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Submitting for Human Ethics Review

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The full Human Research Ethics Committee (HREC) meets monthly. The HREC Executive meets approximately fortnightly.

Meeting dates can be found on the Committee Meeting Dates page.

The full HREC reviews ethics applications for single site and multi-centre studies.

All new project applications must be created in REGIS. Quick Reference Guides are available on the REGIS website. The first step for all projects is Project Registration. You will then be prompted to complete the Human Research Ethics Application (HREA) within REGIS and upload all of your study documents. A hard copy submission to the Research Office is no longer required.

Submission Checklists are available to assist in submitting for HREC review. Please note that these are currently being revised. All references to Online Forms should be disregarded. All applications must now be submitted via REGIS.

Prior to submitting new projects to the full HREC, the Research Office must be contacted and advised of the intent to submit a new project, one week before the submission deadline.

The HREC Executive reviews amendments to approved projects and new projects which are considered to be low or negligible risk and eligible for expedited are review.

If you intend to submit a new low risk study, please contact the Research Office for guidance regarding eligibility.

Guidance on Case Reports can be found here.

IMPORTANT: HREC approval and Site Authorisation 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.

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General Submission Information

All new ethics applications to NSLHD Human Research Ethics Committees (HREC) regardless of study risk level should be completed using REGIS.

The Research Office is available to assist with advice for 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.

The Research Office is available to assist with advice for queries regarding information required on the HREA. However any technical queries regarding the online forms website (HREA) should be directed to online forms (02 9037 8404 or email helpdesk@infonetica.net.

Submission checklists for new projects are available to assist and should be used prior to submitting a completed application. Please note that these are currently being revised. All references to Online Forms should be disregarded. All applications must now be submitted via REGIS.

Please note that if further assistance is required please contact the Research Office.

The Research Office requires that researchers discuss their new project with a member of Research Office staff PRIOR TO SUBMISSION to determine whether it is eligible for the low risk pathway or requires review by the full HREC.

Please click on the below headings for further information about:

Project submissions for review by the Full HREC

Full HREC Submission Checklist (Please note that this is currently being revised. All references to Online Forms should be disregarded. All applications must now be submitted via REGIS.
Research and Ethics Information System (REGIS)

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

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

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 as of 31 August 2017, are eligible for single ethical review.

More information regarding NMA can be found on the NSW Health FAQ pag e or by contacting the Research Office.

In December 2015, NM was expanded to encompass all clinical research (whereas previously only clinical trials could be reviewed under NMA).

As of 31 August 2017, your submission must be prepared using the Human Research Ethics Application (HREA) in Online Forms and the standard document templates on this website.

Please note the following:

HREA has replaced the NEAF and LNR in Online Forms.
Researchers in NSW, QLD, SA, VIC and ACT are to continue using Online Forms to complete the HREA. NHMRC's HREA generating website at HREA.gov.au cannot be used to create a HREA for a NSW public health HREC.

FAQ's regarding the HREA can be found on the NSW Health website.

Applications (both the hard and electonic copy) are due by 12pm on submission day.

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

Multi-centre interstate research (National Mutal Acceptance)

Under the National Mutual Acceptance agreement (formerly the Interstate Mutual Acceptance Initiative), multi-centre clinical research conducted across public health sites in NSW, VIC, SA, QLD and WA as of 31 August 2017, are eligible for single ethical review.

More information regarding Mutual Acceptance can be found on the NSW Health FAQ page or by contacting the Research Office.

In December 2015, the scheme was expanded to encompass all clinical research (whereas previously only clinical trials could be reviewed under NMA).

Low Risk submissions for review by the HREC Executive

New projects which are considered to be low or negligible risk are eligible for expedited review by the HREC Executive.

The Research Office advises that researchers discuss their project with a member of Research Office staff PRIOR TO SUBMISSION to determine whether it is eligible for the low risk pathway or requires review by the full HREC.

Your submission must be prepared using the HREA via REGIS website, please contact the Research Office for further information.

All applications will be submitted on a HREA form regardless of risk level. The HREA has been designed as a smart form to accommodate all risk levels: you only need to answer questions which relate to the type of research you are proposing.

HREA question 4.5 will ask under which review pathway you are intending to submit the application (greater than low risk, low risk, negligible risk).

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

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):

Used 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.

SSA for Low Risk Projects

At NSLHD the Site Specific Authorisation (SSA) assessment for low risk projects is submitted concurrently with the HREA submission to the HREC Executive. Please consult the SSA Checklist to ensure that all documents are completed correctly. For more information, please refer to the Governance information on this website.

Guidance regarding appropriate sign-off from Health Information Services for studies using/accessing medical records can be found here.

If your study involves access to medical records, Health Information Services requires you to follow their standard practices and instructions for record retrieval. Note: this can only be done once you have both HREC and SSA approval/authorisation for your study.

Amendments to approved projects

The HREC Executive reviews amendments to approved projects; including Investigator Brochures, protocol changes, adverse event reports, annual and final study reports. The required amendment forms can be found on the standard forms page.

Guidance for case reports and quality assurance

Quality Assurance

Per the National Statement Section 5.1.22 , the NSW Supplement to the National Statement – Section 5.1.6, and NSW Health Guidelines GL2007_020: Quality Improvement and Ethics Review: A Practice Guide for NSW , quality assurance activities may sometimes be exempt from the requirement for full ethical review.

Please note, however, that as journals increasingly require formal ethical review of any research activity, and the HREC is unable to provide retrospective approval, you are strongly advised to submit contact the Research Office for guidance prior to commencing any study/research-related activity.

Case reports

In keeping with a number of other major ethics committees, the NSLHD HREC supports a process by which case report proposals are reviewed at an HREC Executive Committee level, but do not require submission of an low risk pathway HREA and study protocol. Instead, the HREC requests a cover letter, outlining the background and aims of the case report, and a copy of the consent form which will be provided to the patient. A template has been developed based on the proforma template suggested by the British Medical Journal.

Please note that case reports will only be considered exempt from formal review when they involve less that 5 patients.

Click here for a letter and consent form template.

Helpful Links & Information

New projects which are considered to be low or negligible risk (LNR) are eligible for expedited review by the HREC Executive.

The Research Office advises that researchers discuss their project with a member of Research Office staff PRIOR TO SUBMISSION to determine whether it is LNR or requires review by the full HREC.

Your submission must be prepared using the HREA form (online), the submission checklist and the standard document templates on this website.

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

National Statement Low Risk Definition:

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

Used 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.

LNR SSA

At NSLHD the Site Specific Authorisation (SSA) assessment for low risk projects is submitted concurrently with the LNR submission to the HREC Executive. Please consult the LNR SSA Checklist to ensure that all documents are completed correctly. For more information, please refer to the Governance information on this website.