The STARR Coalition, a national nonprofit focused on mental health clinical research, supports the creation of new or modified safe harbor protections for clinical trial participant compensation. They argue that clear legal protections are necessary to remove barriers for underrepresented populations and recommend that these protections explicitly include third-party intermediaries and consider the specific needs of mental health and CNS research participants.

TechInHSR LLC, a regulatory compliance consulting practice, supports the OIG's effort to address fraud and abuse but argues that IRB review and AKS/CMP analysis are distinct functions that should not be conflated. They advocate for a formal safe harbor that codifies existing OIG practices for copay subsidies to reduce administrative burdens while maintaining robust IRB oversight to prevent coercion.

The commenter argues that the federal government should update beneficiary-inducement exceptions and anti-kickback safe harbors to specifically include clinical-trial-related remuneration. They contend that current regulations create uncertainty that hinders equitable research participation and advocate for new, narrowly tailored safe harbors to provide long-term regulatory clarity.