Institutional Review of Research with Dual Use Potential

Overview

On September 24, 2014, the US Government released its Policy for institutional oversight of Dual Use Research of Concern (“DURC”). The Policy addresses institutional oversight of DURC and identifies the criteria for what qualifies as DURC by listing specific agents and toxins and descriptions of the types of experiments which, when combined, define the parameters for research considered DURC. Compliance with The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (Policy) commenced on September 24, 2015.

What are Dual Use Research and Dual Use Research of Concern?

Dual Use Research is defined as research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products which could be utilized for both benevolent and harmful purposes. 

Dual Use Research of Concern, or DURC, is a subset of Dual Use Research and is 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.

What is Texas A&M University’s Review and Approval Process for DURC?

Texas A&M University is committed to the shared responsibility of upholding the integrity of science and to reducing the risk of its misuse.  Review and oversight of DURC are outlined in  TAMU Rule 15.99.06.M1  Use of Biohazards, Biological Toxins and Recombinant DNA and Dual Use Research of Concern and IRE SOP 019 “Institutional Review of Research with Dual Use Potential”.

Per TAMU Rule 15.99.06.M1, TAMU’s Institutional Biosafety Committee (IBC) serves as TAMU’s Institutional Review Entity (IRE) and is responsible for reviewing potential DURC and executing the requirements in The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern review (September 2014).

Who is TAMU’s Institutional Contact for Dual Use Research (“ICDURC”)?

TAMU’s Vice President for Research has designated Ms. Susan Gater, Responsible Official, to serve as TAMU’s internal resource for issues regarding compliance with and implementation of the requirements for oversight of DURC as well as the liaison (as necessary) between the university and the relevant Federal funding agency.  For guidance about DURC, contact Ms. Gater at .

What research must be reviewed by TAMU’s IRE?

Research with one or more of the fifteen agents and/or toxins currently listed in Section 6.2.1 of the Policy and which  produces, aims to produce or can be reasonably anticipated  to produce one or more of the  effects listed in Section 6.2.2 of the Policy must be evaluated by the IRE for its DURC potential. Additionally, if the USG has notified TAMU that specific research requires IRE review, the research must be reviewed by the IRE.

What do researchers need to do?

  1.  Notify the IRE if:
  • their research involves non-attenuated forms of one or more of the agents listed in Section 6.2.1 of the Policy;
  • their research with non-attenuated 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 experimental effects listed in Section 6.2 the Policy; and
  • The researcher concludes that his/her research with non-attenuated 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.

 
2. Work with the IRE to develop risk mitigation measures where appropriate;

3. Conduct DURC in accordance with the provisions of the risk mitigation plan;

4. Be knowledgeable about, and comply with, all institutional and Federal policies and requirements for oversight of DURC;

5. Ensure that laboratory personnel (i.e., those under the supervision of laboratory leadership including graduate students, postdoctoral fellows, research technicians, laboratory staff and visiting scientists)  conducting life sciences research that falls within the scope of  the Policy have received education and training on DURC; and

6.   Communicate DURC in a responsible manner and in compliance with any risk mitigation plan stipulated by the IRE.

What if research meets the definition of DURC?

If the IRE determines that a research project meets the definition of DURC, the ICDURC will notify the USG in accordance with the Policy and work together with the IRE and the researcher to develop a draft risk mitigation plan for final approval by the USG. Once the draft risk mitigation plan is approved, the IRE will continue to monitor the research project and provide compliance oversight until the project has been completed. Any changes in the status of a DURC project or proposed changes to the risk mitigation plan must be communicated to the USG.  Changes in the risk mitigation plan require USG approval. 

What is not DURC?

The review and oversight requirements presented in the USG Policy do not apply to research that involves the use of the genes from any of the listed agents, in silico experiments (e.g., modeling experiments, bioinformatics approaches) involving the biology of the listed agents, or research related to the public, animal, or agricultural health impact of the listed agents (e.g., modeling the effects of a toxin, developing new vaccine delivery methods, developing surveillance mechanisms for a listed agent).

Does IBC approval for research involving use of select agents satisfy the IRE’s requirement to review the research?

No. IBC review and approval, prior to initiation of any research project involving the use of pathogens, materials potentially containing human pathogens (human blood, tissues or cell lines), rDNA (or rRNA) including the creation of transgenic plants and animals, and select agents and toxins, remains a separate institutional requirement, distinct from the IRE review process. Furthermore, experiments with select agents and toxins (excluding attenuated strains or permissible toxin amounts) also require review by and approval from the Federal Select Agents Program  

How do I contact the IRE?The Texas A&M University IRE is administratively managed and supported by the Office of Biosafety.  For questions related to the IRE, please contact ire@tamu.edu.

Additional Resources

United State Government Policy for Oversight of Life Sciences Dual Use Research of Concern (March 2012) .  http://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf

United States Government Policy for Institutional Oversight of Dual Use Research of Concern (September 2014) http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf

FAQs on USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern

http://www.phe.gov/s3/dualuse/Documents/durc-faqs.pdf

National Institutes of Health – Office of Science Policy: Dual Use Research of Concern.

https://osp.od.nih.gov/biotechnology/dual-use-research-concern

Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern: A Companion Guide to the United States Government Policies for Oversight of Life Sciences Dual Use Research of Concern.

http://www.phe.gov/s3/dualuse/Documents/durc-companion-guide.pdf

Training Slide Set: Training on the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.

http://www.phe.gov/s3/dualuse/Documents/durc-us-policy-trng.pdf