¿Responde la Resolución 8430 de 1993 a las necesidades actuales de la ética de la investigación en salud con seres humanos en Colombia? / Does Resolution 8430 of 1993 respond to the current needs of ethics in health research with human beings in Colombia?

Resumen La verificación del cumplimiento de los principios éticos en la investigación en salud legitima su ejercicio ante la sociedad y posibilita la resolución de dilemas éticos frente a nuevos intereses y métodos de investigación. En Colombia, la Resolución 8430 de 1993 es una de las principales pautas éticas que regulan la investigación en salud. Dado que no ha sido revisada ni actualizada desde su adopción, se hace necesario valorar su vigencia y suficiencia para abordar los potenciales dilemas éticos que se plantean actualmente en la investigación en salud en el país. En este contexto, se detallan algunos vacíos y contradicciones, así como aspectos que requieren de una revisión profunda, a partir de una concepción amplia de las áreas y los métodos de investigación en salud. Tras discutir las principales falencias e imprecisiones, se proponen alternativas para que la Resolución responda a las necesidades actuales del país frente a la ética en investigación en salud con seres humanos.

Abstract Verifying the compliance with the ethical principles of health research legitimizes its exercise in the eyes of the society and allows for the resolution of ethical dilemmas that emerge from new research interests and methods. Resolution 8430 of 1993 is one of the main ethical guidelines governing health research on human beings in Colombia. Considering that the resolution has not been revised or updated since its promulgation it becomes necessary to evaluate its current validity and adequacy to address the potential ethical dilemmas in the existing country's health research. Some gaps, contradictions, and aspects that require a deep review are detailed in this paper from a wide conception of health research areas and methods. After discussing the main weaknesses and inaccuracies, some alternatives are proposed to adjust the resolution to the present needs in health research with human beings.

Assessment of Therapeutic Response of Plasmodium vivax and Plasmodium falciparum to Chloroquine in a Malaria Transmission Free Area in Colombia

In order to determine the frequency of therapeutic failures to chloroquine (CQ) in patients with malaria due to either Plasmodium falciparum or P. vivax, and to explore the usefulness of a malaria-free city as a sentinel site to monitor the emergence of drug resistance, 53 patients (44 infected with P. vivax and 9 with P. falciparum) were evaluated at the Laboratory of Parasitology, Universidad del Valle in Cali, Colombia. Patients received 25 mg/kg of CQ divided in three doses over 48 h; they were followed during 28 days according to WHO/PAHO protocols. While therapeutic failures to CQ in the P. vivax group were not detected, the proportion of therapeutic failures in the P. falciparum group was high (78 percent) and consistent with the reports from endemic areas in Colombia. The diverse origin of cases presenting therapeutic failure confirmed that P. falciparum resistant to CQ is widespread in Colombia, and further supports the change in the national antimalarial drug scheme. Monitoring of drug resistance in malaria free areas would be useful to identify sites requiring efficacy evaluation, and in some situations could be the most appropriate alternative to collect information from endemic areas where therapeutic efficacy studies are not feasible