History: Original Date
Approved: December 16, 2014
Revised: September 29, 2015
Next Review Date: September 2018
The purpose of this policy is to outline Boston University’s (“BU”) institutional oversight of Dual Use Research of Concern according to the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” released on September 24th, 2014.
This policy applies to all individuals engaged in Dual Use Research at or under the auspices of BU.
This policy also applies to all individuals engaged in Dual Use Research at or under the auspices of Boston Medical Center (“BMC”).
Dual Use Research (“DUR”) is defined as research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that could be utilized for both benevolent and harmful purposes. Dual Use Research of Concern (“DURC”) is a subset of Dual Use Research defined as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
On September 24, 2014, the United States Government released the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” with effective date of September 24th 2015. The policy addresses institutional oversight of DURC, which includes policies, practices, and procedures to ensure DURC is identified and risk mitigation measures are implemented, where applicable. Institutional oversight of DURC is the critical component of a comprehensive oversight system because institutions are most familiar with the life sciences research conducted in their facilities and are in the best position to promote and strengthen the responsible conduct and communication of DURC.
On March 29, 2012, the Federal government issued the “United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern” that requires funding agencies to review research and research proposals to identify those that qualify as DURC, and to ensure that acceptable risk-reducing mitigation plans are in place.
A Companion Guide, entitled “Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern,” has been developed to assist institutions, investigators, and Institutional Review Entities in the development of policies and practices for the effective oversight of DURC and in the execution of some of the required steps for institutional review and oversight.
References herein to the Federal government Policies and Companion Guide shall be deemed to include all revisions, updates, and successor federal policies and guidance.
Scope of Research Requiring Oversight Under Dual Use Research of Concern
Agents and Toxins
Research that uses one or more of the agents or toxins listed below, and produces, aims to produce, or can be reasonably anticipated to produce one or more of the effects listed in the following categories of experiments will be evaluated for DURC potential. The Institutional Contact shall revise this policy to update the list of agents and toxins and the categories of experiments from time to time as updates are made in the Federal government Policies and Companion Guide.
Agents and toxins:
- Avian influenza virus (highly pathogenic)
- Bacillus anthracis
- Botulinum neurotoxin (For the purposes of this policy, there are no exempt quantities of botulinum neurotoxin. Research involving any quantity of botulinum neurotoxin should be evaluated for DURC potential.)
- Burkholderia mallei
- Burkholderia pseudomallei
- Ebola virus
- Foot-and-mouth disease virus
- Francisella tularensis
- Marburg virus
- Reconstructed 1918 Influenza virus
- Rinderpest virus
- Toxin-producing strains of Clostridium botulinum
- Variola major virus
- Variola minor virus
- Yersinia pestis
The 15 agents and toxins listed in this policy are subject to the select agent regulations (42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121), which set forth the requirements for possession, use, and transfer of select agents and toxins, and have the potential to pose a severe threat to human, animal, or plant health, or to animal or plant products.
Research involving use of any of the 15 listed agents is not intended to include research that involves only the use of attenuated forms of these agents or the genes from these agents.
Research that does not use any of the listed agents or toxins will also be evaluated for DURC potential as described in this policy.
Categories of Experiments
- Enhances the harmful consequences of the agent or toxin
- Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
- Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
- Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
- Alters the host range or tropism of the agent or toxin
- Enhances the susceptibility of a host population to the agent or toxin
- Generates or reconstitutes an eradicated or extinct agent or toxin listed above
Researchers shall consider whether their research requires review under this policy throughout the lifecycle of the research. They shall initiate review of the research for DURC potential whenever any of the following criteria are met:
- The research directly involves nonattenuated forms of one or more of the listed agents or toxins; or
- The research produces, aims to produce, or can be reasonably anticipated to produce one or more of the listed experimental effects; or
- The research may meet the definition of DURC and should be considered for DURC potential.
