Dual Use of Research Concern Policy

1. Purpose of Policy

The purpose of this Policy is to lay out the processes that make up the institutional review and oversight by Western Michigan University of certain research to identify potential DURC and to develop and implement risk mitigation plans as needed.        

2. Stakeholders Most Impacted by the Policy

This policy applies to all personnel (employees, faculty, students, research staff, contractors, visitors, and collaborators) engaged in research or projects conducted under the auspices of Western Michigan University whether the research is conducted on or off campus.

2.1. These include projects, facility use or use of university resources whether the research is funded or unfunded.

2.2. It is the responsibility of faculty and administrators to be aware of and comply with the law relative to their work, students assisting them in their work or research, agreements and collaborations with others, and foreigners who may have access to their research or labs to ensure no conduct is contrary to law and the University’s policies, procedures, guidelines and instructions.

3. Key Definitions

3.1. Dual Use Research: Any legitimate research that generates new knowledge, information, technologies, or products that could be used for both benevolent and malevolent purposes.

3.2. Dual Use of Research Concern (DURC): 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 consequence to public health and safety, agricultural crops and other plans, animals, the environment, materiel or national security.

3.3. DURC Agents:

The following 15 agents and toxins referred to the in the 2014 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern:

1. Avian influenza virus (highly pathogenic)	9. Marburg Virus
2. Bacillus anthracis	10. Reconstructed 1918 inflenza virus
3. Botulinum neurotoxin	11. Rinderpest virus
4. Burkholderia mallei	12. Toxin-producing strains of clostridium botulinum
5. Burkolderia pesudomallei	13. Variola major virus
6. Ebola virus	14. Variola minor virus
7. Foot-and-mouth disease virus	15. Yersinia pestis
8. Francisella tularensis

3.4. Experimental Effect of Concern: The following 7 categories of experiments referred to in the 2014 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern:

• 3.4.1. Enhances the harmful consequences of the agent to toxin
• 3.4.2. Disrupts immunity or effectiveness of an immunization against the agent of toxin without clinical and/or agricultural justification
• 3.4.3. 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
• 3.4.4. Increases the stability, transmissibility or the ability to disseminate the agent or toxin.
• 3.4.5. Alters the host range or tropism of the agent or toxin
• 3.4.6. Enhances the susceptibility of a host population to the agent or toxin
• 3.4.7. Generates or reconstitutes an eradicated or extinct agent or toxin listed in the definition of DURC Agents above.

3.5. Institutional Biosafety Committee (IBC): Western Michigan University’s Institutional Biosafety Committee

3.6. Principle Investigator - PI: A principle investigator (PI) is the lead researcher/scientist for a particular well-defined science, or other academic project who takes direct responsibility for completion of a funded or unfunded project, directing the research, and reporting directly to the sponsor, IBC, or others as required. 

3.7 Institutional Contact for Dual Use Research (ICDUR): The individual designated by the University to be the institutional point of contact for questions relating to compliance with this Policy and the liaison with the relevant USG funding agencies. The University has designated the Associate Vice President for Research, Associate Director Research Compliance and the Chair of the IBC together as the ICDUR.

3.8. Institutional Review Entity - IRE: Western Michigan University’s IRE is comprised of the Chair of the IBC, the Vice Chair of the IBC, the Associate Director Research Compliance, the Associate Vice President for Research, the University Radiation Officer and the Director of Environmental Health and Safety.

3.9. U.S. Funding Agency: The USG agency that is funding the subject research, or, if the research is not USG-funded, the USG agency designated by the NIH, based on the nature of the research. If a federal department or agency simply passes through funding from another federal department or agency to support life sciences research involving one or more of the DURC Agents, the agency originally providing the funding shall be considered the US Funding Agency.

3.10. Export Administration Regulations EAR

3.11. International Traffic in Arms Regulations ITAR

4. Full Policy Details

4.1. Policy Requirements for the Principal Investigator (PI): The USG specifies that it is the responsibility of the Principal Investigator to submit the institutional review if any of the following criteria are met:

• 4.1.1. The PI’s research directly involves nonattenuated forms of one or more of the listed agents;
• 4.1.2. The PI’s research with nonattenuated forms of one or more of the listed agents also produces, aims to produce or can be reasonably anticipated to produce one or more of the seven listed experimental effects; or
• 4.1.3. The PI concludes that their research with nonattenuated forms of one or more of the listed agents that also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven listed experimental effects may meet the definition of DURC and should be considered (or reconsidered) by the IRE for its DURC potential.

 If the PI's research meets any of the aforementioned criteria, they will notify the IRE immediately, by contacting the Associate Director Research Compliance. The PI will provide the Associate Director Research Compliance with documentation on how the determination of DURC was concluded. Additionally, the PI will include all relevant data to assist the IRE in making a determination about DURC.

4.2. Policy Requirements for Institutional Review

The overall process of the IRE consists of six steps:

• 4.2.1. Verity the use a nonattenuated agent: The first step in review is to determine if one or more of the nonattenuated agents listed above are being used in the current research documents. If they are not, the research is not subject to additional institutional DURC oversight and the entity does not need to continue with the assessment. If an agent is being considered for use, the IRE would continue with additional institutional review.
• 4.2.2. Review the PI’s assessment and determine if proposed research constitutes DURC: The IRE will review the submitted materials and determine if the research produces, aims to produce or is reasonably anticipated to produce one or more of the experimental effects listed above. At any time, the IRE can request additional information from the PI to help with the determination. If none of the listed experimental effects apply, the research is not subject to additional institutional DURC oversight, and the entity does not need to continue with the assessment
• 4.2.3. Conduct a risk assessment to determine whether the research meets the definition of DURC.
• 4.2.3.1. The IRE will review the submitted materials to determine the level of risk associated with the project. The project will be assessed for:
  
  • 4.2.3.1.1. The ways in which knowledge, information, technologies, or products from the research could be misused to harm public health and safety, agriculture, plans, animals, the environment, materiel, or national security.
  • 4.2.3.1.2.  The ease with which the knowledge, information, technologies, or products might be misused and the feasibility of such misuse.
  •  4.2.3.1.3. The magnitude, nature, and scope of the potential consequences of misuse.
• 4.2.3.2. If the IRE determines the submitted project does not meet the definition of DURC, the research is not subject to additional institutional DURC oversight, and the entity does not need to continue with the assessment. If the IRE determines the research is DURC, as defined in the Policy for Institutional DURC Oversight and the March 2012 DURC Policy, it is subject to additional DURC oversight. The IRE will notify the USG funding agency within 30 days of the review.

• 4.2.4. Assess the benefits of DURC.

• 4.2.5. The IRE will determine potential benefits associated with the research. The IRE will use this information to aid in the development of the risk mitigation plan. Develop a draft of the risk mitigation plan.
• 4.2.5.1. After reviewing both risks and benefits of DURC, the IRE will develop a risk mitigation plan. The mitigation plan will be submitted to the USG funding agency within 90 calendar days from the IRE DURC determination.
• 4.2.5.2. Section D.2 of the DURC companion guide suggests several strategies for mitigating risks:
• 4.2.5.2.1. Determine whether current biosafety measures are adequate.
• 4.2.5.2.2. Determine the applicability of existing countermeasures.
• 4.2.5.2.3. Develop a plan for responsibility communicating the findings of DURC.
• 4.2.5.2.4. Educate and train staff using available DURC educational tools
• 4.2.5.2.5. Develop a plan for monitoring the DURC.
• 4.2.5.2.6. Do not conduct certain aspects of the DURC.
• 4.2.6. Review, at least annually, all active mitigation plans. The IRE will review all active mitigation plans annually. Additionally, the IRE will report any changes in the status of the DURC project and/or any changes to the mitigation plan. Changes to the mitigation plan must be approved by the USG funding agency prior to implementation. Any changes will be reported to the USG funding agency within 30 calendar days of receiving the request of change and/or initial approval of the change from the IRE.

 4.3 Ongoing Responsibilities

• 4.3.1. Responsibilities of the Principal Investigator
• 4.3.1.1. Conduct research in accordance with the mitigation plan.
• 4.3.1.2. Notify the ICDUR of any additions to the research protocol, inclusion of additional anticipated experimental effects, and any other substantive changes of the DURC research.
• 4.3.1.3. Ensure all laboratory personnel are provided with adequate training and education of DURC research policies as well as appropriate supervision of all research activities.
• 4.3.1.4. Contract the IRE if at any time PI feels research may be considered DURC, or may no longer be considered DURC.

• 4.3.2. Responsibilities of the Institutional Review Entity – IRE: 

  The IRE will review, at least annually, all active risk mitigation plans at Western Michigan University. This review will consist of the abovementioned steps of initial review to continually assess the current state of the DURC and if needed, modify the risk mitigation plan to ensure it adequately mitigates the risks associated with the DURC to the greatest extent possible.
• 4.3.3. Responsibilities of the IDCUR
• 4.3.3.1. Ensure the IRE reviews every mitigation plan at least annually.
• 4.3.3.2. Provide education and training on DURC for researchers conducting research with one or more DURC agents, and maintain the records of such trainings for the duration of the granting term and three years following the close of the project.
• 4.3.3.3. Maintain the records of institutional DURC reviews and completed risk mitigation plans for a minimum of eight years in total. All DURC reviews and mitigation plans must be maintained for a least three years following the close of the project.
• 4.3.3.4. Notify the USG funding agency within 30 calendar days of any changes made to the DURC research protocol or risk mitigation plan. Similarly, the ICDUR will contact the USG funding agency if said research no longer qualifies as DURC within 30 calendar days of the determination.
• 4.3.3.5. Report to the USG funding agency any instances of non-compliance or deviations from the current policy or risk mitigation plan within 30 calendar days of said instance of non-compliance. The ICDUR will work in conjunction with the IRE to determine future measures to avoid situations of non-compliance in the future.                         

5. Accountability

The USG specifies that it is the responsibility of the PI to submit the institutional review.  If the PI’s research meets any of the aforementioned criteria, they will notify the IRE immediately, by contacting the Associate Director Research Compliance. The PI will provide the Associate Director Research Compliance with documentation on how the determination of DURC was concluded. Additionally, the PI will include all relevant data to assist the IRE in making a determination about DURC.

Most DURC is subject to export controls under the EAR administered by the U.S. Department of Commerce, Bureau of Industry and Security. There are generally two types of export transactions: (1) transferring controlled material or technology outside the United States; and (2) transferring controlled technology to non-U.S. persons who are within the United States which is considered a “deemed export.” 

Under certain circumstances, the ITAR, administered by the U.S. Department of State, may apply to DURC items (including materials and information). 

In addition sanctions and embargoes, administered by the U.S. Department of Treasury, Office of Foreign Asset Control may apply to DURC.

 An export control review is required for all DURC involving international persons/entities.

6. Consequences

6.1. Legal Consequences:       

• 6.1.1. Potential loss of all federal funding and loss of export privileges
• 6.1.2. Significant monetary fines and lengthy prison sentences:
• 6.1.3. Violations under the EAR can bring civil penalties of $295,141 per violation and criminal penalties of $50,000 to $1 million per violation along with up to 20 years in prison.
• 6.1.4. Violations under the ITAR can bring civil penalties of $1,094,010 per violation and criminal penalties of up to $1 million per violation along with up to 20 years in prison.
• 6.1.5. Violations under OFAC regulations can bring civil penalties of $289,238 per violation and criminal penalties of up to $1 million per violation along with up to 20 years in prison.
• Possible individual disciplinary procedures, up to and including expulsion or termination, for failure to follow applicable University policies and requirements.

7. Related Procedures and Guidelines 

A Companion Guide to the United States Government Policies for Oversight of Life Sciences Dual Use Research of Concern.  www.phe.gov/s3/dualuse/Documents/durc-companion-guide.pdf

For any additional information or questions about Dual Use Research, please contact the Institutional Contact for Dual Use Research at @email.

8. Additional Information 

 The United States Government – USG has adopted a policy of Dual Use of Research Concern that defines explicit guidelines for conducting and overseeing this type of research.

https://www.phe.gov/s3/dualuse/Pages/companion-guide.aspx

 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern at https://www.phe.gov/s3/dualuse/Documents/oversight-durc.pdf

9. FAQs 

For frequently asked questions please see http://www.phe.gov/s3/dualuse/Documents/durc-faqs.pdf

10. REFERENCES

 (NIH, 2014)  A Companion Guide to the United States Government Policies for Oversight of Life Sciences Dual Use Research of Concern.  www.phe.gov/s3/dualuse/Documents/durc-companion-guide.pdf

 15 CFR 730-780, Export Administration Regulations (EAR), U.S. Department of Commerce, Bureau of Industry and Security (BIS)

22 CFR 120-130, International Traffic in Arms (ITAR), U.S. Department of State

31 CFR 500-599, Office of Foreign Assets Control (OFAC), U.S. Department of Treasury