Month: June 2025

NIH and FDA Publish Glossary of Clinical Research Terms Related to Innovative Clinical Trial Design

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The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) have published a new glossary of clinical research terms related to innovative clinical trial design, including studies using real-world data to generate real-world evidence. This glossary is intended to facilitate communication within the clinical research community by establishing a common vocabulary.

The glossary can be viewed here. In addition, leaders from both NIH and FDA have authored an article published in JAMA Network Open that describes the joint agency effort.

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NIH Implementation of Executive Order on Improving the Safety and Security of Biological Research

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Pursuant to the May 5, 2025, Executive Order on Improving the Safety and Security of Biological Research, NIH is requiring all NIH awardees to review their research portfolios to identify NIH funding and other support for projects meeting the definition of dangerous gain-of-function research. Review must be complete by June 30, 2025. NIH will also be suspending or terminating awards as directed by Executive Order. For more information please see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-127.html

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Institutional Biosafety Committee (IBC) Transparency 101

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Summer is here!  Like many of you, I have been counting down the days.  In fact, I have been thinking so hard about summer, that I neglected to acknowledge a big milestone.  My last post, in April, was the 100th Under the Poliscope blog! Since we missed the centennial, we are just going to have to celebrate the 101st post (or whatever one calls the 101st of something). 

The beginning of this summer also features some important activities related to biosafety and its oversight.  Right here in our own backyard, Maryland Governor Wes Moore issued a proclamation announcing June 4, 2025, as “Biosafety Day” across the Old Line state.  In addition, NIH has also implemented some transparency enhancements  for biosafety oversight at NIH-supported institutions. 

For those not as familiar with IBCs, these are the committees that are responsible for local biosafety oversight. Over time, IBCs have also taken on increasing responsibility for reviewing a variety of experimentation that involve biological materials. As you might be able to infer, this critical activity demands the highest levels of transparency. 

With that in mind, and the fact that this is blog number 101, I wanted to provide a primer for members of the public on the mechanisms IBCs can utilize to ensure research is conducted safely and transparently.  I hope you find this information helpful!

Resources Referenced

Lyric Jorgenson, PhD
NIH Associate Director for Science Policy
About Lyric
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NIH Strengthens Transparency Measures for Institutional Biosafety Committees

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Institutional Biosafety Committees (IBCs) serve as a critical linchpin in ensuring the safe and responsible conduct of research.  As such they are essential in building public trust on behalf of the biomedical research enterprise.

Effective June 1, 2025, and as announced on March 28, 2025:

  • The NIH Office of Science Policy (OSP) has posted the rosters of all active and registered IBCs via the IBC-Registration Management System. Rosters include contact information for the IBC Chair, Biological Safety Officer, and IBC Contact.
  • Approved meeting minutes from all IBC meetings occurring on, or after, June 1, 2025, must be posted publicly on an institutional website. It is NIH’s expectation that minutes will be posted immediately after approval and once all appropriate and allowable redactions have been made. 

To assist institutions, NIH has revised its FAQs on IBC Meetings and Minutes and has also issued new guidance, IBC Meeting Minutes Template and Points to Consider, to assist IBCs in producing meeting minutes that document fulfillment of its oversight responsibilities.  

Questions may be sent to [email protected]

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