Informed consent Archives - Revista Brasileira de Ginecologia e Obstetrícia
Summary
Rev Bras Ginecol Obstet. 2018;40(2):72-78
To analyze the reaction of women after reading the Informed Consent Form (ICF) before undergoing elective gynecological/urogynecological surgeries.
A qualitative study with 53 women was conducted between September 2014 and May 2015. The analysis of the content was conducted after a scripted interview was made in a reserved room and transcribed verbatim.We read the ICF once more in front of the patient, and then she was interviewed according to a script of questions about emotions and reactions that occurred about the procedure and her expectations about the intra- and postoperative period.
The women had a mean age of 52 years, they were multiparous, and most had only a few years of schooling (54.7%). The majority (60.4%) of them had undergone urogynecological surgeries. Hysterectomy and colpoperineoplasty were themost frequent procedures. Ten women had not undergone any previous abdominal surgery. Fear (34.6%) was the feeling that emerged most frequently from the interviews after reading the ICF, followed by indifference (30.8%) and resignation (13.5%). Nine women considered their reaction unexpected after reading the ICF. Three patients did not consider the information contained in the ICF to be sufficient, and 3 had questions about the surgery after reading the document.
Reading the ICF generates fear in most women; however, they believe this feeling did not interfere in their decision-making process.
Summary
Rev Bras Ginecol Obstet. 2018;40(2):72-78
To analyze the reaction of women after reading the Informed Consent Form (ICF) before undergoing elective gynecological/urogynecological surgeries.
A qualitative study with 53 women was conducted between September 2014 and May 2015. The analysis of the content was conducted after a scripted interview was made in a reserved room and transcribed verbatim.We read the ICF once more in front of the patient, and then she was interviewed according to a script of questions about emotions and reactions that occurred about the procedure and her expectations about the intra- and postoperative period.
The women had a mean age of 52 years, they were multiparous, and most had only a few years of schooling (54.7%). The majority (60.4%) of them had undergone urogynecological surgeries. Hysterectomy and colpoperineoplasty were themost frequent procedures. Ten women had not undergone any previous abdominal surgery. Fear (34.6%) was the feeling that emerged most frequently from the interviews after reading the ICF, followed by indifference (30.8%) and resignation (13.5%). Nine women considered their reaction unexpected after reading the ICF. Three patients did not consider the information contained in the ICF to be sufficient, and 3 had questions about the surgery after reading the document.
Reading the ICF generates fear in most women; however, they believe this feeling did not interfere in their decision-making process.
Summary
Rev Bras Ginecol Obstet. 2002;24(6):407-412
DOI 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.
Summary
Rev Bras Ginecol Obstet. 2002;24(6):407-412
DOI 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.
Summary
Rev Bras Ginecol Obstet. 2002;24(1):59-65
DOI 10.1590/S0100-72032002000100009
Introduction: the Resolution 196/96 of the Conselho Nacional de Saúde (National Council of Health/Ministry of Health) presents the main Brazilian guidelines on research involving human subjects, including the content of written informed consent. Purpose: to present the knowledge and opinion of Brazilian researchers on the contents of Resolution 196/96, specifically related to the informed consent form. Subjects and methods: forty-six doctors responsible for the area of gynecology at Brazilian universities, four directors of research centers and 31 researchers who participated in a study related to fertility regulation during the 12 months preceding September, 2000. Subjects completed a self-reporting questionnaire. Data were analyzed by the chi² test. Results: most subjects declared that they knew the Resolution 196/96 and considered it adequate, although difficult to comply with; they considered that all studies should have an informed consent form, and knew that its content should guarantee confidentiality. More researchers than those responsible for gynecology department/directors knew that the informed consent form should be prepared by the principal investigator. Significantly more responsible for gynecology department/directors than researchers declared that subjects must always sign (or put their thumb print if they do not know how to write) on the informed consent form. Subjects declared that payment of expenses resulting from participation in a study must always be explained in the informed consent form. Conclusion: despite the wide dissemination of the Resolution 196/96, it was not known by all the researchers nor by all those responsible for gynecology departament/directors. The majority agreed with the contents required by the Resolution for the informed consent form.
Summary
Rev Bras Ginecol Obstet. 2002;24(1):59-65
DOI 10.1590/S0100-72032002000100009
Introduction: the Resolution 196/96 of the Conselho Nacional de Saúde (National Council of Health/Ministry of Health) presents the main Brazilian guidelines on research involving human subjects, including the content of written informed consent. Purpose: to present the knowledge and opinion of Brazilian researchers on the contents of Resolution 196/96, specifically related to the informed consent form. Subjects and methods: forty-six doctors responsible for the area of gynecology at Brazilian universities, four directors of research centers and 31 researchers who participated in a study related to fertility regulation during the 12 months preceding September, 2000. Subjects completed a self-reporting questionnaire. Data were analyzed by the chi² test. Results: most subjects declared that they knew the Resolution 196/96 and considered it adequate, although difficult to comply with; they considered that all studies should have an informed consent form, and knew that its content should guarantee confidentiality. More researchers than those responsible for gynecology department/directors knew that the informed consent form should be prepared by the principal investigator. Significantly more responsible for gynecology department/directors than researchers declared that subjects must always sign (or put their thumb print if they do not know how to write) on the informed consent form. Subjects declared that payment of expenses resulting from participation in a study must always be explained in the informed consent form. Conclusion: despite the wide dissemination of the Resolution 196/96, it was not known by all the researchers nor by all those responsible for gynecology departament/directors. The majority agreed with the contents required by the Resolution for the informed consent form.