Conflictividad ética en protocolos farmacológicos

Abstract

Research ethics committees regulate health research where people participate as research subjects. In Mexico, the General Health Law, regulation is implemented through regulations, being specific for health research, without ceasing to apply other regulations, the Regulation of the General Health Law in Health Research. Indicating in its Art. 13 the following references: respect for dignity, protection of their rights and well-being. These considerations must be evaluated from a risk-benefit ratio, with special attention to vulnerable people, considering sick people as a condition of vulnerability. The sequence of pharmacological studies begins with the administration of the drug in animal models, continuing with its application for the first time in humans, until obtaining data regarding therapeutic efficacy and safety; It is carried out following the sequence of Phases from I to IV. In all phases, safety is evaluated through the recording, reporting and care of adverse effects. In Mexico, in the context of the right to health, Phases I and II must be carried out with hospitalized subjects, which implies 24-hour supervision. However, and despite what is established in the legislation, in the pharmacological protocols that are presented before the Research Ethics Committees we find ethical faults, which makes the evaluation carried out in these committees essential.