Submitting a Master Protocol Registration

Researchers may now submit one master protocol registration (MPR) to cover all projects with similar biosafety levels.  Additionally, teaching laboratories that utilize biohazardous materials are required to submit a MPR describing the work and safe handling procedures being conducted in the teaching laboratory. Researchers/professors will combine multiple teaching, or internally- and externally-funded projects under one MPR.  Laboratory activities requiring BSL-1 and BSL-2 work practices may be combined. Projects necessitating BSL-3 work practices must be registered under their own separate MPR.

You will need to initiate a new Master Protocol Registration (MPR) through the UVMClick – IBC module. This will require that you will fill out the SMARTForms and attach completed Standard Operating Procedures (SOPs) or Biohazardous Agent Reference Documents (BARDs) as needed. The Biosafety Officer review will be initiated by IBC staff once the MPR has been submitted.

SOP/BARDs

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Standard Operating Procedures for Work with Biohazardous Agents or Toxins

IBC Forms Library
Initial SubmissionNotes
Standard Operating Procedure (DOC)(if applicable) A Standard Operating Procedure must be submitted for each biohazardous agent listed in your registration.
Biohazardous Agent Reference Documents -BARD Templates

The Biohazardous Agent Reference Document (BARD) is a general guidance resource that reviews and summarizes the nature of a pathogen or biotoxin, and offers safety requirements for work with the agent in the laboratory. During the Risk Assessment, the Biosafety Officer may recommend the use of a BARD, however, additional SOP documentation may be required as determined by the risk assessment.

BSL 3 Training Forms and Templates

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New Researcher Request to Use A/BSL-3 Facility Form- Researchers requesting to use the A/BSL-3 core must meet the minimum research experience criteria as outlined in section 9.1 Biosafety Level 3 Training Guidelines and Practices for Researchers. There will be no exceptions.

Training Record for New A/BSL-3 Users

Form A - A/BSL-3 Techniques Evaulation Worksheet

Form B Training Proficiency Checklist 

Human Gene Transfer

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“Human Gene Transfer” or “HGT” is used to describe research involving the transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human subjects. It is also sometimes referred to as “Gene Therapy.”

Effective April 27, 2016, UVM Institutional Biosafety Committee will determine whether investigator-initiated research requires RAC review based on specific criteria. If the project is sponsored, the sponsor is responsible for determining if RAC review is required.

Review and approval of a gene transfer protocol can be complex, therefore we have developed a step-by-step guide for submission of a human gene transfer protocol at UVM/UVMMC.

Human Gene Therapy Review Procedures (PPT)

Other Resources