The Program has employees trained to assist teachers and students in the processes and flows of submission and communication with the Research Ethics Committees (REC). The Postgraduation Discipline "Methodological Basis of Scientific Research" dedicates part of its workload to the topic "Good Practices in Clinical Research". Regarding experimental research, the Program has the specific discipline "MAN5741 - Good anesthetic practices in experimental research" where the theme is extensively discussed.

 

The Program submits research projects to the evaluation of four institutional IRBs, according to the origin of the proposed project:

 

Research Ethics Committee of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (CAPPesq): to this CEP, clinical research projects to be executed in the Institutes of the Hospital das Clínicas, except for the Cancer Institute, are currently submitted. The CEP has its own digital platform for project submission and the commission meets every two weeks. Until the creation of CEP-FMUSP and CEUA, this CEP was responsible for the evaluation of all institutional research projects.

 

Research Ethics Committee of the Faculty of Medicine of the University of São Paulo (CEP-FMUSP): created in 2011, to this REC are submitted the clinical research projects to be executed at the Faculty of Medicine, the Cancer Institute and institutions outside the University that use the institutional REC. Students who will perform data collection at other institutions must have their research project approved by the REC of their institution of origin and also by this REC. The IRB has its own digital platform for the submission of projects and meets every two weeks to deliberate on the previous analysis of the projects carried out by the members of the commission. From the creation of this CEP until 2013, the clinical projects and those of CEUA (described below) were evaluated by the same committee.

 

Ethics Committee on Animal Use of the Faculty of Medicine, University of São Paulo (CEUA-FMUSP): with regulations created in 2010, this Research Committee worked together with the CEP-FMUSP until 2013, when it was officially dismembered by determination of the National Research Ethics Committee.

 

Research Ethics Committee of the University Hospital of the University of São Paulo (CEP-HU): to this Committee, research projects to be conducted at the University Hospital of the University of São Paulo are submitted.

 

 

When necessary, communication with CONEP and ANVISA is done through the CEPs corresponding to the Research Projects.

 

All Ethics Committees are composed of members who meet regularly and are linked to the competent regulatory bodies. Until the creation of the CEP-FMUSP in 2011 and CEUA in 2013, CAPPesq was responsible for the evaluation of all clinical and experimental animal projects.

 

According to the legislation now in force, experimental animal projects are all submitted to the specific Ethics Committee (CEUA).

 

Students involved in Clinical Research Projects are instructed to register the project in the ClinicalTrials.gov Platform when data collection begins.