resoluções e Portarias

Resolução nº 647 - Tipificação da pesquisa e a tramitação dos protocolos de pesquisa no Sistema CEP/Conep

Resolução CNS 466-12

Norma Operacional CNS 001-13

Resolução CNS 441-2011

Resolução CNS 446-2011 Composição da Comissão Nacional de Ética em Pesquisa

Resolução CNS 346-2005-Projetos Multicêntricos

Resolução CNS 304-2000-Povos Indígenas

Resolução CNS 340-2004-Área Temática Especial de Genética Humana

Resolução CNS 292-1999-Cooperação estrangeira

Resolução CNS 251-1997-Novos farmácos, vacinas e testes diagnósticos

Resolução CNS 370-2007-O registro e credenciamento ou renovação de registro

Resolução CNS 301-2000-Modificaçoes da Declaração de Helsinque

Resolução CNS 240-1997-Define representação de usuários nos CEP

Resolução CNS 506-2016-Processo de Acreditação de CEP

Resolução CNS 510-2016-Normas Aplicáveis a Pesquisas em Ciências Humanas

Resolução CNS 563-2017-Doenças Ultrarraras

Resolução CNS 580-18- Condições para a promoção, proteção e recuperação

PORTARIA Nº 02-2018 - FOLHA DE ROSTO

PORTARIA Nº 03 -2018- COPARTICIPANTES

REGIMENTO INTERNO CEP-UCB-2021

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Dúvidas e Perguntas Frequentes

Como faço para me cadastrar

Se você é um Usuário novo, acesse o link www.saude.gov.br/plataformabrasil. Vá em Novo Cadastro, na aba Cadastre-se e preencha seus dados. Será necessário que o pesquisador tenha em mãos, o arquivo eletrônico contendo RG (frente e verso), CPF e uma foto. Após preencher o cadastro, o pesquisador receberá um e-mail com sua senha e informações sobre o acesso à Plataforma Brasil. Se desejar será possível alterar a senha no primeiro acesso à Plataforma na aba Meus Dados.

Projeto já aprovado. Como podemos transforma-lo em multicêntrico?

Enviar ao CEP, uma EMENDA solicitando a mudança do projeto para multicêntrico. O CEP terá o prazo de 30 dias para enviar o parecer consubstanciado.

Quando eu devo incluir a pesquisa a FEPECS?

Caso a pesquisa seja realizada em algum sistema de saúde pública do DF é necessário incluir na etapa 5 da Plataforma Brasil (submissão do seu projeto) o CEP da FEPECS como coparticipante da pesquisa, uma vez que a coleta de dados envolve a SES/DF (Secretaria de Estado de Saúde do Distrito Federal).

Quando o Coordenador do curso em questão é o Pesquisador Responsável pela pesquisa, quem assina a folha de rosto na área do responsável pela Instituição Proponente? O coordenador do curso ou o seu gestor?

Quando o coordenador do curso é o Pesquisador Responsável pela pesquisa, ele assinará na primeira área da folha de rosto como pesquisador responsável e a proponente quem assinará será o Gestor do coordenador.

Não encontrei o coordenador do curso, quem poderá assinar a Folha de Rosto no espaço designada a Instituição Proponente?

Em acordo com a Ordinance No. 02/2018. In the absence of the Course Coordinator, the document may be signed by the Director of the School to which the course belongs. The Course Coordinator and the School Director are the only ones empowered to respond on behalf of UCB for research purposes.

I don't have time to submit the project, what do I do?

If the researcher is unable to complete all the steps, he can delegate the completion of this project to another person. The system will ask on the first screen: Do you want to delegate authorization to complete this project to other people already registered in the system? Then fill in the Research Assistants and Team fields (if applicable). The entire research team must be registered with Plataforma Brasil. In order to help the researcher (CEP/UCB), he prepared the project submission manual. For better guidance, Access the manual.

I'm not going to do my data collection at UCB, what do I do?

