2016
DOI: 10.1590/1983-80422016241104
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Abstract: During the course of human history, children and adolescents have often been the victims of science in clinical studies. When society was confronted with the horrors of the experiments conducted during World War II, it issued the Nuremberg Code, excluding minors from any such studies as they lack the competence to give autonomous consent. This permanent requirement of the code has resulted in therapeutic orphanhood for many aggravations of the health status of this population. Those who care for children and a… Show more

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Cited by 13 publications
(16 citation statements)
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References 15 publications
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“…If the patients lack the conditions for selfgovernment and self-determination -such as minors or patients in a coma -, they must be legally represented by family members or legitimate third parties 14 . For ethical reasons, even if in these cases the request for consent is made to legal representatives, no one replaces the persons themselves in deciding any conduct, even though the responsibility extends to all those involved, including society and the State 29 . For this reason, with persons of legal age, when the patient and their representative manifest different decisions, the right of the former prevails.…”
Section: Autonomymentioning
confidence: 99%
“…If the patients lack the conditions for selfgovernment and self-determination -such as minors or patients in a coma -, they must be legally represented by family members or legitimate third parties 14 . For ethical reasons, even if in these cases the request for consent is made to legal representatives, no one replaces the persons themselves in deciding any conduct, even though the responsibility extends to all those involved, including society and the State 29 . For this reason, with persons of legal age, when the patient and their representative manifest different decisions, the right of the former prevails.…”
Section: Autonomymentioning
confidence: 99%
“…El acuerdo consciente del menor requiere que el investigador proporcione información en un lenguaje claro y adecuado para su edad y que utilice, en caso de ser necesario, recursos gráficos o audiovisuales que faciliten la comprensión de los principales aspectos de la investigación (17,34). Igualmente, se debe abrir un espacio de comunicación para resolver las dudas que los menores puedan tener sobre la investigación (1,35).…”
Section: Consentimiento Y Asentimiento Informadosunclassified
“…Su papel consiste en garantizar la seguridad, los derechos y el bienestar de los participantes del estudio. Dentro de sus responsabilidades en el desarrollo de la investigación con niños y adolescentes se encuentran (34,50):…”
Section: Rol Del Investigadorunclassified
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“…The low number of clinical trials investigating the pediatric drug use results from the lack of sufficient evidence for the medicines registration. The promotion of ethical and technical requirements for the development of studies to ensure research for this public and protection of their intrinsic vulnerability is seen as necessary 3 .…”
Section: Introductionmentioning
confidence: 99%