HHS OHRP July/August Newsletter

Celebrate the Belmont Report at Belmont (Sunday, July 12, at the Belmont Manor & Historic Park in Elkridge, MD)

In honor of the anniversaries of America’s 250th birthday and the signing of the National Research Act (July 12, 1974), join OHRP and Howard County, Maryland, on Sunday, July 12, 10 – Noon ET for The Belmont Report at Belmont: Where Modern Human Research Protections Were Shaped. This event is free and open to the public and will be held at the historic venue where the Belmont Report was developed in the 1970s.

The event will feature opening speakers from Howard County, the HHS Office of the Assistant Secretary for Health, the National Institutes of Health, and the Voices for Our Fathers Legacy Foundation, an organization founded by descendants of the victims of the U.S. Public Health Service Study of Untreated Syphilis in the Negro Male at Tuskegee and Macon County, Alabama. Public outrage surrounding this unethical study directly led to the passing of the National Research Act and creation of the Belmont Report. The event will conclude with a facilitated panel discussion with human research protections experts, researchers, and community voices.

The agenda and speaker biographies are now available on the event webpage: https://www.hhs.gov/ohrp/education-and-outreach/upcoming-educational-events/index.html

This event is eligible for 2 Certified IRB Professional (CIP®) continuing education credits.

To claim credits for recertification, log into your profile on the PRIM&R Portal and download the Excel CE Tracker. Document 30 eligible continuing education (CE) credits (half of which must be pre-recognized by the CIP Council) and upload the completed tracker along with your source documentation.

This event will be recorded and archived on the OHRP website approximately one month post-event.

Click here to register.

HHS Office of Inspector General Request for Information

OHRP’s colleagues at the Department of Health and Human Services’ Office of Inspector General (HHS-OIG) published a request for information(RFI) in the Federal Register on June 24, 2026. The purpose of the RFI is to understand whether costs or burdens associated with clinical trial participation may create a disincentive to enroll or stay enrolled in a clinical trial and, if so, whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries (Beneficiary Inducements CMP) for remuneration provided to individuals in connection with their participation in clinical trials.

The RFI will give HHS-OIG an opportunity to learn more about the financial arrangements surrounding the provision of remuneration to clinical trial participants and the role of institutional review boards (IRBs) in reviewing the provision of such remuneration, among other topics.

The Federal anti-kickback statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program. Congress has developed several statutory exceptions to the Federal anti-kickback statute and HHS-OIG has promulgated safe harbor regulations that specify certain practices that are not treated as an offense under the Federal anti-kickback statute. The Beneficiary Inducements CMP provides for the imposition of CMPs against any person who offers or transfers remuneration to a Medicare or State health care program beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of Medicare or Medicaid payable items or services.

HHS-OIG will use responses to this RFI to inform their related work. For further information, please refer to the RFI linked above. To ensure consideration, comments responding to the RFI must be received no later than 5 p.m. on August 24, 2026.

World Hepatitis Day: Advancing Public Health Through Ethical Research

Each year on July 28, the global public health community observes World Hepatitis Day, a moment to raise awareness about viral hepatitis (including types A, B, C, D, and E), which infects hundreds of millions of people worldwide and remains a leading cause of liver disease and liver cancer. The development of prevention strategies, diagnostics, and treatments for hepatitis has depended, and continues to depend, on robust clinical and public health research.

Human research protections remains a critical component of all federally supported human subjects research, including infectious disease research. World Hepatitis Day offers an opportunity to reflect on how research oversight and the public health gains from research reinforce each other, and why that relationship matters. This year, the observance falls just two weeks after OHRP will recognize the Belmont Report at a special event on July 12, making it a fitting moment to consider how the principles established in that landmark document continue to shape research involving infectious disease and public health.

A Reminder: 45 CFR Part 46, Subpart C, Additional Protections for Prisoners in Research

Research involving prisoners requires special ethical and regulatory considerations. Recognizing that incarceration may limit an individual’s ability to make fully voluntary decisions about research participation, subpart C of 45 CFR 46 establishes additional safeguards for prisoners who are involved in HHS-conducted or HHS-supported research.

Who Is Considered a “Prisoner”?

Under subpart C, a “prisoner” is any individual involuntarily confined or detained in a penal institution. This definition includes individuals sentenced under criminal statutes, detained pending trial or sentencing, and persons detained under other legal procedures that provide alternatives to incarceration, such as a substance abuse treatment center.

Key Requirements for IRB Review

When research involves prisoners, Institutional Review Boards (IRBs) must meet additional requirements beyond those found in the Common Rule (45 CFR 46 Subpart A). The IRB reviewing the research must include a prisoner or prisoner representative with appropriate background and experience. In addition, a majority of IRB members (excluding prisoner members) must have no association with the prison involved in the research.

Before approving a study, the IRB must make specific findings, including that:

• The research falls within one of the categories of permissible prisoner research.
• Any advantages offered to prisoner participants are not so great that they could impair voluntary decision-making.
• Risks are comparable to those accepted by non-prisoner volunteers.
• Subject selection procedures are fair and immune from arbitrary intervention by prison authorities or prisoners.
• Information is presented in language understandable to participants.
• Participation will not be considered in parole decisions.
• Appropriate follow-up care is available when needed.

Permissible Categories of Research

Subpart C limits prisoner research to specific categories, including studies of incarceration, prisons as institutions, conditions particularly affecting prisoners as a class, and certain research intended to improve the health or well-being of prisoner participants.

Certification Responsibilities

For HHS-supported or conducted research involving prisoners, institutions must certify to OHRP that the IRB has fulfilled the requirements of subpart C. In most cases, OHRP authorization is required before the research may proceed, and a response is generally issued within a week.

Important Reminders

Investigators should promptly notify the IRB if a currently enrolled participant becomes incarcerated during an HHS-supported or conducted study. Subpart C protections will apply, and continued participation will require IRB approval and certification to OHRP.

By understanding and implementing the requirements of subpart C, investigators and IRBs help ensure that prisoner participants receive the additional protections necessary to safeguard their rights and welfare in research.

For more information, see OHRP’s FAQ's on Prisoner Research at
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/prisoner-research/index.html