The U.S. Department of Health and Human Services is Updating its Policies on Research Integrity to Meet the Demands of the Modern Research Environment

September 17, 2023 | By: Sheila Garrity J.D. M.P.H. M.B.A, Director of the Office of Research Integrity, Office of the Assistant Secretary for Health, Department of Health and Human Services

Summary: ORI Releases the 2024 Public Health Service Policies on Research Misconduct

The Office of Research Integrity (ORI) has issued the 2024 Final Rule to update the 2005 Public Health Service (PHS) Policies on Research Misconduct. The 2024 updates to the Final Rule establish requirements for addressing research misconduct in PHS-funded research. In addition, it clarifies ORI’s regulatory oversight responsibilities and outlines the role of PHS-funded organizations in institutionalizing research integrity. 

“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,” ORI Director Sheila Garrity said upon the release of the new regulation. “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.” 

From research on cancer and vector-borne diseases to the health impacts of climate change, PHS-funded research tackles the most pressing health issues, improving public health across the globe. ORI’s mission is to preserve research integrity and scientific advancements that improve public health in the U.S and worldwide. As the research landscape continues to evolve, ORI’s approach to protecting crucial, pioneering scientific advancements is evolving to meet the needs of the research community.

Developing a New Regulation for A New Era 

The research landscape has changed dynamically over the past 20 years. Technology, scientific advances, and the globalization of research have necessitated an updated regulation. More than ever, research collaborations know no borders. Research is no longer done in a silo with a single funding source. The 2024 Final Rule is meant to respond to the demands of the evolving research environment and was drafted in response to the public comments from ORI’s Notice of Proposed Rule Making and internal review. 

Researchers work in complex environments, and institutions need clear, flexible, and transparent regulations to foster research integrity within research communities. The 2024 Final Rule balances the needs of the research community and ORI’s oversight responsibilities.

Details about the Updated Final Rule

The 2024 Final Rule includes the following updates to the 2005 regulation.

The new regulation streamlines institutional responsibilities in the general conduct of misconduct proceedings by:

• Clarifying institutional confidentiality obligations and identifying areas of institutional discretion, such as notifying journals to correct the research record due to a finding of research misconduct.
• Providing a clearer description of research misconduct investigation requirements, distinguishing requirements for transcribed interviews, pursuing leads and addressing situations involving multiple respondents. 

The new regulation also recognizes institutional best practices and establishes realistic timelines by:

• Acknowledging institutional discretion to make determinations of honest error and the application of subsequent use exception when evidence of misconduct occurred. 
• Describing the institutional assessment as a pre-investigation phase within the purview of institutional best practices and realistic timelines—while clarifying institutional documentation requirements for ORI oversight.   
• Extending the timeline of institutional inquiries from 60 to 90 days. The new regulation also clarifies that formal transcribed interviews are not required during assessments and inquiries.
• Highlighting that institutional findings are separate from ORI findings and clarifying institutional discretion to publish findings if they so choose. 

In addition, the 2024 Final Rule provides a clear appeal process and administrative remedies for respondents and adds commonly used definitions in order to highlight how these concepts are applied.

The Final Rule is effective January 1, 2025, and all regulations in the Final Rule apply to PHS-funded institutions 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 policies and procedures specific to your institution; and implementing policies and procedures when the Final Rule goes into effect. As part of their assurance, institutions that receive PHS funding must submit new policies and procedures complying with the Final Rule with their 2025 Annual Report, which is due April 30, 2026. Other stakeholders in the research community should review the Final Rule to understand how it may impact research misconduct proceedings and compliance efforts for PHS-funded research.

ORI will be holding a webinar for stakeholders on Friday, September 20 at 11 am EST. Register for the webinar here.  

As part of the Paperwork Reduction Act, ORI will seek public comment for information collections contemplated by the Final Rule. A notice will go out 60 days prior to the effective date of the rule, which is January 1, 2025. Following this 60-day period, the public will have an additional 30-day period for comment.

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