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The challenge of reviewing ethical aspects of social and human research: the need for specific guidelines

The Brazilian guidelines on ethics in human research are made up of 11 resolutions of the National Health Council (CNS). The Resolution 196/96 was the oldest one until June 2013, when the Resolution 466/12 was enforced, and was applied to human research in all areas. Researchers from social and human sciences are facing difficulties to have their projects approved by the system made up of the Committees on Ethics in Research (CEP) and the National Commission on Ethics in Research (CONEP), even when these projects have no ethical problems. The key question is that the Resolution 196/96, and Resolution 466/12, considers only the biomedical research and does not dialogue with other research traditions. However, because its scope is all human research, this system based on this resolution asks inadequate questions, that show the lack of knowledge about qualitative research - which is very popular among social and human research. Considering that Resolution 466/12 kept the same logic of Resolution 196/96, this paper discusses the historical roots of Resolution 196/96, presents some difficulties that researchers have been facing with CONEP-CEPs system and points out the inadequacy of the research definition and the procedures established by the Brazilian guidelines to the ethical revision of qualitative research. Specific guidelines for social sciences and humanities are necessary, as well as the permanent qualification of the CEP and CONEP members. Although the Resolution 466/12, enforced in June 13, 2013, does not move in this direction, it opens the possibility to have specific resolution to socials and human sciences that, if in addition to permanent capacity building of members of the system CEP/CONEP, can improve this situation.

research ethics; qualitative health research; Research Ethics Committee; Bioethics


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