Draft NIH Biosafety Policy for Research Involving Biohazards

Your project may require review under the proposed policy if it involves:

• Wild-type biological agents (i.e., bacteria, viruses, fungi, or parasites) that cause disease in humans;
• Cells, viruses, or organisms, other than plants, that have been genetically modified;
• Toxins, prions, and other self-aggregating proteins; or 
• Cells or organisms, other than plants, containing 1, 2, or 3 above.

Not sure? Contact the Institutional Biosafety Committee Office at biosafety@drexel.edu.

Review Current and Planned Research

Evaluate whether research involves:

• Wild-type biological agents (i.e., bacteria, viruses, fungi, or parasites) that cause disease in humans;
• Cells, viruses, or organisms, other than plants, that have been genetically modified;
• Toxins, prions, and other self-aggregating proteins; or 
• Cells or organisms, other than plants, containing 1, 2, or 3 above.

Help Shape Drexel's Response to the Draft NIH Biosafety Policy

The proposed Draft NIH Biosafety Policy for Research Involving Biohazards has the potential to significantly impact research oversight, Institutional Biosafety Committee (IBC) operations, protocol review processes, public transparency requirements, incident reporting, and investigator responsibilities. NIH is actively seeking input from the research community before finalizing the policy. 

To ensure Drexel's response reflects the perspectives and experiences of our research community, the Biosafety Office is collecting feedback from investigators, laboratory personnel, and other stakeholders.

Your feedback matters! Investigator input will help Drexel evaluate the practical implications of the proposed policy and advocate for regulatory approaches that support both scientific innovation and responsible biosafety oversight.

Complete the Drexel Biosafety Survey

Drexel researchers are encouraged to complete the Draft NIH Biosafety Policy Investigator Survey to:

• Evaluate how the proposed policy may affect ongoing and future research activities
• Identify operational and administrative challenges associated with implementation
• Assess potential impacts on IBC review, biosafety oversight, and compliance processes
• Understand anticipated resource, training, and infrastructure needs
• Gather recommendations for NIH regarding the draft policy
• Support the development of a comprehensive Drexel comment submission on behalf of the research community

Feedback collected through the survey will help inform Drexel's institutional review and the development of consolidated comments submitted on behalf of the Drexel research community.

Who should participate?

• Principal Investigators
• Co-Investigators
• Laboratory Directors
• Study Teams
• Animal Research Personnel
• Clinical Research Personnel
• Graduate Students and Postdoctoral Researchers working with biohazardous materials
• Professional Staff
• Institutional Biosafety Committee Members

Survey Information

Estimated Completion Time: 5-7 minutes

Number of Questions: 

• 10 multiple choices 
• 4 open ended (optional)
• 14 total

Survey Deadline

The survey will close on October 10, 2026.  

Survey Link

Draft NIH Biosafety Policy Investigator Survey

Submit Comments Directly to NIH

In addition to participating in the Drexel survey, investigators and community members are encouraged to submit comments directly to NIH.

NIH welcomes feedback from researchers, biosafety professionals, institutional officials, animal research programs, and members of the public regarding all aspects of the draft policy, including: 

• Policy scope
• Risk assessment framework
• Risk Groups and Biosafety Levels
• Structure of biosafety oversight
• Institutional Biosafety Committee responsibilities
• Compliance and enforcement mechanisms
• Transparency requirements
• Incident reporting requirements
• Draft templates and implementation guidance 

NIH Public Comment Deadline

• October 19, 2026 

NIH Comment Portal

• https://osp.od.nih.gov/comment-form-draft-nih-biosafety-policy-for-research-involving-biohazards

Nearly 50 years after establishing the original recombinant DNA guidelines, NIH is proposing a comprehensive biosafety framework intended to:

• Modernize biosafety oversight to address contemporary research practices.
• Expand oversight beyond recombinant and synthetic nucleic acid research.
• Improve transparency and public accountability.
• Strengthen the role of Institutional Biosafety Committees (IBCs).
• Align biosafety oversight more closely with other institutional compliance programs, including Institutional Review Boards (IRBs) and Institutional Animal Care and Use Committees (IACUCs).
• Reduce administrative burden for lower-risk research while increasing attention to higher-risk activities. 

