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

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).

Intercellular adhesion molecules and mortality for sepsis in infants younger than 1 year of life.

Background: Adhesion molecules in sepsis syndrome are correlated with the severity of illness and may be considered as predictors of survival outcome in adults. However, only few studies have been performed in infants and none using international criteria for sepsis.

Objective: To determine whether adhesion molecules during the first 7 days of the disease could predict sepsis outcome and its severity.