There will be new oversight roles for researchers, applicants, recipients, NIH, and HHS. The Policy addresses the identification and mitigation of biosafety, biosecurity, and information risks associated with manipulation of certain pathogens that could cause significant harm to society, be it accidental or intentional. Updates reflect the evolving nature of scientific and technological risks.

Researchers are to assess whether their research falls under the scope of Category 1 and/or Category 2 research at the proposal stage and continuously throughout the research life cycle.  Institutions seeking to conduct research within the scope of this policy will be required to have an Institutional Review Entity (IRE) and an Institutional Contact for Dual Use Research (ICDUR). Researchers must work with their IRE to develop a risk-benefit assessment and risk mitigation plan, as needed, that must be approved before this work can begin or continue. Once awarded, the PIs must carry out and oversee research according to the approved plan. The institution is expected to develop necessary infrastructure and personnel to comply with the Policy. 

• A CITI DURC Course has been updated to include this new requirement.  Completion will be a requirement for all researchers conducting BSL-2 work.  A refresher will be required triennially.
• The IBC Policies and Procedures now include sections 3.10. through 3.10.6 for your reference.
  • 3.10 Dual Use Research of Concern and Pathogens of Pandemic Potential
  • 3.10.1  Definitions
  • 3.10.2  Determination of Research Category
  • 3.10.3  Review Steps for both Federally Funded and Non-Federally Funded Projects
  • 3.10.4  Risk Assessment and Risk Mitigation Plan
  • 3.10.5  Institutional Review Entity
  • 3.10.6  Steps to Address Changes in Research that Affects Previous Determination
• United States Government Policy for Oversight of Dual Use Research of Concern and
• DURC/PEPP Policy Implementation Guidance
• January 10, 2025 - NOT-OD-25-061 NIH Implementation of the USG Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)
• Select Agents and Toxins
• NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
• The Institutional Contact for Dual Use of Research Concern (ICDUR) is your contact when you have questions about the process or communication is required with the sponsor regarding this aspect of your project. 

• DURC/PEPP Self-Determination Tool – This tool should be used every time you are required to decide if your research is Category 1 or Category 2 or neither.
• The “PI Benefit/Risk Assessment and Risk Mitigation Plan” form is for use by researchers to describe and document a benefit/risk analysis and creation of a risk mitigation plan. 

The DURC/PEPP Policy requirements apply to all NIH-funded research, including grants and cooperative agreements, Research and Development (R&D) contracts, NIH intramural research projects, and other funding agreements (e.g., Other Transactions). 

UVM has decided to additionally apply these standards to non-federally funded projects.

There are two categories of research.  Category 1 research is subject to oversight by research institutions and federal funding agencies, and Category 2 research is subject to oversight by research institutions, federal funding agencies, and their federal department if applicable due to heightened potential for biosafety and biosecurity risks.

• Category 1 Research
• Category 1 research meets three criteria: (1) it involves one or more of the biological agents and toxins specified below; (2) it is reasonably anticipated to result, or does result, in one of the experimental outcomes specified below; and (3) based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC.
• Category 1 Biological Agents and Toxins
  • All Select Agents and Toxins listed in 9 CFR 121.3–121.4, 42 CFR 73.3 –73.4, and 7
  • All Risk Group 4 pathogens listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) - Classification of Human Etiologic Agents on the Basis of Hazard
  • A subset of Risk Group 3 pathogens listed in Appendix B of the NIH Guidelines - Classification of Human Etiologic Agents on the Basis of Hazard.
  • For biological agents affecting humans that have not been assigned a Risk Group CFR 331.3 and regulated by USDA and/or HHS in the NIH Guidelines, refer to the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL). In such cases, agents affecting humans that are recommended to be handled at Biosafety Level 3 (BSL-3) or Biosafety Level 4 (BSL-4) per the BMBL guidance are subject to this Policy.
  • Biological agents added during future updates to the Implementation Guidance
• Category 1 Research Experimental Outcomes
  • Increase transmissibility of a pathogen within or between host species;
  • Increase the virulence of a pathogen or convey virulence to a non-pathogen;
  • Increase the toxicity of a known toxin or produce a novel toxin;
  • Increase the stability of a pathogen or toxin in the environment, or increase the ability to disseminate a pathogen or toxin;
  • Alter the host range or tropism of a pathogen or toxin;
  • Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
  • Increase resistance of a pathogen or toxin to clinical and/or veterinary  prophylactic or therapeutic interventions;
  • Alter a human or veterinary pathogen or toxin to disrupt the effectiveness of preexisting immunity, via immunization or natural infection, against the pathogen or toxin; or
  • Enhance the susceptibility of a host population to a pathogen or toxin

• Category 2 Research

  Category 2 research meets three criteria: (1) it involves, or is reasonably anticipated to result in, a PPP as specified below; (2) it is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified below; and (3) based on current understanding, the research institution and/or federal funding agency assesses that the research is reasonably anticipated to result in the development, use, or transfer of a PEPP or an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function, or national security.

• Category 2 Biological Agents

  A PPP, or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP.

• Category 2 Research Experimental Outcomes
  • Enhance transmissibility of the pathogen in humans;
  • Enhance the virulence of the pathogen in humans;
  • Enhance the immune evasion of the pathogen in humans such as by modifying the pathogen to disrupt the effectiveness of pre-existing immunity via immunization or natural infection; or
  • Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP

If you only work with attenuated strains, your work would be neither Category 1 or Category 2.  You may complete the DURC/PEPP Self-Determination Tool to receive an email to that effect. 

You will be required to make an initial and ongoing categorization.   The DURC/PEPP Self-Determination Tool can be used as often as necessary to assist with this determination.

You must assess the research at the proposal stage and continuously throughout the research life cycle for whether the research falls under the scope of Category 1 and/or Category 2 research.

The policy indicates that you must continually assess for changes in research that may result in a change to Category 1 or Category 2 research.  For active grants and cooperative agreements, NIH will request applicable DURC/PEPP materials to be provided as part of any non-competing applications, including Research Performance Progress Reports, due on or after May 6, 2025. 

The IBC will require that you indicate your assessment at time of each amendment and possibly at time of continuing review. 

No.  The new policy relies completely upon individual grants; therefore, you will be required to make determinations on each of your grants, those that are active and new submissions. 

The IRE becomes involved if you have determined the project to potentially be Category 1 or Category 2 and your funder requests a verification at JIT. 

This is done by submitting a new master protocol registration to IBC-Click.  IRE members will have access and will conduct a verification process for you.  The IRE will provide a determination for the JIT request. 

Your protocol should already be in the system because of the JIT request.  You will need to complete the  “PI Benefit/Risk Assessment and Risk Mitigation Plan” form and upload to your already submitted protocol.  You will be invited to the next convened IRE meeting (just prior to the monthly IBC meeting) to discuss the analysis and proposed plan. 

Once the plan is approved locally, the final Risk Mitigation Plan will be submitted to the funding agency for additional review and approval prior to the start of research. 

After receiving the materials, NIH will review the IRE determination, risk-benefit assessment, and risk mitigation plan. NIH will refer Category 2 research to HHS for Department-level review. NIH may request additional materials pertaining to the research from the applicants and recipients. The funding Institute or Center will make the final funding determination and add relevant terms and conditions to the Notice of Award.