Glock Rosana Soibelmann, Goldim Jose Roberto
Comite de Etica em Pesquisa da PUCRS, Ave. Ipiranga, 6690, 90619-900 Porto Alegre, RS - Brazil.
Eubios J Asian Int Bioeth. 2003 Jan;13(1):6-8.
The aim of this study was to assess the use and adequacy of informed consent in research involving the elderly in Brazil. Using a reading index, we observed that in 83% of informed consent forms, the text was considered difficult, and demanded a higher schooling level than that presented by the subjects. Whereas 100% of the investigators considered the text in informed consent forms accessible, 75% of the subjects considered it hard to understand. This difference was statistically significant. 94% percent of the elderly participating in research protocols made the decision to participate in the study before reading the term of consent. More attention should be given both to the writing of informed consent forms and to the entire informed consent process, which in gerontology research, should be reviewed at each encounter with study participants.
本研究的目的是评估巴西涉及老年人的研究中知情同意书的使用情况及充分性。通过阅读指数,我们观察到,在83%的知情同意书中,文本被认为难度较大,要求的受教育水平高于受试者的实际水平。虽然100%的研究者认为知情同意书中的文本易于理解,但75%的受试者认为难以理解。这种差异具有统计学意义。94%参与研究方案的老年人在阅读同意条款之前就做出了参与研究的决定。应更加关注知情同意书的撰写以及整个知情同意过程,在老年学研究中,每次与研究参与者接触时都应对此进行审查。