The patient stipend has become an expectation in many, if not most, clinical trials over the last 10 years. Not long ago, stipends were not regulated or required to obtain IRB approval.
Fortunately, as an industry we have policed ourselves in managing stipends ethically, with attention to the importance of reasonable remuneration and how we present this opportunity to potential trial participants. The topic of patient reimbursement has never been directly addressed in the Code of Federal Regulations (CFR); however, there is vague inference (45 CFR Subpart A Section 46.116) as follows:
“An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”
The CFR also gives the same vague guidance to IRBs, even though they are tasked with reviewing and determining appropriate amounts and methods for reimbursing research subjects. FDA Information Sheets give sites and sponsors a little more specification, stating it is not unusual for patients to be paid for their participation, especially in phase I or II studies when direct health benefits to the patient are non-existent. As long as it is not presented as a direct financial incentive that would coerce a patient to do something he or she otherwise would not do, subject reimbursement is acceptable.
Perhaps more relevant at this point in time are the more pressing issues around patient stipends of a site’s management of payments and the fiscal implications. It is an interesting phenomenon that over time we have seen the patient stipend become blended, or “camouflaged,” within the per-patient contract. In reviewing study budgets listed on the NIH, Washington University of St. Louis, Virginia Commonwealth University and University of Texas at Houston websites, depending on the size and complexity of the study the patient stipend can be as much as 13% of the per-patient cost.
This variable per-patient cost can give the impression of an inflated budget, and it should be itemized clearly for a number of reasons. The point is to set a clear understanding of the budget and to document an amount that is fair and ethical to offer the patient. Also, in some cases a sponsor may allocate funds for patient payment but may not be aware of a decision made by a site on the stipend amount. In addition, the combination of per-patient budget with stipend can be misleading, in terms of the amount being paid to cover the cost of performing the study versus the stipend itself. I encourage stipends to be presented as a pass-thru line item to avoid this vagueness.
Another important area is close follow up of payments and fiscal accountability in tracking payments. At large, high-enrolling sites, these allowances can approach hundreds of thousands of dollars annually. In some cases, actual hard copy checks are processed versus a credit card payment method such as Greenphire’s Clincard. These systems often offer a more secure, reliable debit card supported by technology firms that specialize in clinical trial-related compensation. Of course, such services require a fee, usually reimbursed by the sponsor or CRO. These credit/debit card systems also have been documented to improve patient compliance. Attention to tracking the stipend closely can help avoid the potential for misappropriation of funds. A system for checks and balances of payments will assure the proper scrutiny is applied.
A 2014 article by David Vulcano in the Journal of Clinical Research Best Practices identifies 10 stipend issues. He wrote that the area is “ethically, legally and practically complex and uncertain.” Stipends often go by other names, including payment, allowance, reimbursement, compensation and remuneration. Vulcano’s article, Ten Subject Stipend Issues, identified issues including fiscal responsibility for unclaimed stipends (as this is not money a site can keep), adding or deleting stipends mid-study and ethical considerations of financially motivated subjects. Vulcano recommended “all sites (and perhaps sponsors/CROs) should have well-considered practices (and even policies) for handling clinical research stipends.” These practices and policies should be detailed in a site’s Standard Operating Procedures.
While one might at first approach this area as a more superficial element of the clinical trial budget, the stipend is far more important than it appears. Stipends might have more important elements than initially meet the eye. It is prudent, at the very least, to consider the per-patient stipend in your site budgets be closely tracked and monitored.
Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas. Email comments and questions to email@example.com.
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