Submitting Low & Negligible Risk Applications for Approval
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.
IMPORTANT:
All projects undertaken at Western Health should involve a Western Health employee. Where an externally initiated project is being submitted, a Western Health employee should be nominated as a contact person or an associate researcher in ALL projects undertaken at Western Health.
- If a Western Health employee is involved in the project they should be listed, at the very least, as an associate researcher.
- If a Western Health employee is NOT involved in the project they should be listed as the Western Health contact person, and must:
- Have expertise in a discipline relevant to the project.
- 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
Staff/students who have little research experience with <2 publications should not be listed as a Principal Investigator (PI), their Supervisor or Senior should be the PI and they should be responsible for the project management.
The Principal Investigator should have a permanent position at Western Health.
Document Submission Requirements for Low & Negligible 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. | Human Research Ethics Application (HREA) Form | The HREA form is to be created on the Ethics Review Manager (ERM) website: https://au.forms.ethicalreviewmanager.com. 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 LNR VIC 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]. |
| 3. | Victorian Specific Module | You can complete the form on the right hand side link OR; 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. |
| 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. Contact the Office for Research if unsure [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 (2018). 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 the Principal investigators to have completed GCP Training, please provide a copy of their completion certificate. It is also recommended that all investigators undertaking complete GCP Training. 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 "Appendix A: Guideline for Data Management in Research" Please contact the Office for Research if unsure. |
| 14. | Application Fee | All projects incur a review fee. Please see our fee schedule here. |
Submission
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.
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 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
See electronic naming convention document (download on right hand side links) for more details.
One Hardcopy:
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.
