Institutional Review Entity (DURC)

Mission/Goals

The Johns Hopkins Institutional Review Entity (IRE) assesses life sciences research that may fall under the definition of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) as established by the United States Government Policy for Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.

If a research project is determined to meet the Policy’s definition of Category 1 or Category 2 research, the IRE will work with the PI on a Risk-Benefit Analysis and a Risk Mitigation Plan for approval by the appropriate funding agency. Once approved, the IRE and the PI will provide ongoing compliance oversight through the life of the project.

Background

It is the policy of the U.S. Government that federally funded intramural or extramural research that meets the scope of Category 1 or Category 2 research within this Policy is subject to federal and institutional oversight. The purpose of this oversight is to preserve the benefits of such research while minimizing the biosafety and biosecurity risks, including risks that the knowledge, information, products, or technologies generated by the research could be used in a manner that results in harm to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

Research oversight is a critical component of effective biosafety and biosecurity practices and the responsible conduct of research involving biological agents and toxins. The intent of research oversight is to increase the awareness of researchers, research institutions, and federal funding agencies about the biosafety and biosecurity concerns associated with certain types of research and to ensure that appropriate risk mitigation measures are in place to prevent biosafety incidents (e.g., unintended personal exposure or release of an agent outside of containment) or biosecurity incidents (e.g., theft or intentional misuse of information, knowledge, products, or technology).

Institutions and investigators who receive federal funding are required, as a condition of that funding, to comply with the rules established by the US Government for DURC.

Compliance with The United States Government Policy for Dual Use Research of Concern and Pathogens with Pandemic Potential is in force beginning May 6, 2025.

An Implementation Guidance document provided by the United States Government is available here:

Implementation Guidance for the United States Government Policy for Dual Use Research of Concern and Pathogens with Pandemic Potential.

The United States Government Policy for Dual Use Research of Concern and Pathogens with Pandemic Potential describes two categories of research that require federal and institutional oversight.

CATEGORY 1 RESEARCH

Category 1 research involves the use of specific biological agents and toxins and the research is evaluated in terms of the potential to meet any of 9 experimental outcomes.

Category 1 research involves a much larger list of biological agents than was covered by the previous DURC policy. Thus, it is important for all investigators to check the Category 1 Biological Agents and Toxins list at the link below to determine if a research program may be considered Category 1 Research and, thus, be subject to the requirements of The United States Government Policy for Dual Use Research of Concern and Pathogens with Pandemic Potential.

The list of Category 1 Biological Agents and Toxins can be found here:

Category 1 Biological Agents and Toxins

There are nine (9) experimental outcomes that need to be evaluated, in conjunction with the use of any of the biological agents or toxins noted above, to assess the DURC-PEPP potential of a research project.

The list of 9 Category 1 Experimental Outcomes can be found here:

Category 1 Experimental Outcomes

An overview of Category 1 Research excerpted from pages 8-12 of the Implementation Guidance for the United States Government Policy for Dual Use Research of Concern and Pathogens with Pandemic Potential is found here:

Category 1 Research Scope and Oversight

CATEGORY 2 RESEARCH

Category 2 research involves the use or generation of any pathogen with pandemic potential (PPP), the use or generation of any pathogen with enhanced pandemic potential (PEPP), and/or the use, generation, reconstitution, or transfer of any extinct or irradicated PPP. The research is evaluated in terms of the potential to meet any of 4 experimental outcomes.

A Pathogen with Pandemic Potential (PPP) is defined as a "pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.“

A Pathogen with Enhanced Pandemic Potential (PEPP) is defined as "a type of 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 post 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 PPs because of their pandemic potential."

Eradicated or Extinct PPP are also covered by the Policy. "Category oversight is also required for experiments that generate, use, reconstitute, or transfer an eradicated or extinct PPP that may pose a significant threat to public health, the capacity of health systems to function or national security, regardless of whether the experiment enhances the PPP. Current eradicated and extinct PPPs include Variola major and minor, and Influenza A virus subtypes H1N1 (1918) and H2N2 (1957-1968). Any research with these PPPs is considered Category 2 because of the heightened consequences of biosafety or biosecurity incidents that could occur from directly handling or possessing such pathogens, even without any enhancement to virulence or transmissibility."

There are four (4) experimental outcomes, listed below, that need to be evaluated, in conjunction with the use of any PPP or PEPP to assess the DURC-PEPP potential of a research project.
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.
An overview of Category 2 Research including definitions of Category 2 pathogen types and the four (4) experimental outcomes that define Category 2 research from pages 12-22 of the Implementation Guidance for the United States Government Policy for Dual Use Research of Concern and Pathogens with Pandemic Potential is found here:

