Ethical and scientific review

All human research that takes place in NSW Health Organisation and specialty health networks (SHNs) must be ethically and scientifically reviewed and approved by a Human Research Ethics Committee (HREC) in accordance with the:

This includes but is not limited to clinical research, clinical trials, epidemiological research, health services research, population health research, and qualitative research.

For more detailed information please see the NSW Health Research Handbook and Standard Operating Procedures (SOPs). These resources are critical tools to guide safe, ethical and high-quality human research across NSW Health Organisations.

National Mutual Acceptance (NMA) applies to any form of human research, as defined in the latest version of the NHMRC National Statement on Ethical Conduct in Human Research, that requires submission to an HREC for the purpose of being conducted at a NSW Health Organisation.

Under the NMA scheme, single ethical and scientific review is accepted for multi-centre research projects undertaken in public health organisations. All Australian state and territory jurisdictions participate in the NMA scheme. Jurisdiction-specific exemptions apply.

Investigators, trial coordinators, sponsors, and Contract Research Organisations should refer to the contact list available on the Contacts page to confirm each jurisdiction’s NMA participation.

For further information please see the NMA Brochure and Fact Sheet.

The NMA scheme provides for ethical and scientific approval only. All human research that takes place in a NSW Health Organisation must also be authorised by the Chief Executive or their delegate before the research can commence. Further information on site authorisation is provided below.

The HREA is the NHMRC’s online ethics application form developed for all research involving humans.

All new ethics applications to a NSW HREC, regardless of study risk level, must be completed on a HREA using the REGIS. In NSW, REGIS is used to submit and manage both single-site and multi-centre human research projects, including those under the NMA scheme. REGIS also supports the coordination of HREC meetings, ethics approvals, site authorisations, and post-approval activities such as amendments, safety reporting and progress reports.

For studies in Victoria, the Victorian Specific Module (VSM) must be completed in addition to the HREA. See the VSM Guidelines here.

For studies in Western Australia, the Western Australian Specific Module will be created and completed within an RGS Project along with the HREA.

For more information and training resources, visit the REGIS website. 

Use the Project registration roadmap as a guide to applying for ethics approval and/or site-specific authorisation in REGIS.

For single centre research projects in NSW, an application should be submitted to the local HREC.

For multi-centre research projects where all sites are within NSW, an application may be submitted to any NSW Health lead HREC, provided that the Committee is accredited in the research area of the project. This applies to both full and expedited HREC reviews. For example, clinical trials must be submitted to a lead Committee accredited in clinical trials/interventional clinical research. In addition, if the lead Committee operates within a specialised therapeutic area, only research in that therapeutic area may be lodged with that Committee. 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.

A directory of HRECs can be accessed on the ethics and governance contacts page.

The reviewing HREC will have oversight of the human research project and ensure that it complies with all ethical, scientific and safety requirements, as appropriate.

Investigators will be required to provide regular progress reports, other required reports and safety reports to the reviewing HREC (according to the NHMRC).

NSW Health encourages the widespread implementation of quality assurance (QA) programs as an essential part of a learning health care organisation. QA should be conducted as part of conventional clinical service delivery or ‘business-as -usual’. In almost all routine situations, QA projects should not require prior ethical review.

NSW Health adopts the distinctions between projects requiring ethical review and those that do not as set out in the NSW Health GL2007_020: Human Research Ethics Committees - Quality Improvement & Ethical Review: A Practice Guide for NSW.

QA practitioners should assess their project against the NSW Health Guideline to determine whether any ethical risks identified in the Guideline are present.

If ethical risks are identified, the project should be referred to an ethics review body. Practitioners may seek advice from their local Clinical Governance Unit.

If no ethical risks are present, practitioners may proceed with their QA project once all institutional requirements have been met.

NSW Health policy states that ethics review and approval are not required solely for the purpose of publication (see Q16 in GL2007_020). However, as some journals now require a statement from an ethics review body before accepting QA manuscripts, NSW Health has developed a draft letter that an ethics review body (including a HREC) may issue retrospectively. This letter confirms that the project, based on its characteristics, did not involve any ethical risks described in the Guideline and therefore did not require review.

The letter itself is not a statement of ethical approval of the project.

Frequently asked questions

What requires ethics review?

Yes. Student research involving humans that takes place in NSW Health Organisations is subject to the same ethical and scientific review processes as other research.

Yes. Pilot studies involving humans that take place in NSW Health Organisations are subject to the same ethical and scientific review processes as other research.

