Dangerous Gain of Function (DGoF) Research: High-Risk Life Sciences research

The United States Government issued the Policy for Stopping High-Risk Life Sciences Research [PDF] on July 20, 2026. The policy establishes new requirements for identifying, reviewing, and overseeing certain life sciences research activities that may present significant risks to public health, public safety, agriculture, economic security, or national security.

The policy creates a new oversight framework for:

• Dangerous Gain-of-Function (DGOF) Research
• Potential DGOF Research
• International Research of Concern (IROC)

These requirements replace previous federal oversight frameworks for Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP).

The University of South Alabama is actively developing institutional procedures and resources to support researchers and ensure compliance.

DGOF Research involves a biological agent that seeks, achieves, or has a substantial risk of achieving one or more of the following outcomes and could result in significant negative societal consequences:

• Enhance harmful consequences of a biological agent
• Disrupt beneficial immune responses or effectiveness of an immunization against the biological agent
• Confer to the biological agent resistance to clinically or agriculturally useful prophylactic or therapeutic
• interventions against the biological agent or facilitating its ability to evade detection methodologies
  Increase the stability, transmissibility, or ability to disseminate the biological agent
  Altering host range or tissue tropism of the biological agent
  Enhance the susceptibility of human, animal, or plant host populations to the biological agent
  Generating or reconstituting an eradicated or extinct biological agent

Federal funding for DGOF Research is prohibited.

Potential DGOF Research includes research with a biological agent that could reasonably result in one or more DGOF outcomes and could result in significant negative consequences.

These projects are not automatically prohibited but may require additional institutional and federal review and oversight before funding can be awarded.

IROC includes federally funded life sciences research conducted outside the United States:

• In designated countries of concern
• By institutions of concern 
• By individuals identified as entities of concern

Federal funding agencies are prohibited from funding IROC activities.

"Other risky international research" that could reasonably pose a threat to public health, public safety, and economic or national security, conducted in a country with inadequate oversight to ensure that the country is compliant with United States oversight standards and policies is permissible only following a risk-based assessment of the potential threat and the institution's ability to provide adequate oversight.

Your project may require additional review if it involves biological agents and has the potential to:

• Enhance harmful consequences of a biological agent
• Disrupt beneficial immune responses or effectiveness of an immunization against the biological agent
• Confer to the biological agent resistance to clinically or agriculturally useful prophylactic or therapeutic
• interventions against the biological agent or facilitating its ability to evade detection methodologies
• Increase the stability, transmissibility, or ability to disseminate the biological agent
• Altering host range or tissue tropism of the biological agent
• Enhance the susceptibility of human, animal, or plant host populations to the biological agent
• Generating or reconstituting an eradicated or extinct biological agent

Additional review may also be required if your project involves:

• International collaborators
• Foreign research locations
• Foreign institutions
• International funding or support arrangements

Not sure? Contact the Institutional Biosafety Committee (IBC) Office at daniellemiller@southalabama.edu to inquire about ongoing research or experimental designs integrated into future research proposals.

Step 1: Evaluate Your Research

During experimental design and prior to proposal submission, investigators should assess whether their project may qualify as:

• DGOF Research
• Potential DGOF Research
• International Research of Concern (IROC)

Researchers should evaluate biological, physical, technological, informational, and societal risks.

Step 2: Institutional Review

If research may qualify as Potential DGOF Research, investigators will work with Drexel's Institutional Review Entity (IRE) to conduct a risk-benefit assessment.

Review factors may include:

• Scientific benefits
• Biological risks
• Security concerns
• Experimental design
• Risk mitigation measures
• Data-sharing plans

Step 3: Required Disclosures and Attestations

Investigators may be required to disclose:

• Key personnel
• Collaborators
• Foreign partners
• Research locations
• Sources of scientific support
• Activities conducted outside the United States

The Institutional Contact for DGOF Research (ICDGOF) will review applicable life sciences proposals to verify required attestations.

Step 4: Risk Mitigation Planning

Projects identified as Potential DGOF Research may require a formal mitigation plan addressing:

• Experimental safeguards
• Biosafety measures
• Biosecurity controls
• Cybersecurity protections
• Access controls
• Information-sharing restrictions
• Personnel oversight

Step 5: Independent Federal Review

Potential DGOF projects may undergo review by a federal Independent Third-Party Review Body (ITPRB).

Federal reviewers may assess:

• Research benefits
• Potential societal consequences
• Proposed mitigation measures
• Whether the project can proceed without becoming prohibited DGOF research

Step 6: Ongoing Monitoring

Researchers should expect to:

• Continuously assess projects for emerging risks
• Report significant project changes to the IRE through the Biosafety Office
• Notify the institution of changes in collaborators or scope IRE through the Biosafety Office
• Participate in annual reviews with the IRE
• Follow approved mitigation plans

Step 7: Report Emerging Concerns

If ongoing work may become DGOF Research:

• Stop affected activities if required
• Notify the ICDGOF
• Notify the IRE
• Notify the funding agency as required

Step 8: Training and Compliance

Researchers should anticipate mandatory training covering:

• DGOF requirements
• Biosafety and biosecurity
• Risk identification and reporting
• Institutional review processes
• Documentation and recordkeeping

Researchers engaged in life sciences research should begin preparing for implementation by:

Review Current and Planned Research

Consider whether your research could potentially:

• Enhance harmful consequences of a biological agent
• Disrupt beneficial immune responses or effectiveness of an immunization against the biological agent
• Confer to the biological agent resistance to clinically or agriculturally useful prophylactic or therapeutic
• interventions against the biological agent or facilitating its ability to evade detection methodologies
• Increase the stability, transmissibility, or ability to disseminate the biological agent
• Altering host range or tissue tropism of the biological agent
• Enhance the susceptibility of human, animal, or plant host populations to the biological agent
• Generating or reconstituting an eradicated or extinct biological agent

Review International Collaborations

Evaluate:

• Foreign collaborators
• Research locations
• Foreign institutions
• International funding sources
• External research support arrangements

Federal agencies are expected to closely scrutinize international research activities under the new framework.

