Regulatory Focus™ > News Articles > Brazil Clarifies Informed Consent Requirements

Brazil Clarifies Informed Consent Requirements

Posted 03 January 2013 | By Louise Zornoza

Brazil's National Health Surveillance Agency, Anvisa, has released a notice clarifying the rights of individuals who participate as clinical research subjects in the country.

The notice specifies that clinical trial subjects must be informed that Brazilian law prohibits compensation for participating in a trial with the exception of being reimbursed for the cost of transportation and meals. The notice also states that a clinical trial subject has the right to leave a study at any time-even after informed consent has been obtained-and this right must also be specified in the informed consent document. 

Anvisa also explained that it screens proposed clinical trials for compliance with Good Clinical Practice (GCP) requirements and conducts inspections of Brazilian research centers to verify adherence to those requirements.  Further, the agency calls on the public to directly notify the Research Ethics Committee of the Research Center and the National Committee for Research Ethics regarding any violations of the rights of clinical trial subjects. Complaints may also be notified to Anvisa through its Call Center or through the agency's website.


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