O processo de consentimento livre e esclarecido em pesquisa: uma nova abordagem

Goldim, José Roberto; Pithan, Carolina da Fonte; Oliveira, Juliana Ghisleni de; Raymundo, Márcia Mocellin

doi:10.1590/s0104-42302003000400026

Cited by 29 publications

(29 citation statements)

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“…14,22 Subjects should understand procedures, risks, discomforts, benefi ts and rights involved in their participation in the research. 11 However, some studies have shown limited knowledge about the research among individuals that had consented to participate, 13 which may be due to the research subjects' conscious choice to disregard information, or to failures in the communication process. 13 For communication to be effective, it is necessary to adopt a model that values both the transmitted content and the speech act, that is, how the actors involved in the communication act transmit proposals, understand them and respond to them.…”

Section: Right To Autonomy and Informed Consentmentioning

confidence: 99%

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Aspectos eticos em estudos longitudinais: o caso do ELSA-Brasil

et al. 2013

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The debate about ethics in research with human beings has historically emphasized experimental studies because of their greater potential to harm the subjects involved. However, observational studies also include risks and relevant questions to be discussed. This article aims to present and discuss the ethical aspects involved in the implementation of ELSA-Brasil (Brazilian Longitudinal Study for Adult Health), a longitudinal multicenter study, with public funding, in which the research subjects and investigators are employees of the same institutions. The procedures adopted to meet the ethical requirements and commitments are described, as well as the casuistics that guided the actions according to their guiding principles (benefi cence, autonomy and social justice). We present some moral problems that required consideration of risks and benefi ts at the confl uence with the study's objectives, and we conclude with comments on the peculiarities and the potential benefi ts of a longitudinal study.

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Section: Right To Autonomy and Informed Consentmentioning

confidence: 99%

“…Goldim et al, 11 using empirical data, suggest that the collective transmission of information can be effective in the recollection of information that is necessary to the informed consent.…”

Section: Right To Autonomy and Informed Consentmentioning

confidence: 99%

Aspectos eticos em estudos longitudinais: o caso do ELSA-Brasil

et al. 2013

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“…By return mail and phone calls from family members, we were informed that three more patients had died. The time course of return of the forms ranged from 2 to 89 days [median: 10 days; mean: 18 days; 95% confidence interval (CI) [14][15][16][17][18][19][20][21][22], considering a median follow-up of 331 days (mean: 323 days, 95%CI 314-331).…”

Section: Resultsmentioning

confidence: 99%

“…On the other hand, the lack of face-to-face interaction may have minimized the chance of coercion, which can sometimes occur, albeit unintentionally. 19,20 Nevertheless, some patients contacted the researchers by visiting the Institution, calling them or sending written messages.…”

Section: Resultsmentioning

confidence: 99%

Termo de consentimento e análise de material biológico armazenado

Duque¹,

Ramalho

Casali-da-Rocha

2010

Rev. Assoc. Med. Bras.

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objectIve. To report practical experience in obtaining consent for a retrospective study conducted at the Brazilian National Cancer Institute (INCA). The study involved review of medical records and analysis of paraffin blocks of patients surgically treated for colon cancer between 2000 and 2004. Attempts to obtain informed consent were made in compliance with the resolution 196/96 of the Brazilian National Health Council and determination of INCA Research Ethics Committee. Methods. At scheduled appointments, we could approach only four patients for consent during three months. After attempting contact by phone, an information sheet summarizing the content of informed consent, two copies of the consent form and a prepaid return envelope were then mailed to the patients. results. Of the 155 consent forms mailed, 115 were returned (74%). Of these, 111 patients gave consent to participate in the study, one refused consent, and we were informed that three patients had died. The time course of return of these forms ranged from 2 to 89 days (median: 10 days). Attempts to contact patients by phone were successful in 60 out of 160 cases (37.5%). The Research Ethics Committee waived the requirement of consent for those who had died or not responded. Overall mailing cost was R$ 1,004.40. conclusIon. Obtaining consent from patients by phone and mail for a retrospective clinical study is feasible. Most patients responded to contact and gave consent to participate. However, the process entails costs and risks that cannot be overlooked.

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“…Another tool suggested to increase the level of understanding by those invited to participate is their collective communication of the information 48 . This resource consists of explaining the research information of interest to the team, seeking to foster disinhibition and decreased embarrassment, and helping to clarify doubts and particularities.…”

Section: Final Considerationsmentioning

confidence: 99%

O processo de consentimento livre e esclarecido nas pesquisas em doença falciforme

Valêncio

Domingos²

2016

Rev. Bioét.

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Sickle cell disease is a term that refers to a group of hemoglobinopathies associated with the presence of hemoglobin S. Occurring primarily in black population, and affecting mainly the most vulnerable, the homozygous form of the disease, sickle cell anemia, is considered an important public health problem in Brazil. Understanding scientific research as essential to promote health and improve the quality of life of people with sickle cell disease, the informed consent process should be done to overcome, as far as possible, the vulnerabilities which people with sickle cell disease are exposed to. The use of recreational resources, the transmission of collective information, the protection provided by patient associations and the continuous training of ethics in research by the professionals involved in the agreement are shown as tools for the optimization of this process. Keywords: Anemia, sickle cell. Informed consent. Ethics, research. ResumoO processo de consentimento livre e esclarecido nas pesquisas em doença falciforme Doença falciforme diz respeito a grupo de hemoglobinopatias associadas à presença da hemoglobina S. Sendo majoritária na população negra, e acometendo em sua maioria vulneráveis e vulnerados, a forma homozigota da doença -a anemia falciforme -é considerada relevante problema de saúde pública no Brasil. Entendendo a pesquisa científica como essencial para a promoção da saúde e para melhorar a qualidade de vida dos pacientes, o processo de consentimento livre e esclarecido deve ser aplicado para superar, na medida do possível, vulnerabilidades a que as pessoas com doença falciforme estão expostas. Recursos lúdicos, transmissão coletiva de informações, proteção conferida pelas associações de pacientes e a formação permanente em ética em pesquisa por parte dos profissionais que aplicam o consentimento são indicados como ferramentas para otimizar esse processo. Palavras-chave: Anemia falciforme. Consentimento livre e esclarecido. Ética em pesquisa. ResumenEl proceso de consentimiento informado en investigaciones sobre la enfermedad de células falciformes La enfermedad de células falciformes es un término que se refiere a un grupo de hemoglobinopatías asociado con la presencia de la hemoglobina S. La forma homocigótica del gen de la enfermedad se presenta sobre todo en la población negra y se considera un problema importante de salud pública en Brasil, que afecta sobre todo a vulnerables y vulnerados. Entendiendo a la investigación científica como esencial para la promoción de la salud y para el aumento de la calidad de vida de las personas con enfermedad de células falciformes, el proceso de consentimiento libre e informado debe ser aplicado para superar, en la medida de lo posible, las vulnerabilidades a las que las personas con la enfermedad de células falciformes están expuestas. El uso de los recursos recreativos, la transmisión de información colectiva, la protección que ofrecen las asociaciones de pacientes y la formación continua en ética en investigación por parte de los profesion...

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O processo de consentimento livre e esclarecido em pesquisa: uma nova abordagem

Abstract: These results evidence the possibility to inform collectively the research subjects when getting the Informed Consent in those projects where this choice is available.

Cited by 29 publications

References 0 publications

Aspectos eticos em estudos longitudinais: o caso do ELSA-Brasil

Aspectos eticos em estudos longitudinais: o caso do ELSA-Brasil

Termo de consentimento e análise de material biológico armazenado

O processo de consentimento livre e esclarecido nas pesquisas em doença falciforme

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