The National Statement on Ethical Conduct in Human Research 2023 (the National Statement) permits institutions to establish levels of ethical review other than by a Human Research Ethics Committee (HREC) for projects deemed to be no more than low risk (refer Chapter 5).

Northern Health RDGU has therefore initiated a streamlined, fully in-house, combined ethics and governance review process for low-risk Northern Health single site research projects. This pathway is referred to as the non-HREC approval pathway.

To be eligible for review via the non-HREC pathway, projects should have the following characteristics:

  • Not Quality Assurance (a different pathway is available for these projects)
  • Single centre study (conducted at Northern Health only)
  • Data remains at Northern Health – no data sharing across sites
  • Led by an experienced researcher at Northern Health
  • Low or negligible risk to both participants and organization

How to apply for ethics and governance approval via the Northern Health non-HREC approval pathway

Initial Submission:

Step 1:Contact RDGU (ResearchDGU@nh.org.au) to discuss the suitability of your project for the non-HREC pathway. This is especially important if you are new to research, and/or you have not submitted projects for approval via the non-HREC pathway before.

Step 2:Unless you are an experienced researcher, we strongly recommend booking an appointment with the RDGU team to help develop your protocol. This includes booking an appointment with RDGU’s clinical biostatistician, Dr. Mani Suleiman (Biostatistics Service Request Form), to develop your analytical plan. Protocols without a clear analytical plan will not be approved.

Step 3:Prepare the following documents:

  1. Complete and signed non-HREC review request form. Both the Principal Investigator and the Head of Department must sign before we can process your review request.
  2. Separate Project Protocol using the Low Risk Protocol Template. In your protocol, please ensure you have included (where relevant):
    • a literature review demonstrating what is known about your research topic. The literature review should demonstrate a gap in knowledge that you want to address in your project;
    • a clear statement of the research question to be answered, leading from the identified knowledge gaps;
    • the information you need to collect to answer your question, how you will access/collect it, and whether you need permission/consent to do so;
    • how you will ensure the safety and privacy of participants/participant information;
    • How you will analyse the data in order to answer your research question;
    • How the new knowledge you generate has the potential to translate to improved healthcare.
  3. Any relevant participant information sheets and consent forms, or other participant-facing information.
  4. Any instruments and tools required to carry out your project, e.g. surveys, data collection tools (example here), participant ID linking tools (example here).
  5. Any other attachments that support your project protocol.

Please ensure all documents are clearly named by type, and include a version number and date as part of the document name.

Step 4:Submit all documents in a single email to ResearchDGU@nh.org.au. Please submit only one project per email for review.


Important: Submission Deadline

  • The deadline for submitting new applications is 4:30 PM every Monday.
  • If your application is complete, it will be reviewed by the non-HREC panel the following Monday.
  • However, if your application needs additional work, this will delay its review.

Amendment Requests:

Should you wish to amend any aspect of your project, including the protocol, content of participant facing materials, survey questions, investigator list etc, please follow these steps:

Step 1:Prepare the following documents:

  1. Complete and signed Non-HREC Amendment Request form. The Principal Investigator must sign before we can process your amendment request.
  2. ‘Tracked changes’ and ‘clean’ versions of any amended documents, labelled with an updated version number and date so that they can be distinguished from the original approved documents. If there are changes to the information contained in the originally-submitted non-HREC review request form (e.g. changes to the investigator list), please update the form and provide with an updated version number.

Step 2:Submit all documents in a single email to ResearchDGU@nh.org.au, stating the project ID (refer to original approval letter), project title, and name of the principal investigator. Please submit only one project per email for amendment review.

Review and Approval Process:

Once all documentation has been checked for completeness, your project/amendment will be sent for review. The review panel consists of 2-3 experienced research staff within the RDGU, along with at least one other Northern Health experienced clinician researcher. The review panel will assess your application with regard to the four values and principles of the National Statement:

  • Research Merit and Integrity
  • Justice
  • Beneficence
  • Respect

RDGU will endeavor to provide a review outcome within 10 business days of receiving your complete application. Should further information or clarification be required from the investigators in order to fully assess your project, this will be requested following review.

An approval letter will be issued when the project/amended project is cleared to commence. Please note that no activity related to the project can commence until the approval letter has been issued.