Ethics, law and the regulation of biomedical research in chile

Abstract

This article analyzes the relationship between ethics and law in the regulation of biomedical research in Chile. To this end, a comparative study was carried out on the main international ethical regulations (Declaration of Helsinki and Guidelines of the Council for International Organizations of Medical Sciences), having as a reference the ethical requirements for assessing biomedical research proposed by Emanuel, Wendler and Grady. The tensions and inconsistencies found between the two regulatory areas are evaluated and commented, especially those in which the Chilean legislation presents legal gaps, deficiencies or is more demanding than the international ethical standard. We make some suggestions for improving the Chilean legal regulation of biomedical research, including strengthening the deliberative role of ethics committees and systematizing the legal framework related to research to achieve a more structured and complete legal body.