Research Participant Payments

Payment vs Reimbursement

The IRB uses the terms "payment" and "reimbursement" as follows:

  • Payment: Money given to a participant to offset time and inconvenience and/or to provide incentive to participate.
  • Reimbursement: Money given to a participant to reimburse them for out-of-pocket expenses related to study participation (e.g., parking and transportation). Note: Reimbursements are different than payments in that they are not taxable.

Research Payment Considerations

The UCSF IRB encourages paying research participants for their time and effort in research studies. U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) state, “Paying research subjects in exchange for their participation is a common and, in general, acceptable practice.” However, the payment must be ethical. To ensure that the payment is ethical, the payment amount cannot be so much that it may create an undue influence as described in the FDA regulations 21 CFR 50.20 and the corresponding HHS regulations 45 CFR 46.116. HHS defines undue influence as “an offer of an excessive or inappropriate reward or other overture in order to obtain compliance.” 

How much should participants be paid?

The federal regulations set no fixed amounts on participant payments. Participants should be paid enough to recognize their investment of time and inconvenience, but not so much that their decision to participate in a study is unduly influenced by the amount being offered.  

When deciding how much studies should pay participants, investigators should consider points such as the participant population, amount of time a participant is expected to invest to travel to the research site, the time necessary to spend during the visit, the inconvenience encountered, and the relative discomfort or invasiveness of study procedures.

Note: Total payments equal or greater than $600 in a calendar year are reportable as taxable income to IRS.

Resources 

Payment for Extra Time Spent for a Research Visit or Other Research Activity 

The UCSF IRB has determined that paying research participants for extra time spent during a research visit or while engaged in a research activity may be considered appropriate within the framework of ethical conduct of research. The Belmont Report recognizes the importance of respect for persons and justice in research, and emphasizes the need to ensure fairness and promote equitable distribution of burdens and benefits. When research participants invest relatively more time in research activities than anticipated, they experience a greater burden to participation compared to those who spend less time. Payment for this extra time can help address this potential imbalance to participants who contribute more time and effort.

As with all payments for research participation, it is important that the payment for extra time does not create undue inducements that would compromise voluntary informed consent or exploit vulnerable populations. The amount of extra payment must be reasonable and proportionate to the extra time and effort spent.

Example of a reasonable and proportionate payment for extra time spent

  • A study pays participants for a research visit expected to take 60 minutes
  • The research visit ends up taking 90 minutes instead of 60 minutes
  • It is appropriate to pay the participant a reasonable and proportionate amount to address the extra time spent. This visit took 50% more time, so it would be appropriate to pay 50% more for the visit.

Examples of reasons research visits or other research activities may take extra time:

  • Interpreter services are utilized
  • Participant needs extra time to complete study activities
  • Special accommodations for the participant need to be made
  • Issues with study equipment or equipment availability delay completion of the scheduled activity
  • Study team delays for any reason

Q&A

Q: Do I need to state anything in the IRB application or informed consent form about the possibility of payment for extra time spent?

  • A: No.

Q: Do I need to seek IRB approval or permission to pay someone more than indicated on the consent form for extra time spent?

  • A: No. The Principal Investigator makes this decision, keeping in mind the ethical considerations associated with respect for a participant’s time and effort and avoidance of undue influence.

Q: Do I need to report anything to the IRB after a participant is paid for extra time spent?

  • A: No.

When should participants be paid?

Just as the amount of payment can cause undue influence, so can the schedule of payment. Holding payment until the participant has completed every procedure in the study can be inappropriate. The IRB agrees with HHS guidance that studies of considerable duration or that involve multiple interactions or interventions, that payment be prorated for the time of participation in the study rather than delayed until study completion, because the latter could unduly influence a participant’s decision to exercise the right to withdraw at any time.

It is acceptable to offer a small bonus for completing all study procedures, but the bonus should be reasonable in juxtaposition with study payments.

Explain the payment schedule in the Payment section of the consent form and specify any bonuses. 

For SF VA Health Care System policy on paying research participants, see the SFVAHCS page.

Special rules that apply to drawings/lotteries/raffles

There are various federal guidelines including IRS rules, State of California laws, and other statutes that apply to lotteries. When proposing to offer a research-related drawing as a form of compensation, researchers should use the following guidelines from the Office of the President to minimize the likelihood of triggering legal issues.

a. Researchers should use the term “drawing” rather than “lottery” or “raffle,” since the latter terms imply purchase of tickets by participants.

b. To further avoid the possibility that a drawing would be perceived as a lottery, the protocol should describe procedures for ensuring that all individuals who are contacted concerning the research will be allowed to enter the drawing. This would encompass individuals who are invited to participate but decline, prospective participants who are ineligible, and participants who enroll but later withdraw/are withdrawn by the researchers. Additionally, the protocol should affirm that the drawing may be entered by any individual who asks to be included.

c. The protocol and consent document(s) should also include the following information:

  • Description of the prizes, including estimated value, and the total number of prizes to be awarded.
  • The odds of winning a prize, if known, or explanatory language similar to this: “For any drawing, the odds of winning a prize depend on how many people are entered in the drawing. As we do not know how many people will participate in this study related drawing, we cannot predict what will be the odds of winning a prize.”
  • The approximate timing of the drawing (e.g., month/year).
  • How prize winners will be notified.

How to Pay Research Participants

See UCSF Supply Chain Management and contact that office with questions about debit cards, checks, petty cash, special circumstances, taxes in regard to participant payment, paying anonymous participants.

Consent Form Wording

The Payment section of the consent form should explain how participants will be paid (i.e., by debit card, cash, check, or gift card) and how long they will have to wait for payment (i.e., whether they are paid immediately or after a delay of four to six weeks). A frequent participant complaint received by the IRB concerns the timing of payment, so it is important to make the payment plan clear from the start. See the consent form Companion Document for wording. 

Social Security Numbers: If participants are paid by check, investigators will collect the participant’s Social Security Number and home address for check processing purposes. This information will be shared with UCSF Supply Chain Management. Social Security numbers and addresses also must be collected if payment is $600+/year. Explain these reporting requirement(s) in the Payment section of the consent form.

Payment, Reimbursement, Compensation?: The IRB uses the term "payment" when discussing money given to a participant to offset time and inconvenience and/or to provide incentive to participate. The IRB reserves the term "compensation" for discussions of UCSF Treatment and Compensation for Injury policies. The term "reimbursement" is for paying out-of-pocket expenses (e.g., parking and transportation).

What if the Study runs out of money?

Study teams should carefully consider whether study funding will sufficiently cover participant payment prior to proposing payment as part of the research. 

Once the IRB approves participant payment as part of a research study, the study is required to fulfill payment obligations to participants. Failure to pay participants is a reportable protocol violation. If the study loses funding, the study team should consult with their Department Chair, Division Chief, Vice Chancellor and/or the EVCP to secure the funding needed to fulfill participant payment obligations. 

How to Resolve Participant Complaints Related to Payment?

It is the PI’s responsibility to respond promptly when a participant reports that they have not received payment in the amount/time/manner indicated in the consent form. If it is not possible to fulfill payment as described in the approved IRB application and consent form(s), the study team must submit a Protocol Violation Form in iRIS. Note, the IRB will review the proposed corrective and preventive action plan to ensure that the plan to resolve the issue and prevent reoccurrence is adequate.  

Last updated: November 5, 2024