Human Research Ethics Committees

In Australia, HRECs review research proposals that involve human participants to ensure that they meet ethical standards and guidelines.

These guidelines include the National Statement on Ethical Conduct in Human Research (National Statement). The National Statement requires almost all human research to undergo ethics review. It also sets out the requirements for the establishment of HREC membership and its operation.

NHMRC and the Australian Research Council require organisations that receive our funding to conduct human research in accordance with the National Statement. We also administer a registration scheme for HRECs.

Registration

NHMRC administers a registration scheme for HRECs. Institutions that have responsibility for oversight of research and maintain HRECs must register their HRECs with NHMRC (see National Statement 5.8.3).

Approximately 200 HRECs in organisations across Australia are registered with us. Registration involves notifying NHMRC of an HREC’s membership, Terms of Reference and Standard Operating Procedures and facilitates conformance to funding, regulatory or jurisdictional requirements, as discussed below. It also provides confidence to the research community that review of research conforms to the requirements of the National Statement.

Legislative requirements for the registration of HRECs include:

• Clinical trials – The Therapeutic Goods Act 1989 requires an HREC to review and monitor all clinical trials of unregistered therapeutic goods. This means that HRECs that review this research must be notified to us and constituted and operating in accordance with the National Statement.
• Human embryo research – The Research Involving Human Embryos Act 2002, requires HRECs that approve research involving excess human embryos act in conformance with the National Statement. If a HREC is not in conformance, it may have implications for the validity of licences issued.
• Privacy legislation – HRECs that apply the Guidelines under Section 95 (s95 guidelines) and the Guidelines approved under Section 95A (s95A guidelines) of the Privacy Act 1988 are required to report annually to us on the application of these guidelines.
• State/territory requirements – There may be legislation and/or policies within states and territories that require HRECs to be registered.

We maintain a list of all HRECs that are registered with us.

• List of all registered HRECs (see Download section, below)

Apply for registration

Organisations can register their HREC(s) by completing the registration form and uploading documentation that demonstrates that their HREC(s) meets the requirements of the National Statement:

• HREC registration form

Additional documentation required (available from downloads section below):

• Membership profile form
• ToR/SOP requirements form

Organisations should refer to the HREC Registration Guide for guidance on HREC documentation and the registration process.

Change of HREC details

Once an HREC is registered, it must notify us of certain changes to its membership or to the HREC's or its organisation's contact details by completing the following form:

• Change of HREC details form

Closing an HREC

Before an HREC closes or terminates its registration with us, it must complete a Closure Form and demonstrate that its responsibility for monitoring any ongoing research projects has been transferred to another HREC.

• HREC closure form

Health privacy

HRECs also consider the protection of privacy for humans participating in research and their data.

HRECs do this by considering whether the research proposal conforms to relevant legislation, principles and guidelines. This includes Commonwealth and/or state/territory legislation as well as the s95 and s95A guidelines.

We have developed the below flow charts and templates to help researchers and HRECs apply the s95 and s95A guidelines.

• Template – Application of the Guidelines under Section 95 of the Privacy Act 1988 (2014) (available in Downloads section below)
• Flowchart – Determining whether the s95 guidelines apply
• Flowchart – Determining whether the s95A guidelines apply.

Annual reporting

Although organisations are responsible for the activities of their own HREC(s), we require HRECs to self-report to us on their activities over the previous calendar year.

We also collect information on behalf of the Australian Information Commissioner about the application of our two guidelines approved under s95 and 95A of the Privacy Act 1988.

In addition, organisations and their HRECs that are certified under the National Certification Scheme of Institutional Processes related to the Ethical Review of Multi-centre Research, self-report to us on their multi-centre research activities.

We assess all annual reports to see if HRECs have met the requirements of the National Statement and we notify all organisations and HRECs of the outcome.

The data from these annual reports is summarised in an activity report and provided to the Australian Health Ethics Committee. The activity reports from the last two reporting periods are available from the following:

• 2023 activity report (available in Downloads section below)
• 2024 activity report (available in Downloads section below)

For the reports from previous reporting periods, contact HREC.admin@nhmrc.gov.au

Applying for ethics review

Researchers should contact their institution's HREC for advice about how to submit an application for ethics review.

Researchers who are not affiliated with an Australian organisation that has an HREC can contact any HREC from our registration list (provided above) and discuss matters with them directly. Organisations that establish HRECs are required to set out and publicise their terms of reference, including their relationship to non-affiliated or independent researchers.

An Australian organisation and/or HREC is not required to accept an ethics approval from another country and may require its own review. It is up to the researcher(s) to demonstrate that the ethics framework and standards in the reviewing country satisfy the ethical principles outlined in the National Statement.

Additional resources

Template letters to researchers

HRECs can download the below templates and use them as a reference for their letters to researchers.

Further information

Email

HREC.admin@nhmrc.gov.au