Step 5: Receive the HREC decision

Notification process

An 'Outcome Notification' will be forwarded electronically to the principal researcher, as nominated on the application, within 3 working days following the HREC meeting where the application was reviewed.

Research must not commence until an Approval notification has been received.

Approval

  • Approval has been granted to undertake the specified project for the period listed on the approval notification.
  • Maintaining Ethics Approval is contingent upon adherence to all Standard Conditions of Approval as listed on the approval notification, or approval may be withdrawn by the HREC.
  • It is the responsibility of the Principal Researcher to ensure the Ethics Office is contacted immediately regarding any proposed change or any serious or unexpected adverse effect on participants, and to submit Annual/Final reports on the dates listed on the approval notification, or subsequent amendment approval notification.
  • The HREC may conduct random audits and / or require additional reports concerning the research project as part of the requirements for monitoring, as set out in the National statement on Ethical Conduct in Human Research

Approval with comment

  • The committee have made comments regarding your project that should be noted by the research team, as they may be helpful.
  • Approval has been granted to undertake the specified project for the period listed on the approval notification.
  • Maintaining Ethics Approval is contingent upon adherence to all Standard Conditions of Approval as listed on the approval notification, or approval may be withdrawn by the HREC.
  • It is the responsibility of the Principal Researcher to ensure the Ethics Office is contacted immediately regarding any proposed change or any serious or unexpected adverse effect on participants, and to submit Annual/Final reports on the dates listed on the approval notification, or subsequent amendment approval notification.
  • The HREC may conduct random audits and / or require additional reports concerning the research project as part of the requirements for monitoring, as set out in the National statement on Ethical Conduct in Human Research

Provisional approval

  • Your application is close to approval, however minor amendments are required.
  • Return to the Ethics Officer a copy of the 'provisional approval' notification as a cover sheet, with your responses addressing each issue, point by point, explaining clearly how each of the matters raised has been addressed.
  • Include a copy of any amended document; eg. Plain Language Statements, Consent forms, or advertisements.
  • You may need to review aspects of your application and/or supporting documents to successfully progress your application to an approval notification.
  • Highlight all amendments made in your application, or amended supporting documents.
  • Provisional approval responses are reviewed by the HRE Chair. Re-submission to a meeting is not required.
  • Following a review of your responses and any amended documents, you will be issued with a new outcome notification.
  • Provisional approval responses that do not strictly meet the response protocol will not be reviewed by the HRE Chair.
  • Research must not commence until an Approval notification has been received.

Approval withheld

  • Applications receiving this outcome indicate the HREC had significant concerns about the project in its current presentation, which need to be addressed.
  • A re-written application with all supporting documents will need to be re-submitted through the normal channels, to be re-assessed by the full committee at a standard meeting.
  • An expedited application receiving this outcome, may need to be resubmitted using a standard application in order to provide information not required in the low risk application - this will be advised on the notification. If this occurs, the application will need to be reassessed by the full committee at a standard meeting.
  • Include a copy of the 'withheld outcome' notification as a cover-sheet to your re-submitted application. Your responses to each issue addressed point by point, explaining clearly how each of the matters raised has been considered. Include all amended text in your response, that has been added to the new application and/or supporting documents.
  • Note: A response merely stating that the relevant issues have been addressed in the attached application/documentation is not acceptable, and the application may not be reviewed..
  • In addition, highlight all amended text within the new application and supporting documents, for easy visual reference of the committee in re-assessing the application.
  • The re-submission must be a complete application: include all supporting documents whether they required amendment or not, and authorised by all required signatories.
  • Refer to Step 4 for advice on how to re-submit your application.
  • Following the committee's review, you will be issued with a new outcome notification.
  • Resubmitted applications that do not meet these protocols will not be reviewed by the HREC.
  • Be aware that review of the revised application may result in new concerns and new queries being raised by the Committee.
  • Research must not commence until an Approval notification has been received for the resubmitted application.

Not approved

  • Concerns raised by the committee are serious, and this application will not be reviewed.
  • Refer to the National Statement (PDF, 600kb) and FedUni Policies,procedures and guidelines for assistance in preparing any subsequent HRE application.
  • In these instances, the HRE Chair is available to offer guidance in understanding the National Statement, policies, procedures and guidelines, and answer any question or concerns you may have when preparing a new application.
  • Research must not commence on this project.

Appealing against an outcome notification

  • Researchers who wish to appeal against any decision made by the HREC committee about their research project or express concerns about the ethics administration process, they should direct their concern to the Ethics Office.
  • The Ethics officer will consult with the researcher and the Chair of the HREC, and if appropriate, the relevant Associate Dean, Research
  • The Ethics officer will advise the applicant of the outcome of the consideration of their complaint.

Go to step 6