1. Compliance and cordiality with Rutgers University DURC requirements, the Institutional Contact for Dual Use Research (ICDUR), Institutional Review Entity (IRE), respective funding agencies, and government offices
2. Ongoing DURC assessments through grant submissions, IBC submissions, and IRE reviews
3. Education and Training of personnel working on the project
4. Completion of a Risk: Benefit Analysis and Risk Mitigation Plan related to the identified DURC experiment and pathogen, to the satisfaction of the IRE and funding agency (DURC research specific)
5. Progress reports as required by the funding agency and Rutgers (minimally annually for Category 1 and semi-annually for Category 2 (DURC research specific)

It is the responsibility of all Rutgers Principal Investigators to be knowledgeable about and comply with or follow all applicable institutional and U.S. government policies, requirements, and regulations for oversight of biological agent and toxin research.

For PIs and research institutions, failure to follow the USG DURC-PEPP Policy may result in suspension, limitation, or termination of federal funding and loss of future federal funding opportunities for the research proposal and for other life sciences research at the research institution, as imposed by the federal funding agency. Federal funding agencies will consider relevant statutory and regulatory authorities when considering appropriate actions.

³ Note: As of the time of release of this Policy, this subset consists of all RG3 pathogens 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 H. capsulatum var. duboisii. This list may be updated in the Implementation Guidance on a periodic basis. Beyond this list, as stated in Section 6.2, this Policy also provides voluntary guidance to PIs and research institutions for research that is outside of the scope of this Policy but that may pose a potential risk and may warrant oversight and risk mitigation at the institutional level.

⁴ Note: In the event no risk group or Biosafety Level has been assigned to an agent, for example in the case of a newly emerging pathogen or chimeric agent, the appropriate institutional body should perform a risk assessment to determine the appropriate Biosafety Level for handling the agent, given the experimental protocol being proposed. The assessment should take into account known properties of the agent and similarities to existing agents. Such agents requiring handling at BSL-3 or BSL-4 are biological agents under Section 4.1.1 of this Policy.

⁵ In some cases, the federal funding agency and the department funding an in-scope research study are distinct (e.g., the National Institutes of Health and the Department of Health and Human Services). In other cases, they are the same (e.g., the National Science Foundation). Federal departments and agencies will implement this Policy based on their specific departmental structure.

DURC policy is an effect of the 2004 Fink report, where seven hazardous experiment classes were initially outlined. On March 29, 2012, the U.S. government released the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (2012 Federal DURC Policy). This action established a U.S. government policy for the identification and oversight of DURC. The policy applies to a well-defined subset of life sciences research that involves fifteen agents and toxins and seven categories of experiments (from the 2004 Fink Report) and established regular review of U.S. government-funded or conducted research for its potential to be DURC. On September 24, 2014, the U.S. government released the United States Government Policy for

Institutional Oversight of Life Sciences Dual Use Research of Concern (2014 Institutional DURC Policy). This policy addresses institutional oversight of DURC, including policies, practices, and procedures to identify DURC and implement risk mitigation measures, where applicable.

As a result of certain avian influenza studies in 2013, HHS released an additional oversight framework on a particular subset of potential DURC, known as “gain of function” studies. “Gain-of-Function” studies can help define the fundamental nature of human-pathogen interactions, thereby enabling assessment of the pandemic potential of emerging infectious agents, informing public health and preparedness efforts, and furthering medical countermeasure development. Such studies may entail enhanced biosafety and biosecurity risks; therefore, their risks and benefits must be evaluated, both in the context of recent U.S. biosafety incidents and to keep pace with new technological developments, in order to determine which types of studies should go forward and under what conditions. In October 2014, the U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses was issued. A deliberative period began when funding for research expected to confer attributes to influenza, MERS, or SARS viruses, such that the viruses would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route, was paused. During this funding pause, the National Science Advisory Board for Biosecurity (NSABB) was tasked to conduct a deliberative process to draft a set of recommendations for the oversight of gain-of-function research funding that would be reviewed by the broader life sciences community. In 2017, informed by the NSABB recommendations and other inputs, the White House issued the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (OSTP P3CO Policy Guidance). Departments and agencies that adopt review mechanisms consistent with the OSTP P3CO Policy Guidance provisions would satisfy the requirements for lifting that department or agency’s funding pause instituted by the U.S. government in 2014. On certain gain-of-function research under the U.S. Government Gain-of-Function Deliberative Process, later in 2017, HHS issued the 2017 HHS P3CO Framework, in accordance with the OSTP P3CO Policy Guidance, lifting the funding pause at HHS and superseding the 2013 HHS HPAI H5N1 Framework. The 2017 HHS P3CO Framework is broader than the 2013 HHS HPAI H5N1 Framework, addressing a wider range of pathogens. The 2017 HHS P3CO Framework and the 2012 and 2014 DURC policies will be unified within the U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.

