Institutional Research Ethics Committees that have Evaluated Clinical Trials contemplated in the Peruvian Regulations 2010-2023
DOI:
https://doi.org/10.35434/rcmhnaaa.2025.181.2500Keywords:
Ethics Committees, Research, Clinical Trial, Accreditation, PeruAbstract
Introduction: The Declaration of Helsinki recognizes the importance of Institutional Research Ethics Committees (IREC) in experimental studies for consideration, comments and guidance; which has been included in international and Peruvian legislation as a standard of good clinical practice. This study seeks to characterize the IREC that have evaluated clinical trials (CT) framed in the Peruvian Regulation, period 2010-2023. Material and methods: Secondary source. The population was the CT submitted to the National Institute of Health. Inclusion criteria: CT registered in the Peruvian Registry of Clinical Trials, and as exclusion criteria: i) CT with repeated registration, ii) registry without information on the IREC. A descriptive analysis was performed. Results: 927 CT were analyzed, which were evaluated by 36 IREC. The three IREC with the highest number of CT evaluated were private. The private IREC had as their main users private clinics that did not have IREC. Conclusion: There were 36 IREC that evaluated CT in the period 2010-2023. The three IREC that have evaluated the most CT are private. Private IREC do not usually have the research institutions to which they belong as users.
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The World Medical Association. Declaración de Helsinki [Internet]. 2024. Disponible en: https://acortar.link/6hxSDU
El Peruano. Decreto Supremo N.° 006-2007-SA [Internet]. Lima; 2007 [citado el 14 de mayo de 2024]. Disponible en: https://acortar.link/ssCDLj
El Peruano. Decreto Supremo N.° 021-2017-SA [Internet]. Lima; 2017 [citado el 14 de mayo de 2024]. Disponible en: https://acortar.link/bu93rt
El Peruano. Decreto Supremo N.° 028-2023-SA [Internet]. Lima; 2023 [citado el 14 de mayo de 2024]. Disponible en: https://acortar.link/n0hYQq
Flynn KE, Hahn CL, Kramer JM, Check DK, Dombeck CB, Bang S, et al. Using central IRBs for multicenter clinical trials in the United States. PLoS One. 2013;8(1):e54999. doi:10.1371/journal.pone.0054999
Homedes N, Ugalde A. Los Comités de Ética en Investigación y la Protección de los Sujetos que Participan en Ensayos Clínicos. Revista Colombiana de Bioética. 2019;14(1). doi:10.18270/rcb.v14i1.2430
Silberman G, Kahn KL. Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform. Milbank Q. 2011;89(4):599–627. doi:10.1111/j.1468-0009.2011.00644.x
Menikoff J. The paradoxical problem with multiple-IRB review. N Engl J Med. 2010;363(17):1591–3. doi:10.1056/NEJMp1005101
Martin SL, Allman PH, Dugoff L, Sibai B, Lynch S, Ferrara J, et al. Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial. Am J Obstet Gynecol MFM. 2023;5(6):100861. doi:10.1016/j.ajogmf.2023.100861
Salud y Fármacos. Nueva regulación de los ensayos clínicos [Internet]. España: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS); 2016 [citado el 14 de mayo de 2024]. Disponible en: https://acortar.link/fw7tnA
Gordon V, Culp M, Wolinetz C. Final NIH Policy on the Use of a Single Institutional Review Board for Multisite Research. Clinical and Translational Science. 2017;10(3):130–2. doi:10.1111/cts.12447
Ugalde A, Homedes N. Los comités de ética de investigación en América Latina: ¿Para qué sirven? Revista Colombiana de Bioética [Internet]. 2019; 14(1). doi:10.18270/rcb.v14i1.2430
Roque-Henriquez J, Minaya-Martínez G, Salinas-Castro E, Fuentes-Delgado D. Situación de los ensayos clínicos y entidades que participan en su ejecución en el Perú. Revista Peruana de Epidemiología. 2014;18(2):1–4. Disponible en: https://acortar.link/t7ARPf
Lecca Garcia L, Llanos-Zavalaga F, Ygnacio Jorge E. Características de los Comités de Ética en Investigación del Perú autorizados para aprobar ensayos clínicos. Revista Medica Herediana. 2005;16(1):3–10. Disponible en: https://acortar.link/gOKcRu
Lope PC, Carracedo S, Romani F, Lope PC, Carracedo S, Romani F. La regulación de los ensayos clínicos para la COVID-19 en el Perú. Revista Peruana de Medicina Experimental y Salud Publica. 2021;38(1):171–7. doi:10.17843/rpmesp.2021.381.6627
Ugalde A, Homedes N. The Regulatory Framework and Case Studies from Argentina. En: Ugalde A, Homedes N. Clinical Trials in Latin America: Where Ethics and Business Clash. Springer; 2014. p. 79–111. doi:10.1007/978-3-319-01363-3_4
Kaplan S. In clinical trials, for-profit review boards are taking over for hospitals. Should they? [Internet]. 2016. [citado el 9 de febrero de 2025]. Disponible en: https://acortar.link/Vhra56
Abbott D, Califf R, Morrison BW, Pierre C, Bolte J, Chakraborty S. Cycle Time Metrics for Multisite Clinical Trials in the United States. Ther Innov Regul Sci. 2013;47(2):152–60. doi:10.1177/2168479012464371
Klitzman R, Pivovarova E, Lidz CW. Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy. JAMA. 2017;317(20):2061–2. doi:10.1001/jama.2017.4624
Instituto Nacional de Salud [Internet]. Lima: INS; 2024 [citado el 16 de mayo de 2024]. Bienvenido REPEC. Disponible en: https://repec.ins.gob.pe/
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Copyright (c) 2025 Katherine Milagros Rojas Quiche, Luis Felipe Rojas Cama, Duilio Jesús Fuentes Delgado, Joel Christian Roque Henriquez

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