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Professional and academic profile of the Brazilian research ethics committees

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 t...

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Autores principales: de Veras Santos, Eugênio Pacelli, Guerriero, Iara Coelho Zito
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9652890/
https://www.ncbi.nlm.nih.gov/pubmed/36368994
http://dx.doi.org/10.1186/s12910-022-00847-z
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author de Veras Santos, Eugênio Pacelli
Guerriero, Iara Coelho Zito
author_facet de Veras Santos, Eugênio Pacelli
Guerriero, Iara Coelho Zito
author_sort de Veras Santos, Eugênio Pacelli
collection PubMed
description 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. There are Brazilian RECs that review SSH and clinical trials. This study aimed to analyze the academic professional profile of the members of the CONEP and Brazilian RECs, their adequacy to the norms, and the challenges faced by the REC’s Chairs to compose their membership. METHODS: All 779 Brazilian RECs’ chairs are invited to fill in a questionnaire informing academic and professional background of the RECs members, and 92 answered. However, eight were excluded for having sent an incomplete questionnaire, leaving a total of 84 participants. The variables were described by absolute and relative frequency. The Chi-square test and ANOVA was used to analyze regional differences related difficulties to compose the committee. The significance level was 95%. RESULTS: The results showed a predominance of members from the biomedical area (57%), while 33% were members of the Social Sciences and Humanities and 5.5% were community representatives. As for the academic degree, there were (45.2%) PhD and (27.9%) masters. The divergences in relation to the guidelines result from the difficulties of having participants in some areas and the little interest in the work carried out by the committees. CONCLUSION: The RECs are partially adequate to the norms and their performance may be compromised by the low participation of community representatives. The organization of REC’s specifics to review biomedical research could improve the ethical review process, ensuring a membership more qualified for these protocols.
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spelling pubmed-96528902022-11-15 Professional and academic profile of the Brazilian research ethics committees de Veras Santos, Eugênio Pacelli Guerriero, Iara Coelho Zito BMC Med Ethics Research Article 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. There are Brazilian RECs that review SSH and clinical trials. This study aimed to analyze the academic professional profile of the members of the CONEP and Brazilian RECs, their adequacy to the norms, and the challenges faced by the REC’s Chairs to compose their membership. METHODS: All 779 Brazilian RECs’ chairs are invited to fill in a questionnaire informing academic and professional background of the RECs members, and 92 answered. However, eight were excluded for having sent an incomplete questionnaire, leaving a total of 84 participants. The variables were described by absolute and relative frequency. The Chi-square test and ANOVA was used to analyze regional differences related difficulties to compose the committee. The significance level was 95%. RESULTS: The results showed a predominance of members from the biomedical area (57%), while 33% were members of the Social Sciences and Humanities and 5.5% were community representatives. As for the academic degree, there were (45.2%) PhD and (27.9%) masters. The divergences in relation to the guidelines result from the difficulties of having participants in some areas and the little interest in the work carried out by the committees. CONCLUSION: The RECs are partially adequate to the norms and their performance may be compromised by the low participation of community representatives. The organization of REC’s specifics to review biomedical research could improve the ethical review process, ensuring a membership more qualified for these protocols. BioMed Central 2022-11-11 /pmc/articles/PMC9652890/ /pubmed/36368994 http://dx.doi.org/10.1186/s12910-022-00847-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
de Veras Santos, Eugênio Pacelli
Guerriero, Iara Coelho Zito
Professional and academic profile of the Brazilian research ethics committees
title Professional and academic profile of the Brazilian research ethics committees
title_full Professional and academic profile of the Brazilian research ethics committees
title_fullStr Professional and academic profile of the Brazilian research ethics committees
title_full_unstemmed Professional and academic profile of the Brazilian research ethics committees
title_short Professional and academic profile of the Brazilian research ethics committees
title_sort professional and academic profile of the brazilian research ethics committees
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9652890/
https://www.ncbi.nlm.nih.gov/pubmed/36368994
http://dx.doi.org/10.1186/s12910-022-00847-z
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