COVID-19 Biosafety Research Guidelines

WSU Institutional Biosafety Committee (IBC):  SARS-CoV-2 (COVID-19)

All research with SARS-CoV-2 is subject to IBC oversight.  IBC review and approval are required prior to receipt of samples and the initiation of any activities involving SARS-CoV-2.  Table 1 summarizes the Biosafety Level and laboratory practices required for activities involving SARS-CoV-2 samples at WSU.

Table 1. SARS-CoV-2 (COVID-19) WSU Research Laboratory Biosafety Guidelines*

Research Activities with Known or Likely Infected Specimens from Humans or Animal Models

Biosafety Level

Contacts

  • Storage and laboratory work with seed stocks, working stocks or specimens1 with the intent to grow or use live virus at WSU
  • Virus isolation, characterization and/or expansion
  • Viral cultures or isolates should be transported as Category A, UN2814, "infectious substance, affecting humans"
  • Use of live SARS-CoV-2 virus in functional assays:
    • Plaque/Focus Forming Unit assays
    • Serologic virus capture/binding assays
    • Therapeutic MIC assays
    • Live cell sorting with intact virus
  • Use of live SARS-CoV-2 virus in animals
  • Use of nasal or pharyngeal swabs
  • Inactivation of virus by validated methods

 

BSL-3/ABSL3

 

Please note:  There are no A/BSL-3 facilities at WSU.  Work requiring this level of containment will not be approved or considered at this time by the IBC

 

Richard Pearson, Ph.D.,

Biosafety Manager

 

Office of Environmental Health and Safety

Phone: 313-993-7597

fz1981@wayne.edu

https://research.wayne.edu/oehs/bio-safety

 

  • Aliquoting and or diluting specimens1for research use and storage
  • Preparation of chemical- or heat-fixed specimens1 for microscopic analysis
  • Nucleic acid extraction of specimens1 for molecular analysis
  • Preparation of inactivated specimens for other laboratory assessments
  • Performing diagnostic tests (e.g. serology) that do not involve activities with the potential to propagate virus
  • Inoculating bacterial or mycological culture media
  • Processing of environmental samples

BSL-2 with

enhancements

Richard Pearson, Ph.D.

Biosafety Manager

 

Office of Environmental Health and Safety

Phone: 313-993-7597

fz1981@wayne.edu

https://research.wayne.edu/oehs/bio-safety

  • Molecular analysis of already extracted nucleic acid preparations
  • Analysis of specimens1 that have been inactivated by a method approved by WSU IBC
  • Final packaging of specimens1 already in a sealed, decontaminated primary container for transport to collaborating laboratories for additional analyses
  • Specimens from suspected or confirmed cases should be transported as UN3373, "Biological Substance, Category B"
  • Pathologic/microscopic examination of fixed specimens1 (e.g. formalin-fixed tissues or glutaraldehyde-fixed grids)
  • Routine staining and microscopic analysis of fixed smears
  • Routine examination of bacterial and mycotic cultures

BSL-2

Richard Pearson, Ph.D.

Biosafety Manager

 

Office of Environmental Health and Safety

Phone: 313-993-7597

fz1981@wayne.edu

https://research.wayne.edu/oehs/bio-safety

*Adapted from Duke University:  SARS-CoV-2 (COVID-19) Research Laboratory Biosafety Guidelines1

Please note that all proposed research with SARS-CoV-2 (COVID-19) requires review by the WSU IBC and will require approval of a Standard Operating Procedure (SOP) for the research. In addition, some research will also require approval by the IRB.

1Specimens are defined as, but not limited to, blood, serum, plasma, tissues, feces, urine, sputum, mucosal swabs or washes/secretions collected from any species.

 

 

Technical Expertise/Personnel Requirements2

Only principal investigators, post-docs or laboratory technicians with experience working with human pathogens are currently permitted to work with materials containing potentially active SARS‐CoV‐2 or full-length genomic RNA from SARS-CoV-2.  

Undergraduate students, graduate students and students enrolled in professional programs (e.g. medicine, pharmacy, nursing) are not permitted to work with materials containing potentially active SARS‐CoV‐2 or full-length genomic RNA from SARS-CoV-2 at this time. 

It is recognized that specific research protocols may involve work with individual SARS-CoV-2 genes (e.g. coat protein) as recombinant or synthetic nucleic acid molecules. With appropriate approval from the IBC, graduate students and students enrolled in professional programs (e.g. medicine, pharmacy, nursing) may work with recombinant or synthetic nucleic acid molecules coding for individual SARS-CoV-2 genes.

Individuals in high-risk groups such as those who are immunosuppressed or who have medical conditions that might contribute to negative outcomes if infected by SARS‐CoV‐2 are prohibited from working with the SARS-CoV-2.

Individuals working with SARS‐CoV‐2 virus must monitor their health and immediately report any potential illness, especially fever, cough, shortness of breath or flu‐like symptoms to their PI/lab director and the IBC (IBC@wayne.edu).  Any individual experiencing symptoms noted above must self‐quarantine.

Animal/Biosafety Level 3 (A/BSL-3)

Research that requires BSL-3 facilities is not permitted at this time.

Activities involving nasal or pharyngeal swabs are not permitted at WSU due to the level of risk associated with working with these samples. 

SARS-CoV-2 research in animal models requires ABSL3 facilities and is not permitted at WSU.

Biosafety Level 2 (BSL-2)

All proposed activities involving SARS-CoV-2 including those involving currently designated BSL2 facilities must receive written IBC approval following an initial risk assessment and a completed inspection of the proposed work spaces. 

