Dangerous Gain of Function (DGOF) Research

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 biosafety@drexel.edu to inquire about ongoing research or experimental designs integrated into future research proposals.

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.

Maintain Complete Disclosure Records

Researchers should maintain accurate records regarding:

• Key personnel
• Collaborators
• Institutional affiliations
• Research locations
• Sources of scientific support

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

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

Drexel University 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
• Creating a training program
• Coordinating implementation across institutional stakeholders
• Monitoring evolving federal guidance

Institutional Contact for DGOF Research (ICDGOF)

The ICDGOF serves as Drexel'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 Drexel's IRE? Contact biosafety@drexel.edu.

Start Here: Institutional Biosafety Committee (IBC) Office

biosafety@drexel.edu

Contact the IBC Office for:

• DGOF determinations
• Biological risk assessments
• Review requirements
• Policy interpretation
• Training questions
• IRE process questions

Environmental Health & Radiation Safety (EHRS)

ehrs@drexel.edu

Contact EHRS for:

• Biosafety practices
• Containment requirements
• Laboratory safeguards
• Incident reporting
• Risk mitigation implementation

Export Controls Office

export@drexel.edu 

Contact Export Controls for:

• International collaborations
• Foreign institutions
• Research security concerns
• Restricted-party screening
• IROC considerations

Sponsored Programs

duresearch@drexel.edu

Contact Sponsored Programs for:

• Proposal submissions
• Certifications and attestations
• Sponsor requirements
• Award management
• Funding impacts