Bioethical principle of autonomy in research and clinical trials: an integrative literature review

Detalhes bibliográficos
Autor(a) principal: Oliveira, Sandra Barros de
Data de Publicação: 2022
Outros Autores: Felix, Luana Sousa, Badin, Rebeka Caribé
Tipo de documento: Artigo
Idioma: por
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/27441
Resumo: Randomized clinical trials are considered the gold standard of studies to assess the efficacy and safety of clinical interventions such as experimental drugs, health products and/or therapeutic procedures. This is an integrative literature review was developed to identify the importance of the bioethical principle of autonomy in conducting research and clinical trials. Due to its importance in accessing new technologies in the field of health and the challenges related to its adequacy to bioethics principles, the present study aimed to carry out a survey of how this aspect is being addressed. The selected research show investigations and discussions of elements that can compromise and influence individuals' freedom of choice in clinical studies and their opinion about the problems. We conclude that, of the bioethics principles, autonomy is the most likely to be negatively affected in clinical trials, demonstrating the importance of bioethics in identifying gaps and establishing limits between advances in medical research and ethical and moral values.
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spelling Bioethical principle of autonomy in research and clinical trials: an integrative literature reviewPrincipio bioético de autonomía en investigación y ensayos clínicos: una revisión integrativa de la literaturaPrincípio bioético da autonomia na pesquisa e nos ensaios clínicos: uma revisão integrativa da literaturaBioethicsClinical researchClinical trial.BioéticaInvestigación clínicaEnsayo clínico.BioéticaPesquisa clínicaEnsaio clínico.Randomized clinical trials are considered the gold standard of studies to assess the efficacy and safety of clinical interventions such as experimental drugs, health products and/or therapeutic procedures. This is an integrative literature review was developed to identify the importance of the bioethical principle of autonomy in conducting research and clinical trials. Due to its importance in accessing new technologies in the field of health and the challenges related to its adequacy to bioethics principles, the present study aimed to carry out a survey of how this aspect is being addressed. The selected research show investigations and discussions of elements that can compromise and influence individuals' freedom of choice in clinical studies and their opinion about the problems. We conclude that, of the bioethics principles, autonomy is the most likely to be negatively affected in clinical trials, demonstrating the importance of bioethics in identifying gaps and establishing limits between advances in medical research and ethical and moral values.Los ensayos clínicos aleatorizados se consideran el estándar de oro de los estudios para evaluar la eficacia y la seguridad de las intervenciones clínicas, como medicamentos experimentales, productos sanitarios y/o procedimientos terapéuticos. Esta es una revisión integrativa de la literatura que buscó identificar la importancia del principio bioético de autonomía en la realización de investigaciones y ensayos clínicos. Debido a su importancia en el acceso a las nuevas tecnologías en el campo de la salud y los desafíos relacionados con su adecuación a los principios bioéticos, el presente estudio tuvo como objetivo sondear cómo este aspecto está siendo abordado. Las investigaciones seleccionadas muestran discusiones de elementos que pueden comprometer e influenciar la libertad de elección de los individuos en estudios clínicos y su opinión sobre los temas. Se puede concluir que, entre los principios de la bioética, la autonomía es el que tiene mayor posibilidad de ser vulnerada en los ensayos clínicos, demostrando la importancia de la bioética a la hora de identificar falencias y establecer límites entre la generación de datos para el avance de la investigación y la mejora de los servicios médicos y los valores éticos morales.Os ensaios clínicos randomizados são considerados padrão ouro dos estudos para avaliar a eficácia e a segurança das intervenções clínicas como medicamentos experimentais, produtos para saúde e/ou procedimentos terapêuticos. Através de uma revisão integrativa da literatura buscou-se identificar a importância do princípio bioético da autonomia na condução de pesquisas e ensaios clínicos. Dada sua importância no acesso às novas tecnologias no âmbito da saúde e os desafios referente à sua adequação aos princípios bioéticos, o presente estudo teve como objetivo realizar o levantamento de como esse aspecto está sendo abordado. As pesquisas selecionadas evidenciam investigações e discussões de elementos que podem comprometer e influenciar a liberdade de escolha de indivíduos em estudos clínicos e a opinião dos mesmos acerca das problemáticas. Pode-se concluir que dentre os princípios bioéticos, a autonomia é a que possui maior possibilidade de ser lesada em ensaios clínicos, demonstrando a importância da bioética ao identificar falhas e estabelecer limites entre gerar dados para o progresso das pesquisas e aprimoramento de procedimentos médicos e os valores éticos e morais.Research, Society and Development2022-03-27info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/2744110.33448/rsd-v11i4.27441Research, Society and Development; Vol. 11 No. 4; e57811427441Research, Society and Development; Vol. 11 Núm. 4; e57811427441Research, Society and Development; v. 11 n. 4; e578114274412525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIporhttps://rsdjournal.org/index.php/rsd/article/view/27441/24234Copyright (c) 2022 Sandra Barros de Oliveira; Luana Sousa Felix; Rebeka Caribé Badinhttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessOliveira, Sandra Barros deFelix, Luana SousaBadin, Rebeka Caribé 2022-03-27T17:17:09Zoai:ojs.pkp.sfu.ca:article/27441Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-01-17T09:45:10.872421Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv Bioethical principle of autonomy in research and clinical trials: an integrative literature review
Principio bioético de autonomía en investigación y ensayos clínicos: una revisión integrativa de la literatura
Princípio bioético da autonomia na pesquisa e nos ensaios clínicos: uma revisão integrativa da literatura
title Bioethical principle of autonomy in research and clinical trials: an integrative literature review
spellingShingle Bioethical principle of autonomy in research and clinical trials: an integrative literature review
Oliveira, Sandra Barros de
Bioethics
Clinical research
Clinical trial.
