Committed to Research

“Ethical conduct is more than simply doing the right thing. It involves acting in the right spirit, out of an abiding respect and concern for one’s fellow creatures.” (National Health and Medical Research Council, 2023)

These pages contain information to help you prepare and submit your project for ethics approval and governance authorisation. They describe post-approval activities and reporting. You will also find the services the Research & Education Network (REN) provides to WSLHD researchers in areas such as education, statistics, and writing support.


How to navigate these pages

•  Each heading has links to forms, policies, and procedures.

•  There are guides for ethics and governance tasks, so you can easily find the information you need.

•  You will find some forms and templates on more than one page, so they are at your fingertips when you are ready to use them.

•  Information about Pre-Submission meetings and how to book can be found on the Ethics page.

 

Research Office Contacts

Phone: 88909007
Email: [email protected]

Research Office Staff

Administration Officers Human Research Ethics & Governance Officers  Human Research Ethics Committee Secretariat  Research Governance Officers 
 Vin DiProspero
 Seema Manoj
 Johnny Chetty
 Amanda Bryant  Pauline Geale
 Catherine Hemmings
  • Generic telephone and email
  • Booking in new studies
  • Monitoring & Archiving
  • Secretariat support for the Institutional Biosafety Committee
  • REGIS Support
  • All post-approval work for ethics and governance
  • Secretariat support for HREC Sub-Committee
  • REGIS Support
  • Secretariat support for the WSLHD
  • Human Research Ethics Committee, and Scientific Advisory Committee
  • Liaison with Area Drug Committee
  • REGIS Support
  • Review of all site-specific applications to the WSLHD
  • Contract review
  • TGA submission
  • REGIS Support

 

Kellie Hansen – Manager, Research Office.
Telephone 0429 270 660

 

Ethics & Governance

The WSLHD Research Office is in the Research and Education Network (REN) Building on the Westmead Campus. The Research Office provides services for the WSLHD and several affiliated MRIs in
  • Human Research Ethics
  • Research Governance
  • Institutional Biosafety Committee support
  • Animal Ethics Governance

The WSLHD Research Office has representation at the Blacktown Campus on Thursday and Friday. Staff can be found on level 2 of the WSU Clinical School.

The Research Office coordinates and supports the administrative and regulatory aspects of research at WSLHD assisting with research applications, providing support to committees, and ensuring appropriate ethics and governance review are received. These pages have been developed to assist researchers in meeting the requirements of Human Research Ethics and Research Governance.

The website includes guides, forms, policies, and procedures to assist you with:
  • How to apply for ethics and governance
  • The Approval Processes
  • Clinical Trial resources
  • Post approval guidelines and documentation
  • Forms and templates
  • Policy and Guidelines


Pre-Submission Meetings

WSLHD Pre-Submission Meetings will commence (date) and are mandatory for all new submissions. This meeting should be attended BEFORE you begin your application in REGIS
  • Please use the link below to book a convenient time to meet with a member of the research office
  • The pre-submission meeting is a high-level review of your project to assist you in ensuring your project meets the basic
    requirements listed below and identify potential items that could cause delays. We will check that your project:
  • Is being submitted under the right review pathway
  • Meets the eligibility criteria for that pathway
  • Includes the right documents
  • Has the right person named as CPI/PI


This is not a detailed review of your documents, and you may receive review comments from the Human Research Ethics Committee, Scientific Advisory Committee, or Research Governance Officer
Available meeting times will be
  • Tuesday, Wednesday, and Thursday
  • 30-minute slots between 0900-1100 and 1400-1600
  • Meeting can be booked via the link at the end of this page

Please have all study documents ready for the meeting.
Following the meeting, you will receive an email from the Research Office team member you met with. This email will outline any items discussed in the meeting that need to be completed or changed before submission. Please upload that email with your study documents in REGIS. Make sure you complete any changes or additions identified in the email before you submit.

PLEASE NOTE: After (date) submissions will not be accepted without evidence of a pre-submission meeting with the Research Office.


Ethics

The menu items below contain the information and forms you will need for initial submission, post-approval, and reporting activities related to your project.
If you have any questions, please contact the Research Office at 88909007 or [email protected]

WSLHD Research Governance

You can find information and forms you will need for initial submission, post-approval, and reporting activities related to your Research Governance application here.



