Background: Brazil is among the sixteen countries that conducts the most clinical trials in the world. It has a system to review research ethics with human beings made up by the National Commission on Research Ethics (CONEP) and 779 Research Ethics Committees (RECs), in 2017. The RECs are supposed to follow the same rules regarding their membership, although the RECs that review Social Science and Humanities (SSH) researches must respect Resolution 510/16.
View Article and Find Full Text PDFThis article analyzes the current regulatory framework for biobanking, genomic research, and protection of privacy in Brazil. It is divided in four parts. The first describes the biobanking context in Brazil and its evolution in recent years.
View Article and Find Full Text PDFCien Saude Colet
September 2015
The scientific field is characterized by the disputes about the delimitation of the field problems, methods and theories that can be considered scientific. The recognition that it is not neutral, that a researcher is a moral subject, and its practices are moral ones, entail that moral reflections, that is, ethics, should be a core process of every researcher. Therefore ethics is not a heteronomous issue, and cannot be reduced to guidelines.
View Article and Find Full Text PDFThe development of guidelines on research ethics for social science and humanities (SSH) takes place in the scientific field, marked by disputes aimed at the establishment of hegemonic scientific standard. In Brazil, the National Health Council is responsible for approving these guidelines, which involve certain specificities. Based on the authors' experience in the SSH Working Group of the National Commission on Research Ethics (GT CHS / CONEP), this article presents the process of development of guidelines for SSH, and some its challenges: the distance between the statutory guarantee and the effective execution of guidelines; the biomedical hegemony and the marginal position of the SSH in the CEP / CONEP system; the inadequacy of the current resolution facing the research features in CHS; the use of the concept of risk in guidelines aimed at SSH in the health area.
View Article and Find Full Text PDFThis paper seeks to promote reflection on ethics in anthropological and qualitative research and emphasize the comprehensive, relational and reflective character of this process, as well as the advantages and problems that arise from different logic and often conflicting interests between researchers and their interlocutors. The text is divided into four parts and addresses the ethical: (a) significance of these approaches; (b) behavior of the researcher in the field; (c) analysis of the empirical material; and (d) considerations in the preparation of results of anthropological and qualitative studies, using some classic examples from the international literature. The paper concludes by reflecting on the distinction between the requirements of the Ethics Committee and the Ethics of research itself.
View Article and Find Full Text PDFThis article presents a synthesis of the report collectively elaborated in the meeting on Ethics in Qualitative Health Research, which took place in Guarujá, São Paulo State, from August 28 to 30, in 2006. The meeting was organized by the Ethical Committee of the Municipal Health Office of São Paulo, supported by the Special Programme for Research and Training in Tropical Diseases (TDR), sponsored by UNICEF/UNDP/World Bank/WHO and stressed the need to review the Brazilian guidelines for the analysis of the ethical aspects of qualitative health research.
View Article and Find Full Text PDFCien Saude Colet
January 2009
This paper discusses adequacy as to the application of Brazilian guidelines, Resolution 196/96(1) and complementaries to qualitative health researches, considering that these are based on non-positivistic paradigms. Frequently, decisions about the research are made together with the studied community. There is a concern with justice and social change.
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