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.

Human Research Ethics

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 risks to participants. Ethical approval can be sought for studies at single or multiple PHO sites and facilities, and some external organisations  affiliated with WSLHD.

 

 

Human Research Governance

Research governance examines the proposed quality, safety, privacy, risk management and financial management of the study. Research governance approval is required after ethical approval for each PHO site/facility within WSLHD where the study will be undertaken.

 

 

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)

Quality Assurance

Guidance regarding submission of Quality Assurance/Audit projects (pdf)

WSLHD QA Application Form & Checklist January 2019 (pdf)

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 July 2019 (pdf)

WSLHD RGO Ongoing Site Authorisation form (pdf)

 

 

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 (pdf)

WSLHD Research Office Safety Reporting Policy Oct 2018 (pdf)

WSLHD Submission and Meeting Dates Schedule 2019 (pdf)

HREC Position Document for Researchers September 2019 (pdf)


 

Annual/Final Reports

HREC Position Document for Researchers - September 2019 (pdf)

 

 

Useful Links

Research Ethics & Governance Information System (REGIS)

NSW Ministry of Health Office for Health and Medical Research (OHMR) 

National Health & Medical Research Council (NHMRC)

Therapeutic Goods Administration

 

Contact Us:

WSLHD Research Office
Phone: (02) 8890 9007
Email: WSLHD-ResearchOffice@health.nsw.gov.au

 

 

Looking for General
Orientation information?

See more