RESUMO
PIP: This document presents the text of health legislation approved in Mexico on December 23, 1986, setting forth ethical issues and professional responsibilities in the area of health research. Health research is conceptualized as activities that contribute to knowledge regarding biological and physiological processes in humans; knowledge of the links between the causes of disease, medical practice, and social structures; prevention and control of health problems; evaluation of the harmful effects of the environment on health; the study of techniques recommended or used for the delivery of health services; and the production of goods for the health sector. Title 1 of these regulations outlines responsibilities of the Secretariat of Health and calls for the establishment of an Inter-Institutional Commission on Health Research. Title II defines ethical aspects of research on human subjects, with separate provisions for research involving minors, incompetent persons, women of childbearing age, pregnant women, women during labor or childbirth, nursing mothers, embryos, stillborn fetuses, and cadavers. In general, research is permissible on human subjects only if it confers health benefits and carries minimal risks. Title III sets forth regulations on research on new prophylactic, diagnostic, therapeutic, and rehabilitative methods, while Title IV concerns the biosafety of research. Clinical research in the field of pharmacology must include 4 phases preceded by full preclinical studies. Finally, Title V of this legislation defines the duties of internal committees in health institutions.^ieng