The IBC support staff has assessed several months of protocol submissions and it is apparent there are a few common issues delaying the review process. The following is a list of the most avoidable issues the committee sees. If researchers can address these concerns before submission, then they can expect a shorter timeline towards approval.
Top 10 Most Avoidable Stipulations
If you plan to use bleach as a disinfectant, please note that the IBC requires the use of a 10% dilution of household bleach (1 part bleach, 9 parts water) for decontamination with a contact time of at least 30 minutes. A 70% ethanol solution may be used after 30 minutes contact time with a 10% bleach solution to avoid pitting of metallic surfaces.
Regardless of the type of disinfectant to be used, these instructions must be consistent throughout all SOPs and Decontamination/Waste Disposal Plans.
Even if you include this information in your SOPs, the IBC requires that you use the Decontamination and Spill Clean-up Plan Template and the Biological Waste Disposal Template when creating Standard Operating Procedures (SOPs) for management of accidental spills/exposure and waste disposal. Using these formswill ensure ease in training of laboratory staff and consistency in laboratories.
Customization and submission of the templates ensures the committee receives sufficient information for review. The templates are located at:
http://www.dehs.umn.edu/Docs/WasteTemplate.dochttp://www.dehs.umn.edu/Docs/DecontaminationTemplate.doc
It is important to specify the exact type of equipment required for each procedure. The word “hood” should not be used interchangeably with “biosafety cabinet,” “BSC,” or “chemical fume hood.”
This information must be consistent throughout all submitted SOPs.
Whenever applicable, be sure to identify any potential for aerosolization, and describe how aerosolization will be minimized (i.e. secondary containment for centrifugation, using a biosafety cabinet when warranted, instructing for use of masks or N95s when needed, etc.).
The IBC does not allow the practice of UV sterilization for infectious waste and should not be included in any SOP or Decontamination Plan.
Biosafety cabinets require annual certification. If the IBC requires use of a biosafety cabinet, final approval will not be granted unless the certification is up to date. Information regarding biosafety cabinet certification is located at the following website:
http://www.dehs.umn.edu/bio_pracprin_biosafecab_cert.htm
Standard operating procedures (SOPs) must be submitted with each IBC application. Lack of detailed SOPs can often result in a deferral. Be sure to include detailed, step-by step experimental SOPs, and identify all associated biosafety risks. All SOPs should include a description of any procedure that may present biosafety risks (i.e. centrifugation, use of sharps, etc.) and how you will mitigate these risks. For information about writing biosafety SOPs, please refer to the following website:
http://www.dehs.umn.edu/PDFs/writingSOP.pdf
Always provide a schematic diagram and description of vectors referenced in item 3.3 of the rDNA application form. It is important that the committee know the safety features and capabilities of each vector.
Always specify the strain of bacteria with which you will work. Additionally, you should provide any available information regarding antibiotic resistance associated with the bacterial agents in your proposed study. If antibiotic sensitivity profiles are available, be sure to include these in your submission.
Bloodborne and Other Pathogens Training is required for all personnel working with infectious microorganisms, human blood, human body fluids, and/or human/primate cell lines. Personnel must complete the training before beginning work with these materials. The training is online at:
http://www.dehs.umn.edu/bio_pracprin_blood_bpt.htm
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