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Master's Dissertation
DOI
10.11606/D.23.2005.tde-06062005-155926
Document
Author
Full name
Nelson Massanobu Sakaguti
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2005
Supervisor
Committee
Ramos, Dalton Luiz de Paula (President)
Oliveira, Rogerio Nogueira de
Serra, Mônica da Costa
Title in Portuguese
"O conhecimento de usuários de serviços públicos de saúde envolvidos em pesquisas clínicas, sobre seus direitos"
Keywords in Portuguese
Direitos do sujeito de pesquisa
Consentimento livre e esclarecido
Experimentação com seres humanos
Sujeito da pesquisa
TCLE
Termo de consentimento livre e esclarecido
Abstract in Portuguese
O presente trabalho avaliou através de um questionário e entrevistas pessoais no período de maio a setembro de 2004, cinqüenta participantes voluntários sujeitos de pesquisas envolvendo seres humanos, nas unidades de saúde do âmbito da Secretaria Municipal de Saúde – SMS, espalhadas pelo município de São Paulo e na Faculdade de Odontologia da Universidade de São Paulo – FOUSP. Colheu a opinião destes, sobre a experiência da voluntariedade nos experimentos de que participaram nestes locais, abordando questões como: o motivo de terem contribuído, grau de conhecimento do Termo de Consentimento Livre e Esclarecido -TCLE e a importância dispensada a este documento, com que concordaram e autorizaram a participação, de acordo com a determinação da Resolução 196/96, diretriz nacional que regulamenta as pesquisas envolvendo seres humanos. O estudo observou que, passados oito anos da entrada em vigor da Resolução 196/96, o processo de obtenção do consentimento livre e esclarecido ainda carece de cuidados. Participantes efetivamente não são esclarecidos ou não entendem o que lhes foi proposto. Consideramos a necessidade de uma maior difusão, através de ações educativas, do assunto “experimentação com seres humanos”, para um maior entendimento dos voluntários de pesquisas dos seus direitos e deveres, no sentido de manter as pesquisas num elevado padrão ético. O presente estudo pretende contribuir com a hermenêutica desta Resolução e suscitar maiores discussões e reflexões sobre o assunto
Title in English
The users’ health public services knowledge involved in clinical research, about their right.
Keywords in English
Human being experiment
Informed consent
Informed consent form
Research subject
Research subject’s right
Abstract in English
The present assignment evaluated through a questionnaire and personal interviews in the period within May and September 2004, fifty volunteered participants subjects of researches involving human beings, in the units of health SMS) in São Paulo city and at Odontology University of São Paulo - FOUSP. It collected the opinion of these volunteers about the experience of voluntariness in the experiments that took part in these locals, tackling matters as: their reason of having contributed, knowledge degree of free consent form – TCLE and the dispensed importance of this document, to which they agreed and authorized the participation, according to the determination of the Resolution 196/96, national guideline that regulates the researches involving human beings. The study observed that eight years after the Resolution 196/96 was put into effect, the obtainment process of the informed consent still lacks of cares. Participants are not clear or do not understand what they were proposed. We consider the need of a larger diffusion through educational actions, of the subject experimentation with human beings, for volunteers larger understanding of their right and duties, in the sense to maintaining the researches in an elevated ethical standard. The present study intends to contribute with the hermeneutics of this Resolution and to raise larger discussions and reflections on the subject
 
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TeseToda.pdf (798.49 Kbytes)
Publishing Date
2006-04-11
 
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