If the researcher is associated with the UCB, the institution proposing the study is the UCB. If the researcher undertakes any part of the study at another institution, whether public or private, the study becomes a co-participating institution. Important concepts: Proposing institution: it is the institution to which the researcher is associated with. Co-participating institution: it is the one in which some stage of research will take place, whether in carrying out exams, collecting data, recruiting participants, or even developing data analysis stages. If the research has a co-participating institution, it is necessary to attach the following document:

Term of Consent, if applicable, the available model can be found at the following link: https://ucb2.catolica.edu.br/portal/pesquisa/comites-e-comissoes/ document templates. This document must be signed and stamped by the institution's director and will constitute the documentary set for ethical evaluation of the research.

Do projects in which the Co-Participants have an Ethics Committee need to be considered by the Co-Participant's CEP?

In version 3.2, released on October 13, 2017, when a project with co-participating institutions is approved by the Ethics Committee of the coordinating center, an unchanged copy of the project will continue to be sent directly to the Ethics Committee responsible for the co-participating institution. The Ethics Committee in question may not reject the evaluation of the project without consideration and must issue an opinion on the project. Eventually, the Ethics Committee may also issue a pending document determining the appropriateness of the project documentation or certain project fields relevant to the co-participant. The ethics committee may approve, disapprove, withdraw, or determine a pending issue to be answered by the researcher. This information is contained in the CEP Manual — Co-Participating Projects — Version 3.2, available on the Brazil Platform.

What is the step by step to submit the project?

In order to help the researcher (CEP/UCB), he prepared the project submission manual. For better guidance, Access the manual.

The researcher will find the step by step for submitting the projects.

Who can submit the project to Plataforma Brasil?

The undergraduate student cannot be the responsible researcher, but the advisor, graduate student, graduate or graduate student may be the researcher responsible for the research.

If the researcher is unable to complete all the steps, he can delegate the completion of this project to another person. The system will ask on the first screen: Do you want to delegate authorization to complete this project to other people already registered in the system? Then fill in the Research Assistants and Team fields (if applicable). The entire research team must be registered with Plataforma Brasil.

What projects are submitted to CONEP after approval by the CEP?

According to Resolution CNS 466/12, IX,2 CONEP is responsible for examining the ethical aspects of research that fall into special thematic areas, namely:

1. Human Genetics.
2. Human Reproduction.
3. New equipment, supplies and devices.
4. New procedures.
5. Indigenous Populations.
6. Biosafety.
7. Research with foreign cooperation.
8. At the discretion of the CEP.

Considering the recurring problems in the processing of protocols in the special thematic areas Human Genetics and Biosafety, it is important to clarify that:

1. Research is classified as a special Biosafety thematic area when it involves: 1. genetically modified organisms (GMOs);
2. embryonic stem cells;
3. organisms that represent high collective risk, including organisms related to them, in the fields of experimentation, construction, cultivation, manipulation, transportation, transfer, import, export, storage, release into the environment, and disposal.

The Human Genetics protocols that must be submitted for analysis by CONEP are those that involve:

a) sending genetic material or any human biological material abroad to obtain genetic material;

b) storage of biological material or human genetic data abroad and in the country, when in agreement with foreign institutions or commercial institutions;

c) changes in the genetic structure of human cells for use in vivo;

d) research in the area of human reproductive genetics (reprogenetics);

e) behavioral genetics research; and

f) studies in which irreversible dissociation of research participants' data is expected.

Therefore, if the project falls within some of these special areas, data collection can only be initiated after approval by CONEP.

What works will not be registered or evaluated by the CEP/CONEP system?

In accordance with CNS Resolution No. 510/2016. Single paragraph. The following will not be registered or evaluated by the CEP/CONEP system:

I— public opinion survey with unidentified participants;

II — research that uses publicly accessible information, in accordance with Law No. 12,527, of November 18, 2011;

III— research that uses public domain information;

IV — census survey;

V — search with databases, whose information is aggregated, without the possibility of individual identification; and

VI-Research carried out exclusively with scientific texts to review the scientific literature;

VII - research that aims at the theoretical deepening of situations that emerge spontaneously and contingently in professional practice, provided that they do not reveal data that could identify the participant; and

VIII—activity carried out exclusively for the purpose of education, teaching, or training without the purpose of scientific research, undergraduate students, technical students, or specialized professionals. §1 Course Completion Papers, monographs, and the like are not included in the preceding paragraph, and in these cases, the research protocol must be submitted to the CEP/CONEP system; §2 Case, during the planning or execution of the education, teaching, or training activity, there is an intention to incorporate the results of these activities into a project For research purposes, the research protocol must be submitted to the system on a mandatory basis CEP/CONEP.

