University of Minnesota  Procedure

Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential

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Dual Use Research of Concern is defined as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. A Pathogen with Enhanced Pandemic Potential (PEPP) is a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility or virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security. Wild-type pathogens that are circulating in or have been recovered from nature are not PEPPs but may be considered PPPs because of their pandemic potential. A United States Government (USG) policy was released on May 6, 2024 for the oversight of research involving DURC and PEPP (DURC-PEPP). 

Principal Investigators (PIs) proposing to work with or generate any replication-competent infectious agent, or proposing to work with any biologically-derived toxin that requires Institutional Biosafety Committee (IBC) oversight must initially assess whether the research is reasonably anticipated to be within the scope of Category 1 or Category 2 research (see below). This self-assessment should happen at (1) the proposal stage when seeking funding and (2) during ongoing research (continuously throughout the research lifecycle). The USG DURC-PEPP policy applies to research that will be funded or sponsored by grants, contracts, cooperative agreements, and other agreements and transactions issued on or after May 6, 2025. This includes any award amendment or revision that SPA receives from an agency that will be processed and result in a Notice of Grant Award (NOGA) on or after May 6, 2025. 

PIs are to notify the Institutional Contact for Dual Use Research of Concern (ICDUR) if their self-assessment identifies potential Category 1 or Category 2 research. If identification occurs at the proposal stage, a PI should also notify the federal funding agency when they submit the proposal. If identification occurs during the course of experimentation, the PI must halt further work, contact the ICDUR, and prepare to work with the Institutional Review Entity (IRE) to develop the risk-benefit assessment and risk mitigation plan for submission to the federal funding agency for further review and approval to continue.

1. Assess for Category 1 research

Category 1 research meets three criteria (USG DURC-PEPP Policy Sections): (1) it involves one or more of the biological agents and toxins specified in 4.1.1; (2) it is reasonably anticipated to result, or does result, in one of the experimental outcomes specified in 4.1.2; and (3) based on current understanding, the IRE and/or federal funding agency assesses that the research constitutes DURC as specified in 4.1.3.

Biological Agents and Toxins within Scope of Category 1 Research (4.1.1)

  • All Biological Select Agents and Toxins, as listed in 9 CFR 121.3–121.4, 42 CFR 73.3–73.4, and 7 CFR 331.3 and regulated by USDA and/or HHS.
  • All Risk Group 4 pathogens listed in Appendix B of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
  • A subset of Risk Group 3 pathogens listed in Appendix B of the NIH Guidelines (except HIV, HTLV, SIV, Mtb (including Mycobacterium bovis), Clade II of MPVX viruses unless containing nucleic acids coding for clade I MPVX virus virulence factors, vesicular stomatitis virus, Coccidioides immitis, C. posadasii, Histoplasma capsulatum, and var. duboisii).
  • Biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines but are agents that are recommended to be handled at BSL-3 or BSL-4 per the guidance in the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL).
  • Agents for which no risk group or Biosafety Level has been assigned to an agent but the UMN IBC has determined the agent requires handling at BSL-3 or BSL-4.
  • Agents added during future updates to the USG DURC-PEPP policy.

Category 1 Research Experimental Outcomes (4.1.2)

  1. Increase transmissibility of a pathogen within or between host species;
  2. Increase the virulence (e.g. ability to cause disease) of a pathogen or convey virulence to a non-pathogen;
  3. Increase the toxicity of a known toxin or produce a novel toxin;
  4. Increase the stability of a pathogen or toxin in the environment, or increase the ability to disseminate a pathogen or toxin (e.g. environmental stability or aerosolubility);
  5. Alter the host range or tropism of a pathogen or toxin;
  6. Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
  7. Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions (e.g., antimicrobials, antivirals, antitoxins, vaccines);
  8. 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
  9. Enhance the susceptibility of a host population to a pathogen or toxin.

Category 1 Risk Assessment (4.1.3)

Category 1 Risk Assessment: Based on current understanding, the research can be reasonably anticipated to provide, or does provide, knowledge, information, products, or technologies that could be misapplied to do harm with no — or only minor — modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

2. Assess for Category 2 research

Category 2 research meets three criteria (USG DURC-PEPP Policy Sections): (1) it involves, or is reasonably anticipated to result in, a PPP as specified in 4.2.1; (2) it is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified in 4.2.2; and (3) based on current understanding, the IRE 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 as specified in 4.2.3. 

Biological Agents within Scope of Category 2 Research (4.2.1)

Definitions and Scope of Category 2 Oversight: 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 (4.2.2)

  1. Enhance transmissibility of the pathogen in humans;
  2. Enhance the virulence of the pathogen in humans;
  3. 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
  4. Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP. 

