General Recommendations
Laboratory Inspections
All BSL-2 labs must be inspected annually, and all new BSL-1 labs must be inspected prior to the start of work.
Contact Xiaohong Chen, biological laboratory specialist of UHS, at chenx448@umn.edu or (612) 626-5495 to schedule a biosafety inspection of your laboratory.
Vector/Plasmid Maps for rDNA Submissions
Submit a schematic diagram and/or description of any vectors referenced in the “recombinant DNA” section to tell us about the safety features of each vector.
We do not accept entire manuals describing vectors, but you may extract vector maps from manuals for submission.
Strain and/or Sensitivity Profiles of Bacterial Agents
Be sure to specify the strain of bacteria you will use and the strain specific risks in the “Infectious Agents” section.
Provide information regarding antibiotic resistance or sensitivity as attachments to the application.
Justification for Downgrading from BSL-3 to BSL-2 Containment
You must describe any host-vector system you intend to use in your study.
Consideration for a downgrade for a Risk Group 3 viral vector (e.g. lentivirus) is only possible if you provide adequate justification to assure BSL-2 containment is acceptable.
Clarifying Time Between Cell Transduction and Administration to Animals
If you will be administering 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 downgrade.
Biosafety Cabinet Certification
Biosafety cabinets require annual certification and final IBC approval will not be granted unless the certification is up-to-date.
Find more information regarding biosafety cabinet certification.
Aerosol Generation
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.).
Standard Operating Procedures (SOPs) for All Activities
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.
Clear SOPs enable us to assign containment levels, determine NIH and address biosafety issues. If SOPs are missing, unclear, or inconsistent, we may defer your application, requiring you to resubmit it for review in a later month.
Current Biological Waste Disposal & 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 placed in a prominent position in your lab.
They should be clear enough for any laboratory staff member to identify the agents/rDNA/toxins used in your study, the required decontamination procedures, how to safely clean up accidental spills, how to safely dispose of liquid and solid waste, and who to contact in the case of an incident.
Due to important content changes made periodically to these forms, older versions will not be accepted. Link to the current versions in the “Attachments” section of the application, the OBAO/IBC Attachments page or the BOHD Fact Sheets and Templates.