This depends on whether or not the quality improvement project poses any ethical risks to participants. The NSW Health Guideline GL2007_020 Human Research Ethics Committees – Quality Improvement & Ethical Review: A Practice Guide for NSW provides advice on determining when quality improvement activities require ethical review.

Individuals engaged in quality improvement projects should consult each NSW Health Organisation involved in the project in order to identify the process adopted by that NSW Health Organisation for the ethical review of such projects.

About Human Research Ethics Committees (HRECs)

HRECs established by NSW Health Organisations provide full and expedited ethical and scientific review. Full Committee review is required for human research that involves greater than lower risk to participants, while Expedited Committee review can be conducted for human research involving no more than lower risk to participants, as defined in the National Statement on Ethical Conduct in Human Research. For Expedited review, you should consult the NSW Health HREC associated with the site(s) at which you propose to conduct the research to determine if your project can be classified as no more than lower risk research before making an application.

Only human research that involves no more than lower risk to participants, as defined in the National Statement on Ethical Conduct in Human Research, is eligible for expedited Committee review. You should consult the NSW Health HREC associated with the site(s) at which you propose to conduct the research to determine if your project can be classified as no more than lower risk research before making an application.

HRECs can limit the number of research protocols reviewed per meeting. If the limit is reached, your application may be deferred to the next meeting or you can apply to another Committee. Investigators are encouraged to contact the Executive Officer of the HREC before submitting an application.

Some HRECs are not certified to review certain types of applications in a particular area of research. For example, a HREC certified to review general research only will not review clinical trials applications. In addition, any NSW Health HREC can advise an investigator that it does not have the appropriate expertise to review a particular project and suggest another, more appropriate Committee.

When an investigator intends to submit an application as a lower risk project for expedited HREC review, the Committee Executive Officer has the discretion to request that the research project be reviewed under full Committee review.

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 Committee, all documentation associated with the initial application and the reasons for withdrawal must accompany the submission. The new HREC can request that the application is re-submitted to the original Committee for any reason.

All multi-centre research conducted within NSW Health Organisations undergoes a single ethical and scientific review. This ensures each project is reviewed once only, regardless of how many sites are involved. NSW HRECs certified through the NHMRC can carry out these reviews on behalf of all participating sites within the NSW public health system. No opt-in or opt-out is required; projects are automatically included in the single review process.

This system only applies to NSW Health Organisations. For studies across multiple states, the National Mutual Acceptance scheme applies.

About Human Research Ethics Applications (HREAs)

The HREA is the NHMRC’s online ethics application form developed for all research involving humans. The HREA is designed to guide applicants through the ethical principles of the National Statement on Ethical Conduct in Human Research.

All ethics applications to NSW, ACT and Tasmania Health Organisation HRECs must be completed in the Research Ethics and Governance Information System (REGIS) using a HREA.

Please do not use the NHMRC HREA website for NSW applications as those forms cannot be imported into REGIS.

They are essentially the same. REGIS uses a licensed copy of the NHMRC’s HREA, with identical questions.

Use the REGIS Question reference guide: completing an ethics application for step-by-step instructions.

There is no published list of HREA questions. The best way to get to know the HREA is to log into REGIS, create a new HREA, and to activate different questions to see what subsequent questions result. The NHMRC has provided question-specific guidance for many of the questions, which will be visible in the system.

Your organisation’s research office can assist you with the content of your ethics application.

REGIS must be used to complete and submit a HREA to NSW Health Organisation HRECs. If you have used another website to create a HREA, contact the REGIS Helpdesk for assistance.

All applications, regardless of risk level, must use the HREA.

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.

The HREA asks under which review pathway you are intending to submit the application (greater than low risk or lower risk), refer to the NSW Health guidelines for low and negligible risk research review processes or exemption from ethical review for further guidance on interpreting and clarifying some of the concepts contained in the National Statement.

When an investigator intends to submit an application as a lower risk project for expedited HREC review, the Committee’s Executive Officer has the discretion to request that the research project be reviewed under full Human Research Ethics Committee review.

The process for research governance/SSA remains the same under the HREA.

All National Mutual Acceptance HRECs now use the HREA.

Yes. When the HREA is used and the research project involves a site in Victoria, the Victorian Specific Module (VSM) must be uploaded as a supporting document to the HREA and submitted to the reviewing HREC (even if the committee is outside Victoria).

Please contact the National Health and Medical Research Council if you wish to provide feedback on the HREA questions/question-specific guidance specifically.

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