El estado del sistema de evaluación ética de las investigaciones en Argentina y su adaptación a la pandemia de la COVID-19 / Research ethics review system state in Argentina and the adaptation in response to the COVID-19 pandemic

RESUMEN INTRODUCCIÓN un sistema de evaluación ética de las investigaciones en seres humanos es esencial para proteger los derechos de los participantes. Los desafíos impuestos por la pandemia de la COVID-19 para conducir investigaciones éticas que produzcan resultados con rapidez demuestran la necesidad de fortalecerlo. El objetivo de este estudio fue describir el estado de situación de los sistemas de evaluación ética de las provincias de Argentina y las adaptaciones realizadas por la pandemia. MÉTODOS se realizó una encuesta a los comités provinciales de ética en investigación o áreas similares de los ministerios de Salud que ejercen la vigilancia sobre la evaluación ética de las investigaciones de su jurisdicción. RESULTADOS respondieron 16 de las 17 provincias encuestadas. El 93,7% de los comités provinciales evalúa investigaciones en seres humanos y tiene procedimientos operativos estandarizados (POE). El 68,7% lleva un registro de los comités de ética en investigación (CEI) de su jurisdicción. Un 75% acredita a los CEI y un 68,7% los supervisa. El 100% tiene un registro de las investigaciones en salud; en 56,2% de los casos este registro es público. Del total, 81,2% realizan actividades de capacitación. El 100% adaptó los POE para evaluar estudios sobre la COVID-19. DISCUSIÓN los resultados muestran sistemas provinciales consolidados. Se requiere fortalecer la transparencia en la investigación mediante el registro público de las investigaciones. Se identificaron posibilidades de mejora para proponer acciones a futuro.

ABSTRACT INTRODUCTION a research ethics system is essential to protect the rights of research participants. The challenges posed by the COVID-19 pandemic to conduct research ethically to produce rapid results have demonstrated the need to strengthen this system. The objective of this study was to describe the state of the research ethics system of the Provinces of Argentina and the adaptations made due to the pandemic. METHOD: a survey was conducted with provincial research ethics committees or similar areas within the Ministries of Health of the provinces responsible for the oversight of research ethics review under their jurisdiction. RESULTS sixteen of the 17 provinces surveyed responded. 93.7% of the provincial committees review human research and have standard operating procedures (SOPs). 68.7% register the research ethics committees (REC) in their jurisdiction. Seventy-five percent accredit RECs and 68.7% supervise them. 100% have a registry of health research in the jurisdiction, only 56.2% have public access. 81.2% carry out training activities. 100% adapted the SOPs to evaluate studies on COVID-19. DISCUSSION the results show consolidated provincial systems. Transparency in research needs to be strengthened through public registration of research. Possibilities for improvement were identified to propose future actions.

El estado del sistema de evaluación ética de las investigaciones en Argentina y su adaptación a la pandemia de la COVID-19 / Research ethics review system state in Argentina and the adaptation in response to the COVID-19 pandemic

INTRODUCCIÓN: un sistema de evaluación ética de las investigaciones en seres humanos es esencial para proteger los derechos de los participantes. Los desafíos impuestos por la pandemia de la COVID-19 para conducir investigaciones éticas que produzcan resultados con rapidez demuestran la necesidad de fortalecerlo. El objetivo de este estudio fue describir el estado de situación de los sistemas de evaluación ética de las provincias de Argentina y las adaptaciones realizadas por la pandemia. MÉTODOS: se realizó una encuesta a los comités provinciales de ética en investigación o áreas similares de los ministerios de Salud que ejercen la vigilancia sobre la evaluación ética de las investigaciones de su jurisdicción. RESULTADOS: respondieron 16 de las 17 provincias encuestadas. El 93,7% de los comités provinciales evalúa investigaciones en seres humanos y tiene procedimientos operativos estandarizados (POE). El 68,7% lleva un registro de los comités de ética en investigación (CEI) de su jurisdicción. Un 75% acredita a los CEI y un 68,7% los supervisa. El 100% tiene un registro de las investigaciones en salud; en 56,2% de los casos este registro es público. Del total, 81,2% realizan actividades de capacitación. El 100% adaptó los POE para evaluar estudios sobre la COVID-19. DISCUSIÓN: los resultados muestran sistemas provinciales consolidados. Se requiere fortalecer la transparencia en la investigación mediante el registro público de las investigaciones. Se identificaron posibilidades de mejora para proponer acciones a futuro

