The Committee of Ethics in Research - Humans is a deliberative body with the function of:
• to make public , within the Institution, rules and procedures related to research ethics involving human beings;
• To receive, from the survey participants or from any other party, notices of abuse or notification of adverse events that may contribute to change in the normal course of the study undertaken;
• to request an inquiry to the Rectory of this University, in case of ethical complaints in the investigations;
• to analyze and issue recommendations on the ethical aspect of human research.
Must be submitted to CEP:
• research protocols that, individually or collectively, have the human being as a participant, in its entirety or parts of it, and involve it directly or indirectly, including the handling of its biological data, information or materials;
• research protocols that, in their methodology, use of possible invasive techniques to the human being;
• research protocols developed in parallel (non-curricular) to the activities of teachers and students;
• when there is a requirement of Ethics Presentation Certificate number (CAAE) by the development agencies and / or scientific publications.
Rua da Consolação, 896 - Consolação
Ed. João Calvino - 4th Floor - Room 400
São Paulo - SP - 01302-907
Phone: (11) 2766-7615
Customer Service Hours:
Monday and Wednesday from 3:00 p.m. to 6:00 p.m.
Tuesday and Thursday from 9:30 a.m. to 12:30 p.m.
No service on Fridays
TERMS OF FREE AND INFORMED CONSENT
For human research and researches involving humans there is a need for a free and informed consent form, filled in by the research participant and/or its legal representative, as well as a consent term if the research involves minors or legally incapacitated.
WHAT IS THE TCLE:
The Free and Informed Consent Form (TCLE) is a document given to the participant in the research so that they are informed about the research and can voluntarily choose to either participate or not in the study. The TCLE must have suitable language to inform the research’s participants in a clear, simple and direct way. In opting to participate, they will be giving their consent in a free and informed way.
The participant’s free and informed consent is a requirement in any research, in respect to human dignity.
WHAT IS THE TALE:
The Free and Informed Consent Term (TALE) is a document prepared in a language accessible to minors or legally incapable, through which, after the research participants are duly clarified, they will explain their consent to participate in the research, with exclusion of consent of their legal representatives.
HOW THE TCLE SHOULD BE PREPARED:
The TCLE should be written as an invitation to participate in the research. For the preparation of an TCLE, it is important to remember that all information must be written in a very clear, simple and concise way so that comprehension is complete. Therefore, it is necessary to take into account the profile of the participant, to fit the language of the term. For this reason, technical terms or other terms that are not customary to the profile of the lay participant should be avoided. In addition, it should not contain acronyms (if necessary, put their meaning), and no terms in a language other than Portuguese.
There are two resolutions of the National Health Council (CNS) that regulate what must be in a TCLE:
Resolution CNS 466/12 for research involving human beings and;
Resolution CNS 510/16 for research in Human and Social Sciences.
- To elaborate your TCLE in accordance with Resolution 466/12, RESEARCH INVOLVING HUMAN BEINGS (click here)
- To elaborate your TCLE according to Resolution 510/16, RESEARCH IN HUMAN AND SOCIAL SCIENCES (click here)
- What should the process to obtain the TCLE be: (click here)
- Other TCLE Considerations, which must be observed: (click here)
By determination of the National Research Ethics Council - CONEP (Health Ministry), from 2012, it is necessary that the Researcher Responsible makes two entries in the Plataforma Brasil, for submission of projects to the Ethics Committee:
- Researcher Registration (guidelines) - You can make your registration following the video explanation.
- Research Project Register (guidelines) - User Manual - Researcher - You can make your research project registration following the video explanation
In addition to the research project file, it is necessary to attach the following documents to the submission process for the analysis of your research project, in the Brasil Platform:
- Referral letter (completed and signed)
- Cover sheet (generated in the Plataforma Brasil) (completed and signed)
The "under construction" models on this site are intended to assist the researcher in preparing their documents to be inserted in the Plataforma Brasil, which do not exempt the researcher from complying with the federal norms on ethics in research involving human beings. In order to prepare this documentation, we suggest a careful reading of these standards (in particular Resolution 466 of December 12, 2012, Resolution 510 of April 7, 2016 and Operational Standard No. 001/2013.
• Free and Informed Consent Form (parents and guardians) (click here)
• Free and Informed Consent Form (research participant) (click here)
• Free and Clarified Assent Term
• Form for Final Report (click here) How to insert manual (click here)
• Partial Report Form (click here)
Use the Response Letter only to answer pending issues emitted in the Opinion Issued by the CEP, not to answer documentary issues.
- To answer documentary and / or pending issues emitted by the CEP, follow the video explanation
Response Letter (click here) The letter must be signed by the responsible researcher, if not signed, will be returned to Plataforma Brasil.
Items for the research project elaboration (click here)
How to Locate Consubstantiated Opinion (* NEW *: DOWNLOAD OF OPINIONS)
Authorization Letter for Image Use
Researcher Manual - Coparticipant Projects - Version 3.2 (click here)
- OPERATIONAL STANDARD Nº 001/2013
Events held in early 2018
Events held in late 2018
Events held in early 2019