Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projects
Autor(a) principal: | |
---|---|
Data de Publicação: | 2021 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Revista de Gestão e Avaliação Educacional |
Texto Completo: | http://periodicos.ufsm.br/regae/article/view/67392 |
Resumo: | Initially motivated by the discoveries of the atrocities that occurred in experiments during World War II, research ethics became a recurrent theme in the scientific environment. It aims to guide researchers in the conduct of their activities, in order to protect research participants from possible risks and harms and also to ensure the potentiation of benefits, with social return. In this sense, the National Health Council established in 1996 the National Commission on Research Ethics to manage the research ethics committees, which evaluate research projects involving human beings. Based on this context, the objective of this study was to identify the most recurrent pending issues in the opinions issued by the Committee on Ethics in Research with Human Beings of the Federal University of Santa Maria. Data were collected in Platform Brazil, focusing on the opinions issued by the CEP/UFSM in the period from 2016 to 2019, which totaled 1,128. The sample, with confidence interval parameters of 95% and margin of error of 5% resulted in 376 opinions to be analyzed. In the data analysis the guidance of Bardin (2011) was observed, with categories of analysis defined after the event. The pending issues found in the opinions relate to aspects of the Informed Consent Form, methodology, formalities required in the other mandatory documents, and discordant information provided in the project, Platform Brazil and attached documents. It is concluded that its users lack training activities on the preparation of documents and legislation. |
id |
UFSM-7_77235407c69ca7eb64ff2a8be1b6cf3c |
---|---|
oai_identifier_str |
oai:ojs.pkp.sfu.ca:article/67392 |
network_acronym_str |
UFSM-7 |
network_name_str |
Revista de Gestão e Avaliação Educacional |
repository_id_str |
|
spelling |
Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projectsComitê de Ética em Pesquisa com Seres Humanos da UFSM: um estudo sobre as principais pendências na aprovação de projetosComitê de Ética em Pesquisa. Plataforma Brasil. Ética em PesquisaInitially motivated by the discoveries of the atrocities that occurred in experiments during World War II, research ethics became a recurrent theme in the scientific environment. It aims to guide researchers in the conduct of their activities, in order to protect research participants from possible risks and harms and also to ensure the potentiation of benefits, with social return. In this sense, the National Health Council established in 1996 the National Commission on Research Ethics to manage the research ethics committees, which evaluate research projects involving human beings. Based on this context, the objective of this study was to identify the most recurrent pending issues in the opinions issued by the Committee on Ethics in Research with Human Beings of the Federal University of Santa Maria. Data were collected in Platform Brazil, focusing on the opinions issued by the CEP/UFSM in the period from 2016 to 2019, which totaled 1,128. The sample, with confidence interval parameters of 95% and margin of error of 5% resulted in 376 opinions to be analyzed. In the data analysis the guidance of Bardin (2011) was observed, with categories of analysis defined after the event. The pending issues found in the opinions relate to aspects of the Informed Consent Form, methodology, formalities required in the other mandatory documents, and discordant information provided in the project, Platform Brazil and attached documents. It is concluded that its users lack training activities on the preparation of documents and legislation.Inicialmente motivada pelas descobertas das atrocidades ocorridas em experimentos no período da 2ª Guerra Mundial, a ética em pesquisa tornou-se tema recorrente no meio científico. Ela visa a orientar os pesquisadores na condução de suas atividades, a fim de resguardar os participantes da pesquisa contra eventuais riscos e danos e também assegurar a potencialização dos benefícios, com retorno social. Nesse sentido, o Conselho Nacional de Saúde instituiu, em 1996, a Comissão Nacional de Ética em Pesquisa para gerenciar os comitês de ética em pesquisa, os quais avaliam projetos de pesquisas que envolvam seres humanos. Com base nesse contexto, definiu-se como objetivo deste estudo identificar as pendências mais recorrentes nos pareceres emitidos pelo Comitê de Ética em Pesquisa com Seres Humanos da Universidade Federal de Santa Maria. Os dados foram coletados na Plataforma Brasil, atendo-se aos parecer emitidos pelo CEP/UFSM no período de 2016 a 2019, os quais totalizaram 1.128. A amostra, com parâmetros de intervalo de confiança de 95% e margem de erro de 5% resultou em 376 pareceres a serem analisados. Na análise dos dados se observou a orientação de Bardin (2011), com categorias de análise definidas à posteriori. As pendências encontradas nos pareceres dizem respeito a aspectos do termo de consentimento livre e esclarecido, metodologia, formalidades necessárias nos demais documentos obrigatórios e informações discordantes fornecidas no projeto, Plataforma Brasil e documentos anexados. Conclui-se que seus usuários carecem de