The FDA has issued a guidance document reinforcing the responsibility of the Institutional Review Board (IRB) as it relates to the assessment of clinical trial procedures, specifically emphasizing the importance of analyzing study participant payments in order to reduce the likelihood of coercion.
Within this guidance, the FDA notes the significance of the IRB’s role in reviewing the potential risks and benefits involved in a clinical trial. With a focus on protecting the interests of participants, the determined risks and benefits, including payment details, should be reasonable and clearly defined within the consent documentation to adequately inform participants of the study procedures.
Payment considerations
The FDA identifies participant payments into two categories:
1) Payment for study participation
2) Study travel reimbursement
Payment for study participation, though not considered in the weighing of risks and benefits, is identified by the FDA as an area of high importance as it can raise questions and concerns about coercion. Items to consider during IRB assessment include, “how much money should research subjects receive, and for what should subjects receive payment, such as their time, inconvenience, discomfort, or some other consideration.”[i] For example, the FDA determined that payments should typically be disbursed at various milestones throughout the study, rather than a lump sum based upon study completion. “In contrast to payment for participation, FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence.”[ii]
The recently issued guidance further solidifies the notion that paying study participants is a common and acceptable practice. With a mission of study participant welfare, the FDA’s intent is to highlight the importance of the IRB’s review and differentiation of risk by payment type in determining and eliminating any procedures that may result in coercion.
Greenphire ensures compliance via ClinCard
Greenphire’s ClinCard solution is designed specifically to handle the processing, execution and tracking of payments to study participants in exact accordance with the IRB/EC approved participant payment schedule, milestones, payment amounts, travel requirements, etc. Payments are made through a secure web-portal that allows for authorized study coordinators to transfer funds to participants in real time via a reloadable pre-paid card (MasterCard).
ClinCard is designed to be flexible to align with requirements of the:
- Study (e.g., visit schedule cadence)
- Sponsor/Site (e.g., payment parameters)
- Country-specific requirements (e.g., payment only and/or fixed caps on allowable payment amounts)
- IRB/EC (e.g., ensuring non-coercion via a controlled environment)
ClinCard is designed to protect the interests of study participants by ensuring:
- Study participants have ease of access to and use of payments
- payments are tracked, ensuring that research sites are reimbursing study participants as agreed
- Study participant data is secure and protected in alignment with international privacy regulations and software security standards
- Blinded participant identities – By design, the ClinCard solution incorporates centralized blinded reporting via the configuration of various distinct user roles. Personally identifiable information is blinded to anyone with a client role, as participants are only identified by subject ID.
As part of the implementation process, Greenphire works with our clients to ensure both a complete understanding of the ClinCard solution and full compliance by providing detailed system trainings and documentation, including an IRB Submission Overview as well as additional client & participant facing materials.
[i] https://www.fda.gov/regulatoryinformation/guidances/ucm126429.htm
[ii] https://www.fda.gov/regulatoryinformation/guidances/ucm126429.htm
