Biological Safety Responsibilities

A PI’s biosafety responsibilities are divided between ensuring that those who work or enter their labs are safe and that research conforms with related regulatory requirements as detailed below under registrations. The PI is ultimately responsible for the safety and compliance of the research they perform.  Connecticut may be a small state, but it has a large set of unique lab safety rules and requirements. The following links, documents, and requirements are provided to help with the PI’s biosafety responsibilities to protect staff and visitors.

Risk Assessment

A PI must evaluate the hazards involved in research, take into account the procedures that will be performed and assess the likelihood of an exposure and its consequences. Once risks are assessed, risk mitigation or risk control measures are applied to protect researchers and visitors. Risk assessment and risk management for research with biohazards is critical for ensuring that the proposed work is conducted as safely as possible and the appropriate controls have been established to minimize exposure to biohazards. Although the EHS Biosafety registration forms have been designed to collect relevant risk assessment information, the PI is still responsible for preparing a written risk assessment.

The following documents are offered to supplement the risk assessment process for principal investigators:

Health Canada has also provided a very detailed assessment checklist for biohazard risk. Please refer to this for additional information when planning research with biohazards.

Please review the risk assessment sections in each of these two government biosafety documents.

Researcher Competence Verification

The Researcher Competence Verification Form has been created to provide PIs a mechanism to verify that any new staff members have completed all applicable training classes, and that they are proficient in the proposed research procedures and associated biocontainment measures. This form also documents that new staff members have been informed of the emergency response protocols and have been shown the location of emergency response equipment in or adjacent to the lab. Ensure that this form is completed for all new (and existing) researchers in the lab. Maintain copies of this documentation in your files.

Emergency Eyewash Videos

EHS has developed brief videos on how to use emergency water stations around campus to assist PIs with ensuring that their researchers are aware of how to use this equipment to respond to emergencies that may occur in the lab.

PI Responsibilities Checklist

EHS has also developed a Principal Investigator Responsibilities Checklist to help augment the competency verification form. Both documents below can assist with ensuring the duties of the principal investigator have been achieved.

Biosafety Guidance for New Researchers

In addition to your introductory laboratory biosafety and chemical safety courses, these links provide additional visual demonstrations of how to protect yourself from biohazards.

Additionally, the Researcher Competence Verification Form (and training and emergency procedure links above), will help both the principal investigator and lab manager ensure that new employees are provided with baseline information that is needed to begin to work with biohazards in the lab.

Advanced Biosafety Resources

More experienced members of the laboratory should be provided the documents and videos below:

Toxins

In addition to Laboratory Chemical Safety and Biosafety Parts 1 & 2 trainings, researchers handling toxins of biological origin that have a low LD50 must be trained by Yale EHS in standard safety toxin work practices. Please contact your EHS safety advisor for more information and to complete Toxin Safety training.

Non-Human Primate Specimens (NHP) for Lab Use

Laboratories receiving unfixed tisues originating from an NHP must update their Biogeneral registration and not intiate the research until a lab inspection has been completed. Unfixed NHP materials may harbor viral, bacterial, parasitic, and fungal zoonoses that may infect those handling these tissues. Notably, Macacine Herpesvirus 1, also known as B-virus, may be present in specimens from Old World macaques.  B-virus is associated with case-fatality rates up to 70% among those infected. NHP specimen lab training will cover risk mitigation strategies at preventing exposure and will be custom tailored for each laboratory.

Please contact your EHS safety advisor to schedule Toxin Handling or NHP tissue Training

Biosecurity

The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) define laboratory biosecurity as “measures designed to prevent loss, theft, or deliberate misuse of biological material, technology, or research related information for laboratories or laboratory associated facilities.”  CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 6th Edition.  

Laboratory biosecurity begins with the identification of high-risk biological materials (HRB) or valuable biological materials (VBM) with consideration of what could happen if these materials were to get into the wrong hands. What is critical may vary between laboratories and could range from proprietary information that could be patented, to materials that could be used to cause harm.  Foundational elements of biosecurity include restricting access to your lab and storage devices, maintaining an inventory, and reporting any suspicious activities of findings.  This section will provide more details on laboratory biosecurity.

Clean Air Devices

Clean Air Devices, including biological safety cabinets, at Yale are certified annually through a contract with an accredited certification company. Yale Environmental Health and Safety will coordinate and schedule the annual certification for each cabinet on contract. Contact cad@yale.edu to schedule the required re-certification of any cabinets new to Yale after relocation.