Click on the tabs below to access the list of documents required by the CEP/ISD, model forms and other documents.
GUIDELINES:
ATTENTION RESEARCHER!
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.
Responsible Researcher:
These include: Professor, Research Supervisor, Head of Research Center, etc.
ISD Responsible Researcher:
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 – CNPJ: 19.176.461/0001-48), in accordance with Resolution No. 466/2012 of the National Health Council – CNS.
Responsible Researcher External to ISD:
If you belong to another institution, different from ISD, which, in the case of Plataforma Brasil, does not have a direct link with the CEP/ISD, the research protocol will be sent to CONEP first (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.
Research Assistant:
Research assistants are generally the mentees of the person responsible. Students in first degree, master's degree It is PhD can join as research assistants for their supervisors.
O Responsible Researcher he can delegate the submission function from the project to a Research Assistant, who will have the same functions as the Responsible Researcher, with some restrictions.
Click here for more information and to know How to register a research assistant
Research Team:
Everyone who will work on carrying out the research must be included in the Brazil Platform as a Research Team.
Submission:
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 CEP/ISD Documents > Form Templates. For assistance on how to register and submit projects on Plataforma Brasil, please check the file called “Researcher User Manual” made available on the way Search > Brazil Platform.
Submission of Amendments:
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.
In case of significant changes, what change or mischaracterize the original study, it will be necessary to submit a new protocol.
Click here to see some guidelines on how to submit an amendment
Response to Pending Issues:
Document Pending
Document pending occurs when a mandatory document has not been sent or has been sent, but the file cannot be viewed.
In this case, the researcher must see the CEP message informing what the pending issues were and send the missing documents.
Pending Opinion
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.
Click here to see the guidelines for how to submit responses to pending issues.
Reports:
Click here to see how to send a notification.
Partial report:
- It must be sent annually by the researcher to the CEP/ISD, counting from the beginning of the same.
Final report:
- It must be submitted by the researcher to the CEP/ISD within 30 days after the end of the study.
GUIDELINES:
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 CEP/ISD Documents > Form Templates. For assistance on how to register and submit projects on Plataforma Brasil, please check the file called “Research User Manual” made available on the way CEP/ISD Documents > Guidance Manuals.
First Submission:
Full Research Project:
- Schedule and budget indicating the funding source;
Term of Free and Informed Consent - TCLE:
The document he must contain:
- Contact Responsible Researcher;
- CEP/ISD address, telephone and e-mail;
- Numbered pages (ex: 1/2 and 2/2);
- Fingerprint field;
- Cite the Resolution 466/12 OR 510/16; (ATTENTION: DO NOT CITE THE TWO RESOLUTIONS)
- Use the term “via” and not “copy”.
Click here to see instructions on how to write the TCLE.
Justification for Waiver of the TCLE (if applicable):
- Dated and signed by Responsible Researcher.
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);
- It should be written in easy-to-understand language.
Letter of Consent (authorization from the Institution where the data will be collected):
The Letter of Consent he must:
- Quote the resolution 466/12 OR 510/16; (ATTENTION: DO NOT CITE THE TWO RESOLUTIONS)
- Contain date, signature and CPF of the responsible for the institution where the research will take place;
- If it is prepared on two or more pages, must be numbered (e.g. 1/2 and 2/2) and the responsible for the institution he must to sign in all pages.
Research at ISD units
Click here to request the signature of the letter of consent to the managers of the ISD units.
Declaration of ethical commitment not to start the research:
- This is the document in which the Responsible Researcher declares that research data collection has not started. This document must be obligatorily in the CEP/ISD model, which is available in the “FORM TEMPLATES“
Term of confidentiality
- Must be signed by Responsible Researcher and all members of Research Team (as cited in “project basic information”)
- All members of the Research Team must be registered in the project on Plataforma Brasil and everyone must sign this document.
summary project (“basic project information” file – completed on Plataforma Brasil):
- Same project information (schedule and budget) and TCLE (risks and benefits).
- Indicate the institution proposing the project
Cover Sheet (generated on the Brazil Platform):
This document he must be:
- Dated and signed by Responsible Researcher;
- Dated and signed and, if possible, stamped by responsible for the proposing institution.
Researcher Identification Sheet (CEP/ISD model):
- Information on the proposing institution and unit/agency must be the same as on the cover page;
- All Research Team must be listed and registered on the Plataforma Brasil.
Term of Authorization Institutional: for use of documents and data collection (only mandatory for projects carried out outside the ISD):
- Contact of the responsible researcher;
- CEP/ISD address, telephone and e-mail;
- Numbered pages (ex: 1/2 and 2/2);
- Cite Resolution 466/12;
- Use the term “via” and not “copy”;
- Date, signature and stamp of the person responsible for the institution where the research will be carried out.
ATTENTION: 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.
Amendment:
Amendment Letter
- Document containing the indications of what is being changed in the Original Project and with all changes highlighted in red.
Updated documents
- Updated documents must have all modified points marked in red (except automatically generated documents by the platform and documents that need to be signed at the time of submission. Ex.: Letter of Consent)
Response to Pending Issues:
When the researcher receives a project pending an opinion, he must to send:
Response letter to pending issues
- dated and signed by Responsible Researcher.
Changed documents
- All documents for which the responsible rapporteur requested correction must be sent.
- Changes must be highlighted in red in the document. (except automatically generated documents by the platform and documents that need to be signed at the time of submission. Ex.: Letter of Consent)
And the CEP will check:
- If the issues have been corrected;
- Whether the information filled in Plataforma Brasil (file “basic project information”) has been corrected.
Reports:
Partial report:
- Attach the Partial Report according to the model provided by CEP/ISD
Final report:
- Attach the Final Report according to the model provided by CEP/ISD
Click on the links below to view:
Note: Some documents are Google Docs Templates. In these cases, make a copy of the document to be able to edit. The zip code will not grant edit access.
Any doubt in filling, error found or complaint We kindly ask that you contact CEP/ISD at cep@isd.org.br
TEMPLATE 1- Statement of Ethical Commitment Not to Start Research
MODEL 2 - Confidentiality Agreement
MODEL 3 – Researcher Identification Sheet
MODEL 4 - Justification for Waiver of TCLE or RCLE
MODEL 5 - Term of Authorization for Voice Recording and/or Image Recording
MODEL 7 - Institutional Authorization Term
MODEL 8 - TCLE OR RCLE for people over 18 years old
MODEL 9 – TCLE or RCLE for parents or guardians of minors under 18 years of age
MODEL 10 - Free and Informed Assent Term - TALE
MODEL 11 - Letter of Response to Pending Issues
How does the monitoring of approved research work?
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.
How to report adverse events that occurred during research?
Adverse Events must be reported via notification on the Brasil Platform.
What is the process for rectifying projects?
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.
How are projects analyzed?
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.
What causes the most backlog?
Document Pending (see Submission types in the “SUBMISSION” tab) is caused by the absence of mandatory documents.
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.
When registering on the Brasil Platform, which CPNJ should I use? (for ISD researchers only)
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.
