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.
What is the FLA Form?
Most UF studies involving human subjects and services require a Research Billing Compliance (RBC) review conducted by the OCR office prior to final IRB approval. See OCR Submission Criteria for details on which studies require this review.
During this review, the OCR office drafts a Financial Language Assessment (FLA) form that includes the exact Costs and Subject Injury Language to be included in the study’s informed consent(s).
If the study requires an agreement/contract to be negotiated, the OCR office will issue the FLA either
- Immediately after RBC review is completed, or
- When fiscal language in the agreement/contract has been negotiated with sponsor, or
- After the agreement /contract is fully executed.
OCR will work with the study team to ensure that the FLA is drafted and issued at the time that is the most effective in reducing the potential risk of conflict between the fiscal language in the Informed Consent Form and the final executed contract.
You must have this FLA form in order to obtain a final approved Informed Consent Form from any IRB used for UF studies involving human subjects and services.
What is the “Triad of Documents”?
The three key clinical research documents must be consistent. The Protocol (including the Schedule of Events), Contract/Agreement/Award (including the budget), and the Informed Consent Form must all be in agreement regarding the financial responsibilities for the study.
1) Protocol & Schedule of Events
The first part of the Triad of Documents is the Protocol and the Schedule of Events. For studies designed by outside Sponsors, the Sponsor typically sends a protocol, which is a Sponsor-produced document that outlines the work scope of the study. It usually contains some type of Schedule of Events that outlines what services will need to be conducted to complete the study requirements.
Although the Schedule of Events is very helpful, often it is incomplete. Be sure to read through the protocol carefully and look for additional services not included in the Schedule of Events that will be required. For example, additional blood tests may be required for a subset of subjects and not mentioned on the Schedule of Events. It is helpful to review the inclusion and exclusion criteria that may mention additional services that need to be conducted.
For studies designed by UF Principal Investigators, it is strongly recommended that the PI include a complete and accurate Schedule of Events when writing the protocol. The Schedule of Events can help reviewers quickly and easily analyze what is happening in the study.
Whether your study has an Schedule of Events or not, it is very important that all study activities are identified in the protocol so that each activity can be included in the billing plan for the study. See Billing Plan.
2) Contract/Agreement/Award & Budget
The second part of the Triad of Documents is the legal agreement between the Sponsor and the University of Florida that contains the terms and conditions under which the study will be conducted. This agreement could be in the form of a Contract, Agreement, or simply an Award.
Contracts and Agreements usually have lengthy legal sections that must be negotiated by the Office of Clinical Research (OCR). The agreement could include sections on Subject Injury, Arbitration, Confidentiality, Copyright, Intellectual Property, Liability, Indemnification, Publication, Records Storage, Export Control, Termination, etc. that must be reconciled with University of Florida and State policies/guidelines.
Awards usually do not have negotiable terms, but it is still important that the terms in the Award are accurately represented in the budget and Informed Consent Form (ICF).
The budget should reflect the study billing plan, clearly identify all services that are required as part of the study, and indicate the services for which the Sponsor is (or is not) paying. The budget must be finalized so that the fiscal terms can be accurately outlined in the contract and ICF.
3) Informed Consent Form
The third part of the Triad of Documents is the Informed Consent Form (ICF), which is part of the Institutional Review Board (IRB) submission. The importance of the ICF cannot be overemphasized. The ICF is designed to accompany the process of informing potential study participants about all aspects of the study in a non-coercive manner. See the UF Institutional Review Boards website for details on completing the form and the entire consenting process.
The financial disclosure and subject injury information provided to participants in the ICF must be consistent with the contract/agreement/award, the billing plan, and UF policy. See Billing Plan. These fiscal terms are usually laid out in the ICF sections entitled:
- If you choose to take part in this research study, will it cost you anything? (Costs language)
- What if you are injured because of the study? (Subject Injury language)
UF General Counsel and UF IRB have developed template language for the Costs and Subject Injury sections of the ICF. These templates should be used by study teams when drafting ICFs. The templates are also used by the Office of Clinical Research (OCR) reviewers when they are issuing the Financial Language Assessment (FLA) for your study.
Reconciliation of Informed Consent and Contract
BEFORE the study starts, the Study Team MUST review the final executed contract/agreement or award and the final informed consent to ensure that the fiscal terms do not conflict. If the terms conflict (or you are not sure) contact the OCR immediately for assistance.
Consequences of a Conflict
When the informed consent fiscal terms conflict with the award or contract/agreement, consequences may include the following:
- Participant is provided unclear or incorrect information when he/she is trying to decide to join the study.
- If an error in the consent is found after the study starts, participants will have to be re-consented, which could affect their willingness to continue in the study.