Category 2 Research Scope and Oversight
In accordance with this Policy, PIs are to:
1. Be knowledgeable about and comply with or follow all applicable institutional and USG policies, requirements, and regulations for oversight of biological agent;
2. Assess their research at the proposal stage, and continuously throughout the research lifecycle, to identify whether there is research reasonably anticipated to be within scope of Category 1 or Category 2, and notify the IRE and follow the IRE process set forth in this Policy for all such research, regardless of funding;
3. Following identification of potential Category 1 or Category 2 research, notify the federal funding agency and the IRE, and be prepared to develop a risk-benefit assessment and a risk mitigation plan;
4. Work with the IRE to assess the risks and benefits of the proposed research and submit the risk-benefit assessments and draft risk mitigation plan for Category 1 or Category 2 research to the federal funding agency for review and approval when appropriate. For non-federally funded research, to work with the IRE as set forth in this Policy:
  1. If research is being proposed as part of a new funding proposal, submit the risk-benefit assessments and draft risk mitigation plan to the federal funding agency for review and approval following scientific merit review.
  2. If the research is being funded under an existing funding mechanism but has not yet been reviewed by the federal funding agency, then submit the risk-benefit assessments and draft risk mitigation plan to the federal funding agency for approval before conducting such work.
  3. If research is first identified as potentially within scope of Category 1 Research or Category 2 Research during the course of experimentation, halt further work and work with the IRE to develop the risk-benefit assessments and risk mitigation plan for submission to the federal funding agency for further review and approval to continue. Be knowledgeable about and comply with all institutional and USG policies and requirements for oversight of DURC.
5. Conduct Category 1 Research and Category 2 Research in accordance with the provisions identified in the risk mitigation plan approved by the federal funding agency or the IRE, for non-federally funded research.
6. Provide annual progress reports for Category 1 Research and semiannual progress reports for Category 2 Research, and as requested by the federal funding agency (e.g., as part of terms and conditions of award or risk mitigation plans), for review, evaluation, assessment, and, where necessary, clarification or confirmation.
7. Ensure that laboratory personnel (i.e., those under the supervision of laboratory leadership, including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists) conducting life sciences research with one or more of the agents listed above have received education and training on all research oversight policies and processes and demonstrated competency.
8. Communicate Category 1 Research and Category 2 Research in a responsible manner. Communication of research and research findings is an essential activity for all researchers, and occurs throughout the research process, not only at the point of publication. Researchers planning to communicate Category 1 Research and Category 2 Research should do so in a responsible manner and in compliance with the approved risk mitigation plan.
Ensure that any resulting biological agent or toxin from Category 1 Research and Category 2 Research are properly accounted for and destroyed when no longer needed, in accordance with all legal and University policy requirements.
A. Federally Funded Research Projects
1. The PI makes an initial assessment of whether their proposed or ongoing research may be within the scope of Category 1 Research or Category 2 Research.
2. The PI, through their appropriate research administration office, submits the research proposal to the federal funding agency including notification that the research may be within scope of Category 1 Research or Category 2 Research based on the biological agent or toxin and the experiment. The PI is required to notify the IRE office of their preliminary determination.
3. When the federal funding agency has completed merit review of the proposed research and if it is considering funding the proposed research, the federal funding agency notifies the University of its preliminary determination of the research category. This notice must be immediately forwarded to the IRE.
4. The IRE reviews the PI’s initial assessment and confirms whether proposed or ongoing research is within the scope of Category 1 Research or Category 2 Research. The University then notifies the federal funding agency of the results of its IRE’s determination, and the federal funding agency evaluates and verifies the IRE’s assessment.
5. If the research is assessed to be within scope of Category 1 Research or Category 2 Research, the IRE conducts a risk-benefit assessments and develops a draft risk mitigation plan for the conduct and communication of research. The IRE will engage in an ongoing dialogue with the PI of the research in question when developing appropriate risk mitigation plans.
6. The ICDUR submits the risk-benefit assessment and a draft risk mitigation plan to the federal funding agency through the appropriate research administration office.
7. The federal funding agency reviews the risk-benefit assessment and draft risk mitigation plan, and completes its required reviews. Only when the federal agency has communicated back to the University its approval for the research and the risk mitigation plan may the research commence.
8. Faculty must refer their research to the IRE if at any time PI has reason to believe that the research meets the criteria for Category 1 Research or Category 2 Research or if the PI otherwise believes the project should undergo IRE review.
9. The IRE has the authority to review and request modification of risk mitigation plans at any time. The IRE shall provide the PI written notice of any requested modification of a risk mitigation plan, and the PI shall have an opportunity to respond, but must adhere to any halt of research requested by the IRE pending the outcome of the IRE review. The PI should halt further work in such a case, and work with the IRE to notify the federal funding agency and commence the submission necessary for the IRE to conduct the review required by this Policy.
B. Non-Federally Funded Research
1. The PI makes an initial assessment of whether their proposed or ongoing research may be within the scope of Category 1 Research or Category 2 Research.
2. For non-federally funded research, the PI must make a submission to the IRE before the grant may be submitted to the funding entity, if external funding is sought for the work, or before the work commences, if no external funding is sought for the work.
3. The IRE reviews the PI’s initial assessment and confirms whether proposed or ongoing research is within the scope of Category 1 Research or Category 2 Research. The University then notifies the PI and the proposed external funder if any, of the results of its IRE’s determination, and the funder evaluates and verifies the IRE’s assessment.
4. If the research is assessed to be within scope of Category 1 Research or Category 2 Research, the IRE conducts a risk-benefit assessments and develops a draft risk mitigation plan for the conduct and communication of research. The IRE will engage in an ongoing dialogue with the PI of the research in question when developing appropriate risk mitigation plans;
5. The ICDUR submits the final risk-benefit assessment and final risk mitigation plan to the PI and the external funder, if any, and the risk mitigation plan must be accepted by the PI and external funder before any funding agreement is accepted and/or any work commences.
6. Faculty must refer their research to the IRE if at any time PI has reason to believe that the research now meets the criteria for Category 1 Research or Category 2 Research or if the PI otherwise believes the project should undergo IRE review.
US Government
JH-IRE – Category 1 and Category 2 Research Lists and Experimental Outcomes
JH-IRE Forms and Training
JH-IRE – Useful Excerpts from the Implementation Guidance Document

Institutional Review Entity (DURC)

Mission/Goals

Background

Biological Agents, Toxins, and Categories of Experiments Covered by DURC-PEPP Regulations

CATEGORY 1 RESEARCH

CATEGORY 2 RESEARCH

Investigator Responsibilities

DURC-PEPP Procedures & Review Process

Links & Useful Reference Material

Committee Members

Contact Information