IBC Guidance for BUAs involving SARS-CoV-2 and COVID-19

New: SARS-CoV-2 and COVID-19 Guidance

IBC Guidance for BUAs involving SARS-CoV-2 and COVID-19.

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IBC Guidance for BUAs involving SARS-CoV-2 and COVID-19

The University of California Davis Institutional Biosafety Committee (IBC) is responsible for the oversight and approval of UC Davis biological research projects that involve the use of recombinant DNA materials and infectious agents, as well as potentially infectious materials. A Biological Use Authorization (BUA) application must be created online (https://ehs.ucop.edu/use-authorization/biosafety/) and submitted by the responsible Principal Investigator (PI). The BUA (or BUA amendment) is then pre-reviewed by the UC Davis Biosafety group to make sure it contains all the relevant safety information. Once the BUA is ready, it must go before the IBC for formal review. Typically it takes about 30 days from when a BUA is submitted to when it is reviewed and approved by the IBC. Given the urgent nature of the SARS-CoV-2 research the IBC has agreed to hold an additional meeting each month to review SARS-CoV-2 BUA submissions. In order to streamline the process, we provide the following list of important points to address in your BUA application. For BUA amendments, enter the information in these sections – Project Summary, Experimental Procedures, and Risk Assessment (in each section, enter the new information at the top of the textbox with dashes separating the new text from the old). Also update the Biological Materials, Personnel, and Location, as necessary.

  • What will you be working with? (1) patient samples, (2) the virus, (3) cells or tissues experimentally infected with the virus, or (4) animals experimentally infected with the virus? What containment level is needed to carry out this work?
    • Patient samples in which the virus has been inactivated for downstream analysis can be worked with safely in a Biological Safety Cabinet (BSC) at Biosafety Level 2 (BSL-2). All other applications require BSL-3 containment (specify the inactivation procedures and reference for method).
    • Work with clinical samples that are not inactivated can be performed within a BSC at BSL-2 as long as there are no procedures that generate aerosols outside of the BSC, steps that result in significantly greater viral load (e.g. overnight incubation), or other factors that increase the risk profile (e.g. samples with known high titers of virus). The IBC may still require additional containment practices and PPE.
    • If working with patient samples please ensure that the samples have gone through the Institutional Review Board (IRB).
  • Will you be culturing or enriching a patient sample to support viral growth? If so, this work must be conducted at BSL-3.
    • Which BSL-3 facilities will be used?
    • Who will conduct the work in the BSL-3 facility and what BSL-3 specific training do those personnel have? If they do not have BSL-3 safety training, how soon will this training be needed? Please reference the training policy for requirements and expectations.
  • Do you plan to genetically modify the virus? If so, please address the relevant sections of the NIH Guidelines. Define the expected changes to viral fitness and pathogenesis these modifications will create.
    • In the Dual Use Research of Concern section of the BUA submission page, check relevant boxes if the modification may result in:
      • Enhancing the harmful consequences of the virus
      • Disrupting the typical immune response to the virus
      • Conferring to the virus resistance to clinically useful prophylactic, therapeutic interventions, or facilitates their ability to evade detection methodologies
      • Increasing the stability, transmissibility, or the ability to disseminate the virus
      • Altering the host range or tropism of the virus
      • Enhancing the susceptibility of a host population to the virus

If you do not think that a statement above applies to your research, leave the related box unchecked. However, if a box was left unchecked for this submission but you later discover that it applies to your research, amend the BUA with the new information.

  • What procedures will be performed with the virus in BSL-3 containment? Do any of these procedures (e.g. centrifugation) have the potential to produce aerosols outside of the biosafety cabinet? If yes, please provide detailed information on how you will prevent exposure of personnel to potential aerosols.
  • If sharing a BSL-3 facility in which work with other high-risk organisms is performed, please define how everyone will be cross trained on all the potential work place hazards. Include spatial/temporal separation of projects with different agents.
  • If the project will be conducted at BSL-2 please describe containment measures (e.g. aerosol-gasketed centrifuge cups) as well as steps taken to ensure inactivation of potential viral particles (e.g. Trizol treatment with a 5 minute vortex).
  • What personal protective equipment (PPE) will be used to conduct this research? Given the current shortages, are you able to obtain these PPE throughout the course of the project?
  • What hospital grade disinfectant will be used for this project? Given the current shortages, are you able to have this disinfectant throughout the course of the project?
  • Will you be inactivating samples of viral culture or tissues from infected animals to work with them outside of BSL-3 containment? If yes, please create a detailed SOP, as well as a plan for verifying that the samples you will be removing from containment contain no infectious virus.
  • Upload a standard operating procedure (SOP) for the order in which each PPE item will be put on (donned) on entry to the BSL-3 lab and taken off (doffed) upon leaving. Others working in the facility may already have this information and you should consider adopting their donning and doffing procedures.