As a recipient of federal funds, Brown must comply with the U.S. Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential [PDF] (“DURC/PEPP Policy”), which applies to all research funded by a federal agency or department, and which requires the designation of an institutional review entity (IRE) to review DURC and research involving PEPP and its associated risks and devise ways to mitigate these risks. 

The DURC/PEPP Policy designates both the PI of a research project and the IRE as responsible parties for identifying and reviewing potential DURC and research involving PEPP.

•  Principal Investigators (PIs) on federally funded research must be knowledgeable about and comply with all applicable institutional and U.S. government policies, requirements, and regulations regarding the oversight of biological agent and toxin research.
• PIs are responsible for assessing their research at the proposal stage and continuously throughout the research lifecycle to identify whether there is research reasonably anticipated to be within the scope of Category 1 or Category 2 research.
• PIs are responsible for notifying the federal funding agency and the research institution of any identified Category 1 or Category 2 research.
• PIs are required to work with the IRE, follow and comply with any risk mitigation plans, as applicable, and provide progress reports as required by the IRE. 

Assessment of Proposed Research

PIs are responsible for assessing their research at the proposal stage and continuously throughout the research lifecycle to identify whether there is research reasonably anticipated to be within the scope of Category 1 or Category 2.

As part of the Biological Research Authorization process, all PIs working with Select Agents and Toxins or with pathogens with pandemic potential must complete a PI Self-Assessment Form [PDF] to identify if their research falls under Category 1, Category 2, both, or neither. 

If the research in a grant proposal is found to potentially fall within Category 1 or Category 2 Research, PIs must inform the federal funding agency and Brown University.

Notifying Brown University / Notifying the Federal Funding Agency

• PIs are responsible for evaluating their research and whether it may fall under DURC policies.
• If a PI completes the required self-assessment when submitting an IBC registration through Cayuse, and then notes that their research proposal is potentially DURC or research involving PEPP, the Biological Safety Officer will consult with the PI and refer the proposal to Brown’s IBC and IRE.
• If at any point while conducting research, the PI determines that any of the experimental outcomes of said research would fall under DURC/PEPP policy in Category 1 or Category 2, all research in the laboratory must cease immediately, and the Biological Safety Officer  must be contacted to determine the next course of action.
• The Biological Safety Officer will consult with the PI about any concerns relating to DURC/PEPP and assist the PI with notifying the IRE and federal funding agencies.
• After the federal agencies have been notified, PIs are responsible for working directly with their federal funding agencies and Brown University’s IRE to complete the required risk mitigation plans and other mandatory reviews and submitting required progress updates to both the IRE and any funding agencies involved.

• Establish and implement internal policies and practices that provide for the identification and ongoing oversight of Category 1 and Category 2 research;
• Establish an Institutional Review Entity (IRE) and ensure Category 1 and Category 2 research is identified through appropriate PI and IRE review;
• Maintain appropriate records of IRE reviews and completed risk mitigation plans for the term of the research grant, contract, cooperative agreement, or other agreement or transaction, plus three years after its completion, unless a longer period is required by law or regulation;
• Certify at the time of seeking funding (e.g., by signing the face page of a grant application) that their research institution fully follows the research oversight framework under the DURC/PEPP Policy;
• On an annual basis, provide a formal assurance to relevant federal funding agencies that the research institution is operating consistently with the DURC/PEPP Policy;
• Designate an Institutional Contact for Dual Use Research (ICDUR) to serve as an internal resource regarding oversight of Category 1 or Category 2 research;
• Provide education and training on research oversight for Category 1 or Category 2 research for individuals conducting life sciences research that may be within the scope of the DURC/PEPP Policy.

Per the DURC/PEPP Policy, the IRE should be composed of at least five members, have sufficient breadth of expertise, to include biosafety and biocontainment expertise, to assess DURC and research involving PEPP, understand biosafety and biosecurity implications of such research, and understand risk assessment and risk management considerations, to be able to develop risk mitigation strategies and plans.

At Brown, the IRE is composed of a subset of the Institutional Biosafety Committee (IBC) and includes the Deputy Vice President for Research, the Biological Safety Officer, and the Senior Director of Research Integrity. 

IRE Meetings

The IRE will meet at least once a year and on an ad hoc basis when the assessment by a PI indicates that a study might be subject to IRE review, or if the IBC refers a study to be reviewed by the IRE. 

When reviewing potential DURC or research involving PEPP, the IRE will:

• Assess whether the research is within the scope of Category 1 or Category 2;
• Work with the PI to conduct a risk-benefit assessment and develop a risk mitigation plan for Category 1 or Category 2 research, as necessary;
• Ensure that the federal funding agency is notified within 30 days of the institutional review and that a risk mitigation plan is reviewed, approved, and implemented within 90 days before the initiation of the proposed Category 1 or Category 2 research;
• Assist with and oversee the implementation of the risk mitigation plan. The research must be conducted in accordance with the approved risk mitigation plan.
• Evaluate risk mitigation plans at least annually (a shorter mitigation plan review cycle may be elected, especially for Category 2 research) and modify them as necessary for the duration of the research. 

Risk mitigation plans should provide sufficient details on the research in question to enable the federal funding agency to adequately assess the institution’s plan for managing the risks associated with DURC and research involving PEPP identified by the IRE.  

The IRE will work closely with the U.S. government funding agency and Brown’s Institutional Biosafety Committee  to develop the draft risk mitigation plan.  For risk mitigation plans involving Category 2 research, the federal funding agency will conduct an additional review with its department-level review entity to determine if the proposed risk mitigation plan is feasible and acceptable. The department-level review entity may propose additional mitigation measures.

Risk mitigation plans should include the following:  

• The name and contact information for the PI(s)
• The name and contact information for the authorized institutional official or their designee
• The dates and details of the reviews and assessments of the research by the IRE
• The dates and details of the PI’s initial review or ongoing assessment of the research.  Identification of whether the research has been identified as Category 1 or Category 2 Research.
• Persons working on research determined to be under DURC regulations, and demonstrations of their competency to conduct said research
• Details of the risks identified by the IRE in its review of research procedures, and an explanation of the risk mitigation strategy or strategies that are being implemented by the institution to address those risks
• Procedures to be followed in the event of an accidental release, exposure, theft, or misuse of any biohazardous agents covered under DURC policies
• Other materials, such as proposals and progress reports related to the research that may be requested by the U.S. government agency

The University must submit a copy of the draft risk mitigation plan within 90 calendar days of the IRE’s determination that the research is Category 1 or Category 2 research to the designated federal agency for review and final approval. 

Dual Use Research of Concern (DURC) and research involving PEPP may also necessitate export control review. 

DURC or research involving PEPP may be subject to the Export Administration Regulations (EAR) or the International Traffic in Arms Regulations (ITAR). For example, a research project may lose its Fundamental Research status and become subject to U.S. export control regulations if, under the DURC/PEPP policy, risk mitigation measures limit the release of the informational results. 

Brown’s Export Control Officer will be able to help determine which, if any, export restrictions apply. Export licenses are required for any exports of DURC agents. In addition, export licenses may also be required in certain circumstances for foreign persons to have access to information that is restricted under a risk mitigation plan.

Questions or requests for additional information should be directed to the Export Control team at Brown University.

Brown’s Biological Safety Officer will be the Institutional Contact for Dual Use Research (ICDUR). Contact Brown University’s Institutional Contact for Dual Use Research (ICDUR) at biosafety@brown.edu.