Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) in Research

• Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
• Deterioration of food, water, equipment, supplies, or material of any kind; or
• Deleterious alteration of the environment.

• Involves one or more of the biological agents or toxins within scope of Section 4.1.1 of the USG Policy (pdf);
• Is reasonably anticipated to result, or does result, in one or more of the experimental outcomes listed in Section 4.1.2 of the Policy (pdf); and
• Based on current understanding, the research institution and/or federal funding agency assesses that the research constitutes DURC, as specified in Section 4.1.3 of the Policy (pdf).

• 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.

• Involves, or is reasonably anticipated to result in, a PPP as specified in Section 4.2.1 of the Policy (pdf);
• Is reasonably anticipated to result in, or does result in, one or more of the experimental outcomes or actions specified in Section 4.2.2 of the Policy (pdf); and
• Based on current understanding, the research institution, federal funding agency, and/or Departmental multidisciplinary review entity 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 Section 4.2.3 of the Policy (pdf).

• 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;
• Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP.

• Be composed of at least five (5) members;,
• Execute the functions described in this policy;,
• Include persons with sufficient breadth of expertise to assess the potential of the range of relevant life sciences research conducted at BU/BMC;
• Include persons with sufficient breadth of expertise to assess whether the research meets Criteria 1 or Criteria 2, and assess its risk and mitigation efforts;
• Include persons with knowledge of relevant Federal policies and understanding of risk assessment and risk management considerations, including biosafety and biosecurity.
• Include, or have available as advisers, University faculty and staff knowledgeable in BU/BMC’s pertinent commitments, policies, and standard operating procedures;
• Recuse any member who is involved in the research project and who has a conflict of interest in the research (financial or otherwise, serving as PI or research personnel), and may not be present for the vote on protocols in which they have such conflicts except to provide specific information requested by DURCCom; and
• Engage in dialogue with the Principal Investigator (PI) of the research when conducting a risk assessment and developing a risk mitigation plan.

• DURCCom Chair
• Chair of the Institutional Biosafety Committee (IBC)
• Director of Research Safety
• Chief Safety Officer, NEIDLNational Emerging Infectious Diseases Laboratories The NE...
• Chief of the BU Police Department
• Export Control Officer
• One (1) community member
• A representative from Public Relations
• Two (2) faculty representatives in scientific and technology fields (these faculty are not otherwise represented above, e.g. IBC or DURCCom Chair).

• DURRCom Chair
• Chair of the IBC;
• Director of Research Safety;
• At least one faculty member of the DURCCom

• Subcommittee meetings are scheduled as needed to review research that may meet criteria for Category 1 or 2.
• Full committee meetings will be scheduled to review research that the subcommittee recommends as meeting criteria for Category 1 or 2, along with their corresponding risk mitigation plans. If there are no active protocols, risk mitigation plans or other business to discuss, the Chair may choose to cancel the annual DURCCom meeting. The Chair’s decision to cancel the annual DURCCom meeting will be clearly communicated in writing by the Research Compliance staff as a formal record of the cancellation.

• If the subcommittee determines that the research does not meet the criteria of Category 1 or Category 2, the IBC staff will communicate this determination to the PI in writing, ordinarily within 5 business days of the meeting. The IBC staff will notify the PIs that they are expected to continue to assess their research for any changes that may alter this status at least annually. The PI shall notify the IBC immediately if there is a potential for the research project to change in any way that may affect the category of research. The PI may also communicate these changes to the IBC via amendments and/or protocol renewals.
• If the subcommittee determines that the research meets the criteria of Category 1 or Category 2, it will be referred to the DURCCom full committee.

Stage 2: When the subcommittee determines that the research meets the criteria of Category 1 or 2, the full DURCCom will conduct a review according to the established criteria and develop a risk mitigation plan (details described in Section 12)

When the DURCCom determine that Criteria 1 or 2 are met, the IBC staff will arrange a meeting between the DURCCom Chair and other designated DURCCom members, the PI and appropriate University officials (e.g., Deans, Provosts, AVPRC) to discuss the research in more detail, including the security aspects. Internal experts (e.g., other researchers, security experts), and external experts (e.g., National Science Advisory Board for Biosecurity) may also be consulted for advice on the development of the security management which may include limiting access to the research protocol, limitation of information that will be publicly disclosed (e.g., in publications, presentations at scientific forums), and potentially curtailing certain aspects of the research. For research projects that meet the criteria of Category 1 or Category 2, these components of the project must not be initiated until an approved risk mitigation plan is in place.

The ICDUR and the DURCCom should consider the strategies outlined below in 12.3 to determine the most effective risk mitigation measures that are tailored specifically to the research. These strategies are not mutually exclusive and may be used alone or in combination with other strategies. Note, however, that no risk mitigation strategy (or combination thereof) can reduce risks to zero; the aim should be to adequately and appropriately manage the identified risks.

Although it is the responsibility of the ICDUR and the DURCCom to develop the draft risk mitigation plan, there may be situations that require consultation with the relevant Federal agency; such consultations may be appropriate when, for example:

• The DURCCom requires guidance on developing an adequate risk mitigation plan in cases where the potential risks are perceived as particularly high;
• The DURCCom considers the only viable risk mitigation measures to be not conducting the research in question or not communicating its results.

The ICDUR and the DURCCom shall work with the relevant Federal agency to finalize the risk mitigation plan. The final risk mitigation plan shall be subject to the approval of the ICDUR.

• Determine whether existing biosafety and biosecurity measures are adequate;
• Evaluate applicability of existing countermeasures;
• Develop a plan for responsibly communicating the findings of the relevant category of research;
• Educate, develop, and train research staff using available educational tools, including seeking out specific expertise in the creation of the training;
• Develop a plan for monitoring the research;
• Do not conduct certain aspects of the research.

For details about each strategy, please refer to Section F of the USG Policy (pdf).

• The name and contact information for the PI(s);
• The name and contact information for the authorized institutional official;
• The name of the ICDUR (if different from the authorized institutional official);
• The dates and details of the reviews and assessments of the research by the DURCCom;
• 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 under the federal Policy;
• Details of the risks identified by the DURCCom and an explanation of the risk mitigation strategy or strategies;
• Other materials, such as proposals and progress reports related to the research that may be requested by the relevant Federal agency.

• Any change in the status of this project (including whether the research is determined by the DURCCom to no longer meet the criteria of Category 1 or Category 2), and;
• Details of any changes to risk mitigation plans (such changes to be approved by the relevant Federal agency).

• Is the requestor from a legitimate institution and are they engaged in the type of research for which the information is being requested?
• Is the requestor familiar with the concept of this work and its requirements?
• What specific data, materials, or technologies are being requested and for what purpose?
• Will the requestor agree to certain limitations or restrictions regarding access to the data, materials, or technology?
• Will the requestor’s institution agree to such limitations or restrictions?

Once the information is gathered, the ICDUR and DURCCom will review the findings and, after consultation with the relevant Federal agency, if necessary, will determine whether approval should be granted. Once the due diligence is completed, the material transfer agreement will be handled by the Office of Industry Engagement after consultation with the Export Control Officer, according to existing policies and procedures.

In conjunction with this policy, PI’s shall review BU’s Export Control Policies and Procedures as outlined in the Export Control Manual to ensure compliance with BU and U.S. export controls.

The listed agents in Section 6 of this policy are controlled under the Export Administration Regulations, Category 1 of the Commerce Control List. There are two types of transactions: 1) export of controlled material/technology or software; and 2) transfer of technology or software to non-U.S. Persons in the Unites States or abroad. Export licenses may be required in both circumstances. As a result, the Office Industry Engagement shall consult with the Export Control Officer prior to the execution of Material Transfer Agreements. Principal Investigators shall consult with the Export Control Officer prior to the transfer of controlled technology or software to non-U.S. Persons.

To foster scientific advances, certain information is exempt from the Export Administration Regulations including information that is publicly available, information resulting from fundamental research, and educational information. A vast majority of research is considered fundamental research, which means basic and applied research in science and engineering where the resulting information is ordinarily published and shared broadly with the scientific community. The techniques used during the research are publicly available or part of the published information. Fundamental research is exempt from the Export Administration Regulations unless the researcher: a) accepts restriction on publication of the research results; b) accepts restriction on foreign national participation; c) uses techniques/data that are not publicly available; or d) participates in proprietary/industrial development without the intent to publish the research results. Principal Investigators shall consult with the Export Control Officer on the application of export controls to the research prior to accepting restrictions from a sponsor.

