Regulatory Focus™ > News Articles > RAND Study: Inefficient IRBs Add Costs, Delay Regulatory Approval

RAND Study: Inefficient IRBs Add Costs, Delay Regulatory Approval

Posted 12 January 2012 | By

A RAND Corporation study of Institutional Review Boards (IRBs) released in the December issue of The Milbank Quarterly titled, Burdens on Research Imposed by Institutional Review Boards: The State of the Evidence and Its Implications for Regulatory Reform, shows that inefficient IRBs are adding unnecessary costs, failing to add significant protections to study participants, and delaying regulatory approval by lengthening clinical trial completion times.

The US Department of Health and Human Services (DHHS) has announced that it is looking to overhaul the regulations governing IRBs.

The study looked at 52 studies that had an IRB and found unnecessary project delays, IRBs asking for different and sometimes competing revisions when presented with the same protocols, and IRB decisions made in violation of federal regulations or guidance.

The study notes that while there is a lack of uniformity when it comes to IRB decision making, the study sample size was too small to make any concrete recommendations and further research is needed.

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