Document Detail


Navigating the Institutional Review Board Approval Process in a Multicenter Observational Critical Care Study.
MedLine Citation:
PMID:  24368345     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Carmen C Polito; Sushma K Cribbs; Greg S Martin; Terence O'Keeffe; Dan Herr; Todd W Rice; Jonathan E Sevransky
Related Documents :
19358385 - An impacted malformed primary maxillary central incisor diagnosed as a compound odontoma.
8611485 - Orthodontic goniometry: a control technique after p. planas transversal expansion metho...
10734615 - Factors related to decisions to extract or retain at-risk teeth.
1498045 - Early eruption and advanced root development of the permanent cuspids in a six-year-old...
3341225 - Cardiac malformations in relatives of children with truncus arteriosus or interruption ...
7629445 - An infant with down-turner double aneuploidy: a case report and literature review.
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-12-23
Journal Detail:
Title:  Critical care medicine     Volume:  -     ISSN:  1530-0293     ISO Abbreviation:  Crit. Care Med.     Publication Date:  2013 Dec 
Date Detail:
Created Date:  2013-12-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0355501     Medline TA:  Crit Care Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Infection hospitalization increases risk of dementia in the elderly.
Next Document:  Impact of Critical Care Nursing on 30-Day Mortality of Mechanically Ventilated Older Adults.