Apply for ethics approval for a clinical trial

Learn about multicentre research, the web-based ethics approval application process, and different state and territory ethics review processes.

For multicentre research

Clinical trial research in Australia must undergo ethics review. If you are conducting a clinical trial at:

  • a single site, you will only require ethics review by one human research ethics committee (HREC)
  • multiple sites, you may require review by more than one HREC.

When you apply for ethics approval, you need to show that:

  • your research has scientific merit
  • the benefits outweigh the risks
  • the people who work on your research have the proper qualifications
  • you treat all participants with respect
  • you have considered the ethical issues.

Read more about multicentre research.

Some research, including clinical trials, can be considered low risk research. Low risk research may not require review by an HREC. Instead, you can use other ethics review processes. The National Health and Medical Research Council provides information on this in the National Statement on Ethical Conduct in Human Research.

Human Research Ethics Application (HREA)

The Human Research Ethics Application (HREA) is a web-based application that:

  • enables researchers to submit research ethics proposals to HRECs
  • helps HRECs to consistently and efficiently assess these proposals.

It uses dynamic content and guidance to help researchers address the principles of the National Statement on Ethical Conduct in Human Research.

The HREA provides:

  • relevant guidelines
  • FAQs
  • an online help guide.

You can find current resources on the NHMRC website.

State and territory ethics review processes

Clinical trials in publicly funded health services across jurisdictions use a national system for mutual acceptance of scientific and ethics review. All state and territory-certified public health organisations in Australia are part of the National Mutual Acceptance Scheme (NMA). This is facilitated by the Australian Government’s Encouraging More Clinical Trials in Australia measure.

In addition to getting ethics approval, each institution at which a clinical trial will take place must also authorise the trial.

Information and resources for the NMA are available from the Victorian Government’s clinical trials and research website.

The Australian Commission on Safety and Quality in Health Care is developing for HRECs operating under the NMA scheme.

States and territories also provide information about their ethics review processes:

Date last updated:
  • Running clinical trials