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You can find all the information on our website including templates, guidelines, checklists and more. When you have explored the WSLHD’s Research Office website and are still unable to find what you are looking for, then please do not hesitate to contact us on 8890 9007.
To conduct research in Australia it is a requirement that you obtain approval from an NHMRC certified Human Research Ethics Committee (HREC). The HREC reviews the study's ethical acceptability. The National Statement on Ethical Conduct in Human Research (2007) defines human research as follows:
“Human research is conducted with or about people, or their data or tissue. Human participation in research is therefore to be understood broadly, to include the involvement of human beings through:
It is important to note that this includes research that the participants themselves are not aware of. An understanding of the levels of risk defined by the National Statement will help you to assess if your proposal requires ethical approval. If you have ethics approval this does not mean that you can commence your study at a NSW Public Health Organisation, in order for you to begin your research at such organisation you must complete a site specific application for Research Governance.
Human Research Ethics is conducted with or about people, or their data or tissue. Institutions are responsible for establishing procedures for the ethical review of human research. That review can be undertaken at various levels, according to the degree of risk involved in the research.
Human Research is governed by Australian law that establishes rights for participants and imposes general and specific responsibilities on researchers and institutions. The National Statement focuses on the ethical aspects of the design, review and conduct of human research. Ethical review is guided by the values and principles of ethical conduct:
Human Research Governance can be defined as a framework for effective oversight of research, such that it meets appropriate standards of quality, safety, privacy, risk management, financial management and ethical acceptability in the Public Health Organisation. It provides a framework for the Local Health District, hospital/facilities, managers and researchers in a shared responsibility and accountability for the conduct of research.
Each research proposal is also subject to local governance review for each site at which the project is to be conducted. There are no governance equivalent of a lead HREC.
Research governance ensures that:
A junior researcher, for example, RMO, registrar, student, PhD candidate cannot be listed as the Principal Investigator for a study as a senior researcher needs to be responsible. The role of the Principal Investigator is to provide oversight and guidance on all stages of the research process. WSLHD requires a senior clinician with research experience employed by the LHD to be listed as Principal Investigator on all NEAF, LNR, QA and SSA applications. The senior researcher can delegate principal investigator duties to a junior researcher listed on the SSA.
Before you begin your project you should read the relevant guide for the type of project you wish to undertake. The guidance documents for each type of research can be found on the Submitting a Research Proposal page. Once you have read the guides and developed your study protocol you should make an appointment to discuss your project with the Ethics and Governance staff.
The simple diagram below shows the basic process. The full process flow is shown on the first page of the Research Approval Process.
An activity where the primary purpose is to monitor, evaluate or
improve health service delivery through a systematic review of service/s
against explicit criteria. No governance application is required for
Section 2.1.6 of the National Statement on Ethical Conduct in Human
Research describes research as “Low Risk” where the only foreseeable
risk is one of discomfort. Negligible risk research is where there is no
foreseeable risk of harm or discomfort and any foreseeable risk is no
more than inconvenience.
NEAF – All other research where the risk is considered more serious than Low or Negligible risk, as outlined above.
If your project is multi-centre this means that it is being conducted at
more than one facility e.g. Westmead Hospital, Blacktown Hospital, and
Nepean Hospital. The documents you submit will be master documents:
You will need to submit to the relevant research governance office for that site:
Different sites within WSLHD will have different
complaints contact personnel. You can find the complaints contact
Yes, your new PICF will now become a master version 1 submitted to
the lead HREC as an amendment for ethics approval. Once approved you
will need to submit the approved master with the site specific PICF’s to
the Research Governance Officer at each site.
Yes, please discuss this with the research office as a file audit/case
review involving less than ten people may be undertaken as a case study
and requires a different form to be completed.
Once your application has been submitted, the principal investigator
will receive an acknowledgement letter from the Research Office.
Applications for drug studies will be sent to the Drug Committee which
is held the first Monday of each month. All applications are sent out
for review (LNR projects receive ethics review at this time also) and
then presented to the Scientific Advisory Committee (SAC) which is held
the second Monday of each month. NEAF projects, if recommended by the
SAC, are presented to the HREC meeting which is held on the last Tuesday
of the month. Following each of these review points correspondence
will be sent to the Principal Investigator. Governance review will be
undertaken in parallel with this committee process.
You will need to complete the request for amendment/modification form.
Ensure you answer every question, specifically question 6. Attach all
relevant documentation in both clean and tracked changes with updated
version number and date (1 original and 9 copies) and submit this to the
Senior Ethics Officer in the Research Office. The HREC sub committee
meets every fortnight and the dates can be viewed here.
Please see Section E on our Website.
One of the roles of Research Governance is to review all personnel listed on the SSA and their accreditation to perform research within WSLHD Organisations. If you have a researcher involved in your study who is not an employee of WSLHD please contact the Research Office to discuss requirements for this researcher to be on site for any research activity.
For multi-centre research the only changes made between the Master Participant Information Sheet and Consent Form (PICF) (approved by ethics), and the site specific PICF are:
For studies approved by a reviewing HREC external to WSLHD please submit all documents listed on the ethics approval letter with the site specific submission to the Research Governance office.
Any research being conducted in WSLHD will need to gain site authorisation from the Research Governance Officer for WSLHD. If the study is being conducted at multiple WSLHD sites (e.g. Westmead Hospital and Auburn Hospital) then a separate SSA must be submitted for each site.
LNRSSA - A LNRSSA must be submitted when a LNR ethics application was submitted to the HREC
SSA - A SSA must be submitted when a Full Ethics application (NEAF) was submitted to the HREC for a study
Access Request – An Access Request Form can be submitted with either a LNR ethics or a Full Ethics application (NEAF).
Contracts must be provided for any research project being conducted within WSLHD organisations that are sponsored by an external Organisation (eg. Pharmaceutical company) or in collaboration with an external organisation (eg. Universities). There are standard contracts in place for this purpose and they can be found at the Medicines Australia (MA) and for devices Medical Technology Association of Australia (MTAA).
If you have any further queries contact research governance.
The WSLHD research team will need to be listed on the SSA/LNRSSA form, which is any research personnel who will be conducting study activity (eg. consenting participants, data collection, completion of CRFs) at the WSLHD site. This includes registrars, nursing staff, allied health professionals and clinical trial co-ordinators.