Journal article
Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis
Pediatric critical care medicine, Vol.19(4), pp.E180-E188
04/01/2018
DOI: 10.1097/PCC.0000000000001455
PMID: 29377867
Abstract
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.
Details
- Title: Subtitle
- Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis
- Creators
- Kelly N. Michelson - Lurie Children's HospitalGary Reubenson - University of the WitwatersrandScott L. Weiss - Children's Hospital of PhiladelphiaJulie C. Fitzgerald - Children's Hospital of PhiladelphiaKate K. Ackerman - University of RochesterLeeAnn Christie - Dell Childrens Med Ctr Cent Texas, Div Crit Care, Austin, TX USAJenny L. Bush - Children's Hospital of PhiladelphiaVinay M. Nadkarni - Children's Hospital of PhiladelphiaNeal J. Thomas - Pennsylvania State UniversityMark S. Schreiner - Children's Hospital of PhiladelphiaSepsis Prevalence, Outcomes, and Therapy (SPROUT) Study InvestigatorsPediatric Acute Lung Injury and Sepsis Investigators Network
- Contributors
- C Tigges (Contributor) - University of Iowa, Critical CareM Chegondi (Contributor) - University of Iowa, Stead Family Department of Pediatrics
- Resource Type
- Journal article
- Publication Details
- Pediatric critical care medicine, Vol.19(4), pp.E180-E188
- DOI
- 10.1097/PCC.0000000000001455
- PMID
- 29377867
- NLM abbreviation
- Pediatr Crit Care Med
- ISSN
- 1529-7535
- eISSN
- 1947-3893
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 9
- Grant note
- AstraZeneca Patient-Centered Outcomes Research Institute (PCORI); Patient-Centered Outcomes Research Institute - PCORI CareFusion Center for Pediatric Clinical Effectiveness at The Children's Hospital of Philadelphia U.K. National Institute of Health Research (NIHR) Clinical Research Network; National Institute for Health Research (NIHR) Southampton NIHR Wellcome Trust Clinical Research Facility Gene Fluidics ONY, Inc. Therabron Endowed Chair, Department of Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine ThermoFisher Scientific K23GM110496 / National Institute of General Medical Sciences; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of General Medical Sciences (NIGMS) American Cancer Society (ACS); American Cancer Society K23GM110496 / National Institute of General Medical Sciences (NIGMS); United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of General Medical Sciences (NIGMS) Bristol-Meyers Squibb; Bristol-Myers Squibb Children's Hospital of Philadelphia Center for Pediatric Clinical Effectiveness
- Language
- English
- Date published
- 04/01/2018
- Academic Unit
- Critical Care; Stead Family Department of Pediatrics
- Record Identifier
- 9984354147702771
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