Any changes to your study (e.g., study team members, study title, documents, etc.) must be submitted and approved through an Amendments to Study PAA prior to enacting the change.
Any changes to the application should be clearly explained in the PAA coversheet, along with a brief overview of the rationale behind these changes.
How to submit an amendment
- For step-by-step RISe submission instructions
- For a copy of the Amendment PAA coversheet
What to know before writing and submitting an amendment
There are multiple steps involved in submitting an amendment. Please review the below information prior to submitting your amendment to avoid unnecessary delays in the review.
Completing the PAA Coversheet
Prior to making changes to your ethics application, you will need to complete a PAA Coversheet. The coversheet should be used to summarize the changes that are being made to your application and include a short progress report of where you are in your study.
A list of all study documents that are being added or changed should be included at the end of the coversheet.
Please note that submitting a summary of changes in your PAA coversheet will not update your actual ethics application. All changes must also be made to your application. Changes can be made to your ethics application by navigating to the PAA homepage and clicking "Edit Application" on the left side of the screen.
When making edits to the content of your ethics application
When making changes to your application, all new details should be added under a dated subheading (e.g. MONTH YEAR Amendment) at the bottom of each box.
Only if previously approved procedures have not been used and will not be used in the study, can the information be removed or over-written. When doing this, please make it clear in the PAA coversheet that the procedures did not and will not take place.
If aspects of the application remain the same, the information does not need to be repeated again under a dated subheading. Only the changed details need to be indicated.
When changing study documents
When adding new versions of documents to page 9, do not remove previous versions that have been used with participants. Documents that were used with participants need to remain on file so we have a complete history of the project.
When revising previously approved documents, please first accept all changes and/or remove any notes from the previous versions. Please use track changes or text highlighting to show all changes that have been made since the last version.
Ensure that the footer of all new documents includes an updated version date that matches the date entered for the document in RISe.
Commonly seen amendments
The BREB sees many of the same type of amendments. As such, we have developed guidance specific to these common amendments. Please see below for more information about each type of Amendment.
Changing the Principal Investigator (PI)
#changingPIPrior to submitting an amendment to change the PI, the current Principal Investigator, the new Principal Investigator, and the Department/School Head, must sign the following form: Changing the PI on an ethics application.
Note: The Department/School Head approving the change must not be either the current PI or the new PI.
In order to change the Principal Investigator on the study you will need to follow these steps:
- Select "yes" in Box 1.5 of the PAA Coversheet.
- Attach the signed Change to PI form to Box 1.5 of the PAA Coversheet
- Address any required changes throughout your ethics application (e.g. Box 1.3, 7.3, 8.2, 8.5, and study documents on page 9).
You will not have access to change the PI in Box 1.1 of the ethics application. Once the amendment has been approved, the REB administrator will update the PI on the study and Box 1.1 will update accordingly.
Changing Study Team Members
#ChangingTeam Study team personnel other than the PI can be added to Box 1.3, 1.4, or 1.5 of the ethics application depending on their role in the study and whether or not they have a RISe account.
Adding co-investigators (Box 1.3): Individuals listed in this box must have a RISe account and will have online access to the application. They will also be listed on the certificate of approval. All co-investigators should also be included on any in-use consent forms.
Adding other study team members with RISe account (Box 1.4): Add any other study team members who have a RISe account but will not be serving as co-investigator to this box. Individuals indicated here will have online access to the application, but will not be listed on the certificate of approval.
Adding other study team members who do not have a RISe account (Box 1.5): All other study team members who do not have a RISe account can be included in this box. Individuals indicated here will not have online access to the application and will not be listed on the certificate of approval.
Each of the above-mentioned boxes includes two sections: Section A allows for individuals to be added to the application and Section B is a space for a description of the individual's role in the study. When adding an individual to any of these boxes, please be sure to complete both A and B.
Adding Funding
#AddingFunding All funding that will be used to undertake the project should be listed on Page 2 of your ethics application and on any active consent forms.
If the funding has a FAS number, it will be available to select in Box 2.3.A. If the funding does not have a FAS number the sponsor and funding title can be added to box 2.4.A.
For more detailed information about adding funding to your ethics application, please see our funding and ethics guidance document.
Adding Research Methods
#AddingResearchMethods Additional research methods can be added under an ethics application as long as the changes are still within the scope of the original study. New studies that are complimentary to (but not dependent on) must be submitted under a new ethics application.
When adding new research methods, ensure you complete each relevant box with updates under a dated subheading at the bottom of the box. Check these pages to ensure that the new research methods don’t require changes here:
- Page 2: If there are any changes to the study timeline, funding, or conflict of interest.
- Page 4.A: For any changes to the study sites.
- Page 4.B: For any changes in the level of risk.
- Page 5: For any changes in the study procedures including inclusion criteria and recruitment methods.
- Page 6: For any changes in the consent process, risk mitigation strategies, remuneration, and time to participate.
- Page 7: For any changes related to external institutional approval and number of participants. For section G if your study involves Indigenous topics, check to ensure that additional details are not required.
- page 8: For any changes related to data security, retention, and access.
- Page 9: If any of the study documents have changed or need to be added.
Changes to Survey Only and Secondary Use Only Applications (shortened applications)
#ShortenedApplications Our shortened forms were created to simplify the review of research that uses only one method of data collection. For that reason, if you are submitting an amendment on a shortened form, you can only make changes that do not alter the application from a survey-only or secondary use of data-only form.
For example, Survey Only (page K) application cannot be edited to add any additional research methods such as interviews or focus groups. A new full ethics application is required.
Similarly, a Secondary Use of Data Only (page L) application cannot be amended to add prospective data collection. This application only asks questions relevant to secondary use of data studies and does not cover the collection of prospective data (e.g. surveys, interviews, focus groups).