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Revista Brasileira de Ginecologia e Obstetrícia

Print version ISSN 0100-7203

Abstract

HARDY, Ellen; BENTO, Silvana Ferreira; OSIS, Maria José Duarte  and  HEBLING, Eliana Maria. Informed Consent in a Clinical Trial: Theory and Practice. Rev. Bras. Ginecol. Obstet. [online]. 2002, vol.24, n.6, pp. 407-412. ISSN 0100-7203.  http://dx.doi.org/10.1590/S0100-72032002000600008.

Purpose: to evaluate the agreement between the theory about informed consent, represented by Resolution 01/88, and the practice according to the report of researchers and of women who were subjects of their research. Methods: eleven researchers from three centers of excellence in research related to fertility regulation in Brazil and 18 women, subjects of their research. Information was obtained through in-depth interviews and content analysis was carried out. Results: the report of the researchers agreed with the requirements of the Resolution; however, the women's report showed that most of the required items were not referred to when they were invited to participate in the research. Conclusion: a disagreement was observed between theory and practice in obtaining informed consent. This may be explained by difficulties in complying with the requirements of the Resolution in force at the time. On the other hand, it is also possible to imagine difficulties experienced by researchers when approaching the women and/or that the women also forgot the received information. Finally, a bias may have resulted from the researchers and women who had to give consent to participate in this study.

Keywords : Informed consent; Bioethics; Clinical research.

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