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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.

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 a report in one of two ways.

  1. If your project was approved in REMS, please visit your REMS Portal and click on the report icon for the appropriate project and enter the online reporting system; or
  2. If your project was approved in our old ethics system, STREAM, please download and complete the Ethics Report Form.

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 review the following:

  1. If your project was approved in REMS, please visit your REMS Portal and click on the report icon for the appropriate project and enter the online reporting system and choose the 'Extensions' tab; or
  2. If your project was approved in our old ethics system, STREAM, please download and 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 review the following:

  1. If your project was approved in REMS, please visit your REMS Portal and click on the report icon for the appropriate project and enter the online reporting system and choose the 'Amendments' tab; or
  2. If your project was approved in our old ethics system, STREAM, please download and complete the Ethics Report Form (Section 4).

Adverse or unforeseen events

Researchers are required by the conditions of your ethics approval 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.

Delays in reporting an adverse incident may result further impacts, such as:

  • Breach of National Statement obligations;
  • Breach of ECU’s Duty of Care to research participants and stakeholders; and
  • Breach ECU’s Duty of Disclosure obligations to its Insurers, requiring notification of any incidents that may give rise to a claim as soon as reasonably practicable.

Where there are long delays in reporting of adverse incidents, ECU (or the research participant) may have reduced or limited capacity to make a claim against an insurance policy, or cover may not be available.  If cover is not available due to a delay in reporting, it may result in the research budget being called upon to cover any costs associated with the adverse event.

To report an adverse or unforeseen event, please:

  1. Contact the Research Ethics Team and provide as much detail as possible including a description of the event and any actions already taken.  If your project has been approved in REMS this can be actioned by entering your REMS Portal and reporting an Adverse Event; and
  2. Log the event in the Incident/Hazard Module of RiskWare (Easy Login link via the Student / Staff Portal or via the OSH website).

Research Complaints

If you wish to lodge a complaint or concern about research conduct at ECU please do so through the ECU Research Concerns and Complaints Report form. More information is available at the Managing and Reporting Breaches to the Code webpage or from research.integrity@ecu.edu.au

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