Post-approval responsibilities
After your study has been given ethics approval, there are a number of responsibilities that you will need to maintain:
Submitting an amendment
Please submit an amendment if you want to change the study design, study team or request a time extension.
Your ethical approval is based on the ethics form and supporting documents you originally submitted. If a change is made to your original ethics submission and you do not notify the RGI team, then your ethics approval may become invalid.
Worktribe amendments
Amendments for studies completed and approved via Worktribe, go to your approved application in Worktribe. In addition, please complete the Notice of Amendment (Worktribe) and upload to Worktribe with your updated documentation.
Pre Worktribe amendments
Amendments for studies approved pre Worktribe the Notice of study amendment [Word] form should be used. Once completed, this form should be submitted to the Ethics and Research Governance Coordinator.
Annual progress report
The Annual progress report [Word] for studies approved pre Worktribe must be submitted to the Ethics and Research Governance Coordinator within 30 days of the anniversary of a project being granted ethics approval. If a study is completed within a year of first obtaining ethical approval, an End of Study Notification must be submitted instead.
This is a condition of receiving ethics approval. If you do not submit an Annual Progress Report, your study will be assumed to be closed, and ethics approval will be stopped.
Annual progress reports for studies completed and approved via Worktribe, go to your approved application in Worktribe to upload the documents.
End of study notification
You must notify the RGI team when your study has ended; within 90 days of the termination of your study or when the practical research activity ended. The notification must be supported by an end of study summary report.
For studies approved pre Worktribe You must also notify the committee within 15 days if you have terminated the study early. Once completed, this form should be submitted to the Ethics and Research Governance Coordinator.
End of study reports for studies completed and approved via Worktribe, go to your approved application in Worktribe to upload the documents.