Research Involving Human Subjects and the Role of Institutional Review Boards in Brazil

Abstract

Background, The regulation of research involving human subjects through the creation of Institutional Review Boards (IRBs) aims to consolidate a culture of respect for human rights, mainly of research subjects.

Method, This study discusses the regulations for the development of research involving human subjects and the role of IRBs in Brazil.

Results, More than half of the IRBs are located in the South and Southeast, where IRBs are being consolidated. Progress is being made in Brazil as a result of Resolutions 196/96 and 466/12, however, challenges continue. In response to deficits in researchers’ and research institutions’ appreciation of, and lack of commitment to, ethical research practice IRBs have an important educative role. IRBs need to make their work transparent for the entire community and demonstrate the ability to enhance the organizational climate of institutions.

Conclusions, Some deficits exist in the scientific community’s understanding of the importance and role of IRBs, as well as in the excessive bureaucratization of the relationship between researchers and IRB members. In a country with so many regional differences, despite national regulations, IRB members should recognize and effectively deal with local particularities to guarantee respect for research subjects’ dignity.