Subject compensation for participation is evaluated by the Board on a site-by-site basis, according to the schedule of events outlined in the protocol.
Compensation must be included with the Research Site Submission Form in order for the site submission to be reviewed by the Board. It is advisable for the sponsor or CRO to provide the individual completing the submission form with any template compensation information. Please review the schedule of events outlined in the protocol before submitting compensation amounts.
Board guidelines for subject compensation/reimbursement for participation:
- Compensation must be described in the informed consent document.
- Compensation should be based on time and inconvenience to the subject (not risk and procedures).
- Compensation should be equal for all subjects (an investigator may request, in writing, supplementation compensation for a subject with special circumstances).
- Compensation should be prorated across study visits and not contingent on completion of the entire study.
- Raffles and coupons for a discount on the purchase price of the study product are not permitted as a form of compensation.
To avoid delays in initial site approval due to compensation/reimbursement:
- Ensure proper timing or schedule of subject compensation/reimbursement. It is Schulman’s expectation that, for studies lasting more than one year, subjects are compensated at least on an annual basis.
- If there is a sub-study or addendum, indicate whether compensation/reimbursement will be provided for participation. If compensation/reimbursement will be provided, include compensation/reimbursement amount.
- If any unscheduled visits or telephone calls may occur, include those in your compensation/reimbursement plan. Also indicate if no compensation/reimbursement will be provided for these visits as a “0” or “not paying.”
To submit a request to change the compensation amounts, complete the Revised Compensation/Reimbursement Form.
Additional guidance can be found in the Payment to Research Subjects – Information Sheet on FDA’s website.