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Research Ethics and Governance

Research Ethics and Governance

All research involving humans conducted within the NSW public health system must be ethically and scientifically reviewed and approved by a NSW Health Human Research Ethics Committee (HREC) in accordance with the

Human Research Ethics Committees (HRECs)

There are around 60 HRECs in NSW. Of these, 23 serve the public health system.

The role of HRECs is to protect the welfare and rights of research participants. Health Research and Ethics supports and develops the network of NSW Health HRECs through:

information sharing;
education;
policy development;
mechanisms for the streamlining of processes; and
development and implementation of policies to manage emerging research ethics issues.

A number of NSW Health HRECs are accredited as 'lead HRECs', that is, HRECs accredited by the NSW Department of Health to conduct the single ethical and scientific review of multi-centre research projects on behalf of all sites within the NSW public health system.

NSW Population & Health Services Research Ethics Committee

The NSW Population & Health Services Research Ethics Committee is jointly convened by the Cancer Institute NSW and NSW Department of Health. The Committee is accredited as a lead HREC for general research, specifically cancer related epidemiology research. In addition, all research involving access to state-wide data collections owned or managed by NSW Health must be reviewed by this HREC. Information on the NSW Population and Health Services Research Ethics Committee including application forms and meeting dates, is available at:

Single ethical & scientific review of multi-centre research

In 2007 a system of single ethical & scientific review of multi-centre research was implemented, with the aim that every research project conducted within the NSW public health system is scientifically and ethically reviewed once only. Lead HRECs are accredited to conduct a single ethical and scientific review of multi-centre research on behalf of all sites within the NSW public health system at which a research project is to be conducted, thereby eliminating the need for each local HREC to conduct its own review. Public health organisations (that is, hospitals and area health services) retain responsibility for authorising the commencement of research to be undertaken within their institutions.

Introduction to single ethical review (brochure)

Site-Specific Assessment of Research Proposals

All research projects involving humans must be authorised by the Chief Executive or their delegate before it may commence. As such, public health organisations are required to undertake a site-specific assessment (SSA) of each research project, thereby allowing the organisation to consider whether it has the capacity to conduct the research at that site. This SSA involves consideration of such matters as resources, staff, insurance and indemnity requirements etc.

The SSA and HREC ethical review may occur in parallel, however the decision to authorise or not authorise the commencement of a research project is only made by the public health organisation when the responsible HREC has granted approval and the SSA has been satisfactorily completed.

All applications for SSA must be made on the standard Site-Specific Assessment Form and submitted to the relevant Research Governance Officer within the public health organisation.

Research Governance Officer contacts

Clinical Trial Research Agreements

NSW Health supports the advancement of knowledge and the pursuit of better health care treatments for the people of NSW through research and teaching. It supports clinical and non-clinical research involving humans, including clinical trials, in the NSW public health system.

Each clinical trial to be conducted at a NSW public health organisation, which is sponsored by a commercial entity or a not-for-profit organisation such as a collaborative research group, must be governed by a clinical trial research agreement. The agreement is reviewed by the public health organisation during site specific assessment.

NSW Health, in collaboration with key stakeholder organisations, has developed a set of standard clinical trial research agreements:
(i) Clinical Trial Research Agreement - Medicines Australia Standard Form (Commercially Sponsored CTRA);
(ii) Clinical Trial Research Agreement - Medicines Australia Form: Contract Research Organisation acting as the Local Sponsor (CRO Sponsored CTRA)
(iii) Clinical Trial Agreement: Collaborative or Cooperative Research Group (CRG) Studies - Standard Form (CRG Sponsored CTRA).

Details on the use of standard CTRAs for clinical trials to be conducted at a NSW public health organisation can be found under Research Governance Policies in this section.

The current version (January 2009) of the three CTRAs approved for use by NSW Health can be accessed from Medicines Australia website at:

Shared Scientific Assessment Committee

The Shared Scientific Assessment Committee provides independent scientific review of clinical drug trials for NSW Health Human Research Ethics Committees (HRECs) that are unable to meet the provisions in the NSW Health policy on standards for scientific review of clinical trials.

A NSW Health HREC may refer to the Shared Scientific Assessment Committee:

all clinical drug trials;
a pre-determined subset of clinical drug trials (for example, first time in human, specific clinical disciplines); or
clinical drug trials raising complex or unusual issues on an ad-hoc basis.

Each HREC will advise investigators of those studies that will be submitted to the Shared Scientific Assessment Committee.

Click on the appropriate file for more information about the Shared Scientific Assessment Committee:

Frequently asked questions

Click below for answers to frequently asked questions on the following topics: