FAQ: Applying to a NSW Health HREC
Which HREC should I submit my application to? | Can a multi-centre research application be submitted to more than one lead HREC? | Will an HREC automatically accept my application? | Which application form should I complete? | What is the difference between the NSW Health NEAF and the NHMRC NEAF? | Who should submit the application for HREC review? | Can an application be withdrawn from one HREC and submitted to another? | What are the processes for submitting a CTN/CTX form for HREC signature?Which HREC should I submit my application to?
For single centre research projects, an application should be submitted to the local HREC.
For multi-centre research projects, an application may be submitted to any NSW Health lead HREC, provided that the HREC is accredited in the research area of the project. This applies to both full HREC review and expedited HREC review. For example, clinical trials must be submitted to a lead HREC accredited in clinical trials/interventional clinical research. In addition, if the lead HREC operates within a specialised therapeutic area, only research in that therapeutic area may be lodged with that HREC. Where possible, the application should be submitted to a lead HREC associated with one or more of the sites at which the research is to be conducted.
For clinical trials submitted for review under the Interstate Mutual Acceptance initiative, an application may be submitted to any NSW Health certified HREC that is certified to review clinical trials.
Details of NSW Health HRECs are maintained on the NSW Ministry of Health's website at:
Can a multi-centre research application be submitted to more than one lead HREC?
No.
Will an HREC automatically accept my application?
HRECs can cap the number of research protocols they review at each meeting. If your application arrives after the cap for the next meeting has been met, the HREC will inform you that your application can be held over to the following meeting, or that you can apply to another HREC.
Lead HRECs will not accept a multi-centre application if they are not accredited to review multi-centre research proposals in a particular area of research. For example, a lead HREC accredited to review general research only, will not review multi-centre research applications for clinical trials. In addition, any HREC within NSW Health can advise an investigator that it does not have the appropriate expertise to review a particular project and suggest another, more appropriate HREC. Investigators are therefore encouraged to contact the Executive Officer of the HREC before submitting an application.
When an application is made for expedited HREC review, the HREC Executive Officer has the discretion to request that the research project is submitted for full HREC review if they consider the risk to participants to be greater than low risk. The HREC has the discretion to request that an application for full HREC review is made, following assessment of the application for expedited review, if it considers the risk to participants to be greater than low risk.
Which application form should I complete?
(i) National Ethics Application Form (NEAF); or
(ii) Application Form for Ethical and Scientific Review of Low and Negligible Risk Research (LNR Application Form).
The NEAF should be used for all applications for full HREC review relating to research in which the risk to participants is more serious than discomfort, as described in the National Statement on Ethical Conduct in Human Research (2007).
The LNR Application Form should be used for all applications for expedited HREC review relating to research in which the risk to participants is no more than discomfort or inconvenience, as described in the National Statement on Ethical Conduct in Human Research (2007).
The forms must be completed online via the Online Forms Website at https://ethicsform.org/au/. The Online Forms Website provides guidance on how to complete the application forms and supporting documents required for making an application.
What is the difference between the NSW Health NEAF and the NHMRC NEAF?
Essentially the two forms are the same. NSW Health uses a licensed copy of the NHMRC NEAF. The questions on the NSW Health NEAF are identical to those on the NHMRC NEAF. The only difference between the two forms is that the NSW Health NEAF allows data to be imported into the Australian Research Ethics Database, which is an online research application tracking and management system used by research offices in the NSW public health system.
If you are making an application to a NSW Health HREC using NEAF, you must complete the NSW Health NEAF even if you have already completed the NHMRC NEAF. However, data can easily be imported from the NHMRC NEAF into the NSW Health version.
Who should submit the application for HREC review?
Applications for review by a NSW Health HREC must be made by the Co-ordinating Investigator. For single centre research, the Co-ordinating Investigator and Principal Investigator are synonymous.
Can an application be withdrawn from one HREC and submitted to another?
An application can be withdrawn at any time prior to receipt of the HREC review outcome. Where an application is subsequently submitted to a different HREC, all documentation associated with the initial HREC application and the reasons for withdrawal must accompany the submission. The new HREC can request that the application is re-submitted to the original HREC for any reason.
What are the processes for submitting a CTN/CTX form for HREC signature?
For single centre research projects, the CTN/CTX form should be signed by the Co-ordinating Investigator and provided to the HREC at the time of application for HREC review. If the project is approved, the HREC will sign the form and return it to the Co-ordinating Investigator.
For multi-centre research projects, the CTN/CTX form should be signed by each Principal Investigator and provided to the HREC at the time of application for HREC review. The Co-ordinating Investigator could submit a CTN/CTX form for each site, or one CTN/CTX form with a separate page for each trial site (section 1.5), Principal Investigator (section 2), and Approving Authority (section 4). If the application is approved, the lead HREC will sign and return the form(s) to the Co-ordinating Investigator for dissemination to the Principal Investigators.
Where a single CTN/CTX form has been submitted to the HREC for a multi-centre research project, the trial cannot commence at any site until signatures have been obtained from all approving authorities.