Amendments and Reporting
Variations and Amendments
It may be necessary to make amendments to the protocol approved by the HREC. Please submit amendments for projects through the new online system, please contact the Research and Integrity Team to request access to your project. firstname.lastname@example.org.
Cross Institutional Approval
If you have received Ethics approval from another institution (including ACT Health), please submit this through the online application process. (Please select the Cross Institutional Option)
Reporting of adverse events
Any unexpected adverse events or complications that occur anytime during the conduct of a research study or during the follow up period after the research must be reported to the Research Ethics & Integrity team. These matters must be reported promptly via email to email@example.com.
The following information must be provided:
- Chief Investigator and Ethics approval details
- Description of the adverse event
- Date and site of adverse event
- Impact on participants
- Immediate actions taken to mitigate harm and risk to participants
- Actions required to reduce the risk of recurrence
Failure to report adverse events promptly may result in the withdrawal of the Ethics approval.
The HREC is required by the National Health and Medical Research Committee to monitor the conduct of approved research. It is mandatory, therefore, for researchers to submit annual review reports during the approval period of your project.
Please use the forms for your review: