Comment on FR Doc # 2026-12676

The STARR Coalition is a national nonprofit dedicated to advancing mental health clinical research through collaboration, stigma reduction, and community engagement. We work directly with clinical research sites, pharmaceutical sponsors, CROs, advocacy organizations, and the communities they serve. We strongly support the issuance of new or modified safe harbor protections for clinical trial participant compensation and urge OIG to act with specificity and urgency. The Absence of Clear Legal Protection Is a Real and Measurable Barrier For more than two decades, entities seeking clarity on legally supporting trial participants with cost-sharing subsidies, transportation, or stipends have been required to seek individual advisory opinions. That process is inaccessible to smaller research sites, nonprofits, and community-based organizations serving the populations most in need. The result is a chilling effect: sponsors limit what they offer, sites operate conservatively, and third-party intermediaries have no legal framework to rely on. The people who bear the cost are the participants themselves. A clearly defined safe harbor would replace that uncertainty with a durable, accessible rule. Mental Health and CNS Research Warrants Specific Attention People living with serious mental illness are among the most underrepresented in clinical research and face the most acute participation barriers. Transportation, childcare, lost wages, and copays are frequently the deciding factor between enrollment and dropout. Mental health trial participants are also disproportionately likely to rely on Medicare or Medicaid, precisely where the legal gap is most consequential. Clinical trial diversity is not only a matter of equity. It is a matter of scientific validity. Data developed without representative participants may not generalize to the people who need those treatments most. The Safe Harbor Should Explicitly Address Third-Party Facilitators We urge OIG to extend any new safe harbor to cover third-party intermediaries that administer participant compensation on behalf of sponsors or sites. Models where an independent organization manages stipend disbursement and transportation coordination reduce compliance burden, improve support consistency, and allow community-based organizations to play a meaningful role. Without explicit guidance, that potential will remain unrealized. Addressing the Tax Burden: A Necessary Complement Safe harbor protections are necessary but not sufficient. Under current tax rules, participant payments are treated as taxable income, threatening eligibility for Medicaid, SNAP, and other income-sensitive benefits. Even where a sponsor has legal authority to offer compensation, participants may be unable to accept it without personal risk. The Harley Jacobsen Clinical Trial Participation Income Exemption Act, reintroduced in June 2025, would make all clinical trial compensation tax-exempt. The safe harbor question and the tax treatment question are two sides of the same coin. STARR encourages OIG to note this complementary gap in any resulting guidance and support interagency coordination toward a comprehensive resolution. Summary of Recommendations STARR respectfully urges OIG to: 1. Establish explicit safe harbor protections for participant remuneration, including stipends, transportation, childcare, and cost-sharing subsidies for Medicare and Medicaid beneficiaries. 2. Extend safe harbor protections to cover third-party intermediaries administering compensation on behalf of sponsors and sites. 3. Give specific consideration to mental health and CNS trial populations, including their disproportionate reliance on federal benefits. 4. Acknowledge the tax treatment of participant compensation as a complementary barrier and affirm support for solutions such as making clinical trial compensation tax-free to participants. Mental health clinical research depends on real people who face real barriers. The legal framework has not kept pace with what participation actually requires. This RFI is an important opportunity to begin closing that gap. The STARR Coalition thanks OIG for the opportunity to comment and welcomes further engagement.