LNR Submission process

Low & Negligible/Minimal Risk (LNR) research projects are eligible for expedited review, as per the National Statement. We have no submission closing dates for LNR projects. This means you can submit LNR applications for review at any time. All LNR applications must be submitted using a Human Research Ethics Application Form (HREA) via ERM. 

To determine if your project is classified as Low or Negligible/Minimal Risk (LNR) Research, please complete the Checklist with the REG Application Coversheet. This will enable you to instantly classify your research in accordance with local, state and national requirements. 

From 17^th February 2024, as per the updated 2023 National Statement minimal risk research projects will no longer be subject to ethics review. These projects will need to be submitted through MCC DERP and still subject to campus governance requirements. If you are unsure the risk profile of your project, MCC DERP will walk you through what is required for your submission.

You will also need to fill out a pre submission form.  

The application process for LNR applications is the same as for all greater-than-low risk research. Thus please see the relevant page below for the submission requirements:

• Single-site LNR applications
• Multi-site LNR Applications

FAQs

How can I confirm if my study is classified as LNR?

Please complete the checklist on the RCH REG Application Coversheet . If you have any questions, please call REG on 03 9345 5044.

Does the full HREC review LNR studies?

LNR applications are eligible for expedited review by the HREC Chair or other delegate. As such, LNR projects are not generally reviewed at meetings of the HREC unless this is recommended following review. Instead, a list of all approved LNR projects is submitted to the full HREC each month for ratification.

What are the review and approval timelines for LNR Review?

Following the submission of a complete application to REG for expedited review, the time to approval is two to four (2-4) weeks dependent upon whether additional information or changes are requested OR if an independent scientific review is required. To reduce this time, please respond promptly to any queries received.

What form do I complete on ERM?

You need to complete the HREA for an LNR application. 

Please do not complete the LNR Vic form. Our office does not accept these, and for this reason the RCH HREC is not listed on the form. 

What documents do I submit through ERM?

ERM must be used to complete and submit the Human Research Ethics Application Form (HREA) and for multi-site applications, a Site Specific Assessment Form (SSA). All study documents need to be uploaded through the ERM portal. The review of the application will not be start if the application is not complete.  

From 17^th February 2024, only your study protocol and all patient facing materials need to be uploaded to ERM. These can be uploaded within the HREA or SSA, for ethics or governance submissions respectively. The rest of your required documents should be uploaded/completed via MCC DERP