Compensation

Some departments or individual instructors may offer extra credit for participating in research. Since the researchers are not providing the incentive, then awarding extra credit for participation in the study is not an incentive for that study.

Example: IRB submission may state, “No incentives will be provided by the PI. Any extra credit provided by course instructors for participating in research is outside the scope of this individual project and at the discretion of the course instructor".

Tip: Asking the subject to give their personal information to the study team to get extra credit will require the researcher to address confidentiality issues with identifiers being collected for research purposes. For an anonymous survey, this would make the project no longer anonymous. For an online survey, consider having a completion certification page presented that subjects can print and give to their professor for extra credit so that identifiers would not be required.

Incentives do not have to be in the form of cash to be coercive. If gifts are being given out for participating in a study, then this needs to be described in the IRB submission.

If handed out in general, then no IRB submission is needed. For example, if a department is conducting a “research day” where students/faculty present ongoing research and pens are being handed out to anyone who attends. This is not related to a specific research project and not being used as a recruitment incentive and, therefore, would not require IRB review.

The value of the gift should be calculated as the cost(s) of the item, if a person were to purchase or acquire the item outside of the context of research (not a discounted purchase price). For example, if the item is an iPad, the value is the cost a consumer would pay for purchasing the iPad, not a discounted or volume price available to the research team or study sponsor.

What is a lottery?

Lottery. “Any scheme or procedure whereby one or more prizes are distributed by chance among persons who have paid or promised consideration for a chance to win anything of value, whether such scheme or procedure is called a pool, lottery, raffle, gift, gift enterprise, sale, policy game, or some other name.” A “lottery” is a “scheme or plan which provides for a distribution of [1] prizes by [2] chance among those who have paid, or agreed to pay, a [3] consideration for the right to participate therein.”

Conducting a lottery, raffle, or similar game of chance implicates state gaming/gambling laws that could, depending on state law, subject persons to criminal charges if not followed properly.  Any lottery, raffle, or game of chance proposed in connection with a research study may be conducted only if it meets state and local gaming/gambling laws.

State of Texas: Generally, participation in a research study where the time and effort involved to participate in the research study is brief and where the participant is in control at all times to end participation does not supply the requisite “substantial consideration” element to constitute a “lottery” under section 47.03 of the Texas Penal Code.

The “time, effort, and inconvenience” of the participant cannot be substantial.  In general, most minimal risks studies using brief surveys or interview procedures would not be considered as having “substantial consideration” to constitute a lottery. Should an IRB member question whether the time, effort and inconvenience of a study could reasonably be said to be substantial, a review by Office of General Counsel may be required to get a specific opinion as to the application of state law to that particular study.

Lotteries with a prize of a value of greater than $50 for exempt studies will require Chair review level.

Other states: Study teams should seek legal counsel advice on whether state law would likewise prohibit such recruitment methods. A copy of this determination should be provided to the IRB in the submission for consideration.

Federal regulations governing research with human subjects contain no specific guidance for IRB review of payment practices. There is no consensus as to whether this kind of inducement is unacceptable. There is no set number for how much compensation is too much.

IRBs must consider whether paid participants in research are recruited fairly, informed adequately, and paid appropriately. Taking into consideration the subjects’ medical, employment, and educational status, and their financial, emotional and community resources, the IRB must determine whether the rewards offered for participation in research constitute undue inducement.

The amount and type of payment is based on:

• The complexity of the research as it relates to participant inconvenience;
• The type and number of procedures to be performed;
• The time involved;
• The anticipated discomfort of the study;
• The schedule of payment.

Including the amount of compensation in the recruitment material is generally discouraged. This will be considered by the IRB on a case-by-case basis. Although compensation or reimbursement may influence one’s decision to participate in research, the advertisement must be carefully worded so that it does not coerce a subject to participate.

Yes. A reimbursement is money paid to subjects to pay for direct expenses incurred because of their participation in the study. Reimbursements are characterized as payment for actual expenses versus payment for their participation. Examples include payment for mileage for travel to study, bus passes, hotel costs for overnight stays required, etc. The amount paid for reimbursement is looked at differently because you are essentially making the subject whole versus incentivizing them to participate.

Tip: Describe clearly in your study application whether money being provided to the subject is for reimbursement purposes.

Example: IRB submission may state, “All participants will be provided a parking validation ticket (estimated value of $X) to reimburse for parking expenses when participating on campus".

There is no defined monetary value provided in regulations or in agency guidance that would clearly be coercive or cause undue influence. Additionally, what would be coercive to one person may differ to the next depending on their economic situation. The IRB will review all proposals involving the payment of participants on a case-by-case basis. When considering whether the payment is coercive or could create undue influence, it may be helpful to take into consideration the pay rate of other comparable studies.