Essential Information for All New Applications

Prior to submitting an application, researchers are advised to refer to the Flow Chart for Risk Assessment.  Depending on the level of risk involved in a particular study will depend on the sort of review required. This flowchart (as shown below) shows the review process and timelines for the various sorts of research projects.  The flowchart can be downloaded or viewed by clicking the image below.

Click to enlarge and download

Application Guidance for Research Governance Submissions (Site Specific Assessments)

These application instructions refer to studies which have been reviewed by another accredited institution under the Streamlined Ethical Review Process (SERP) for the review of multi-site clinical trials.
 
Researchers are not required to submit a full Human Research Ethics Application to the Southern Health HREC for review. Instead, researchers are required to submit a research governance application (Site Specific Assessment). Research Governance submissions are reviewed outside of the usual HREC meeting schedule and may be submitted at any time.
 
All submissions must contain the following completed forms/documents:

In addition, the final version of the Southern Health Site Specific Participant Information and Consent Form/s must be emailed to Deborah Dell along with the Southern Health HREC Reference number, so that an electronic barcode may be inserted on the final approved document/s. The final approved Southern Health Site Specific Participant Information and Consent Form/s will then be emailed to the researcher at the same time as the letter of Site Specific Authorisation. The barcode will ensure that a scanned copy of the Participant Information and Consent Form/s are placed under the Legal Tab on the Participant’s Scanned Medical Record.  Researchers will still be required to complete an orange alert for each participant.

For detailed information on SERP please refer to the Consultative Council for Human Research Ethics (CCHRE) website http://health.vic.gov.au/cchre/

For further information please refer to the Research Directorate contact list for the person/people able to assist with submission enquires and their availabilities. Please note that staff are able to meet with researchers prior to a submission but researchers will need to make an appointment first.

Application for Low and Negligible risk projects (including Quality Assurance)

Prior to submitting an application, researchers are advised to refer to the Flow Chart for Risk Assessment because depending on the level of risk involved will depend on the sort of review required. Sometimes the project itself is not high risk, but the population being studied is deemed under the National Statement on Ethical Conduct in Human Research (NHMRC 2007) to be a vulnerable group and therefore exempt for expedited/low risk review. Prior to preparing a negligible/low risk submission (including quality assurance projects) researchers should refer to the National Statement on Ethical Conduct in Human Research (NHMRC 2007) , complete the Allocation to Different Levels of Review – Checklist on page 2 of the Victorian Low/Negligible Risk HREC Application Form VIC LNR HREC Application Form and contact the Research Directorate to confirm that would be suitable for Negligible/Low Risk Review.
 
Once confirmation is sought that the study would be eligible for negligible/low risk review, researchers are required to submit the following to the Research Directorate:
 
1 hard copy of the application and 1 electronic copy on CD including:
 
 
For further information please refer to the Research Directorate contact list for the person/people able to assist with submission enquires and their availabilities. Please note that staff are able to meet with researchers prior to a submission but researchers will need to make an appointment first.

Application Guidance for Clinical Research Projects

These instructions refer to all research projects that are submitted to the full Human Research Ethics Committee for review. If the study is a drug/device study, please refer to the application guidance for Clinical/Drug Device Studies.
 
All applicants are required to complete the National Ethics Application Form and Victorian Site Specific Module
All Participant Information and Consent Forms must follow the Department of Health templates.
 
In addition, the final version of the Participant Information and Consent Form/s must be emailed to Julie Gephart along with the Southern Health HREC Reference number, so that an electronic barcode may be inserted on the final approved document/s. The final approved Participant Information and Consent Form/s will then be emailed to the researcher at the same time as the letter of HREC Approval and/or Site Specific Assessment Authorisation. The barcode will ensure that a scanned copy of the Participant Information and Consent Form/s are placed under the Legal Tab on the Participant’s Scanned Medical Record.  Researchers will still be required to complete an orange alert for each participant.
 
In addition, all submissions must contain the following completed forms/documents:
Please submit 1 hard copy (this must be double sided with no staples) and 1 copy on CD to the Research Directorate.
 
 
For further information please refer to the Research Directorate contact list for the person/people able to assist with submission enquires and their availabilities. Please note that staff are able to meet with researchers prior to a submission but researchers will need to make an appointment first.
 

Application Guidance for Clinical Drug/Device Projects being submitted for Single Site Review to Southern Health

These application instructions refer to drug/device studies where the researcher is only applying to Southern Health for single site HREC approval and Site Specific Authorisation. If a researcher wishes to apply for multi-site approval, please refer to the Application Guidance for Clinical Drug/Device Projects being submitted for Multi-Site Review.
 
All applicants are required to complete the National Ethics Application Form and Victorian Site Specific Module

All Participant Information and Consent Forms must follow the Department of Health templates.
 
In addition, the final version of the Participant Information and Consent Form/s must be emailed to Deborah Dell along with the Southern Health HREC Reference number, so that an electronic barcode may be inserted on the final approved document/s. The final approved Participant Information and Consent Form/s will then be emailed to the researcher at the same time as the letter of HREC Approval and/or Site Specific Assessment Authorisation. The barcode will ensure that a scanned copy of the Participant Information and Consent Form/s are placed under the Legal Tab on the Participant’s Scanned Medical Record.  Researchers will still be required to complete an orange alert for each participant.
 
In addition all submissions must contain the following completed forms/documents:
 
 
For further information please refer to the Research Directorate contact list for the person/people able to assist with submission enquires and their availabilities. Please note that staff are able to meet with researchers prior to a submission but researchers will need to make an appointment first.

Application Guidance for Clinical Drug/Device Projects being submitted for Multi-Site Review

These application instructions refer to drug/device studies where the researcher is applying for multi-site approval.
 
Southern Health is an accredited HREC under the Streamlined Ethical Review Process (SERP) for the review of multi-site clinical trials being conducted in Victoria. The submission requirements are same as for the Southern Health projects with the following exceptions.
  • All applications must be booked through the Central Allocation System (CAS) (61 3) 9092 1983, Monday to Friday 10am to 5pm EST
  • A research governance checklist does not need to be submitted unless Southern Health is a participating site
  • All documents must be uploaded onto the online forms website
  • A HREC Review Only Form of Indemnity must also be provided with the submission

Required documents:

For detailed information on SERP please refer to the Consultative Council for Human Research Ethics (CCHRE) website http://health.vic.gov.au/cchre/
 
For further information please refer to the Research Directorate contact list for the person/people able to assist with submission enquires and their availabilities. Please note that staff are able to meet with researchers prior to a submission but researchers will need to make an appointment first.

Document downloads

Date
Title
Type
Size
Document Submission Requirements:
 
Low and Negligible risk projects (including Quality Assurance)
Please submit:
  • 1 hard copy of the application
  • 1 electronic copy on CD
Clinical Research Projects
Please submit:
  • 1 hard copy (double sided with no staples)
  • 1 copy on CD to the Research Directorate.
Clinical Drug/Device Projects being submitted for Single Site Review to Southern Health
Please submit:
  • 1 hard copy (double sided with no staples)
  • 2 further hard copies (double-sided)
  • 1 copy on CD to the Research Directorate.