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Managing your approved research ethics application

Conducting research ethically means making ethical considerations throughout the project, not just during the ethics approval process.

It may be necessary to seek further approval from the Ethics Committee in some circumstances.

This section includes information on:

  • conditions of approval;
  • requesting an extension of ethics approval;
  • informing the Ethics Committee about changes to the project and requesting approval for them; and
  • managing adverse or unforeseen events.

All applications are approved with standard conditions of approval. Some projects may also have further specific conditions of approval. For more information download the HREC Conditions of approval.

For managing an approved animal ethics application, please see the Managing your approved animal research ethics application web page.

Monitoring

All research projects are approved subject to compliance with monitoring procedures. Monitoring is the process of verifying that the conduct of research conforms to the approved ethics application.

The guidelines for human research indicate that all approved research must be monitored. Institutions are responsible for ensuring that research is reliably monitored and establishing that a research project is being, or has been, conducted in the manner approved by the Human Research Ethics Committee.

Monitoring involves completion of an annual progress report (if your project is longer than one year) and completion of a final report at the end of your project. You will be notified when a report is due and will need to complete the Ethics Report Form. The same form can be used for an annual progress report and the final report.

The Human Research Ethics Committees also reserve the right to adopt any additional appropriate mechanism for monitoring approved research projects.

Extension of ethics approval

All research projects are approved for a specified period of time – from the date of approval until the date of completion provided in the ethics application.

Ethics approval covers both the collection and use/analysis of data, information and/or samples. Researchers should ensure that the period of time requested for ethics approval is sufficient.

If an extension of the approval period is required, a request must be submitted to the Human Research Ethics Committee – before the original approval expires. To request an extension of ethics approval, please complete the Ethics Report Form (Section 1).

Changes to your project

The Ethics Committee understands that research designs do change, particularly for long-term projects. Amendments to the research design that may affect participants and/or that may have ethical implications, must be reviewed and approved by the Human Research Ethics Committee before commencement.

Any changes to documents and other material used in recruiting potential research participants, including advertisements, letters of invitation, questionnaires, information sheets and consent forms, should also be approved by the HREC.

To request approval for a change, please complete the Ethics Report Form (Section 4).

Adverse or unforeseen events

Researchers are required to immediately report to the Human Research Ethics Committee anything that might warrant review of ethical approval of the research project, including:

  • serious or unexpected adverse events; and
  • unforeseen events that might affect continued ethical acceptability of the project.

To report an adverse or unforeseen event, please contact the Research Ethics Team and provide as much detail as possible. including a description of the event and any actions already taken.

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