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.

Acceso a cuidados de salud: discursos bioéticos del Norte y del Sur / Access to healthcare: bioethical discourses from North and South

RESUMEN Estudio comparativo adoptando la técnica de investigación bibliográfica, mediante identificación y lectura de obras de referencia de consagrados autores de la bioética, con el objetivo de analizar discursos bioéticos sobre la temática del acceso a la salud en Estados Unidos y Brasil. Identificamos que el énfasis de los discursos estadounidenses está en la adquisición de bienes y servicios de salud y en estrategias para garantizar el acceso a seguros de salud, que es vista como una mercancía. Por el contrario, los discursos brasileños se centran en defender el derecho y acceso universal a la salud, que es vista como un valor social, un derecho humano fundamental. Los autores concluyen que los discursos bioéticos sobre el acceso a la salud encarnan diferentes perspectivas ético-políticas. En este sentido, las políticas de salud pueden promover - o no - los derechos humanos, incluyendo el derecho a la salud, dependiendo de cómo son concebidas o ejecutadas.

ABSTRACT Comparative study, with a hermeneutical approach, adopting the bibliographic research technique, through identification and reading of reference works by renowned authors of bioethics, with the aim of analyzing bioethical discourses on the subject of access to healthcare in the United States and Brazil. We identify that the emphasis of American discourses is on the acquisition of health goods and services and on strategies to guarantee access to health insurance, which is seen as a commodity. On the contrary, Brazilian discourses focus on defending the right and universal access to health, which is seen as a social value, a fundamental human right. The authors conclude that bioethical discourses on access to health embody different ethical-political perspectives. In this sense, health policies may or may not promote human rights, including the right to healthcare, depending on how they are conceived or executed.

Access to health care as a human right in international policy: critical reflections and contemporary challenges. / El acceso a la salud como derecho humano en políticas internacionales: reflexiones críticas y desafíos contemporáneos.

Using the United Nations (UN) and its subordinate body, the World Health Organization (WHO), as a frame of reference, this article explores access to healthcare as a human right in international intergovernmental policies. First, we look at how the theme of health is treated within the UN, focusing on the concept of global health. We then discuss the concept of global health from a human rights perspective and go on to outline the debate surrounding universal coverage versus universal access as a human right, addressing some important ethical questions. Thereafter, we discuss universal coverage versus universal access using the critical and constructivist theories of international relations as a frame of reference. Finally, it is concluded that, faced with the persistence of huge global health inequalities, the WHO began to reshape itself, leaving behind the notion of health as a human right and imposing the challenge of reducing the wide gap that separates international intergovernmental laws from reality.

Access to health care as a human right in international policy: critical reflections and contemporary challenges

Using the United Nations (UN) and its subordinate body, the World Health Organization (WHO), as a frame of reference, this article explores access to healthcare as a human right in international intergovernmental policies. First, we look at how the theme of health is treated within the UN, focusing on the concept of global health. We then discuss the concept of global health from a human rights perspective and go on to outline the debate surrounding universal coverage versus universal access as a human right, addressing some important ethical questions. Thereafter, we discuss universal coverage versus universal access using the critical and constructivist theories of international relations as a frame of reference. Finally, it is concluded that, faced with the persistence of huge global health inequalities, the WHO began to reshape itself, leaving behind the notion of health as a human right and imposing the challenge of reducing the wide gap that separates international intergovernmental laws from reality.