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Statement  Tuesday, September 9, 2025

NIH Launches Initiative to Modernize and Strengthen Biosafety Oversight

As the world’s largest public funder of biomedical research, NIH is committed to ensuring that gold-standard science is conducted under gold-standard biosafety conditions. Today, NIH is launching its Biosafety Modernization Initiative – a comprehensive effort to modernize and strengthen biosafety policies, practices, and oversight to keep pace with the evolving risks posed by today’s rapidly advancing science and technology.

Nearly 50 years ago, NIH introduced the foundational Guidelines for Research Involving Recombinant DNA Molecules, which established the biosafety framework for much of today’s research enterprise. However, the increasingly multi-disciplinary, cross-sector, and global nature of modern science calls for a paradigm shift.

In the coming months, NIH will work closely with the research community and stakeholders to create the biosafety framework of the 21^st century. First, NIH will revamp biosafety oversight to address potential risks beyond recombinant or synthetic nucleic acid technologies. At the same time, the widespread use of certain low-risk recombinant technologies may no longer warrant the oversight once deemed necessary, allowing us to reduce red tape for some research.

Second, NIH will strengthen our partnerships with institutional oversight bodies to empower Institutional Biosafety Committees (IBC), reinforcing their position as the front lines of biosafety oversight. This will also provide an opportunity for institutional leadership to reassess whether their IBCs are receiving support and resources equal to other institutional committees, such as those who review human subjects research and the care and use of animals.

By leading with these pillars, we can usher in a more effective, transparent, and modern biosafety system.

The work ahead is significant, and we will soon post opportunities to engage at . I look forward to hearing your ideas on how NIH can safely guide the next 50 years of groundbreaking research to improve health for all.

Dr. Jay Bhattacharya
NIH Director

About the ľ¹ÏÖ±²¥ (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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