HREC post-approval reporting & procedures
The Chief Investigators of approved ethics applications must ensure that their research project continuously meets the approval requirements of Victoria University’s Human Research Ethics Committees (HRECs).
Approval conditions
The conditions of approval include:
- submitting an Annual and/or Final Report
- notifying the HREC of any intent to modify the approved research protocol
- immediately informing the HREC of all adverse events and any unforeseen events that may affect the continued ethical acceptability of the project.
In the unlikely occurrence of adverse or unforeseen events, researchers must immediately cease all data collection until the HREC reviews the event and permits data collection to continue.
Annual & final reports
As per the conditions of approval, the Chief Investigator is responsible for submitting Annual Reports and, at the conclusion of the project, a Final Report.
Submissions must be made using the annual/final report form.
If the Chief Investigator fails to meet approval requirements, the HREC has the right to withdraw approval, and research must immediately cease.
If the research project is greater than 12 months in duration, the Chief Investigator is required to submit an Annual Report in the first 12 months and a Final Report on completion of the project.
If the research project is less than 12 months in duration, the Chief Investigator is only required to submit a Final Report.
Changes to the research project
The HREC understands that researchers may wish to change their research protocol after the research has commenced. Where this is the case, the Chief Investigator must notify the HREC of the intent to modify the approved research protocol. These requests must be approved by the Chair of the HREC.
Researchers must not implement a modified research protocol until the modifications have been approved by the HREC Chair.
Request for an extension
From 2024 onwards, once your Ethics Application is formally approved, you will receive approval for a period of 3 years, projects approved prior to 2024 will have received approval for a period of 2 years unless otherwise approved in Quest.
However, the HREC understands that research and data collection may need to continue for a longer duration. Where this is the case, the Chief Investigator must submit a request for an extension. The process for requesting an extension is the same regardless of whether the original application was submitted using the online form or a superseded paper application form.
The Chief Investigator must email a memorandum detailing the request for an extension to the Ethics Secretary. The memorandum must briefly outline the justification for the request for extension and quote the HRE number, project title, and progress to date.
The Ethics Secretary will forward your request for extension to the HREC Chair for review and approval. The Ethics Secretary will subsequently advise you of the outcome of your request by email. Extension requests are granted for a maximum of one year.
Please note: Extension requests will not be considered unless the Chief Investigator has submitted an Annual Report for the research project.
Adverse events
The Chief Investigator must immediately inform the HREC of all unexpected adverse effects on participants and any unforeseen events. Adverse events may affect the continued ethical acceptability of the project.
Failure to report an adverse or unforeseen event will result in immediate withdrawal of approval and the research must immediately cease - the researchers may also face disciplinary action.
To report an adverse event, please contact the Chair, Human Research Ethics Committee:
Associate Professor Deborah Zion
Email:
Phone: +61 3 9919 4058
Complaints
Any queries about participation in a project may be directed to the researcher. However, if you have any queries or complaints about the way you have been treated as a participant during a research project, you may contact the Ethics Secretary.
All complaints will be handled sensitively and with appropriate confidentiality. Complaints may be reported by participants, researchers, staff of institutions, or any others involved in the conduct of a human research project.
To lodge a complaint, please contact the Ethics Secretary, Human Research Ethics Committee.
Ethics Secretary
Office for Research
Victoria University
PO Box 14428
Melbourne VIC 8001
