AGEUFMA

CEP-UFMA (UFMA RESEARCH ETHICS COMMITTEE)

The Research Ethics Committee of the Federal University of Maranhão (CEP / UFMA), and its Internal Regulations were created through Resolution 460 / CONSEPE, dated May 31, 2006, and its registration approved by the National Ethics Commission in Research ( CONEP), an organ of the NACONAL HEALTH COUNCIL (CNS), on June 20, 2007.

The Research Ethics Committee (CONEP) is an interdisciplinary and independent collegial body of technical, scientific, advisory and normative nature, linked to the Research and Postgraduate Pro-Reitoría (PPPG) and the National Commission for Research Ethics (CONEP) , deliberative, and educational, with autonomy and action in the exercise of its functions, and is intended to act in the field of research ethics.

1. COMPOSITION

Seven professionals from the specific areas (Biological and Health Sciences, Exact Sciences and Technology, Human Sciences and Social Sciences) and; Two representatives of society.

1.1 THE ADMINISTRATIVE AND ORGANIZATIONAL STRUCTURE

 The Ethics Committee is composed of a Coordination, a Vice Coordination and a Secretariat (1st and 2nd Secretary), all elected by their peers. The indication will be made by the Stricto Sensu Graduate Programs and, in their absence, by the UFMA Center Councils.

 Ordinance for the appointment of CEP / UFMA members (click here)

2. ALLOCATIONS

2.1 COMPETE TO THE RESEARCH ETHICS COMMITTEE:

Analyze research projects and protocols (including multicenter, interdisciplinary and interdepartmental) in human beings, ethnic or racial social groups, transgenic products, environmental and technological implications in biological cells and tissues and issue opinions from the point of view of ethical requirements, within a period of thirty days;

2.2 Issue instructions with technical standards to guide researchers on ethical issues;

2.3 Guarantee the maintenance of the ethical aspects of the research, as well as obtaining the free and informed consent of the individuals or groups for their participation;

2.4 Maintain regular and permanent communication with the National Commission for Research Ethics and, if necessary, forward projects and research protocols for its consideration.

3. OPERATION

The Research Ethics Committee will meet ordinarily once a month or on an extraordinary basis, when convened by the Coordinator or by the absolute majority of their peers.

Calendar of Meetings CEP-UFMA 2018

4. PROJECTS TO BE PRESENTED TO THE CEP

According to Chapter m Art. 70 of Resolution 460 / CONSEPE of May 31, 2006, which approves the Internal Regulations of the Research Ethics Committee of UFMA (CEP / UFMA), establish that the Research Projects sent to CEP whether involving research involving human beings, ethnic or racial social groups, transgenic products, environmental implications and technologies in biological cells and tissues. Research on human beings must comply with the determinations contained in CNS Resolution 466/2012 and other correlates of the National Health Council.

5. PROTOCOL OF RESEARCH

RESEARCH PROTOCOL - Document contemplating the description of the research in its fundamental aspects, information regarding the subject (PARTICIPANT OF THE RESEARCH), the qualification of the researchers and all the responsible instances;

The Research Protocol that forms the process for ethical analysis in CEP / UFMA must contain the following documents to meet the standards established in Resolution 466/2012 and other correlates of the National Health Council;

5.1 FACE SHEET, generated by the system in the act of registering the research, with the term of commitment of the researcher and the institution to comply with Res. CNS No. 466/2012. This is the document that gives legal consistency to the project, because it identifies the responsible researcher, the institution, the sponsor and is duly filled;

5.2 RESEARCH PROJECT it is necessary to present this document because it is through it that the ethical analysis will be done and the methodological adequacy verified. It is important to emphasize that, although the adequacy is not made by the CEP, but its evaluation, the solidity; is itself an ethical question. A research project with serious methodological failures necessarily entails failure from the ethical point of view as well. The research project must include, as a minimum, the one required by Res. CNS n.º 466/2012;

5.3 FREE AND CLOSED CONSENT TERM (TCLE) / ASSIGNMENT TERM (TALE) prepared by the researcher in charge is the document in which the free and informed consent of the participant and / or their legal guardian in written form, and must contain all the necessary information, in clear and objective language, of easy understanding, for the most complete clarification on the research that it proposes to participate Res. CNS nº 466/2012;

ATTENTION: In the cases of research with children, adolescents or legally incapacitated it is necessary to insert tam

5.4 DETAILED RESEARCH PROJECT BUDGET - resources, sources and destination, as well as the form and value of the researcher's remuneration, according to CNS Res. 466/2012;

5.5 CURRICUL LATTES of the executing team of the Research Project (CNS Res. 466/2012). The reference to "Curriculum Lattes", together with CNPq, may be sufficient. The main justification for the request of this document is for the evaluation of the technical capacity and ethical adequacy of the researcher for the accomplishment of that research. This is not to say that the researcher has already carried out similar research, but only that he has the technical capacity to carry it out.

6. LIST OF DOCUMENTS REQUIRED BY CEP / UFMA AND GUIDELINES TO RESPOND TO PENDING OPINION.

8. IMPORTANT INFORMATION

• Upon receipt of the project, CEP-UFMA will have a period of 40, days for evaluation and issuance of a Pending / Approved / Not Approved opinion;

• After the opinion issued by CEP-UFMA, the researcher will have a deadline of up to 30 days to provide for Pending Issues in case of Perish pending, this period begins on the date of the meeting in which the project was judged by CEP-UFMA

• The CEP / UFMA does not evaluate research already completed or those that are in progress.

TIPS OF THE PLATFORM BRAZIL:

Researcher's Training Address:

 Dear Researcher and / or CEP Member, welcome to the TRAINING environment of Plataforma Brasil (PlatBr). This environment (http://189.28.128.37/plataformabrasil-treina) is freely accessible and should only be used for training, testing or simulation purposes. Everything you experience in this environment will not have any effect on the official environment and vice versa (including the user registration, since both systems do not share the database) nor will it be recognized by any ZIP code or CONEP.

PRODUCTION ENVIRONMENT: The production link of the system, which has validity for the research process in the CEP's, CONEP and that should be used is: platformbrasil.saude.gov.br in this environment the researcher will make his personal registration again and will register his research in (new submission) to send to CEP / UFMA for evaluation, for that the researcher must link his research to UFMA through the CNPJ, in this way the project is sent directly to CEP / UFMA.

9. SITE OF OPERATION.

CEP / UFMA works at Avenida dos Portugueses s / n, Bacanga University Campus, CEB Velho Building, in front of PPPGI's multimedia auditorium. E-mail correspondence cepufma@ufma.br

Inquiries call: 3272-8708

10. CURRENT COORDINATION

The current team that administers CEP / UFMA is the Coordinator, Prof. Dr. Francisco Navarro and the Deputy Coordinator Prof. Dr. Diego Diego Leite and Mr. Adelvano Frazão Administrative Secretary.

11. RESOLUTIONS OF THE NATIONAL HEALTH COUNCIL

To assist and facilitate the use of standards, the resolutions issued by the National Health Council dealing with research on human beings and on the site www.conselho.saude.gov.br/comissao/conep/resolucao are in the area of ANNEXES. html

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