Under certain circumstances, Category 1 or 2 may involve items, materials, data or services developed for military use and controlled under the International Traffic in Arms Regulations (ITAR). ALL research with materials, items or data enumerated on the U.S. Munitions List (USML) requires Technology Control Plan and license authorization for non-U.S. Persons. Therefore, PI’s shall consult the Export Control Officer prior to conducting research with materials that could have been developed for military use.

Note: Identification of Category 1 or Category 2 research has no direct bearing on whether or not an export license is required. However, certain risk mitigation measures (e.g., the imposition or acceptance of restrictions on publication) MAY affect whether the research is subject to export authorization requirements. Please contact the Export Control Office for more information.

1. Communicate or publish as is.
2. Communicate or publish with addition of appropriate contextual information. For example, it may be important to address:
   • The significance of the research findings for public health and/or public safety, agriculture, the environment, or materiel;
   • How the new information or technology will be useful to the scientific community;
   • The biosafety and biosecurity measures in place as the research was conducted; and
   • The careful consideration that was given to the concerns about dual use in the decision to publish (e.g., a formal biosecurity review).
3. Communicate or publish openly but withhold specific information that is of concern. For example, “decouple” the material that poses security concerns from some or all of the potentially useful scientific information, or remove information (e.g., technical details about an enabling technology). For example, it may be important to address:
   • Deleting certain information and then communicate or publish openly;
   • Communicating information “of concern” through nonpublication/non-presentation channels;
   • Identifying what parties should be given the restricted information and how it should be distributed.
4. Communicate only to selected parties (not openly communicate). For example, it may be important to address:
   • Communication to selected parties—need to specify who they are and the mechanisms of communication;
   • Communication of selected information to selected parties, but the rest of the information is not communicated at all, to anyone.
5. Do not communicate at all.

• Communicate immediately, to the extent decided above;
• Defer communication (to the extent decided above) until a clearly defined and agreed-upon endpoint is reached (e.g., a condition is met such that communication no longer poses the same degree of risk).

• Does the proposed course of action mitigate, to an acceptable level, the risks that were identified in the risk-benefit analysis?
• Are new risks introduced as a result of changes/modifications? Are there new concerns or unintended consequences regarding the proposed communication? If so, what are they and can they be mitigated?
• Is it likely that the proposed course of action will be challenging to implement or enforce? Is a contingency plan necessary? Would additional resources be required?

• Unique expertise (e.g., on national security) is needed to assess the potential risks associated with communicating the research;
• The DURCCom requires guidance on developing an adequate risk mitigation strategy for communication in cases where the potential risks of communication are perceived as particularly high;
• The DURCCom considers the only viable risk mitigation strategy to be not conducting the research in question or not communicating its findings;
• The PI whose research has been reviewed does not agree with the DURCComs findings, and the institution would like to request outside advice; or
• The research in question represents a particularly complex case or appears to fall outside the criteria of Category 1 or Category 2, but still seems to present significant concerns.

• Recognizing and understanding what types of research could be considered DURC.
• A discussion of the seven types of “experiments of concern” that are described in the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” released September 24, 2014.
• Issues pertaining to potential limitation of such research or publication of data, materials, or technology produced from such research.

Additional training will be required for researchers who engage in research that involves the use of one or more of the fifteen (15) listed agents and toxins or research that has otherwise been determined by the DURCCOM to meet the definition of DURC. These individuals will be provided with additional training to enhance their understanding of the issues related to the conduct of such research. The training will be customized for the targeted audience and will cover the following general topics:

• What is Dual Use Research (DUR)?
• What is DURC?
• Need for continued monitoring of DUR and recognizing when it might become DURC.
• What is biosecurity?
• What is the culture of responsibility?
• What is “due diligence”?
• Communications (what to say, when, and to whom)?
• Introduction to relevant documents and references from the NSABB.
• The role of the Dual Use Research Review Committee (DURCCOM).
• The roles and responsibilities of participants.