DURC Review and Risk Mitigation
Institutional Contact for Dual Use Research (ICDUR)
6.2 Dual Use Research Review Committee (DURRC)
- Be composed of at least five members;
- Execute the functions described in this policy;
- Include persons with sufficient breadth of expertise to assess the dual use potential of the range of relevant life sciences research conducted at BU/BMC;
- Include persons with knowledge of relevant Federal policies and understanding of risk assessment and risk management considerations, including biosafety and biosecurity. The DURRC shall also include, or have available as advisers, University faculty and staff knowledgeable in BU/BMC’s pertinent commitments, policies, and standard operating procedures;
- On a case by case basis, recuse any member who is involved in the research project in question or has a direct financial interest, except to provide specific information requested by DURRC; and
- Engage in an ongoing dialogue with the Principal Investigator (Principal Investigator View Boston University's policy on...) of the research in question when conducting a risk assessment and developing a risk mitigation plan.
- Director of Research Safety
- Chair of the Institutional Biosafety Committee (“IBC”)
- Executive Director of Research Compliance
- Chief Safety Officer, National Emerging Infectious Diseases Laboratories The NE...
- Chief of the BU Police Department
- One community member
- A representative from Public Relations
- Four faculty or staff representatives in scientific and technology fields
The chair of the DURRC shall be appointed by the AVPRC from among the faculty or staff members in scientific and technology fields. If a particular study or issues raised during the review require expertise that is not represented on the DURRC, the chair of the DURRC may appoint ad hoc members.
DURRC Subcommittee:A Subcommittee of the DURRC is established for purposes of conducting initial reviews of potential DURC. The chair of the DURRC Subcommittee shall be the faculty or staff member in a scientific or technology field. DURRC Subcommittee Membership:
- Director of Research Safety
- Chair of Institutional Biosafety Committee The IBC is an instituti...
- One faculty or staff member of the DURRC in a scientific or technology field, who shall be appointed by the AVPRC
The DURRC and the DURRC Subcommittee will seek advice and guidance from other offices and committees at the University, including the Office of the General Counsel, as needed.
Requirements for the DURRC Review Process:
The DURRC and DURRC Subcommittee shall undertake the following steps in its review of research, which shall involve a two-stage review process as described in Sections 6.4 and 6.5. (See the flowchart in Appendix I.)
- Determine whether the research utilizes nonattenuated forms of one or more of the listed agents or toxins.
- Determine whether the research produces, aims to produce, or is reasonably anticipated to produce one or more of the listed experimental effects.
- Determine whether the research is subject to further review in accordance with this policy.
- Conduct a risk assessment and determine whether the research meets the definition of DURC. This assessment should involve the PI, as appropriate.
- Assess the benefits of the DURC while also considering the risks identified in the previous step.
- Develop a draft risk mitigation plan for the identified DURC. This plan should be based on the assessment of the risks and benefits performed in the previous steps. More information on drafting risk mitigation plans can be found in Section D of the Companion Guide.
- Review, at least annually, all active risk mitigation plans. If the research in question still constitutes DURC, the DURRC should modify the plan as needed. More information on the annual review of active risk mitigation plans can be found in Section E of the Companion Guide.
Education and Outreach
IBC Screening for DURC
If the answer to any of the screening questions is “Yes”, the IBC Office will forward the protocol to the DURRC Subcommittee, who will review the application and determine whether the study may be DURC.
The IBC may forward applications to the DURRC Subcommittee where the PIs replied “No” to all 7 questions if the IBC believes the study should be reviewed by the DURRC.
Two Stage Review of DURC
If the DURRC Subcommittee review determines that the research in question does not meet the definition of DURC, the Subcommittee will determine any management plan necessary for the ongoing monitoring of the research project. The research is not subject to additional review or oversight but shall continue to be assessed by the PI for DURC potential (at least annually). The PI shall notify the IBC and the DURRC Subcommittee as soon as possible if there is a potential for the research project to become DURC.
If the DURRC Subcommittee determines that the research is DURC, then the study will be referred to the full DURRC.
If a study is considered to be DURC, then the full DURRC will conduct a review according to the established criteria and develop a risk mitigation plan.
The DURRC will open a dialogue with the PI in order to determine whether the research should proceed as planned. During this consultation, the security aspects of the research will be reviewed with the appropriate officials (e.g., deans, provosts, AVPRC). Internal experts (e.g., other researchers, security experts), and external experts (e.g., National Science Advisory Board for Biosecurity (“NSABB”)) 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.
Regular (at least once each calendar year) meetings will be scheduled to review all DURC studies and risk mitigation plans.
