Access to a specialty treatment through a clinical trial often comes paired with some hurdles of its own. Many clinical trials come with financial aid of some form to support participation, but the amount offered and the form it is offered in can vary from trial to trial. The one major rule that the FDA enforces is that payments should never be presented in a way that could coerce a patient to do something that he or she would not otherwise do. Usually these payments are presented in the form of reimbursements for travel-related costs patients incur while participating in a trial.
Keep in mind that the FDA states that payment should be made periodically throughout the study. In other words, being paid or reimbursed for participating should not depend entirely on completing the whole study. You should always feel safe and never feel forced to follow through with a study if it isn't in your best interest.
Finding a clinical trial that offers compensation
To find a paid clinical trial, you can follow these general steps of finding and applying to any clinical trial. Please note that almost all platforms which list available clinical trials will not specify how much payment is given to participants, as it varies from location to location. Contacting your local study team is the easiest way to get that information on compensation amounts. If you need help reaching the study team, services like Clara Health can help you get started!
While most clinical trials offer the treatment for free, the amount of extra reimbursement and compensation can depend on the condition the trial is targeting, as well as the phase the treatment is in. For example, phase 1 studies tend to compensate participants much more, and so do studies that are looking for healthy participants or patients with chronic conditions.
Different types of payments
A few models exist that structure how different studies outline their finances. It is important to ask questions and understand which model the researcher is using for your trial.
The participant provides receipts for reimbursable activity -- primarily gas, parking, lodging, and meals. This can even include reimbursement for lost wages. This model is primarily meant to incentivize and support patients living further away from the trial site.
Participants can earn a standardized hourly “wage” offered as compensation for their participation, or by reaching certain study milestones. This amount is based on the time and effort required of the participant.
This tends to come in the form of a token of appreciation at the end of the study. Unlike the other three models, it has little impact on study recruitment and is more likely to require study completion.
Taxes and compensation
If you have enrolled in a clinical trial, you may have to revisit your payment records come tax season.
The IRS requires that payments over $600 for clinical trial participation must be reported on tax returns.
Reimbursements (or any other payments based on receipts which cover expenses incurred by the participant) are excluded from this requirement. These include receipts you submitted to the study staff for pre-approved travel, lodging, and meals up the to the maximum allowed limit.
President Barack Obama’s “Ensuring Access to Clinical Trials Act of 2015” allows patients with rare diseases to receive up to $2,000 per year without having the payment count as income. It also, won’t jeopardize eligibility for SSI and Medicaid. This differs from the $600 payment limit which is targeted at healthy individuals taking part in research trials.
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