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). 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 any adverse or unforeseen events, researchers must immediately cease all data collection until the HREC reviews the event and permits data collection to continue.

Annual and 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 (.docx, 56KB).

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.

Online applications

To request a change to the approved research protocol, the Chief Investigator must email a memorandum of intent to modify the approved research protocol to the Ethics Secretary. In this memorandum the proposed changes will be briefly outlined.

The Ethics Secretary (in consultation with the Chair of the HREC) will use the memorandum to determine whether the request can be processed as a modification to the existing research protocol.

The Chief Investigator may be required to submit an entirely new application if the changes are too significant or raise additional high risks (e.g. recruitment of children, etc.). Please contact the Ethics Secretary if you require further information regarding this.

If the request is assessed as an appropriate modification to the research protocol which can be reviewed out-of-session, the researchers will be notified by email. This email will also outline the next step in the process, as defined below.

After notification, researchers must log in to Quest, open their ethics application form and amend the application as required. Once the application has been revised, the researchers must enter a comment on each relevant page, briefly outlining the changes that were made to respective sections of the application (to confirm to the HREC Chair as to the nature of the changes to the application). Once the application has been amended, the Chief Investigator must click on 'Submit Amendment Request', under the 'Action' tab. This will submit the application for review.

The request will then be reviewed by the HREC Chair. The Chief Investigator will subsequently be notified of the outcome of the request for amendment by the Ethics Secretary by email.

Paper applications

If you received approval for your research project using the superseded paper application form and wish to change your research protocol you are required to follow the process below.

The Chief Investigator must email a memorandum detailing the request for changes to their research project to the Ethics Secretary. The memorandum must outline the reason/s for the changes and quote the HRE number, project title, and progress to date. In addition to the memo, you must also submit:

  • a copy of the revised ethics application highlighting all changes/amendments, using the 'Track Changes' function (signed by the Chief Investigator)
  • a copy of the revised application with the changes/amendments accepted
  • any revised Consent Form/s (if applicable)
  • any revised Information to Participants Form/s (if applicable)
  • any revised surveys/tests/interview schedules (if applicable)
  • any additional supporting documentation (for example, letters of approval from other organisations).

You must email electronic copies of all documentation to the Ethics Secretary.

The Ethics Secretary will forward your request to the HREC Chair for review and subsequently advise you of the outcome of your request by emailed memorandum.

Request for an extension

Ethics approval is granted for two years from the approval date. 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 two years.

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.

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.

You may wish to refer to the Ethics Complaints Management Process guidelines for further details:

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

Phone: +61 3 9919 4781 | +61 3 9919 4461
Email: researchethics@vu.edu.au