Argentina

Circular ANMAT 0003/08 Inclusion of an explanatory text in the Informed Consents for Patients

This circular requires the inclusion of an explanatory text in the document of consent that patients have to sign to participate in a clinical research. The text must point out the following: 1- the experimental character of the research 2.-that it was authorized by ANMAT and 3.- ANMAT FREE HELPDESK NUMBER for those patients that wish to carry out any enquiry. This requirement is in force from 07.04.2008 on.
The text must be written in capital red and framed in letter size Times New Roman – Type 11.

http://www.anmat.gov.ar/comunicados/Circular_Ensayos_Clinicos.pdf