One participant in a multisite study needs to travel several hours for a study visit and cannot afford the airfare upfront. At another site, a participant needs childcare for their kids during a long appointment. The study may allow assistance with both expenses, but uncertainty around Federal fraud and abuse rules can make organizations hesitant to authorize the support both people need.
At Scout, we’ve seen that uncertainty lead Sponsors and research institutions toward highly conservative approaches to participant payments. In some cases, reasonable support programs are never authorized because the rules are unclear. When appropriate support is withheld, the participant may be left to absorb a cost created by participating in the study.
In August 2026, Scout submitted a public comment to the Office of Inspector General in response to its request for information on the Federal anti-kickback statute and Beneficiary Inducements Civil Monetary Penalty. Our position is straightforward. Clearer Federal protection could give organizations greater confidence to provide legitimate participant support while maintaining strong safeguards against fraud, abuse and inappropriate influence.
Not every payment to a study participant serves the same purpose. Reimbursement may pay a participant back for a documented study-related expense. Direct booking or advance payment can remove the need to front that expense at all. Compensation for a participant’s time serves another purpose. Incentive payments raise additional questions because they may influence decisions about enrollment or continued participation.
OIG guidance should reflect those differences. A documented reimbursement for a necessary hotel stay presents a different set of considerations from a payment intended specifically to encourage study completion. Scout is asking OIG to evaluate different payment categories according to their purpose, their connection to study participation and the controls surrounding them.
Expense reimbursement presents the clearest case. Compensation and incentives require their own scrutiny. Treating every form of participant payment as though it carries the same risk can lead to broad restrictions that blur the difference between legitimate assistance and arrangements that warrant greater scrutiny.
Reimbursement policies can still leave participation financially out of reach. Someone with enough available cash or credit may be able to purchase a plane ticket and wait to be repaid. Someone without that flexibility can’t. The timing of support can determine whether support is useful at all.
Fixed reimbursement caps can create similar problems. Legitimate costs vary by location, study requirements and participant circumstances. A hotel room near one research site may cost substantially more than a room near another. Travel to a specialized site can involve expenses that a standard limit never anticipated.
Scout has asked OIG to consider reasonableness standards or flexible benchmarks for documented study-related expenses. This approach would still require review and documentation, while allowing legitimate costs to reflect what participation actually requires.
The principle is simple: financial neutrality. Participants already contribute significant time and accept the burdens associated with research. Study participation shouldn’t also depend on whether someone has the funds available upfront to cover necessary expenses.
Participant payments can create legitimate compliance concerns. Even a well-documented payment can raise questions if its amount, purpose or conditions could improperly influence a participant’s decisions. Clearer rules would help organizations separate those situations from appropriate support for legitimate study-related costs and burdens.
Our comment calls for protection around arrangements that are documented, reasonable and auditable. Approval authority should be clear, and records should establish the study-related basis for the support provided. The safeguards should also reflect the payment itself. Receipts and underlying expenses can support review of reimbursements. Flat stipends call for different controls. Incentive payments deserve additional scrutiny because their purpose differs from replacing an incurred cost.
Third-party administration can create a useful level of separation between clinical research activities and payment execution. Third-party administration does not remove the need for appropriate oversight. It can, however, make documentation and payment processes easier to administer consistently.
Organizations currently make participant-support decisions within overlapping legal, ethical and institutional requirements. The resulting interpretations can vary, even with similar underlying arrangements.
Scout is asking OIG to establish a participant-support safe harbor or modify existing protections to expressly address documented and reasonable arrangements that are unrelated to clinical decision-making or utilization outside the study. Regulatory protection would establish clearer boundaries. Practical OIG guidance could then help Sponsors, sites, IRBs and third-party administrators apply those protections more consistently.
Some participant concerns extend beyond OIG’s authority. Research payments can intersect with tax treatment, public-benefit eligibility and requirements administered elsewhere in the Federal government. Scout has therefore also called for greater coordination among Federal agencies so participants and research organizations are not left to reconcile conflicting requirements on their own.
Greater certainty in one area won’t resolve every barrier to participation, but it can remove one source of avoidable hesitation.
Clinical trial participation can ask a lot of people: travel, time away from work, and significant disruption to their daily lives. Some protocols ask even more from participants because of visit frequency, specialized assessments, or the effects of illness itself. While reasonable reimbursement and logistical assistance can’t eliminate those demands, they can help keep necessary study expenses from becoming one more condition a person has to be able to absorb.
Scout is urging OIG to protect appropriate participant support with rules specific enough to give research organizations confidence and safeguards strong enough to address genuine risks. KimberLee Heidmann’s full public comment provides Scout’s detailed recommendations on participant remuneration, Federal protections and implementation guidance.
Click here to read Scout’s full comment to the Office of Inspector General.