Research involving human subjects conducted in Brazil, in accordance with Chapter XII.2 of CNS Resolution 466/2012 from the Ministry of Health/National Health Council, must provide documentation of project approval by the Research Ethics Committee and/or CONEP. For studies with human subjects, all patients or their legal guardians must consent to participate by signing an informed consent form (ICF), as per CNS Resolution 466/2012. Research involving human subjects conducted in other countries must provide local ethics documentation.

Research involving animals in Brazil, in accordance with CONCEA Normative Resolution 30/2016, must provide documentation of project approval from the Ethics Committee on the Care and Use of Animals. Research involving animals conducted in other countries must provide local ethics documentation.