O processo de consentimento na pesquisa clínica: da elaboração à obtenção

Silva, Luci Meire Pereira da; Oliveira, Filipe de Menezes; Muccioli, Cristina

doi:10.1590/s0004-27492005000500026

Cited by 9 publications

(7 citation statements)

References 4 publications

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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%

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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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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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“…Isso se deu pelas indexações nas ferramentas de busca (PubMed e ISI) assim como pelo acesso eletrônico gratuito via Scielo (1) . Em anos recentes o tema da ética na pesquisa e na publicação cientifica foi abordado em editoriais dos ABO, de forma competente e didática (2)(3)(4) . O papel e a responsabilidade do elenco de autores foi também tema de editorial (5) .…”

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“…Em editorial de 2008, a justificativa e caminho para obtenção de aprovação prévia por comitê de ética foi claramente exposta. O texto esclarece que todos os tipos de artigos, provenientes de instituições públicas ou privadas, devem e podem recorrer aos comitês de ética em pesquisa (3) . A Comissão Nacional de Ética em Pesquisa (CONEP) está pronta para orientar e oferecer esse serviço de utilidade pública (6) .…”

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Ética em publicações científicas: um trabalho de todo dia - a busca do valor absoluto no mundo relativizado

Rocha¹

2010

Arq. Bras. Oftalmol.

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“…Enquanto que o conhecimento filosófico capturava a essência imutável do real, partindo para a investigação racional da forma e das leis da natureza (SILVA, 2001 A ciência moderna manteve, durante muito tempo, a certeza de ser uma atividade objetiva, benéfica para a humanidade por promover o conhecimento, e eticamente neutra, na medida em que apenas valores morais relacionados a uma prática correta devem ter importância. Max Weber (1864-1920) é citado para fundamentar a tese da neutralidade moral da ciência, a partir do momento em que defendeu que esta recebe da sociedade o encargo de solucionar determinados problemas, sendo seus resultados aplicados segundo prioridades também sociais.…”

Section: Histórico Da Pesquisa Científicaunclassified

Avaliação do processo de consentimento de participantes de pesquisa clínica

Nascimento¹

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Informed consent consists a process that is able to inform, the research participant, of the planned medical interventions to be apply during the course of the study, and actively participate in the decision-making process. The Informed Consent Form (ICF) characterized by being an explanatory document, in written form, in which information about the research project is addressed, with the purpose of guaranteeing the individual's willingness. The quality of ICF in clinical research determined by the degree of understanding that participants develop during the informed consent process. The objective of this study is to evaluate the consent process of clinical research participants. It is a hybrid study, with prospective collection. For its development, it divided into the following phases: Elaboration and validation of the form, Training of the Team of Interviewers, Pilot Study, Data Collection and Evaluation of the Readability of ICF. A descriptive analysis of the data and a comparison between the variables performed using univariate analyses. Of the 70 participants, 83% were women, mean age was 46,7 years (S ± 13.99 years), 55,7% were white, 45,75% married, 52,9% illiterate or basic education, 49,3% economically active and average income of 1496,2 Reais. Of the participants, 35,7% didn't know the type of study they participated in, 38,6% didn't know about the research they participated, 64,7% didn't receive information regarding other types of treatment, 62,7% didn't have information about compensation, 66,2% didn't read the entire ICF before signing, 86,8% reported that the document was easy to read, 62,2% found the document long. After the ILFK calculation of the 12 ICF analysed, 100% presented values from 0 to 30, considered as very difficult reading. It is extremely important to encourage the development of national studies that evaluate the perception of research participants regarding their rights and the creation of instruments that enable such verification in the Brazilian population.

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O processo de consentimento na pesquisa clínica: da elaboração à obtenção

Cited by 9 publications

References 4 publications

Termo de consentimento e análise de material biológico armazenado

Termo de consentimento e análise de material biológico armazenado

Ética em publicações científicas: um trabalho de todo dia - a busca do valor absoluto no mundo relativizado

Avaliação do processo de consentimento de participantes de pesquisa clínica

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