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Navigating the Institutional Review Board Approval Process in a Multicenter Observational Critical Care Study*

Polito, Carmen C. MD1; Cribbs, Sushma K. MD, MSc1; Martin, Greg S. MD, MSc1; O’Keeffe, Terence MB, ChB, MSPH2; Herr, Dan MD3; Rice, Todd W. MD, MSc4; Sevransky, Jonathan E. MD, MHS1

doi: 10.1097/CCM.0000000000000133
Clinical Investigations

Objective: To characterize variation in the institutional review board application process of a multicenter, observational critical care study.

Design, Setting, and Subjects: Survey analysis of 36 investigators who applied for participation in the United States Critical Illness and Injury Trials Group: Critical Illness and Outcomes Study, an observational study of 69 adult ICUs.

Interventions: None.

Measurements and Main Results: Analysis of investigator-specific characteristics, institutional review board process, application and approval dates, and level of difficulty in obtaining approval. Surveys were analyzed from 36 sites (95%) that applied for institutional review board approval. Level of review ranged from full board, expedited, to exempt. Seventy-five percent of applications were submitted by an experienced investigator while 25% were submitted by a less experienced investigator. Median time to institutional review board approval was 30 days (interquartile range, 14–54) and ranged from 5 days to 5.5 months. Time to approval was 29 days (interquartile range, 17–48) for applications submitted by an experienced investigator compared with 97 days (interquartile range, 25–159) for those submitted by a less experienced investigator (p = 0.08). Subjective level of difficulty was significantly higher for less experienced investigators (4 of 10; interquartile range, 2–8) vs experienced investigators (2 of 10; interquartile range, 1–3) (p = 0.04). Four sites cited institutional review board concern regarding waiver of consent as a major barrier to approval and were required to perform revisions or participate in board meetings regarding this concern.

Conclusions: In a multicenter, observational critical care study, significant variation was observed between sites in all aspects of the institutional review board evaluation and approval process. The level of difficulty was significantly higher for less experienced investigators with a trend toward longer time to institutional review board approval. Variation in institutional review board interpretation of waiver of informed consent regulations was cited as a major barrier to approval.

1Divison of Pulmonary and Critical Care Medicine, Emory University, Atlanta, GA.

2Division of Trauma, Critical Care and Emergency Surgery, University of Arizona, Tuscon, AZ.

3Departments of Medicine and Surgery, University of Maryland, Baltimore, MD.

4Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University, Nashville, TN.

* See also p. 1292.

This work was performed at Emory University.

Dr. Polito is supported by the National Institutes of Health (NIH) (T32GM095442). Dr. Martin served as a board member of Cumberland Pharmaceuticals and Pulsion Medical Systems, consulted for AstraZeneca and Agennix, and received support for article research from the NIH. His institution received grant support from the NIH, U.S. Food and Drug Administration, Baxter Healthcare, and Abbott Laboratories. Dr. O’Keeffe lectured for University of Arizona Department of Emergency Medicine (received honorarium). His institution received grant support from the NIH (Dr. O’Keeffe is local principal investigator for the Pragmatic Randomized Optimal Platelet and Plasma Ratios trial). Dr. Rice consulted for Avisa Pharma and GlaxoSmithKline, received support for development of education presentations from Oakstone Publications, and received support for article research from the NIH. Dr. Sevranksy received support for article research from the NIH. His institution received grant support from Abbot laboratories (sepsis biomarker study) and support from the NIH. The remaining authors have disclosed that they do not have any potential conflicts of interest.

For information regarding this article, E-mail: cpolito@emory.edu

© 2014 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins