HHS OIG Considers Changes to Clinical Trial Participant Compensation Rules

Overview

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has issued a Request for Information (RFI) that could have important implications for clinical trial recruitment, retention, and participant support programs.

At the center of the discussion is a question that has become increasingly relevant for sponsors, research sites, manufacturers, nonprofit organizations, and other stakeholders involved in clinical research: Should organizations have clearer protection for providing appropriate remuneration to clinical trial participants, particularly Federal health care program enrollees, without raising concerns under federal fraud and abuse laws?

The RFI seeks public feedback on whether additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute (AKS), or to the exceptions to the Beneficiary Inducements Civil Monetary Penalty (CMP) provisions, for remuneration provided to individuals in connection with participation in clinical trials.

For organizations involved in clinical research, this could influence how participant support programs are structured, how recruitment strategies are designed, and how financial barriers to research participation are addressed in the future.

HHS OIG Is Reevaluating Rules Surrounding Clinical Trial Participant Remuneration

The OIG noted that clinical trial participation often creates financial and logistical burdens for participants. Examples discussed in the RFI include transportation expenses, lodging costs, parking fees, childcare expenses, cost-sharing obligations, stipends, compensation for time, and other forms of support that may be offered in connection with participation in a clinical trial.

According to the agency, these burdens can discourage eligible individuals from enrolling in studies or remaining in trials through completion.

The RFI asks whether existing fraud and abuse laws may unintentionally limit the ability of sponsors, clinical trial sites, manufacturers, nonprofit organizations, and other stakeholders to provide support that could facilitate participation in clinical research.

Importantly, the OIG is not proposing a new regulation at this time. Instead, the agency is gathering information to determine whether future guidance, new regulatory safe harbors, or modifications to existing protections may be warranted.

Why This Matters for Clinical Research

Clinical trial recruitment and participant retention remain persistent challenges across many therapeutic areas.

The RFI notes that the reliability and validity of clinical trial results depend on recruiting enough eligible individuals with characteristics that reflect the intended use population and maintaining participant cooperation throughout the study and follow-up process. The agency further acknowledges that additional costs and burdens associated with trial participation may discourage individuals from enrolling in or remaining enrolled in a clinical trial.

Transportation costs, childcare responsibilities, lodging expenses, insurance cost-sharing obligations, and other out-of-pocket expenses can create barriers to participation. These burdens may affect whether enrolled participants reflect the intended use population, particularly when costs create obstacles for individuals with fewer financial or logistical resources.

By seeking input on reimbursement models, cost-sharing support, childcare assistance, stipends, compensation for participants’ time, and other forms of remuneration, the agency is exploring whether current regulations appropriately balance participant access with protections against fraud and abuse.

What the OIG Wants To Learn

The RFI poses a broad set of questions aimed at understanding both the benefits and risks of compensating clinical trial participants.
Rather than focusing solely on whether remuneration should be allowed, the OIG is seeking information on how such support should be structured and what safeguards may be necessary.

Among the issues under consideration are:

• Whether remuneration improves clinical trial recruitment and participant retention.
• Do concerns regarding the Federal anti-kickback statute or the Beneficiary Inducements CMP discourage organizations from offering participant support?
• What types of remuneration are most useful, including travel, lodging, meals, parking, childcare, stipends, and compensation for participants’ time?
• Whether existing payment limits or eligibility criteria are sufficient to reduce fraud and abuse risks.
• The role Institutional Review Boards (IRBs) play in reviewing participant compensation arrangements.
• Whether additional safeguards, disclosure requirements, or oversight mechanisms are necessary.
• Whether new safe harbors or regulatory exceptions should be established.

The agency is also seeking input on whether guidance such as FAQs, advisory bulletins, or other interpretive materials could provide sufficient clarity without requiring formal regulatory changes.

Submit a comment on regulations.gov by August 24, 2026 no later than 5:00 p.m.

Why Existing Regulations Create Uncertainty

The Federal anti-kickback statute is intentionally broad. It prohibits certain remuneration arrangements involving business reimbursable under Federal health care programs and carries significant potential consequences, including criminal penalties, civil monetary penalties, exclusion from Federal health care programs, and potential False Claims Act liability.

