Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 4 de 4
Filtrar
Mais filtros

Eixos temáticos
Ano de publicação
Tipo de documento
Intervalo de ano de publicação
1.
Rev Invest Clin ; 71(4): 217-225, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31448777

RESUMO

Vulnerability in research occurs when the participant is incapable of protecting his or her interests and therefore, has an increased probability of being intentionally or unintentionally harmed. This manuscript aims to discuss the conditions that make a group vulnerable and the tools and requirements that can be used to reduce the ethical breaches when including them in research protocols. The vulnerability can be due either to an inability to understand and give informed consent or to unequal power relationships that hinder basic rights. Excluding subjects from research for the only reason of belonging to a vulnerable group is unethical and will bias the results of the investigation. To consider a subject or group as vulnerable depends on the context, and the investigator should evaluate each case individually.


Assuntos
Pesquisa Biomédica/ética , Ética em Pesquisa , Sujeitos da Pesquisa , Populações Vulneráveis , Viés , Pesquisa Biomédica/organização & administração , Humanos , Consentimento Livre e Esclarecido/ética , Pesquisadores/ética , Pesquisadores/organização & administração
2.
Rev Invest Clin ; 71(5): 297-305, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31599878

RESUMO

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects' first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.


Assuntos
Ensaios Clínicos como Assunto/métodos , Indústria Farmacêutica/economia , Comitês de Ética em Pesquisa/organização & administração , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Humanos , Consentimento Livre e Esclarecido , Apoio à Pesquisa como Assunto/economia
3.
Rev. invest. clín ; 71(4): 217-225, Jul.-Aug. 2019. graf
Artigo em Inglês | LILACS | ID: biblio-1289690

RESUMO

Abstract Vulnerability in research occurs when the participant is incapable of protecting his or her interests and therefore, has an increased probability of being intentionally or unintentionally harmed. This manuscript aims to discuss the conditions that make a group vulnerable and the tools and requirements that can be used to reduce the ethical breaches when including them in research protocols. The vulnerability can be due either to an inability to understand and give informed consent or to unequal power relationships that hinder basic rights. Excluding subjects from research for the only reason of belonging to a vulnerable group is unethical and will bias the results of the investigation. To consider a subject or group as vulnerable depends on the context, and the investigator should evaluate each case individually.


Assuntos
Humanos , Pesquisa Biomédica/ética , Ética em Pesquisa , Sujeitos da Pesquisa , Populações Vulneráveis , Pesquisadores/organização & administração , Pesquisadores/ética , Viés , Pesquisa Biomédica/organização & administração , Consentimento Livre e Esclarecido/ética
4.
Rev. invest. clín ; 71(5): 297-305, Sep.-Oct. 2019. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1289699

RESUMO

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects’ first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.


Assuntos
Humanos , Ensaios Clínicos como Assunto/métodos , Comitês de Ética em Pesquisa/organização & administração , Indústria Farmacêutica/economia , Apoio à Pesquisa como Assunto/economia , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Consentimento Livre e Esclarecido
SELEÇÃO DE REFERÊNCIAS
Detalhe da pesquisa