Biosafety and Biosecurity Policy

Life sciences research thrives in environments that are safe and secure. To ensure responsible progress, strong biosafety practices and policies must be embedded at every stage of the research lifecycle. OSP develops and helps ensure effective implementation of biosafety and biosecurity policies to safeguard the benefits of life sciences research while reducing the risk of misuse.

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FAQs and Fact Sheets

Optimizing Security of Biological Research

United States federally funded research must benefit American citizens without jeopardizing our Nation’s security, strength, or prosperity.  This requires balancing the prevention of catastrophic consequences with maintaining readiness against biological threats and driving global leadership in biotechnology, biological countermeasures, biosecurity, and health research.

The Federal Government has issued the United States Government Policy for Stopping High-Risk Life Sciences Research. This policy implements a comprehensive, risk-based framework that strengthens accountability, transparency, enforcement, and oversight across the Federal government. It includes explicit prohibitions on two broad categories of the highest risk life sciences research: dangerous gain-of-function research (DGOF) and international research of concern (IROC), as defined in the USG Policy.

All research activities identified as potential dangerous gain-of-function research per NOT-OD-25-127 and NOT-OD-25-112 remain paused until NIH specific implementation requirements are established.

 

USG Policy and Executive Order

 

NIH Policies and Announcements

The policies and announcements below provide NIH-specific details on implementation of the above Executive Orders and policies. NIH will continue to provide updates as additional implementation details are available.

 

Additional Resources

ASPR High Consequence Research Oversight

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.

NEW: Implementation Update: Promoting Maximal Transparency Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

All IBC minutes resulting from meeting taking place on or after June 1, 2025, must be posted on a public-facing institutional website.  For more information, please see the guidance below. Updated FAQs on IBC meetings and minutes are available along with a new resource that details Points to Consider when generating IBC meeting minutes and includes an IBC Minutes Template to assist IBCs in producing meeting minutes that adequately document fulfillment of their biosafety review and oversight responsibilities:

Incident Reporting

The NIH Guidelines require that any significant problems, violations, or any significant research-related accidents and illnesses” be reported to OSP within 30 days. Appendix G of the NIH Guidelines specifies certain types of accidents that must be reported on a more expedited basis. Specifically, Appendix G-II-B-2-k requires that spills and accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to the OSP (as well as the IBC). In addition, Appendices G-II-C-2-q and G-II-D-2-k require that spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to OSP (as well as the IBC and BSO).

*Incident reports may be released to the public in full. Please note that incident reports should not include personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in the report.  If it is necessary to include such information, please clearly mark it as such so that it can be considered for redaction in accordance with Freedom of Information Act exemptions.*

IBC RMS and Registration Information

The Institutional Biosafety Committee Registration Management System (IBC-RMS) supports the online submission of IBC registrations and annual registration updates. IBC-RMS users can access the system to keep track of their institution’s registration status, view IBCs currently registered with OSP, and access important compliance guidance relating to the NIH Guidelines. The IBC-RMS also allows users to send policy questions directly to OSP through the Web interface.

IBC Self-Assessment Tool

Investigator Brochure

Modernizing and Strengthening Oversight of Biosafety

On September 2025, NIH launched its Biosafety Modernization Initiative to strengthen biosafety policies, practices, and oversight to keep pace with the evolving risks posed by today’s rapidly advancing science and technology.

Since then, NIH has been engaging stakeholders to inform the development of the draft biosafety policy that, when finalized, will replace the current NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).

On August 19, NIH released its Draft Biosafety Policy for Research Involving Biohazards (NIH Biosafety Policy) for public comment:

Comments on the above will be accepted until October 19, 2026, and must be submitted at the online portal found here. In addition, NIH released a set of FAQs and a table of the major changes being proposed.

Additional Resources

 

NIH has conducted a rigorous public engagement program since announcing the launch of the Biosafety Modernization Initiative. This included six-regional listening sessions which have been viewed more than 4,000 times on NIH Videocast. We also engaged professional societies, trade associations, individual Institutional Biosafety Committees (IBC) and many others throughout the course of the draft policy development process. In addition, NIH launched a Biosafety Badge (link)where interested parties could provide on-demand 24/7 feedback and suggestions to help inform the draft policy. Between the feedback received at the regional listening sessions, and through submission via the Biosafety Badge, NIH received over two hundred comments that were considered while developing the draft policy.

Summaries of all the engagements referenced above can be found here.

NIH has approached the Biosafety Modernization Initiative in phases. Currently, we are in Phase III as described in the continued plan of action found below. As we continue this process we are committed to ensuring:

  • Transparency in how we communicate and carry out our work
  • Open and inclusive dialogue, including a willingness to challenge the status quo
  • Multiple methods of engagement, actively seeking input from both experts and the public

 

 

Links to Other Biosafety Resources

Additional Resources