If you received an approval letter as your outcome, congratulations your ethics application has been approved, and this means that the data collection phase of your research may commence.

Once approval is obtained, a researcher is only approved to undertake the research as outlined in the application and its approval conditions. Any changes or amendments must be approved before they are implemented.

All approved projects must follow the HREC Standard Conditions of Approval.

How to View Your Approved Application

When your application is approved it turns from a ‘Coversheet’ to a ‘Protocol’ on IRMA. You will be issued a protocol ID in IRMA and on your approval letter. When referring to your protocol use the protocol ID provided. 

Managing Approved Research

Now that your project is approved data collection can commence. To keep your project up to date an Annual Report must be provided to the human.ethics@murdoch.edu.au email on the anniversary of the approval date. IRMA will send out a reminder approximately two weeks before this report is due. The Annual Report is the minimum reporting required by the National Statement to maintain approval. If this report is not provided, the HREC may re-consider the approval status of the research project including suspension or cancellation of ethics approval.

Amendments

Changes to the research project following approval must be made through an amendment application on IRMA which asks:

  • what are the proposed changes; and
  • justify why these changes are needed.

Most amendments are reviewed at the low-risk level, some may be reviewed out of meeting session. This is up to the discretion of the HREC Chair and Human Ethics Office.

    Adverse Events

    Occasionally things go wrong, and unexpected, or unforeseen things happen with a negative impact on participants. Sometimes participants can make a complaint. In rare instances, a participant may be hurt or harmed in some way. In such events, notify Research Ethics and Integrity immediately that the event has occurred. This is done through reporting in IRMA.

    In some cases, the research may need to halt at least until the HREC has reviewed the adverse incident report and determined its seriousness, potential for impact on the remainder of the project and any additional conditions which may need to be met by the researcher/s. Possible considerations include modification of the project to avoid similar events occurring.

    In extreme cases, the project may have to cease if continuation might prove harmful to participants.

    Breaches

    A breach is a failure to follow the standard conditions of approval given by the HREC, as well as a failure to meet the requirements of the NHMRC’s National Statement (2023). If a breach occurs, report it to Research Ethics (human.ethics@murdoch.edu.au) immediately and it will be investigated thoroughly.

    Actions may be required of the Chief Investigator of the project. Cease any data collection until the breach is handled.

    Approval Expiry

    When approval is received it has a lifespan of 4 years (if annual reports have been submitted).

    Once all 4 years have been completed the lifespan of the ethics approval has come to an end.

    The next course of action will be to submit a Renewal Resubmission or a Closure.

    Renewal Resubmissions

    A renewal resubmission undertakes the same process of submitting a new application . When you submit this new application, include very clearly that this is a ‘Renewal Resubmission’ of the previously approved project. Include the title and previous protocol ID in this application. Also consider any amendments that occurred over the protocol’s lifespan.

    A renewal resubmission will only be viewed at the low-risk level as the Committee has approved the project previously.

    Once approval is received for this renewal resubmission, a lifespan of another 4 years will be given, the renewal resubmission application will be made inactive as you will continue working with the previously approved protocol ID.

    If the project is complete and another 4 years won’t be needed, it is recommended to submit a closure of the project.

    Closures

    Closures can be submitted at the end of the approvals 4-year lifespan or when the project is considered completed (all communication with participants, including the provision of feedback, has been completed) This is done via the Annual Project Report. This is an important compliance requirement.

    Please note, the closure report can be provided even if the thesis or publications are still being written up, so long as no participant will be contacted again as part of this research project.

    To submit a closure, fill out an Annual Project Report, and in the status question 2.1 select ‘Closure of permit’. Answer the following questions given.

    Make sure the storage and security of the data is in line with what was previously approved on the application. This is also the case for feedback given to participants.

    Return the completed report to human.ethics@murdoch.edu.au for it to be processed. The Chief Investigator will receive a notification when the closure has been completed.
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