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In Australia, all research studies involving human participants, human tissues and clinical data must adhere to the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007, updated May 2015) (the National Statement). Projects for every such research study must be approved by an accredited Human Research Ethics Committee (HREC). From 1st July 2007, the NSW Department of Health introduced a system for the single ethical review of multicentre and all other human research to be conducted in New South Wales. NSW Health Policy Directive PD2010_056 Research - Authorisation to Commence Human Research in NSW Public Health Organisations sets out the mechanism to be used by Public Health Organisations (PHO) to authorise the commencement of human research projects at sites under their control. LHD compliance with this policy is mandatory. All research projects involving humans must be authorised by the Chief Executive (or Designee) before research may commence at any PHO, eg Westmead Hospital.
Within WSLHD, human research proposals are first submitted to the Research Office for managing and administering the ethical and governance review processes. If you are new to making ethics and governance submissions, or would like to refresh your knowledge, please read the guides listed on the right hand column.
Ethics examines the proposed study for scientific, clinical and ethical validity, ensuring as far as reasonably practicable, that the benefits of the study outweigh any side effects. Ethical approval can be sought for studies at single or multiple PHO sites and facilities, and some external organisations affiliated with WSLHD.
Research governance examines the proposed quality, safety, privacy, risk management and financial management of the study, and does not look at the scientific, clinical or ethical validity of the study. Research governance approval is required after ethical approval for each PHO site/facility within WSLHD where the study will be undertaken.
Are you proposing doing research involving human subjects, human tissues or access to medical records? The flow chart below shows the approval process outline. Details steps are shown in the submission page.
WSLHD Research Governance Guide January 2019 (pdf)
2018 HRE submission and meeting schedule (pdf)
WSLHD Research Office Fee Policy (pdf)
WSLHD Research Office Safety Reporting Policy 2018 (pdf)
WSLHD RGO Ongoing Site Authorisation form (pdf)
Guidance regarding submission of Quality Assurance/Audit projects (pdf)
WSLHD Guide to HREC Submission January 2019 (pdf)
WSLHD QA Application Form & Checklist January 2019 (pdf)
WSLHD Submission and Meeting Dates Schedule 2019 (pdf)
SPIRIT Checklist CLINICAL TRIALS (pdf)
WSLHD Protocol Guidance Document - Clinical Research, LNR, QA (doc)
WSLHD Ethics Review Pathway Checklist. (doc)