OIG Seeks Comments on Research Participant Compensation and Fraud and Abuse

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a request for information (RFI) on June 24, 2026, seeking public input on whether new or modified safe harbors under the federal Anti-Kickback Statute (AKS) or new or modified exceptions to the Beneficiary Inducements Civil Monetary Penalties (CMP) law are needed for remuneration provided to individuals in connection with their participation in clinical trials. Clinical trial participants often receive cash stipends, expense reimbursement or other financial incentives to reduce burden and encourage participation in clinical research. RFI comments are due by 5 p.m. ET on August 24, 2026.

The RFI arrives amid HHS' broader clinical research reform agenda, including its Operation TrialBlazer Roadmap, an initiative intended to maintain U.S. leadership in early clinical research and development. Operation TrialBlazer identifies improving patient access and engagement in clinical trials as one of HHS' core fronts for reform. The road map recognizes that clinical trial participation can create financial hardship for patients and families, including co-payment obligations for standard-of-care services delivered during a trial, unexpected tax liability for trial-related compensation and potential effects on eligibility for federal programs such as Medicaid. By seeking input on whether new or modified AKS safe harbors and Beneficiary Inducements CMP exceptions are needed for participant remuneration, the RFI may present an opportunity to address those financial barriers and increasing trial enrollment and retention.

Why the RFI Matters

Reliable and valid clinical trial results, as well as any ensuing medical advances, depend on recruiting enough eligible individuals and retaining them for the duration of a research protocol. OIG acknowledges that for some individuals, extra costs or burdens associated with clinical trial participation may discourage enrollment or continued participation.

The RFI focuses on remuneration to federal healthcare program enrollees and notes that clinical trial participants historically have been offered various forms of support in connection with participation in a clinical trial, including cash payments, expense reimbursement, lodging, transportation, and other compensation and support intended to facilitate participation. In light of the breadth of federal kickback and patient inducement prohibitions, OIG has in the past received requests for a safe harbor that would protect such remuneration to clinical trial participants.

OIG notes that it has published 10 favorable advisory opinions throughout the last two decades permitting the waiver or subsidization of certain federal healthcare program cost-sharing obligations for clinical trial participants in specified clinical trials by entities including manufacturers, clinical trial sites and nonprofit organizations. OIG also notes, though, that it has not issued advisory opinions or guidance relating to other types of remuneration provided to clinical trial participants, such as transportation costs, childcare costs or stipends. These types of costs have become more common as research studies increase in scientific and administrative complexity, in some cases drawing participants from all over the world or requiring extended hospital stays, repeated study site visits, time out of work and other financial burdens. The RFI signals OIG's interest in exploring whether broader regulatory protection is warranted for these different categories of participant support.

Key Areas Where OIG Is Seeking Input

1. Identifying Appropriate Remuneration Limits: OIG asks whether offering remuneration to federal healthcare program enrollees facilitates clinical trial participation and what factors make that remuneration effective or ineffective. OIG also asks whether stakeholders view the AKS or the Beneficiary Inducements CMP as barriers to offering and providing appropriate remuneration to clinical trial participants and how those legal barriers relate to other barriers to participant compensation or remuneration. OIG also asks whether clinical trials currently impose value caps or other limits, including demonstrated financial need or reimbursement only for actual documented costs incurred.
2. Types of Remuneration Needed: The RFI seeks specific input on multiple categories of remuneration that may facilitate clinical trial participation, including reimbursement for actual incurred expenses such as travel, lodging, parking, childcare and meals, along with stipends, compensation for a participant's time, and incentives to encourage enrollment in and completion of a trial. OIG asks what levels of remuneration are useful, what categories are not useful, the extent to which such remuneration already is offered and whether any categories may present heightened fraud and abuse risks. The RFI also seeks information on whether clinical trials currently impose value caps or other limitations on provision of such remuneration, including demonstrated financial need or restrictions on who can provide the remuneration, and whether such caps or limitations permit remuneration adequate to facilitate trial participation.
3. Timing of Remuneration: OIG further asks whether remuneration is provided during all stages of product development, including Phase 1 through Phase 4 trials, and whether different amounts or types of remuneration are needed in early-stage versus late-stage development.
4. IRB Oversight: The RFI includes questions about Institutional Review Board (IRB) oversight, participant steering, trial phase distinctions and advertising. OIG asks commenters to explain the role of IRBs in reviewing the type, amount and frequency of participant remuneration and the advertising of that remuneration.
5. Types of Clinical Trials Where Remuneration Is Appropriate: OIG's questions also invite comments on whether certain categories of clinical trials should or should not pay participant remuneration because of their relative fraud and abuse risk under the AKS and Beneficiary Inducements CMP. For example, OIG specifically asks whether protection should be limited to remuneration provided to participants in government-sponsored clinical trials. OIG also asks whether advertising limitations related to participant remuneration are needed to protect clinical trial integrity and guard against fraud and abuse.
6. Utility of Existing Safe Harbors: OIG also asks why existing AKS safe harbors or Beneficiary Inducements CMP exceptions do not adequately protect arrangements needed to provide remuneration to clinical trial participants. OIG asks commenters to identify key provisions that should be included in any new safe harbor or exception, including conditions and disclosures designed to protect against fraud and abuse harms.

Considerations for Stakeholders

Clinical trial sponsors, research sites, patient assistance organizations, investigators and other stakeholders should consider submitting comments addressing both operational barriers and legal uncertainty surrounding research participant compensation. Note that the RFI does not address the ethics of research participant compensation, such as the risk of coercion or impact of remuneration on informed consent, which are also important considerations. OIG encourages specific examples and states that respondents are not required to address every issue or question in the RFI for their responses to be considered.

The RFI is for information and planning purposes only and does not constitute a request for proposal, application, proposal abstract or quotation. Still, stakeholders considering comments should view the August 24, 2026, deadline as an opportunity to shape OIG's understanding of how participant remuneration intersects with clinical trial access, fraud and abuse risk, and the administration's broader clinical research modernization agenda.