Research Incentives

Gift Cards

The distribution of gift cards must be documented on the UWF Gift Card Log.

Payments to UWF Employee Participants

If the participant is a UWF employee, payment will be made through the university payroll system as additional pay. Taxes will be withheld and the payments will be reported on the employee's form W-2. To pay a UWF employee, a personnel action form must be completed.

Taxation

UWF is required to report payments equal to or greater than $600 on Form 1099-MISC. The reporting threshold is a cumulative amount in a year. For non-cash payments, such as gift certificates or gift cards, the value of the non-cash payments must be determined and the $600 threshold applied.

Allowable UWF Account Funds For Gift Cards: For more information regarding allowable fund sources, see UWF's Expenditure Guidelines.

IRB Approval for Patient Incentives

The Institutional Review Board (IRB) should determine that the risks to subjects are reasonable in relation to anticipated benefits [21 CFR 56.111(a)(2)] and that the consent document contains an adequate description of the study procedures, risks, and benefits [21 CFR 50.25(a)(1-3)]. It is not uncommon for subjects to be paid for their participation in research, especially in the early phases of investigational drug, biologic or device development. Payment to research subjects for participation in studies is not considered a benefit, it is a recruitment incentive. The amount and schedule of all payments should be presented to the IRB at the time of initial review. The IRB should review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence [21 CFR 50.20].

Any credit for payment should accrue as the study progresses and not be contingent upon the subject completing the entire study. Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. For example, in a study lasting only a few days, an IRB may find it permissible to allow a single payment date at the end of the study, even to subjects who had withdrawn before that date.

While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to FDA, providing that such incentive is not coercive. The IRB should determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn. All information concerning payment, including the amount and schedule of payment(s), should be set forth in the informed consent document.

Any changes to payments, the amount, method or timing, must be reviewed and approved prior to the initiation of such changes via an amendment.

Incentive Drawings/Raffles/Lotteries

Florida state law (Florida Statute Section 849.0935) prohibits drawings, raffles, or lotteries and should not be used as incentives for completing surveys, or human subject research. This includes random selection drawings and predetermined winner drawings (Ex: 10th enrollee or the first 25 enrollees are given a prize).

Although Florida law allows certain nonprofit and charitable organizations to conduct drawings under specific situations, the context of human subject research would not be included in these situations.