Clinical trial participants are often asked to perform a variety of tasks and procedures that likely would not be requested during routine care. For example, they may need to undergo additional lab testing, x-ray procedures, answer questionnaires, or make extra trips to the clinic. When and how to offset subject inconvenience with some kind of compensation is often debated throughout the stages of protocol building, review and approval. The following paragraphs highlight some factors that institutional review boards (IRBs), sites and sponsors should consider when proposing subject reimbursements in trials.
The topic of subject reimbursement is not directly addressed in the Code of Federal Regulations (CFR); however there is some inference from them (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 guidance to IRBs in the same vague manner, yet they are responsible for reviewing and determining the appropriateness of the amount and methods for reimbursing research subjects. Food and Drug Administration (FDA) Information Sheets give sites and sponsors a bit more direction by stating that it is not unusual for subjects to be paid for their participation, especially in phase 1 or phase 2 studies when direct health benefits to the subject are non-existent (Cola & Makesh, 2010). Given this information, we know subject reimbursement is acceptable as long as it is not presented as an incentive that would induce a patient to do something they would not otherwise agree to, basing their decision solely on the financial motivation.
Factors to consider
Grady (2005) offers the following considerations when deciding to provide payments to research subjects:
- Does reimbursing the subject make the study revenue-neutral for participants? A barrier to participation for some subjects may be that they cannot afford, or are not willing, to make the financial or time sacrifices needed to complete the trial. In this approach, subjects might feel that their time and effort are being fairly compensated and would be willing to join the trial.
- Could compensation provide a recruitment incentive that would help overcome inertia or lack of interest? This concept could apply to subgroups in the population that may be needed to achieve the study goals as far as gender, racial, ethnic and social diversity.
- Is the incentive too high, such that it could blind potential research subjects to the risks involved when they are making their decision? In other words does money lead to impaired judgment?
- Is the payment enough that subjects would be willing to conceal information that might disqualify their participation? Or, if they change their mind half way through the trial, could they fabricate symptoms in order to withdraw early and end up jeopardizing the scientific rigor?
- What payment model works best for the study and research site?
- A market model would be driven by the market rates in the subject’s location. Supply and demand of research subjects drives the rate.
- Wage-payment could be considered, providing a standard amount for time and effort on the part of the patient.
- A strict reimbursement model could be used where the research subject would provide receipts for the reimbursable activity such as mileage, parking, lodging or meals.
- Appreciation gifts such as mugs, keychains, pens, bags or other such items can be considered.
- How will the site track and monitor payments after all the decisions have been made on when and how much? Sites have many details to consider when seeing patients in research studies. A system for tracking payments and paying them in a timely manner is important.
Decisions in research on the conduct of a protocol are made with a systematic review of references and extreme care. The decision to reimburse subjects for participation in research is no different. However the site and sponsor decide to proceed, it is imperative to connect with the IRB and obtain approval prior to moving forward on any payment initiative.
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Cola, P. A., & Mukesh, K. (2010, October). Reimbursement to research subjects enrolled in clinical research studies. , Cleveland, OH. Retrieved from http://www.srainternational.org/sra03/uploadedFiles/Reimbursement to subjects enrolled in Clinical Research Studies 101310.pdf
Grady, C. (2005). Payment of clinical research subjects. Journal of Clnical Investigation, 117(7), 1681-1687. doi: 10.1172/JCI25694