Guidance

Payment to Research Participants

IRBMED

Apr 17, 2024 10:30 am

The IRBMED reviews the amount of payment, the proposed method, and timing of disbursement of payments investigators give to study participants to assure that they do not present undue influence [45 CFR 46.116, 21 CFR 50.20].

There is no set guideline regarding the total amount of payment investigators may give to study participants. Payments to subjects are not required.

All information concerning payment, including the amount and schedule of payments, should be clearly explained in the consent document.

Human Subjects Incentive Program (HSIP) office processes incentive payments for human subjects research participation.

Acceptability of Payment

Incentive payment amounts are assessed to identify any potential undue influence which may compel individuals to participate.

In most cases, reimbursement is more acceptable pro-rated over the course of study participation. Lump sums, given only upon completion of the entire research project, are generally not acceptable by the IRBMED; and investigators will be asked to revise lump-sum payments so as to avoid compromising a participant's decision to withdraw prior to the study end.
Reimbursement

Reimbursement is payment for out-of-pocket expenses that participants incur related to their participation in the research, such as transportation and parking fees.

Reimbursement must be documented by receipts and is tracked by Accounts Payable.

HSIP guidance compares and contrasts Incentives v. Reimbursements.
Incentive
Incentives compensate for time away from work or other activities due to participation, and acknowledge the participant’s effort. Typically, incentive payments are disbursed throughout the course of the study and associated with the completion of certain research-related activities, whether done optionally or as a condition of participation, such as imaging assessments, collection of biospecimens, or study visits. Study teams may choose to utilize a different payment method and structure, such as a lottery or sweepstakes.

HSIP guidance compares and contrasts Incentives v. Reimbursements.
Lottery

Researchers may also choose to incentivize study subjects by utilizing a lottery payment structure, in which subjects’ names are entered in a lottery operated by the study team. If a study’s incentive budget is small, a lottery allows one subject, drawn at random from the pool, to receive the full amount of the incentive amount. Subjects may find the chance to win this somewhat larger amount more attractive than the certainty of receiving a smaller amount.

In most cases, Michigan law requires anyone operating a lottery (also known as raffle) to obtain a raffle license from the state. The law allows an exemption, however, for qualified organizations to operate lotteries without a raffle license.

As a qualified organization, the University of Michigan is authorized to conduct lotteries without a raffle license, as long as the lotteries meet the following criteria for the statutory exception:

There may be no presale of tickets.

There may be only one prize drawing per day,

No more than $100 total in prizes may be awarded in one day (to one winner or multiple winners).

There may be no second-chance drawings for those who do not win. (In the context of a research lottery, this means that a researcher who wishes to offer multiple prizes must organize subjects in separate pools, to ensure that each subject has only one chance to win.)

Researchers are responsible for knowing the regulatory requirements for lotteries conducted outside Michigan.

When conducting a research lottery, the University of Michigan study team is responsible for

operating the lottery

maintaining the pool (or pools) of potential winners

drawing the winners

awarding prizes

The State of Michigan Charitable Gaming Division offers guidance on legal requirements for raffles conducted in Michigan.
Sweepstakes

In a sweepstakes, all those invited to participate are eligible to win, whether or not they actually participate. A sweepstakes structure allows for a higher-value prize without requiring a raffle license. Participants (and researchers) will be familiar with sweepstakes from cereal boxes and candy wrappers with a "no purchase necessary to win..." prize offer.

Human Subjects Incentive Program (HSIP)

Human Subjects Incentive Program (HSIP) tracks incentive payments, according to SPG 501.07. HSIP should be involved in IRB-approved ("non-exempt") studies, as well as Exempt studies and Not Regulated projects, unless a third-party vendor, or another institution is handling the incentives.

Incentive payment for research is taxable income. When an individual receives more than $600 in one calendar year from the University of Michigan (cumulative from one or multiple studies), the University issues an IRS 1099 form. HSIP tracks payment per participant across multiple studies and reaches out to study teams with participants whose aggregate compensation nears $400.

Studies that do not collect personal information for processing cannot issue payment by payment coupons, checks, or mailed gift cards.

Collecting participant information for payment processing

Payment is NOT more than $400 per year:

Studies that pay a maximum of $400 or less to a participant in a calendar year should usually collect name and physical address from each participant. Collection of email is optional. If collecting personal information may be burdensome to study team, or may make study participants uncomfortable, explain the plan to collect less information in eResearch question 13.5 (or a free-text question for the Exempt applications).

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Payment can be more than $400 per year

If a participant could receive more than $400 incentive in a single calendar year (including payment for optional procedures), the study should collect Social Security Number as well as name and address from each participant.

Participants who decline to provide SSN may not receive more then $400 in a year from the study, even if they continue participating. HSIP-required language in the Informed Consent Document reflects this possibility.

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