With so many innovative research technologies available in the Vanderbilt Community, it is likely that researchers from a broad spectrum of disciplines could find themselves in a scenario where they may be planning to work with biological materials that are potentially infectious to humans. It’s important for those planning this work to consider all factors that could lead to (or increase the likelihood of) an accidental exposure to infectious material before they commit to receiving these materials and starting this work. Both risk assessment and institutional biosafety approval of biosafety/biocontainment procedures is necessary to ensure that this work will be done safely and in compliance with applicable standards.
Planning for work with COVID-19/SARS-CoV-2 associated materials?
In response to the COVID-19 pandemic that is impacting public health worldwide, the "call" has gone out to the scientific research community to develop screening tests and therapeutics, as well as studies to better understand the virus itself.
If you are planning to work with COVID-19 clinical specimens or SARS-CoV-2 associated materials, it is important to have a risk assessment completed in conjunction with OCRS Biosafety before finalizing these plans or submitting a grant proposal. You can initiate this process by completing and submitting a OCRS Biosafety Intake Form for Research with COVID-19/SARS-CoV-2 materials.
Additionally, please review the COVID-19/SARS-CoV-2 material biosafety action grid to determine actions that will likely apply to your research plans. If your materials or activities are not specifically addressed in this grid, but are related to research involving COVID-19/SARS-CoV-2 materials, please contact Robin Trundy or Bettye Ridley for assistance.
Biosafety Recommendations - National Organization Links:
- Considerations for Handling Potential SARS-CoV-2 Samples (ABSA International)
- COVID-19 Clinical & Research Lab Workers & Employer Guidance (OSHA)
Vanderbilt COVID-19 Research Biosafety Links:
- Biosafety & Biocontainment Action Grid: Research Activities Involving COVID-19 Specimens & SARS-CoV-2 Materials
- BSL-2 with Enhanced Containment Practices for Activities Involving Potential COVID-19/SARS-CoV-2 Specimens
- OCRS Biosafety Intake Form for Research Activities Involving COVID-19 Clinical Specimens or SARS-CoV-2 Associated Materials
- Biological Inactivation of COVID-19/SARS-CoV-2 Specimens for Handling under BSL-2 Containment Conditions (for internal Vanderbilt use only)
- Blood-based Products from Recovered COVID-19 Human Subjects (for internal Vanderbilt use only)
- COVID-19/SARS-CoV-2 Research FAQs & Resources for Core Labs
Institutional Biosafety Committee (IBC) Approval Considerations
Any Vanderbilt researcher who is planning to receive any biological specimens from COVID-19 patients (or any other materials associated with the SARS-CoV-2 virus) must submit a biological materials registration or amendment to their entity’s IBC. If you submit a OCRS Biosafety Intake Form for Research with COVID-19/SARS-CoV-2 materials, OCRS Biosafety will send you an IBC registration or amendment form (as applicable) with instructions regarding completion.
The IBC must review and approve the risk assessment and biocontainment plan for the proposed activities before shipment/transfer of these materials is initiated. (Note: This is not a new requirement but a reminder of the existing requirements for using any potentially infectious materials that have not been previously documented with and approved by the IBC.)
Other policies related to the receipt and work with materials potentially containing infectious agents include:
- High Risk Biological Agents: Safeguarding Against Accidental Exposures
- Expedited Institutional Biosafety Approval: Testing/Analyses Requested by Public Health Authorities
- Temporary Trainee Researchers Working with Infectious Agents
- Biosafety Level 2 with Enhanced Practices (BSL2+) for Basic Research Applications
Please note that Biological Material Registration forms are not available online at this time. Please contact Robin Trundy or request assistance via the OCRS Biosafety email account to file a biological materials registration or amendment.
Additional risk assessment and biocontainment resources:
- Risk Assessment from “Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories”
- BSL-2 with BSL-3 practices summary based on CDC/NIH “Biosafety in Microbiological and Biomedical Laboratories”, 5th ed.
- Health Canada’s Biosafety Advisory on Novel Coronavirus
- CDC’s FAQ’s about Biosafety and COVID-19
Resources for Clinical Sample Collection:
- Sample Collection & Transport for Clinical Research Personnel
- Transporting Clinical Research Samples from Offsite Locations
- Transporting Biological Research Materials On Campus
- Clinical Specimens Shipping Training Requirements