Research and the (free and) informed consent

Concone, Maria Helena Villas Bôas; Cerveny, Ceneide Maria de Oliveira

doi:10.1590/s1413-81232008000200009

Cited by 5 publications

(2 citation statements)

References 2 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%

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%

Termo de consentimento e análise de material biológico armazenado

Duque¹,

Ramalho

Casali-da-Rocha

2010

Rev. Assoc. Med. Bras.

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“…Especialmente em pesquisas que envolvam questões sobre uso de drogas, violência doméstica, crime organizado, abuso sexual (30). Apesar desta constatação, em um grupo de entrevistados que passaram durante o ano de 2010, foi possível constatar a eficiência do processo a partir da percepção do entendimento do processo por qual o doador e, posteriormente, seus dados genéticos passariam.…”

Section: Introductionunclassified

Consentimento informado em genética forense

Garrido¹,

Garrido

2013

Acta bioeth.

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Resumo: O consentimento informado é uma demanda ética e legal na pesquisa com seres humanos, visando a expressão autônoma dos sujeitos. Contudo, a autonomia fica em risco quando os envolvidos encontram-se vulneradas socioculturalmente. Nos casos forenses, a Lei 12.654 de 2012 exclui a necessidade do consentimento e torna obrigatória a doação de material biológico pelos condenados por crimes hediondos. O trabalho buscou avaliar o nível de vulneração dos sujeitos encaminhados a exames de DNA no Instituto de Pesquisa e Perícias em Genética Forense (IPPGF). Foram avaliadas a legibilidade e adequação normativa do Termo de Consentimento Informado (TCI) utilizado. Tentou-se também, identificar o grau de instrução e o hábito de leitura dos doadores para relacionar ao entendimento correto do processo. Pôde-se constatar que o TCI apresentava legibilidade acima da requerida à média dos encaminhados ao IPPGF, além disso, apresentava carências normativas. Por fim, verificou-se que muitos doadores têm restrito hábito de leitura e sequer liam o TCI quando consentiam. Os resultados da análise levaram a profundas mudanças no procedimento de obtenção de consentimento para exames de DNA forense no IPPGF.Palavras chave: DNA, bioética, crime, gene Consentimiento informado en genética forenseResumen: El consentimiento informado es una demanda ética y legal en la investigación con seres humanos, respetando la manifestación autónoma de los sujetos. Pero, la autonomía queda en riesgo cuando los sujetos se encuentran vulnerados socioculturalmente. En los casos forenses, la Ley 12.654 de 2012 excluye la necesidad del consentimiento informado y hace obligatoria la donación de material biológico por los condenados de crímenes graves. Este trabajo buscó evaluar el nivel de vulneración de los sujetos sometidos a exámenes de ADN en el Instituto de Investigación y Pericias en Genética Forense (IPP-GF). Fueron evaluadas la legibilidad y la idoneidad normativa del Término de Consentimiento Informado (TCI) utilizado. Se intentó, también, identificar el grado de instrucción y el hábito de lectura de los donantes para relacionarlos a la comprensión correcta del proceso. Se puede constatar que el TCI presentaba inteligibilidad por encima de la requerida en la media de los encaminados al IPPGF; además de eso, presentaba carencias normativas. Por fin, ha verificado que muchos donantes tienen insuficiente hábito de lectura y siquiera leían el TCI al consentir. Los resultados del análisis llevaron a profundos cambios en el procedimiento de obtención de consentimiento informado para exámenes de ADN forense en el IPPGF.Palabras clave: DNA, bioética, crimen, gene Informed consent in forensic geneticsAbstract: Free and informed consent is an ethical and legal request in research involving human beings, seeking the manifestation of autonomy of the subject. However, autonomy is at risk when those involved are socio culturally vulnerable. In forensic cases, Law 12,654 of 2012 excludes the consent and makes mandatory the donation of biological materials by those...

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