Category 2 Risk Assessment (4.2.3)

Assess for Potential to be in Scope of Category 2 Research: The research can be 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. Any research meeting the definition of Category 1 and Category 2 is designated as Category 2.

3. Notify the ICDUR and the funding agency

PIs must notify the ICDUR to refer the research to the IRE if their assessment of their proposed or on-going research identifies the potential of Category 1 or Category 2 research. PIs must also notify the funding agency and be prepared to develop a risk-benefit assessment and a risk mitigation plan. Notification will be done via the Office of Biotechnology Activities Oversight (OBAO).

Non-University Entities

Non-University entities renting, leasing or otherwise using University property, equipment or facilities, and that are using or storing any of these agents must notify the Health, Safety and Risk Management (HSRM). HSRM has the authority to prohibit unacceptable storage of DURC-PEPP agents.

4. Institutional review and approval of Category 1 or Category 2 research

The effective oversight of DURC-PEPP is based on identifying Category 1 and Category 2 research and its associated risks and benefits, then devising ways to mitigate these risks. After notification by a funding agency or by a PI, the IRE will review the PI's assessment and confirm whether the proposed or ongoing research is within the scope of Category 1 or Category 2 research. The ICDUR will notify the funding agency whether the IRE determined the research does or does not meet the definition of Category 1 or Category 2 research.

If within the scope, the IRE will perform a risk assessment to determine if the research is Category 1 or Category 2. The IRE will work with the PI to conduct a risk-benefit assessment and develop a draft risk mitigation plan for the conduct and communication of the research. If the IRE was notified by a funding agency because after a merit review the funding agency is considering funding the proposed research, the ICDUR will submit the risk-benefit assessment and risk mitigation plan to the funding agency. 

If the funding agency approves the risk mitigation plan, whether at the proposal stage or after halting ongoing research, the PI must obtain IBC approval for the activities involving agents subject to IBC and DURC-PEPP oversight prior to initiating Category 1 or Category 2 research. PIs must implement the approved risk mitigation plan and account for any modified activities prior to their IBC approval.

Continuing Review

Under the USG DURC-PEPP Policy, an approved and implemented risk mitigation plan must be reviewed at least annually. Plans must be modified as warranted. 

5. Progress reports to funding agency

The USG Policy for DURC-PEPP Oversight requires that a PI must provide annual progress reports for Category 1 research and semiannual progress reports for Category 2 research, and upon request by the federal funding agency, for review, evaluation, assessment, and, where necessary, clarification or confirmation.

6. Completing appropriate training

All researchers and staff involved in DURC-PEPP research must receive training and education related to the USG DURC-PEPP oversight policy. IREs may also consider whether additional training is required to address specific concerns raised by the research in question. Training will be mandated via the risk mitigation plan and/or as determined by the IRE and IBC.

7. Biosecurity and storing DURC-PEPP agents

The IBC, IRE or BOHD will assist in the determination of security needs according to a risk assessment and in accordance with federal and state regulations. All DURC-PEPP agents must be stored in a secure manner and storage conditions must be described in the risk mitigation plan. Access to DURC-PEPP agents must be limited to only those approved and with a legitimate need to use them. All stored material must be claimed by an individual, who is a University employee (or an entity as described above) and who is responsible for the storage and use of the material. Investigators must label all materials so that contents can be properly identified. Investigators must establish a tracking mechanism for all DURC-PEPP agents to document inventories and keep the documentation up-to-date - adjusting for when agents are generated, transferred, and destroyed.

8. Conducting inventories and inspections

HSRM has the authority to conduct inventories and inspections of all laboratories that use DURC-PEPP agents. Researchers are required to cooperate with inventories and inspections of their laboratories, which may be announced or unannounced and are conducted at intervals determined by the IBC or BOHD.

Non-University entities using University property are subject to the same requirements and inspection of their storage, security, and facilities.

9. Transferring DURC-PEPP agents

The transfer of any DURC-PEPP agents must be described in the risk mitigation plan to be allowable. Shipments are subject to Federal Select Agent regulations and/or CDC/USDA permitting requirements where applicable.

10. Decontamination and Disposal of biological materials

The methods for the disposal of agents must be included in the risk mitigation plan. Agents and contaminated materials must be appropriately decontaminated. The IBC and BOHD will determine appropriate decontamination procedures and disposal requirements for biological agents. Any costs associated with decontamination and disposal will be borne by the laboratory/department/college in which the material originated or was created.

11. Laboratory close out

The risk mitigation plan should include plans in case of a laboratory close out, which includes a final inspection by HSRM and BOHD. In the event that a PI leaves the University or moves their laboratory area, the PI and the Department are responsible for ensuring that appropriate laboratory closeout procedures are followed.