Low Risk Research and Quality Assurance
Low Risk
Case Study Reports
Quality Assurance
Low Risk Research
SVHM HREC provides an expedited review pathway for all projects which are considered as “low risk”.
There are no closing dates applicable for Low Risk Research.
The expression "low risk research" describes research in which the only foreseeable risk is one of discomfort. Research, in which the risk for participants is more serious than discomfort, is not low risk. (NS Chapter 2.1)
To be eligible for Low Risk Review, the project MUST NOT INCLUDE:
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Women who are pregnant
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Children or young people under the age of 18
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Persons with an intellectual disability or mental impairment of any kind
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Persons highly dependent on medical care
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Persons incompetent to provide informed consent
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People involved in illegal activities
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Prisoners or people on parole
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Research specifically recruiting Aboriginal and / or Torres Strait Islander people
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Persons not usually considered to be vulnerable but would be considered vulnerable in the context of this research project
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Additional clinical interventions and/or therapies
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Derivation or use of human stem cells
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Discomfort or risk beyond that of routine care
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Deception of participants, concealment or covert observation
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Examining potentially sensitive or contentious issues
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Additional Radioactive substances / ionizing radiation
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Assisted reproductive technology (ART)
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Xenotransplantation
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Toxins / mutagens / teratogens / carcinogens
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Collection, use or disclosure of identifiable information
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The HREC reserves the right to promote projects to high risk at any time.
Site-Specific Guidelines
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Please ensure the SVHM Site Specific Guidelines for submissions are followed when submitting your application
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SVHM Research Collaboration Agreement (RCA) with SVHM details inserted can be found under our Forms Tab.
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Please ensure standard DHHS templates and formatting are used for submissions
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Please ensure the Low and Negligible Risk Requirements are met
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Chief Principal Investigator / Principal Investigator Responsibilities in Trials
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Ethics Submission Guide - This guide can also be used for any questions regarding the necessity and role of the required documents.
To Submit a New Ethics Application:
Legal documents: please adhere to the SVHM Digital Signature Guidelines.
1. Cover Letter and Checklist - Ethics – Mandatory
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1x e-copy
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2. Fee Form – Mandatory
Please include remittance advice when paying with EFT
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1x e-copy
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3. Human Research Ethics Application (HREA) Form – Mandatory
*Please refer to the ERM User Guide for detailed instructions on how to create a HREA application on the ERM. If you still have troubles you can contact Infonetica on 02 9037 8404.
*As of 01 January 2020, we will no longer accept LNR Forms. Low Risk Applications MUST complete a HREA.
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1x e-copy
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4. Victorian Specific Module (VSM) – Mandatory if Victorian Sites are involved
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1x e-copy
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5. Master Participant Information and Consent Form (PICF) – if participants are enrolled in the study
Different templates are available on the Department of Health website.
IMPORTANT: SVHM will only consider PICF templates from the Department of Health.
Please use the template(s) that are appropriate for the type of research you are conducting.
- Non-Interventional
- Interventional
- Participant Partner Pregnancy
The following PICFs will need to be submitted for HREC Review:
Participant Information and Consent Form Footer need to include the Version and Date. Please see below for recommendation:
Master Template - [ProtocolNo.]National Mutual Acceptance PICF[type eg. Main / Optional genetic] Verx.x Date dd/mm/yyyy
Complaints Contact Person
Position
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Patient Liaison Officer at St Vincent’s Hospital Melbourne
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Telephone
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(03) 9231 1954
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Email
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PLO@svhm.org.au
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Reviewing HREC Approving this Research and HREC Executive Officer Details
Reviewing HREC Name
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St. Vincent’s Hospital Melbourne HREC
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Position
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HREC Executive Officer
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Telephone
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(03) 9231 6970
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Email
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Research.ethics@svhm.org.au
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*Please note: these details must appear exactly as it is shown below
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1x e-copy
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6. Protocol or Research Plan – Mandatory
*Australia's leading public funder for health and medical research (NHMRC) supports the use of the SPIRIT Statement and Checklist in the development of protocols.
Please refer to the SPIRIT Statement for guidance on developing a protocol
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1x e-copy
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7. Budget – as per sponsor or institution guidelines
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1x e-copy
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8. Patient-Facing Materials – if participants are enrolled in the study
Such as surveys, brochures, advertisements or questionnaires
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1x e-copy
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9. Form of Indemnity - HREC Review Only – for commercially sponsored studies where SVHM is providing premises for the conduct of HREC review
SVHM Indemnified Party Details
St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, Victoria 3065, ABN 22 052 110 755
What is Required? - Insurance for Clinical Trials Information and Guide (2020)
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1x e-copy (either scanned wet ink signature or docu-sign signature)
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10. Letter of Support from Head of Department - for a single-site, low-risk application to SVHM
Due to a conflict of interest, any Head of Department that is listed as a Principal Investigator or Associate Investigator on the study CANNOT sign off on the study.
In this instance, a Letter of Support from the Chief Medical Officer is required.
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1x e-copy
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11. Certificate of Insurance – for all commercially sponsored studies
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1x e-copy |
12. Research Team Good Clinical Practice (GCP) Certificates – Mandatory
Provide a current and valid GCP certificates for the following study personnel:
- For Multi-site study – Coordinating Principal Investigator
- For Single-site study – Principal Investigator
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1x e-copy
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13. Research Team Curriculum Vitae (CVs) – Mandatory
Provide a Curriculum Vitae for the following study personnel:
- For Multi-site study – Coordinating Principal Investigator and Principal Investigators of each site
- For Single-site study – Principal Investigator
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1x e-copy
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Ethics Submission Guide - This guide can also be used for any questions regarding the necessity and role of the required documents.
