Research Ethics and Governance
Human Research Ethics Committees (HRECs) | NSW Population & Health Services Research Ethics Committee | Single ethical and scientific review of multi-centre research within NSW | Mutual acceptance of ethical and scientific review of interstate multi-centre clinical trials | Site Specific Assessment | Clinical Trial Research Agreements (CTRAs) | Shared Scientific Assessment CommitteeAll research involving humans conducted within the NSW public health system must be ethically and scientifically reviewed and approved by a Human Research Ethics Committee (HREC) in accordance with the:
Human Research Ethics Committees (HRECs)
There are around 60 HRECs in NSW. Of these, 22 serve the public health system.
The role of HRECs is to protect the welfare and rights of research participants. The NSW Ministry of Health 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 Ministry 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 and Health Services Research Ethics Committee is jointly convened by the Cancer Institute NSW and NSW Ministry 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 statewide 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 and scientific review of multi-centre research within NSW
In 2007, a system of single ethical and 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 local health districts and statewide and specialist health networks) retain responsibility for authorising the commencement of research to be undertaken within their institutions.
Mutual acceptance of ethical and scientific review of interstate multi-centre clinical trials
In 2011, the NSW Ministry of Health and Queensland and Victorian Departments of Health signed a Memorandum of Understanding to introduce mutual acceptance of ethical and scientific review of multi-centre clinical trials undertaken in public health organisations across the three states. Under the Interstate Mutual Acceptance initiative, each proposal for a multi-centre clinical trial conducted across the participating states will be ethically and scientifically reviewed once by a public health organisation Human Research Ethics Committee (HREC) that has been certified by the National Health and Medical Research Council (NHMRC) to review clinical trials.
Site Specific Assessment
All research projects conducted within NSW public health organisations must be authorised by the Chief Executive or their delegate before they 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 and scientific 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.
Clinical Trial Research Agreements (CTRAs)
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 and investigations, in the NSW public health system.
Each clinical trial to be conducted at a NSW public health organisation, that is sponsored, either 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:
- Standard Medicines Australia CTRA for Commercially Sponsored Trials (Commercially Sponsored CTRA);
- Standard Medicines Australia CTRA for Contract Research Organisations acting as the Local Sponsor (CRO Sponsored CTRA); and
- Standard Collaborative or Cooperative Research Groups CTRA (CRG Sponsored CTRA).
The current versions of the three Medicines Australia CTRAs approved for use by NSW Health can be accessed from the Medicines Australia website at:
NSW Health, in collaboration with key stakeholder organisations, has also developed a Clinical Investigation Research Agreement (CIRA) for use when a medical device company sponsors a clinical trial. In keeping with the terminology used in the industry, the research is known as a ‘clinical investigation’ rather than a ‘clinical trial’.
The current version of the Standard Medical Technology Association of Australia (MTAA) CIRA can be accessed from the MTAA 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.