Protocol Applications and Submissions for the Institutional Biosafety Committee

An IBC Activities 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, Institutional Animal Care and Use Committee and Institutional Review Board protocol applications, and as a reference 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 include:

• 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, maintenance, 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.

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.

The user 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.  

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.

Full committee protocols are active for a period of 3 years. The expiration date for the protocol is provided in the protocol approval letter and in IBC Protocol Management.  Prior to the expiration of the protocol, you will need to submit a renewal protocol. You will receive reminder messages from IBC Protocol Management beginning 28 weeks prior to the expiration of your protocol. It is suggested that you submit your renewal at least 2 months prior to the expiration date to avoid disruption of your research activities. 

The IBC renewal involves a full review of your protocol by you.  You will have the opportunity to edit any section of the protocol as needed.  You will need to review all sections, but we recommend that you pay close attention to your personnel list, lab-specific biosafety manual, and standard operating procedures because these are the items that typically change over time and will need to be updated.

You can submit your renewal at any time, starting 28 weeks prior to the expiration date.  When the renewal is approved, regardless of when it was submitted, your expiration month and day will remain the same.