Análise, à luz da bioética, do perfil das publicações científicas de autores brasileiros, antes e após e homologação das diretrizes éticas referentes à pesquisa clínica (ensaios) no Brasil

Abstract

The research in humans being has a history marked by advances and also abuses. To prevent abuse and ensure the ethicality of these studies, documents have emerged with the aim of regulating research on humans. Noteworthy are the Nuremberg Code, the Declaration of Helsinki and, at the national level, the Resolutions 01/88 and 196/96 and its complementary Resolutions. Within the research on human beings, in medical field, it has increased the importance of clinical research or clinical trials. This paper aims to outline the profile of scientific publications by Brazilian authors before and after the approval of the ethical guidelines pertaining to clinical research in Brazil, attempting to perceive the quality of information offered to the reader and the influence of the documents that regulates ethics in the clinical researches with human beings in the profile of these publications. If the scientific publications are intended for the reader and to the scientific community, do they provide these data required in these documents so that they can make a critical analysis of the research reported, especially from the point of view of ethics? The sample comes from the bibliographic databases PubMed and Lilacs and consists of scientific publications of the years 1987, 1996 and 2005 reporting clinical trials. From the ethical requirements in the documents was drawn up a roadmap for data collection. The results indicate that, although the quality of information from scientific publications in 2005, highlighted by being more recent and by being approved throw the resolution that is currently in effect, the publications improved in some respects, remaining scarce the ethical requirements in the documents. We conclude that the reader and the scientific community are not receiving the necessary and sufficient information to enable them to perform their analyzes and reviews of the research reported, especially from the point of view of ethics. The deployment of the CEP / CONEP required by Resolution 196/96 changed the profile of research in humans in Brazil, and the reader, by finding in 90.1% of the publications from 2005 the information that the reported research was approved by CEP, can assume that it also followed the ethical demanding by this Resolution and its complementary resolutions. However, the confidence that the reader puts in the work of the CEP does not invalidate its expectation and its right to find in the articles the items on which we reflect, so the reader can perform its critical analysis.