Inconvenience and costs to subjects related to research impose impediments to enrollment and research participation. Ideally, payments are designed in a way that they "zero out" the subject's costs and burdens of study participation. When the size of payment to subjects is disproportional, subjects may be unduly influenced to assume risks that they would not otherwise be willing to assume. When the risks are minimal, this concern is of limited concern. As the risks increase, the concern is heightened.
The ideal of designing payments so that they zero out is difficult to achieve in practice; the IRB's test as to whether or not the payment proposed is acceptable is whether it creates on undue influence. The IRB tries to balance all of the competing interests when approving payment levels for clinical research participation. The IRB reserves the right and has the obligation to review and approve all types of payments.
Permissible Categories of Payment
Payments that compensate for time, effort and inconvenience to parents and child participants are permissible. For tax purposes, flat-rate payments for travel, parking and meals is grouped with compensation payments. The size of payments vary with the demands of each study. The CHOP IRB prefers a that the payments be based on a wage model. This is a method of determining the amount of payment by using a standardized hourly wage and an estimated time for completing the research tasks.
- Wages for adults should be calibrated to the least well-off;
- For older child participants, this should be based on the wages that children can actually earn;
- Children younger than 9 cannot generally grasp the concept of payment based on effort; a flat fee or payments limited to tokens of appreciation are therefore more appropriate for younger children.
Reimbursement for expenses incurred as a result of research participation, such as taxi fare, other travel expenses, parking, babysitting fees, or meals, should be designed to offset actual anticipated expenses so as not to create an undue inducement. A flat-rate reimbursement might be used to offset travel and other expenses but in accordance with hospital policy and from the IRS perspective, only payments based on actual expenses can be called reimbursement.
- Reimbursement payments must be based on actual incurred expenses;
- Subjects that do not have any additional expenses as a result of study participation should not receive reimbursements;
- Reimbursements are not taxable income and therefore, the IRB asks that these be identified separately in the application and consent form.
Tokens of Appreciation:
Appreciation gifts for research participation are essentially bonuses to thank the child for their participation. These should be limited to no more than items of token value such as T-shirts, mugs, calendars, books, stuffed animals, etc.
Non-Permissible Categories of Payment
The IRB usually does not permit any of the following forms of payment/compensation or financial arrangements:
- Lottery or prize drawings for individuals who participate in research;
- Use of finders' fees, recruitment bonuses or incentives for those who refer prospective subjects.
Tax Implications of Payments
The Hospital and Research Administration have policies and legal obligations that require tax reporting in some instances. Please refer to the Research Finance’s policy Payments to Human Subjects.
Payments, except for reimbursements for expenses based on actual receipts, are taxable. CHOP Research Finance does not track payments to subjects for the purpose of reporting to the IRS unless there is the possibility that an individual could receive $600 or more over the course of a single year. The IRB's template consent forms include language to be inserted if a subject may earn $600 or more in a single year.
- Reimbursement for expenses (receipts required)
- Payment to parent
- Payment to subject
- Method of reimbursement and payment
- Prorating of payments (if applicable)
Example ICF Payment Language:
You will be reimbursed to cover the costs of travel, parking and meals. In order to be reimbursed you must provide receipts for these items.
To compensate for the time effort and inconvenience of participating, parents will be paid at the end of the study $100 for Study Visit 1 and
$200 for Study Visit 2 (8 hour PK visit) and children will be paid $25 for Visit 1 and $50 for Visit 2. Payments to parents will be in cash and to children as gift cards to a store (Target or Borders). If you do not complete both study visits, you will be paid for the portion that you complete at the schedule end of the study.
References and Resources
- IRB SOP 704: Payment to Subjects and Families
- Bagley SJ, et al. Is a "wage-payment" model for research participation appropriate for children?
- Bentley JP, et al. The influence of risk and monetary payment on the research participation decision making process. J Med Ethics 2004
- Grady C. Payment to Subjects. JCI 2005
- Grady C, et al. Paying research subjects: an analysis of current policies. Ann Int Med 2002
- Iltis AS, et al. Payments to children and adolescents enrolled in research: a pilot study.
- Weise K, et al. National practices regarding payment to research subjects for participating in pediatric research. Pediatrics 2002
- Scherer DG, et al. Financial compensation to adolescents for participation in biomedical research: adolescent and parent perspectives in seven studies.J Pediatr 2005