There are specific IBC Guidelines for SARS-CoV-2 (COVID-19) related research conducted on campus. Please note that oversight will be site specific and activity specific. This guidance applies to SARS-CoV-2 research and does not involve the propagation of the virus. The viable, replication-effective SARS-CoV-2 virus is a Risk Group 3 pathogen and requires a BSL-3 laboratory. Any work related with animal population using live, replication-effective SARS-CoV-2 requires ABSL-3 facility. Currently Auburn University does not have a BSL-3 and ABSL-3 facility. 

  • Risk assessment will be conducted based on the type of samples used for analysis, procedures and protocol, equipment  and containment need - for example, loading and unloading of sealed centrifuge cups, grinding, blending, vigorous shaking or mixing, sonic disruption, opening of containers of infectious materials.

  • All equipment used for research analysis will be included in the risk assessment.

  • Competence level requirements of lab personnel will depend on the research to be conducted.

  • As per NIH guidelines, any recombinant DNA/RNA must be approved by the full IBC committee. This applies to any new BUA and BUA amendments. 

  • Note: The flow cytometry lab at Auburn University does not have the capability to process non-fixed samples for Fluorescence-activated cell sorting (FACS) analysis

Types of Samples/Agents

  • Molecular analysis of pre-extracted nucleic acid preparations from any specimens

  • Using inactivated specimens, such as specimens in nucleic acid extraction buffer

  • Staining and microscopic analysis of fixed smears of bacterial cultures.

  • Pathologic examination and processing of formalin-fixed or inactivated tissues/samples (Inactivation methods should be validated)

Required Barriers

  • Work in an isolated designated area (minimum) or a biosafety cabinet (BSC)

  • Work with samples performed on top of a benchtop pad

  • Potentially infectious materials must be placed in a durable, leak proof container during handling, processing, storage, or transport within a facility.

Personal Protective Equipment

  • Lab coat

  • Single gloves

  • Mask

  • Eye protection/face shield (optional)

  • Training and competency verification on donning and doffing required PPE

Administrative Controls

  • Laboratory personnel have specific training in handling pathogenic agents and working inside BSC and are supervised by competent scientists

  • Mandatory reporting of laboratory exposures to PI and RMS On-the-Job-Injury Program.

Types of Samples/Agents

  • Stool and urine

  • Whole blood, plasma, and serum for SARS-CoV-2 antibody screening

  • Samples on which no nucleic acid extraction will be performed

  • Using any automated instruments and analyzers for research

  • Fluorescence-activated cell sorting (FACS) – only pre-fixed samples

Required Barriers

  • Work in an isolated designated area (minimum) or a biosafety cabinet (BSC)

  • Mandatory work inside BSCs which are properly maintained and certified

  • Mechanical ventilation systems that provide an inward flow of air without recirculation to spaces outside of the laboratory

  • Potentially infectious materials must be placed in a durable, leak proof container during handling, processing, storage, or transport within a facility.

Personal Protective Equipment

  • Lab coat

  • Single gloves

  • Surgical mask

  • Eye protection/face shield

  • Training and competency verification on donning and doffing required PPE

Administrative Controls

  • Laboratory personnel have specific training in handling pathogenic agents and working inside BSC and are supervised by competent scientists

  • Mandatory reporting of laboratory exposures to PI and RMS On Job Injury Program.

BioSafety Level 2 with Enhancements are ONLY for SARS-CoV-2 research and NOT for other agents.

Types of Samples/Agents

  • Performing diagnostic tests that do not involve propagation or growing of viral agents in vitro or in vivo

  • Nucleic acid extraction procedures from respiratory samples, whole blood/serum involving potentially infected specimens

  • Any protocol which involves aliquoting and/or diluting specimens that can create aerosols – mainly with respiratory samples and secretions  

  • Preparation of chemical or heat-fixing of smears for microscopic analysis or any type of inoculation into culture media mainly for bio-chemical tests

Required Barriers

  • Work in an isolated designated area (minimum) or a biosafety cabinet (BSC)

  • Mandatory work inside BSCs which are properly maintained and certified

  • Mechanical ventilation systems that provide an inward flow of air without recirculation to spaces outside of the laboratory

  • Infectious materials must be placed in a durable, leak proof container during handling, processing, storage, or transport within a facility.