atividades de capacitação sobre a elaboração de documentos e legislação.Universidade Federal de Santa Maria2021-11-03info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttp://periodicos.ufsm.br/regae/article/view/6739210.5902/2318133867392Regae: Revista de Gestão e Avaliação Educacional; v. 10, n. 19, 2021, publicação continua; e67392, p. 1-14Revista de Gestão e Avaliação Educacional; v. 10, n. 19, 2021, publicação continua; e67392, p. 1-142318-13382176-2171reponame:Revista de Gestão e Avaliação Educacionalinstname:Universidade Federal de Santa Maria (UFSM)instacron:UFSMporhttp://periodicos.ufsm.br/regae/article/view/67392/pdfCopyright (c) 2021 Revista de Gestão e Avaliação Educacionalinfo:eu-repo/semantics/openAccessHeinz, GabrielaZucatto, Luis Carlos2021-12-07T13:02:11Zoai:ojs.pkp.sfu.ca:article/67392Revistahttps://periodicos.ufsm.br/regaePUBhttp://cascavel.ufsm.br/revistas/ojs-2.2.2/index.php/regae/oai||revistaregae@gmail.com2318-13382176-2171opendoar:2021-12-07T13:02:11Revista de Gestão e Avaliação Educacional - Universidade Federal de Santa Maria (UFSM)false |
dc.title.none.fl_str_mv |
Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projects Comitê de Ética em Pesquisa com Seres Humanos da UFSM: um estudo sobre as principais pendências na aprovação de projetos |
title |
Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projects |
spellingShingle |
Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projects Heinz, Gabriela Comitê de Ética em Pesquisa. Plataforma Brasil. Ética em Pesquisa |
title_short |
Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projects |
title_full |
Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projects |
title_fullStr |
Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projects |
title_full_unstemmed |
Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projects |
title_sort |
Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projects |
author |
Heinz, Gabriela |
author_facet |
Heinz, Gabriela Zucatto, Luis Carlos |
author_role |
author |
author2 |
Zucatto, Luis Carlos |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Heinz, Gabriela Zucatto, Luis Carlos |
dc.subject.por.fl_str_mv |
Comitê de Ética em Pesquisa. Plataforma Brasil. Ética em Pesquisa |
topic |
Comitê de Ética em Pesquisa. Plataforma Brasil. Ética em Pesquisa |
description |
Initially motivated by the discoveries of the atrocities that occurred in experiments during World War II, research ethics became a recurrent theme in the scientific environment. It aims to guide researchers in the conduct of their activities, in order to protect research participants from possible risks and harms and also to ensure the potentiation of benefits, with social return. In this sense, the National Health Council established in 1996 the National Commission on Research Ethics to manage the research ethics committees, which evaluate research projects involving human beings. Based on this context, the objective of this study was to identify the most recurrent pending issues in the opinions issued by the Committee on Ethics in Research with Human Beings of the Federal University of Santa Maria. Data were collected in Platform Brazil, focusing on the opinions issued by the CEP/UFSM in the period from 2016 to 2019, which totaled 1,128. The sample, with confidence interval parameters of 95% and margin of error of 5% resulted in 376 opinions to be analyzed. In the data analysis the guidance of Bardin (2011) was observed, with categories of analysis defined after the event. The pending issues found in the opinions relate to aspects of the Informed Consent Form, methodology, formalities required in the other mandatory documents, and discordant information provided in the project, Platform Brazil and attached documents. It is concluded that its users lack training activities on the preparation of documents and legislation. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-11-03 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://periodicos.ufsm.br/regae/article/view/67392 10.5902/2318133867392 |
url |
http://periodicos.ufsm.br/regae/article/view/67392 |
identifier_str_mv |
10.5902/2318133867392 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
http://periodicos.ufsm.br/regae/article/view/67392/pdf |
dc.rights.driver.fl_str_mv |
Copyright (c) 2021 Revista de Gestão e Avaliação Educacional info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2021 Revista de Gestão e Avaliação Educacional |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Universidade Federal de Santa Maria |
publisher.none.fl_str_mv |
Universidade Federal de Santa Maria |
dc.source.none.fl_str_mv |
Regae: Revista de Gestão e Avaliação Educacional; v. 10, n. 19, 2021, publicação continua; e67392, p. 1-14 Revista de Gestão e Avaliação Educacional; v. 10, n. 19, 2021, publicação continua; e67392, p. 1-14 2318-1338 2176-2171 reponame:Revista de Gestão e Avaliação Educacional instname:Universidade Federal de Santa Maria (UFSM) instacron:UFSM |
instname_str |
Universidade Federal de Santa Maria (UFSM) |
instacron_str |
UFSM |
institution |
UFSM |
reponame_str |
Revista de Gestão e Avaliação Educacional |
collection |
Revista de Gestão e Avaliação Educacional |
repository.name.fl_str_mv |
Revista de Gestão e Avaliação Educacional - Universidade Federal de Santa Maria (UFSM) |
repository.mail.fl_str_mv |
||revistaregae@gmail.com |
_version_ |
1809281068797263872 |