Request amendment of an ethics application
Submit a request for amendment to change an ethics application that has been approved by the HEAG or HESC
- Log in to Themis using your UOM research self service responsibility.
- Select the ‘human ethics workbench’. This is listed under ‘ethics’. The ‘human ethics home page – researcher worklist’ screen will display.
- Click the ‘create’ button in the ‘create new documents’ section to create an ethics application amendment. The ‘request for amendment’ screen will display ethics applications on which you are named. The create icon will be inactive if a request for amendment is already in progress, or if it is currently under review by the HEAG or HESC.
- Click ‘create’ for the project you would like to amend. The ‘request for amendment details’ screen for the selected ethics application record will display.
- Enter the details of your request for amendment. You must complete all fields before you will be able to update the application.
- Click ‘next’. The version of the ethics application you are working on is a copy of the original application. It will retain the same ethics application ID, but will have a new version number, indicated by ‘.2’ at the end of the ID. The status will be ‘draft’/
- Progress through ethics application updating details as required.
- Attach any new or modified documents. This may be consent forms, plain language statements, etc.
- Click ‘submit application’. You will receive confirmation that the amendment request has been submitted to the relevant HEAG. It will display in the ‘current applications’ section of your workbench.
- Print a copy of the amendment request and any new attachments.
- Make sure the responsible researcher signs the request.
- Submit the paper copies of your request for amendment and any attachments to the HEAG.
Request for amendment details
|Nature of/reasons for amendment||Enter details of the changes you propose to make. Explain why they are necessary.|
|Impact on documentation||Indicate whether the changes will require modification to documentation relating to the project. Include details of which attachments will be updated or what new attachments will be added.|
|Possible inconveniences or risks to participants||Enter any inconveniences or risks to participants as a result of the changes.|
|Actions to be taken by researcher to reduce risk||Enter any additional actions or support that you need to provide as a result of the changes.|
|Expected date of implementation of amendment to research||Enter the date you intend to implement the changes.||Allow time for your request to be reviewed.|
|Possible effect on funding arrangements||Enter details of any effects the changes will have on funding arrangements.|
|Possible implications for compliance with legislative requirements||Enter details of any effect the changes will have on compliance with legislative requirements.|