How to submit for Human Ethics review

All new ethics applications to NSLHD HREC must be completed using REGIS . The Research Office is available to assist with queries regarding information required for your application however any technical queries regarding the REGIS website should be directed to the REGIS Help Desk on 1300 073 447.

A hard copy submission to the Research Office is no longer required.

Please contact the Research Office one week before the submission deadline, to advise of your intention to submit a new application to the HREC. This is so the Research Office can assist you in ensuring you have all the information/documentation required which should prevent any unnecessary delays in processing. Additionally this will enable the Research Office to expect your application in REGIS.

Submission Checklists are available to assist in submitting for HREC review.

Applications not completed according to the requirements set out in the submission checklist will not be accepted.

It is strongly advised that the templates found on the Standard Forms page of this site are used for your study documents.

Multi-centre interstate research (National Mutual Acceptance)

Under the National Mutual Acceptance (NMA) agreement (formerly the Interstate Mutual Acceptance Initiative), multi-centre clinical research conducted across public health sites in NSW, VIC, SA, QLD and WA are eligible for single ethical review.

More information regarding NMA can be found here .

Project submissions for review by the full HREC

The Human Research Ethics Committee (HREC) meets monthly. Meeting dates can be found on the Committee Meeting Dates page. The HREC reviews ethics applications for single site and multi-centre studies.

Low risk submissions for review by the HREC executive

The HREC Executive meets fortnightly. Meeting dates can be found on the Committee Meeting Dates page. New projects which are considered to be low or negligible risk are eligible for expedited review by the HREC Executive. The HREC Executive also reviews amendments to approved projects.

National statement low risk definition:

The National Statement defines low risk research as follows; "Research is 'low risk' where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk." (Chapter 2.1)

Examples of low/negligible risk research include (but are not limited to):

• Use of previously stored human tissue (consent for storage of that tissue for research will also need to be considered)
• Anonymous questionnaires/surveys in non-sensitive populations
• Medical record review/retrospective review where all data extracted are coded or de-identified.

Examples of research which are not LNR include (but are not limited to):

• Collection of a blood specimen (although in some instances, an additional specimen may be added at the time of routine collection)
• Research in sensitive/vulnerable populations
• Research that changes a participant's standard management, for example changes to an intervention or addition of non-routine investigations.

IMPORTANT: HREC approval (Ethics) and Site Authorisation (Governance) are required prior to commencement of research at any site. Requirements for site authorisation at interstate and private sites may vary. Researchers are advised to contact each site prior to commencing any research-related activities.

Please read the information on submission to research governance for a NSLHD site

Helpful links and information

  HREC only indemnity form institution details

 Guidance for case reports and quality improvement

 Clinical trial registry  - For any research project that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes, researchers must register the project as a clinical trial on a publicly accessible register complying with international standards before the recruitment of the first participant.

 Australian New Zealand Clinical Trial Registry (ANZCTR)  - It is not compulsory that the Australian New Zealand Clinical Trial Registry be used, however, use of this registry is strongly suggested.

 Sydney Health Partners Data Sharing Accord  - The Accord and its associated checklist are for researchers and clinicians who wish to use de-identified health (patient) data from one or more of the following Sydney Health Partners organisations: Northern Sydney Local Health District, Sydney Children's Hospitals Network, Sydney Local Health District, Western Sydney Local Health District and the University of Sydney. The Accord and its associated Checklist provide common-sense language guidance on the issues researchers need to consider when requesting health data across organisational boundaries.

 Sydney Health Partners Human Research Ethics Committee Meeting Calendar

HREC submission schedule across Sydney Health Partners - Use the responsive calendar to find the next suitable HREC submission deadline across all Committees within Sydney Health Partners (SLHD, WSLHD, NSLHD and SCHN).