The RFI notes that OIG has issued 10 favorable advisory opinions over the last two decades permitting the waiver or subsidization of certain Federal health care program cost-sharing obligations for clinical trial participants in specified circumstances involving different types of organizations, including manufacturers, clinical trial sites, and nonprofit organizations.

However, the agency also notes that it has not issued advisory opinions or guidance relating to other common forms of participant support, such as transportation assistance, childcare reimbursement, or participant stipends. As a result, some stakeholders may be uncertain about how certain participant compensation arrangements fit within existing regulatory frameworks.

The RFI suggests that OIG is interested in understanding whether this uncertainty has become a barrier to facilitating clinical trial participation and whether additional regulatory protections or guidance may be appropriate.

What This Could Mean for Sponsors and Research Sites

For sponsors, research institutions, healthcare organizations, nonprofit organizations, and other stakeholders involved in participant support programs, the RFI signals that federal regulators are actively evaluating how participant remuneration fits within existing fraud and abuse frameworks.

If future regulatory changes emerge from this process, organizations could eventually receive clearer guidance regarding permissible reimbursement arrangements and participant compensation models.

That could be particularly meaningful for studies seeking to reduce financial or logistical barriers that may discourage participation.

At the same time, the OIG repeatedly emphasizes the importance of preventing fraud, abuse, inappropriate patient steering, excessive financial incentives, and other practices that could compromise participant decision-making or trial integrity.

Any future safe harbor or exception would likely include safeguards designed to balance participant access with program integrity and the protection of Federal health care programs.

Why Should You Care?

Even organizations that do not currently offer participant remuneration should pay attention to this development.

The RFI reflects a broader industry discussion about improving access to clinical research while maintaining appropriate safeguards against fraud and abuse. Financial and logistical barriers have long been recognized as factors that may limit participation for some individuals.

The questions raised by the OIG suggest that regulators are examining whether existing frameworks appropriately address modern clinical research practices and participant support needs.

For sponsors, research sites, and other stakeholders, this may be an opportunity to help shape future policy by sharing operational experiences, compliance concerns, and data on participant support programs.

For compliance professionals, the RFI may provide insight into areas where regulatory expectations could evolve in the years ahead.

Looking Ahead

One aspect of the RFI that may be particularly noteworthy for compliance professionals is that OIG is not only asking whether new regulations are needed. The agency specifically asks whether additional clarity could be provided through guidance, such as FAQs, Special Advisory Bulletins, or other interpretive materials, rather than through formal rulemaking.

This signals that future changes, if any, may come in multiple forms and not necessarily through the creation of a new safe harbor regulation.

The OIG is accepting comments through August 24, 2026, and is encouraging sponsors, research sites, manufacturers, nonprofit organizations, compliance professionals, and other stakeholders to submit data, analyses, studies, and specific examples supporting their positions. Submit a comment now.

While the agency has not proposed specific regulatory changes, the breadth of questions included in the RFI suggests a serious interest in understanding whether current fraud and abuse protections create unintended obstacles to clinical trial participation.

Organizations involved in clinical research should view this effort as an opportunity to contribute to a policy discussion that could influence participant compensation practices, recruitment strategies, and compliance expectations across the broader research ecosystem.

Whether the result is a new safe harbor, an expanded exception, additional guidance, or no regulatory change at all, the issues raised in this RFI highlight growing attention to the balance between participant support and robust fraud and abuse safeguards.

Frequently Asked Questions

What is the HHS OIG seeking input on?
The OIG is requesting information on whether changes are needed to safe harbor regulations under the Federal anti-kickback statute or exceptions under the Beneficiary Inducements CMP relating to remuneration provided to clinical trial participants.

Is the OIG proposing a new regulation?
No. The agency has issued a Request for Information (RFI) to gather public input. The RFI does not itself establish new requirements or regulatory changes.

What types of participant remuneration are being discussed?
Examples identified in the RFI include reimbursement for actual incurred expenses such as travel, lodging, parking, childcare, and meals, as well as cost-sharing assistance, stipends, compensation for participants’ time, and incentives related to enrollment or trial completion.

Why is the OIG examining this issue?
The agency recognizes that financial and logistical burdens may discourage participation in clinical research and is evaluating whether existing regulatory frameworks create barriers to providing appropriate participant support.

When are comments due?
Comments must be submitted no later than 5:00 p.m. on August 24, 2026.