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Master's Dissertation
DOI
10.11606/D.5.2005.tde-15092005-120212
Document
Author
Full name
Sérgio Slawka
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2005
Supervisor
Committee
Novaes, Hillegonda Maria Dutilh (President)
Castilho, Euclides Ayres de
Zoboli, Elma Lourdes Campos Pavone
Title in Portuguese
"O termo de consentimento livre e esclarecido e a pesquisa em seres humanos na área de saúde: uma revisão crítica"
Keywords in Portuguese
BIOÉTICA/tendências
CONSENTIMENTO ESCLARECIDO/história
CONSENTIMENTO ESCLARECIDO/legislação & jurisprudência
DIREITOS HUMANOS
ÉTICA MÉDICA
EXPERIMENTAÇÃO HUMANA
PROBABILIDADE
RELAÇÕES MÉDICO-PACIENTE
TOMADA DE DECISÕES
Abstract in Portuguese
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
Title in English
The informed consent and the research in human beings within the health area : a critical review
Keywords in English
BIOETHICS/trends
DECISION MAKING
ETHICS MEDICAL
HUMAN EXPERIMENTATION
HUMAN RIGHTS
INFORMED CONSENT/history
INFORMED CONSENT/legislation & jurisprudence
PHYSICIAN-PATIENT RELATIONS
PROBABILITY
Abstract in English
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
 
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SergioSlawka.pdf (989.50 Kbytes)
Publishing Date
2005-10-04
 
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