Pay Research Subject Stipends

Compliant Subject Stipends

Subject stipends in clinical research studies should be scrutinized in light of several federal regulations and guidance, including:

• Anti-Kickback Statute (AKS) 
• Civil Monetary Penalties Law (CMPL)
• FDA Guidance on Payment and Reimbursement to Research Subjects 
• The Physician Self-Referral Statute (Stark Law)

When are Subject Stipends Compliant?

Subject stipends are considered compliant if they meet all of the following criteria:

1. Improve patient’s ability to obtain items and services payable by Medicare/Medicaid;
2. Are unlikely to interfere with, or skew, clinical decision making;
3. Are unlikely to increase costs to Federal health care programs;
4. Do not lead to over-utilization or inappropriate utilization;
5. Are not raising patient safety of quality-of-care concerns.

UF Human Subject Payments (HSP) System

• The Human Subject Payments (HSP) system is a myUFL module that enables researchers and their support staff to request payments for research participants and provides a secure method of recording those payments.
• For more details, see UF Research Participant Payments.