Current NIH Guidelines

The existing NIH Guidelines primarily apply to research involving recombinant or synthetic nucleic acid molecules conducted at NIH-supported institutions. 

Proposed NIH Biosafety Policy

The draft policy would apply to NIH-supported biomedical research conducted in laboratory settings involving known or potential biohazards, including:

• Wild-type biological agents that cause disease in humans
• Genetically modified cells, viruses, and organisms (excluding plants)
• Toxins
• Prions and other self-aggregating proteins
• Cells or organisms containing any of the above materials

This represents a substantial expansion beyond the current scope of the NIH Guidelines. 

Institutional Assurances

Under the draft policy:

• Institutions would submit a formal Biosafety Assurance through their Authorized Organizational Representative.
• NIH approval would be required.
• Assurances would remain valid for four years.
• Institutions would maintain publicly accessible information on biosafety programs and current IBC membership.
• Annual NIH IBC roster submissions would no longer be required. 

Enhanced Transparency Requirements

The draft policy introduces significantly expanded public transparency requirements.
Institutions would be required to:

• Post IBC meeting minutes on a public-facing website.
• Post biosafety incident reports on a public-facing website.
• Maintain public access to these records for specified retention periods.
• Use NIH-required templates for both meeting minutes and incident reporting. 

Incident Reporting

The proposed policy establishes new reporting thresholds.

Incidents Requiring NIH Notification

Examples include:

• Confirmed or potential laboratory-acquired infections (LAIs)
• Loss of containment with potential community risk
• All incidents occurring at BSL-3/ABSL-3 or BSL-4/ABSL-4
• Certain BSL-2 exposures requiring agent-specific medical treatment
• Biosafety compliance violations

These incidents would require rapid notification to NIH, followed by comprehensive reporting. 

Institutional-Only Reporting

Some lower-risk incidents would be reviewed and managed internally, including:

• Animal bites, scratches, and escapes involving research covered by the policy at BSL-1 or BSL-2.
• Minor incidents requiring only basic first aid.
• Certain low-risk containment events.

These incidents would still require institutional documentation and public posting. 

Delegated IBC Review

A notable change is the introduction of delegated review authority for certain lower-risk research activities.

Examples include:

• Research involving Risk Group 2 wild-type biological agents
• Genetically modified Risk Group 1 agents
• Certain transgenic organism research
• Research involving well-characterized cell lines
• Research involving low-risk plasmids and viral vectors
• Non-select-agent toxin proteins

This flexibility is intended to streamline review of lower-risk activities while maintaining oversight. 

Clinical Research Oversight

Under the proposed policy, IBC review would be required for certain clinical research involving:

• Replicating products
• Shedding products
• Integrating products
• Higher-risk product manipulations
• Risk Group 2 or higher wild-type biological agents

The draft policy focuses IBC oversight on biosafety-related risks associated with human participant research. 

Lowering Containment Levels

The proposal establishes a risk-based framework for determining when NIH approval is required for work conducted below standard containment recommendations.

Depending on the biological agent and associated risk:

• NIH approval may be required.
• IBC approval alone may be sufficient.
• Previously approved NIH determinations may be used in some circumstances. 

Research Involving Genetically Modified Plants

Unlike the current NIH Guidelines, genetically modified plants and plant pathogens that do not cause human disease would generally fall outside the scope of the proposed policy. 

Drexel University is actively evaluating the proposed policy and potential impacts on biosafety oversight.

Current activities include:

• Reviewing draft policy requirements
• Evaluating impacts on IBC procedures
• Assessing institutional transparency requirements
• Reviewing incident reporting workflows
• Evaluating investigator training needs
• Evaluating staffing needs
• Monitoring NIH implementation guidance
• Coordinating across compliance and research administration offices

Institutional Biosafety Committee (IBC) Office

biosafety@drexel.edu

Contact for:

• Biosafety determinations
• IBC review requirements
• Policy interpretation
• Investigator guidanc
• Implementation questions

Environmental Health & Radiation Safety (EHRS)

ehrs@drexel.edu

Contact for:

• Laboratory biosafety
• Containment requirements
• Incident response
• Risk mitigation practices