White House Issues Executive Order on Improving the Safety and Security of Biological Research

On May 5, 2025, President Trump issued an Executive Order on Improving the Safety and Security of Biological Research, which pauses dangerous research that could or will make a naturally occurring pathogen or toxin more dangerous to American citizens, and directs the Director of the Office of Science and Technology Policy (OSTP) and the National Security Advisor to work with funding agencies to develop such a policy within 120 days. This new Policy is intended to replace the 2024 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC/PEPP Policy) and supersedes its implementation at NIH previously set to take effect today.

NIH will work closely with OSTP and our federal partners to ensure the safe and secure conduct of biological research. NIH will also provide more guidance regarding implementation of this Executive Order in the coming weeks.

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NIH Issues Agency Implementation Information on U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential

NIH has issued agency specific information regarding its implementation of the U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.  The policy, which goes into effect May 6, 2025, is a unified federal oversight framework for conducting and managing certain types of federally funded life sciences research on biological agents and toxins.

The implementation information can be found at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-061.html. NIH will continue to provide updates as additional implementation details are finalized.

Questions may be sent to [email protected]  

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NIH Releases New Public Access Policy and Supplemental Guidance; Releases Plan for Metadata and Personal Identifiers (PIDs)

Today, NIH is releasing its new 2024 Public Access Policy along with supplemental guidance on government license use and rights and publication costs. The final Public Access Policy builds upon NIH’s long history of providing public access to scholarly publications, and it details steps to accelerate access, particularly through removal of the current twelve-month embargo period before manuscripts are made freely available to the public.   

The policy was developed after significant public engagement and feedback and is in keeping with the 2022 Memo Ensuring Free, Immediate, and Equitable Access to Federally Funded Research.  The 2024 Public Access Policy is effective for manuscripts accepted for publication on or after December 31, 2025. Until then, NIH’s current Public Access Policy remains in effect.

In addition to the release of the 2024 Public Access Policy, NIH is also releasing its Plan on Metadata and Personal Identifiers (PIDs) for public comment. The plan outlines how researchers and institutions should be using metadata and PIDs, and also outlines proposed requirements for NIH-supported repositories to collect and make relevant metadata publicly available and searchable. 

To view the Plan and provide comments please utilize the portal found here.  Comments will be accepted until February 21, 2025

For additional context on these releases, please see a statement made today by NIH Director, Dr. Monica Bertagnolli, and an Under the Poliscope blog co-authored by Dr. Lyric Jorgenson and Dr. Stephen Sherry. 

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Reaffirming NIH’s Commitment to Scientific Integrity

Dr. Lyric Jorgenson has co-authored this blog with NIH Deputy Director for Intramural Research, Dr. Nina Schor, NIH Deputy Director for Extramural Research, Dr. Michael Lauer and NIH Deputy Director for Management, Dr. Alfred Johnson 

The final policy incorporates and is responsive to the principles and directives of the Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based PolicymakingProtecting the Integrity of Government Science, and A Framework for Federal Scientific Integrity Policy and PracticeThe end goal of these efforts was to institutionalize a culture of scientific integrity across the federal government by requiring that agencies either develop or update their existing policies.

As you are most likely aware, NIH has for many years been a leader in promoting practices, policies, and procedures that help ensure the research it funds and conducts is done in accordance with the highest possible standards.  We already have in place a suite of complementary efforts to protect the integrity of research processes from bias and interference.  These efforts rely on transparent processes, diverse community engagement, management of real or apparent conflicts of interest, and robust and open dialogue.

However, we did see opportunities where we could strengthen our existing system.  These areas are articulated in the final policy and include:

  • Defining the term “scientific integrity” for consistent use across the U.S. Government
  • Establishing the new positions of NIH Chief Scientist and NIH Scientific Integrity Official and defining the roles and responsibilities of these positions
  • Establishing the NIH Scientific Integrity Council to coordinate scientific integrity activities across the Agency; and
  • Adding additional protections against inappropriate political interference

The above measures, in concert with NIH’s existing policies and procedures, will foster scientific integrity, by helping to ensure that (1) research findings are objective, credible, and readily available to the public, and (2) policies and programs are developed and implemented in a transparent, accountable, and evidence-based manner.

It is vital to recognize that the final policy is grounded in the philosophy that all NIH staff, and everyone within the biomedical research enterprise. have a role to play in supporting the integrity of the research we fund, conduct, manage, communicate, or use.  As such, all NIH researchers and staff are expected to: 

  • Foster an organizational culture of scientific integrity.
  • Protect the integrity of the research process, and
  • Communicate science with integrity.

The Final NIH Scientific Integrity Policy will go into effect December 30, 2024. To ensure that NIH stays a leader in this space, we will reevaluate the policy one year after the effective date and then every two years after that. 

Finally, to mark this occasion, Dr. Monica Bertganolli has issued a NIH Director’s statement which can be found at https://www.nih.gov/about-nih/who-we-are/nih-director/statements/ensuring-trust-science-nih-s-commitment-scientific-integrity.

Lyric Jorgenson, PhD
NIH Associate Director for Science Policy
About Lyric