The advance of medicine in search of new forms of diagnosis and clinical or surgical treatments directly or indirectly involves studies with human participation. Even the use of animal testing, the emergence of the most advanced mathematical and statistical models, and the intensive use of information technology have not been able to exclude this step. Currently, there is a consensus that projects of this nature must pass through the evaluation of an independent research ethics committee. However, there is always the possibility of potential tensions between the individual participating in the study protocols and researchers and sponsors with their teams.

In Brazil, the evaluation of ethics is developed in a system of voluntary and non-remunerated members consisting of 877 Research Ethics Committees (CEPs), responsible for the process of reviewing protocols in different institutions dedicated to research and supported by them. The CEPs, in turn, are coordinated by the National Commission for Ethics in Research (Conep), a collegiate body with national scope that integrates the National Health Council (CNS) and regulates the system.

"The entire system of ethical regulation in the country is governed by the CEP/Conep System, and its resolutions are periodically updated," explains Prof. Dr. Alfredo J. Mansur, Coordinator of the Ethics Committee for Analysis of Research Projects (CAPPesq), responsible for evaluating studies involving human participation in the Academic System formed by the Faculdade de Medicina da Universidade de São Paulo and the Hospital das Clínicas (FMUSP-HC System).

In 2016, CNS promoted an unprecedented action in order to gain greater efficiency in the management of ethical analysis of research protocols, initiating a decentralization process. High complexity, multicenter, and special thematic area research, such as genetic manipulation and human reproduction, which previously required additional approval from Conep, were gradually assigned to accredited committees.

"It was a long process of dialogue construction and integration," says Prof. Dr. Mansur. He emphasizes that, in CAPPesq, this process was supported by institutional leadership and involved the contribution of doctors, dentists, nurses, biologists, members of the multiprofessional team, and user representatives of the FMUSP-HC System, as well as other members of the community.

Last year, CAPPesq achieved pre-accredited CEP status, allowing for faster analysis and approval of new research or changes to those already approved. At the moment, new projects that would require Conep evaluation are being evaluated within Cappesq (while older projects continue in their original process).

To accomplish this, almost a year of training, internal evaluations, and workshops was necessary, in addition to the creation of a Special Chamber of members trained by Conep. Currently, members of CAPPesq participate in Conep meetings and vice versa, in order to promote integration and agility in the System.

"The ethical criteria are the same for the entire System," says Prof. Dr. Sonia Regina Testa da Silva Ramos, one of the members of the new Chamber. The epidemiologist emphasizes that the issuance of an ethical opinion "depends heavily on judgment based on Conep resolutions and is not something mathematical," and that, despite the great variation in the complexity of each project analyzed by CAPPesq, the new accreditation allows for the researcher's work and the scientific development of the FMUSP-HC System to be expedited.

The numbers don’t deny the scale of the Commission's assignments and the speed brought by the joint competence and dedication of its members. According to data provided by the entity, 989 new projects were received in 2022, of which 167 (16.9%) were eligible for Conep-type processing and received local evaluation. In total, 6,268 decisions were issued, with approximately 65% of them issued within two weeks. Projects that have previously been processed through Conep continue to do so.

"The reporting process is dynamic and coordination has the mission of reconciling content, demands, availability, and competencies, so that evaluations can be carried out in the most ergonomic way possible," says Prof. Dr. Alfredo Mansur about the process of issuing ethical decisions. He also emphasizes that researchers have access to CAPPesq and that it is always open to receiving demands, as well as adjusting to issues such as epidemiological windows, deadlines and priorities, so that the specificities of each research can be addressed. Thus, the Research Ethics Committee works in harmony with both the FMUSP-Hospital das Clínicas System and the CEP/Conep national regulation System.

Contact with CAPPesq can be made by phone (2661-7585) or through email (cappesq.adm@hc.fm.usp.br). For more information, visit: www.hc.fm.usp.br/hc/cappesq/cappesq#