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.

 

External Resources

For information on policies related to dual use research of concern and enhanced potential pandemic pathogens please see:

https://aspr.hhs.gov/S3/Pages/High-Consequence-Research-Oversight.aspx

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

NIH is launching a new 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. As part of this initiative, NIH will modernize our existing biosafety policy to holistically address the emergent biosafety needs of today.

NIH will also strengthen our partnerships with institutional oversight bodies to empower Institutional Biosafety Committees, reinforcing their position as the front line of local oversight, akin to other oversight structures like Institutional Review Boards and Institutional Animal Care and Use Committees required for ensuring a safe, responsible research ecosystem.

The goal is to fulfill NIH’s commitment to ensuring that gold standard science is conducted under gold standard biosafety conditions, ushering in a more effective, transparent, and modern biosafety system.

Timeline

The Biosafety Modernization Initiative will unfold over the next year, with regular opportunities for the public and expert engagement nationwide. For this initiative, we will prioritize:

  • 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

We’re also taking a phased approach – see below for key milestones and what to expect at each stage.

Engagement Opportunities

NIH will engage early and often, implementing a comprehensive outreach and engagement strategy to ensure that 21st century biosafety oversight meets the research needs of both today and tomorrow. To support this effort, NIH will initially host focus groups across the country to discuss the shift from a technique-based to a risk-based biosafety framework.

Engagements:

 

Contact Us

We encourage our stakeholders to share their feedback on biosafety modernization at any time. To get in touch, please email us at [email protected].

Links to Other Biosafety Resources

Additional Resources