Documents are all downloadable on the right hand side links.
Please ensure you are familiar with the WH Standard Operating Procedures - Good Clinical Practice (WH SOP-GCP) for research. The WH Office for Research may conduct an audit at any time.
Check the Submission Deadline and Meeting Dates and note that applications submitted after the deadline WILL NOT BE ACCEPTED. This includes having BOTH hardcopies and electronic submissions (ERM & email) before the deadline.
All projects undertaken at Western Health must involve a Western Health employee. Where an externally initiated project is being submitted, a permanent Western Health employee should be nominated as the Principal Investigator in ALL projects undertaken at Western Health.
Students who have little research experience or less than 2 publications should not be listed as a PI, their Supervisor or Senior should be the PI and they should be responsible for the project management.
Incomplete applications will not be accepted and will be returned to the principal investigator and study contact without being reviewed.
Why are we enforcing this instruction?
Receiving a complete application in one package allows that application to be reviewed once, as opposed to multiple times. This promotes efficiency and will allow the Office for Research team to provide a more timely and comprehensive service to all of our researchers and research partners.
The Victorian Low and Negligible Risk application form (LNR VIC)
The LNR VIC form is to be created on the Ethics Review Manager (ERM) website: https://au.forms.ethicalreviewmanager.com
To ensure you are able to submit to Western Health please answer these questions in the LNR VIC form (Level of Risk section) with the following:
The system will generate an ethics reference number for you. Please ensure that the form is formally submitted on ERM to be reviewed. You will know this form is submitted successfully if you have a review reference number located on the bottom left of the page when the PDF is generated.
DO NOT COMPLETE THE HREA FORM
ALL investigators are required to sign and date the researcher declarations either electronically through their own ERM logins OR Please sign the Investigator Declaration Page (right hand side link).
For ERM technical assistance, email Infonetica Helpdesk [email protected].
See the following website for useful guides and tools for ERM: https://www.clinicaltrialsandresearch.vic.gov.au/ethical-review-manager
The Victorian Low and Negligible Risk application SSA Form (LNR VIC SSA)
The LNR VIC SSA Form is to be created under the LNR VIC Form as a "Sub-Form"
You can complete the form in the ERM system, please ensure that the form is formally submitted on ERM to be reviewed. You will know this form is submitted successfully if you have a review reference number located on the bottom left of the page when the PDF is generated.
Research Protocol Template available on the right hand side.
Submit a detailed protocol and any other documentation such as:
Please insert a version number and date either in the footer or header of all documents.
Useful Assessment Tool (no need to submit for ethics review)
Privacy & Data Management
We are all responsible for the protection and handling of private personal information at Western Health. The WH Office for Research highly recommends that a Privacy Impact Assessment (PIA) is performed and completed during the development and planning of your project and protocol to identify potential privacy risks and to implement mitigation strategies to comply with the Privacy & Data Protection Act 2014 (PDP Act 2014) before a project commences. Please see the Office of the Victorian Information Commission (OVIC) website for the PIA and guidelines. Please note that this form does not need to be submitted to the Office for Research. For guidance and review of data management plans, contact the WH Corporate Records Manager, Alan Kong [email protected] Please also note that if your project is audited, this document may be requested for review as a supporting document.
Western Health LREP Site Specific Form
Is to be completed to clarify site specific requirements for resources and facilities required at Western Health to conduct your project.
This form is downloadable on right hand side links.
This is NOT the Site Specific Assessment (SSA) Form on ERM, please complete the correct form. Contact the Office for Research if unsure [email protected]
Statement of Approval Form
Head of Department and Heads of Supporting Department signatures required, please ensure their names and department names are clearly stated and that they have ticked the relevant boxes.
Where an investigator on the team is the also Head of Department, sign off should be obtained from the next line of reporting e.g. Divisional Director/Clinical Director
Curriculum Vitae using the WH CV template from all investigators with signatures indicating that they have read and understood the WH Research Code of Conduct (2018).
A revised CV and declaration is required every 2 years
It is mandatory for all investigators (Principal/Associate Investigators, Study Coordinators, Students etc.) to have completed GCP Training, please provide a copy of their completion certificate.
GCP Training must be valid and completed within the last 3 years.
Please use the WH Low Risk PICF template.
Complete a PICF if the study involves participants from whom you are obtaining consent.
Electronic PICFs submission must be submitted in an editable MSWord format and NOT PDF so that reviewers are able to make comments if required.
Only required if applicable.
In accordance with the Australian Code for the Responsible Conduct of Research, organisations involved in a joint research project should ensure that agreement is reached with the partners on the management of the research. This agreement should be in writing.
Please see the Research Agreement page here for submission requirements.
A minimum of 2 x original wet signatures of the agreement once endorsed must be provided.
This is required only if applicable.
If you are creating or using a Databank/Database for possible future studies, you may need to complete a Databank Registration Form.
If you are collecting data for this project only, a Databank Registration Form is not required.
Please see the OG-GC7 Data Management in Research Guideline, please contact the Office for Research if unsure.
All applications will only be accepted by the Office for Research as one complete package in hardcopy and electronic (ERM & email) by the deadline. Do not try to submit your application in multiple separate parts.
This instruction applies to all applications.
Applicants must submit both the ethics application via ERM and email [email protected] by the 4pm deadline.
Mandatory Electronic file name convention:
To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. As shown in example below, include version numbers and dates in the file name.
Projects submitted with documents that do not follow the below naming convention/format will not be considered and will be returned via email to sender.
Convention: [ERM Project ID] [Document Name] [version number] [Date DDMMMYY]
E.g. 41234 Protocol v1 01Jan19
CVs, GCP & Codes (where applicable) to be named as:
See electronic naming convention document (download on right hand side links) for more details.
NO HARDCOPIES required as part of COVID-19 contingency.
By post/drop-off: Manager Office for Research Level 3 Western Health Centre for Health Research & Education – Sunshine Hospital, Furlong Road, St Albans VIC 3021
Drop-off/after hours: A drop off box is located in the Ground Level Staircase (right of the elevators) of the Western Health Centre for Health Research & Education Building, Sunshine Hospital, Furlong Road, St Albans VIC 3021. Please note that this box will be checked once a day.
Please ensure both hard copy and electronic copies are submitted before 4pm of submission deadline date. Late submissions will not be accepted.
Please note that your project will undergo preliminary review by the Office for Research after your initial submission. You may be given 1-2 days to revise or provide further documents, if a full submission has not been provided after the preliminary review deadline given, your project may not be reviewed at that month's meeting.