Because the financial language in a Human Subjects Research study’s Informed Consent Form (ICF) must be consistent with any applicable contract/award/agreement budget and billing plan the Office of Clinical Research (OCR), Division of Sponsored Programs (DSP), and the Institutional Review Board (IRB) have implemented a Financial Language Assessment (FLA) process in order to:
- Provide the study team with UF-approved Costs and Subject Injury language for the study’s Informed Consent Form.
- Help ensure that study participants are properly informed regarding the study Costs and Subject Injury coverage before they consent to join a study.
- Decrease the need for changes/corrections to the Informed Consent Form after patients have already enrolled.
- Minimize the possibility of billing non-compliance by ensuring that the study’s billing plan conforms to research billing regulations.