Western Sydney Local Health District (WSLHD) Human Research Ethics Committee (HREC)

Fees

Consent

Data

  1. Research Data Management plan / checklist (pdf) (must be completed and presented to the RedCap superuser if using WSLHD RedCap)
  2. PD2018_001 Release of Unit Record Data (pdf)
  3. WSLHD HREC DSMB Charter Template (doc)
  4. NHMRC Data Safety Monitoring Boards (pdf)

 

Radiation Safety

WSLHD Radiation Safety Committee contributes to the continued provision of safe, efficient, and effective services to patients, staff, and consumers, through the implementation of radiation safety standards and compliance with the internal and external governing bodies. The Radiation Safety Committee must

Submission and Meeting Dates

The submission and meeting dates for 2024 can be found in the documents below. Please note gazette closing dates are fixed and cannot be extended.

Document 1 includes the dates for the Area Drug Committee (ADC), Scientific Advisory Committee (SAC), and Human Research Ethics Committee (HREC).

Document 2 includes the dates for the HREC Sub-Committee for ethics amendments to approved studies.
  1. HREC Sub-Committee Submission and Meeting Dates 2024 (pdf)
  2. WSLHD Submission and Meeting Dates Schedule 2024 (pdf)

 

Amendments

Any changes made to an approved project must receive ethics approval and governance authorization. Regardless of the size of the change, it cannot be incorporated into the project until it is approved.
Amendments are submitted in REGIS, using the “Forms” tab on the ETH. There are several forms available, please choose the one that describes your requested change:
  • Notification of an amendment to a research study
    • General Amendment
    • *Request for Extension
    • Addition of a new site
    • Change in CPI/PI/Administration Contact
  • Serious Breach Notification form (third party)
  • Significant Safety Issue Notification


*The WSLHD HREC Request for Extension Application form must be submitted with your amendment in REGIS. Please read the guidance at the head of the document to decide what is required for your project.
Amendments will not be accepted if annual reports are not up to date.

 

Quality Assurance & Case Reports

Quality Assurance (QA)
QA is a local process only. Applications are accepted under anytime submission via email to the generic research office email address [email protected]. QA is not submitted via REGIS. The eligibility criteria for QA is
  • a review of routinely collected data either retrospective or prospective.
  • does not interact with participants.
  • does not add anything or undertake new work.
  • includes data held and owned by WSLHD (including LHD data contributed to state-wide databases e.g. e-maternity)
  • does not use identifiable data.
  • all study team members must be employees of the WLSHD.


All QA applications must be submitted with a study protocol and data collection form.

Ethically approved QA projects can be published in peer-reviewed journals and presented at conferences. If your project is for internal use only, an application is not required and can be done with Head of Department approval.

For further information please refer to QA Submission Guidance, V2, January 2024.

Case Reports (CR)
CR is a local process only. Applications are accepted under anytime submission via email to the generic research office email address [email protected]. QA is not submitted via REGIS. The eligibility criteria for CR is
  • can only include 1-5 patients.
  • all authors must be employees of the WSLHD.
  • A signed consent form must be provided for each patient included in the CR. (the consent form template is included in the application template)
  • To assist you there is a CR template available for your use.

 

Authorised Prescriber

Authorised Prescriber applications are reviewed by the WSLHD Area Drug Committee on behalf of the WSLHD Human Research Ethics committee. They are considered under sub regulation 12B (1B) and 12B (1C) of the therapeutic Goods Regulations 1990. The drug committee sends their recommendation to the WSLHD Health Research Ethics Committee (HREC) who will send a letter of endorsement to you.

If you wish to apply for Authorised prescriber approval, please apply to
  1. The WSLHD Drug Committee for WSLHD drug and formulary approval by email, [email protected].
Please read through the TGA link below and include all information, including references as described by the TGA guidance document.
  1. Unapproved products for multiple patients (Authorised Prescriber) | Therapeutic Goods Administration (TGA) for TGA approval. The HREC endorsement letter is required to be uploaded to your application.
Please note: Both applications can only be done on-line. There are no paper forms available.
For further information please email [email protected] and [email protected]

 

 

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