Termo de consentimento e análise de material biológico armazenado

Abstract

OBJECTIVE: To present practical experience in obtaining consent form (CF) for a study performed at the "Instituto Nacional de Câncer" involving research on stored biologic samples from patients operated for colon cancer from 2000 to 2004. According to the Brazilian National Health Council resolution nº196/96, researchers must make every effort to obtain consent from patients participating in clinical studies, which is reinforced by the Research Ethics Committee (REC). METHODS: After attempting phone contact, two copies and a synopsis of the CF were posted to each patient, with a stampedreturn envelope. RESULTS: 160 patients were included in the study. The attempt of phone contact was successful with 60 of them (37.5%). The consent form was mailed to 155 patients: 115 posted it back (74%) Three patients had already passed away, 111 accepted and one refused to participate. The median time between posting and receiving the CF back was 10 days (interval: 2-89). The REC waived the requirement of CF for those who died and for the ones who did not reply. The final cost for sending the CF was R$1,004.40. CONCLUSION: Obtaining consent by postal and phone communication for retrospective genetic research with stored tissue samples is feasible. Most responded to contact and consented to participate, but there were costs and risks that cannot be neglected.