Animal Subjects/IACUC

Animal Subjects/IACUC Allison Koss

At right, please see the Animal Subjects/IACUC related Kuali training guides (click the down arrow to expand). You can also step through them by hitting Next below.

The following topics are covered in this section:

  • Create an IACUC Protocol
  • Add a Procedure to an IACUC Protocol
  • Amend an IACUC Protocol
  • Renew an IACUC Protocol
  • IACUC 3rd Year Renewal
  • Close an IACUC Protocol

Create an IACUC Protocol

Create an IACUC Protocol Allison Koss

 

Step 1 - Click + New Protocol in the upper right of screen. Then select IACUC.

new protocol

 

Step 2 - Type in your name in the Principal Investigator field; your name will populate from a drop- down list. Select your department in the Lead Unit field. Type in your protocol title, then click Next in the upper right-hand corner.

Next

 

Step 3 - You will then need to describe your protocol and answer if your protocol contains category D or E procedures.

category d or e

 

The screen you see next will look like this:

people

 

Step 4 - You will already be listed in the People section because you are the PI, however, you must click the Pencil icon to add information and answer additional questions about yourself. If you forget to do this, it will not let you submit your protocol. Here is what it looks like when you click the Pencil:

people section

 

As you can see, you need to check whether or not you are Working with animal models and then describe your Role and Experience.

Step 5 - Next you will be able to add additional personnel if there are others you want to list on the protocol. You do this by clicking +Add Line or +Add Info. Both tabs do the same function. The Columns tab will then organize what information you can see on the page.

add line

 

Step 6 - The form continues to save as you add information and advances to the next section as you complete sections. On the left side of the screen you will see the different sections of the form and a green check will appear next to sections that are complete:

general questions

 

The description and the pain category question you already answered are here and then Species is next.

Step 7 -  Click +Add Line to add Species. You will be able to select from a drop-down, or if your species is not listed you can select Other. You will need to complete information about your selection.

Step 8 -  Continue through the form to answer YES/NO questions. Depending on your answer this may prompt further information that is needed. This is generally self-explanatory and uses a similar system of +Add Line or +Add Info as described previously.

Step 9 -  Some of the sections may ask personnel responsible for, or working with, this substance or procedure. When you click +Add Line there will then be an arrow, you must click the arrow and there will be a drop-down list. Only Personnel listed on the protocol can be selected.

personnel

 

Step 10 - Additionally, throughout the protocol there may be guidelines that you will need to read and agree to. They will look similar to this:

guidelines

 

You must click +Add Line or +Add Info. This will open up the guideline which you must read, check the box that you agree, and click Done. It will look similar to this:

animal biosafety level

 

Step 11 - Once you feel you have completed the protocol, click Submit in the upper right-hand corner of the page.

submit

 

Step 12 - If you have not completed areas of the form which are required you will get something that looks similar to this:

Incomplete

 

Scroll through the form to find the fields that need further completion.

Step 13 - For example you may see that species has a red ! next to it. Click the Pencil icon to open the box to see what is missing.

pencil icon

 

species

 

Step 14 - Complete the missing information.

Step 15 - Click Submit.

Step 16 - Once your protocol has been submitted you will receive an email that it was submitted. The top of your form will look similar to this, with the status and date that it was submitted:

submitted

Add a Procedure to an IACUC Protocol

Add a Procedure to an IACUC Protocol Allison Koss

 

Step 1 - Click + New Protocol in the upper right of screen. Then select IACUC.

new protocol

Step 2 - Select IACUC and follow instructions on How to create an IACUC protocol in Kuali (separate document) OR select an already approved protocol and open it to amend it.

Step 3 - Go to Procedures and then click + Add Line.

add line

 

Step 4 - When you do, the following with pop up:

add line popup

 

The above fields are either drop down selections or free text fields.

Step 5 - There are several fields that must be completed in this pop up. When you come to USDA Pain Category, you MUST select a pain category even if your protocol is not USDA covered.

A description of the pain categories is provided to help you choose the correct category.

Amend an IACUC Protocol

Amend an IACUC Protocol Allison Koss

 

Select an approved protocol from your list of protocols and click on it to open.

Click Amend in the upper right corner of your screen.

amend

 

Note: If it is greyed out like above, there is an action in progress and you opened a previous version of the protocol. Go back to your main screen and select the Amendment in Progress version.

protocol list

 

Finish your updates to the protocol and then select Submit from the upper right corner.

submit

 

Renew an IACUC Protocol

Renew an IACUC Protocol Allison Koss

All protocols require continuing review/annual renewal. When your protocol is approved, for example 8/31/19, it must be renewed and re-approved by 8/31/20 to continue work.

You will receive a Kuali email notification 30 days prior to your protocol expiring.

Step 1 - When you receive the renewal email, please log in to Kuali and select the most recent copy of your protocol and open it.

Step 2 - Click Renew or Renew/Amend from the right side of the screen.

renew

 

Note: The IACUC office recommends renewing without amending your protocol, especially if you are close to your protocol expiring. This will expedite the review and approval process, you can then submit an amendment once your renewal is approved.

HOWEVER:

  • If you have category D or E procedures you MUST select Renew/Amend. This will allow you to update your alternative search which is required.
  • If you are making changes to your animal numbers, you MUST select Renew/Amend.

Step 4 - If you have started a Renew, you can Abandon and then select Renew/Amend. Once selected, you will see this:

renewal screen

 

Step 5 - Complete this simple Renewal form. Then click Submit on the right side of the screen.

submit

IACUC 3rd Year Renewal

IACUC 3rd Year Renewal Allison Koss
  • IACUC protocols are approved for a three year period, with annual renewals/continuing review at the one and two year anniversary of the original approval date.
  • You will receive system emails from Kuali at 90, 60, and 30 days prior to your protocol expiring. This should prompt you to log in to Kuali and Create a DUPLICATE protocol.
  • Open your current protocol and select Duplicate as New on the right menu. Shown below:
Duplicate as New
  • Once you have done this, go through the entire protocol and review and make updates, as needed.
  • Pay particular attention to the question in the rationale asking for numbers used on last protocol and what aims were accomplished.
  • Review and update numbers throughout the protocol and all the procedures.
  • Submit your protocol.

Close an IACUC Protocol

Close an IACUC Protocol Allison Koss

If a protocol is completed and no longer needed, or if a replacement protocol has been approved (after 3 years), a PI should submit a CLOSE REQUEST.

 

Step 1 - Click the protocol you wish to close.

Step 2 - When you open the protocol select Request Close on the right side of the screen. There will be a form to fill out with the number of animals used.

Request close

 

close request page

 

Step 3 - Once you complete the form, click Submit on the right side of your screen.

submit