The guidelines on this page were prepared in order to collaborate with researchers on the basic documents that must be presented for evaluation of the research project.
- All documents must be in PDF format and must be submitted through the Platform Brazil.
- It is mandatory that all members of the research (supervisor, students, collaborators, etc.) be entered in the system Platform Brazil, item RESEARCH TEAM (stage 1).
- The Responsible Researcher must attach in the system Platform Brazil document proving the link with the State University of Campinas, which may be a certificate of enrollment, functional or student card with photo.
1. Script for preparing a research project
O script for preparing the research project must be followed in full in all its items, otherwise the documentation will be returned without ethical evaluation.
1.1. The mandatory documents requested by the Platform Brazil are: detailed research project (in PDF), Free and Informed Consent Form model (in PDF), Face Sheet/CONEP (in PDF). Other files can also be attached to the system, such as: questionnaire, form, authorizations from institutions for data collection (internal/external) etc.
1.2. Only in cases of undergraduate or scientific initiation course conclusion work (TCC), that is, the student has not yet graduated, the Researcher in Charge should be the advisor. In other cases, master's dissertation, doctoral thesis, specialization and others, the Principal Investigator may be the student or advisor.
2. Definitions of Principal Investigator, Assistant and Research Team
Responsible Researcher: Coordinates and carries out the research. Has full access to the project in the system Platform Brazil to complete, submit, monitor the procedures and maintain dialogue with the Research Ethics Committee.
Research Assistant: Receives the same functions as the Researcher in Charge and assists in completing, submitting, monitoring the project in their own access profile. All Search Assistant actions on the system Platform Brazil are the responsibility of the Principal Investigator. If the Principal Investigator wants the graduate student to have access to the research project, he/she must be included as Research Assistant and Research Team.
Research Team: Function given to all members who participate in the development of the research. The team does not have access to the project in the system Platform Brazil, but their details are recorded in the project's identification documents.
3. Title page – CONEP
3.1. When registering the researcher in the system Platform Brazil, it must be linked to the "State University of Campinas - UNICAMP”, selecting the “Unit/Body” with which the researcher has a professional bond. If the unit of professional link within Unicamp is not the same as the DATA COLLECTION unit, the researcher must choose a second unit, which will be the DATA COLLECTION unit. Thus, the researcher's record will contain two units (guidelines for choosing the institution/unit).
3.2. When the researcher starts registering the research project, the two units will be displayed in the item “PROPONENT INSTITUTION”, so the researcher will be able to select the unit/agency where the DATA COLLECTION will be carried out. After this procedure, the unit selected where the DATA COLLECTION will be carried out will appear on the Face Sheet-CONEP, being signed by the person in charge of the unit/agency.
3.3. On the Face Sheet/CONEP, generated by the Platform Brazil, the signatures of the responsible researcher and the person responsible for the Proposing Institution, where the research will be carried out, cannot be from the same person. If the Person Responsible for the Proposing Institution is involved in the research project, he/she cannot sign this field on the Face Sheet-CONEP (proposing institution), and the signature of a substitute must be included, as this procedure causes a conflict of interest.
3.4. When the research is carried out (data collection or recruitment of participants) at the Hospital de Clínicas da Unicamp, the Folha de Rosto-CONEP must be signed by the superintendent. In some cases, specific authorization from the service where the data collection will be carried out may be requested.
3.6. In cases where data collection or recruitment of participants is not carried out at UNICAMP, the unit in which the researcher has a professional link must be stated in the proposing institution (unit/agency).
With this, the place where data will be collected or recruitment of participants must be included in the Plataforma Brasil system with a co-participating institution (system screen 5), in addition to submitting authorization (model below) on letterhead with the name and stamp of the person responsible for the institution.
3.5. We remind you that the signature of the proposing institution field must be identified with the STAMP of the person in charge, in addition to filling in all the fields that are requested in the Face Sheet-CONEP.
3.7. In cases where the co-participating institution has a CEP, the researcher should contact the co-participating CEP to verify which additional documents are required for ethical appreciation.