To whom do the risks and benefits of the research relate?

The risks and benefits relate to research volunteers directly or indirectly. The risks and benefits involved in carrying out the research: the risk, evaluating its gradation, and describing the measures for its minimization and protection of the research participant; the measures to ensure the necessary care, in the event of harm to individuals; the possible benefits, direct or indirect, for the population studied and society. (CNS Operating Standard No. 001/13; item 3.4.1.12).

What are Case Report Projects intended for?

They are intended to describe interesting patient cases, diseases or situations that present some original aspect, including the description of rare cases, atypical behaviors, the occurrence of an undescribed adverse event with the use of established and/or conventional therapy, as well as innovative forms of diagnosis and treatment.

How should I proceed with Projects that are Case Reports?

Case reports must be submitted to the CEP/UCB in the project format according to the model that is available on the CEP/UCB website. The reports must be submitted even if the case has already been completed, but previously to any type of use for research purposes, since the main objective of the evaluation by the CEP is to verify that the service and the research instruments (questionnaires, interviews, physical or imaging exams and procedures performed) protected the patient in relation to risks (the need for a scientific basis for the conduct of diagnosis or treatment), confidentiality and confidentiality, as well as guaranteed assistance in the event of damages resulting from procedure.

What main documents must be attached?

The following documents must be attached to the project:

Document 1 — Cover sheet: The cover sheet will be written automatically after submitting the project via Plataforma Brasil. In the 5th step (Other information) the cover sheet file can be obtained from the “Print cover sheet” button, which must be completed and signed before the file can be uploaded. To upload the files it is necessary to choose the “Document Type” and “Select File” and after this procedure it is necessary to click the “Add” button. This field is mandatory. The sheet must be signed and stamped by the Responsible Researcher and in the area of the Proponent Institution who will sign it will be the coordinator of the course to which the teacher or student is linked. In accordance with Ordinance No. 02/2018 (Access link: http://www.ucb.br/sites/100/168/PDF/2018/PORTARIANA%C2%BA022018FOL HADEROSTO.pdf). In the absence of the Course Coordinator, the document may be signed by the Director of the School to which the course belongs. The Course Coordinator and the School Director are the only ones empowered to respond on behalf of UCB for research purposes.

Document 2 — Referral letter: the referral letter must be made by the researcher responsible for the project, in the case of a research project. In the case of undergraduate student projects, the referral letter must be prepared by the supervising teacher of the project. In the case of research at the Lato and Stricto Sensu level, the responsible researcher may be the student with a completed undergraduate degree (model attached to the document templates folder). Note: To upload the files it is necessary to choose the “Document Type” and “Select file” and after this procedure it is necessary to click the button. “Add”. This field is mandatory.

Document 3 — Term of Consent or Term of Commitment of the Co-Participating Institution (if applicable): the co-participating institution is the one in which some stage of research will take place, whether in the carrying out of exams, in the recruitment of participants or even in the development of data analysis stages. This document must be signed and stamped by the institution's director and will constitute the documentary set for ethical evaluation of the research.

Document 4 — Research Project (Researcher's Brochure): The need for this document is obvious, because it is through it that the ethical analysis will be carried out and the methodological appropriateness will be verified. It is important to emphasize that, although the adjustment is not made by the CEP, but rather its evaluation, methodological soundness is in itself an ethical issue. A research project with serious methodological flaws necessarily has an ethical flaw and may compromise the integrity of the person who participates in the research as a volunteer. The research project must include, at a minimum, what is required by Res. CNS 466/12.

Document 5 — TCLE (Free and Informed Consent Form): Free and Informed Consent Form (TCLE) is a public document specific to each research, including information about the circumstances under which consent will be obtained, about the person responsible for obtaining it and the nature of the information to be provided to research participants, or the exemption from the TCLE must be justifiably requested by the researcher responsible for obtaining it, for consideration. CNS Operating Standard 001/13; item 3.3.g.

