Variation among institutional review boards in evaluating the design of a multicenter randomized trial
- 1 October 2009
- journal article
- research article
- Published by Springer Science and Business Media LLC in Journal of Perinatology
- Vol. 30 (3), 163-169
- https://doi.org/10.1038/jp.2009.157
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.Keywords
This publication has 51 references indexed in Scilit:
- Outcomes of patients who participate in randomised controlled trials compared to similar patients receiving similar interventions who do not participatePublished by Wiley ,2007
- Variation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research ProtocolAcademic Emergency Medicine, 2007
- Variation in Standards of Research Compensation and Child Assent Practices: A Comparison of 69 Institutional Review Board–Approved Informed Permission and Assent Forms for 3 Multicenter Pediatric Clinical TrialsPediatrics, 2006
- Feasibility of a National Fatal Asthma Registry: More Evidence of IRB Variation in Evaluation of a Standard ProtocolJournal of Asthma, 2006
- Impact of Institutional Review Board Practice Variation on Observational Health Services ResearchHealth Services Research, 2005
- When should an effective treatment be used?: Derivation of the threshold number needed to treat and the minimum event rate for treatmentJournal of Clinical Epidemiology, 2001
- Do sick newborn infants benefit from participation in a randomized clinical trial?The Journal of Pediatrics, 1999
- The “inclusion benefit” in clinical trialsThe Journal of Pediatrics, 1999
- Equipoise and the Ethics of Clinical ResearchNew England Journal of Medicine, 1987
- Inconsistency and institutional review boardsPublished by American Medical Association (AMA) ,1982