Bioética
Investigación clínica
Ensayo clínico.
Bioética
Pesquisa clínica
Ensaio clínico.
title_short Bioethical principle of autonomy in research and clinical trials: an integrative literature review
title_full Bioethical principle of autonomy in research and clinical trials: an integrative literature review
title_fullStr Bioethical principle of autonomy in research and clinical trials: an integrative literature review
title_full_unstemmed Bioethical principle of autonomy in research and clinical trials: an integrative literature review
title_sort Bioethical principle of autonomy in research and clinical trials: an integrative literature review
author Oliveira, Sandra Barros de
author_facet Oliveira, Sandra Barros de
Felix, Luana Sousa
Badin, Rebeka Caribé
author_role author
author2 Felix, Luana Sousa
Badin, Rebeka Caribé
author2_role author
author
dc.contributor.author.fl_str_mv Oliveira, Sandra Barros de
Felix, Luana Sousa
Badin, Rebeka Caribé
dc.subject.por.fl_str_mv Bioethics
Clinical research
Clinical trial.
Bioética
Investigación clínica
Ensayo clínico.
Bioética
Pesquisa clínica
Ensaio clínico.
topic Bioethics
Clinical research
Clinical trial.
Bioética
Investigación clínica
Ensayo clínico.
Bioética
Pesquisa clínica
Ensaio clínico.
description Randomized clinical trials are considered the gold standard of studies to assess the efficacy and safety of clinical interventions such as experimental drugs, health products and/or therapeutic procedures. This is an integrative literature review was developed to identify the importance of the bioethical principle of autonomy in conducting research and clinical trials. Due to its importance in accessing new technologies in the field of health and the challenges related to its adequacy to bioethics principles, the present study aimed to carry out a survey of how this aspect is being addressed. The selected research show investigations and discussions of elements that can compromise and influence individuals' freedom of choice in clinical studies and their opinion about the problems. We conclude that, of the bioethics principles, autonomy is the most likely to be negatively affected in clinical trials, demonstrating the importance of bioethics in identifying gaps and establishing limits between advances in medical research and ethical and moral values.
publishDate 2022
dc.date.none.fl_str_mv 2022-03-27
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 https://rsdjournal.org/index.php/rsd/article/view/27441
10.33448/rsd-v11i4.27441
url https://rsdjournal.org/index.php/rsd/article/view/27441
identifier_str_mv 10.33448/rsd-v11i4.27441
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/27441/24234
dc.rights.driver.fl_str_mv Copyright (c) 2022 Sandra Barros de Oliveira; Luana Sousa Felix; Rebeka Caribé Badin
https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2022 Sandra Barros de Oliveira; Luana Sousa Felix; Rebeka Caribé Badin
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 Research, Society and Development
publisher.none.fl_str_mv Research, Society and Development
dc.source.none.fl_str_mv Research, Society and Development; Vol. 11 No. 4; e57811427441
Research, Society and Development; Vol. 11 Núm. 4; e57811427441
Research, Society and Development; v. 11 n. 4; e57811427441
2525-3409
reponame:Research, Society and Development
instname:Universidade Federal de Itajubá (UNIFEI)
instacron:UNIFEI
instname_str Universidade Federal de Itajubá (UNIFEI)
instacron_str UNIFEI
institution UNIFEI
reponame_str Research, Society and Development
collection Research, Society and Development
repository.name.fl_str_mv Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)
repository.mail.fl_str_mv rsd.articles@gmail.com
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