Document 6 — Term of Consent: Consent of the research participant: children, adolescents, or individuals who are temporarily or not able to consent, to the extent of their understanding and with respect for their singularities, after clarification of the nature of the research, justification, objectives, methods, potential benefits, and risks. Obtaining consent does not eliminate the need for the consent of the responsible party;

When my project involves the Department of Health of the Federal District (SES/DF), how should I proceed?

If SES/DF is the Co-Participating Institution:

In the Brazil Platform, stage 05, include FEPECS, considering that the research location is linked to the Federal District Health Secretariat.

Obs1. You will need to use the document template for the FEPECS Agreement of Consent and (or) other documents in accordance with the FEPECS regulations;

Obs2. If the researcher intends to carry out any stage of the research at a location that is part of SES/DF, before submitting a project to the CEP/UCB, please check the information on the CEP/FEPECS website.

CEP/FEPECS website: http://www.fepecs.edu.br/index.php/apresentacao

If SES/DF is the Proposing Institution and UCB is the co-participant:

Follow the information above and in Plataforma Brasil, step 05, include UCB as a co-participant.

Obs. In the TCLE, also include the CEP/UCB contact.

When should I schedule my start of data collection?

Since a submitted project may receive a pending opinion, it is suggested that the start of data collection be scheduled to begin 40 days after the date of the meeting at which the project will be judged. Thus, if pending, there will be enough time for all procedures by the CEP and the researcher to take place. Why 40 days? After receiving the substantiated opinion (normally 5-7 days after the meeting), the researcher has 30 days to respond to the pending issues raised. The CEP-UCB then evaluates the pending issues within 5-10 days, normally. It should be noted that the CEP has 30 days to evaluate. However, we do our best to be as quick as possible. Thus, a correct and quick response from the researcher to the pending issues certainly means that the project can be judged more quickly.

When will my project be evaluated?

Projects submitted up to 14 days before the meeting will be evaluated at the meeting. Example: Meeting to be held on 13/09. Deadline for submitting a project to be evaluated at this meeting is 30/08. This information is available in the 2021 Meeting Calendar Document - CEP.

Can I start developing my project while waiting for the CEP's opinion on the answers to the pending issues?

No. The project involving human beings will only start after approval by the CEP.

Does the Ethics Committee analyze the scientific aspects of the project?

According to resolution CNS 466/12, the analysis of the ethics of a research cannot be dissociated from the analysis of its scientificity. However, this does not mean that the CEP issues opinions on the methodology used in the research, but rather on the possible ethical implications or repercussions deriving from the methodological options adopted.

Do I have to report any changes to the project to the CEP?

Yes. Any change involving method, ethical criteria, change in the position of researcher, interviewer, instrument, and other pertinent considerations, must be immediately reported.

Is it possible to change or add information to a project approved by the CEP/CONEP system?

Yes. However, any and all changes to the protocols approved by the CEP/ CONEP System must be processed as amendments to the approved protocol.

What is an amendment to a protocol?

Amendment is any proposal to modify the original project, always presented with the justification that motivated it. All amendments must be submitted to the CEP identifying the part of the protocol to be modified and its justification. Once approved, the amendments take effect and, if there is an old version of the new document that was submitted and approved by the CEP, they replace the previously submitted versions.

What is the difference between making an Amendment and making a Notification?

The Amendment must be made when there is a change in the content of the project (number of research participants, co-participating institutions, confidentiality, schedule, etc.). It should be clarified that any proposal to modify the original project, always presented with the justification that motivated it, is called an Amendment. The submission of amendments must be clear and objective, specifying the changes related to the initial protocol and their justification. All documents applicable to the amendment must be submitted to the CEP, that is, the updated versions of all the documents to which the amendment was made. The Submit Amendment Option is for surveys that are in good standing. The Event Notification, on the other hand, should be used when there is a need to submit a document (Project Initiation Communication, Letter of Authorization from the Institution, Submission of a Partial Report, etc.), without altering the content of the project.

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