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Adequacy of informed consent in research carried out in Brazil
Goldim, José Roberto Clotet, Joaquim Ribeiro, Jorge Pinto
Goldim, José Roberto
Clotet, Joaquim
Ribeiro, Jorge Pinto
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EJAIB112007.pdf
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Abstract
This cross-sectional study aimed to assess the adequacy of the informed consent process in six research projects carried out at HCPA. The 59 participants were interviewed; all had signed informed consent forms. Most patients were females (relative frequency of 71%); and the mean age was 50.17±15.24. Informed consent adequacy was assessed through the amount of information received and degree of difficulty in understanding the form. Having received previous explanations was reported by 53%, and having had doubts cleared up, by 24%. Comprehension of what was being proposed was reported by 56%, but the text was considered accessible by only 25%. In conclusion, the use of informed consent in research projects should be considered seriously, and Ethics Committees should review all the stages involved. Aspects such as comprehension of information, clearing up of doubts, and access to the investigator should always be guaranteed to participants.
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2007-11
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With permission of the license/copyright holder