Ethics approval

Human Research Ethics Committee (HREC) approval is the first step in the research process, required for all human research conducted within Metro North. This is the first step in the research process required for all human research conducted within Metro North. There are two HRECs within Metro North for researchers to submit their ethics applications:

• Metro North Health HREC A
• Metro North Health HREC B

Metro North is also a participant of the national approach to single ethical review of multi-centre research. Single ethical and scientific review of multi-centre clinical trials can occur via an appropriate NHMRC certified HREC in other jurisdictions and, for other study types, at another certified HREC in Queensland Health.

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) available via Ethical Review Manager (ERM).

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.

Ethics application process

The steps outlined below are a guideline for the ethics application process.

1. Protocol

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.

2. Participant information and consent forms

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.

3. Ethics application

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 out-of-session;
  • LNR Checklist – checklist for determining the review pathway
  • LNR review process – this document outlines the process for the review of LNR projects

  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.

  4. HREC checklist

  Complete the Human Research Ethics Committee site requirements HREC Checklist – Please refer to the checklist for the Metro North Human Research Ethics Committee site requirements.

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

  Please see fee requirements and fee templates for commercial, collaborative research groups, externally led investigator-initiated studies/exemption requests. Failure to provide a signed fee template may delay the review of your application.

  5. Submission

  Applications must be submitted by 12.00pm on the closing date via the Ethical Review Manager system (ERM). View Metro North HREC Meetings and submission closing dates.

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

  Low or negligible risk projects are reviewed out-of-session. Please refer to the

  • LNR Checklist – checklist for determining the review pathway
  • LNR review process – this document outlines the process for the review of LNR projects

  6. Site-authorisation

  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.

  Frequently asked questions

  Is my project low/negligible risk?

  The National Statement on Ethical Conduct in Human Research (2007) (NS) describes ‘low risk research’ as research in which the maximum foreseeable risk is discomfort, and ‘negligible risk research’ as research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Research in which the risk for participants is more serious than discomfort is classed as ‘greater than low risk’.

  At Metro North Health (MNH) Low/Negligible Risk (LNR) projects are reviewed out-of-session and can be submitted at any time for review; this is called the ‘Low/Negligible Risk Review Pathway’.

  It is important to understand that Risk Level and Review Pathway are not the same thing.

  Some projects must be reviewed by the full HREC even though the risk level appears to be low. Examples include, but are not limited to:

  • Research involving prospective collection of bio-specimens; including tissue normally removed and discarded as part of usual care
  • Research involving vulnerable participants
  • Research involving risk to the researcher
  • Research involving genetic analysis
  • Establishment of data registries and biobanks
  • Low risk research involving sites outside of Queensland

  Please refer to our LNR Checklist for further advice.

  I want to make a change to my project post ethics approval. What do I do?

  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.

  What if I disagree with the HREC ruling?

  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.

  Single and multi-centre amendments

  Remember that HREC approval is required for any amendments to the protocol, PICF s, advertisements, radio scripts, questionnaires, patient cards, etc.

  • Amendment checklist
  • Post Approval Reporting

  Data archiving, retention and disposal

  This guideline provides details on archiving, retention and disposal of research data.