Ethics & Governance

Research Approval Processes

The Research Office at Western Sydney Local Health District is located within the Research & Education Network building just outside the education block at Westmead Hospital. The staff in the research office can assist researchers with all aspects of their Ethics and Governance submission for their research projects. The Ethics and Governance guides to submission are below to assist researchers, but if you need further assistance please don’t hesitate to contact the office on 8890 9007.

Ethical Review of Research

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).This is known as Ethical Approval.

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. This is known as Research Governance Site Authorisation.

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, information documents provided to you below.

Covid-19 Information Western Sydney Local Health District (WSLHD) Research Office Procedure Document COVID-19.(doc) WSLHD Clinical Research - continuation and cessation rules in response to the COVID-19 pandemic - 23 March 2020.(pdf) WSLHD Request for Amendment COVID-19 Expedited Review Form.(doc) Oral Consent Process - May 2020. (pdf)

 

Human Research Ethics The following information documents are provided to assist you with preparing your applications for review and approval from the WSLHD HREC. Ethics Guides WSLHD Ethics Review Pathway Checklist. (doc) WSLHD Guide to HREC Submission May 2019 (pdf) HREA Submission Checklist 6 February 2020 (pdf) Human Research Ethics Committee Meeting Submission Deadlines (pdf) Quality Assurance Guidance regarding submission of Quality Assurance/Audit projects (pdf) WSLHD QA Application Form & Checklist December 2019 (pdf) Case Reports WSLHD Case Report Template (doc) WSLHD Case Report Application Form (doc) Protocol Writing SPIRIT Checklist CLINICAL TRIALS (pdf) WSLHD Protocol Guidance Document - Clinical Research, LNR, QA (doc) Amendments WSLHD HREC - Request for Amendment/Modification (doc) WSLHD HREC and Research and Governance Adding/Removing a Site and/or CPI/PI  (doc)

Human Research Governance The following information documents are provided to assist you with preparing your applications for review by the WSLHD Research Governance Office. Guides WSLHD Research Governance Guide October 2020 (pdf) WSLHD RGO Ongoing Site Authorisation form (doc)

 

Research Office Documents The following information documents are provided to assist you with general information regarding the approval and monitoring of Human Research within WSLHD. WSLHD Research Office Fee Policy July 2020 (pdf) WSLHD Research Office Safety Reporting Policy Oct 2018 (pdf) WSLHD Submission and Meeting Dates Schedule 2021 (pdf) HREC Position Document for Researchers September 2019 (pdf) WSLHD Human Research Ethics Committee Terms of Reference Nov 2018 (.doc) WSLHD Human Research Ethics Committee Standard Operating Procedures Sept 2018 (.doc)