The United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (“Policy”) is a unified federal oversight framework for conducting and managing certain types of federally funded life sciences research on biological agents and toxins. This Policy addresses oversight of research on

biological agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security, or national security.¹ It supersedes the 2012 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (Federal DURC Policy),² the 2014 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (Institutional DURC Policy),³ and the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO Framework).⁴ This Policy is issued by the Office of Science and Technology Policy (OSTP) in accordance with the directives established by the 2022 National Biodefense Strategy and Implementation Plan,⁵ as directed by National Security Memorandum 15,⁶ to complete an interagency review of efforts to strengthen responsible conduct for biological research. This Policy has also been issued pursuant to Section 2315 of the Consolidated Appropriations Act, 2023 (42 U.S.C. § 6627) to achieve consistent review and oversight of life sciences research proposed for federal funding that may be reasonably anticipated to involve the creation, transfer, or use of pathogens with enhanced pandemic potential (PEPPs).⁷

¹ Risks to national security can arise from, but are not limited to, public health, agriculture, food security, or economic security risks.

² United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (2012), https://aspr.hhs.gov/S3/Documents/us-policy-durc-032812.pdf.

³ United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (2014), https://aspr.hhs.gov/S3/Documents/durc-policy.pdf.

⁴ Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (2017), https://aspr.hhs.gov/S3/Documents/P3CO-FinalGuidanceStatement.pdf.

⁵ National Biodefense Strategy and Implementation Plan (2022), https://www.whitehouse.gov/wpcontent/uploads/2022/10/National-Biodefens….

⁶ National Security Memorandum on Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (2022), https://www.whitehouse.gov/briefing-room/presidentialactions/2022/10/18….

⁷ Consistent with 42 U.S.C. § 6627, Category 2 research within this Policy is meant to provide additional oversight and risk mitigation for research with any pathogen that is reasonably anticipated to result in the development, use, or transfer of a PEPP, including the creation of new pathogens with pandemic potential (PPP) from nonPPPs as well as the enhancement of existing PPPs. The United States Government Policy for Oversight of Dual

Rutgers University has included DURC as a training topic for biological safety since 2010. It has included the hazardous experiment classes within it in IBC protocol review since 2011 (irrespective of the pathogen being worked with). The IRE will primarily oversee DURC reviews in coordination with the Office of Research and the Biosafety program. Initial DURC review will occur before grant submission to the respective funding agency. Ongoing DURC reviews will be conducted through the IRE and IBC. After receiving IRE and Funding Agency approval (e.g. acceptable Risk: Benefit analysis and Risk Mitigation Plan) IBC approval will be required before the work is allowed to commence per requirements of the NIH Guidelines For Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) April 2024.

IRE Meeting

IRE meeting will be held independently and separately from other institutional committees. Quorum for an IRE meeting will be one representative from each position above for a total of 5 for each IRE review that requires an IRE action. IRE actions are Approve (acceptable to the IRE), Approve with Conditions, Reject (unacceptable to the IRE), Move (time or quorum constraints), and Table (additional information is needed to reach an action). A majority vote is required to allow a submission to proceed in the review process.

IRE Composition

• Committee Chair
• Associate Vice President for Rutgers Research Administration
• Office of General Council Representative to the Office for Research
• Institutional Contact for Dual Use Research (ICDUR)
• Alternate Institutional Contact for Dual Use Research (AICDUR)
• Subject Matter Expert (as required by IRE agenda): Virology, Bacteriology, Mycology, Parasitology, Insects, Animals, Plants, Humans, Transmission, additions can be made at the discretion of the IRE

IRE Review Process

For additional resources, please visit the US Department of Health and Human Services Dual Use Research of Concern or contact durc@research.rutgers.edu.

• Improving The Safety and Security of Biological Research
• United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential
• Implementation Guidance for the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential
• History of Research Oversight Policies
• Select Agent Regulations
• National Research Council (US) Committee on a New Government-University Partnership for Science and Security. Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities. Washington (DC): National Academies Press (US); 2007. IV, Biosecurity and Dual-Use Research in the Life Sciences. Available from: www.ncbi.nlm.nih.gov/books/NBK11496
• Press Statement on the NSABB Review of H5N1 Research
• NIH Guidelines For Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) April 2024.

General DURC Email: durc@research.rutgers.edu

Institutional Contact for Dual Use Research (ICUDR):
Ryan McAllister Ph.D., M.S., B.S., RBP (ABSA), BRM (IFBA)
Rutgers University Biological Safety Officer, Biosafety Program Manager, and Alternate Responsible Official

Alternate Institutional Contact for Dual Use Research:
Brian Eggert, MPH, RBP(ABSA)
Senior Biosafety Officer

Alternate Institutional Contact for Dual Use Research:
Jacquelyn Vidal, MS
Assistant Biosafety Officer