Ethics approval

A project protocol is an essential element of all applications, and should be developed early in the research process. The protocol guideline is provided to help you write your research protocol for HREC submission.

The NHMRC provides researchers with Participant information and consent form (PICF) templates. It is not compulsory to use these templates however they are useful tools and accepted by both HRECs located within Metro North. Standardised PICF templates can be obtained from the NHMRC website:

• Participant Information and Consent Forms (PICF) templates
• Follow the PICF preparation checklist
• Incorporate the Metro North header logo within your forms.

There are three types of applications submitted to an HREC, based on the level of risk to the human participants of the research:

• Human Research Ethics Application (HREA) for standard risk research: reviewed by the HREC
• Low or negligible risk (LNR) research: reviewed by a HREC sub-committee
• Request for exemption from ethics review: reviewed by the HREC Chairperson (out of session). To complete this application process follow the request for exemption from ethics review guideline in place of the process below.  

All ethics applications, apart from requests for ethics exemption (which follows the Request for exemption guideline), should be made to a Metro North HREC using the Human Research Ethics Application (HREA) or Low or Negligible Risk (LNR) form available via Ethical Review Manager (ERM).

The Online forms – How to make an application is a guideline designed to help you through the process of completing ethics and Site Specific Assessment applications using Ethical Review Manager (ERM). Further help and information is available at Ethical Review Manager (ERM) under the ‘Help’ tab (see the ‘Applications within Qld Health’ under the ‘Guidance’ sub-heading).

The HREA Form is now live. If you created a National Ethics Application (NEAF) before 31 August 2017, you can complete the form, upload supporting documents, electronically authorise and submit the application. Site specific assessment (SSA) forms can still be created.

Complete the Human Research Ethics Committee site requirements HREC Checklist.

The checklist outlines the mandatory submission requirements, including supporting documentation.

This should be completed by the Coordinating Principal Investigator (CPI). The CPI is the person who will submit the research project to the HREC on behalf of other sites and coordinate the ethical submission.

Fee template for commercially Sponsored trials – please submit the completed and signed fee template with your Ethics submission.

Applications must be submitted by 12.00pm on the closing date. View Metro North HREC Meetings and submission closing dates.

Please note there are no exceptions. Incomplete applications will not be accepted.

Submission of hard copy applications can be made by post or in person to the correct HREC office. Once the online ethics application is finalised, create a submission code using the “Submission” tab. Refer to the Metro North HREC Checklist for full electronic submission requirements.

Low or negligible risk guideline describes the ethics review process for low or negligible risk research within Metro North.

After obtaining ethics approval from the Human Research Ethics Committee (HREC) applicable to your research, you must obtain site authorisation by submitting a site specific assessment (SSA) for research governance approval at all facilities you intend to conduct research.

Investigators are required to obtain ethical approval and site authorisation before implementing any amendment to a previously authorised study. Any changes to the project, e.g. addition of a site, changes to the protocol, PICF or study personnel, should be outlined in a cover letter from the Principal Investigator to the Chairperson of the relevant HREC and accompanied by all updated documents in two forms: one with tracked changes and one clean copy. The cover letter should state the changes and the reason for the changes.

For projects approved by a Metro North HREC, the relevant documents should be submitted to the HREC office both electronically (via email) and in hard copy and uploaded through the Online Forms website by the Principal Investigator. The Chair will review the amendments and make a decision outside of the HREC meeting or refer the amendment to the next scheduled HREC meeting for review.

If the amendment involves the addition of a site, then a new Site Specific Assessment will need to be submitted to the Research Governance Officer at that site. The relevant site Research Governance Officer should be notified of all HREC approved amendments to existing site approved projects.

HREC decisions, or requests for additional information prior to an HREC decision, will be made in writing to the Principal Investigator with reference to the National Statement on Ethical Conduct in Human Research. If you disagree with the HREC ruling or have concerns about the ethical review process, it is recommended that you discuss your concerns with the HREC Chairperson or Coordinator in the first instance to ensure both parties are aware of the basis for the decision and the concerns raised. Alternatively, and in all cases where the issue cannot be resolved via discussion, you should put your concerns, including the basis for these concerns, in writing to the Chairperson of the HREC to enable a formal review and response to occur. The Executive Director of Research should be notified of matters not adequately addressed by this process.