Research and Sponsored Programs

Research Involving Coronavirus (COVID-19)

Updated: April 15, 2020 - 3:40 PM

What if I wish to conduct research involving blood or other samples (tissue, fluids) from COVID-19 infected Human patients?

This type of research requires approval from the Institutional Review Board (IRB). Per UToledo Policy, human tissues, fluids, and other products (including blood, urine, saliva, fecal materials, etc.) that are taken to and analyzed within the hospital clinic or pathology laboratory solely for diagnostic purposes only are not subject to Institutional Biosafety Committee (IBC) review. However, any human tissues, fluids, and other products that are to be used for research purposes, and taken to research laboratories, must receive appropriate IBC approval.  Based on the protocol that you submit, a risk analysis must be performed by the IBC to determine whether the research must be conducted using enhanced Biosafety Level 2 procedures, referred to hereafter as BSL2+, or using BSL3 facilities and precautions.  Again, any work with COVID-19 patient samples in your laboratory requires approval from the IBC, including review of detailed standard operating procedures and a risk assessment of the studies.  Enhanced BSL2 (BSL2+) practices are defined as studies performed at BSL2 with Biosafety Level 3 (BSL3) precautions, including: all manipulations of patient samples (including diluted samples) must be performed inside a certified Class II Biological Safety Cabinet (BSC), generation of aerosols must be minimized, all waste materials must be decontaminated before being removed from the BSC, no samples can be removed from the BSC without being treated to kill any virus, and personnel must wear double gloves, sealed eye protection, N-95 mask (which requires medical clearance and fit testing through EHRS, and a liquid-impervious gown.  Failure to follow these strict biocontainment and regulatory standards can result in suspension of funded research at The University of Toledo campuses.  These guidelines are based on national standards, including the CDC’s 5th edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL), NIH's Interim Laboratory Biosafety Guidance for Research with SARS-CoV-2, and the Association for Biosafety and Biosecurity (ABSA).

What if I wish to Conduct Research Involving Animals and Coronavirus?

This type of research requires approval from the Institutional Animal Care and Use Committee (IACUC) and the IBC.  If a BSL2-level coronavirus (non-COVID-19) will be used, this type of research must be conducted at minimum of Animal Biosafety Level 2. If the COVID-19 (SARS-CoV2) virus will be used, the research must be performed under BSL3 containment, including approval of detailed standard operating procedures (SOPs), FBI-level security background checks, and acquisition of sufficient supplies of BSL3 personal protective equipment (PPE) to complete all proposed studies. 

What If I Wish to Conduct Research Directly With Coronavirus Itself?

All types of research that will manipulate any of the coronaviruses require IBC approval.  Depending on the type of research to be performed and the risk assessment, this work will need to be performed at either:  1. BSL2 (for designated BSL2 coronaviruses only);  2. BSL2+ (patient samples; described above); or 3. BSL3 (isolation of COVID-19 or research with patient samples that could propagate virus). Biocontainment level will be determined by the IBC based on the strain of coronavirus used, propensity to generate aerosols, ability to neutralize the virus before performing procedures outside of the Biological Safety Cabinet (BSC), types of assays to be performed, biosafety measures incorporated into the research equipment that will be utilized, and amounts of virus to be generated.  Regardless, all research must be reviewed and approved by the IBC before any experiments can be performed on archived or freshly generated samples.  

  

 

Last Updated: 5/18/20