The guidelines below are provided to help prevent common stipulations received after IBC committee review of applications. Use these recommendations to help speed up the review process and ensure that the IBC committee has enough information to perform a risk assessment of your proposed work.
Laboratory Inspections & Laboratory Locations
All new labs must be inspected prior to the start of work. BSL-2 labs are typically inspected annually thereafter and BSL-1 labs approximately every 3 years.
Contact Xiaohong Chen, biological laboratory specialist of HSRM, at firstname.lastname@example.org or (612) 626-5495 to schedule a biosafety inspection of your laboratory. Scheduling a lab inspection before the review of your IBC application will help speed up the review process if you are a new PI or have a new lab space.
Make sure that all the work locations listed within your SOPs, Biological Decontamination and Spill Clean-up Plan, and Biological Waste Disposal Plan match the work locations listed within Safety section 7)a)i of the application. Include a description of the work performed in each location within section 7)a)i. Include short statements describing the types of procedures performed (example: cell transfections).
Biosafety Cabinet Certifications
Biosafety cabinets (BSCs) require annual certification and final IBC approval will not be granted unless the certification is up to date. If your BSC is past its certification date, you may still submit a continuing review or IBC application/renewal but please ensure that a re-certification of the BSC is scheduled. You will receive a stipulation requesting confirmation of the re-certification before the continuing review or application is approved.
Online Training for Personnel
Ensure that you as the PI, your laboratory staff or teaching staff, and volunteers working in the lab complete the required online training courses.
For the IBC to perform a robust biosafety risk assessment, your study objectives should briefly describe the procedures performed with agents (and r/sNA molecules) subject to IBC purview from the beginning use (or generation of agents) until they are decontaminated, disposed of, destroyed, or inactivated. Your related SOPs will show what steps may increase biosafety risk to staff or the environment, and how you will mitigate risks (PPE, handling, equipment use, location of procedure, transportation, environmental controls, etc.).
r/sNA Molecule Section
Create separate line items for each method or agent in section 2a and for each type of genetic material in section 2b. Do not include plasmid names in section 2b. Instead list each transgene, fluorescent reporter, gRNA, siRNA, etc. expressed by the plasmid. To prevent confusion, include gene names not solely an abbreviation or acronym. Include specifics as the IBC is unable to grant blanket approvals as the function of the gene and the proteins to be expressed remain unspecified. This prevents accurate assessment of biohazardous risk. Please provide, at a minimum, groupings based upon gene function. If specific genes remain unknown, genes may be added to the study on an as-needed basis by submitting an amendment request.
Justification for Downgrading from BSL-3 to BSL-2 Containment (for use of HIV-based lentivirus)
Consideration for a request to downgrade the containment level for a Risk Group 3 viral vector (e.g. HIV-based lentivirus) is only possible if you provide adequate justification to assure BSL-2 containment is acceptable. Please be sure to complete section b)ii of the pop-up window for viral vectors in the r/sNA section (2a) to describe the generation of packaging system used. Include plasmid names or the name of the packaging kit used.
Submit a schematic diagram and/or description of any vectors referenced in the “r/sNA molecule” section to show us the safety features of each vector.
We do not accept entire manuals describing vectors, but you may extract vector maps from manuals for submission. Be sure to include any packaging vector maps associated with HIV-based lentiviruses if applicable.
Infectious Agents Section
Be sure to specify the species and/or strain of bacteria you will use and the strain specific risks in the “Infectious Agents” section. Include information on the risk group associated with the agent within the pop-up windows (note: ATCC biosafety levels are not indicative of the risk group as the ATCC includes biosafety levels only for the purpose of packaging products for shipment). Ensure that there is consistency between the agents listed in your Study Objectives, SOPs, and what is listed in your Infectious Agents section (4a). If the infectious agent is also recombinant then it should be listed in both the Infectious Agents section (4a) and the r/sNA molecule section (2a). Do not list replication incompetent viral vectors or K-12 strains of E. coli used for common cloning techniques in the Infectious Agents section.
Clarify Time Between Cell Transduction and Administration to Animals
If you will be administering replication incompetent adenovirus or HIV-based lentivirus transduced cells to animals, please clarify the time frame between cell transduction and administration to animals.
Providing this information, in the “Study Objectives” section and/or standard operating procedures (SOPs), aids in determining the appropriate animal housing level and often leads to a housing containment downgrade.
Be sure to identify any potential for aerosolization, and describe how aerosolization will be minimized (e.g., secondary containment for centrifugation, using a biosafety cabinet when warranted, instructing for use of masks or N95s when needed, etc.).
Flow Cytometry or Cell Sorter Space
If you will require BSL-2 containment for flow cytometry procedures, please contact the flow cytometer resource manager at email@example.com to obtain a consultation to determine which approved flow cytometer or sorting facility is available to meet your needs. Once determined, include the flow cytometer or cell sorter location in your Flow Cytometry table (7-g) accordingly.
Standard Operating Procedures (SOPs)
Detailed step-by-step experimental SOPs are needed for all experimental activities performed in your study for reviewers to understand and assess the proposed work.
Describe any procedures that may present biosafety risks and how you will mitigate these risks. Ensure that you clearly describe the PPE required for the proposed procedures.
Clear SOPs enable us to assign containment levels and address biosafety issues. If SOPs are missing, unclear, or inconsistent, we may defer your application, requiring you to resubmit it for review at a later month’s IBC meeting. Be sure to include a description in your SOPs to clarify how any cells, tissues, or animals containing r/sNA molecules, infectious agents, or biological toxins are used up to their point of decontamination, destruction, disposal, or inactivation.
If your application covers work performed in a teaching laboratory, be sure to include SOPs that teaching staff will use to prepare material for the lab course as well as SOPs to cover the work that will be performed by the students. It is often helpful if the lab manual that the students will use in the course is included as an SOP attachment in the application.
See the Writing Biosafety Standard Operating Procedures section of our website for more guidance on how to write an SOP and for an SOP template that you may download to use in your application. We do not recommend including user manuals from vendors as they are not lab specific. Please instead extract specific pages/sections which contain methodology and include it in a lab specific SOP.
Biological Waste Disposal and Biological Decontamination Spill & Clean-Up Plans
The latest version of the Biological Decontamination and Spill Clean-Up and the Biological Waste Disposal plans should be included with your application.
Due to important content changes made periodically to these forms, older versions of the forms should not be used.