There's a common misconception that patients cannot be paid outside of the US. Greenphire's ClinCard solution has automated payments and reimbursements for hundreds of thousands of patients in dozens of countries. So why is there this perception that it is not allowed?
We recently sat down with a group of site staff representing more than seven different regions in the EU to discuss if and how they are reimbursing their patients to participate in clinical research.
Although not always a standard, in many clinical trials participants receive some form of compensation for their participation. This may take the form of money, or the reimbursement of travel expenses, food or food vouchers, or other services. This is particularly common in the United States, where the NIH even has a standard tariff for participation.
According to the EU Clinical Trial Directive (2001/20/EC) and Regulation (536/2014), no incentives or financial inducements are given to incapacitated participants or minors (or either of their legally designated representatives), or to pregnant women, except for compensation for expenses and loss of earnings directly related to participation in the clinical trial. Otherwise, this EU legislation dictates that ‘no undue influence, including that of a financial nature, [must be] exerted on subjects to participate in the clinical trial.’
This directive clearly illustrates the ambiguity around what can be permitted and how a site may believe that they are not permitted to issue compensation. This was also evident in the discussion with sites on the topic – where there was little agreement around what was allowed.
The three things that the group could agree on were:
- Any compensation is reviewed and approved by the respective Ethics Committee
- Paying or reimbursing patients is critical to retention and engagement
- Distributing compensation to participants should be timely, and not such an administrative burden to the site staff
At one point in time all the sites in the group did note that they have provided reimbursements to their participants. Some did it within their own accord to keep patients engaged and others only did it when the Sponsor provided budget to provide a stipend or travel reimbursement.
What was very clear among the group was that the language provided to an Ethics Committee to “approve” a patient reimbursement in a study needed to clearly state what the compensation was for – travel, expense, etc. The more specific about what the reimbursement is for, the less possibility there is for an Ethics Committee to think that the compensation is for coercion or something potentially unethical. Specificity, set amounts and clear communication is critical to allowing reimbursements in a trial.
Mostly all transactions were done with petty cash or direct deposit, with direct deposit being the more common or preferred method. There was a lot of excitement around the ability to reimburse patients through a solution such as ClinCard, as it would streamline the ability to receive funds from Sponsors and CROs to eliminate the time and resources spent doing this task manually. Understanding how to position the request to Ethics Committees is critical to unlocking the opportunity that automation can deliver.