Questions and answers on research ethics
1. Who conducts ethical review for the NSW public health system?
A NSW Human Research Ethics Committee, which is certified by the NHMRC and works to
NSW MoH Policies and Operating Procedures. NSW HRECs are listed on the NSW Ministry
of Health website
2. What is meant by Ethical review for ‘Multicentre’ research in NSW?
Research is reviewed and approved by an accredited NSW ‘LEAD’ HREC - the ethical
approval is accepted for ALL of the NSW public health system. A NSW policy governs single
ethical review for multicentre research
However in addition to ethical APPROVAL researchers must submit a formal ‘site specific
assessment’ application to each NSW organisation where the project will be conducted (e.g.
each local health district or hospital), and receive AUTHORISATION from the LHD Chief
Executive or their delegate. Without this authorisation the research cannot proceed. Find
more details about this process in Southern NSW LHD on the research governance tab [this
will be a link to the research governance, SSA’s and authorisation’ tab).
3. Is there research that does not require ethical review?
ALL research must meet the standards of the NHMRC National Statement on Ethical
Conduct in Human Research.
However, the National Statement indicates at 5.1.22 and 5.1.23 that certain types of
research may be exempt from ethical review, at the discretion of an HREC, including:
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Negligible risk research as discussed on page 16 of the National Statement
Research involving ONLY the use of existing collections of de-identified data or
records
4. If my research is ethically approved by another state or territory will that ethical
approval be accepted in the NSW public health system?
For CLINICAL TRIALS ONLY but not for other types of research, there are four states
(NSW, Victoria, South Australia and Queensland) participating in a scheme called National
Mutual Acceptance (NMA) of Ethical Review.
For the purposes of National Mutual Acceptance (NMA) of ethical decisions, a clinical trial is
defined as ‘clinical interventions trialing a drug and/or a device, radiation therapy, surgery,
treatment or diagnostic procedure; and also studies associated with ongoing activities
relating to trials that have been conducted. This may include post-trial activities such as
observational research and evaluation of a trial, developing a registry and other postmarketing surveillance activities’.
Under the scheme, ethical approval for a CLINCIAL TRIAL, granted by a certified HREC is
accepted in other participating states - thus only one ethical review is required. Currently the
ACT is not part of this scheme
Specific legislative requirements of participating states Jurisdictional Legislative
Requirements and state policy directives also apply to limit the scope of the scheme (eg in
NSW clinical trials with certain populations (such as prisoners and Indigenous Australians)
are not part of the NMA scheme, so separate NSW ethical approval must still be obtained
NB Site Specific Assessment and authorisation is required for research approved under
National Mutual Acceptance in the same way as for all other research. Click on the
Research Governance tab for details.
5. If my research is ethically approved by a university or private HREC will that ethical
approval be accepted in the NSW public health system?
NO. You must apply for ethical review and approval by a NSW HREC.
6. If my research is not ‘on premises’ of a NSW Public Health Organisation is that
external to the NSW System and therefore not subject to NSW policies?
The research may still be subject to NSW MoH Policies. As per NSW Ministry of Health
Policy Research - Ethical & Scientific Review of Human Research in NSW Public Health
Organisations [PD2010_055] human research taking place in NSW Public Health
Organisations means research that is:
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conducted at sites under the control of Public Health Organisations; and/or
involving participants, tissue or data accessed through Public Health Organisations.
7. What ethics application form is required?
Online Ethics forms are mandatory for all research in the NSW Public Health System,
however you should first contact the Executive Officer of the HREC for information about
requirements for submission. Templates for research protocols, participant information
statements and consent forms exist, and may be provided by the HREC that you apply to.
Southern NSW LHD has templates for Non-Clinical Trials that are adapted from NSW
Ministry of Health Templates: check the research governance tab [linked to research
governance SSAs and authorisation tab] tab for details.
