A R Stark1, J E Tyson, P L Hibberd. 1. Department of Pediatrics, Section of Neonatology, Baylor College of Medicine, Houston, TX 77030, USA. arstark@bcm.edu
Abstract
OBJECTIVE: The objective of the study was to examine the variation among institutional review boards (IRBs) in evaluation of the study design of a multicenter trial. STUDY DESIGN: We assessed the first written response of local IRBs to each site investigator for a multicenter trial of vitamin A supplementation in extremely low birth weight (ELBW) infants performed by the National Institute of Child Health and Human Development Neonatal Research Network. Each author of this paper independently reviewed and categorized IRB concerns as major, minor or none, according to the predefined criteria. RESULT: Initially, 9 of 18 IRBs withheld approval because of at least one major concern. These concerns reflected difficulties in evaluating specific scientific issues for the design of the trial, including its justification, enrollment criteria, control and experimental therapies, co-interventions, toxicity assessment, outcome monitoring and informed consent. CONCLUSION: The difficulty in assessing appropriate trial design for the specific hypothesis under investigation resulted in considerable variability in the evaluation by local IRBs.
RCT Entities:
OBJECTIVE: The objective of the study was to examine the variation among institutional review boards (IRBs) in evaluation of the study design of a multicenter trial. STUDY DESIGN: We assessed the first written response of local IRBs to each site investigator for a multicenter trial of vitamin A supplementation in extremely low birth weight (ELBW) infants performed by the National Institute of Child Health and Human Development Neonatal Research Network. Each author of this paper independently reviewed and categorized IRB concerns as major, minor or none, according to the predefined criteria. RESULT: Initially, 9 of 18 IRBs withheld approval because of at least one major concern. These concerns reflected difficulties in evaluating specific scientific issues for the design of the trial, including its justification, enrollment criteria, control and experimental therapies, co-interventions, toxicity assessment, outcome monitoring and informed consent. CONCLUSION: The difficulty in assessing appropriate trial design for the specific hypothesis under investigation resulted in considerable variability in the evaluation by local IRBs.
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