- Participants receive bills for items promised “at no cost”.
- Insurance companies may refuse to pay.
- Sponsors may refuse to pay.
- Principal Investigator’s department must pay for study services that were promised to the participant “at no cost” and sponsor has not agreed to pay.
In addition, errors may be made in billing that may result in a “False Claim”, which could lead to fines and fees for the Principal Investigator, UF and Services providers.
Medicare Secondary Payer Mandatory Reporting Language in the FLA
Medicare rules state that any time a sponsor has offered to cover any Subject Injury costs for a research study, the sponsor is required to report the following to Medicare:
- “The identity of a Medicare beneficiary whose illness, injury, incident, or accident was at issue as well as such other information specified by the Secretary to enable an appropriate determination concerning coordination of benefits, including any applicable recovery claim”.
As a result, many sponsors want to add language about sharing subjects’ personal information into the Subject Injury section of the Informed Consent Form. Per UF Legal Counsel, this type of language should NOT be added to the Subject Injury section, as it is already addressed in the UF Informed Consent Form HIPAA sections (see IRB webpage on Informed Consent Forms).
FLA Submission to IRB
To assist in the drafting of the FLA, the OCR has the ability to look at a study in the myIRB system if the study team has:
- indicated in myIRB that the study involves “Human Subjects and Services” AND
- clicked the “submit” button in the myIRB system.
For any study reviewed by OCR prior to the myIRB “submit” button is clicked, you will receive the following message from OCR, which describes the steps in this scenario:
- You have indicated that you will be submitting this study to IRB-01 through myIRB.
- OCR reviewed the documents you submitted directly to our office for this study and we have issued a FLA .
- Please review the attached copy of the FLA and verify that the language reflects the study billing plan. If changes are needed to the FLA, please contact our office ASAP.
- Submit your ICF and other documents into myIRB per IRB-01 process.
- Please ensure that the final ICF has the FLA language inserted.
For studies reviewed (or re-reviewed) by OCR after the myIRB “submit” button is clicked, you will receive the following message from OCR, which describes the steps in this scenario:
- This study was submitted to IRB-01 through myIRB.
- OCR has <re-> reviewed the documents you submitted for this study.
- OCR has uploaded a copy of the FLA (issued on xx/xx/xxxx) directly to myIRB.
- Please review the attached copy of the FLA and verify that the language <still> reflects the study billing plan. If changes are needed to the FLA, please contact our office ASAP. If changes are needed to any other part of the ICF, please contact IRB-01 directly.
- Please ensure that the final ICF has the FLA language inserted.
- IRB-02 generally does not review “Human Subjects and Services” studies, but if it does, it follows the IRB-01 process described below.
- Other questions about the IRB-02 process should be directed to IRB-02 staff.
WCG IRB (formerly WIRB)
- All UF WCG IRB submissions must include a FLA issued by the OCR.
- OCR will review the OCR RBC submission documents and issue a FLA at the time point that will be the most effective in reducing risk of any conflict between the Informed Consent Form and the contract.
- Study team must review the FLA and verify that the language reflects the study billing plan. If changes are needed to the FLA, contact the OCR office to revise the final FLA language.
- All UF UF WCG IRB consent drafts must first meet the requirements of the applicable WCG IRB standard consent template, then UF-specific sections must be added or adapted per UF’s template for WCG IRB consent forms.
- Some Sponsors wish to review the final consent draft prior to submission to WCG IRB. If any changes are needed to the FLA language, work with OCR to get a revised FLA.
- The study team must attach the FLA to the WCG IRB submission.
- All UF WCG IRB submissions must include a UF Cover Letter. The cover letter includes a field for the provision of your study’s Institutional Number. This Institutional Number is listed at the top of the study’s FLA form.
- The study team must ensure that the final ICF has the FLA language inserted.
- Also see UF IRB WCG IRB webpage for additional requirements and information about the WCG IRB process.
- Studies that are reviewed by an “external IRB” (sometimes referred to as a “Single” or “Central” IRBs) will also need to be submitted to UF IRB-01.
- In most cases, you will need to obtain a FLA prior to submitting to UF IRB-01 and the external IRB.
- OCR will review the study documents and issue a FLA for your study.
- Study team must review the FLA and verify that the language reflects the study billing plan. If changes are needed to the FLA, contact the OCR to revise the final FLA language.
- Study team must add the FLA language to the ICF following the approving external IRB ’s instructions.
- The FLA and final ICF draft must be submitted to UF IRB-01 prior to submission to the external (Single) IRB following UF IRB-01’s instructions. Contact UF IRB-01 for additional information.