Amendment

 Before you begin the IACUC amendment process, consider whether you should address other issues that may affect your request for changes.

  • If you are changing personnel, have you considered the institution’s training requirements for the new members of your team?
  • Do the changes to the project require approval by other committees?
  • Have any new funding and other support issues been considered?
  • Are you collaborating with new institutions?

Contact your department's Designated Animal Research Officer (DARO) or the IACUC office if you need assistance.

The amendment will be pre-reviewed by the OIACUC staff and one of the veterinarians. You may be contacted to clarify or correct the amendment application.

Once the pre-review issues have been resolved, the amendment will be sent for review by the Institutional Animal Care and Use Committee (IACUC).  The IACUC may use one of two review processes: Full-committee review (FCR) by a convened quorum of the members of the IACUC, or Designated member review (DMR) by one or more members, employed only after all voting members have been provided an opportunity to call for full-committee review.

 

Who can initiate the Amendment?

The PI, Delegate or Co-PI can initiate the Amendment process. If the Delegate or Co-PI require the PI to review the Amendment, it is important to not progress passed the Audit page. The Delegate or Co-PI should communicate to the PI that their review is required before continuing passed the Audit page. After the Audit page and once you have arrived to the Administrative Changes section, pages within the Amendment cannot be edited.  

Delegate initiated Amendment

If a Delegate is initiating the Amendment it is important STOP at the Audit page in the event the PI will need to make edits. Otherwise the pages of the amendment application will not be editable.

Locate your Protocol

In order to begin the Amendment process:

  1. Log into O.R.C.A.
  2. From the Dashboard, go to Your Protocols
  3. Click the Protocol Number



You will be viewing the IACUC Protocol Information page. From this page:

  1. Click the Action button

  2. Select Start an Amendment



During the Amendment process

  1. Application pages - complete all required pages

    1. You will be presented with all required pages for the protocol and will have the ability to edit your information

    2. The Administrative section within the online application will not be available but you will have an opportunity to update your Study Personnel, Grants and Occupational Health and Safety information. 

    3. Continue on with the application all the way to the Application Summary and Audit page.
       
  2. Application Summary

    1. You will be presented with a summary of your Amendment and will see the areas that have been edited. 

    2. If there is content that needs editing, use the left menu to navigate back to the area that requires edits.

  3. Audit 

    1. The audit page will indicate if all required pages have been completed or indicate which pages have not been completed.

    2. At a successful audit, you will have a Next Page button.  

    3. Click Next Page

      Amendment Submission

      Once you click Start Administrative Section, the amended application can no longer be edited.

    4. Amendment Submission message will display

      1. The message provides instruction on what happens next. 

      2. The Administrative Changes section must be completed before you can submit your Amendment.

    5. Click Start Administrative Section


  4. Administrative Changes 

    1. The Administrative section will display a yellow banner indicating this section is in an Amendment process.

    2. Updates to this section which require IACUC review will be placed in the Review & Submit tab. 

    3. Changes that do not require IACUC review will not be displayed in the Review & Submit tab.

    4. After you have or have not made edits to this section, click the Review & Submit tabThe tab messaging will be cater to whether or not administrative changes have been made.

    5. Click Finalize Admin Changes

    6. Click Close

  5. Amendment Assurance 

    Amendment Submission

    If a Delegate submits an Amendment, the Amendment will be submitted to the PI. It is important that the Delegate communicate to the PI if PI review is needed, prior to the Amendment being submitted.

     

    1. Review the assurances 
    2. Click Submit to IACUC for Review
    3. Once clicked, a Final Amendment Submission message will display describing what happens next. 
    1. Click, Continue to Amendment Justification

    2. Click, Next Page


     

  6. Amendment Justification

    1. You will see a left and right panel. The left panel will display track changes to the areas you have made edits to.

    2. The right panel will list all sections that have been changed and will provide a text field to enter a justification.

    3. You can group sections together and provide a justification if necessary or you can provide individual justifications for each section.

  7. After you have completed your justifications, click Submit Amendment to IACUC for Review

Dashboard

  1. PI - if the PI submitted the Amendment, the Amendment will be listed in the Submitted section.
  2. CoPI/Delegae - if the Co-PI or Delegate submitted the Amendment, the Amendment will be listed in the In-Progress section. 

 

 

Withdraw your Amendment

From the Dashboard, you will be able to see the progress of your submission as it is routed through the IACUC office. For a short period, you will have the ability to withdraw your Amendment and continue editing. At the time of withdraw 

  • Administrative Changes will be lost.
  • Amendment Justification comments will not be lost.

Amendment Status on Dashboard

LocationStatus 
In-ProgressDraft An Amendment was initiated but has not gone through submit
In-ProgressPendingAmendment has been submitted but not Finalized. It is possible:
  • Amendment was initiated but Administrative Changes have not been completed.
  • The Delegate has submitted the amendment and now the PI must review and finalize. 
Submitted ItemsAcceptedThe Amendment has been submitted and is in the Office of the IACUC's queue for review.
Submitted ItemsUnder ReviewThe Amendment has been assigned to an analyst and can no longer be withdrawn.

 

 

Things to know

  1. An amendment cannot be submitted if there are no changes or updates to the application (Project Information page to the Optional Attachments page).
  2. If your only change is to the Administrative Section, go to the Administrative section from the Actions drop down, do not begin an Amendment.
  3. An amendment can be initiated if there are pending Administrative Changes but cannot be submitted. Once Administrative Changes are approved, an Amendment can be submitted. If there are pending Administrative Changes, at the Amendment's Audit page, there will not be a Next Page button, but a Return to Dashboard button.

 

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If you have technical difficulties contact vpr-it@uthscsa.edu OR 210-562-5691.
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