Research Ethics Committee

About zip code

The Research Ethics Committee of the Mario Penna Institute (CEP-IMP) was created on May 11, 2001, in compliance with Resolution No. 196 of 10/10/1996 of the National Health Council (replaced by Resolution 466/2012), being later recognized by administrative minutes.

Over the years, it has had the participation of several professionals and collaborators, both from IMP and from the community, who meet monthly to analyze and discuss the submitted research projects, from the standpoint of ethics and compliance with related resolutions and standards .

The CEP’s Internal Regulation was last updated in 2020 during its renewal period with CONEP after approval by the President and the Institution’s legal department.

The CEP is made up of at least seven full members, and at least 50% of the members must demonstrate research experience. The choice of members is based on the personal profile and interest of each one in the growth of bioethics, approved by more than 50% (fifty percent) of the members who are already members, at a regular meeting.

The term of office of CEP members is 3 (three) years, with only one reappointment allowed, for an equal period of time.

EXTENSION: 9047 – Jony Marques Geraldo (Physicist);
RAMAL: 9103 – Juliana Alves Ferreira Freitas (Lawyer);
EXTENSION: 9572 – Juliana Maria Braga Sclauser (Stomatologist);
EXTENSION: 9543 – Cintia Maria de Lima (Nurse);
EXTENSION: N/A – Keyla Daniele Lacerda Rodrigues (Physician);
EXTENSION: 9008 – Pollyane Lacerda Coelho (Pharmacist);
EXTENSION: N/A – Barbara Marques Costa(Oncologist);
EXTENSION: N/A – Warley Alisson Souza (Nutritionist);
EXTENSION: 9980 – Delaine Silva Nascimento (Secretary);
EXTENSION: N/A – Talita Pollyana Moreira dos Santos (Dentist).
RAMAL: N/A – Mauricio Silva Vitor Amaral (Research participant representative)

Schedule of CEP-IMP meetings-2021

MêsDiaHorário
Março25/03/202113:30h as 15h
Abril20/04/202114h
Maio27/05/202113:30h as 15h
Junho24/06/202113:30h as 15h
Julho29/07/202113h as 14h
Agosto26/08/202113:30h as 15h
Setembro30/09/202113:30h as 15h
Outubro28/10/202113:30h as 15h
Novembro25/11/202113:30h as 15h
Dezembro16/12/202113:30h as 15h

Note: If it is necessary to change the day or time of the meetings, the team will be communicated in the WhatsApp group.

CEP considerations

Deadline for the researcher to submit the submission: up to 15 days before the next meeting

CEP Opinion Deadline: Up to 7 days after CEP meeting

Research project

The CEP may analyze research projects that will be developed at the Mario Penna Institute (or at any other institution), as long as they are directed for such analysis by the National Research Ethics Commission (CONEP).

Research projects must be sent to the CEP exclusively by Plataforma Brasil ( https://plataformabrasil.saude.gov.br/ ).

The research to be carried out at Instituto Mário Penna must have the detailed project forwarded to the Teaching and Research Nucleus of Instituto Mario Penna.

The Teaching and Research Nucleus will be responsible for saying whether the project is feasible at the Mário Penna Institute and, if so, the researcher will register the research project at Plataforma Brasil, having the Institute as the proposing institution.

The registration of the project on Plataforma Brasil generates a cover sheet, whose signature collection by the IMP’s Board of Directors is under the responsibility of the Teaching and Research Nucleus.

After having all the mandatory documentation, the researcher submits the research project to the Research Ethics Committee, 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.

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: comiteetica@mariopenna.org.br

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

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