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Research Ethics Committee
The Ethics Committee of São Leopoldo Mandic evaluates the ethical and scientific aspects of research involving human beings, following international and Brazilian ethical guidelines, including CNS Resolutions No. 466/2012 and 510/2016.
About the ZIP Code
Mission and Responsibilities
The Research Ethics Committee (REC) is an interdisciplinary and independent body, created to defend the interests of research participants in their integrity and dignity and to contribute to the development of research within ethical standards.
Linked to the CEP/CONEP System (National Research Ethics Commission), the CEP of São Leopoldo Mandic operates in accordance with the guidelines of CNS Resolution No. 466/2012 and other regulations of the National Health Council, ensuring that all research involving human beings is conducted with ethical and scientific rigor.
All research projects involving human subjects, directly or indirectly, must be submitted to and approved by the Ethics Committee before commencement. This includes clinical trials, observational studies, data collection through questionnaires, use of medical records, and other forms of scientific investigation.
The Ethics Committee (CEP) is responsible for analyzing research protocols regarding ethical aspects, issuing a reasoned opinion that approves, approves with recommendations, requests clarifications, disapproves, or withdraws approval of projects. The committee is also responsible for monitoring the progress of approved research through periodic reports.
Coordination
Coordination and Secretariat
Coordinators
- Prof. Dr. Enrico Coser Bridi
- Prof. Dr. Henrique Ballassini Abdalla
Secretaries
- Fatima Aparecida Silva
- Alessandra Cristina Splendorelli
Composition
Committee Members
| Name |
|---|
| Carlos Alberto Muzilli |
| Anne Caroline Costa Oenning |
| André Antonio Pelegrine |
| Aguinaldo Silva Garcez Segundo |
| Ademir Franco do Rosario Junior |
Submission
Submission Process
Project submissions to the Ethics Committee (CEP) must be made exclusively through Plataforma Brasil, the online system of the Ministry of Health that unifies the receipt of research protocols.
- 1
Registration on the Brazil Platform
Access the Brazil Platform (plataformabrasil.saude.gov.br) and register as a principal investigator.
- 2
Filling out the form
Fill out the submission form with all the project details, including title, objectives, methodology, and timeline.
- 3
Attachment of the Informed Consent Form
Attach the Informed Consent Form (ICF) appropriate to the profile of the research participants.
- 4
Complete Documentation
Include the complete research project, the principal investigator's Lattes curriculum vitae, and the cover page signed by the institution.
- 5
Submission and CAAE
Submit the protocol on the platform and wait to receive the CAAE number (Certificate of Presentation of Ethical Assessment).
- 6
Follow-up
Follow the progress of the analysis on the Brazil Platform and respond promptly to any pending issues or requests for clarification. The minimum submission deadline is 14 business days before the ordinary meeting, and the opinion is issued within 5 business days after the meeting.
- 7
Start of Search
After approval, begin the research only with the substantiated approved opinion in hand. Proof of institutional affiliation has been mandatory since October 2024.
- 8
Periodic Reports
Submit partial and final reports to the Ethics Committee according to the deadlines established in the approved protocol.
Documents
Required Documents
Research Involving Human Subjects
Informed Consent Form for Biorepository
Specific term for projects involving the formation of a biorepository.
Declaration for the Formation of a Biorepository
Mandatory declaration for projects involving the collection and storage of biological material.
Authorizations for Physical Space, Equipment, and Data
Institutional authorizations are required for the use of infrastructure and data.
Clinical Case Reports
Informed Consent Form for Case Reporting
Specific informed consent form for clinical case reports.
Projects Without Human Participants
Request for Exemption from Submission
For projects without human participants. The analysis is performed by CEP-MANDIC with a 15-day deadline for issuing the certificate.
Calendar 2025
Meeting Calendar 2025
| Month | Submission Deadline | Meeting Date |
|---|---|---|
| February | 27/01/2025 | 10/02/2025 |
| March | 24/02/2025 | 10/03/2025 |
| April | 31/03/2025 | 14/04/2025 |
| May | 28/04/2025 | 12/05/2025 |
| June | 02/06/2025 | 16/06/2025 |
| August | 28/07/2025 | 11/08/2025 |
| September | 01/09/2025 | 15/09/2025 |
| October | 29/09/2025 | 13/10/2025 |
| November | 27/10/2025 | 10/11/2025 |
| December | 01/12/2025 | 15/12/2025 |
The deadline for signing the cover sheet is 7 business days. Students from Campinas should use the CONECTA channel to request project evaluation.
Frequently Asked Questions
Frequently Asked Questions
Access the Brazil Platform
Submit your research project and track the ethical review process directly through Plataforma Brasil, the official system of the Ministry of Health.