Dangerous Gain of Function (DGOF) Frequently Asked Questions
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
Still Have Questions?
Federal implementation guidance is expected to continue evolving over the coming months. Drexel will update this webpage regularly as new information becomes available, and institutional procedures are finalized.
Additional guidance and implementation updates will be posted as federal agencies release institution-specific requirements.
Researchers with questions are encouraged to contact the IBC Office at biosafety@drexel.edu before preparing proposals involving biological agents, genetic modifications, novel biological constructs, or international life sciences collaborations.