Clinical trials play a crucial role in advancing medical knowledge, but they can be demanding for human participants in terms of time, effort, and potential risks. To ensure that these participants are treated with respect and dignity, it is crucial for life science researchers to establish fair compensation and/or reimbursement policies. However, these policies are complex and can have ethical and legal implications. I recently took a LinkedIn poll that showed quite a bit of debate in payment versus reimbursement for patients, which indicates that there is a need for greater clarity and understanding of these policies in our community.
Imagine a patient, Janet, who cannot afford to participate in a clinical trial due to travel costs and lost wages. While some have criticized access to technology as a source of bias, the lack of fair compensation and reimbursement policies to accommodate Janet’s situation can create a different source of bias. By offering reimbursement for expenses incurred and fair compensation for their time and effort, Janet would be able to participate in the study and contribute to medical research. Here’s the rub: there is a lack of clarity and agreement on the philosophies and drivers of reimbursement and compensation in the clinical research community (as evidenced by the poll results above).
Firstly, we can at least all agree that it is essential to differentiate between compensation and reimbursement. Compensation refers to the disbursement of cash payment or other rewards provided to research participants in exchange for their time, effort, and potential risks. Reimbursement, on the other hand, involves disbursing payment for expenses incurred by research participants due to their participation in the study, such as travel costs, parking fees, childcare, or lost wages. Understanding the difference between the two is crucial in establishing fair compensation and reimbursement policies. Now comes the other million-dollar question – how much is ethically appropriate?
Ethics committees play a vital role in ensuring that research studies are conducted fairly and responsibly. Compensation and reimbursement policies are viewed as essential to respect the rights and well-being of research participants – hear more on that from James Riddle, VP of Research Services & Strategic Consulting Advarra on a recent episode of the Research Confidential Podcast. Evaluating potential risks and benefits are critical when deciding on compensation and reimbursement amounts, as well as gauging the potential for coercion or undue influence vis-a-vis those risks and benefits.
Sponsors of research studies also play a key role in determining internal compensation and reimbursement policies as they are the ones to put forth the proposed amounts to ethics committees. They must also consider practical factors such as the study budget, site burden, and how best to implement the compensation and reimbursement model in a global setting. For example, the Tri-Council Policy Statement in Canada requires fair compensation for time and effort and reasonable reimbursement for expenses incurred during the study. Meanwhile, the European Journal of Clinical Investigation reported that in France, this remains a topic of debate as “ethical aspects of compensation were viewed differently by Clinical Investigation Centres and Research Ethics Committees...Most of the proposed expenses incurred were to be compensated, but an agreement to reimbursement of petrol bills or childcare expense was lower.”
In the United States, the Code of Federal Regulations (CFR) governing clinical trial payments and reimbursements to participants are outlined specifically in Title 45, Part 46, and Title 21, Part 50. They require that payments and reimbursements to participants must not be coercive or unduly influence participation and must be proportionate to the time and effort required of participants. Additionally, the US National Institutes of Health (NIH) provides similar guidelines which recommend compensating participants for their time and inconvenience and reimbursing for reasonable expenses incurred. Some states within the US may also have specific laws and regulations regarding clinical trial payments and reimbursements. But again, how much is ethically appropriate?
Traditionally, most sponsors and ethics committees have settled on a one-size-fits-all approach to disbursement of payments out of ease of implementation and a perception that equal means fair - I.e., completion of certain visits results in a payment of X dollars no matter the situation of each patient. While there are exceptions for certain trials where a sponsor will pay large travel costs for out-of-state participants, the vast majority of participant payments are treated this way. But based on some of the regulations, is paying all participants “equally” the same as being “fair?”
To complicate matters, as participants do more things at home with the rise of decentralized clinical trial methods and connected/wearable devices, how are they being reimbursed fairly for non-clinic-based activities? And for those that might want the option to take public transit vs. self-drive vs. rideshare vs. walk or ride a bike, how might we fairly reimburse for this variety of costs?
While the infinite payment permutations might be unrealistic to solve today, what we can leave behind right now are the conventional, oversimplified payment models that were borne out of convenience and current limitations more than anything. The right mix of technologies can serve to deliver a wide range of payment models that better meet the spirit of current regulations and ethics, without creating more work or confusion for the site or the sponsor. Particularly, the combination of digital protocol automation, married with mobile payments, modern expense reporting, and rideshare capabilities can deliver a customized, purpose-fit compensation and reimbursement model that meets patients where they are. You don’t have to imagine enabling our patient, Janet, to pick a ride share for Visit 1, but then get reimbursed for parking on Visit 3, while receiving consistent payments for clinic visits, as well as micropayments for answering her eDiaries. ProofPilot can do this today with our partnership with Mural Health!
A final thought: the battle may rage on as to whether sponsors or trials should reimburse or compensate participants. But the fact remains that in the US, no matter what you call it, nearly all participants are required to pay income tax on cash payments in excess of $600 in a year – which means you are compensating them. Reimbursers of the world, make this make sense.