(1324) Barriers to Single IRB Study Initiation in Pediatric Critical Care Trials

Tuesday, February 25, 2025

8:45am – 9:45am Eastern Time

Location: Connections Central - RST 13

First Author(s)

JG

John W. Grunyk, MD

Lucile Packard Children's Hospital at Stanford University, USA

Co-Author(s)

PS

Philip C. Spinella, MD

Professor of Surgery and Critical Care Medicine
University of Pittsburgh, United States
CL

Christine M. Leeper, MD, MSc

Assistant Professor of Surgery and Critical Care Medicine
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
KS

Katherine Steffen, MD, MHS (she/her/hers)

Clinical Associate Professor, Pediatric Critical Care
Stanford University School of Medicine
Palo Alto, California, United States

Introduction: The National Institutes of Health (NIH) mandates the use of a single institutional review board (sIRB) for all U.S. federally funded multisite human participant research. Anecdotal evidence suggests this mandate has not consistently met its goals of reducing administrative burden and research costs. This project aims to evaluate the effectiveness of this mandate within the context of pediatric critical care research.

Methods: To assess the impact of the sIRB mandate, we conducted two focus groups with members of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Coordinator Network and performed semi-structured interviews with project investigators and research coordinators involved in a large multicenter pediatric trial. Interviews explored the mandate’s impacts on timelines, communication, and administrative burden.

Results: Twenty research coordinators participated in the focus groups and semi-structured interviews were conducted with 22 individuals. All respondents reported encountering barriers with the transition to the sIRB system. Sites with frequent multicenter trial involvement developed individualized processes to address these barriers, while other sites faced ongoing challenges, leading to project delays. Common barriers included:

1. Lead site issues: Lack of a clear point of contact, task optimization challenges, difficulties in project monitoring, and insufficient understanding of local site conditions.

2. Local site issues: Complications and delays with local IRB ceding protocol review to the sIRB, lack of optimized electronic platforms for sIRB protocol submissions, inadequate staffing, and duplicative administrative tasks involving both local and single IRBs.

3. Systemic issues: Insufficient training and support for the transition to the new model, highly variable IRB processes, technology limitations, and the impact of COVID-19 on the research environment.

Conclusions: The absence of universal policies and procedures for multicenter studies using sIRB review has led to significant delays in pediatric critical care research projects. Further investigation is needed to understand these barriers, assess the mandate’s impact on project costs and timeline, develop strategies for process improvement, and inform potential national policy changes.