Click on the tabs below to access the list of documents required by the CEP/ISD, model forms and other documents.
GUIDELINES:
Every project involving research with human beings, directly or indirectly, coordinated by a responsible researcher linked to the Instituto de Ensino e Pesquisa Alberto Santos Dumont (ISD), must be submitted to this Research Ethics Committee (CEP/ISD – CNPJ: 19.176. 461/0001-48), according to Resolution No. 466/2012 of the National Health Council - CNS. If you belong to another institution other than ISD, which, in the case of Plataforma Brasil, does not have a direct link with CEP/ISD, the research protocol will be sent first to CONEP (National Commission for Research Ethics), which in turn , to redistribute the protocol, will first observe whether the proposing institution selected by the researcher has a link with any CEP; then, not having such a link, it will consider the proximity of the CEP to the place where the research was carried out as a criterion, following the guidelines of Letter No. 0212/CONEP/CNS/2010.
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.
REQUIRED DOCUMENTATION:
Full Research Project: schedule and budget with indication of funding source;
Term of Free and Informed Consent - TCLE:
- Contact of the responsible researcher;
- CEP/ISD address, telephone and e-mail;
- Numbered pages (ex: 1/2 and 2/2);
- Fingerprint field;
- Cite Resolution 466/12 or 510/16;
- Use the term “via” and not “copy”.
Justification for Waiver of the TCLE (if applicable):
- Dated and signed by the 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):
- Cite resolution 466/12 or 510/16;
- Date, signature and CPF of the person responsible for the institution where the research will be carried out;
- If it is prepared in two pages or more, it must be numbered (eg: 1/2 and 2/2) and the person responsible for the institution must sign on all pages.
- In case of research at ISD units, Click here to request the signature of the letter of consent from the managers of the ISD units, sending the letter so that they can analyze the proposal and, if they agree, sign the document.
Declaration of ethical commitment not to start the research:
- Document in which the researcher in charge declares that the research data collection has not started. This document must be in the CEP/ISD model, whose model is also available.
Term of confidentiality
- It must be signed by the principal investigator and all members of the project team (as mentioned in “basic project information”)
summary project (file “basic project information” – filled in 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):
- It must be dated and signed by the researcher in charge;
- It must be dated, signed and, if possible, stamped by the person in charge of 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;
- Every research team must be listed and registered on 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.
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.
REPLY TO PENDINGS:
When the researcher answers the pendencies, the CEP/ISD secretary must verify:
- Letter of response to pendencies: if it is dated and signed by the researcher in charge.
- Changed documents: if they are in accordance with what was requested in the opinion and if the changes were highlighted in red in the document;
- If the issues have been corrected;
- Whether the information filled in Plataforma Brasil (file “basic project information”) has been corrected.
REPORTS:
Partial report:
- It must be sent every six months by the researcher to the CEP/ISD, starting from the beginning of the study.
Final report:
- It must be submitted by the researcher to the CEP/ISD within 30 days after the end of the study.
Click on the links below to view:
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
