Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis.

Journal Article (Journal Article;Multicenter Study)

OBJECTIVES: Duplicative institutional review board/research ethics committee review for multicenter studies may impose administrative burdens and inefficiencies affecting study implementation and quality. Understanding variability in site-specific institutional review board/research ethics committee assessment and barriers to using a single review committee (an increasingly proposed solution) can inform a more efficient process. We provide needed data about the regulatory oversight process for the Sepsis PRevalence, OUtcomes, and Therapies multicenter point prevalence study. DESIGN: Survey. SETTING: Sites invited to participate in Sepsis PRevalence, OUtcomes, and Therapies. SUBJECTS: Investigators at sites that expressed interest and/or participated in Sepsis PRevalence, OUtcomes, and Therapies. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Using an electronic survey, we collected data about 1) logistics of protocol submission, 2) institutional review board/research ethics committee requested modifications, and 3) use of a single institutional review board (for U.S. sites). We collected surveys from 104 of 167 sites (62%). Of the 97 sites that submitted the protocol for institutional review board/research ethics committee review, 34% conducted full board review, 54% expedited review, and 4% considered the study exempt. Time to institutional review board/research ethics committee approval required a median of 34 (range 3-186) days, which took longer at sites that required protocol modifications (median [interquartile range] 50 d [35-131 d] vs 32 d [14-54 d)]; p = 0.02). Enrollment was delayed at eight sites due to prolonged (> 50 d) time to approval. Of 49 U.S. sites, 43% considered using a single institutional review board, but only 18% utilized this option. Time to final approval for U.S. sites using the single institutional review board was 62 days (interquartile range, 34-70 d) compared with 34 days (interquartile range, 15-54 d) for nonsingle institutional review board sites (p = 0.16). CONCLUSIONS: Variability in regulatory oversight was evident for this minimal-risk observational research study, most notably in the category of type of review conducted. Duplicative review prolonged time to protocol approval at some sites. Use of a single institutional review board for U.S. sites was rare and did not improve efficiency of protocol approval. Suggestions for minimizing these challenges are provided.

Full Text

Duke Authors

Cited Authors

  • Michelson, KN; Reubenson, G; Weiss, SL; Fitzgerald, JC; Ackerman, KK; Christie, L; Bush, JL; Nadkarni, VM; Thomas, NJ; Schreiner, MS; Sepsis Prevalence, Outcomes, and Therapy (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators Network,

Published Date

  • April 2018

Published In

Volume / Issue

  • 19 / 4

Start / End Page

  • e180 - e188

PubMed ID

  • 29377867

Pubmed Central ID

  • 29377867

International Standard Serial Number (ISSN)

  • 1529-7535

Digital Object Identifier (DOI)

  • 10.1097/PCC.0000000000001455


  • eng

Conference Location

  • United States