For research projects that have been determined to be DURC, the DURC component of the project must not be initiated until an approved risk mitigation plan is in place.
Report to Federal Funding Agency (or NIH-Designated Agency for Non-Federally Funded Research)
Risk Mitigation Plan
Federal Policy Requirements
For research that involves one or more of the 15 listed agents and toxins and one or more of the 7 listed experimental effects and meets the definition of DURC, the ICDUR and the DURRC shall work with both the PI and the Federal funding agency, or for non-Federally funded DURC, the NIH-designated Federal agency, to develop a risk mitigation plan. Within 90 calendar days of the DURRC’s determination that the research is DURC, the ICDUR shall provide the draft risk mitigation plan to the Federal funding agency or for non-Federally funded DURC, the NIH designated Federal agency, for final review and approval. Federal agencies are required to provide an initial response within 30 calendar days and should finalize the plan within 60 calendar days of receipt of the draft plan.
Note: Notice to and approval by the relevant Federal agency is not required for research that does not involve at least one of the 15 listed agents and toxins.
Developing a Draft Risk Mitigation Plan
The DURRC shall conclude their risk-benefit assessment of DURC by developing a draft risk mitigation plan in consultation with the ICDUR. The plan should indicate the DURC-associated risks identified by the DURRC, the specific risk mitigation measures to be employed, and how these measures address the identified risks.
The ICDUR and the DURRC should consider the strategies outlined below to determine the most effective risk mitigation measures that are tailored specifically to the research in question. These strategies are not mutually exclusive and may be used in combination. More than one strategy may be applicable for addressing a given risk. Also, the same strategy may be appropriate for addressing more than one risk. Lastly, the risk mitigation strategies are general in nature; the list is not meant to be exhaustive. The ICDUR and the DURRC are encouraged to consider additional strategies for mitigating the concerns about dual use raised by the research in question. 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.
Note: Although it is the responsibility of the ICDUR and the DURRC 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 DURRC requires guidance on developing an adequate risk mitigation plan in cases where the potential risks are perceived as particularly high;
- The DURRC considers the only viable risk mitigation measures to be not conducting the research in question or not communicating its results.
The ICDUR and the DURRC 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.
Strategies for Mitigating DURC-associated Risks
- Determine whether existing biosafety and biosecurity measures are adequate
- Evaluate applicability of existing countermeasures
- Develop a plan for responsibly communicating the findings of DURC
- Educate and train research staff using available DURC educational tools
- Develop a plan for monitoring the DURC
- Do not conduct certain aspects of the DURC
For details about each strategy, please refer to Section D of the Companion Guide
Elements of a Draft Risk Mitgation Plan and Implementation
- 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 DURRC.
- 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 DURC under the March 2012 DURC Policy.
- Details of the risks identified by the DURRC in its review of the research, and an explanation of the risk mitigation strategy or strategies that are being implemented by the University to address those risks.
- Other materials, such as proposals and progress reports related to the research that may be requested by the relevant Federal agency.
After a risk mitigation plan is developed and is approved by the relevant Federal agency, the DURC must be conducted in accordance with that plan. The DURRC shall review all active risk mitigation plans at least annually, and modify the plans as needed, subject to the approval of the ICDUR and the relevant Federal agency.
Monitoring of DURC and Appeals by PIs
PIs must report any noncompliance with this policy promptly to the DURRC and IBC. The DURRC shall review all reports of noncompliance and recommend an appropriate risk mitigation plan or change to a plan, including mitigation measures to prevent recurrences of similar noncompliance, for approval by the ICDUR and the relevant Federal agency.
The ICDUR shall report instances of noncompliance with this policy, as well as mitigation measures undertaken by the University to prevent recurrences of similar noncompliance, within 30 calendar days to the Federal funding agency or, for non-Federally funded research, to the Federal agency designated by NIH.
The ICDUR shall also provide notification, within 30 days, of: 1) any change in the status of a DURC project (including whether the research is determined by the DURRC to no longer meet the definition of DURC), and 2) details of any changes to risk mitigation plans (such changes to be approved by the relevant Federal agency). Such notification should be made to the Federal funding agency or, in the case of non-Federally funded research, to the Federal agency designated by NIH.
