Abstract

Brazilian associations for research in human, social and applied social sciences have long sought ethical aspects regulation compatible with the epistemological, theoretical and methodological specificities of these sciences. Consequently, the Brazilian regulatory system (Research Ethics Committees/CEPs of the National Research Ethics Commission/CONEP) is currently undergoing an important review process. This article presents the positions taken by the National Association of Research and Postgraduate Studies in Psychology - ANPEPP. The article: (1) highlights the origins of the current ethics review model, based on biomedical research; (2) summarizes criticisms recurrent to this model; (3) identifies the directions required for the improvement of the system; and (4) lists the challenges to be overcome in the current process of creating specific regulations for the human and social sciences. The considerations presented highlight two crucial points that challenge the construction of a specific resolution for research ethics in the human and social sciences: (1) the clear characterization of what is meant by 'research in the human and social sciences' - and that would, therefore, have its ethical review regulated from the perspective of the specific resolution for the human and social sciences; and (2) the definition of parameters from which different risk levels in studies can be identified.

Highlights

  • Brazilian associations for research in human, social and applied social sciences have long sought ethical aspects regulation compatible with the epistemological, theoretical and methodological specificities of these sciences

  • The text is organized into four sections that briefly focus on: (1) origins of the reference points of the current ethical regulatory model, based on biomedical practice and explained in CNS Resolution 466/12; (2) recurring criticisms of this model from researchers in human and social areas; (3) advances and limits perceived in the replacement of CNS Resolution 196/96 with CNS Resolution 466/12, as well as new demands arising in the context of the Forum of Human, Social and Applied Social Science Research Associations and of the Human and Social Sciences Working Group (GT) of the National Research Ethics Commission (CONEP); and (4) trends and challenges in the development of a specific resolution for research in these areas

  • Two decades after Resolution 196/96 of the National Health Council (CNS) came into effect it can be observed that the review system of ethical aspects of research involving human subjects, in Brazil, has undergone considerable expansion and consolidation

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Summary

Foundations of the current research ethics regulatory system

Two decades after Resolution 196/96 of the National Health Council (CNS) came into effect it can be observed that the review system of ethical aspects of research involving human subjects, in Brazil, has undergone considerable expansion and consolidation. It should be noted that criticism of the content of the Resolutions does not address the existence of regulation, but the fact that the existing Resolutions establish the biomedical framework as the only one applicable to any research Such an approach has been considered insensitive to the specificities of the problems and to the multiple methodological perspectives that characterize research in human and social sciences. National Research Ethics Commission/CONEP creates a working group to address the issues of human and social sciences reviewed by the GT-CONEP should be referred for the assessment of scientific associations and the wider society through public consultation. At the end of this consultation, the draft must once again be returned to the GT-CONEP for review and be forwarded to CONEP for reconsideration, before being submitted to the National Health Council for final approval and promulgation

Seeking a specific resolution for the humanities and social sciences
Relationship between risk level of the project and type of review
Final Considerations
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