HHS OIG Opens Public Comment on Compensating Clinical Trial Participants

A rare policy window just opened. The HHS Office of Inspector General is asking the public a direct question: should the rules be updated to make it easier, and legally safer, to compensate people who participate in clinical trials?

For mental health clinical research, this matters enormously. Stipends, transportation reimbursements, childcare support, and cost-sharing subsidies are often the difference between someone being able to participate in a trial and simply not being able to.

Right now, there is no clear federal legal protection for those payments. OIG wants to know if that should change.

Your voice belongs in this conversation. Comments are due August 24, 2026.

*See below right for sample submission with letter attachment.

What Is the OIG Requesting?

On June 24, 2026, the HHS Office of Inspector General (OIG) published a Request for Information (RFI) in the Federal Register asking whether the safe harbor regulations under the Federal Anti-Kickback Statute (AKS) should be updated to explicitly protect compensation provided to clinical trial participants. This includes stipends, transportation, childcare, and cost-sharing waivers for Medicare and Medicaid beneficiaries.

The Anti-Kickback Statute prohibits payments intended to induce participation in federally funded healthcare programs. Safe harbors are legal exceptions that protect certain payment arrangements from prosecution. Right now, there is no safe harbor that clearly covers clinical trial participant compensation. That legal uncertainty has a real effect on who gets to participate in research, and on how confidently sponsors and sites can support the people in their trials.

Here is a table of some of the issues with the current rules and why your voice matters:

Issue	What the current rules say	Why your voice matters
No safe harbor exists for participant compensation	The Anti-Kickback Statute prohibits payments that could be seen as inducing participation in Medicare- or Medicaid-covered programs, and no explicit safe harbor protects clinical trial stipends, transportation, or childcare reimbursements.	OIG is directly asking whether one should be created. A comment from someone with real clinical research experience makes the case with evidence that a policy analyst cannot.
Cost-sharing waivers operate in legal gray area	OIG has issued favorable advisory opinions on a case-by-case basis for 20+ years but has never issued a formal rule. That means every sponsor or site offering a cost-sharing subsidy is operating without guaranteed legal protection.	A formal safe harbor would replace uncertainty with clarity. Without public comments documenting that uncertainty as a real barrier, OIG has no record to act on.
Low-income participants face a double barrier	Participants who rely on Medicare or Medicaid may be deterred from accepting compensation because it can be treated as income, threatening benefit eligibility. This is compounded by the absence of legal clarity on the sponsor’s side.	Mental health trial populations disproportionately rely on federal benefits. If your organization serves this population, yours is exactly the voice OIG needs to hear from.
Third-party facilitators lack a legal framework	No guidance addresses whether a nonprofit or intermediary organization can administer participant compensation on behalf of a sponsor, even when that structure would reduce compliance risk for everyone.	This gap directly affects how participant support programs can be structured. Comments that name this specifically help OIG understand the full scope of what needs to be addressed.
Mental health trials are not explicitly addressed	The RFI is broad, covering all clinical trials. Without input from the mental health research community, the resulting guidance will almost certainly be shaped by oncology and rare disease precedents, which do not reflect psychiatric trial realities.	CNS and psychiatric trials have unique enrollment challenges, participant vulnerabilities, and logistical barriers. That perspective will not be in the record unless the mental health community puts it there.
Deadline: August 24, 2026	Submit comments electronically at regulations.gov. Reference file code OIG-2602-N. A full comment letter can be attached as a PDF.	OIG weighs both the volume and specificity of public comments. Even a brief, focused submission from your organization adds to the record.

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Advocates, patients, caregivers, and community organizations all have standing to comment. Personal, real-world perspectives on how financial and logistical barriers affect access to mental health clinical research are exactly what OIG needs to hear.

Once you click on the SUBMIT A PUBLIC COMMENT button, the following page will open:

Why This Matters for Mental Health Research

People living with mental health conditions are among the most underrepresented in clinical research, and also among those who face the most practical barriers to participation. Transportation, lost wages, childcare, copays: these are not abstractions. They are the reasons trials fall short on diversity and enrollment targets.

The OIG’s RFI creates an opportunity to make a clear, evidence-backed case for legal protections that support more equitable, more accessible, and ultimately more scientifically valid mental health research.

Comments are due August 24, 2026.

Submit via regulations.gov using file code OIG-2602-N.

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This issue connects directly to the Harley Jacobsen Act, STARR-supported legislation that would make all clinical trial compensation tax-exempt. The two issues are related but distinct. The Harley Jacobsen Act addresses the tax burden on participants; this OIG RFI addresses whether sponsors, sites, and intermediaries can legally provide that compensation in the first place. Both protections are needed for the system to work optimally.

Learn more about the Harley Jacobsen Act.

Download the STARR comments submitted to HHS OIG:

Download the STARR letter attached to the submission:
(supplement to limited comments):