Biosecurity & Dual Use Research

Biosecurity refers to measures designed to protect microbiological agents from loss, theft, misuse or intentional release, and to protect research-related information from loss, theft or misuse. This can be accomplished by limiting access to facilities, biological materials and research-related information.  Sufficient security for the biological materials in use may already be in place for laboratories that do not handle select agents, exempt levels of toxins on the select agent list or exempt strains of select agents. These security measures include access controls and training requirements outlined for BSL-1 and BSL-2 laboratories.

The risk assessment conducted as part of the biosafety program gathers information on the type of organisms handled, location of work, and personnel handling these agents. Based on this information, the potential for use of these agents for harmful purposes can be assessed. If such a threat is identified, a Biosecurity program should be implemented to protect possible misuse of these agents.  Such a program should involve participation from PIs, biosafety officers, laboratory staff, information technology staff, law enforcement agencies, and building security staff.

The following items should be considered when implementing a Biosecurity program:

• Threat Identification: Internal and/or external threats should be considered once a risk assessment has determined the risk associated with the theft of, intentional or accidental release of biological materials or from loss of research related data.
• Physical Security: Access control and monitoring are intended to prevent the removal of materials for unauthorized purposes. Access should be limited to authorized personnel based on the necessity of entering sensitive areas.  At a minimum, laboratory doors must be locked when no one is present in the lab, all storage units housed in a shared space (i.e. hallway, storage room, etc.) must be locked, and all persons entering the laboratory should be asked for identification and questioned as to their purpose for being there.
• Inventory and Accountability:  It is the responsibility of each laboratory to establish material accountability procedures. These should be designed to track the inventory, storage, use, transfer and destruction of biological materials.  The purpose is to know what agents are housed in the lab, where they are located and if they are all accounted for.
• Transport of Biological Agents: Material transport policies are in place that outline the requirements for transporting locally on campus and outside of campus.  
• Reporting and Communication: In addition to the following departmental reporting requirements should a security breach occur, the laboratory should also notify University Police and the Biological Safety Officer.  Investigation into the breach will occur as appropriate.
• Training: Laboratory security awareness training is required for anyone who has access to a laboratory.  General Biosafety and Biosecurity training is available through EH&S. Laboratory specific security training should be provided by the PI or laboratory supervisor.  Drills and exercises to evaluate and reinforce the Biosecurity program are strongly encouraged and should be updated and re-evaluated as necessary.

Dual Use Research

Dual use research of concern (DURC) is that which, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or material. 

The Institutional Review Entity (IRE) reviews research involving one or more select agents.  Stony Brook's oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

Contact the Department of Environmental Health & Safety (EH&S) to obtain necessary approvals for access to Biological Select Agents & Toxins (BSAT).  Submit (via the IBC submission process) to the IRE a completed DURC.   If the IRE determines that the proposed works constitutes DURC, and is subject to the polices listed with the Office of Research Compliance (ORC), https://www.stonybrook.edu/commcms/research-compliance/Dual-Use-Research-of-Concern/Regulations , then the proposed research may not commence until an approved risk mitigation plan is in place. Once an approved risk mitigation plan is in place, and the IRE approves the research to commence, the investigator must conduct and/or communicate the research in accordance with the provisions of the risk mitigation plan.