Research Ethics Committee

The researcher must register the research project on Plataforma Brasil.

When registering the project on Plataforma Brasil, its cover sheet will be generated, whose signature collection will be under the responsibility of the researcher.

After having all the mandatory documentation, the researcher submits the research project to the CEP, exclusively electronically, on Plataforma Brasil.

Required documentation:

– Cover sheet duly filled in and signed;

– Detailed research project;

– Basic project information (filled in by the researcher on the Plataforma Brasil website);

– Informed consent form (or request for waiver thereof);

– Term of commitment of the researchers involved;

– Letter of agreement: It must contain the signature of the person responsible for the area/sector where the research will be carried out;

– Letter of consent: Must contain the signature of the Institution’s legal representative
Done;

– Detailed financial budget and remuneration of the researcher(s).

The CEP has a maximum period of 10 days to review the submitted documentation and accept the project’s processing.

In case of refusal of any document, the responsible researcher will be notified, through Plataforma Brasil, with a suggestion of adaptation. In case of acceptance of the documentation, a CAAE number will be automatically generated and the project will be evaluated, with the issuance of a substantiated opinion, within 30 days after validation of the documentation, on Plataforma Brasil.

Every research project must contain, among the mandatory documents, the Free and Informed Consent Term (TCLE), in accordance with Resolution 466/2012, of the National Health Council – CNS (section IV).

Formal elements in all TCLE:

Form required in all ICs: clear language accessible to everyone, with special care so that it is easy to read and understand. In research with foreign cooperation conceived internationally, be adapted to ethical norms and local culture;

Be approved by the Research Ethics Committee and by CONEP, when relevant;

Be prepared in two copies;

Rubrics of the guest to participate in the research (or its legal representative) and the responsible researcher, or its delegate, on all its pages;

Signature of the person invited to participate in the research, or their legal representative, and the responsible researcher, or their delegate, on the same signature page;

In both copies, the complete postal address and telephone contact of the persons responsible for the research, the zip code and CONEP, when applicable. Rua Gentios, 1420, 3rd floor, Bairro Luxembourg – BH/MG. Phone: (31) 3299.9980. E-mail: [email protected]

Mandatory content in all TCLE:

Information, clarifications and explanations about the following contents are required in all ICs:

Full title of the research and identification of the main researcher;

Justification of the research;

Research objectives;

Procedures that will be used in the research: information on the maintenance of research data in archives (physical or digital) under the custody of the researcher responsible for a period of 5 years after the end of the research;

Details of the methods to be used: inform about the use of biological material and data obtained in the research exclusively for the purpose provided for in its protocol, or according to the consent given by the research participant;

Explanation of possible discomforts and risks arising from participation in the research;

Explanation of the expected benefits of this participation;

Presentation of measures and precautions to be used to avoid or reduce adverse effects and conditions that may cause damage;

Clarification on the form of follow-up and assistance to which research participants will be entitled, including considering benefits and follow-up after the end and/or interruption of the research;

Guarantee of full freedom for the research participant to refuse to participate or withdraw their consent, at any stage of the research, without any penalty;

Ensuring the confidentiality and privacy of research participants is maintained during all phases of the research;

Guarantee that the research participant will receive a copy of the TCLE;

Explanation of the reimbursement guarantee and how the expenses incurred by the research participants and resulting from it will be covered. If participation in the survey does not generate expenses for the volunteer, this should be made clear (“There will be no form of reimbursement of money, as with participation in the survey you will not have any expenses”);

Explanation of the indemnity guarantee for any damages arising from the research;

Statement by the responsible researcher that expresses compliance with the requirements contained in items IV. 3 and IV.4, the latter if pertinent.

Cases of restriction of freedom or clarification:

In cases of restriction of freedom or clarification necessary for adequate consent, it should also be noted:

• Assent to surveys whose guests are children, adolescents, people with mental disorders or illnesses or those in a situation of substantial reduction in their decision-making capacity. In the case of research involving teenagers (between 12 and 17 years old), CONEP also suggests the development of a specific term (Consent Term) for them, when the age group in which they are situated already allows the understanding of the research objectives. . Parental authorization/consent, however, is still required for all minors;

• There must be a clear justification for your choice, specified in the protocol and approved by CEP and CONEP, when relevant;

• In these cases, the steps of clarification and free and informed consent must be completed, through the legal representatives of those invited to participate in the research, preserving their right to information, within the limits of their capacity;

• The freedom of consent should be particularly guaranteed for those research participants who, although fully capable, are exposed to specific conditioning, or the influence of authority, characterizing situations likely to limit autonomy, such as students, military personnel, employees, prisoners and inmates in rehabilitation centers, shelters, nursing homes, religious associations and the like, assuring them full freedom to participate, or not, in the research, without any reprisals.

ICF waiver:

In some researches, it is not possible to use the IC.

In this case, the waiver of the term must be requested, justifying the non-presentation of the term, being insufficient to mention that the TCLE “does not apply”.

It is necessary to clarify the source of the data that will be used in the research, whether they will be medical records, information stored in banks, etc., and explain why the subjects will not be consulted for the use of this information and whether they have already authorized the use of their data in future research.

Related to the development of research projects and CEP/CONEP system:

• Resolution 466/2012

• Resolution 510/16

• Operational standard 001/2013

• Internal Regulation of CEP/IMP