HHS Finalizes Rule on Research Misconduct to Foster Research Integrity

ORI issued the 2024 Public Health Service Policies on Research Misconduct to increase transparency, efficiency, and objectivity in research misconduct proceedings

Today, the U.S. Department of Health and Human Services, through the Office of Research Integrity (ORI), finalized the 2024 Public Health Service (PHS) Policies on Research Misconduct. This rule updates the 2005 regulation and clarifies requirements for addressing research misconduct in 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."

This updated regulation clarifies both ORI's regulatory oversight responsibilities and the role of PHS-funded organizations in institutionalizing research integrity in addition to refining requirements for addressing research misconduct in PHS-funded research.

"ORI's role in overseeing research integrity activities for PHS funding is critical to ensuring pioneering research is conducted with integrity," said 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."

The 2024 Final Rule highlights several major updates to the 2005 regulation:

• Streamlining 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, the pursuit of leads, and addressing situations involving multiple respondents.
• Recognizing institutional best practices and 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 updated 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.
• Providing a clear appeal process and administrative remedies for respondents.
• Adding commonly used definitions to clearly highlight how these concepts are applied by ORI when conducting oversight of research misconduct proceedings.

"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 takes effect January 1, 2025, and becomes applicable on January 1, 2026. In the coming months, ORI plans to release sample policies and guidance to help prepare PHS-funded entities. The Final Rule can be found here https://www.federalregister.gov/public-inspection/2024-20814/public-health-service-policies-on-research-misconduct.

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