IRB Guidance on Compensation to Research Subjects:
Compensation to research subjects is not a benefit of research. Rather, compensation is meant to offset the time and inconvenience of participation, as well as to serve as an incentive to participate. The federal regulations do not set limits on compensation to participants. However, both researchers and the IRB are tasked with ensuring that research subjects provide voluntary, informed consent that is free from coercion or undue influence.
Compensation that is excessive or inappropriate in relation to the research procedures is problematic for a number of reasons. It can induce subjects to participate against their better judgment. In addition, excessive compensation incentives can encourage some individuals to lie or to withhold information in order to participate in the study when they don’t meet the eligibility criteria. This impacts not only the integrity of the research and the validity of the data, but can also compromise the safety of subjects. Inappropriate compensation can also create coercive situations when given to third parties. For example, a parent may coerce or pressure their child into participating in a study when payment is significant.
All potential research participants – and, in the case of children, their parent/guardian – should be able to make informed decisions about participation based on the true risks and benefits of the research, not on compensation.
The Form and Amount of Compensation:
Compensation can take on many forms and can include monetary (cash, gift cards, etc.) and/or non-monetary (gifts, course credit, extra credit, etc.) payments to subjects. Your protocol (research plan) should clearly specify what form(s) of compensation would be provided to participants in your study and the amount of payment. For non-monetary items, please provide an approximate value.
Compensation can also take the form of a drawing. When considering using a drawing or lottery form of compensation, researchers should ensure that there is a fair method for selecting winners and that the value of the prize divided by the number of subjects is reasonable in relation to the procedures involved.
Compensation may be awarded or accrued by participants in response to various tasks in a study. For example, compensation may be accrued in process of playing a game where certain decisions warrant an award. For these studies, participants should be informed of the minimum and maximum compensation amounts involved in participation.
For student subjects, reasonable levels of extra credit may be offered as compensation for participating in research. If extra credit is offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized. (source)
Payments or compensation should not require subjects to spend their own money. For example, a gift card to a coffee shop would be acceptable if it was sufficient to purchase a drink or other items without spending further money. However, a 50%-off coupon for a coffee drink would not be an appropriate form of payment.
Proposed cash payments to research subjects must be appropriate for the study and subjects population and must be consistent with all Accounting Services policies and procedures.
Timing of Compensation:
In addition to the form and amount of compensation to subjects, researchers should give consideration to the timing of payments.
In many studies, the procedures occur only once in a short period of time (e.g., completion of a 15 minute survey). Making compensation contingent on completion may be appropriate if the procedures are short. However, subjects who are disqualified during the study or are unable to complete the research through no fault of their own should still receive compensation.
In other studies, participation involves tasks completed over time or through multiple interactions or interventions (e.g., a one-hour interview done once a month for three months). Making compensation entirely conditional on the completion of multiple procedures could undermine a participant’s ability to withdraw at any time. In most cases, payments should be prorated, and subjects who are not able to complete the research should receive compensation proportional to their participation, regardless of whether they withdraw or are withdrawn by the researchers. Prorating payments to subjects is required for FDA-regulated research. Researchers are allowed to withhold a portion of the payment until completion (e.g. a completion bonus), provided that the amount does not exceed more than 50% of the total compensation.
Compensation for Research-Related Injury:
If research-related injury (i.e., harm that is physical, psychological, social, financial, or otherwise) is possible in research that is more than minimal risk, an explanation must be given of whatever voluntary compensation and treatment will be provided. Note that the federal regulations do not limit injury to only physical injury. 45 CFR 46.102(g)
Information Collected for Accounting and Reporting Purposes:
It is the responsibility of the PI to maintain accurate payment records according to MSU Denver accounting standards and sponsor requirements. The IRB needs to be informed of any required collection of subject information (e.g., name, SSN, 900#, etc.) for accounting purposes.
At MSU Denver, reporting information on individual research subjects is not required for accounting purposes if the total compensation to each subject is $50 or less (monetary amount and/or value of non-cash items).
For compensation plans that exceed $50 to individual subjects, information must be collected to ensure that the University can fulfill any state or federal income tax reporting requirements that may apply. Please consult with Accounting Services for questions on accounting policies or the requirements for collecting and reporting research participant information.
When identifiable information is collected for accounting purposes, researchers are reminded to follow all appropriate standards to maintain the confidentiality of participant information.
Disclosure to Research Subjects:
Research subjects should be accurately informed through the consent process about any compensation for participation. The consent form should clearly state what form of payment will be provided, the amount or value of the payment, and the timing of compensation. If or when questions or complaints arise regarding compensation, the consent form becomes the source document for the information that was provided to participants. The information about compensation should be clear, detailed, and consistent with your protocol.
In the case of drawings or lottery compensation, potential participants need to be informed of the odds of winning (i.e., how many individuals are participating divided by the number of prizes), how participants can enter the drawing, how winners are chosen, and how winners are notified.
In any study where information is being collected from participants for accounting purposes, individuals need to be informed about what information will be requested (e.g., name, SSN, 900#, etc.) and how that information will be used and stored, including any reporting to the Internal Revenue Service. Some examples of consent form language include:
“Financial rules require us to have your 900 number [or name, SSN, address] in order to compensate you for your participation. This information and your payment amount will be kept secure and confidential in our research financial records, our department’s financial office and the University’s financial office. This information will not be associated with the study name or the research data you provide as a participant.”
“If you are paid a total of $600 or more as a research subject in a calendar year, the University is required to report the payment to the Internal Revenue Service as miscellaneous income. MSU Denver will send you a form (IRS form 1099) in January documenting the payment total. This form is also sent to the IRS to report any money paid to you. You can use the form with your income tax return, as appropriate.”
Based on your study and your subject population, this sample language should be modified and/or additional details can be provided during the consent process about how and where the information will be stored and who will have access to it.
Use the HRP-316 WORKSHEET: Payments to evaluate any proposed compensation or payments in the same way that the IRB reviewer will. Please contact the HSPP for any questions concerning compensation to research participants.