Appeals by PIs:
PIs shall have 10 days from receipt of institutional decisions regarding research that is determined by the DURRC to meet the definition of DURC to submit an appeal in writing to the ICDUR. The appeal shall include the reason for the appeal and justification for the requested change to the decision.
The ICDUR may conduct an inquiry and may solicit internal or external consultation during the inquiry, including consultation with the DURRC and the relevant Federal agency. After completing the inquiry, the ICDUR shall issue a final determination and shall report the determination to the PI and the DURRC.
DURC Carried Out at Multiple Sites
Transfer of Data and Materials
Transfers Out to External Institutions:
For the limited number of studies that are categorized as DURC, it is important to conduct appropriate due diligence prior to sharing data, materials, or technology with external institutions. The PI, with help from the Office of Research Compliance, should obtain some basic information from the requestor. This should include:
- Is the requestor from a legitimate institution and is he or she engaged in the type of research for which the information is being requested?
- Is the requestor familiar with the concept of DURC 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 DURRC 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 Technology Development, after consultation with the Export Control Director, according to existing policies and procedures.
Transfers In From External Institutions:
The transfer of data, materials, or technology from an external institution may trigger evaluation of the research for DURC potential or, for research that has been categorized as DURC, may involve special consideration in light of the risk mitigation plan. For BU researchers, the Office of Sponsored Programs shall consult the ICDUR or DURRC and the Export Control Director prior to executing a material transfer agreement, as needed. For BMC researchers, the ICDUR and DURRC shall be available for consultation with the appropriate BMC office(s).
Export Controls and DURC
The 15 listed agents 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 US Person in the Unites States or abroad. Export licenses may be required in both circumstances. As a result, the Office of Technology Development shall consult with the Export Control Director prior to the execution of Material Transfer Agreements. Principal Investigator shall consult with the Export Control Director prior to the transfer of controlled technology or software to non US Persons.
To foster scientific advances, certain information is exempted 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: a) the researcher 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 Director on the application of export controls to the research prior to accepting restrictions from the sponsor.
Under certain circumstances, DURC research 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 US Munitions List (USML) requires technology control plan and license authorization for non US Persons. Therefore, Principal Investigators shall consult the Export Control Director prior to conducting research with materials that could have been developed for military use.
Note: Identification of research as DURC 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 check with the IBC Office ([email protected]) directly for more information about export controls.
Publication and Dissemination of Information to the Public
- General Overview of the Research Information
- Risk Analysis
- Benefit Analysis
- Considerations for Weighing Risk and Benefits of Communicating DURC Findings
- Formulation of Recommendation(s) Regarding Responsible Communication of DURC Findings
Possible communication or publication actions (more than one may be applicable):
- Communicate or publish as is.
- 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).
- 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).
- Delete certain information and then communicate or publish openly.
- Communicate information “of concern” through nonpublication / nonpresentation channels. Identify what parties should be given the restricted information and how it should be distributed.
- Communicate only to selected parties (not openly communicate).
- Communicate to selected parties—need to specify who they are and the mechanisms of communication.
- Communicate selected information to selected parties, but the rest of the information is not communicated at all, to anyone.
- Do not communicate at all.
Timing of communication, based on considerations set forth above:
- 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).
Final consideration of the agreed-upon course for going forward:
- 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?
Criteria for Consulting the US Government
It is expected that the ICDUR and the DURRC can develop plans for the responsible communication of DURC findings in the majority of cases. However, there may be some rare situations in which consultation with the relevant Federal agency may be helpful. The Federal agency may be consulted by the ICDUR or the DURRC (not by individual researchers) for cases where:
- Unique expertise (e.g., on national security) is needed to assess the potential risks associated with communicating the research;
- The DURRC 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 DURRC 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 DURRC’s 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 definition of DURC but still seems to present significant concerns.
Appendix-II: Enhanced Dual Use Research Training
Boston University’s Dual Use Research of Concern (“DURC”) education and training program for faculty and staff is focused on providing a general framework for:
- 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 15 listed agents and toxins or research that has otherwise been determined by the DURRC 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 (“DURRC”).
- The roles and responsibilities of participants.
Principal Investigators who receive an iDURC policy form from the Department of Homeland Security (DHS), should contact the IBC office.