Personal Protective Equipment

  • Tyvek suit with hand cuffs (impervious gown)

  • Surgical mask (blood)/N-95 (respiratory secretions) – fit testing needs to be done by RMS Respiratory Protection Program administrator.

  • Double gloves

  • Eye and all mucous membrane protection – face shields with sides closed.

  • Training and competency verification on donning and doffing required PPE

Administrative Controls

  • Scheduled time and two-person rule for handling SARS-CoV-2 samples (best practice) inside the BSC

  • Centrifuging of blood specimens is in safety cups or sealed rotor, loaded and unloaded in a BSC

  • Specific training on use of N95 respirators, if applicable (includes pulmonary function, medical clearance, and fit testing) – Contact RMS

  • Limited use of sharps

  • Laboratory personnel have specific training in handling pathogenic agents and working inside BSC and are supervised by competent scientists

  • Mandatory reporting of laboratory exposures to PI and RMS On Job Injury Program

Treat it as any other biohazard waste. Dispose in blue/clear autoclave bags, autoclave at a temperature of 121° C for at least 30 minutes by using saturated steam under at least 15 psi of pressure. Lab personnel are responsible for taking autoclaved bags to the dumpster.

Commonly used disinfectant agents are  

  • Bleach: Liquid sodium hypochlorite (5.25%) -  20 ml bleach to 980 ml water
  • Accelerated Hydrogen Peroxide ≥0.5%
  • Contact time: Minimum 5 mins

 

Commonly used agents for cleaning after disinfecting are:

  • Ethanol 70-90% (not recommended as a disinfectant)
  • Chlorine-based products (e.g., sodium hypochlorite at min. of 0.5% )
  • Contact time: Minimum 1 min

For more agents and contact times refer to https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sar-cov-2 

Precautions should be taken while receiving any type of SAR-CoV-2 specimens/samples. All the samples should be sealed in a primary containment, followed by a secondary containment and labelled properly. Timely communication between the sender and laboratory staff is essential to minimize the risk incurred in handling samples while receiving. 

Contact RMS at 334-844-4870 for guidance on packing and shipping of suspected or confirmed SARS CoV-2 patient specimens, culture, or isolates.

EXPEDITED REVIEW PROCESS FOR SARS-CoV-2 RESEARCH

Expedited review will be performed on a case-by-case basis. The following criteria will be used for determining the need for an expedited review:

  • The BUA specifically involves work with the SARS-CoV-2 virus-related research.

  • A strong rationale is provided for expediting the BUA review in which waiting for the regular monthly IBC meeting will compromise project funding.

 

Approval Time: The IBC will work diligently with the PI to achieve approval of his/her BUA in a timely manner. Each expedited BUA will require a customized approach to review and approval.  The PI will be notified if delays arise in the review process or if quorum was not obtained.

 

For SARS-CoV-2 BUA’s that involve recombinant DNA constructs and involve work with SARS-CoV-2 containing specimens

  • The full IBC is required to review the BUA; these BUA’s will be handled similarly to how non- SARS-CoV-2 BUA’s are processed, with the exception of IBC meeting logistics.

  • BUA’s that require full IBC review will trigger a called IBC meeting to occur outside of the regular monthly IBC meeting if necessary.

  • A quorum of members will still be required for called IBC meetings to conduct votes on BUA’s.

  • Depending on the protocol, the committee can recommend to (i) approve the BUA; (ii) approve the BUA with revisions; (iii) request a risk assessment be performed; (iv) defer the BUA; (v) reject the BUA

 

For BUA’s that do not involve recombinant DNA constructs but involve work with SARS-CoV-2 specimens

  • A sub-group of the IBC will be formed for review and recommendation. Once submitted the biosafety level will be determined or the committee will exempt the protocol from IBC review.

  • Depending on the protocol, the subcommittee can recommend to (i) approve the BUA; (ii) approve the BUA with revisions; (iii) request a risk assessment be performed; (iv) defer the BUA; (v) reject the BUA.

 

Deepika Suresh
BioSafety Officer
dzs0023@auburn.edu

Dr. Michael D. Roberts
IBC Chair
mdr0024@auburn.edu

Valerie Riggins
IBC Administrator
mornsvv@auburn.edu