Scientific breakthroughs from PHS-funded research save countless lives worldwide through research on cancer, vector-borne diseases, and the health effects of climate change. ORI’s mission is to preserve the integrity of these scientific advancements that improve public health in the U.S. and across the globe. As scientific research continues to evolve, ORI’s work to protect these important advancements is evolving, too.

The research landscape changed dynamically over the past 20 years. Technology, scientific advances, and the globalization of research necessitated an updated regulation. More than ever, research knows no borders. HHS is releasing the 2024 Final Rule on Public Health Service Policies on Research Misconduct to promote the responsible conduct of research across PHS-Funded agencies and organizations. The new regulation is displayed here: https://www.federalregister.gov/public-inspection/2024-20814/public-health-service-policies-on-research-misconduct

Researchers work in complex environments and need clear, flexible, and transparent regulations. The 2024 Final Rule balances the needs of the research community and ORI’s oversight responsibilities. The Final Rule was drafted in response to the public comments on the Notice of Proposed Rule Making and internal review. The 2024 Final Rule clarifies the 2005 regulation by providing:

• Clearer assurance, compliance, and research misconduct processes for institutions to follow.
• An expanded list and clarifications of commonly used terms.
• A streamlined appeals process for respondents who wish to challenge ORI’s findings of research misconduct and proposed HHS administrative actions.

Fostering a world where we build trust in science together is the kind of world we want to live in and a world we want to leave for future generations. The applicable date of ORI’s Final Rule is
January 1, 2026. Institutions play a crucial role in upholding research integrity and can prepare for the Final Rule by: Reviewing forthcoming sample policies, procedures, and guidance, drafting institution-specific policies and procedures and implementing policies and procedures when the Final Rule becomes applicable.

A webinar providing details on the Final Rule will occur on
September 20, 2024. Visit ori.hhs.gov for further details when they are available.

ORI is making history by preserving the integrity of PHS-funded research with the updated regulation. Our work is essential to the groundbreaking science that saves lives in the US and across the world.

Sheila Garrity, JD MPH MBA
Director, Office of Research Integrity