As a follow-up to the 3/8/18 Tip of the Week related to subaward types, there is now further clarification and guidance from the National Institutes of Health (NIH) on when to issue cost-reimbursable, fixed-price, and fixed-rate subaward agreements.
NIH Notice NOT-OD-18-222, issued on 9/6/18, clarifies the distinction between the terms “fixed-amount” (fixed-price) and “fixed-rate,” which is commonly used by Clinical Trial Coordinating Centers to distribute capitation (amount distributed per enrolled subject) funds.
This Notice eliminates:
- The need to obtain NIH prior approval for fixed-price clinical trial site subawards
- The need to obtain approval to exceed the Simplified Acquisition Threshold (currently $250,000) on the same transactions. Note that prior approval is still needed if there are other factors that would require NIH prior approval consistent with section 22.214.171.124 of the NIH Grants Policy Statement (GPS).
Effective immediately in the Office of Sponsored Programs, subawards of clinical trials under NIH Notices of Award (NOAs) with budgets based on capitation/milestones will be issued as fixed-rate subawards under the fixed-price Federal Demonstration Partnership (FDP) template. This includes budgets that require invoicing on a “dollars per X” basis (i.e., dollars per subject recruited, per subject milestone, etc.). No subawards for clinical trials that include a milestone payment schedule will be issued on the cost-reimbursement template.
Also, the Office of Sponsored Programs has begun more closely reviewing incoming subawards from other institutions to ensure that the appropriate type of agreement is being issued to the University under NIH awards.
Please direct any questions about this information to your Subaward Officer (for outgoing subawards) or your Grants and Contracts Officer (for incoming subawards).