09/12/2024 | Press release | Distributed by Public on 09/12/2024 07:25
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:
"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.