F&A Rate for Federal Clinical Trials

The UF federally negotiated Other Sponsored Research (OSA) F&A Rate is acceptable for clinical studies that meet ALL of the following conditions:

  • Prime funding from a federal entity, including flow-through funding from an external sponsor to UF.
  • Protocol or research orders are prescribed and controlled by the sponsor or the prime agency:
    • The local UF principal investigator (PI) does not have scientific freedoms generally understood to be a part of fundamental and/or basic research projects.
    • Generally these protocols follow a clinical calendar, prescribing visits, data and order tissue/sample collections.
    • These studies generally involve human or vertebrate animal subjects and are under the oversight of a UF approved IRB or IACUC Committee.
    • These studies may include observational or data-collection-only studies without analytical reports provided to the funding source.
  • The compensation for these studies are driven by milestones or deliverables, such as:
    • Enrollment or accrual (per case reimbursement language or capitation language)
      • Also sometimes referred to as “completely enrolled subjects”
      • Generally as a protocol site, UF is permitted only a finite number of enrollment slots
    • Payment Fact Sheets from DHHS/NIH divisions, such as the National Cancer Institutes – National Clinical Trials Network – Cooperative Groups, such as
      • ECOG
      • SWOG
      • NSABP
      • RTOG
      • HOG
    • Upon completion of “case report forms” commonly called CRF’s or eCRF’s

If the UF PI has control over the scope of work and experimental design or if the UF PI must submit analytical reports on the study data and results, the federal research rate would apply.  Clinical and research studies funded by nonfederal sources will follow UF’s standard F&A policy.

 

Addendum (list of Federal Cooperative clinical trial groups for support in determining appropriateness of the application of this policy):

Legacy NCI Clinical Trials Cooperative Groups

  • American College of Radiology Imaging Network (ACRIN)
  • American College of Surgeons Oncology Group (ACOSOG)
  • Cancer and Leukemia Group B (CALGB)
  • Children’s Oncology Group (COG)
  • Eastern Cooperative Oncology Group (ECOG)
  • Gynecologic Oncology Group (GOG)
  • National Surgical Adjuvant Breast and Bowel Project (NSABP)
  • North Central Cancer Treatment Group (NCCTG)
  • Radiation Therapy Oncology Group (RTOG)
  • Southwest Oncology Group (SWOG)

Newly Consolidated NCI Clinical Trials Groups

  • NRG (consolidation of NSABP, RTOG, and GOG)
  • ECOG-ACRIN
  • ALLIANCE (consolidation of ACOSOG, NCCTG, and CALGB)
  • SWOG