Specific activities listed in Table 1 require "BSL-2 with enhancements."  This term refers to the implementation of BSL-3 practices in a BSL-2 facility. 

IBC Protocol Submissions

WSU researchers must have approval from the WSU Institutional Biosafety Committee prior to receiving and initiating any work with materials (including inactivated samples) containing or derived from SARS-CoV-2 virus or COVID-19 patients

Local IBCs have been directed by the NIH Office of Science Policy to consider SARS-CoV-2 to be a RG3 agent as a starting point in their risk assessments when reviewing research subject to the NIH Guidelines.  Any research that involves the use of recombinant or synthetic nucleic acid molecules coding for SARS-CoV-2 full genome, or individual genes of interest, must be approved the IBC. 

All IBC submissions for work involving SARS-CoV-2 must be submitted through the WSU e-Protocol platform3.  All protocols must be "new" protocols.  Amendments to existing protocols to incorporate SARS-CoV-2 research will not be accepted for review.

Receipt of Inactivated SARS-CoV-2 Samples

Research utilizing inactivated SARS-CoV-2 samples requires BSL-2 containment practices and a completed Inactivated Biological Agents form3 must be included with their IBC e-Protocol submissions.  The inactivation process document must be completed by the sample supplier and evaluated and approved by the WSU IBC prior to this material being shipped to WSU. 

Supplementary Information and References

IBC Review:

The IBC will review all work for consistency with the CDC Guidelines5 and the American Biological Safety Association (ABSA) International5 (PDF) guidance document, as well as the biosafety practices and policies described in the Biosafety in Microbiological and Biomedical Laboratories7 (BMBL, 5th Edition) publication.  The WSU IBC will consider these the minimum standard and can request more stringent containment requirements if deemed necessary for the research being proposed.

When considering applying for permission to work with SARS-CoV-2 related materials, it is recommended that investigators read the original documents for:

  • updated guidance and recommendations from these organizations;
  • additional details on the type of work that can be performed in specific laboratory settings; and
  • requirements specific to sample types and/or associated procedures. 

ABSA International has additional relevant laboratory/research resources available in their SARS-CoV-2/COVID-19 Toolbox8.

Biosafety Level 3 Facilities:

WSU does not have any A/BSL-3 facilities, and any work that requires this level of containment will not be permitted at this time.

Nasal and pharyngeal samples have been shown to contain high loads of SARS-CoV-2 virus and the CDC recommends the use of BSL-3 practices within a BSL-2 facility (BSL-2 with enhancements).  Other institutions have restricted work with these high titer samples to BSL-3 facilities. 

The WSU Biosafety Program has adopted a conservative approach for any proposed work with samples that contain high viral loads and, due to the lack of BSL-3 facilities, all work of this nature is prohibited at this time.

Biosafety Level 2 Facilities:

The CDC's risk assessment has determined that certain research activities with SARS-CoV-2 material can be conducted in BSL-2 facilities. This is because the current available literature regarding viral load of SARS-CoV-2 in blood, plasma, and urine suggests that these patient samples have low titers and may safely be manipulated with strict BSL-2 containment procedures and practices by investigators experienced in handling human pathogens

Note that there is no guarantee of a sample having low or no viral titer, so care must still be used in handling these samples.

SARS-CoV-2 is a positive strand RNA virus; work with extracted genetic material will require strict adherence to BSL-2 containment requirements.

Facility Inspections:

All BSL-2 facilities listed in the IBC application will be inspected for compliance with BSL-2 practices and procedures9 as a part of the review process. Any work that requires "BSL-2 with enhancements" will need to clearly state in the protocol submission what enhancements are being employed in the BSL-2 facility.  All facilities must be completely set-up, with all required engineering controls, PPE, disinfectants (as described in the protocol) in place at the time of the inspection.  As stated above, prior BSL-2 approval does not carry over to any new research activity involving SARS-CoV-2.  All facilities must be inspected, and any deficiencies corrected, prior to an IBC protocol being approved.

Links and References

  1. Duke University: SARS-CoV-2 (COVID-19) Research Laboratory Biosafety Guidelines: https://www.safety.duke.edu/sites/default/files/SARS-CoV-2%20(COVID-19)%20Biosafety%20Guidelines.pdf
  2. Johns Hopkins University: IBC SARS‐CoV‐2 (COVID‐19) Laboratory Requirements Document: https://hub.jhu.edu/assets/uploads/sites/2/2020/03/SARS-CoV-2-Guidance-JHU-IBC-2020-03-26.pdf
  3. e-Protocol Applications: https://research.wayne.edu/oehs/bio-safety/new-applications
  4. Inactivated Biological Agents Form: https://research.wayne.edu/oehs/bio-safety/rg3_4_inactivation_document_final.docx
  5. CDC Interim Guidance for Laboratories: https://www.cdc.gov/coronavirus/2019-ncov/lab/index.html
  6. ABSA International Guidance Document: https://absa.org/wp-content/uploads/2020/03/ABSA2020_Covid-19-dr3.pdf
  7. Biosafety in Microbiological and Biomedical Laboratories (BMBL, 5th Edition), CDC/NIH: https://www.cdc.gov/labs/BMBL.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fbiosafety%2Fpublications%2Fbmbl5%2Findex.htm
  8. WSU BSL-2 Inspection: https://research.wayne.edu/oehs/bio-safety/bsl-2_visit_wsu_2018.pdf
  9. ABSA International COVID-19 Toolbox:  https://absa.org/covid19toolbox/