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Protocol Amendments and Addressing Clarifications Within the Approved Protocol

Historically, any time a researcher needed to amend their IACUC protocol, the University Veterinarian and the IACUC member would review the currently approved protocol, whether it was in paper format or electronically in InfoEd, to determine if the proposed amendment was appropriate.  In the new Click system, we are finding improved transparency in review of amendments, which in turn results in IACUC reviewers picking up on issues not necessarily associated to the proposed amendment but are still important to resolve to maintain compliance. 

Currently, we are only discovering these additional protocol issues during review of an amendment.  Addressing issues beyond those required for the originally proposed amendment may lengthen approval time.  To address this issue, beginning immediately, the IACUC will give you a choice as to how you wish to address the non-amendment issues.  As part of the amendment clarification, you will be provided with the full list of required changes sorted by those that are related to the amendment versus those that are not but are required for regulatory compliance. Dependent upon the urgency of the amendment, you may choose to either address these additional protocol issues at time of the amendment response (allowing approval of all changes at once) or you may defer until after the amendment is approved.  An IACUC request for completion of those additional items will follow and they must be addressed as soon as possible to avoid delays in your ongoing research.  Review of these items is dependent upon the nature of the changes. 
Separately, the IACUC will also be conducting an internal review of each protocol that has not previously been updated through the amendment process.  IACUC staff will communicate via email when a protocol review has been completed and requires changes. 

These activities will help to prepare the institution for the Spring AAALAC site visit and provide researchers/designates the opportunity to work individually with IACUC staff for continued specific training on the ����̽̽Click-IACUC system.

Changes to Occupational Health and Safety Animal Handler Form

For ����̽̽ employees only, Risk Management and Safety has moved to an online version of the Animal Handler form. The new form can be accessed . Students should continue to follow the instructions for submitting the paper form found under the Occupational Health and Safety Program tab here on the IACUC website until further notice. An online student version should be available by the end of the year.

Recently Updated Sections of the IACUC Policies and Procedures

/rpo/iacuc-policies-and-procedures

• 15.4 Blood Collection
• 15. 13 Post-Approval Monitoring
• 19.19 Storage of Controlled Substances
• 15.26 Aged Animals (Inactivated)
• 15.27 Random-Sourced Animals
• 15.28 Non-Pharmaceutical Grade Drugs
• 15.29 Reuse of Animals
• 15.32 Animal Breeding Guidance (New)

����̽̽Click-IACUC Educational Opportunities

• Instructional User Guides are posted here.
• Coming soon! ����̽̽Click Quick Clips – ����̽̽Click how-to videos. If there are topics you’d like to see covered in a video, please email aubrie.clas@uvm.edu.

����̽̽Click Guidance

FAQs/Tips

1. I need to increase my approved number of animals – how do I do that? 

You can find submission deadlines for materials that require Full Committee review on the RPO website. Please be aware that submissions require multiple mandatory reviews prior to the Full meeting so you will see more than one deadline listed for each month’s meeting. Once you click the “Submit” button on your new project or amendment, the IACUC will assign it to the veterinarian for the Veterinarian Review. You will work directly with the University Veterinarian during this review phase. If the veterinarian requires any revisions, those need to be made by the submission deadline for RPO Pre-Review. If submission deadlines are not met then we cannot guarantee your materials will be added to that month’s agenda.

2. How do I edit a procedure that is on an approved protocol?
(please note, this is a previously posted tip. Updated instructions are in red)
The process for updating a procedure on a protocol is to;

1) Create a copy of the existing procedure that requires the edit. If this is a substance administration procedure, you will also need to create a new substance if the substance needs to be edited.

(if applicable)

2) Archive the original version of the procedure and substance as applicable (which removes the procedure and if applicable substance from your Team library) Archive the original version of the procedure and substance as applicable (which removes the procedure and if applicable substance from your Team library)

3) Edit the new procedure or substance with all the updates you wish to make,

4) Add the updated copy to all applicable experiments on the Experiments page,
5) Remove the archived copy from all applicable experiments.
 

3. I’m listed as Key Personnel on the protocol, why can’t I submit?
A PI must assign you the Proxy role on an individual protocol basis to give you authority to edit and submit new submissions on their behalf.
To assign a proxy, the PI of the protocol needs to click on the Assign PI Proxy activity on the left side of the screen. Follow the prompts on the pop-up screens and choose the name of the study team member that is to be assigned as Proxy.

4. Adding your funding information to your ����̽̽Click-IACUC protocol
Sponsored funding goes through SPA and has two numbers associated with the funding; a Funding Proposal number and an Award number. When you are filling out your IACUC protocol application, please enter the Funding Proposal, or “FP” number on the Funding Sources page.  The number that is entered in this field will be linked to your protocol, allowing SPA to release your funds once your protocol has been approved.

 

5. All prospective key personnel must complete training in order to be added to the protocol roster. Want to know an easy way to check which trainings you and your key personnel have completed? Look at the “Training” tab on the protocol workspace.

This tab lists all IACUC CITI training that has been completed by each member of the team, as well as Biosafety Training, IRB training, and other compliance related trainings such as Responsible Conduct of Research. 

Please note that your training completion information will not show up in the Click protocol record if you have not correctly logged into the CITI program through the process.  If you have completed the required CITI training and the Click training tab record indicates “No Training on File “appears next to your name, please follow these instructions to associate your NetId to your CITI account.

6. You can also check occupational health expiration dates on the Training tab.
You can find occupational health expiration dates for all protocol team members on the Training tab under the heading “Non-Citi Training”. Staff check training and occ health expiration dates at the time of every amendment and continuing review. Expiration of either requirements will hold up approval.