• Ellen Hardy, Silvana Ferreira Bento, and Maria José Duarte Osis.
• Departamento de Tocoginecologia, Faculdade de Ciências Médicas, Universidade Estadual de Campinas, Campinas, SP, Brasil. hardy@unicamp.br
• Cad Saude Publica. 2004 Jan 1; 20 (1): 216-23.

AbstractThis study aimed to evaluate the experience of Brazilian researchers in relation to: assessment of the research protocol by a research ethics committee with the elaboration of a free informed term of consent (FITC) and the process of obtaining consent, as well as to verify whether the content and wording of the term of consent complies with Federal Ruling 196/96. Thirty-four researchers filled out a questionnaire and returned it by electronic mail. The vast majority of the respondents (91%) reported that the respective study protocol had been evaluated by a research ethics committee. More than half reported that they had received a previously prepared FITC; that consent from potential study subjects had been obtained by the researcher in charge; and that the subjects had received a copy of their signed FITC. Approximately one half of participants stated that the form of reimbursement of subjects was specified in the FITC, and 44% reported the same in relation to occasional damages resulting from the study. According to participants, in general the provisions of Ruling 196/96 had been met.

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