Should Sponsors Cover 100% of Clinical Trial Costs? – An IRB Perspective
Author: Melissa Fink, Senior Director of IRB Operations, IRB Services
In the United States, most clinical trials are conducted with funding provided by a government agency, industry or other sponsor. Typically, these sponsors cover some costs of research, such as medical drugs and devices under study. However, it is also common for study participants to bear the cost of study procedures that are associated with usual care – procedures that patients would have undergone for treatment of their condition regardless of whether they were taking part in a clinical trial.
This cost structure can make it challenging for economically disadvantaged persons to take part in clinical trials. Not only might the cost of usual care be prohibitive, but compound that with the potential of loss of wages, cost of transportation, and cost of childcare or other expenses that come with research participation and taking part in a clinical trial may be out of reach. This can especially affect racial minorities who are disproportionately impacted by poverty in the US, and already underrepresented and reticent to take part in clinical trials due to historical injustices that contributed to a mistrust in research.
A common strategy sponsors use to minimize financial burdens for participants is to provide direct compensation or reimbursement for transportation, childcare, and lost wages incurred by taking part in a study. However, what if a sponsor wants to take things further and cover 100% of clinical trial participation costs to promote access to studies? Is this something the IRB can support?
As is often the case in research ethics, the IRB’s assessment involves multiple ethical principles and a balance between potential risks and benefits.
Potential Benefits to Sponsor Coverage
- Equity and Access: Sponsors covering all usual care procedures performed as part of a study can reduce financial burdens on participants, ensuring that costs don’t deter participation or create inequities in access to the study. Covering all procedures ensures that participants are not excluded based on their insurance status or ability to pay, which promotes equity in research participation and aligns with The Belmont Report’s principle of justice and regulatory criteria for approval at 45 CFR 46.111 and 21 CFR 56.111.
- Minimizing Financial Risks: Requiring participants to use their insurance to cover the costs of usual care procedures performed as part of a study could lead to financial harm, such as high out-of-pocket costs, denied claims, or increased insurance premiums. Covering all usual care procedures performed as part of a study protects participants from these risks.
- Cost Transparency: When sponsors pay for all procedures, it simplifies the financial arrangements, making it easier for participants to understand their responsibilities.
Potential Risks to Sponsor Coverage
- Undue Inducement: Paying for all procedures might create an undue inducement for participation. Individuals might enroll in a study primarily to access free study “treatment” which could compromise their ability to weigh the risks and benefits of participation objectively against other alternatives (including other trials or clinical care options). This is particularly challenging when “therapeutic misconception” already runs high, that is, the challenge in seeing the difference between investigational research “treatment” and individualized clinical care.
To weigh the level of concern of undue inducement, the IRB may consider the phase of the study (first in human versus a later phase), whether the study offers first-line or last-line treatment, and what alternatives exist for eligible participants. Would eligible participants have failed all available standard treatment(s)? Could there be other, potentially more advantageous treatments or trials to consider, some that may be in a later phase of testing? Are study doctors in a position to have these discussions with their patients?
- By covering all costs, could sponsors be in a position to influence standard clinical decision-making which may vary by institution or region? For example, procedures included in the study might be over-utilized or performed in ways that deviate from usual clinical context.
Informed consent and regulatory compliance should also be considered:
- Billing practices in research must align with federal/state rules and regulations. For example, Medicare rules and the Affordable Care Act have specific provisions about billing for research-related procedures. Will 100% cost coverage be offered to all participants?
- The IRB ensures that consent forms clearly explain any potential costs to participants. Participants must understand what procedures will be billed to them or their insurance and which are covered by the sponsor. It is clear and easy to understand when sponsors pay for all procedures. It can be difficult to determine and explain when costs are divided.
In summary, there is no black or white answer here, but a weighing out of the potential concerns, which can vary based on the particulars of the study and study population involved. On the one hand, complete sponsor coverage would benefit persons who might otherwise face financial barriers to research participation. On the other, it could push patients to select clinical trial participation over other available alternatives primarily for financial reasons (rather than potential medical benefit), which would be particularly concerning for patients who are economically disadvantaged and more vulnerable to undue influence.
The IRB team at Sabai stands ready to support our study sites and sponsors who are navigating this delicate balance to promote broader access to clinical trials.
