COVID-19 Research Biosafety

This guidance is intended to assist investigators planning research involving severe acute respiratory syndrome virus 2 (SARS-CoV-2) to understand the health and safety considerations and compliance expectations necessary to safely facilitate the research.

Biosafety requirements for COVID-19 research are based on determinations by the UW Institutional Biosafety Committee (IBC), the Environmental Health & Safety Department (EH&S), the Centers for Disease Control and Prevention (CDC) Interim Guidelines for Biosafety and COVID-19, and the National Institutes of Health (NIH) Interim Laboratory Biosafety Guidance for Research with SARS-CoV-2 and IBC Requirements Under the NIH Guidelines.

Principal investigators are required to submit a Biological Use Authorization (BUA) application and obtain approval from the IBC and EH&S before starting research activities involving SARS-CoV-2 virus. This includes work involving the SARS-CoV-2 virus or viral RNA, clinical samples suspected of containing SARS-CoV-2, and fixed or inactivated samples or tissues. See Biological Research Approval for more information and submission deadlines.

Required Biosafety Levels

The following are general biosafety level requirements which are subject to change as we learn more about SARS-CoV-2. Follow all EH&S and IBC requirements as communicated in your BUA Letter. Additional site-specific requirements may be required for certain facilities or shared laboratory spaces.

Summary of Required Biosafety Levels

Sample or Specimen Type	Biosafety Level	Medical Counseling
Nucleic acids and fixed/inactivated SARS-CoV-2 samples or tissue	BSL-2	Not required
Clinical specimens from COVID-19 patients	BSL-2 with enhancements	Required
SARS-CoV-2 in vitro and in vivo experiments	BSL-3	Required

Biosafety level 2 (BSL-2) is required for work with nucleic acids fixed/inactivated SARS-CoV-2 samples or tissues. Perform aerosol-generating activities inside a biosafety cabinet. Wear a lab coat and gloves in addition to appropriate laboratory clothing that covers the legs and closed toe shoes that cover the feet. If there is a potential for splash or spatter, wear face protection that covers the eyes and mucous membranes. An EH&S biosafety officer can work with your lab to implement BSL-2 practices and PPE for this work.

BSL-2 is required for the following activities:

Flow cytometry of fixed samples
Staining and microscopic analysis of fixed smears
Pathologic examination and processing of formalin-fixed or otherwise inactivated tissues (inactivation method should be validated)
Molecular analysis of extracted nucleic acid preparations (see information on amplicon contamination below in Biosafety Practices)
Using inactivated specimens, such as specimens in nucleic acid extraction buffer
Performing electron microscopic studies with glutaraldehyde-fixed grids

Biosafety level 2 (BSL-2) with enhancements is required for work with clinical specimens from known or suspected COVID-19 patients. The following table describes the enhancements required in addition to standard BSL-2 work practices.

BSL-2 enhancements for work with SARS-CoV-2 clinical samples
Personal protective equipment (PPE)	Required PPE in addition to appropriate laboratory clothing that covers the legs and closed toe shoes that cover the feet includes: Moisture-resistant procedure mask in combination with eye protection such as safety goggles, close-fitting safety glasses with solid side shields, or chin-length face shields Gloves Closed-front gown
Laboratory-specific procedures	Prepare a site-specific standard operating procedure (SOP) for work with COVID-19 clinical specimens. Train all staff working with clinical specimens on the SOP, and keep documented training logs in the lab.
Additional signage	Post a sign on the lab door during work stating that COVID-19 clinical specimens are in use. This is to be posted in addition to the Biohazard Warning sign.
Heat treatment vs. heat inactivation	Use the term “heat-treated” rather than “heat inactivated” if your procedures have not been validated. If shipping samples to other labs, include a letter stating the samples have been heat-treated.
Medical counseling	Medical counseling must be completed by all personnel handling COVID‑19 clinical specimens. Personnel must contact the Employee Health Center at 206-685-1026 to schedule counseling with an occupational health nurse, and complete the counseling prior to starting work.

Follow required standard BSL-2 practices including:

Performance of procedures in a way that minimizes production of aerosols
Use of a Class II biosafety cabinet (BSC)
Use of centrifuges with aerosol containment safety cups that are loaded/unloaded inside the BSC
Decontamination of work surfaces and lab equipment after completion
Immediate decontamination in the event of a spill or splash
Treatment and disposal of biohazardous waste by autoclaving or shipping off-site
Transport of biohazardous materials using leak-proof secondary containers labeled with a biohazard symbol
Keeping lab doors closed during BSL-2 work with a biohazard warning sign displayed

Biosafety level 3 (BSL-3) is required for working with the SARS-CoV-2 virus that includes isolation, culture and amplification. Use of SARS-CoV-2 in animals requires ABSL-3. Research at BSL-3 includes additional personal protective equipment (PPE) such as respiratory protection as well as engineering controls that provide enhanced containment. Registration and ongoing training with EH&S and the Department of Comparative Medicine (DCM) are also required. To inquire about research in the BSL-3 facility, contact the SLU 3.1 BSL3/ABSL3 Facility by email.

