The users’ health public services knowledge involved in clinical research, about their right. / "O conhecimento de usuários de serviços públicos de saúde envolvidos em pesquisas clínicas, sobre seus direitos"

AUTOR(ES)
DATA DE PUBLICAÇÃO

2005

RESUMO

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

ASSUNTO(S)

research subject’s right direitos do sujeito de pesquisa termo de consentimento livre e esclarecido experimentação com seres humanos human being experiment informed consent consentimento livre e esclarecido tcle research subject sujeito da pesquisa informed consent form

ACESSO AO ARTIGO

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