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| THE HUMAN RESEARCH PROTECTION PROGRAM |
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THE COMMITTEE ON HUMAN RESEARCH GUIDELINES FOR PAYMENT OF RESEARCH
SUBJECTS
• Introduction Once an investigator decides to pay a subject for participation in research, a number of points need to be considered. First and foremost, subject payment raises ethical issues around voluntary participation and the individual's need to make informed choices about research that are based on the real risks and benefits of participation, not on financial incentives. Federal regulations and commentaries offer guidance about such incentives, but set no strict limits, leaving Principal Investigators and local Institutional Review Boards to decide how much payment is too much or not enough. Voluntary participation is the major ethical issue The Food and Drug Administration cautions against payments that are "...coercive or present undue influence." The National Institutes of Health similarly warns IRB's about payments that cause "undue inducement." Following these general cautions and based on its own experience, the Committee on Human Research (CHR) has developed recommendations about subject payment. Which Term Should be Used: Payment, Reimbursement, Compensation? The CHR prefers the term "payment" when discussing money given to a subject to offset time and inconvenience and/or to provide incentive to participate. The CHR reserves the term "compensation" for discussions of UCSF Treatment and Compensation for Injury policies. The term "reimbursement" suggests that subjects must provide receipts for particular out of pocket expenses (for instance, parking and transportation), which they often cannot. Special Considerations When Recruiting Subjects from the VAMC VAMC Subjects may not be paid for participation in research when the research is integrated with the patient’s medical care and makes no special demands on the patient.
How Much Should Subjects be Paid? There are no hard and fast rules about how much subjects should or should not be paid. Subjects should be paid enough to make up for their time and trouble, but not so much that their decision to volunteer or continue in a study is influenced by the amount being offered. Subjects should not see research participation as a way to make a living or regularly supplement their income. Large payments can suggest this possibility and can be coercive. Residents of the Bay Area make an average of $15 to $20 an hour, and this is a reasonable upper limit for studies involving lengthy or periodic visits to the lab or clinic and fairly low risk procedures that are routine in clinical practice, such as venipuncture, physical exams, MRI or x-ray, ECG, interviews, or questionnaires. Other payments (to cover parking or transportation fees, child care expenses) can and often should be added to adjust this hourly amount. In some cases, an hourly range is clearly not appropriate. A half-hour spent with an endotracheal tube in place or undergoing a biopsy is not comparable to a half-hour having height, weight, and blood pressure measured. The CHR has generally accepted specific payments for complex, invasive, and uncomfortable procedures, but here it is difficult to advise. The Committee has approved procedure-specific payments of many different amounts but the question of "undue influence" begins to surface once $200-300 per procedure is reached or when total study payment nears $1000. One exception to procedure-specific payments is payment for blood samples; the Committee does not allow paying subjects based on volume of blood taken. No matter how payment is calculated (hourly, per procedure, or some combination of both), the Payment section of the consent form should state the maximum amount of payment available. Just as the size of payment can put inappropriate pressure on subjects, so can the schedule of payment. Holding payment until the subject has completed every procedure in a long, multi-week, multi-visit study is inappropriate. For studies with more than two or three visits, payment should be prorated, that is, based on the amount of time subjects have spent participating so far. It is acceptable to offer a small bonus for completing all study procedures, but the bonus should be no more than 30% of the total available payment. Be sure to explain the payment schedule in the Payment section of the consent form and specify any bonuses. Researchers should set up their own accounts at UCSF and pay subjects from those accounts. Accounts Payable Guidelines for Research Subject Payments of the CHR Guidelines gives relevant instructions for check and petty cash accounts, and explains how to make payments that allow subjects to remain anonymous. The consent form should explain how subjects will be paid (i.e., in cash or by check) and how long they will have to wait for payment (i.e., whether they are paid immediately or after a delay of four to six weeks). The most frequent subject complaint heard by the CHR concerns the timing of payment, so it is important to make the payment plan clear from the start. If subjects are paid by check, they will have to give their Social Security numbers; this should be spelled out in the Confidentiality or Payment sections of the consent form. Are Subject Payments Reported to the Internal Revenue Service? If a subject is paid more than $600 in a calendar year, University accounting must report the payment to the IRS. The Payment section of the consent form should explain this reporting requirement. Payment If you complete the entire study, you will be paid $625 ($525 for the clinic visits and bronchoscopies and a $100 bonus for finishing everything). If you withdraw early, you will receive $20 for each visit and $100 for each bronchoscopy. You will be paid by check, which you should receive four to six weeks after your last visit. You must give the researchers your Social Security number so the check can be processed. The University must notify the Internal Revenue Service when it pays a subject $600 or more in a year. Thus, your payment will be reported to the IRS. |