Resources
rDNA and Biohazardous Materials Guidelines
These condensed guidelines can assist researchers in determining whether or not their research requires Institutional Biosafety Committee (IBC) approval. If so, the researcher should submit a registration form to the IBC. Unsure if your program needs review? Contact the IBC.
See the IBC Classification Cheat Sheet and the complete NIH Guidelines for Research Involving Recombinant DNA Molecules for further details.
Those researchers proposing human gene therapy protocols must submit additional information. Specific points to consider can be found on a separate form available through Research Administration.
BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES (BMBL)
Dual Use Research of Concern (DURC) Guidelines
Research involving any of the 15 below-listed agents or toxins that could lead to one or more of the 7 types of effects listed below must be evaluated to determine if it qualifies as Dual Use Research of Concern:
- Avian Influenza Virus (Highly Pathogenic)
- Bacillus Anthracis
- Botulinum Neurotoxin (Any Quantity)
- 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
- Enhances the harmful consequences of the agent or toxin
- Disrupts 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
- Know and comply with all UT Health Science Center and government policies and requirements for DURC oversight.
- Submit an IBC protocol for any research involving infectious agents, recombinant or synthetic nucleic acid molecules, or human materials (all protocols are reviewed for dual use potential).
- Watch for changes in the dual-use status of research projects and inform the IBC when any changes occur.
- Ensure laboratory personnel (i.e., anyone supervised by laboratory leadership, including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists) conducting life sciences research with any of the 15 listed agents or engaged in any of the 7 listed experiment categories have received education and training on DURC.
- If DURC is identified, work with the IBC to assess the dual-use risks and benefits and to develop a risk mitigation plan.
- Conduct DURC in accordance with the provisions in the approved risk mitigation plan.
- Communicate DURC in all publications and presentations to comply with the approved risk mitigation plan.
- Work with the IBC on any necessary changes and revisions to an approved risk mitigation plan.
- The UT Health Science Center IBC and Office of Research can provide DURC training. Personnel working with any of the 15 listed agents or toxins or engaged in any of the 7 listed experiment categories may be required to attend an in-person DURC training session.
- All IBC protocols are screened for dual use potential
- If the protocol does not involve any of the 15 listed agents or toxins, but produces, aims to produce, or is reasonably anticipated to produce any of the 7 listed effects, the IBC may require a risk/benefit analysis and risk mitigation plan as part of its approval process.
- If the protocol involves any of the 15 listed agents or toxins or involves any of the 7 listed experiment categories, the IBC will meet the Institutional Review Entity’s requirement for identifying DURC as outlined in the US Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern.
- When DURC is identified, the IBC will work with the principal investigator to draft a risk/benefit analysis and risk mitigation plan (as detailed in the US Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern).
- The Biosafety Officer will act as the Institutional Contact for Dual Use Research (ICDUR) to communicate with the government funding agency (or NIH in the case of no USG funding).
- The IBC protocol of any DURC project, and the project’s risk mitigation plan, will be reviewed at least annually.
- Training on the US Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern
- A Companion Guide to the US Government Policies for Oversight of Life Sciences Dual Use Research of Concern
- DURC Case Studies
- NIH Office of Science Policy (OSP) webpage on Dual Use Research of Concern
- HHS Science Safety and Security (S3) website
- US Government Policy for Institutional Oversight of Life Sciences DURC
- Deliberative Process and Funding Pause on Certain Types of Gain-of-Function Research
- DHHS Framework on H5N1 DURC Research
- Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO)
- Framework for Guiding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens
Investigators should keep in mind the dual use potential of all their work, conduct
and communicate their research responsibly, and seek guidance when unsure about DURC
qualification.