Research Compliance Guidance on the Use of SARS-CoV-2 Variants
BACKGROUND AND PURPOSE
The causative agent for the current COVID-19 pandemic is a coronavirus designated as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Coronaviruses are enveloped, positive sense RNA viruses whose genomes range from 25 to 35 Kb in size. At least seven species of these viruses are known to cause human diseases. However, despite genetic similarities, the severity of the disease they cause and extent of community transmission by these viruses varies widely. The unprecedented rate of SARS‐CoV‐2 transmission worldwide compelled the World Health Organization (WHO) to classify COVID-19 as a pandemic. Based on etiology, risk factors, treatment options and comorbidities, the Center for Disease Control (CDC) and the WHO classified SARS-CoV-2 as a Risk Group 3 biological agent. Stringent guidelines with appropriate protective equipment and laboratory work practices in a BSL3 or a higher containment facility is essential to avoid laboratory acquired infections while working with live viruses.
Multiple variants of SARS-CoV-2 have been identified in the United Kingdom, South Africa, Brazil and the United States and these variants appear to spread more easily and quickly than others. Boston University researchers are interested in studying these variants.
SCOPE AND APPLICATION
Studies so far suggest that antibodies generated through vaccination with currently authorized vaccines recognize the new SARS-CoV-2 variants. However, these variants seem to spread more easily and quickly than other variants, which may lead to more cases of COVID-19, increased strain on health care resources, more hospitalizations and subsequent ramifications (for more information on SARS-CoV-2 variants, visit CDC website). State and City health officials, including the University are monitoring the available information and the research work being done in local laboratories.
Since these variants are the same species as the original SARS-CoV-2, the containment level and biosafety practices for handling these variants are no different than those of the original SARS-CoV-2. Practices and procedures will be the same as will be the level of risk. The Biological Use Authorization application (the IBC application), with the review of the Biological Safety Officer (BSO), does not ask for information on strain variants unless there is a change in the biosafety level or other increased level of risk. The use of these variants does not constitute Dual Use Research of Concern (DURC) as they exist in nature.
PRINCIPAL INVESTIGATOR PRACTICES AND PROCEDURES
In order to streamline research with these variants while maintaining compliance with Boston Public Health Commission (BPHC) requirements and Boston University’s own public health surveillance, PIs who have IBC approval to conduct research with SARS-CoV-2 will maintain an inventory of all SARS-CoV-2 mutants and variants that they receive and use in their labs. They will notify the BSO (with a copy to the Laboratory Acquired Infection, or LAI, subcommittee) of these materials. The BSO will share this information with the BPHC as required and will also share any new or updated information with the IBC at its regular monthly meetings. If you are not specifically receiving mutants/variants but identify that you have mutants/variants in your lab or plan to culture them for further studies, please contact your BSO for further instructions.
Note: PIs who do not have existing IBC approval to use SARS-CoV-2 must obtain IBC approval prior to any work with these materials.
RECORD KEEPING
Individual PIs working on SARS-CoV-2 variants purchased or obtained from other Environmental Health and Safety (EHS) approved sources must maintain an inventory in the following format (next page). A copy of this inventory must be provided to the BSO, with a copy to the LAI subcommittee, in real time.
List of SARS-CoV-2 Strain Variants (this spreadsheet may also be used)
PI Name: Updated: xx/xx/xx
| Virus | Strain Name | Source | Date of BSO contact/Name of BSO | Date of contact with IBCInstitutional Biosafety Committee The IBC is an instituti... | Proposed work with the strain | Date acquired | Shared with other PI? | IBC approval # for the parent isolate | |
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| 9 |
Send completed form to:
IBC Office: ibc@bu.edu
BSOs: Ron Morales (rmorales@bu.edu); Anwaar Ahmad (anwaar@bu.edu); Shannon Benjamin (sbenjami@bu.edu)
LAI Sub-Committee: Robin Ingalls (ringalls@bu.edu); Thomas Winters (twinters@bu.edu)