Ethical regulation of biomedical research in Brazil: a quality improvement initiative.

BACKGROUND: Q-CEP (Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil's national system of institutional review boards. The aim of this study was therefore to report on the experience and results of the Q-CEP project. METHODS: An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies. RESULTS: In 2019-2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs. CONCLUSIONS: Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world's largest research ethics evaluation systems.

Implementation research: towards universal health coverage with more doctors in Brazil.

OBJECTIVE: To evaluate the implementation of a programme to provide primary care physicians for remote and deprived populations in Brazil. METHODS: The Mais Médicos (More Doctors) programme was launched in July 2013 with public calls to recruit physicians for priority areas. Other strategies were to increase primary care infrastructure investments and to provide more places at medical schools. We conducted a quasi-experimental, before-and-after evaluation of the implementation of the programme in 1708 municipalities with populations living in extreme poverty and in remote border areas. We compared physician density, primary care coverage and avoidable hospitalizations in municipalities enrolled (n = 1450) and not enrolled (n = 258) in the programme. Data extracted from health information systems and Ministry of Health publications were analysed. FINDINGS: By September 2015, 4917 physicians had been added to the 16 524 physicians already in place in municipalities with remote and deprived populations. The number of municipalities with ≥ 1.0 physician per 1000 inhabitants doubled from 163 in 2013 to 348 in 2015. Primary care coverage in enrolled municipalities (based on 3000 inhabitants per primary care team) increased from 77.9% in 2012 to 86.3% in 2015. Avoidable hospitalizations in enrolled municipalities decreased from 44.9% in 2012 to 41.2% in 2015, but remained unchanged in control municipalities. We also documented higher infrastructure investments in enrolled municipalities and an increase in the number of medical school places over the study period. CONCLUSION: Other countries having shortages of physicians could benefit from the lessons of Brazil's programme towards achieving universal right to health.

The Mais Médicos (More Doctors) Program: the placement of physicians in priority municipalities in Brazil from 2013 to 2014. / O Programa Mais Médicos: provimento de médicos em municípios brasileiros prioritários entre 2013 e 2014.

The inadequate placement and distribution of health professionals are problems that occur in various countries. The scope of the "Programa Mais Médicos" (More Doctors Program) was to reduce the shortfall of physicians and diminish regional inequalities in health. A descriptive study on the placement of physicians between 2013 and 2014 using the Ministry of Health database is presented. There was an allocation of 14,168 physicians to the 3,785 municipalities that signed up to the program: 2,377 met the priority and/or vulnerability criteria and received 77.7% of the physicians; 1,408 received 22.3% of the physicians, but did not meet the established priorities. This study reveals the reduction in the lack of physicians, mainly in the North and Northeast. These regions account for 36% of the Brazilian population and 46.3% of the physicians were allocated there. However, the introduction of an eligibility profile, which allocated 3,166 physicians in 1,408 non-priority municipalities is questionable. The conclusion drawn is that this may have hindered the ability of the Mais Médicos Program to fully achieve its objectives as a public policy aimed at reducing regional inequalities of access to primary healthcare. Further studies are necessary to evaluate the impact of the Mais Médicos Program.

O Programa Mais Médicos: provimento de médicos em municípios brasileiros prioritários entre 2013 e 2014 / The Mais Médicos (More Doctors) Program: the placement of physicians in priority municipalities in Brazil from 2013 to 2014

Resumo O provimento e a distribuição inadequada de profissionais de saúde são problemas que ocorrem em diversos países. O Programa Mais Médicos tem como objetivos a diminuição da carência de médicos e a redução das desigualdades regionais em saúde. Apresenta-se estudo descritivo sobre a alocação de médicos entre 2013 e 2014, empregando o banco de dados do Ministério da Saúde. Houve o provimento de 14.168 médicos nos 3.785 municípios que aderiram: 2.377 atendiam aos critérios de prioridade e/ou vulnerabilidade e receberam 77,7% dos médicos; 1.408 municípios, que receberam 22,3% dos médicos, não correspondiam às prioridades estabelecidas. Apresentam-se evidências da redução da carência de médicos, sobretudo nas regiões Norte e Nordeste. Nestas áreas residem cerca de 36% da população brasileira e houve a alocação 46,3% dos médicos. Contudo, questiona-se a introdução de um perfil de elegibilidade que possibilitou alocar 3.166 médicos em 1.408 municípios não prioritários. Conclui-se que este fato pode ter comprometido a capacidade de o Programa Mais Médicos atingir plenamente seus objetivos como política pública que visa à redução das desigualdades regionais no acesso à atenção básica em saúde. Outros estudos serão necessários para avaliar o impacto gerado pela implementação do Programa Mais Médicos.

Abstract The inadequate placement and distribution of health professionals are problems that occur in various countries. The scope of the “Programa Mais Médicos” (More Doctors Program) was to reduce the shortfall of physicians and diminish regional inequalities in health. A descriptive study on the placement of physicians between 2013 and 2014 using the Ministry of Health database is presented. There was an allocation of 14,168 physicians to the 3,785 municipalities that signed up to the program: 2,377 met the priority and/or vulnerability criteria and received 77.7% of the physicians; 1,408 received 22.3% of the physicians, but did not meet the established priorities. This study reveals the reduction in the lack of physicians, mainly in the North and Northeast. These regions account for 36% of the Brazilian population and 46.3% of the physicians were allocated there. However, the introduction of an eligibility profile, which allocated 3,166 physicians in 1,408 non-priority municipalities is questionable. The conclusion drawn is that this may have hindered the ability of the Mais Médicos Program to fully achieve its objectives as a public policy aimed at reducing regional inequalities of access to primary healthcare. Further studies are necessary to evaluate the impact of the Mais Médicos Program.