A medical management plan is in place for BSL-3 research with SARS-CoV-2. As part of the plan, all persons working with SARS-CoV-2 at BSL-3 must receive medical counseling from the Employee Health Center prior to work with the virus.

Biosafety Practices for Research with SARS-CoV-2

Each laboratory should perform a site-specific and activity-specific risk assessment to identify and mitigate potential risks prior to starting work. Laboratory hazards include activities that may generate aerosols or splashes, potentially contaminated equipment, and proficiency of staff.

Laboratory SOPs should include information on measures in place to mitigate risks, including training, engineering controls, PPE, appropriate waste collection and treatment, and spill and exposure response procedures.

Gather all needed PPE before starting work, and don in a clean area. Don PPE in the following order:

Closed-front gown
Face and eye protection
Gloves

When doffing, take special care to avoid contamination. Remove PPE in the following order:

Remove gloves using a method to prevent contamination.
Remove closed-front gown avoiding forceful movements. Gently pull gown down away from the body or roll down.
Wash hands or don clean gloves before removing eye and face protection.
Wash hands.

Do not reuse PPE used for work with biohazards. Dispose of all PPE used for work with biohazards as biohazardous waste. Always wash your hands after removing gloves and after handling any biohazards. See these additional PPE donning and doffing resources:

Ensure the Spill Response Poster is posted in the lab. If a spill occurs, follow the EH&S protocol for biohazardous spills. Pay special attention to spills outside of a biosafety cabinet. If a sample suspected of containing COVID-19 is spilled outside of a biosafety cabinet, personnel should leave the room immediately and close the door. Indicate a spill is inside the room so others do not enter. Wait 30 minutes before re-entering the room to allow aerosols to settle.

When polymerase chain reaction (PCR) is used to amplify gene targets, large numbers of amplified nucleic acid molecules, or amplicons, are generated. Nucleic acid amplicons are not infectious or hazardous to human health. However, if not contained, amplicons can potentially contaminate surrounding surfaces and equipment, personnel and research experiments. Contamination is also possible when working with DNA and DNA products such as plasmid preparations.

If SARS‑CoV‑2 nucleic acid contamination reaches one’s nasal passages via inhalation or touching of one’s face with contaminated hands, COVID-19 nasal swab test results may be affected and return as positive or inconclusive, despite the individual not having an active SARS-CoV-2 infection at the time of testing. Such personnel may be asymptomatic with no known exposure to a COVID-19 positive individual. Preventing and managing amplicon contamination is essential to focus public health guidance to those affected by active SARS-CoV-2 infections and to prevent unnecessary isolation or quarantine of those working with SARS‑CoV‑2 nucleic acids or their close contacts.

If your lab uses polymerase chain reaction (PCR) to amplify SARS-CoV-2 gene targets or works with PCR product, plasmid preps or any nucleic acid from SARS-CoV-2, please review our Prevent and Manage Amplicon Contamination in Your Lab Focus Sheet.

Occupational Health Requirements

Medical counseling is required before starting work with SARS-CoV-2 clinical samples. Researchers in the BSL-3 program working with SARS-CoV-2 are required to adhere to the requirements in the medical management plan.

The Principal Investigator or supervisor is required to review any occupational health recommendations or medical management plans with staff and must ensure that their staff contact the Employee Health Center for medical counseling prior to work. Occupational health information and medical management plans will be provided upon research approval.

In the event of an exposure to SARS-CoV-2, follow the steps on the Exposure Response Poster. Report all exposures and near misses via the Online Accident Reporting System (OARS). For researchers in the BSL-3 program, follow any additional program procedures for exposures and symptom development.

Frequently asked question

If your lab work includes handling hazardous materials (or is in an area where hazardous materials are being used) and you want to wear a mask for COVID-19 prevention, wear a disposable medical/procedure mask along with other appropriate PPE.

If you wear a mask for work with biohazards, whether required or by choice, a disposable medical/procedure mask is required at BSL-2 and higher. Do not wear cloth masks during BSL-2 and higher work. Dispose of the mask following work, as it could have become contaminated. You can replace your disposable mask with a clean face covering of your choice if you want to wear a mask outside the lab. Read this article on the EH&S website for more information.