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

dc.contributor.authorLopez-Baron, Eliana
dc.contributor.authorAbbas, Qalab
dc.contributor.authorCaporal, Paula
dc.contributor.authorAgulnik, Asya
dc.contributor.authorAttebery, Jonah E.
dc.contributor.authorHolloway, Adrian
dc.contributor.authorKissoon, Niranjan Tex
dc.contributor.authorMulgado-Aguas, Celia Isabel
dc.contributor.authorAmegan-Aho, Kokou
dc.contributor.authorMajdalani, Marianne
dc.contributor.authorOcampo, Carmen
dc.contributor.authorPascal, Havugarurema
dc.contributor.authorMiller, Erika
dc.contributor.authorKanyamuhunga, Aimable
dc.contributor.authorTekleab, Atnafu Mekonnen
dc.contributor.authorBacha, Tigist
dc.contributor.authorGonzález-Dambrauskas, Sebastian
dc.contributor.authorBhutta, Adnan T.
dc.contributor.authorKortz, Teresa B.
dc.contributor.authorMurthy, Srinivas
dc.contributor.authorRemy, Kenneth E.
dc.contributor.authorGlobal Health Subgroup of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network
dc.contributor.departmentPediatrics, School of Medicine
dc.date.accessioned2024-12-11T12:40:05Z
dc.date.available2024-12-11T12:40:05Z
dc.date.issued2024-11-05
dc.description.abstractBackground: 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.
dc.eprint.versionFinal published version
dc.identifier.citationLopez-Baron E, Abbas Q, Caporal P, et al. Challenges in institutional ethical review process and approval for international multicenter clinical studies in lower and middle-income countries: the case of PARITY study. Front Pediatr. 2024;12:1460377. Published 2024 Nov 5. doi:10.3389/fped.2024.1460377
dc.identifier.urihttps://hdl.handle.net/1805/44934
dc.language.isoen_US
dc.publisherFrontiers Media
dc.relation.isversionof10.3389/fped.2024.1460377
dc.relation.journalFrontiers in Pediatrics
dc.rightsAttribution 4.0 Internationalen
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.sourcePMC
dc.subjectIRBs
dc.subjectInstitutional Review Boards
dc.subjectChallenges
dc.subjectEthics
dc.subjectGlobal
dc.subjectLow- and middle-income countries
dc.subjectResearch
dc.titleChallenges in institutional ethical review process and approval for international multicenter clinical studies in lower and middle-income countries: the case of PARITY study
dc.typeArticle
Files
Original bundle
Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
LopezBaron2024Challenges-CCBY.pdf
Size:
6.19 MB
Format:
Adobe Portable Document Format
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
2.04 KB
Format:
Item-specific license agreed upon to submission
Description: