University of Florida Policy on Dual Use Research of Concern

Introduction

Dual use research (DUR) is research conducted for legitimate purposes that generates knowledge, information, technologies, and or products that can be utilized both for benevolent and harmful purposes. A limited subset of this research is termed Dual Use Research of Concern (DURC), 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”.

In March 2012, the United States Government (USG) issued its “Policy for Oversight of Life Sciences Dual Use Research of Concern” that formalized a process of review by USG sponsors for research involving certain high-consequence pathogens and toxins to identify DURC and implement risk mitigation measures. In September of 2014 an additional policy was issued requiring institutions to identify DURC, put specific mitigations in place once identified, and communicate this information to the USG sponsor or NIH. The two policies are intended to be complementary and ensure shared responsibility for responsible science

Applicability

The University of Florida, as an institution that receives USG funding for life sciences research, must adhere to the oversight requirements specified in the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern  even for research that is not funded by the Federal Government.

Timing of Review

The institution must “at the time of application for USG funds for life sciences research” provide certification to the funding agency or agencies that the institution is in full compliance with all aspects of the federal policy or will be at the time the research is initiated.

Certification and Annual Assurance

In addition to certification at the time of application, an annual assurance of compliance to the funding agency by the institution is also required. Each USG funding agency will implement the certification requirement for applications and grantees according to their own agency policies.

Compliance

The university must report instances of noncompliance with the federal policy, as well as mitigation measures undertaken by the institution to prevent recurrences of similar noncompliance, within 30 calendar days to the USG funding agency (or to the NIH in the case of non-USG funded research). Non-compliance with the policy may result in suspension, limitation, or termination of USG funding, or loss of future USG funding opportunities for the non-compliant USG-funded research project and of USG funds for other life sciences research at the institution, consistent with existing regulations and policies governing USG funded research, and may subject the institution to other potential penalties under applicable laws and regulations.

Institutional Responsibilities

Risk Assessment

Research determined to be DURC should not be conducted until an approved risk mitigation plan has been implemented. The Principal Investigator (PI) is required to notify the institution through its institutional review entity (IRE) if their research directly involves use of one or more of the 15 agents or toxins listed below.

At UF, the institutional review entity (IRE) is the Dual Use Research of Concern Committee (DURC committee).

Agents and toxins relevant to the policy*:

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

*Attenuated strains of these agents that are specifically excluded from Select Agent Regulations and inactive forms of botulinum neurotoxin are not subject to the policy.

The 15 agents and toxins are regulated by HHS/USDA Select Agents Regulations for security and safety to avoid accidents or deliberate misuse. The USG DURC Policy directly addresses the potential risk of the misuse of the research results – its dual uses – and provides for oversight of the agents and toxins that complements, but is different from, current regulations.

Further, the PI will provide an assessment of whether s/he feels the research meets the definition of DURC and produces, aims to produce, or can be reasonably anticipated to produce one or more of the 7 effects of concern listed below:

Categories of experiments relevant to the policy:

  1. Enhances the harmful consequences of the agent or toxin
  2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
  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
  4. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
  5. Alters the host range or tropism of the agent or toxin
  6. Enhances the susceptibility of a host population to the agent or toxin
  7. Generates or reconstitutes an eradicated or extinct agent or toxin from the list of 15 agents subject to the policy

Since the possession or use of any of the 15 agents subject to the policy requires UF Biosafety Office and UF Institutional Biosafety Committee review, the DURC Committee will receive the protocols requiring a DURC determination from UF’s Biosafety Office.

The DURC Committee will review the PI’s assessment and the research project as a whole and conduct a risk assessment that considers the agent(s) being used, anticipated effects of the proposed experiments, and the definition of DURC to determine if the work constitutes DURC.

Within 30 calendar days of the committee review of the research for DURC potential, the DURC Committee notifies the USG funding agency of any research that involves one or more of the 15 listed agents and one or more of the seven listed experimental effects, including whether it meets or does not meet the definition of DURC. In the event that the research project is not funded through a USG sponsor, the results of the review process are submitted to the NIH Program on Biosecurity and Biosafety Policy at DURC@od.nih.gov.

Risk Mitigation Plans

In the event a DURC determination is made, a draft risk mitigation plan for the conduct and communication of DURC must be submitted to the USG (or NIH for non-USG funded research) within 90 days of the DURC committee’s determination. The plan will indicate the DURC-associated risks identified by the committee, the specific risk mitigation measures to be employed, and how these measures address the identified risks. The funding agency is required to provide an initial response to institutions within 30 calendar days and finalize and approve the plan within 60 days of receipt of the draft plan. The DURC Committee will review plans at least annually and modify them as needed.

Training

Education and training on DURC is required for all for individuals conducting life sciences research with one or more of the 15 agents subject to the policy. At this time, the US Dept. HHS training slide set http://www.phe.gov/s3/dualuse/Documents/durc-us-policy-trng.pdf will be used for this purpose.

Record Retention and Access

Records regarding DURC committee review and risk mitigation plans must be kept for the duration of the project plus 3 years, but not less than 8 years, unless a shorter period is required by law or regulation. Records of education and training must be kept for the term of the research grant or contract plus 3 years after its completion.

Principal Investigator Responsibilities

  1. Be knowledgeable about and comply with all UF and USG policies and requirements for the oversight of DURC.
  2. Submit the appropriate registration form to the EH&S Biological Safety Office. As part of the normal registration process for biohazards, all registration submissions are reviewed for dual use potential. Projects utilizing one or more of the 15 agents subject to the policy will be forwarded to the DURC Committee for review and risk assessment.
  3. Document an assessment for DURC. A form will be provided to the PI for this purpose.
  4. If DURC is identified, work with the DURC Committee to assess the dual use risks and benefits and to develop a risk mitigation plan.
  5. Conduct DURC in accordance with the provisions in the approved risk mitigation plan.
  6. Communicate DURC 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 DURC should do so in compliance with the approved risk mitigation plan.
  7. Remain vigilant for changes in the dual use status of ongoing research projects and communicate with the DURC Committee (DURC@research.ufl.edu) when a change occurs.
  8. If changes need to be made to an approved risk mitigation plan, work with the DURC Committee to revise the plan (which then needs to be reviewed and approved by the US Government funding agency (or NIH) prior to implementation of any changes).
  9. Ensure that all project personnel, including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists, conducting life sciences research with one or more of the 15 agents listed above have received training on DURC.

Other Institutional Responsibilities

The DURC Committee must also notify, within 30 calendar days, the USG sponsor (or NIH as applicable) of any change in the status of a DURC-designated project at the institution (e.g. unexpected experimental outcomes) and/or the details of any changes to risk mitigation plans.

An Institutional Contact for Dual Use Research (ICDUR) will serve as the institutional point of contact for questions regarding compliance with, and implementation of, requirements that apply to DURC. The ICDUR serves as the liaison (as necessary) between the institution and the relevant program officers at the USG funding agencies, or for non-USG funded research, between the institution and NIH. At this institution, the ICDUR is the Responsible Official for the Select Agent Program and is a member of the DURC Committee.

Information about the process for reviewing life sciences research for dual use will be made available upon request as consistent with applicable law.

Funding Agency Review

Federal agencies can notify an institution when they believe research meets the definition of DURC or when they don’t agree with an institution’s assertion that it is. Open communication between PIs, UF’s DURC Committee, and federal agencies on what constitutes DURC is important, especially when:

  1. The DURC Committee requires guidance on developing an adequate risk mitigation plan in cases where the potential risks are perceived as particularly high;
  2. The DURC Committee considers the only viable risk mitigation measure to be not conducting or not communicating the research in question;
  3. The PI does not agree with the finding of the DURC Committee and so the institution would like to request outside advice;
  4. The research in question represents a particularly complex case or appears to fall outside the scope of the USG policy, but still seems to present significant concerns; or
  5. Guidance is required to ensure a clear understanding of how the USG interprets the definition of DURC and related terms.

Federal agencies may opt to terminate funding or future funding opportunities for USG-funded research projects and USG funds for other life sciences research at an institution if they believe institutions are not in compliance with the DURC Policy. Questions about the possible DURC nature of a particular project should be addressed to the program official at the pertinent funding agency, unless the project is not federally funded, in which case questions can be sent to: DURC@od.nih.gov.

 

Additional Information and Resources