RELEASE DATE:  May 22, 2003

NOTICE:  NOT-OD-03-042

National Institutes of Health (NIH)

This is a reminder that no costs associated with the review of human 
research protocols by an Institutional Review Board (IRB) may be 
charged as direct costs for NIH-funded research involving human 
participants, unless such costs are not included in the institution's 
facilities and administrative rate (F&A). This policy is consistent 
with OMB Circular A-21 which requires that "all costs incurred for the 
same purpose, in like circumstances, are either direct costs only or 
F&A (indirect) costs only with respect to final costs objectives." 

The NIH recognizes the increased compliance costs associated with human 
subjects protection and is addressing this issue through the Human 
Subject Research Enhancement Program. The NIH continues to explore the 
feasibility of alternative approaches to further address this issue. 

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