Clinical Research and Good Clinical Practice. More Stories to TellPesquisa clínica e boas práticas clínicas. Mais histórias por contarFor guaranteeing the ethical conduct of scientific research on human beings in which the interest in the health and well-being of the participating subjects prevail, various guidelines, standards, and parameters have been established for the scientific community. One of these regulatory parameters is good clinical practice, which, after its implementation by Resolution 2378 of 2008, has become a highly relevant guide for clinical (...) trials in Colombia. This article relates its origins and versions and goes over its limitations regarding the ethical debate on ethics committees evaluating research protocols.Para citar este artículo / To reference this article / Para citar este artigo Suárez-Obando F. Investigación clínica y buenas prácticas clínicas. Más historias por contar. 2020; 24: 188-204. DOI: https://doi.org/10.5294/pebi.2020.24.2.6Recibido: 29/09/2019Aceptado: 07/06/2020Publicado: 27/11/2020. (shrink)

La necesidad de pasar de las teorías y los marcos legales idealizados a medidas prácticas y reales que se puedan vivir en la escuela, configuran una de las más significativas barreras a la hora de alcanzar la educación inclusiva; por lo anterior los escenarios prácticos como los laboratorios, son espacios que permiten la construcción de nuevas herramientas, fracturando dichas barreras excluyentes desde un enfoque centrado en las buenas prácticas. En consonancia a lo anterior la investigación plantea como objetivo reconocer las (...) comprensiones y las prácticas que han emergido desde Latinoamérica en el marco de los laboratorios didácticos para la educación. (shrink)

Ethics in research are norms for conduct based on local regulations and universal recommendations such as the Nuremberg Code or the Declaration of Helsinki. However, these documents have a number of shortcomings that thwart the construction of a comprehensive ethical framework to guide research on humans in an effort to make better use of research results and to provide for ethical construction of knowledge. A broader ethical framework is suggested in this article, consistent with Ezekiel J. Emanuel's proposal, specifically one (...) that allows for evaluation, reflection and debate about scientific research on humans, based on eight fundamental principles. (shrink)

La presencia e integración de la investigación cualitativa a los protocolos de investigación biomédica ha cobrado cada vez mayor relevancia, por la importancia de la antropología cultural. El caso particular de la etnografía adquiere aún más preeminencia en relación con la definición de riesgo para el sujeto de investigación. El presente artículo expone las principales características de la investigación etnográfica que deben ser evaluadas por un comité de ética de la investigación, y define una serie de recomendaciones para la evaluación (...) del riesgo para los sujetos que se someten a este tipo de estudio. Los miembros de los Comités de Ética en Investigación deben tener en cuenta la etnografía para realizar a cabalidad su función. (shrink)

Research protocols are joining the list of inclusion criteria for signing informed consent. This may be due to conceptual confusion, intent to manipulate the subject, or even discrimination and coercion. This article reviews the basic concepts of inclusion criteria and analyzes the negative consequences of reducing a person’s voluntary participation in research and the process of informed consent to merely signing a document that is likened, in turn, to a criterion for recruiting subjects.

Caracterización de un grupo de comités de ética en investigación en Colombia Caracterização de um grupo de comitês de ética em pesquisa na Colômbia In the last decades, controlled clinical trials sponsored by the pharmaceutical industry have increased considerably. This has led to the need for greater control and assistance by regulators and ethics committees to ensure appropriate compliance with established ethical standards and good clinical practices in general. In Colombia, the National Food and Drug Surveillance Institute, the regulator in (...) the country, controls and monitors the operation of clinical research with drugs. In 2008, this entity issued Resolution 2378, which provides and regulates research actors in Colombia, including ethics committees. After being in force for several years, it is necessary to know whether research ethics committees in Colombia operate in accordance with this regulation and to determine the status of implementation of the requirements therein. For this purpose, a survey was designed to be voluntarily answered and a response was obtained from 25 of the 69 certified committees in Colombia. Twenty-two of them could be analyzed because their information was complete. Compared with previous studies, favorable changes in development and organization were observed in accordance with the current proposed regulation. Para citar este artículo / To reference this article / Para citar este artigo Suárez-Obando F, Reynales H, Urina M, Camacho J, Viteri M. Caracterización de un grupo de comités de ética en investigación en Colombia. pers. bioét. 2018; 22: 303-318. DOI: 10.5294/pebi.2018.22.2.8. (shrink)

The coronavirus disease pandemic fundamentally disrupted humans’ social life and behavior. Public health measures may have inadvertently impacted how people care for each other. This study investigated prosocial behavior, its association well-being, and predictors of prosocial behavior during the first COVID-19 pandemic lockdown and sought to understand whether region-specific differences exist. Participants from eight regions clustering multiple countries around the world responded to a cross-sectional online-survey investigating the psychological consequences of the first upsurge of lockdowns in spring 2020. Prosocial behavior (...) was reported to occur frequently. Multiple regression analyses showed that prosocial behavior was associated with better well-being consistently across regions. With regard to predictors of prosocial behavior, high levels of perceived social support were most strongly associated with prosocial behavior, followed by high levels of perceived stress, positive affect and psychological flexibility. Sociodemographic and psychosocial predictors of prosocial behavior were similar across regions. (shrink)