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.
Eligibility Requirements for HREC Submission
All HREC submission must adhere to the following points. If they do not the submission will not be accepted and will be returned for resubmission.
- PI – All WSLHD sites must have a PI with an appointment with WSLHD
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Fee Form - (Proof of payment must be included in the submission – Different fee applies e.g. – Investigator Initiated, Collaborative, Sponsored etc)
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Protocol - Study must have a protocol – The protocol & PICF etc should only list the CPI/PI.
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Sites & PIs - Sites & PIs must be listed consistently in the Submission Checklist, Project Registration and HREA
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HREC Submission Checklist – HREC Submission Checklist must be uploaded with the correct information (The documents uploaded in REGIS must be listed in the submission checklist. Also, the version number and date recorded in the footer of each document matches those recorded in the submission checklist.)
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Document version number - (Each document must have version number and date -Incl. Sponsored study & International study. Also, the version number and date recorded in the footer of each document matches those recorded in the submission checklist.
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Waiver Of Consent Application Form ( If Waiver of Consent a WSLHD WoC Application must be submitted)
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Research Governance Eligibility Criteria for New Submissions
Mandatory as at 1st November 2022.
If any of the following criteria are not met, the submission will be marked ineligible and returned to you.
- Cover letter – RGO submission cover letter with the usual info on it
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Staff link numbers for all investigators
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Fee form - (Cost codes – for all submissions)
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PICFs correctly tracked from the HREC approved Master/s – including correct referencing to the Master in the footer
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PICFs to have the correct complaints contacts (below)
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Clinical contact must be the Principal Investigator
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Ensure the complaints contact is correct for the cohort
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| Site complaints contact |
Office of the General Manager, Blacktown-Mt Druitt Hospitals |
| Telephone |
02 9881 8000 (Blacktown Hospital switchboard) and ask to be connected to the Office of the General Manager |
| Email |
Wslhd-bmdhexec@health.nsw.gov.au |
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