All comments from the HREC or ethics panels are located within the application form and are marked as ‘Action Comments’ or ‘General Comments’.
A red bubble indicates that you need to respond to one or more comments.
To reveal the comment, click the ‘Comments’ button and then the arrow.
Respond to each question within the application by clicking ‘Reply’.
Once you have completed your response, click ‘Post’ and the red flag/bubble will turn yellow to show it has been actioned.
Ensure that all bubbles have changed from red to yellow, as you cannot re-submit when the status of any comment is still red.
In addition to
responding to comments, you must also amend your actual application in the relevant section, to
include/clarify the information requested by the HREC/ ERP. The benefit of this change is to ensure
the final approved application will reflect the changes requested by the HREC/ERP, AND it will assist
your research team members (and NEW team members) to easily identify what has been approved
as part of the ethics review process (noting that non approved activities would have been deleted
from the application form and a record of changes is kept via the commenting system).
The whole application needs to reflect the changes, so that the final approved version is the most
recent iteration.
Attachments (section M)
- All supporting documents should be uploaded with track changes (or highlighting) within Word so that reviewers can easily identify what has been changed. If track changes are not added, the documents will be returned and not reviewed.
- You can upload new/revised attachments on Section M – Attachments. When editing documents ensure to use track changes and rename the documents to indicate the new version. Examples:
- Protocol - V2 - 01 May 2023
- Participant information letter and consent form - V2 - 01 May 2023
- Use ZIP files if there is more than 1 document per item.
- For HREC reviewed applications that have been reviewed at the HREC meeting, a Word document will be uploaded into ORION at section M.3. Respond to all queries and upload the response document at M.3 along with track-changed documents and re-submit.
- Add all new documents before responding to the last comment at section M, as Orion will close off the ‘add’ button in the documents section once all comments are responded to and you won’t be able to upload any documents.
Re-submit the application
Once all comments have been responded to and all red flags/bubbles have changed to yellow, and
new or altered documents have been uploaded, click on the ‘toolbar’ on the right-hand side of the
page and click ‘submit application’.
Note, you can also click on ‘Reports’ to save a copy of the application or run a comment report.
What happens next?
Your responses will be reviewed by the ethics panel or HREC, and will either be returned with further
comments, or forwarded to the Chair for final approval. This process may take up to 2 weeks.