[Ethical principles of medical research using human subjects]. / Los principios éticos de la investigación médica en seres humanos.

ABSTRACT

Medical research involving human beings has contributed to the advancement of knowledge about prevention, diagnosis, and treatment of the diseases. All researchers, independently of their working country, must always have in mind the international ethical principles as a guide in the solution for the ethical problems that they may face during the practice of research activities on human beings. Among the ethical principles more widely accepted in the western culture, three are of upstanding importance for clinical research in human subjects: a) the principle of respect for persons, based upon the conception of the individual as an autonomous being, capable of shaping and directing his own life; b) the principle of beneficence, that refers to the ethical obligation to maximize benefits and to minimize harms and wrongs; and c) the principle of justice, that refers to the ethical imperative to treat each person in accordance with what is morally right and proper. The application of these theoretical principles to the real life problems is not easy, especially in cases in which the research group belong to a developed country, and the group of participating subjects, to an underdeveloped one. It is worthy to ask if the three mentioned ethical principles are universally acknowledged, and whether in the Latin American and Caribbean region, these principles are recognized as the gold rules for the solution of the ethical problems of medical research involving human subjects.