Challenges in institutional ethical review process and approval for international multicenter clinical studies in lower and middle-income countries: the case of PARITY study.

Autor:	Lopez-Baron E; Departamento de Pediatría y Cuidado Crítico Pediátrico, Hospital Pablo Tobón Uribe, Universidad EIA, Medellín, Colombia.; Departamento de Pediatría, Universidad de Antioquia, Medellín, Colombia., Abbas Q; Department of Pediatrics and Child Health, Aga Khan University Hospital, Karachi, Pakistan., Caporal P; Health Systems Program, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.; Red Colaborativa Pediátrica de Latinoamérica (LARed Network), La Plata, Argentina., Agulnik A; Division of Critical Care and Pulmonary Medicine, Department of Pediatrics, St Jude Children's Research Hospital, Memphis, TN, United States.; Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN, United States., Attebery JE; Department of Neurosurgery, Barrow Global, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, AZ, United States., Holloway A; Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD, United States., Kissoon NT; Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.; Division of Critical Care, British Columbia Children's Hospital, Vancouver, BC, Canada., Mulgado-Aguas CI; Unidad de Terapia Intensiva Pediátrica, Hospital General León, León, México., Amegan-Aho K; Department of Pediatrics and Child Health, School of Medicine, University of Health and Allied Sciences, Ho, Ghana., Majdalani M; Division of Pediatric Intensive Care Unit, Department of Pediatrics and Adolescent Medicine, American University of Beirut Medical Center, Beirut, Lebanon., Ocampo C; Grupo Quirón Salud, Clínica Imbanaco, Cali, Colombia., Pascal H; Department of Pediatrics and Child Health, University Teaching Hospital of Butare, Butare, Rwanda., Miller E; Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD, United States., Kanyamuhunga A; Department of Pediatrics and Child Health, University Teaching Hospital of Kigali, Kigali, Rwanda., Tekleab AM; Department of Pediatrics and Child Health, St. Paul's Hospital Millennium Hospital Medical College, Addis Ababa, Ethiopia., Bacha T; Department of Pediatrics and Child Health, St. Paul's Hospital Millennium Hospital Medical College, Addis Ababa, Ethiopia., González-Dambrauskas S; Red Colaborativa Pediátrica de Latinoamérica (LARed Network), Montevideo, Uruguay.; Departamento de Pediatría y Unidad de Cuidados Intensivos de Niños del Centro Hospitalario Pereira Rossell, Facultad de Medicina, Universidad de la República, Montevideo, Uruguay., Bhutta AT; Division of Pediatric Critical Care Medicine, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IA, United States., Kortz TB; Division of Critical Care, Department of Pediatrics, University of California, San Francisco, CA, United States.; Institute for Global Health Sciences, UCSF, San Francisco, CA, United States., Murthy S; Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, BC, Canada., Remy KE; Division of Pediatric Critical Care Medicine, Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in pediatrics [Front Pediatr] 2024 Nov 05; Vol. 12, pp. 1460377. Date of Electronic Publication: 2024 Nov 05 (Print Publication: 2024).
DOI:	10.3389/fped.2024.1460377
Abstrakt:	Background: One of the greatest challenges to conducting multicenter research studies in low and middle-income countries (LMICs) is the heterogeneity in regulatory processes across sites. Previous studies have reported variations in requirements with a lack of standardization in the Institutional Review Board (IRB) processes between centers, imposing barriers for approval, participation, and development of multicenter research. Objectives: To describe the regulatory process, variability and challenges faced by pediatric researchers in LMICs during the IRB process of an international multicenter observational point prevalence study (Global PARITY). Design: A 16-question multiple-choice online survey was sent to site principal investigators (PIs) at PARITY study participating centers to explore characteristics of the IRB process, costs, and barriers to research approval. A shorter survey was employed for sites that expressed interest in participating in Global PARITY and started the approval process, but ultimately did not participate in data collection (non-participating sites) to assess IRB characteristics. Results: Of the 91 sites that sought IRB approval, 46 were successful in obtaining approval and finishing the data collection process. The survey was completed by 46 (100%) participating centers and 21 (47%) non-participating centers. There was a significant difference between participating and non-participating sites in IRB approval of a waiver consent and in the requirement for a legal review of the protocol. The greatest challenge to research identified by non-participating sites was a lack of research time and the lack of institutional support. Conclusions: Global collaborative research is crucial to increase our understanding of pediatric critical care conditions in hospitals of all resource-levels and IRBs are required to ensure that this research complies with ethical standards. Critical barriers restrict research activities in some resource limiting countries. Increasing the efficiency and accessibility of local IRB review could greatly impact participation of resource limited sites and enrollment of vulnerable populations. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (© 2024 Lopez-Baron, Abbas, Caporal, Agulnik, Attebery, Holloway, Kissoon, Mulgado-Aguas, Amegan-Aho, Majdalani, Ocampo, Pascal, Miller, Kanyamuhunga, Tekleab, Bacha, González-Dambrauskas, Bhutta, Kortz, Murthy, Remy and the Global Health Subgroup of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network.)
Databáze:	MEDLINE
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