AI Article Synopsis
- Many clinical researchers feel that IRB requirements have grown heavier in recent years, but there's a lack of objective data to confirm this.
- Over a 7-year study by the Reproductive Medicine Network, researchers noted an increase in IRB submission size and requirements, along with inconsistencies in IRB efficiency when reviewing multicenter trials.
- These heightened regulatory demands create significant challenges for both researchers and IRBs, prompting a reevaluation of whether these changes genuinely enhance participant safety and interests in research.
Article Abstract
Unlabelled: Many clinical investigators think that the burden of Institutional Review Board (IRB) requirements has been consistently increasing over recent years, although there are few objective data describing these trends. Over a period of 7 years, the Reproductive Medicine Network observed a significant increase in the size and requirements of IRB submissions and significant variability of IRB performance in reviewing multicenter trials. These additional regulatory and administrative demands represent substantial burdens to researchers and to the IRBs themselves. It is timely to consider whether these changes better protect the interests and safety of human research participants.
Clinical Trial Registration: ClinicalTrials.gov NCT00068861 and NCT00719186.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3151556 | PMC |
| http://dx.doi.org/10.1016/j.fertnstert.2011.05.069 | DOI Listing |
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