Definitions

The University of Utah IRB uses the term “compensation” for payments made to research participants for participation in a study. Compensation may be provided to reimburse participants for their time, effort or for other expenses. Compensation includes any monetary compensation, gift certificates or vouchers, mileage reimbursement, movie tickets, promotional items, etc.

Guidance

The IRB reviews payment arrangements to research participants (compensation) to ensure an equitable selection of subjects by only approving payment methods that are not coercive and do not present undue influence. Additionally, compensation must be described in the consent document. Therefore, the IRB will review the description of compensation in the consent document to prevent any violation of the regulatory requirements of consent.

Because compensation is not a method of offsetting risk, the IRB will first consider if the research can be approved. The IRB reviews the proposed compensation plan to ensure it isn’t structured so that it could pressure someone into participating without fully considering the risks.

If compensation is offered to participants, the IRB will adhere to the following guidelines:

• The IRB does not set a fixed minimum or maximum, compensation should reflect the time and effort contributed by study participants.
• Credit for payment should be based on study progress, not on  completing the entire study. Investigators must include a plan for pro-rate compensation if a participant withdraws. Pro-rating compensation may not be practical in some studies, and exceptions can be approved on a case-by-case basis.
• While the total compensation should not depend on completing the entire study, it is acceptable to provide a small incentive for completion, provided that the incentive is not coercive. The IRB should ensure that any amount paid as a bonus for completion (if applicable) is reasonable and not so great as to unduly induce participants to stay in the study when they might otherwise have withdrawn.
• Compensation for participants who withdraw from the study may be provided at the time they would have completed the study (or completed a phase of the study) had they not withdrawn.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 participants who had to withdraw before that date.
• All information concerning payment, including the total amount, schedule of payment(s), and any plan for prorating payments if a participant does not complete the study must be described in the informed consent document.

Compensation must be paid to University of Utah participants according to the guidelines set forth by Accounts Payable. The guidance is meant to ensure the proper handling of confidential information and to reasonably ensure compliance with reporting requirements. The guidance, Human Subject Payment Procedure, is found the Accounts Payable website. Investigators should review and be familiar with the policy if research participants are compensated for participating in University of Utah research projects. Depending on the amount of compensation and the method used to make the payment (e.g., check), the investigator may need to collect tax information using an IRS W-9 form and forward it to Accounts Payable. If the collection of social security numbers is required to pay participants, the consent must disclose such a requirement.

• Sample consent language when collecting tax information for Accounts Payable: Since you will be paid for participating in this study, it is necessary for us to collect your Social Security Number. You will provide this information for a Federal W-9 Form that is filed with our Accounts Payable department. The amount you receive for taking part in this study will be turned into the Internal Revenue Service (IRS) as taxable income. You can choose not to provide us with your Social Security Number for this form and still participate in this study; however, we will not be able to pay you as outlined in this consent form.

What are the additional considerations for compensation to participants in Clinical Trials subject to FDA regulations?

• FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence.
• Compensation for participation in a clinical trial offered by a sponsor may not include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.

What are the additional considerations for compensation to participants for Department of Defense studies?

• Participants may be compensated for research participation as long as the participant is involved in the research when not on duty. Enrolled individuals may not receive payment of compensation for research participation during duty hours.
• Federal employees while on duty and non-Federally employed individuals may be compensated for blood draws for research up to $50 for each blood draw.
• Non-Federally employed individuals may be compensated for research participation other than blood draws in a reasonable amount as approved by the IRB.

Documents and References

FDA Guidance: Payment and Reimbursement to Research Subjects – Information Sheet

Payments to Human Research Participants (Accounts Payable Guideline)

SACHRP Recommendations: Attachment A – Addressing Ethical Concerns Regarding Offers of Payments

University of Utah Consent Document Checklist

Points to Consider