Human Research Ethics Committee (HREC) Review

Prior to commencing, each clinical trial in Australia must be reviewed by a HREC.  Each state has its own system for ethical and scientific review. Both public and private HRECs operate in Australia so it is important to check with the site for submission dates and documentation requirements.

• A list of all HRECs registered with the NHMRC.
• A list of all NSW Health HRECs
• ClinicalTrialsNSW has compiled a calendar of NSW Health HREC meetings to assist researchers in identifying relevant review dates. Many of the NSW Health HRECs have Memorandums Of Understanding in place with research institutes outside the public health system. Refer directly to your HREC for further information.

National Ethics Application Form (NEAF)

NEAF is a web-based tool that enables researchers of all disciplines to complete research ethics proposals for submission to Human Research Ethics Committees (HRECs).   Not all HRECs accept the NEAF form so you will need to first check with the HREC to confirm that they will accept a NEAF application form.

For multi-centre studies across multiple states including NSW complete the NEAF application  on the NHMRC website first. From here you can then export this application form to the NSW Health site which uses the AU RED system. Researchers can find more information and answers to their queries about this system at the NSW Health Research and Ethics Branch website.

Researchers needing to submit ethics applications to a HREC in the NSW Health system only, should access the NSW Health on-line forms website.

Single Ethical Review in NSW

Single ethical review for multi-centre studies conducted within NSW public health system.

The system ensures that every research project conducted within the NSW public health system will be reviewed once only by a HREC. Accredited Lead HRECs are able to conduct a single ethical and scientific review on behalf of all sites within the NSW public health system, thereby eliminating the need for each local HREC to conduct its own review.

Public health organisations (hospitals and area health services) will retain responsibility for authorising the commencement of research to be undertaken within their institutions and will be required to undertake a site-specific assessment (SSA) of each research project to assess capacity to conduct the research at that site. The SSA considers matters such as resources, staff, patient availability, budgets, indemnity etc.

The SSA and lead HREC ethical review may occur in parallel, however the decision to authorise the commencement of a research project will only be made by the public health organisation when the lead HREC has granted approval and the SSA has been satisfactorily completed.

For information on HREC review of research conducted in non-public health organisations such as private hospitals or research institutes please contact the research office of the participating institution.