Human research ethics application

Submitting an ethics application for approval is the one of the final steps in setting up your trial documentation. Once all your documentation, such as protocol, risk assessment, budget, participant information sheet and consent form are complete, the documentation is to be reviewed and approved by a Human Research Ethics Committee. 

The HREC plays a critical role in overseeing the ethical aspects of research involving human participants, ensuring it complies with ethical standards and guidelines. It ensures the rights, safety and well-being of participants are protected, that informed consent is obtained, confidentiality is maintained and that participants are treated with respect and fairness.

Preparation

• Contact your local HREC Office to see if there are any specific local requirements, as some institutions may require initial review before submission and not all use the HREA.
• Formulate a submission strategy if your ethics application has to be submitted to more than one HREC.
• Gather all information and documentation.
• Register your trial on a clinical trial registry, for example, ANZCTR or Clinicaltrials.gov.
• If you haven't already done so for trials conducted in Australia that involve the use of an unapproved investigational therapeutic medical product or device a Clinical Trial Notification (CTN) or a Clinical Trial Approval (CTA) scheme. Check with your organisation as they may submit this on your behalf.
• Ensure all investigators have completed the required Good Clinical Practice (GCP) Training.

Complete the application

• Access the HREA through your local State or Territories portal. If the lead organisation’s HREC doesn’t use the HREA complete a copy of their application form.
• Complete each section of the application thoroughly and accurately.
• Attach all supporting documents.

Review and submit

• Review the application for completeness and accuracy. Ask a colleague to check the application.
• Submit the application through the online portal.