Dual Use Research of Concern
Dual Use Research of Concern (DURC) is 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.
The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern outlines the criteria for what qualifies as DURC, listing 15 specific agents and toxin and descriptions of 7 types of experiments that, in combination, define the parameters for research to be classified as DURC and subject to oversight under the policy.
To better understand the DURC requirements or if research meets the DURC criteria, please review the training slides provided by the US Department of Health and Human Services.
Review of Potential DURC Projects
To comply with the U.S. Government DURC policy, a standing committee was assigned as the Institutional Review Entity for DURC. A formal review process for potential DURC projects has been established, which involves review by both the IBC and IRE. Training on DURC is provided via the CITI training modules, for individuals involved in projects that involve one or more of the 15 high-consequence pathogens and toxins.
It is the responsibility of the Principal Investigator to identify research involving one or more of the agents or toxin on the DURC list and notify the IBC for review of its DURC potential. After notification, a formal review process will start where the IBC will determine whether or not the project falls into the DURC definition.
Although few research activities at MUSC would qualify as DURC under the definition in the Policy, we (institution and researchers) must comply with the USG Policy for DURC where applicable.
In case a project is determined to be DURC, The IRE will work with the PI to draft a risk mitigation plan to be submitted to the applicable U.S. Government funding agency.
To register a potential DURC project with the IRE, please take the following steps:
- Submit an IBC protocol which will then be routed for review by both the IBC and DURC committee. Instructions for the IBC submission process are located here.
- To the IBC protocol, please upload the MUSC Dual Use Research of Concern form (contact the IBC administrator for a copy). After completion, please print out this form, sign it and upload it as attachment to an IBC registration form via the eRMA electronic system.
- Upload a safety protocol for handling the toxin (template is located here [DOC]).
- Take DURC training: this applies to all personnel (incl. you as PI) that maybe handling the product. These individuals need to be listed in section 1e of the IBC form. To take the CITI Biosecurity modules, take the following steps:
- Log in to http://www.musc.edu/cgi-bin/citi/login.cgi with your NetID
- Click on the hyperlink “Main Menu” (almost at the top, left)
- Click on the hyperlink “Add a Course or Update Learner Groups” (in the black rimmed-box, titled My Learner Tools for Medical University of South Carolina)
- Click the box for Biosafety/Biosecurity Course, click Next
- Click ONLY the boxes for “Select Agents” and “Dual Use Research of Concern (DURC)”, then click Next
- You’ll be guided back to the list of courses you should complete. But before you can access the modules, you need to click the link “Complete The Integrity Assurance Statement before beginning the course”
- After completing all required modules, you may print out a Completion Report. There is, however, no need to email or submit this to the IBC. The IBC can check your completion records with administrative access to CITI database.
- Log out.
- Schedule time with the Biosafety Officer, Dr. Chris Voelkel-Johnson (792-3125 firstname.lastname@example.org) to conduct an inspection of the rooms to be used for this project. It is possible that the lab inspection is conducted after the IBC the meeting. If so, the IBC may issue approval with the contingency of achievement of a satisfactory laboratory inspection and correction of the inspection date in section 2a of the IBC form.
Detailed information and resources for the USG Policy for DURC are linked below:
- United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern http://www.phe.gov/s3/dualuse
- Companion Guide to the USG Policies for Institutional Oversight of Life Sciences Dual Use Research of Concern http://www.phe.gov/s3/dualuse/Documents/durc-companion-guide.pdf
- Frequently Asked Questions (FAQ) about USG Policies for Institutional Oversight of Life Sciences Dual Use Research of Concern http://www.phe.gov/s3/dualuse/Documents/durc-faqs.pdf
- Case Studies on the Implementation of USG Policies for Institutional Oversight of Life Sciences Dual Use Research of Concern http://www.phe.gov/s3/dualuse/Documents/12-case-studies-durc.pdf
- United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern http://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf
- Department of Health and Human Services (DHHS) general information on the USG Dual Use Research Policy http://www.phe.gov/s3/dualuse/Pages/default.aspx
- Additional USG resources https://www.phe.gov/about/pages/default.aspx