Free informed consent: the experience of Brazilian researchers in the area of fertility regulation

This 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.O objetivo deste estudo foi avaliar a experiência de pesquisadores com a apreciação do protocolo por um Comitê de Ética em Pesquisa (CEP); com a elaboração do Termo de Consentimento Livre e Esclarecido (TCLE) e com a obtenção do consentimento, e verificar se o conteúdo do TCLE estava de acordo com as exigências da Resolução 196/96. Trinta e quatro pesquisadores completaram um questionário auto-respondido, enviado por correio eletrônico. Quase todos os participantes (91%) relataram que o protocolo desse estudo havia sido avaliado por um CEP. Mais da metade deles referiram que o TCLE utilizado havia sido recebido pronto; que o consentimento do possível sujeito havia sido obtido pelo pesquisador responsável, e que os sujeitos haviam recebido uma cópia do Termo assinada. Cerca da metade dos participantes afirmaram que a forma de ressarcimento das despesas dos sujeitos, decorrentes da participação na pesquisa, e 44% disseram que as formas de indenização, no caso de eventuais danos, constavam no Termo. De acordo com o relato dos participantes, em geral as exigências da Resolução avaliadas haviam sido cumpridas.216223Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP