OBJECTIVES:: Drug utilization studies (DUS) are increasingly requested by regulatory authorities and payers to evaluate the benefit-risk of drugs in real-life. DUS usually aim at evaluating prescribing practices, including off-label use or contra-indications, quantitatively or qualitatively against recommendations. Currently, most DUS involve clinical chart review, sometimes supplemented by interviews with patients or prescribers. Ethical requirements for these studies appear heterogeneous across countries and settings. The present study aims at defining the ethical and/or legal framework applicable for the conduct of DUS in hospital and ambulatory care settings in selected Latin American countries. METHODS:: Two complementary strategies were used: (i) a review of existing legislative sources in selected Latin American countries and, (ii) a survey submitted to ethics committees and/or key informants which included case studies corresponding to different data collection methods, study populations and health care settings. RESULTS:: The literature review confirmed the great disparity across local legislations on DUS in Latin America. In most countries, national regulations or guidelines are in existence but requirements differ from one country to another. In addition, ethical requirements at the level of institutions are also heterogeneous. Survey revealed that a site-specific ethics approval is commonly required for DUS involving ad hoc data collection and that data protection legislation varies between countries. For example, in Brazil, it appears that no specific regulation applies to observational studies including DUS whereas in Argentina, patient informed consent might be required for reviewing medical charts. Based on information collected, most ethics committees refer to the Declaration of Helsinki regarding requirements applicable for DUS. Complete results with details per country will be presented at ISPOR. CONCLUSIONS:: Preliminary results suggest lack of consensus in the legislative and ethical framework for DUS across different Latin American countries. Such heterogeneity therefore leads to operational challenges for the implementation of cross-national studies.