Low & Negligible Risk Projects

Complete the LNR SSA/SSA form that is generated from the Ethics Review Manager (ERM). All investigators are to sign individual declarations in ERM.

Please note: SSAs are generated from the LNR Vic/HREA forms reviewed by the ethics committee. 

ERM Applicant User Guide - DHHS

Note common errors - please ensure these are correct before submitting:

Investigator details

• Non WH address provided for WH personnel who may have multiple positions at other health services/organisations. Researchers should provide the address the personnel can be found at WH sites.
• Email address – personal email addresses not linked to Western Health or an organisation e.g. Gmail, Hotmail, Yahoo addresses. It is preferred that the WH email address for the WH personnel to be used or an email address that is linked with another organisation.
• Role in Project, researchers have often just stated the position of the research personnel e.g. "Principal Investigator" or "Associate Investigator" which is incorrect. This section requires further clarification regarding their duties within the project for example; Consent, data collection, ethics & governance submissions, interviews, blood collection etc. you may also wish to state the position as well for further clarification.
• CVs and GCP certificates not uploaded onto ERM form

Site Departments

• 4.2 All departments listed in this section must also provide a Head of Department/Supporting Department signature.

Supporting documents:

• Uploading of all documents relevant to the study

Signatures

• Not signed by all research personnel involved at WH site – including Study Coordinators and students
  

Signature/s from each Head of Department/Head of Supporting Department can be obtained in two ways:

1. ERM SSA Form Digital Declaration signature/s; OR
2. Statement of Approval Form (Wet ink/scan)

Submit all current approved trial documents as submitted to the Reviewing HREC e.g.:

• Final approval letter and acknowledgements from the reviewing HREC Please ensure that the HREC lists "Western Health" as an approved participating site or any of the following only:
• Sunshine Hospital 
• Please note that if the site involves Joan Kirner Women's & children's Hospital (JKWCH), the approval must state 'Sunshine Hospital' and not JKWCH
• Footscray Hospital
• Williamstown Hospital
• Sunbury Day Hospital
• Drug Health Services
• Hazeldean Transition Care
• Sunshine Radiation Therapy Care
• Bacchus Marsh and Melton Regional Hospital
• Melton Health & Community Services
• Bacchus Marsh Community Health Centre
• Grant Lodge Residential Aged Care

• As applicable: LNR Vic/HREA - non original signed copy

• Victorian Specific Module – signed (non-original signed copy is acceptable) or ERM generated

As applicable:

• Master approved Participant Information and Consent Forms (PICF)
• Site specific Participant Information and Consent Forms based on Master approved PICFs
• Site Specific PICFs must include: WH Logo, local governance/site specific version number and date, PI/researchers contact details & WH local governance contacts details for complaints
• Questionnaires/surveys
• Data Collection Forms
• Letters of Invitation
• Advertisements
• etc 

Curriculum Vitae (CV)

Researchers involved at WH site are required to provide a CV using the Western Health CV template and sign the declaration that they have read and understood the WH Research Code of Conduct (2018). If researchers do not use the WH CV template, please sign and date their preferred full CV and sign and date the declaration located on the last page of the WH Research Code of Conduct (2018).

International Conference on Harmonisation – Good Clinical Practice (GCP)

It is mandatory for the Principal Investigator to have completed GCP training. Please provide a certificate of completion; this must be completed within the last 3 years.

Honorary Researcher Appointment

This is required for any external researchers who may be coming on site and who may have contact with patients, access identifiable data, or using our resources/facilities. Please see Honorary Researcher Appointment process.

Research Agreement (Commercial, Investigator-Initiated or Collaborative studies) – see requirements and process here for legal review of endorsement of agreements.

Once endorsed, please provide 3 x copies with original wet ink signatures in hardcopy for signing.

Please contact Bill Karanatsios for any queries. [email protected]; 03 8395 8073

Two electronic copies must be submitted to be considered a full submission.

See Submission deadline dates here (Effective from 01 November 2021)

Electronic Copies:

Applicants must submit both the ethics application via:

1. Ethics Review Manager (ERM) and
2. Email [email protected] 

NO hardcopies are currently required due to COVID-19 contingencies.

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.

Please do not use the following symbols in your electronic filename: ! @ $ % & ?

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: 

• [First Name][Last Name] WH CV DDMMMYY
• [First Name][Last Name] GCP DDMMMYY
• [First Name][Last Name] WH Code DDMMMYY

See electronic naming convention document (download on right hand side links under 'Information and Guides') for more details.

What to expect from the Office for Research after you submit:

You will receive a generic automatic reply indicating the submission email has been received by the Office for Research.

Your application will be checked to determine that ALL the requisite submission elements have been included. 

• For incomplete submissions; where it is missing any requisite submission elements (as described above) you will be notified via email that your submission is incomplete.  We will not provide a report as to what essential elements are missing.
• For submissions that have ALL the requisite submission elements for us to be able to conduct the governance review, you will receive a valid submission notification email. You will then receive a comprehensive governance review/response within 4 weeks of the initial submission date.  Please be aware this timeline may change depending on the volume of submissions at the time.

What you must do:

For complete (valid) submissions that have been reviewed and comments provided, you will be given 4 weeks to respond. 

Failure to respond or address queries within this timeframe will result in your governance application being put on hold and to be reviewed at the next available date.

The next available date will be determined by the number of complete (valid) submissions that need to be processed at that time of your resubmission. 

Incomplete submissions and failure to address requirements within the required response times may be withdrawn and a new resubmission and fee may be imposed.

Please Note: Site Initiation Visit meetings should not be booked prior to governance review.