July 20, 2026

• Federal policy issued.

October 2026

• Federal agencies establish the Independent Third-Party Review Body (ITPRB).

November 2026

• Federal agencies issue implementation guidance and identify entities of concern.

January 2027

Institutions receiving federal life sciences funding must:

• Designate an ICDGOF
• Establish an IRE
• Implement institutional procedures
• Develop researcher training
• Create DGOF review processes

Change this label to University of South Alabama’s Efforts

The University of South Alabama is actively preparing for implementation of the DGOF policy.

Current activities include:

• Reviewing federal guidance
• Evaluating existing research compliance and grant proposal workflows
• Establishing an ICDGOF and IRE
• Developing review procedures
• Creating investigator self-assessment tools
• Developing risk-benefit assessment templates
• Developing mitigation plan templates
• DGOF Training (only if needed)
• Coordinating implementation across institutional stakeholders
• Monitoring evolving federal guidance

Institutional Contact for DGOF Research (ICDGOF)
The ICDGOF serves as South Alabama’s institutional resource for interpretation and implementation of the policy, verifies investigator attestations, and acts as a liaison with federal agencies.

Institutional Review Entity (IRE)

The IRE will:

• Review potential DGOF research
• Conduct risk-benefit analyses
• Evaluate mitigation plans
• Monitor approved projects
• Maintain compliance documentation

Interested in being involved with USAs IRE? Contact dlayton@southalabama.edu

No. The policy applies broadly to life sciences research involving biological agents that could meet DGOF criteria. 

No. The policy specifically addresses research that meets the definition of Dangerous Gain-of- Function Research or has the potential to do so. 

Potentially. Research involving animal models may be subject to review if the biological agents used or modified could meet DGOF criteria. 

While the policy directly governs federally funded research, institutions receiving federal life sciences funding are expected to establish oversight mechanisms to identify and monitor non-federally funded DGOF research activities. 

Your project may require further review if it has the potential to:

• Enhance harmful consequences of a biological agent
• Disrupt beneficial immune responses or effectiveness of an immunization against the biological agent
• Confer to the biological agent resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against the biological agent or facilitating its ability to evade detection methodologies
• Increase the stability, transmissibility, or ability to disseminate the biological agent
• Altering host range or tissue tropism of the biological agent
• Enhance the susceptibility of human, animal, or plant host populations to the biological agent
• Generating or reconstituting an eradicated or extinct biological agent

Researchers should consult the IBC office early in proposal development if any of these activities may be involved.

The policy intentionally uses a risk-based framework that considers potential impacts on public health, agriculture, public safety, economic security, and national security when evaluating research activities.

Purely computational or in silico research is generally not prohibited under the policy. However, if such research is used to create or modify biological agents that could meet DGOF criteria, the project may still fall within the policy's scope. The government is also monitoring developments at the intersection of artificial intelligence and life sciences research.

No. Federal funding for research that meets the definition of DGOF Research is prohibited.

Maybe. Potential DGOF Research may proceed only after additional institutional and federal review and a recommendation from an Independent Third-Party Review Body (ITPRB).

Yes. Investigators are expected to continuously assess ongoing projects. If an existing project begins to meet the criteria for potential DGOF or DGOF research, additional review may be required.

Possibly. Projects identified as potential DGOF research may undergo institutional review and external federal review before funding decisions can be made. Researchers should anticipate additional review time for projects involving biological agents and potential DGOF-related activities

Not necessarily. The policy requires creation of an IRE and encourages institutions to include IBC members where appropriate. Drexel is currently evaluating how DGOF oversight will integrate with existing compliance committees and workflows.

No. Only projects identified as potentially meeting DGOF criteria are expected to require IRE review. Most life sciences research will likely continue through existing review pathways.

Investigators are expected to continuously monitor their work and report significant changes in study aims, collaborators, institutions, or risk profiles through applicable institutional procedures.

Research activities may need to be paused while the investigator works with institutional reviewers and the funding agency to determine the next steps and appropriate oversight.

The policy requires immediate action, including halting relevant research activities and notifying institutional and federal oversight officials.

Yes. Failure to comply with policy requirements may result in:

• Suspension or termination of awards
• Revocation of federal funding
• Up to five years of ineligibility for federal life sciences funding
• Additional actions authorized under federal law and regulations

Yes. The policy does not prohibit international collaboration generally. However, international research activities will receive additional scrutiny to ensure compliance with federal requirements and research security standards. 

Yes. Researchers must identify key personnel, institutional affiliations, international collaborators, and research locations as part of proposal submissions and ongoing project oversight.

The policy requires investigators to report changes in personnel, institutions, and other project elements that may affect compliance determinations.

Investigators are expected to continuously monitor their work and report significant changes in study aims, collaborators, institutions, or risk profiles through applicable institutional procedures.

Yes. Failure to comply with policy requirements may result in:

• Suspension or termination of awards
• Revocation of federal funding
• Up to five years of ineligibility for federal life sciences funding
• Additional actions authorized under federal law and regulations