TY - JOUR
T1 - Diagnóstico situacional de los Comités Institucionales de Ética en Investigación de la SeguridadSocialenPerú
AU - Herrera-Añazco, Percy
AU - Urrunaga-Pastor, Diego
AU - Soto-Ordoñez, Suly
AU - Failoc-Rojas, Virgilio E.
AU - Estrada-Martínez, Maggie
AU - Del Carpio Toia, Agueda Muñoz
N1 - Publisher Copyright:
© 2022 Columbia Data Analytics. All rights reserved.
PY - 2022/3/31
Y1 - 2022/3/31
N2 - Background: Although the Instituto de Evaluación de Tecnologías e Investigaciones en Salud (IETSI) has promoted the formation of Institutional Research Ethics Committees (IRECs) in the social security of Peru (EsSalud), there may be perfectible aspects. The characteristics of the IREC of EsSalud and its members during 2021 are described. Material and Methods: A descriptive and observational study was carried out using a secondary database. IREC members were surveyed using a virtual form created by IETSI. 114 members belonging to 18 EsSalud networks were included. Results: 52.6% of the participants were male, the mean age was 50.6 ± 11.9 years, and 42.1% had a scientific role. In 38.8% of the IREC were evaluated more than five clinical trials in the last two years and 72.2% more than five observational studies in the same period. The members reported limitations for holding virtual meetings or supervisions, lack of time to carry out their tasks due to the high workload and the need for training on research methodology and biostatistics. Conclusion: it is necessary to improve the administrative support and the training plan for the members of the IREC of EsSalud, to achieve methodological, ethical, and regulatory competencies that ensure an improvement in the processes of evaluation and ethical monitoring of human research.
AB - Background: Although the Instituto de Evaluación de Tecnologías e Investigaciones en Salud (IETSI) has promoted the formation of Institutional Research Ethics Committees (IRECs) in the social security of Peru (EsSalud), there may be perfectible aspects. The characteristics of the IREC of EsSalud and its members during 2021 are described. Material and Methods: A descriptive and observational study was carried out using a secondary database. IREC members were surveyed using a virtual form created by IETSI. 114 members belonging to 18 EsSalud networks were included. Results: 52.6% of the participants were male, the mean age was 50.6 ± 11.9 years, and 42.1% had a scientific role. In 38.8% of the IREC were evaluated more than five clinical trials in the last two years and 72.2% more than five observational studies in the same period. The members reported limitations for holding virtual meetings or supervisions, lack of time to carry out their tasks due to the high workload and the need for training on research methodology and biostatistics. Conclusion: it is necessary to improve the administrative support and the training plan for the members of the IREC of EsSalud, to achieve methodological, ethical, and regulatory competencies that ensure an improvement in the processes of evaluation and ethical monitoring of human research.
KW - Clinical Trials as Topic
KW - Ethics
KW - Ethics, Institutional
KW - Peru
KW - Research
KW - Research Design
UR - http://www.scopus.com/inward/record.url?scp=85133870905&partnerID=8YFLogxK
U2 - 10.35434/rcmhnaaa.2022.151.1057
DO - 10.35434/rcmhnaaa.2022.151.1057
M3 - Artículo
AN - SCOPUS:85133870905
SN - 2225-5109
VL - 15
SP - 53
EP - 59
JO - Revista del Cuerpo Medico Hospital Nacional Almanzor Aguinaga Asenjo
JF - Revista del Cuerpo Medico Hospital Nacional Almanzor Aguinaga Asenjo
IS - 1
ER -