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"O termo de consentimento livre e esclarecido e a pesquisa em seres humanos na área de saúde: uma revisão crítica"

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Author(s)
Sérgio Slawka
Contributor(s)
Elma Lourdes Campos Pavone Zoboli
Euclides Ayres de Castilho
Hillegonda Maria Dutilh Novaes
Keywords
BIOETHICS/trends
BIOÉTICA/tendências
CONSENTIMENTO ESCLARECIDO/história
CONSENTIMENTO ESCLARECIDO/legislação & jurisprudência
DECISION MAKING
DIREITOS HUMANOS
ETHICS MEDICAL
EXPERIMENTAÇÃO HUMANA
HUMAN EXPERIMENTATION
HUMAN RIGHTS
INFORMED CONSENT/history
INFORMED CONSENT/legislation & jurisprudence
PHYSICIAN-PATIENT RELATIONS
PROBABILIDADE
PROBABILITY
RELAÇÕES MÉDICO-PACIENTE
TOMADA DE DECISÕES
ÉTICA MÉDICA
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URI
http://hdl.handle.net/20.500.12424/99613
Online Access
http://www.teses.usp.br/teses/disponiveis/5/5137/tde-15092005-120212/
Abstract
In order to evaluate the effectiveness of the process for obtaining the informed consent (IC) within the context of clinical research in human beings, systematic-like analysis were performed on the key elements supporting the IC (bioethics within the research in human beings, human rights for the research subject, history of the obtainment for the IC, and Brazilian regulation within research in human beings), as well as systematic-like analysis on the effectiveness of the major processes involved in the obtainment for the IC (physician-patient communication, decision-making for the research subject, and interpretation of the probability expressions in the IC by the research subject). Eventhough these three processes involved in the obtainment for the IC present, individually, a few effective procedures, the obtainment of a truly autonomous IC is utopia and thus the process for obtaining the IC is considered non-effective
Para avaliar a efetividade do processo de obtenção do termo de consentimento livre e esclarecido (TCLE) no contexto da pesquisa clínica em seres humanos, foram realizadas análises sistematizadas sobre os principais elementos de sustentação do TCLE (bioética na pesquisa em seres humanos, direitos humanos do sujeito da pesquisa, história da obtenção do TCLE, e regulamentações brasileiras na pesquisa em seres humanos), assim como também análises sistematizadas sobre a efetividade dos principais processos envolvidos na obtenção do TCLE (comunicação médico-paciente, tomada de decisão pelo sujeito da pesquisa, e interpretação das expressões de probabilidade no TCLE pelo sujeito da pesquisa). Ainda que estes três processos envolvidos na obtenção do TCLE apresentem, individualmente, alguns procedimentos efetivos, verificou-se que a obtenção de um TCLE verdadeiramente autônomo é utópica e, portanto, o processo de obtenção do TCLE é considerado não-efetivo
Date
2005-08-05
Type
Electronic Thesis or Dissertation
Identifier
oai:teses.usp.br:tde-15092005-120212
http://www.teses.usp.br/teses/disponiveis/5/5137/tde-15092005-120212/
oai:teses.usp.br:tde-15092005-120212
Copyright/License
Liberar o conteúdo para acesso público.
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