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 Initiates Access Planning Efforts within Intramural Research Program

NIH is issuing an Intramural Research Program (IRP) policy to promote access to IRP-supported inventions resulting in drugs, biologics, vaccines, or devices. As of June 1, 2025, organizations applying to NIH for certain commercial patent licenses will be required to submit Access Plans to NIH outlining steps they intend to take to promote patient access to those licensed products. NIH will continue working with industry partners to develop additional resources and guidance in support of these efforts. 

For more information see https://osp.od.nih.gov/policies/innovation-and-translation#tab1/

Questions may be sent to [email protected]  

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The Twelve Days of (OSP) Christmas

The Twelve Days of (OSP) Christmas
Lyrics by: An old friend of OSP

On the first day of Christmas in science policy,
We started our engagement strategy!

On the second day of Christmas in science policy,
Terminology in clinical research,
And we started our engagement strategy.

On the third day of Christmas in science policy,
An AI policy resource, terminology in clinical research,
And we started our engagement strategy.

On the fourth day of Christmas in science policy,
Scientific integrity, an AI policy resource, terminology in clinical research,
And we started our engagement strategy.

On the fifth day of Christmas in science policy,
ENGAGE is the best acronym!!
Scientific integrity, an AI policy resource, terminology in clinical research,
Now we’ve named our engagement strategy.

On the sixth day of Christmas in science policy,
We honored Tuskeegee survivors,
ENGAGE is the best acronym!!
Scientific integrity, an AI policy resource, terminology in clinical research,
On the road with our engagement strategy!

On the seventh day of Christmas in science policy,
Rolled out the new DURC policy,
Honored Tuskeegee survivors,
ENGAGE is the best acronym!!
Scientific integrity, an AI policy resource, terminology in clinical research,
And implementing the engagement strategy.

On the eighth day of Christmas in science policy,
New language in informed consent.
Rolled out new DURC policy, honored Tuskeegee survivors,
ENGAGE is the best acronym!!
Scientific integrity, an AI policy resource, terminology in clinical research,
And even more engagement strategy!

On the ninth day of Christmas in science policy,
Hired awesome summer interns, informed consent language,
Rolled out new DURC policy, honored Tuskeegee survivors,
ENGAGE is the best acronym!!
Scientific integrity, an AI policy resource, terminology in clinical research,
Talked to more folks about engagement strategy!

On the tenth day of Christmas in science policy,
Went to Geneva for the BWTC,
Awesome summer interns, informed consent language,
Rolled out new DURC policy, honored Tuskeegee survivors,
ENGAGE is the best acronym!!
Scientific integrity, an AI policy resource, terminology in clinical research,
Still excited about engagement strategy!

On the eleventh day of Christmas in science policy,
Public access policy!
Geneva is expensive, awesome summer interns, informed consent language,
Rolled out new DURC policy, honored Tuskeegee survivors,
ENGAGE is the best acronym!!
Scientific integrity, an AI policy resource, terminology in clinical research,
Have I mentioned our engagement strategy?

On the twelfth day of Christmas in science policy,
Jessica Tucker is named Deputy!
Public access policy, diplomacy in Geneva, awesome summer interns, informed consent language,
Rolled out new DURC policy, honored Tuskeegee survivors,
ENGAGE is the best acronym!!
Scientific integrity, an AI policy resource, terminology in clinical research,
And continued our engagement strategy!

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

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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