Social control, transparency, accountability, and scientific integrity in medical research

Detalhes bibliográficos
Autor(a) principal: Dantas, Flávio
Data de Publicação: 2023
Tipo de documento: preprint
Idioma: por
Título da fonte: SciELO Preprints
Texto Completo: https://preprints.scielo.org/index.php/scielo/preprint/view/5289
Resumo: The CEP/CONEP System, submitted to social control, is responsible for the ethical approval of research in Brazil to protect research participants. The Informed Consent Form (ICF) is the public document that implements the protection of participants. The paper presents two cases of medical research in the Amazon region on malaria and the use of chloroquine for treating COVID-19. The participants were uninformed in the ICF on relevant aspects of the two studies, with serious health risks. For the sake of increasing transparency and social control, it is proposed the mandatory publication of the ICF in studies supported by public funds, presentation of an objective summary of the study at the beginning of the ICF, publication of central elements of the protocol of clinical trials in open access Brazilian virtual platforms, and promulgation of a dedicated law to improve scientific and ethical integrity in Brazilian medical research.
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spelling Social control, transparency, accountability, and scientific integrity in medical researchControl social, transparencia, responsabilidad y integridad de la investigación médicaCONTROLE SOCIAL, TRANSPARÊNCIA, INTEIREZA CIENTÍFICA E RESPONSABILIDADE EM PESQUISAS MÉDICASÉtica em PesquisaExperimentação humanaConsentimento livre e esclarecidoTermos de consentimentoControle social formalMá conduta científicaComitês de Ética em PesquisaEthics, ResearchHuman experimentationInformed consentConsent formsFormal social controlScientific MisconductEthics Committees, ResearchÉtica en InvestigaciónExperimentación humanaConsentimiento informadoFormularios de consentimientoControl social formalMala Conduta CientíficaComités de Ética en InvestigaciónThe CEP/CONEP System, submitted to social control, is responsible for the ethical approval of research in Brazil to protect research participants. The Informed Consent Form (ICF) is the public document that implements the protection of participants. The paper presents two cases of medical research in the Amazon region on malaria and the use of chloroquine for treating COVID-19. The participants were uninformed in the ICF on relevant aspects of the two studies, with serious health risks. For the sake of increasing transparency and social control, it is proposed the mandatory publication of the ICF in studies supported by public funds, presentation of an objective summary of the study at the beginning of the ICF, publication of central elements of the protocol of clinical trials in open access Brazilian virtual platforms, and promulgation of a dedicated law to improve scientific and ethical integrity in Brazilian medical research.El Sistema CEP/CONEP es responsable del análisis ético de la investigación en Brasil, sometida al control social, con la misión de proteger a los participantes en la investigación.  El Formulario de Consentimiento Libre e Informado es el documento público que implementa la protección de los participantes. El artículo presenta dos casos de investigación médica en la región amazónica sobre malaria y tratamiento con cloroquina para COVID-19, en que los participantes no fueron informados, en el documento de consentimiento informado, aprobado por el sistema CEP/CONEP, sobre aspectos relevantes de los estudios, con graves riesgos para la salud.  Para aumentar la transparencia y el control social, el artículo propone la divulgación obligatoria del modelo de consentimiento informado en estudios financiados con recursos públicos, la presentación de un resumen objetivo del estudio al inicio del documento de consentimiento, la publicación de elementos centrales del protocolo de ensayos clínicos en plataformas virtuales brasileñas de acceso abierto, y la promulgación de una ley para perfeccionar la integridad científica y ética en la investigación médica brasileña.O Sistema CEP/CONEP é responsável pela regulação ética de pesquisas no Brasil, comprometido com o controle social, para proteger os direitos dos participantes em pesquisas. O Termo de Consentimento Livre e Esclarecido (TCLE) é o documento público que concretiza a proteção dos participantes. O artigo aborda dois casos de pesquisas médicas na região amazônica, sobre malária e tratamento com cloroquina para COVID-19, em que os participantes foram desinformados no TCLE, aprovado pelo sistema CEP/CONEP, sobre aspectos relevantes dos estudos, com sérios riscos à saúde.  Para ampliar a transparência e  controle social, propõe-se a divulgação obrigatória do modelo de TCLE em pesquisas que usem recursos públicos, apresentação de resumo itemizado no início do TCLE, publicação de elementos centrais do protocolo de ensaios clínicos em plataformas virtuais brasileiras de acesso aberto e promulgação de lei para aprimorar a inteireza científica e ética nas pesquisas médicas brasileiras.SciELO PreprintsSciELO PreprintsSciELO Preprints2023-01-31info:eu-repo/semantics/preprintinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://preprints.scielo.org/index.php/scielo/preprint/view/528910.1590/SciELOPreprints.5289porhttps://preprints.scielo.org/index.php/scielo/article/view/5289/10499Copyright (c) 2023 Flávio Dantashttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessDantas, Flávioreponame:SciELO Preprintsinstname:Scientific Electronic Library Online (SCIELO)instacron:SCI2023-01-13T19:54:10Zoai:ops.preprints.scielo.org:preprint/5289Servidor de preprintshttps://preprints.scielo.org/index.php/scieloONGhttps://preprints.scielo.org/index.php/scielo/oaiscielo.submission@scielo.orgopendoar:2023-01-13T19:54:10SciELO Preprints - Scientific Electronic Library Online (SCIELO)false