8. If my research is low or negligible risk does it still require ethical review?
Different levels of review are required depending on levels of foreseeable risk of harm
to participants. Risk level is defined in the National Statement chapter 2.1 page 15-16:
1. If foreseeable risk is determined as no more than ‘inconvenience’ it is negligible risk
2. If foreseeable risk can be defined as no more than ‘discomfort’ it is low risk
Low and negligible risk projects are submitted using a ‘low and negligible risk’ (LNR) ethics
application form on the online forms site and undergo ‘expedited review’ by a subcommittee
(or similar) of an HREC. 5See Greater Western HREC Subcommittee meeting dates for
2014
If risk is greater than 1 or 2 above it is ‘more than low risk’ and the project requires review at
a ‘full HREC’ meeting See GWHREC Full Meeting dates for 2015. Applications must be
submitted on a National Ethics Application Form (NEAF) via the online forms site
NB Discuss level of risk with the HREC Executive Officer prior to submission. The HREC
makes the final decision on level of review required.
9. Where do I access information about clinical trials?
Access the required guidance, regulatory information and templates as follows:
Guidance and Clinical Trial Notification/Clinical Trial Exemption forms for clinical trials of
devices and drugs are on the TGA website
Information and guidelines, along with standard forms for clinical trials research agreements
and indemnity in clinical trials can be found on the Medicines Australia Website
Information about National Mutual Acceptance (NMA) of Ethical Review.of Clinical Trials
(clinical trials to be conducted across participating States)
NSW policies that relate specifically to Clinical Trials:
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Clinical Trial Research Agreements for Use in NSW Public Health Organisations
[PD2011_028]
Clinical Trials - Insurance and Indemnity [PD2011_006]
Fee Policy for Review of Commercially Sponsored Research [PD2008_030
The HREC officer of the reviewing HREC and Research Support Officer at the sites where
the research will take place can assist you further.
10. When can I start my research?
Only once you have both ethical approval and authorisation as per Authorisation to
Commence Human Research in NSW Public Health Organisations [PD2010_056]
Please refer to the Research Governance tab [link to research governance SSAs and
authorisation tab] on this website and contact the Southern NSW LHD Research Support
Officer on 02 6492 9682 email ethics for more information
11. What if my project is possibly a quality activity?
Some quality projects may need ethical review. Consider whether your project is:
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a ‘low /negligible risk’ research project, as discussed on page 15 of the National
Statement - which will require an expedited HREC review process or
a quality activity (which may or may not require ethical review) - see the following
NSW guideline /checklist that may help you make a decision Quality Improvement &
Ethical Review: A Practice Guide for NSW [GL2007_020]
The Southern NSW LHD Research Support Officer can be contacted to discuss
these matters - 02 6492 9682 or gsahs.ethics@gsahd.health.nsw.gov.au
The Southern NSW LHD Research Support Officer can be contacted to discuss these
matters - 02 6492 9682 or email ethics
12. Once I am conducting research what are my responsibilities as a researcher?
All research must be undertaken in accordance with the National Statement on Ethical
Conduct in Research and the Australian Code for the Responsible Conduct of Research;
researchers must be familiar with these documents. In addition:
Researchers must comply with standard monitoring and reporting requirements - outlined in
the letter of ethical approval that you receive from the Human Research Ethics Committee
and the letter of authorisation that you receive from the Local Health District
All research must be undertaken in accordance with the National Statement on Ethical
Conduct in Research and the Australian Code for the Responsible Conduct of Research;
researchers must be familiar with these documents. In addition:
Researchers must comply with standard monitoring and reporting requirements - outlined in
the letter of ethical approval and letter of authorisation
Your letter of ethical approval indicates your ethical responsibilities e.g:
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Duration of ethical approval (3 years is usual)
When/how to submit to HREC for review (for example of an amendment or extension
of project)
What reports you must submit (eg annual progress reports; adverse events; final
report)
Your letter of authorisation outlines your responsibilities to the organisation including
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Providing copies of annual, adverse event, final reports
Participating in site audits
MORE IMPORTANT INFORMATION and templates for reporting are on the research
governance tab [link to research governance SSAs and authorisation tab] of this website or
contact the Southern NSW LHD research support officer on 02 6492 9682 or email ethics
NSW Ministry of Health Research Ethics and Governance pages have a range of useful
resources, policies, links to other key sites and FAQs. If you are unable to find an answer to
a question, NSW Ministry of Health Research Ethics and Governance Policy Advisors will be
able to assist with policy interpretation and can be contacted through
healthethics@doh.health.nsw.gov.au