Making changes to the study protocol after approval
Any changes to the study protocol must be submitted in the research ethics system and receive approval confirmation prior to implementing any changes. Minor administrative changes can be reviewed and approved at any time, but most amendments must be reviewed by the Animal Care Committee (ACC) subcommittee before approval. If you have any questions, please email the research ethics manager for assistance.
Amend the protocol
If changes need to be made to the study, an amendment must be submitted in the research ethics system and receive clearance before any changes are implemented. An amendment can be submitted anytime throughout the year for an ACC subcommittee to review the request at a monthly meeting or can be combined with the annual renewal as a renew/amend request.
When should an amendment be submitted?
An amendment request is normally appropriate for minor changes to an approved application. The following are examples of changes that can be made:
- Adding and/or removing a research team member (e.g., co-investigator, student researcher, research assistant, etc.).
- Minor changes in numbers of animals from the number initially approved.
- Changes, additions or deletions of species where the procedures remain the same.
- Minor changes to procedures where the invasiveness category remains the same as that approved.
Amendments can be categorized as administrative in nature, minor or major. Major amendments are reviewed by a subcommittee of the ACC and are subject to the same submission deadlines as full applications.
When is a new application needed?
A new application will be required in the following situations:
- The study objectives change significantly.
- The modification includes the addition of a D or E category.
- Substantial extension/changes to endpoints, for example.
Other situations may require a new application. If you are unsure whether you should submit an amendment or a new application, please email the research ethics manager to discuss.
How to prepare and submit an amendment request
Step 1
In the research ethics system, select "Amend" from the menu on the right-hand side of the application. Any research team member given full access can start the amendment and make changes.
Step 2
In the amendment justification, briefly outline the changes that you are making and why.
Step 3
Read through the full application and update any section that is impacted by the amendment.
For example, if you are adding a new person to the team, you should update the "People" section of the application.
The amendment process involves updating the application with the changes to the study. After the amendment is approved, the new version incorporates the original and all approved amendments.
An application can only have one amendment or one renewal in progress at a time.
From the “Manage Protocols” screen, open the application you want to amend.
Select the “Amend” button from the right-hand menu.
Enter the reason for the amendment in the Amendment Justification box and select "Continue."
If the buttons are greyed out, there is likely another amendment or renewal in progress, or you are not on the latest approved version of the application.
Open the Version screen and check for an in-progress version and the latest approved version to see the current state of the application.
An amendment can only be submitted by the principal investigator/faculty supervisor. When you are finished making changes, you can submit the amendment with the "Submit" button.
Renew your application
Renewal requests must be submitted using the research ethics system.
An approved application is valid for 12 months from the ethics approval date and must be renewed each year by a subcommittee of the ACC prior to the project continuing. The subcommittee meets monthly (except August) to review renewals and amendments.
Researchers will receive a notification from the system two months before the AUP expires to be able to submit the renewal.
An AUP can only be renewed up to three times for a total maximum active period of four years. Once the project has been renewed three times, a new protocol must be submitted for full ACC review.
How to submit a renewal (or renewal/amendment) request
Step 1
In the research ethics system, select "Renew" from the menu on the right-hand side of the application. Any research team member given full access can start the renewal. If you wish to also amend the protocol to be reviewed at the same time, please select "Renew/Amend" from the menu on the right-hand side of the application. For the amendment portion of the changes, please see the Amendments section for further assistance.
Step 2
PI submits the renewal (or renewal/amendment) by clicking on the "Submit" button on the right-side menu. Please note that only the PI can submit new applications in the research ethics system. Other team members with full access are able to submit revisions to the applications.
If you are updating animal numbers, then the “Animal Numbers” section will need to be updated.
Step 3
PI submits the amendment by clicking on the "Submit" button on the right-side menu. Please note that only the PI can submit new applications in the research ethics system. Other team members with full access can submit revisions to the applications.
Close a study
An AUP can be renewed a maximum of three times before a new application must be completed for full ACC approval.
Regardless if the AUP will be replaced with a new application, the previous application must be closed by submitting a closure request form in the research ethics system.
How to prepare and submit a closure request
Step 1
In the research ethics system, select "Close" from the menu on the right-hand side of the application.
Step 2
Fill out the closure report and submit the closure request by clicking on the "Submit" button on the right-side menu.
If you have any questions, please email oreaupp@uwaterloo.ca.