As a condition of continued ethics clearance, researchers must conduct their research according to the details provided in their originally approved application. If modifications 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.
When should an amendment be submitted?
- adding and/or removing a research team member (e.g., co-investigator, student researcher, research assistant, etc.)
- changing the sample size
- altering or adding a new procedure, method, measure, or questionnaire
- changes within study documents (e.g., revisions to the information letter, recruitment materials, etc.)
When is a new application needed?
A new application will be needed when the proposed modifications:
- do not align with the original study objectives
- the changes are substantial (e.g., a new phase or sub-study is being added with many components)
- study purpose, aims, or objectives are changing
If you are unsure whether you should submit an amendment or a new application, please contact Research Ethics 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. See guidance on beginning an amendment.
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 (e.g., if you are adding a new participant group, you would update the "Participants" section of the application). See guidance on making an update.
Step 4: PI submits the amendment by clicking on the "Submit" button on the right-side menu. Please note that only the PI can submit applications in the research ethics system. Other team members with full access are able to submit revisions. See guidance on submitting an amendment.
Tips to facilitate the review of the amendment
- Include an overview of all proposed changes and why they are needed. Describe the changes in the amendment justification section. This provides important context about what you are modifying in the application and the reasons for making changes to the study.
- Highlight or use track changes within study documents (e.g., recruitment messages, information-consent letter, etc.) to show where changes have been made before uploading them to the amended application. This will help expedite the review process by allowing reviewers to easily locate revisions.
- Read through the entire application to identify areas to update or change that pertain to the amendment.
- The research ethics system automatically highlights for reviewers any changes made to the application fields once the amendment request has been submitted (e.g., new text or materials added to an application section). There is no need to try to distinguish changes made to the application fields by typing text in caps as reviewers will be able to see your edits.
- Do not remove or delete details or documents already used as part of the study. For updated documents, use the replace button to upload revised versions of materials.
- Keep text or materials that are: a) still relevant to the ongoing study and/or b) have already taken place. For instance, if you are adding a second phase to your study, do not delete any details or materials that were used during the first phase. Simply add the new details in a sequential manner in a new paragraph.
Frequently asked questions
Question: How long does a review of an amendment take?
Response: Expect the review to take 10 to 15 business days after being submitted.
Question: I have submitted an amendment, and it is under review. Why can't I submit another amendment?
Response: Only one amendment may be submitted on an application at a time. Any outstanding submissions (e.g., an in-progress amendment or a renewal request) need to receive ethics clearance before any other request can be submitted.
Question: I have some questions, who should I contact?
Response: Reach out to Research Ethics.
Updated September 2024