Conflict of Interest
Principal of Incentive and Reimbursement
You may pay research participants, but the payment for participation is not considered a benefit but rather a recruitment incentive or reimbursement for time and effort. All payments to participants in research must be fair and equitable.
Principle of Reasonable Compensation
The IRB will review and determine that the amount is reasonable and not so large as to unduly induce participation. All information concerning payment, including the amount and schedule of payment should be clearly stated in the application and reflected in the consent documents.
When the IRB evaluates the selection of participants, it considers the influence of payments to participants. While the Federal Regulations do not specifically state how much researchers should pay subjects or what that payment should look like, the IRB will apply a principle of reasonable compensation as it reviews participant payment for their time, effort and inconvenience.
Community and Culture
The IRB will also take into account information from the community and culture as it evaluates the appropriateness of participant payment.
Method of Disbursement
You should submit your payment plan when you submit the initial application for IRB review. The IRB will review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive nor present undue influence.
Advertising Payment
Your advertisement may state that participants will be paid, but should not emphasize the payment or the amount to be paid, by such means as large or bold type.
IRB Policy-403B
OHSR Sheet
UMN Policy 3.9
Examples
Examples of compensation: small gifts, payments, compensation, reimbursement, services without charge or extra credit points. Researchers cannot pay subjects to take risk.
Pro-Rated Payment and Bonuses
Payment 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. While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable providing that such an incentive is not coercive. If a bonus is given at the completion of the trial it should not be more than ½ of the total reimbursement.
No Discounts Allowed
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.
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