1. COMPLETE RESEARCH PROJECT

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It is the fundamental document for the CEP-CONEP System to carry out the ethical analysis of the proposal, and must be formulated by the researcher. The research project must make clear the objective of the research, who will be researched and how the research will be carried out, therefore the methodology must be described in a clear and detailed way. All research projects must contain, necessarily:

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1 -  Front cover

two -  cover sheet

3 -  summary

4 -  Delimitation of the topic / Introduction

5 -  Justification

6 - Search problem

7 - Hypothesis(es) if applicable

8 - Objectives (General and Specific)

9 - Theoretical framework

10 - Methodology

11  - Schedule

12 - References

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Note: The  schedule  it must describe the total duration and the different stages of the research, with the researcher's explicit commitment that the research will only start after approval by the CEP-CONEP System. In other words, in the schedule it must inform:  "the schedule for the research to be carried out if the project is APPROVED by the CEP/CONEP System […]."

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1. COVER SHEET

The cover sheet is a document automatically generated by Plataforma Brasil, which must include the name, signature and stamp of the Director General (Solimar Roberto Riva) of Faculdade Vale do Cricaré.

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Note: Only masters/doctoral students and adults of legal age can register projects on Plataforma Brasil. In this way, projects of undergraduate students and minors must be inserted by the research supervisor professor.

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1. FREE AND INFORMED CONSENT FORM (TCLE)

The TCLE is a document written in the form of an invitation that aims to ensure that the research participant is of legal age, legally capable or legally responsible, that he is consulted and can express in writing his interest in participating in the research, knowing its risks and benefits research can bring to you or to society. As well as the actions that will be taken so that the risks are mitigated.

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The TCLE must be written in two copies, one for the researcher and one for the participant, and in clear and objective language, considering the intellectual contribution of the target audience, for a good understanding of the proposal to participate in the study.

Note: The TCLE must be signed upon approval of the research project by the CEP/CONEP System, considering that this signature formalizes the participation of the researched.

Model:  Informed Consent Form (TCLE)

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NOTE:

Whenever it is necessary to use the TERM OF CONSENT, a FREE AND CLARIFIED TERM OF CONSENT must also be attached to the system for the minor's legal guardian, according to the model available below.

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Model:  Informed Consent  Clarified (TCLE) – Legal Responsible.

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1. TERM OF REQUEST FOR WAIVER OF THE TCLE

As provided for in resolution 466/12 (IV.7), in cases where it is impracticable to obtain the Informed Consent Form (DATA AND RECORDS) or that this acquisition entails substantial risks to the privacy and confidentiality of the participant's data or to the bonds of trust between researcher and researched, the waiver of the TCLE must be justifiably requested by the responsible researcher to the CEP/CONEP system, for consideration.

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Example: In the case of studies with materials already collected and/or investigation of medical records with information regarding patients. Investigation of data from deceased patients and from other locations, that is, when it is really impossible to have contact with the patient.

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Model:  Term of Request for waiver of the TCLE

1. TERM OF COMMITMENT FOR THE USE OF DATA AND RECORDS (TCUD)

It is a document prepared every time the researcher uses data from any institution, such as: medical records, spreadsheets, cards, etc. The use of the TCUD does not waive the “Co-Participating Institution Authorization Term”. The TCUD must be signed by the responsible researcher and also by the person responsible for releasing the data in the respective sector.

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Model:  Term of Commitment for the Use of Data and Medical Records (TCUD)

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1. TERM OF AUTHORIZATION OF THE PARTICIPATING INSTITUTION

The co-participating institution is the institution where the research and data collection will take place. For example, if a research project is developed with teachers or students from a school, the Term of  Authorization of the Co-Participating Institution, which must be signed by the responsible person responsible for the place where the research will take place,  this Term must be on the letterhead of the  co-participating institution, with the name, function and stamp of the legal representative.

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Model:  Co-participating Institution Authorization Term

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1. RESEARCHER'S STATEMENT ASSURING THE START OF THE RESEARCH ONLY AFTER THE AUTHORIZATION OF THE CO-PARTICIPATING INSTITUTION.

This statement must be used whenever the researcher, for some reason, is unable to obtain the signature of the Co-participating Institution  (AUTHORIZATION TERM OF THE PARTICIPATING INSTITUTION),  before the approval of the research project by CEP-CONEP. With this document the researcher  declares to have the  commitment to only start the study after appraisal and approval.  of the Research Ethics Committee, and signature of the responsible person responsible for the place where the research will take place. For example: if the research is carried out in a hospital, the director may only allow the researcher to enter after approval by the CEP. Therefore, a declaration from the responsible researcher will be required assuring the start of the research only after authorization from the co-participating institution so that, after approval by the CEP, the responsible for the hospital can sign the Co-participating Institution Authorization Term.

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Model:  Researcher's statement assuring the start of the research only after authorization from the co-participating institution

1. STATEMENT OF CONSENT (MINORS / LEGALLY INCAPABLE / VULNERABLE)

The Term of Assent is a document prepared in  accessible language  and should be required for the  minors or for the legally incapable, through which, after the research participants are duly informed, they will explain their consent to participate in the research, without prejudice to the consent of their legal guardians; is for  vulnerable,  understood, according to resolution 466/12 (II.25), the status of persons or groups that, for any reasons or reasons, have their capacity for self-determination reduced or impeded, or in any way are prevented from resisting, especially in the which refers to free and informed consent.

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Model:  Informed Consent Term