Submitting a Human Research Ethics Application
Did you know that rigorous ethical review processes are crucial for protecting the safety, rights and well-being of research participants?
In Australia, all research with human participants must be reviewed by a Human Research Ethics Committee (HREC).
What is the Human Research Ethics Committee (HREC)?
Human Research Ethics Committees (HRECs) ensure that research involving human participants is conducted ethically and in compliance with regulatory standards.
In Australia, HREC approval ensures that the study design and conduct of human research meet the ethical standards set out in the National Statement on Ethical Conduct in Human Research (2023).
An ethics review application form is submitted to an NHMRC-registered Human Research Ethics Committee. In Australia, the NHMRC developed a nationally accepted ethics application form known as the Human Research Ethics Application (HREA).
Starting a clinical trial without ethics approval breaches the Australian Code for Responsible Conduct in Research (2018) and the National Statement.
What is the Human Research Ethics Committee (HREA)?
The Australian Human Research Ethics Application (HREA) is a standardised form for obtaining human research ethics approval. It is managed by the National Health and Medical Research Council (NHMRC) and aims to simplify and facilitate timely and efficient ethics reviews.
The HREA assists researchers in considering the ethical principles outlined in the National Statement. These are:
- Merit and integrity: Does the proposed research have merit, and do the researchers carrying out the research have integrity?
- Justice: Fair distribution of benefits and burdens.
- Beneficence: Maximising the benefits and minimising harm.
- Respect: Is there regard for participants' welfare, privacy, and cultural sensitivities?
The HREA is submitted through an online portal to facilitate easier submission, review, and application tracking. At present, each Australian State and Territory use different online systems.
Supporting documents to be submitted to the HREA
- Study protocol.
- Investigator brochure.
- CVs of investigators.
- Clinical Trial Notification (CTN).
- Letters of support.
- Other HREC approval, where it has been sought.
What is the HREC review process?
After compiling the documentation required for ethics review and submitting the application to an HREC, an application goes through the following process:
Initial review
HREC administrative staff conduct an initial review to ensure the application is complete and all required documentation has been submitted.
Allocation of reviewers
The HREC Chair assigns committee members to review the application. These members will include members with relevant ethics and legal expertise and knowledge of the application’s subject area. Reviewers with a conflict of interest in the application are removed from reviewing the study.
Committee review
The Committee receives applications before the committee meeting to conduct a preliminary review and prepare a written assessment highlighting any ethical concerns, strengths and areas where clarification or modification is to be sought.
A lead reviewer will introduce the application at the meeting and present their assessment to the committee. Following a robust discussion covering the areas of the National Statement, the Committee will reach a consensus.
Possible outcomes of an application are:
- Approval: The application meets all ethical requirements.
- Conditional approval: The application is generally acceptable but requires clarification or modification. The Chair can approve the application on behalf of the Committee if the Chair is satisfied with the clarification or minor changes.
- Deferral: The Committee requires additional information and substantial revisions. The application will be discussed further at a committee meeting when the applicant has addressed the concerns.
- Rejection: The application has significant ethical concerns.
Post-approval responsibilities:
Post-approval monitoring ensures that a study meets ethical standards, complies with regulatory standards, and protects participant welfare. Key components include:
- Progress reports: HRECs generally require progress reports annually. They include information on recruitment numbers, adherence to the study protocol, deviations, interim results, and any challenges encountered. HRECs review progress reports to ensure the study is proceeding as approved.
- Adverse event reporting: Adverse events (AE) are any unfavourable or unintended sign, symptom or disease associated with the trial drug/device. AEs may be reported in progress reports. Serious adverse events (SAE) must be reported to the HREC immediately. Check with your local HREC for submission deadlines. A HREC will assess the incident, determine if any additional safeguards are necessary, and ensure appropriate action is taken.
- Amendments and modifications: Before implementation, any amendments to the study protocol must be submitted to the HREC for approval.
FAQs about clinical trial ethics
In a single-site study, the Principal Investigator (PI) is responsible for the ethics application. In multi-site research, the Coordinating Principal Investigator (CPI) is responsible for the ethics application and the conduct of the research. Each site involved in the study may have its own PI, who is responsible for the site’s research.
Each State and Territory health service uses a different HREA portal. The following are links to State and Territory portals:
- ACT - Research and Governance Information System
- NSW - Research and Governance Information System
- NT - NHMRC portal
- QLD - Ethics Review Manager
- TAS - Research and Governance Information System
- SA - Research Governance and Ethics Management System
- VIC - Ethics Review Manager
- WA - Research Governance Service
If you need to submit an application to a public health service, check with the organisation for instructions on how to do so.
National Mutual Acceptance (NMA) is a national system for mutually accepting scientific and ethical reviews of multi-centre clinical trials undertaken in publicly funded health services. It aims to enable the acceptance of a single ethical and scientific review of human research projects in participating jurisdictions.
