Ethics Committee Archives - Revista Brasileira de Ginecologia e Obstetrícia

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.