Financial & Injury Language (Previously Known as FLA)

Templates

Discontinuation of the Financial Language Assessment (FLA)

PIs are now responsible for inserting the cost language into informed consent forms (coverage analysis done on the back end)

Effective 06/03/24, the historical FLA process is being streamlined. Earlier this year the injury language was standardized for all studies and removed from the FLA. The remaining cost language in the FLA, which the Clinical Research Hub (CRH) in Gainesville (formally OCR) and the Office of Research Affairs (ORA JAX) in Jacksonville previously generated after coverage analysis was completed, has been standardized into 4 possible templates depending on the details of a study contract and/or coverage analysis.

What is the new process?

  1. Researchers determine and select the most appropriate template option (there are 4) that best describes the cost language and inserts that language into the informed consent (ICF); no modification of the template is allowed. Researchers can immediately submit to the appropriate IRB (internal or external) and in parallel to CRH/ORA JAX
    • The IRB can proceed to review and approve the protocol using the chosen ICF cost template language without waiting for CRH/ORA JAX assessment. However, researchers cannot enroll any participants until they receive an activation notification from CRH/ORA JAX.
  2. An activation notification will be generated by CRH/ORA JAX upon completion of the coverage analysis and CTA execution.    
    • CRH/ORA JAX will audit all consents upon completion of coverage analysis. If CRH/ORA JAX determines the wrong cost language template was submitted to the IRB, the researcher will be informed by CRH/ORA JAX to submit a revision to the IRB to insert the correct language.

Cost template language is available at:
• CRH’s website: https://research.med.ufl.edu/wordpress/files/2024/06/FINAL_-UF-Cost_ICF-Template-Language_2024-04-22855366.docx
• ORA JAX’s website: https://med.jax.ufl.edu/research/resources/
• New workflow diagram: https://research.ufl.edu/wp-content/uploads/Visio-Consent-cost-workflow.pdf

*Protocols already submitted to an IRB before 6/3/24 at UF main campus do not have to convert to the new process.