3.8. Regarding the SPONSOR field, the same items are mandatory, when there is a main sponsor. In the specific case of national funding agencies (such as, for example, FAPESP, CNPq, FINEP, FAPs, etc.) and international (for example, US-NIH) and, as we understand the difficulty of collecting the signature, it is accepted that the fields name, position/function, CPF, signature and date are blank in the part reserved for the sponsor, provided that the financing body is expressly identified in the Cover Sheet and that a document proving the financing is presented. It should be clarified that filling in the name of the sponsor (field 18 of the Cover Sheet) is automatic, being linked to the “FUNDING” field of Plataforma Brasil. Only the name of the person responsible for “Primary Funding” will be listed on the Cover Page as a sponsor.
3.9. Failure to comply with the above items will result in the RETURN of all material without ethical evaluation.
4. Change of Proposing Institution
To change the proposing institution, just follow the Guide to Change Bidder Institution, remembering that when changing the proposing institution, the Research Ethics Committee that will evaluate the project will remain the same or unchanged.
5. When Unicamp is a Co-Participating Institution
For cases in which Unicamp is the co-participant institution, the project must first be processed by the Research Ethics Committee of the proposing institution and, after approval, it will be sent to Unicamp's CEP (co-participant) automatically.
With this, an authorization from Unicamp with the signature and stamp of the person responsible for the unit where the data will be collected must be presented to the bidder's CEP, in addition to an TCLE with the data (address, telephone, e-mail, opening hours) of the CEP from Unicamp and the description of the procedures that the research participants from Unicamp will be submitted, for the cases in which the TCLE is applied.
In addition, the role of each co-participating institution must be included in the research project.
6. Basic structure for the Free and Informed Consent Form (TCLE);
Basic structure for the Informed Consent Form (TCLE) for Research in Virtual Environments;
The basic framework for the TCLE was developed to assist researchers in the elaboration of the TCLE model. We remember that each research has its peculiarity, with that the items IV, IV.1, IV.2, IV.3, IV.4, IV.5, IV.6 and IV.7 of Resolution 466/12 of the National Health Council (CNS) of the Ministry of Health (MS) must be analyzed.
Research in virtual environments has been widely used, mainly because of health issues caused by the COVID-19 pandemic, and Circular Letter No. 01/2021-CONEP/SECNS/MS was also available, which provides for research in virtual environments . Thus, we sought to elaborate a Basic Structure of TCLE specific to the modality of studies in virtual environments.
For cases where the application of the TCLE is not feasible, there is the possibility of requesting a waiver. In item IV.8 of Resolution 466/12 of the National Health Council (CNS) of the Ministry of Health (MS) contain more information about the waiver.
7. Authorization for data collection
As mentioned in item 2.6. above, a report must be submitted to the Research Ethics Committee authorization in cases of research not carried out at Unicamp, which must be sent on the institution's letterhead with the signature and stamp of the person in charge.
Remember that in the system Platform Brazil the co-participating institution item must be completed.
8. Data Use Commitment Term (TCUD)
TCUD is a commitment document signed by research researchers that use sensitive data from participants, in which it will not be possible to obtain the Term of Free and Informed Consent (TCLE), submitted to the Research Ethics Committee of Unicamp, from all participants of the search.
TCUD is applied to the use of anonymized databases and this situation must be duly explained and justified by the researcher responsible for the research project. The pertinence of its use will be evaluated, and the waiver of the TCLE and use of the TCUD may or may not be accepted.
Observation: TCUD cannot be used to access medical records of patients who are being followed up or who are possible to be contacted. For these cases, it will be necessary to apply the individual TCLE or, for underage research participants, apply the TCLE for their legal guardian and the TALE for the minor.
9. Amendment to the Project
Amendment is any proposal for modification to the original project, presented with the justification that motivated it. Amendments must be presented to the CEP in a clear and succinct manner, identifying the part of the protocol to be modified and its justifications. (Circular Letter No. 038/2014 CONEP/CNS/GB/MS). The proposed modifications cannot mischaracterize the study originally proposed and approved by the CEP-CONEP system. In general, substantial changes in the study design, hypotheses, methodology and primary objectives cannot be considered amendments, and the responsible researcher must submit a new research protocol for analysis.
More information on amendment submission is available at Researcher's Handbook or in the Plataforma Brasil system in the option “Plataforma Brasil Manuals” –> “Researcher's Manual – version 3.3”.
O Amendment Letter Template must be used mandatorily in the submission of amendment requests from 20/01/2023.