Tips for Protocol Amendments

IACUC Amendment meetings are held twice each month. Please see our meeting deadlines and schedule.

Important

Do not start experiments proposed in the amendment until it has been approved by the IACUC. You will receive a purple disposition sheet once the amendment has been approved. If you do start without IACUC approval, then you are in violation of your protocol

How to write an amendment in eSirius:


2

Log into eSirius and in your Mailbox

Make sure you are in “Protocol Actions”

3

From your List of Approved Protocols, click on the protocol you want to amend to turn it yellow

Click on the tab “Start an Amendment”.

4

In the section labeled, “Please summarize the significant changes you are proposing in this  amendment request and provide scientific justification for the changes”, please put the following:

  1. What you are adding to/changing on the protocol. Please make this brief. Put the details  in Description of Procedures in the main protocol.
  2. Why you making the addition/change
  3. Number of animals you are adding to the protocol with a brief explanation as to why you  need that many, i.e. 45 experimental, 4 breeders, 45 euthanized weanlings.

5

Click on “Amend Protocol”

6

If the changes include non-routine restraint, surgery, or breeding, and there is no previously  approved non-routine restraint, surgery, or breeding on the protocol, you will have to edit the  table at the bottom of the page Protocol Introduction.

Do not unclick anything already there!

Regarding Strains


DO NOT USE YOUR BROWSER’S BACK BUTTON, PLEASE USE THE TABLE OF  CONTENTS ON THE LEFT SIDE TO MOVE BETWEEN SECTIONS! 

As you are going through every section, make the necessary changes to the protocol that are  needed with the amendment like adding a new chemical agent, updating animal numbers, and  updating the Description of Procedures. 

Don’t forget that the strain list in your protocol is directly connected to animal ordering, so if you  are adding a new Jackson Lab strain and you don’t add it, you won’t be able to order it. 

Also regarding strains, if you are getting the strain from a collaborator on campus, please use the  exact strain name other PI uses on their protocol. If you don’t, it will delay transfer requests. Ignore Non-Surgical Procedures. Put any new procedures – surgical and non-surgical – into  Description of Procedures.

Regarding Radioactive/Chemical Agents


Regarding Radioactive/Chemical Agents, when looking for the agent make sure you use  “contains” in the search parameters. You can search by CAS# by choosing Agent Abbrv.  Here are some other things to remember: 

  • Is it an antibody? List it as the type of antibody i.e. Rabbit immunoglobins/Antibodies  and put the name of the antibody in the Description of Procedures 
  • Is it a peptide? Just select “Peptide” and put the name of the peptide in the Description of  Procedures 
  • Is it a recombinant protein? Just select “Recombinant Protein” and put the name of the protein in the Description of Procedures. 
  • Is it a cell line? That’s an IBC agent. Just put the cell line in the Description of  Procedures 
  • Is it a bacterium? That’s an IBC agent. Just put the virus in the Description of Procedures. 
  • Is it a virus? That’s an IBC agent. Just put the virus in the Description of Procedures 
  • Is it a chunk of DNA or RNA? That’s an IBC agent. Just put it in the Description of  Procedures

Additional Information


If your new agent doesn’t fit any of the above and it not in the list, send the SDS of the agent to  Carol.Palmer@ucdenver.edu and tell her that’s it’s for an amendment. 

For the added chemical, click on it to turn it yellow and then click on “Edit Agent”. Fill out the  information on the page that appears and then click on “Save”. 

In the section Animal Numbers and Categories, you will need to update your attached animal spreadsheet.  

Download the “Animal Numbers Spreadsheet for eSirius Protocol Submission”. Fill it out for the animal numbers for this amendment and attach it to the protocol at the bottom of the Animal  Numbers and Categories page. If you already have an animal numbers spreadsheet attached to the protocol, just add to it, save it, and re-attach it. 

If you don’t go through every section, you will be unable to submit the amendment. 

If you need to go back to the amendment section, look at the list on the left-hand side and click on “Amendment Reason”, and it will take you back to the amendment section. 

Please remember, when you amend your protocol, just add, do not delete. The IACUC will just ask you to put it back in. 

If you have any problems accessing eSirius program or your protocol, please contact  Laura.Richardson@cuanschutz.edu