Committed to Research

Approval Research Process2

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.

  1. PI - The PI must be a WSLHD employee or have an honorary appointment with the LHD
  2. Fee Form - (Proof of payment must be included in the submission – Different fee applies e.g. – Investigator Initiated, Collaborative, Sponsored etc)
  3. Protocol - Study must have a protocol – The protocol & PICF etc should only list the CPI/PI.
  4. Sites & PIs - Sites & PIs must be listed consistently in these 5 documents (Submission Checklist, Project Registration, HREA, Protocol, PICF)
  5. 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.)
  6. 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.
  7. Waiver Of Consent Application Form ( If Waiver of Consent a WSLHD WoC Application must be submitted)

 

 

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.
  1. Cover letter – RGO submission cover letter with the usual info on it
  2. Staff link numbers for all investigators
  3. Fee form - (Cost codes – for all submissions)
  4. PICFs correctly tracked from the HREC approved Master/s – including correct referencing to the Master in the footer
  5. PICFs to have the correct complaints contacts (below)
  6. Clinical contact must be the Principal Investigator
  7. Ensure the complaints contact is correct for the cohort

 

 

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 October 2021 (doc)

HREA Submission Checklist January 2022 (doc)

Quality Assurance

QA Submission Guidance October 2021 (pdf)

WSLHD QA Application Form & Checklist August 2021 (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)



 

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 May 2021 (pdf)

Access Request 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 October 2021 (pdf)

WSLHD Safety Reporting Policy for Pharmaceutical Sponsored Trials July 2021 (pdf)

WSLHD Submission and Meeting Dates Schedule 2022 (pdf)

WSLHD Submission and Meeting Dates Schedule 2023 (pdf)

HREC Sub-Committee Submission and Meeting Dates 2022(pdf)

HREC Sub-Committee Submission and Meeting Dates 2023(pdf)

HREC Position Document for Researchers October 2021 (pdf)

WSLHD Human Research Ethics Committee Terms of Reference Sept 2022 (doc)

WSLHD Radiation Safety Report February 2022 (pdf)

Research Data Management plan / checklist (pdf)

Request for Extension - AUGUST 2022 (doc)


 

Complaints for patients Westmead & Auburn

Site complaints contact Patient Experience Unit
Telephone 02 8890 7014
Email Wslhd-westmead-feedback@health.nsw.gov.au

 

Complaints for non-patients and staff

WSLHD Research Office WSLHD Research Governance Office
Telephone 02 8890 9007
Email Wslhd-researchoffice@health.nsw.gov.au

 

Complaints for contact for BMDH

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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