Challenges in Institutional Ethical Review Process and Approval for International Multicenter Clinical Studies in Lower and Middle-Income Countries: the case of PARITY Study

Abstract

Objectives: To describe the regulatory process, variability and challenges faced by pediatric researchers in low- and middle-income countries (LMICs) during the institutional review board (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. Subjects: PIs from the Global PARITY Study Interventions: None. Results: Ninety-one sites pursued local IRB approval and 46 sites obtained IRB approval and completed data collection. Forty-six (100 %) participating centers and 21 (47%) non-participant centers completed the survey. Despite receiving approval from the study's lead center and being categorized as a minimal risk study, 36 (78%) of the hospitals involved in PARITY study required their own full board review. 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.