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IBC Protocol Submission

Are you unsure if your research or instructional activities require IBC approval?   If yes, you can submit an IBC Activities Determination.   An IBC Activitities Determination is a process in which the IBC Program staff will review a summary of your activities to provide you with

  • A determination of whether or not your research activities require IBC approval.  This determination is useful if you are unsure if you need to start a full IBC protocol application.
  • Confirmation that your research activities do not require IBC approval.  This type of determination is useful if you'd like to register your activities with the IBC Program office to have an IBC protocol number associated with the described work.  The IBC protocol number can be used for proposal/agreement submissions in SUMMIT, IACUC and IRB protocol applications, and as a refrence to other collaborating institutions.

If your activities do not require IBC approval, you will receive a confirmation email and letter, with an IBC protocol number, that can be provided to anyone requesting this type of confirmation (e.g., other institutions, funding agencies, etc.).  Examples of activities that may benefit from requesting an IBC Activities Determination inlcude:

  • Those activities that only require BSL-1 containment and do not involve the use of recombinant/synthetic nucleic acid molecules.  
  • Generating mutants through the use of non-recombinant/synthetic nucleic acid (non-rsNA) processes (e.g., UV, chemical) or isolation of natural or spontaneous mutants.
  • The use, culturing, maintenenace, and/or breeding of naturally occurring or non-rsNA mutants, or non-modified RG-1 agents.
  • The use of commercially available, FDA-approved, non-regulated genetically modified or engineered plants.

To submit an IBC Activities Determination, use IBC Protocol Management to submit an IBC Activities Determination request.

 

The IBC Approval Process

Principal Investigators (PIs) seeking initial IBC approval are required to submit a completed Protocol Application at least three weeks prior to the desired IBC meeting date. IBC meetings are generally held on the 2nd Tuesday of each month at 2:00 p.m. When a protocol is approved the PI will receive a formal letter of approval.

All IBC protocol applications (new and existing) must be submitted using the IBC Protocol Management online system. Launched in July 2017, the online system will be the only accepted source for submission of new protocols and amendments to active protocols.

IBC Protocol Management will allow you to view all information submitted and approved as part of your existing protocol. You can also view the training status of all personnel listed on your protocol, submit personnel changes and amendments, and obtain a copy of your approval letter(s).

If you are planning to submit a new protocol or to amend an existing protocol, and have any questions, please contact the IBC Program Director who will assist you with this process at ibc@vt.edu or (540) 231-1910.

 

New Protocol Applications

You will need to use IBC Protocol Management to submit your new protocol. Use your Virginia Tech PID and password to log into the system. To begin a new protocol, click “Start New Protocol”.

The online system will guide you through the completion of your IBC protocol, and submission of the completed application to the IBC Program Office.

User Manual: This manual provides an overview of the online system, and how to navigate through the system. This manual also provides information regarding the submission of new protocols and the actions that can be performed after a protocol has been approved.

All offline documents that will need to be uploaded as part of your IBC protocol can be downloaded from within IBC Protocol Management.  Those documents can also be downloaded from this website (below).

 

Updating an Existing Protocol

You will need to use IBC Protocol Management to amend your existing protocol. Use your Virginia Tech PID and password to log into the system. Click on the protocol number that needs to be updated.

You can only initiate a single update at a time. If you require updates to multiple sections of the protocol, please submit them as a single amendment.

If you only need to update your list of personnel, choose “Start a Personnel Change Application.”

To update any other section(s) of the protocol, choose “Start an Amendment Application.”  You can update personnel during an amendment.

User Manual: This manual provides an overview of the online system, and how to navigate through the system. This manual also provides information regarding the submission of new protocols and the actions that can be performed after a protocol has been approved.

 

IBC Offline Documents

Some of the documents below are not required for all protocols. We recommend that you use IBC Protocol Management as a guide to which documents are applicable to your specific protocol before completing any of the documents below.

All documents listed below can also be downloaded from IBC Protocol Management as you complete your protocol application.

  1. Biohazard Awareness Training Guide and sign-in sheet
  2. BSL-1 Self-Inspection Checklist
  3. BSL-2 Self-Inspection Checklist: This checklist is used for annual reviews of BSL-2 labs.
  4. Lab Sketch Template
  5. IACUC Appendix G Form
  6. rsNA and Toxin Form
    Due to updates in various browsers, your default settings may not be set to automatically use Acrobat to open this file from the internet. Only Acrobat can be used to open and use the form. If you are taken to a page with a message stating “please wait,” please use one of these methods. Please use Acrobat Pro or Acrobat Reader to open and complete the form.
  7. Lab-Specific Biosafety Manual
  8. SOP Template
  9. Pathogen Safety Data Sheets
  10. Notification of Toxin Transfer Form: Complete this form if you will be transferring toxin(s) listed in the Federal Select Agent Toxins Due Diligence Requirement.
  11. Toxin Inventory Sheet
 
 

University Biosafety Manual (online)

University Biosafety Manual: This manual contains the SOPs and requirements to be followed when working in a Virginia Tech BSL-1 and/or BSL-2 lab. The university biosafety manual is maintained and updated by Virginia Tech Environmental Health and Safety.  This manual is separate from your Lab-Specific Biosafety Manual.

All personnel and Principal Investigators will need to review this manual. You do not need to submit any information or print this manual, but all personnel should be aware of how to access the manual online.

The manual may be updated without notice. For this reason, we do not suggest saving a copy on computers in your lab. Always download the most recent version online.