dc.title.none.fl_str_mv Social control, transparency, accountability, and scientific integrity in medical research
Control social, transparencia, responsabilidad y integridad de la investigación médica
CONTROLE SOCIAL, TRANSPARÊNCIA, INTEIREZA CIENTÍFICA E RESPONSABILIDADE EM PESQUISAS MÉDICAS
title Social control, transparency, accountability, and scientific integrity in medical research
spellingShingle Social control, transparency, accountability, and scientific integrity in medical research
Dantas, Flávio
Ética em Pesquisa
Experimentação humana
Consentimento livre e esclarecido
Termos de consentimento
Controle social formal
Má conduta científica
Comitês de Ética em Pesquisa
Ethics, Research
Human experimentation
Informed consent
Consent forms
Formal social control
Scientific Misconduct
Ethics Committees, Research
Ética en Investigación
Experimentación humana
Consentimiento informado
Formularios de consentimiento
Control social formal
Mala Conduta Científica
Comités de Ética en Investigación
title_short Social control, transparency, accountability, and scientific integrity in medical research
title_full Social control, transparency, accountability, and scientific integrity in medical research
title_fullStr Social control, transparency, accountability, and scientific integrity in medical research
title_full_unstemmed Social control, transparency, accountability, and scientific integrity in medical research
title_sort Social control, transparency, accountability, and scientific integrity in medical research
author Dantas, Flávio
author_facet Dantas, Flávio
author_role author
dc.contributor.author.fl_str_mv Dantas, Flávio
dc.subject.por.fl_str_mv Ética em Pesquisa
Experimentação humana
Consentimento livre e esclarecido
Termos de consentimento
Controle social formal
Má conduta científica
Comitês de Ética em Pesquisa
Ethics, Research
Human experimentation
Informed consent
Consent forms
Formal social control
Scientific Misconduct
Ethics Committees, Research
Ética en Investigación
Experimentación humana
Consentimiento informado
Formularios de consentimiento
Control social formal
Mala Conduta Científica
Comités de Ética en Investigación
topic Ética em Pesquisa
Experimentação humana
Consentimento livre e esclarecido
Termos de consentimento
Controle social formal
Má conduta científica
Comitês de Ética em Pesquisa
Ethics, Research
Human experimentation
Informed consent
Consent forms
Formal social control
Scientific Misconduct
Ethics Committees, Research
Ética en Investigación
Experimentación humana
Consentimiento informado
Formularios de consentimiento
Control social formal
Mala Conduta Científica
Comités de Ética en Investigación
description The CEP/CONEP System, submitted to social control, is responsible for the ethical approval of research in Brazil to protect research participants. The Informed Consent Form (ICF) is the public document that implements the protection of participants. The paper presents two cases of medical research in the Amazon region on malaria and the use of chloroquine for treating COVID-19. The participants were uninformed in the ICF on relevant aspects of the two studies, with serious health risks. For the sake of increasing transparency and social control, it is proposed the mandatory publication of the ICF in studies supported by public funds, presentation of an objective summary of the study at the beginning of the ICF, publication of central elements of the protocol of clinical trials in open access Brazilian virtual platforms, and promulgation of a dedicated law to improve scientific and ethical integrity in Brazilian medical research.
publishDate 2023
dc.date.none.fl_str_mv 2023-01-31
dc.type.driver.fl_str_mv info:eu-repo/semantics/preprint
info:eu-repo/semantics/publishedVersion
format preprint
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://preprints.scielo.org/index.php/scielo/preprint/view/5289
10.1590/SciELOPreprints.5289
url https://preprints.scielo.org/index.php/scielo/preprint/view/5289
identifier_str_mv 10.1590/SciELOPreprints.5289
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://preprints.scielo.org/index.php/scielo/article/view/5289/10499
dc.rights.driver.fl_str_mv Copyright (c) 2023 Flávio Dantas
https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2023 Flávio Dantas
https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv SciELO Preprints
SciELO Preprints
SciELO Preprints
publisher.none.fl_str_mv SciELO Preprints
SciELO Preprints
SciELO Preprints
dc.source.none.fl_str_mv reponame:SciELO Preprints
instname:Scientific Electronic Library Online (SCIELO)
instacron:SCI
instname_str Scientific Electronic Library Online (SCIELO)
instacron_str SCI
institution SCI
reponame_str SciELO Preprints
collection SciELO Preprints
repository.name.fl_str_mv SciELO Preprints - Scientific Electronic Library Online (SCIELO)
repository.mail.fl_str_mv scielo.submission@scielo.org
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