INTRODUCTION: a research ethics system is essential to protect the rights of research participants. The challenges posed by the COVID-19 pandemic to conduct research ethically to produce rapid results have demonstrated the need to strengthen this system. The objective of this study was to describe the state of the research ethics system of the Provinces of Argentina and the adaptations made due to the pandemic. METHOD: a survey was conducted with provincial research ethics committees or similar areas within the Ministries of Health of the provinces responsible for the oversight of research ethics review under their jurisdiction. RESULTS: sixteen of the 17 provinces surveyed responded. 93.7% of the provincial committees review human research and have standard operating procedures (SOPs). 68.7% register the research ethics committees (REC) in their jurisdiction. Seventy-five percent accredit RECs and 68.7% supervise them. 100% have a registry of health research in the jurisdiction, only 56.2% have public access. 81.2% carry out training activities. 100% adapted the SOPs to evaluate studies on COVID-19. DISCUSSION: the results show consolidated provincial systems. Transparency in research needs to be strengthened through public registration of research. Possibilities for improvement were identified to propose future actions.

Vascular Function in Children with Low Birthweight and Its Relationship with Early Markers of Cardiovascular Risk.

UNLABELLED: Low birthweight (LBW) increases the risk of developing cardiovascular diseases (CVD). Few studies have established its impact at early ages. AIMS: To study endothelial function (EF) and arterial stiffness (AS) and their relationship to early markers of CVD risk in children with LBW. METHODS: In children with LBW (4-6 years; n = 53), anthropometric, haemodynamic and laboratory parameters, including HOMA-IR, hs-CRP, adiponectin and leptin, were determined. EF and AS were evaluated by digital pulse plethysmography. Data were compared with a control group (n = 33). RESULTS: In both groups, anthropometric parameters remained within normal limits. Insulin and HOMA-IR had normal values, but they were significantly augmented in LBW children. LBW children showed higher leptin and hs-CRP levels than the control group. The LBW group had decreased EF (37.5 ± 5.6%) compared with the control group (75.0 ± 11.9%; p < 0.01), however without differences in AS. In LBW children, EF was negatively correlated with waist circumference, leptin, hs-CRP and with a cumulative score of risk factors. CONCLUSIONS: LBW children display altered EF that is related to early changes in CVD risk factors. The differences found in the metabolic parameters might indicate a pro-inflammatory state. This hypothesis is also supported by the laboratory findings and the correlation between EF and the number of CVD risk factors, suggesting that very early lifestyle interventions may be needed.

Arterial stiffness and endothelial function in obese children and adolescents and its relationship with cardiovascular risk factors.

BACKGROUND: Obesity is related to an increase in the rates of cardiovascular disease. OBJECTIVE: To establish the impact of obesity on vascular function (endothelial function and arterial stiffness) in children and adolescents and its relationship to cardiovascular risk factors. METHODS: In obese (OB) children and adolescents, endothelial function and arterial stiffness were evaluated by a pulse plethysmography method (reactive hyperemia and index of digital volume waveforms, respectively). Data were compared with the non-obese (non-OB) group (body mass index >10th to <97th percentile). Anthropometric parameters, body fat percentage, fasting glucose, lipid profile, insulinemia, HOMA-IR and hemodynamic parameters were determined in both groups. RESULTS: Body mass index, weight, waist circumference, body fat, insulinemia and HOMA-IR were significantly higher in the OB group. The OB group showed impaired endothelial function (15.8 ± 0.2%, n = 37) compared to the non-OB group (41.4 ± 5%, n = 20; p < 0.001) and increased arterial stiffness. Endothelial function was only negatively correlated with waist circumference and HOMA-IR in the OB group, whereas a positive correlation was found between insulinemia and HOMA-IR. CONCLUSIONS: This study shows that impaired vascular function is already present in OB children and adolescents. The fact that obesity is associated with some markers of cardiovascular risk suggests the importance of early lifestyle interventions in this population to prevent cardiovascular disease.