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How To Submit Amendments to Animal Use Protocols in Darwin

Sections to choose when amending | How to submit an amendment

 

What you should know:

  • An amendment in the software is actually the act of revising sections of the protocol.
  • More than one section can be revised in an amendment.
  • Only one amendment can be submitted to the FACC at a time.
  • Because training requirements for personnel can take a while to obtain, it is strongly suggested that addition of personnel be done separately from any other amendment. Submit the personnel amendment after the amendment without personnel is approved.
  • If the section you want is not among the choices, choose the section “Species Information”; this will permit you to change a “No” answer to a “Yes” for doing surgery, drugs, euthanasia, hazards, non-surgical procedures, etc. This will create a new section if it is not currently in the approved protocol.
  • If you selected a section and find out that you do not need to revise it, remove it from the list; otherwise the software will not allow you to submit without editing (this is to ensure you edited all the sections).
  • Only the Principal Investigator (PI) can submit to the FACC. People in his/her research group can complete an amendment which will remain "unfinished" until the PI logs into Darwin, reviews the amendment and submits to the FACC.

 

Sections to choose when amending

 

If only adding animals of the same species and strains as is currently on the protocol, select the following sections to revise:

  • Species Information - Note that you are revising the new total number for the species so please add your requested number to the approved one currently in the protocol. for example, if 20 mice were approved and you want 8 more, you need to change the total of 20 with the new total of 28.
  • Justification for Number Requested
  • Category of invasiveness

 

If adding animals of the same species but new strains as is currently on the protocol, select the following sections to revise:

  • Species Information - Note that you are revising the new total number for the species so please add your requested number to the approved one currently in the protocol. for example, if 20 mice were approved and you want 8 more, you need to change the total of 20 with the new total of 28.
  • Justification for Number Requested
  • Strain list and the newly generated Strain Information
  • Category of invasiveness

 

 If adding a species, choose the sections:

  • Species List (this generate numerous sections to complete)

  

 If only adding a person, choose the sections:

  • Personnel List (when the list is opened, click the person’s name and do not forget the list of activities performed by this person on the person's 2nd page which shows a choice of "Activities" to select).

 

If only removing a person, shoose the sections:

  • Personnel List (when the list is opened, check the box next to the name of the person you want to remove and click the button "Remove Selected person(s)". See screenshot.

 

If adding a funding source, choose the sections:

  • Funding Sources or one of the subsections if applicable.

 

If adding anything else such as a procedure, drug, hazardous agent, housing or procedure location, euthanasia method, choose the sections:

  • of the appropriate list (Non-Surgical Procedures or Surgical Procedures or Drug and Other Substances or Hazardous Material or Housing Location or Procedure Location or Euthanasia Methods)
  • Description of Procedure

 

How to submit an amendment

1- Launch the amendment process by selecting "Submitting an Amendment to an Existing Protocol" in the bottom of your home page.

selecting the amendment option in the homepage

 

2- Choose which Animal Use Protocol to amend:

Reason for amendment and choosing the sections

 

3- Add the reason why you need to amend (please keep it short) and select the sections you want to revise:

Reason for amendment and selecting the sections

 

4- Revise a section by clicking on the section's name. Do this one by one.

Revision of each protocol section

 

5- When the section's name is clicked, it will open the Web page but the original approved text will appear as a reference. White fields will permit you to make changes to text.

Current approved text as a reference

 

6- When all the sections have been revised, click the 'Continue' button in the bottom.

Ready to submit to the FACC

 

7- Type your password and click the 'Continue' button.

Password and continue

 

8- To submit to the FACC, click the 'Submit to the FACC Office' button. For Principal Investigators, the amendment has been submitted. For those in the research group, the PI must now login, review the amendment labelled 'unfinished' in his/her homepage, and submit to the FACC. Only the Principal Investigator can submit.

Submitting to the committee

 

The amendment once submitted cannot be edited anymore. If you wish to recall it, please contact the FACC's Administrator and ask that he/she sends it back to you via Darwin.

It will be reviewed and may be sent to you with recommendations to correct or supply more information. Please revise as specified and submit back to the FACC in the same way. Once approved, an email is sent by the software and the Alert will disappear from your homepage. Changes are now part of the main current protocol which can be viewed by clicking "Protocol Search" in the bottom of your homepage.

 

 Removing a person