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

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. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://ift.tt/2gIrZ5Y). Supported, in part, by the Endowed Chair, Department of Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine and the Center for Pediatric Clinical Effectiveness at The Children’s Hospital of Philadelphia. Financial support for data collection in all U.K. centers was provided by the U.K. National Institute of Health Research (NIHR) Clinical Research Network and in Southampton by the Southampton NIHR Wellcome Trust Clinical Research Facility. Dr. Michelson disclosed grant funding from the Patient-Centered Outcomes Research Institute (PCORI) and American Cancer Society (ACS), and she received funding from AstraZeneca (consultant on a data safety monitoring board (DSMB)). Dr. Weiss was supported by National Institute of General Medical Sciences (NIGMS) K23GM110496 and his institution received funding from the Center for Pediatric Clinical Effectiveness at The Children’s Hospital of Philadelphia, the National Institute of General Medical Sciences K23GM110496, ThermoFisher Scientific (honorarium for lecture), and Bristol-Meyers Squibb (honorarium for clinical trial advisory board), Dr. Fitzgerald’s institution received funding from the Children’s Hospital of Philadelphia Center for Pediatric Clinical Effectiveness. Dr. Ackerman received funding from ONY, Inc. (consultant, neonatology drug development). Dr. Thomas’ institution received funding from Gene Fluidics, and he received funding from Therabron and CareFusion. The remaining authors have disclosed that they do not have any potential conflicts of interest. ©2018The Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

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