Motivations, Understanding, and Voluntariness in International Randomized Trials

Kass, Nancy E.; Maman, Suzanne; Atkinson, Joan

doi:10.2307/3563534

Cited by 53 publications

(64 citation statements)

References 29 publications

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“…Apesar de vários autores insistirem que esse fator é mais comum nos países em desenvolvimento 54 , estudos demonstram que ele é encontrado em sujeitos de estudos em todo o mundo 55,56 , inclusive no Brasil 57 . Como implicação ética dessa influência, destacase que a busca por tratamento médico pode ser um indício da precariedade de serviços de saúde disponíveis para a população, impelindo esses participantes a fazerem parte de pesquisas clínicas 13 .…”

Section: Discussionunclassified

Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico

Lobato

Gazzinelli

et al. 2014

Cad. Saúde Pública

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O objetivo deste estudo é avaliar o conhecimento sobre as informações do Termo de Consentimento Livre e Esclarecido (TCLE) e a voluntariedade de participantes de um ensaio clínico. Trata-se de um estudo quantitativo, descritivo, transversal, realizado em novembro de 2011 com participantes de um ensaio clínico realizado em Americaninhas, no Nordeste de Minas Gerais, Brasil. Amostra por conveniência, com 143 adultos de 18 a 45 anos, de ambos os sexos. Utilizou-se um questionário estruturado, aplicado uma semana após a assinatura do TCLE. A maioria dos participantes do ensaio clínico assinou o TCLE sem o conhecimento suficiente das informações da pesquisa, e sofreu influência em sua decisão de participar do ensaio clínico. Concluímos que a assinatura do TCLE não garante a expressão da autonomia de todos os participantes de pesquisa clínica.

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Section: Discussionunclassified

Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico

Lobato

Gazzinelli

et al. 2014

Cad. Saúde Pública

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show abstract

“…El investigador debe explicar la voluntariedad de la participación, debe responder a las expectativas que le surjan (45,46) y aclarar que puede retirar su consentimiento en cualquier momento sin que exista alguna penalidad o pérdida de beneficios a los cuales el sujeto tiene derecho.…”

Section: Voluntariedadunclassified

Consentimiento Informado en Investigación Clínica: Un Proceso Dinámico

Carreño-Dueñas

2016

pers. bioet

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ReSUmenEn investigación clínica, el consentimiento informado es un documento legal y un mecanismo para respetar la dignidad y proteger los derechos y el bienestar de los sujetos participantes; debe incluir información sobre el propósito de la investigación, la justificación, los riesgos y beneficios, que le permitan a un sujeto decidir voluntariamente su participación. Como es deber del investigador velar por la protección de la vida, la salud, la dignidad, la integridad, el derecho a la autodeterminación, la intimidad y la confidencialidad de los sujetos que enrole en un estudio, tiene que establecer un diálogo permanente con estos para valorar los riesgos y la seguridad de la participación; esta condición se convierte en un proceso dinámico que no comienza ni termina únicamente con la firma del documento, y que no solamente debe trascender la legalidad, sino acercarse a la ética y la legitimidad. PALAbRAS CLAve: consentimiento informado; sujetos de investigación; experimentación humana; ensayos clínicos controlados; investigación biomédica (Fuente: DeCS, Bireme).

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“…She thought they have already done the research, and they are trying to implement the results of the research with these children." (Stakeholder) 38 "Your main concern is to get your child treated. They could even ask you to stand by a fi re all day, and you'd do it!"…”

Section: Tablementioning

confidence: 99%

“…22 Disempowerment Hampering Informed Consent: Stakeholders believed that disempowerment, poor education, and difficulty in translating scientific concepts were barriers to informed decisionmaking. 30,38,39 They recommended that consent forms be simplified and presented in a culturally and linguistically appropriate format with verification of parental comprehension. 17 Parents' implicit trust in physicians was a concern because the physician's recommendation of the trial could be misinterpreted as endorsement that the intervention is effective.…”

Section: Contending With Power Differentialsmentioning

confidence: 99%

“…[58][59][60] However, findings from the present literature review reaffirm observations that meaningful decision-making is further compromised in LMICs by disempowerment, cultural idiosyncrasies, extensive illiteracy, and/or decision-making styles. 18,38,59 Thus, the Western ethical principles of informed consent and child assent, autonomy, and individualism need to be contextualized. 18,45,61 Many of the controversial ethical issues (eg, the use of placebo, the appropriate local standard of care, resource constraints in complying with the rigorous trial requirements) we reported in this literature review are part of the international agenda.…”

Section: Conducting Trials In Children Inmentioning

confidence: 99%

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Stakeholder Views of Clinical Trials in Low- and Middle-Income Countries: A Systematic Review

et al. 2016

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CONTEXT: Clinical trials are necessary to improve the health care of children, but only onequarter are conducted in the low-to middle-income countries (LMICs) in which 98% of the global burden of disease resides. OBJECTIVE:To describe stakeholder beliefs and experiences of conducting trials in children in LMICs.DATA SOURCES: Electronic databases were searched to August 2014. Five themes were identified: centrality of community engagement (mobilizing community, representatives' pivotal role, managing expectations, and retaining involvement); cognizance of vulnerability and poverty (therapeutic opportunity and medical mistrust); contending with power differentials (exploitation, stigmatization, and disempowerment); translating research to local context (cultural beliefs, impoverishment constraints, and ethical pluralism); and advocating fair distribution of benefits (health care, sponsor obligation, and collateral community benefits). LIMITATIONS:Studies not published in English were excluded. CONCLUSIONS:Conducting trials in children in LMICs is complex due to social disadvantage, economic scarcity, idiosyncratic cultural beliefs, and historical disempowerment, all of which contribute to inequity, mistrust, and fears of exploitation. Effective community engagement in recruiting, building research capacities, and designing trials that are pragmatic, ethical, and relevant to the health care needs of children in LMICs may help to improve the equity and health outcomes of this vulnerable population.

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Motivations, Understanding, and Voluntariness in International Randomized Trials

Cited by 53 publications

References 29 publications

Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico

Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico

Consentimiento Informado en Investigación Clínica: Un Proceso Dinámico

Stakeholder Views of Clinical Trials in Low- and Middle-Income Countries: A Systematic Review

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