The U.S. Department of Health and Human Services (HHS), through the Office of Research Integrity (ORI), has finalized the 2024 Public Health Service (PHS) Policies on Research Misconduct. This new rule updates the 2005 regulation, aiming to enhance transparency, efficiency, and objectivity in research misconduct proceedings for PHS-funded research.
“The research landscape has changed over the past 20 years, thanks to new technology, scientific advances, and the globalization of research. To preserve the integrity of the research that we help to fund, it is necessary to update the regulations around how that research is conducted. And that is what we are doing today,” said HHS Secretary Xavier Becerra. “The Biden-Harris Administration continues to support cutting-edge research to help discover novel treatments for various illnesses, including cancer, and to address the health effects of climate change. The successful results of this work save countless lives worldwide and helps to improve the health and well-being of all Americans.”
The updated regulation clarifies ORI’s regulatory oversight responsibilities and outlines the role of PHS-funded organizations in maintaining research integrity while refining requirements for addressing misconduct.
“ORI’s role in overseeing research integrity activities for PHS funding is critical to ensuring pioneering research is conducted with integrity,” stated Admiral Rachel Levine, Assistant Secretary for Health. “The 2024 Final Rule aims to increase collaboration, transparency and efficiency in an ever-evolving research landscape that is much needed to bring life-saving treatments and interventions to those who need it the most.”
Key updates include streamlining institutional responsibilities during misconduct proceedings by clarifying confidentiality obligations and identifying areas where institutions have discretion. The rule also provides a clearer description of investigation requirements and distinguishes between transcribed interviews, pursuit of leads, and situations involving multiple respondents.
Additionally, it recognizes institutional best practices by acknowledging discretion in determining honest errors and applying subsequent use exceptions when evidence of misconduct exists. It describes institutional assessments as pre-investigation phases within realistic timelines while extending inquiry timelines from 60 to 90 days.
The rule also provides a clear appeal process and administrative remedies for respondents while adding commonly used definitions relevant to ORI's oversight functions.
“The research landscape has changed over the past 20 years with new technology, scientific advances, and globalization, which increases the need for ORI to remain nimble and collaborative. ORI is committed to keeping up with the needs of the research community,” said ORI Director Sheila Garrity. “The Final Rule aims to adapt to our current time, support our colleagues in the research community, and fortify ORI’s role in fostering research integrity and preserving public trust in science for future generations.”
The Final Rule will take effect on January 1, 2025, becoming applicable on January 1, 2026. In preparation for its implementation, ORI plans to release sample policies and guidance documents.
