Submitting Low & Minimal Risk Applications for Approval
PLEASE NOTE: 2024 LREP SUBMISSION CLOSING DATE
We have set a final closing date for LREP submission for 2024 to allow for the submissions received and in process by this date to be finalised before the end of 2024. The CLOSING DATE for New Low Risk applications is 22 November 2024, Friday at 5pm. Any LREP submissions made after this date will be NOT processed until 27 January 2025, Monday. Thank you for your understanding.
What if my matter is URGENT?
Researchers are asked to contact the Office for Research in person or via telephone 03 8395 8070 or email [email protected] to ensure that urgent matters are brought to the attention of the appropriate team member so they can be reviewed and actioned in a timely manner.
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 electronic submissions via ERM & email to [email protected] before the deadline.
IMPORTANT:
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.
- The nominated Western Health employee/Principal Investigator must:
- Have expertise in a discipline relevant to the project.
- Have more than 2 research publications or equivalent research experience if no publications made (to be clarified in Curriculum Vitae (CV))
- Provide a link between the researchers and Western Health
- Provide local knowledge that can facilitate the conduct of the research.
- Be updated on the progress and status of the project on a regular basis by the external researchers
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.
Document Submission Requirements for Low & Minimal Risk projects:
| 1. | Cover Letter | Ensure this letter is submitted with your application. Please make sure all sections are complete and attached documents clearly listed. If a cover letter is not provided, your project will be rejected at the next meeting. You do not have to use the template provided however, a brief summary of your project and clear listing of the attached documents are required if you wish to provide your own cover letter. |
| 2. | The Victorian Low Risk application form (LR VIC) | The LR 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 LR VIC form (Level of Risk section) with the following: - Question - HREC or ethics review body to which this application will be submitted - Please select "Western Health"
- Question - Have you consulted the organisation's research office regarding the risk level for this research project - Please select "Yes"
- Question - Did the organisation's research office advise completion of the LR VIC - Please select "Yes"
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 |
| 3. | The Victorian Low Risk application SSA Form (LR VIC SSA) | The LR VIC SSA Form is to be created under the LR 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. |
| 4. | Research Protocol | Research Protocol Template available on the right hand side. Submit a detailed protocol and any other documentation such as: - documents to be given to participants e.g. letters of invitation, transcripts for telephone contact, questionnaires, patient diaries
- verbal scripts
- assessment tools
- advertising materials
- data collection sheets and case report forms
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, Mymoena Abrahams [email protected]
Please also note that if your project is audited, this document may be requested for review as a supporting document. |
| 5. | 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. If unsure contact the Office for Research [email protected] |
| 6. | 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 |
| 7. | Curriculum Vitae | 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 (2023). A revised CV and declaration is required every 2 years |
| 8. | International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) Training Certificate | 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. |
| 9. | Participant Information and Consent Form (PICF) | 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. |
| 10. | Research Agreement | 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. |
| 11. | Budget | This is only required if the project is funded. Itemised budget is to be signed by the Principal Investigator and approved/endorsed by the departmental Business Analyst (signature on budget/email confirmation is acceptable) |
| 12. | Honorary Researcher Application Form | This form is intended for use where an external researcher wishes to conduct research which requires access to Western Health patients and/or their associated data by way of an honorary researcher appointment. A police check and immunisation clearance may be required, please contact your WH Supervisor or the Head of Department for cost centre details. See the Honorary Researcher Eligibility flowchart to determine whether this is required. |
| 13. | Databank Registration Form | 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. |
| 14. | Application Fee | All projects incur a review fee. Please see our fee schedule here. All fees must be accompanied with a completed Compliant Tax Invoice. |
Submission
All applications will only be accepted by the Office for Research as one complete package via ERM & email to [email protected] by the deadline. Do not try to submit your application in multiple separate parts.
This instruction applies to all applications.
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.
Electronic Copy:
Applicants must submit the ethics application via ERM.
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:
- [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) for more details.
