Principle of Reasonable Compensation
Compensating research participants is a way to thank them for contributing their time and recognizing their willingness to take on some of the research-related risks of study activities. As compensation is an expression of gratitude by researchers for their participants, it is not a benefit of participation, and it must be fair and equitable based. However, offering compensation is not required or expected.
The IRB/HRPP will review and determine whether the compensation is reasonable and if it unduly influence participation. All information concerning compensation, including the method, amount, and/or schedule of payment, should be clearly stated in the IRB/HRPP Application and reflected in applicable study material.
Compensation & Informed Consent | Compensation & Taxes | Reimbursement vs. Compensation | Compensation Methods at Brown | ClinCard | Cash & Gift Cards/Certificates | Community & Culture | Method of Disbursement | Advertising Compensation | Pro-rated Compensation & Bonuses | No Discounts allowed | Compensation that is not allowed
Unsure what compensation language may be appropriate for your consent document? Review the IRB’s approved additional language!
All payments and gifts to research participants are considered income by the Internal Revenue Service (IRS) and may be reportable to the IRS as taxable income. You are responsible for informing participants during the consent process that the payment they receive is taxable income and may be reportable to the IRS.
If a participant receives $600 or more from one or across a combination of research studies at Brown University within one calendar year, they will be taxed on this income. You are required to provide to Accounts Payable a participant’s legal name, address, Social Security number, and the amount paid for participation. Brown uses this information to issue 1099 statements to study participants.
Reimbursement is not compensation for research participation.
You may reimburse research participants (or their caregivers) for out-of-pocket expenses they have as result of study enrollment, such as transportation, childcare, meals, and similar expenses.
Reimbursement payments are not are reportable to the IRS as taxable income.
Offering reimbursement is not required or expected.
The Brown University’s Controller’s Office is responsible for ensuring the proper stewardship of the University’s financial resources. The IRB/HRPP relies on the Controller’s Office to determine which forms of compensation comply with federal and State laws, and University policy. Only these forms of compensation are available to investigators for human subjects research.
We strongly encourage you to design your study using one of the compensation methods approved by the Controller’s Office listed below. If you intend to use a method of compensation that is not approved, you will need to contact Accounts Payable for consultation and approval for its use before including the compensation in an IRB/HRPP Application.
Brown uses ClinCard to manage the reimbursement process for study participants. ClinCard is a participant payment system that makes it easier, faster and more secure to provide compensation to participants and to track payments through an online system. Studies that use the ClinCard as a means to provide monetary compensation to participants must include required language in the consent document as well as an IRB-approved FAQ document about the system. Study staff may also be required to attend a training on the use of the system. If study participants wish to cash out their ClinCard balance at a bank teller, as a means to get cash without incurring a fee, it is recommended that they take a copy of this form to the bank with them.
If you are interested in using the ClinCard in your study, please contact the Controller's Office. More information about the ClinCard can be found on the Controller's Office ClinCard page.
Cash payments and gift cards (plastic, paper, or electronic) are common ways to compensate participants. Please review Brown’s Gift Cards policy for any requirements that may apply to your study.
Even if you will not collect identifying information about your participants, you should establish a way to track the cash payments and/or gift cards given to participants for reporting purposes to the Controller’s Office.
For example, consider keeping an Excel sheet which links a unique identifying number from each gift card to an assigned study ID associated with a given participant.
The IRB/HRPP will take into account information from the community and culture as it evaluates the appropriateness of participant compensation.
You should submit your compensation plan when you submit the IRB/HRPP Application for review. The IRB/HRPP will review the amount of compensation, the proposed method, and timing of disbursement to assure that they do not involve undue influence or coercion on a prospective participant’s decision to enroll in the study.
Your advertisement may state that participants will be compensated, but should not emphasize the compensation by font (i.e. large or bold type) or design enhancements (i.e. exclamation marks, stars, subject/tag lines in electronic communications).
Compensation for participation in research should not be contingent upon the participant completing the entire study but rather be prorated as the study progresses to insure voluntary participation. However, compensation of a small proportion as an incentive for completion of the study is acceptable providing that such an incentive does not constitute undue influence.
If a bonus is given at the completion of the study it should not be more than ½ of the total study compensation.
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.
The Controller’s Office may determine that a compensation method does not meet Brown’s requirements for a number of reasons (i.e. it does not offer buyer or seller protection, there are no special authorizations, no offers of controls or reconciliation capability that would be acceptable to Brown, or no ease of payments for the user.)
The determination of which compensation options are available for human subjects research is not a decision that is made by or can be overturned by the IRB/HRPP.
If you would like to request that the Controller’s Office consider a method of compensation that is not already approved by Brown for use in human subjects research, please contact Accounts Payable at [email protected] or (401) 863-2716.
At this time, the following compensation methods are specifically not allowed for human subjects research studies, as determined by the Controller’s Office:
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