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:
- Improve patient’s ability to obtain items and services payable by Medicare/Medicaid;
- Are unlikely to interfere with, or skew, clinical decision making;
- Are unlikely to increase costs to Federal health care programs;
- Do not lead to over-utilization or inappropriate utilization;
- 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 https://clinicalresearch.ctsi.ufl.edu/resources/data-systems/human-subjects-payment/.