Institutional Review Entity (DURC)
Mission/Goals
The Johns Hopkins Institutional Review Entity (IRE) assesses proposed life sciences research that may fall under the definition of Dual Use Research of Concern (DURC) as established by the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.
If a research project is determined to meet the definition of DURC, the IRE will communicate the assessment to the appropriate funding agency and, working with the PI, submit a draft risk mitigation plan for approval by the funding agency. Once a risk mitigation plan is approved, the IRE will provide ongoing compliance oversight through the life of the project.
Background
Certain types of research conducted for legitimate purposes can be utilized for both benevolent and harmful purposes. Such research is called “dual use research.” Dual use research of concern 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.” The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern specifies the practices and procedures required to ensure that dual use research of concern is identified at the institutional level and risk mitigation measures are implemented as necessary.
Institutions and investigators who receive federal funding are required, as a condition of that funding, to comply with the rules established by the US Government for DURC.
Compliance with The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern is in force beginning September 24, 2015.
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Work with one or more of the following fifteen (15) agents and/or toxins listed in the US Government DURC Policy may constitute DURC and must be evaluated by the IRE. (Note that all agents and toxins listed below also are controlled by the US Government as Select Agents, see HSE505 for details):
- Avian influenza virus (highly pathogenic)
- Bacillus anthracis
- Botulinum neurotoxins (any quantity and includes Botox)
- 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
Categories of Experiments
The following seven (7) categories of experiments are evaluated, in conjunction with the use of one of the fifteen (15) agents or toxins above to assess the dual use potential of a research project:
- Enhances the harmful consequences of the agent or toxin.
- Disrupts the 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.
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In accordance with this Policy, PIs are to:
- Notify the Institutional Review Entity (IRE) as soon as:
- The PI’s research involves one or more of the agents or toxins listed above;
- The PI’s research with one or more of the agents or toxins listed above also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven effects listed above or
- The PI’s research that is within the scope of using one or more of the 15 agents/toxins listed above may meet the definition of DURC
- The notification must include the PI’s assessment of whether any research involving these agents or toxins produces, aims to produce, or is reasonably anticipated to produce one or more of the effects listed above.
- Work with the IRE to assess the dual use risks and benefits of the DURC and to develop risk mitigation measures.
- Conduct DURC in accordance with the provisions in the risk mitigation plan.
- Be knowledgeable about and comply with all institutional and USG policies and requirements for oversight of DURC.
- 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 with one or more of the agents listed above have received education and training on DURC.
- 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.
- Notify the Institutional Review Entity (IRE) as soon as:
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Principal investigators should notify the IRE as soon as a research project is anticipated to involve one of the listed agents or toxins.
Notification should include both the identity of the listed agents and/or toxins that will be used and an assessment if the research using the listed agents and/or toxins will produce or is anticipated to produce any of the listed categories of experiments and/or their effects.
Upon receipt of a notification of potential DURC, IRE management will contact the principal investigator to confirm the notification was received and then disseminate the notification to the IRE membership for review.
IRE review will include verification that the proposed research uses one of the listed agents and/or toxins and a review of the PI’s assessment regarding whether the proposed research will or is anticipated to achieve any of the listed categories of experiments and/or their effects.
If the IRE determines that the research in question does not involve one or more of the categories of experiments detailed above, the research will not be subject to additional review or oversight, but shall continue to be assessed by the PI going forward. If the IRE determines the research falls within the scope of DURC the IRE will notify the US Government funding agency within 30 days of review. If the IRE further determines that the research meets the definition of DURC the IRE will work with the PI to develop a draft risk mitigation plan and submit to the US Government funding agency within 90 days for review and approval.
Once a risk mitigation plan is approved, the IRE and PI will implement the plan and the IRE will review the plan and research at least annually.
Any change in the status of a DURC project or risk mitigation plan must be communicated to the IRE as soon as possible and the IRE will notify the US Government funding agency within 30 calendar days.
Submissions for IRE review should be mailed, faxed, emailed or otherwise delivered to the Biosafety Office at the following address:
Institutional Review Entity (IRE)
Biosafety Office/HSE
2024 East Monument Street, Room B-200
Baltimore, MD 21287Fax: 410-955-5929
Email: [email protected] or [email protected] -
- United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
- US Department of Health and Human Services: Science, Safety and Security website that covers Dual Use Research
- DURC FAQs
- Companion guide that explains the DURC policy
- Federal Select Agent Program
- CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition.
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The following roster of IRE members is current as of January 27, 2021:
Stephen C. Dahl, Ph.D., RBP; Institutional Contact for Dual Use Research (IC-DUR)
Director, Biological Safety
Biosafety Officer
Johns Hopkins InstitutionsThomas Burns, JD, MBA
Assistant Dean for Research Affairs and Executive Director, Research Administration
Johns Hopkins University and MedicineFrank Barker, JD.
Export Control Officer
Johns Hopkins UniversityJonathan M. Links, Ph.D.
Vice Provost and Chief Risk and Compliance Officer
Professor of Environmental Health Sciences, Health Policy & Management, Radiology,
Emergency Medicine, Public Safety Leadership, and Civil Engineering
Johns Hopkins UniversityAndrew Pekosz, Ph.D.
Associate Professor, Department of Molecular Microbiology & Immunology
Johns Hopkins Bloomberg School of Public HealthStefanie Gregory, JD., MS
Assistant General Counsel
Johns Hopkins UniversityAlan F. Scott, Ph.D.
Associate Professor, Institute of Genetic Medicine
Director, Genetic Resources Core Facility
Johns Hopkins School of MedicineDenis Wirtz, Ph.D.
Vice Provost for Research
Johns Hopkins University
Professor, Department of Chemical and Biomolecular Engineering
Johns Hopkins Whiting School of Engineering -
The Johns Hopkins Institutional Review Entity is managed through the Biosafety Office which is located in room B-200 (basement) of the 2024 East Monument Street Building.
Questions regarding the day to day operations of the IRE should be directed to the IRE Coordinator, Ms. Tylicia McRae.
Institutional Review Entity
Biosafety Office/HSE
Johns Hopkins Institutions
2024 East Monument Street, Room B-200
Baltimore, MD 21287Email: [email protected]
Office: 410-955-5918
Fax: 410-955-5929