ABSTRACT
Exceptions or waivers to informed consent in research in Chile are an ethical issue that has not been addressed in all its complexity by the scientific community. The possible waivers to this process could make the difference for the feasibility, success or failure of a study. The purpose of this document is to clarify within the available information, what is the current situation about the exceptions to informed consent in research and what are the ethical-legal guidelines in Chile. Articles were reviewed in both English and Spanish from indexed journals and those documents that meet the inclusion criteria were selected. There is limited information available about waivers to informed consent, which indicates that the ethical guidelines are similar among countries that honor the Declaration of Helsinki, including Chile. However, the current Chilean legislation does not include exceptions. Ethics Committees that authorize research in line with international ethical guidelines could allow possible exceptions. Based on our findings, it is necessary to evaluate possible exceptions for informed consent for research performed in Chile, both from the legal point of view and based on the experience of scientists.
Subject(s)
Ethics, Research , Informed Consent/ethics , Informed Consent/standards , Research Subjects , Chile , HumansABSTRACT
Exceptions or waivers to informed consent in research in Chile are an ethical issue that has not been addressed in all its complexity by the scientific community. The possible waivers to this process could make the difference for the feasibility, success or failure of a study. The purpose of this document is to clarify within the available information, what is the current situation about the exceptions to informed consent in research and what are the ethical-legal guidelines in Chile. Articles were reviewed in both English and Spanish from indexed journals and those documents that meet the inclusion criteria were selected. There is limited information available about waivers to informed consent, which indicates that the ethical guidelines are similar among countries that honor the Declaration of Helsinki, including Chile. However, the current Chilean legislation does not include exceptions. Ethics Committees that authorize research in line with international ethical guidelines could allow possible exceptions. Based on our findings, it is necessary to evaluate possible exceptions for informed consent for research performed in Chile, both from the legal point of view and based on the experience of scientists.
Subject(s)
Humans , Ethics, Research , Research Subjects , Informed Consent/standards , Informed Consent/ethics , ChileABSTRACT
Mundialmente se reportan elevadas tasas de morbilidad y mortalidad por sepsis en lactantes.Objetivo: determinar los factores epidemiológicos, el comportamiento clínico y el abordaje terapéutico de los pacientes ingresados con el diagnóstico de sepsis en la sala de lactantes del Hospital Escuela. Metodología: estudio observacional transversal descriptivo realizado del 26 de mayo al 20 de junio del 2008. La información se obtuvo a partir de la revisión de 180 expedientes clínicos, obteniéndose una muestra de 34 pacientes, con diagnóstico de sepsis. Resultados: los afectados de acuerdo a la edad y sexo fueron los lactantes menores de 6 meses de edad en 58.8%, con mayor frecuencia en el grupo de 1 a 3 meses 32.4%, predomino el sexo masculino con 58.8%. El 79.4% de los lactantes tenían menos de 7 días de hospitalización. El 70.6% de los lactantes adquirió la infección extra hospitalaria y 29.4%en el hospital. El estado nutricional de cada lactante, 32% presentaban algún grado de desnutrición. A 38.5% de los lactantes no se les efectuó el diagnostico oportuno de sepsis al ingreso. El 44.1% tenían factores de riesgo asociados a sepsis. El foco de entrada de la infección fue el respiratorio 47%, con diagnóstico de neumonía 29.4%. Los hallazgos clínicos y laboratoriales son: fiebre 97.06%,leucocitosis 76.47%, rechazo al alimento 58.82%. El 85.7% de los lactantes se encontraron en un estadío clínico de sepsis y 4.8% en estadío de shock séptico tardío. El estudio bacteriológico realizado fue el hemocultivo en 55.9%, y de este, en 88.2% no hubo crecimiento de bacterias. El tratamiento antimicrobiano utilizado fue cefalosporinas 73.5% y penicilina 38.2%....(AU)
