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.
Highlights
Regulations for scientific research involving human subjects have been developed in countless countries in recent decades
Institutional Review Boards (IRBs) represent an important tool to safeguard the rights of research participants and researchers. Emphasizing their relevance, this paper aims at presenting the scenario for the implementation of IRBs in Brazil
In view of advances achieved as a result of international rules for scientific research involving human beings and the challenges to be faced, especially by countries that are still consolidating their rules, this paper focuses on the implementation context of ethical guidelines for research development involving human subjects in Brazil
Summary
Regulations for scientific research involving human subjects have been developed in countless countries in recent decades. These boards should be independent from research teams and should not gain any financial or material benefit from the research process In this direction, there is an international movement to increase the legal and regulatory control of research involving human beings and four models of IRB regulation can be found (Barbosa & Boery, 2010): a) model based on legislation or detailed regulation, which establishes a regulatory structure for the IRBs, as in France and Denmark; b) the establishment of formal legal responsibility requisites, leaving research institutions in charge of developing their own ethical review systems, maintaining centralized support mechanisms, as in the USA; c) a model in which governmental entities, often scientific research funding agencies, adopt guidelines or recommendations for research protocols with governmental funding, as in Canada, South Africa and Australia and d) the adoption of a legal structure that integrates international guidelines into existing national standards, as in the European Union through the establishment of the EU Directive on Clinical Trials in 1997. In view of advances achieved as a result of international rules for scientific research involving human beings and the challenges to be faced, especially by countries that are still consolidating their rules, this paper focuses on the implementation context of ethical guidelines for research development involving human subjects in Brazil
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