To Submit a New Governance Application:
Legal documents: please adhere to the SVHM Digital Signature Guidelines.
1. Cover Letter and Checklist - Governance – Mandatory
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1x e-copy
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2. Fee Form – Mandatory
Please include remittance advice when paying with EFT
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1x e-copy
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3. HREC Approval Letter (including any amendment approval) – Mandatory
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1x e-copy
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4. Original Human Research Ethics Application (HREA) Form – Mandatory
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1x e-copy |
5.Site-Specific Assessment (SSA) Form – Mandatory
*Please refer to the ERM User Guide for detailed instructions on how to create an SSA application on the ERM. If you still have troubles you can contact Infonetica on 02 9037 8404.
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1x e-copy
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6. Victorian Specific Module (VSM) – Mandatory if Victorian Sites are involved
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1x e-copy
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7. Master Participant Information and Consent Form (PICF) –if participants are enrolled in the study
Submit all the original Master PICFs approved by the reviewing HREC.
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1x e-copy |
8. Site-Specific Participant Information and Consent Form (PICF) – if participants are enrolled in the study
The following PICFs will need to be submitted for HREC Review:
Create the SVHM Specific Participant Information and Consent Form based on the Reviewing HREC Approved Master PICF.
Both tracked and clean SVHM Specific Participant Information and Consent Form Version are required for submission.
SVHM Specific Participant Information and Consent Form Footer needs to include the Document name, Version and Date. Please see below for recommendation:
Site Specific-[Protocol No.] SVHM Specific PICF [type eg. Main / Optional genetic] Verx.x Date dd/mm/yyyy
Complaints Contact Person
Position
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Patient Liaison Officer at St Vincent’s Hospital Melbourne
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Telephone
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(03) 9231 1954
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Email
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PLO@svhm.org.au
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Local HREC Officer Contact
Reviewing HREC Name
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St. Vincent’s Hospital Melbourne HREC
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Position
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HREC Executive Officer
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Telephone
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(03) 9231 6970
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Email
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Research.ethics@svhm.org.au
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*Please note: these details must appear exactly as it is shown below
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1x e-copy
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9. Protocol or Research Plan – Mandatory
Submit the original Protocol approved by the reviewing HREC.
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1x e-copy
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10. Budget – as per sponsor or institution guidelines
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1x e-copy
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11. Patient-Facing Materials – if participants are enrolled in the study
Such as surveys, brochures, advertisements or questionnaires. All documents must have a footer that includes document name, version number and date.
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1x e-copy
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12. Form of Indemnity - Standard – for commercially sponsored studies where SVHM is providing premises for the conduct of the study
SVHM Indemnified Party Details
St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, Victoria 3065, ABN 22 052 110 755
What is Required? - Insurance for Clinical Trials Information
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1x e-copy (either scanned wet ink signature or docu-sign signature)
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13. Clinical Trial Research Agreement (CTRA) – for commercially sponsored, multi-site studies
-or-
14. Research Collaboration Agreement (RCA) – for investigator initiated, multi-site studies
SVHM Details for the RCA:
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Name of Institution: St Vincent's Hospital (Melbourne) Limited
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Address: 41 Victoria Parade, Fitzroy VIC 3065
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ABN: 22 052 110 755
Research Collaboration Agreement (RCA) with SVHM details inserted can be found on our 'Forms' Page here.
Please note that only the Director of Research and the Executive Officer can sign off on behalf of the institution, the principal investigator does not have the authority to sign off on behalf of the institution.
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1x e-copy (either scanned wet ink signature or docu-sign signature)
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15. Letter of Support from Head of Department
Due to a conflict of interest, any Head of Department that is listed as a Principal Investigator or Associate Investigator on the study CANNOT sign off on the study.
In this instance, a Letter of Support from the Chief Medical Officer is required.
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1x e-copy
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16. Certificate of Insurance – for commercially sponsored studies
Submit the original Certificate of Insurance approved by the reviewing HREC.
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1x e-copy |
17. Research Team Good Clinical Practice (GCP) Certificates – Mandatory
Provide a current and valid GCP Certificates for the following study personnel:
- SVHM Principal Investigator
- SVHM Associate Investigators / Research Coordinators
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1x e-copy
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18. Research Team Curriculum Vitae (CVs) – Mandatory
Provide a Curriculum Vitae for the following study personnel:
- SVHM Principal Investigator
- SVHM Associate Investigators / Research Coordinators
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1x e-copy
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To Submit a Study Amendment:
*Please note: the RGU does not accept hard copy submission. Only submissions via SAGE will be accepted.
Legal documents: please adhere to the SVHM Digital Signature Guidelines.
Change of Principal Investigator (Permanent)
Change of Principal Investigator (Temporary - less than 6 months)
Changing Members of a Research Team (Associate Researcher or Research Coordinator)
1. Changing Members of a Research Team Form
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1x e-copy (either scanned wet ink signature or docu-sign signature)
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2. CV of the new Research Team Member
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1x e-copy
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3. GCP Certificate of the new Research Team Member
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1x e-copy
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Updated Protocol
1. Amendment Request Form
*Explaining the nature of the amendment and whether the changes/updates warrants an updated PICF
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
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1x e-copy
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3. Updated Protocol/ Investigator Brochure – including updated version numbers and dates
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1x e-copy
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4. Tracked Changes of the Protocol/Investigator Brochure
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1x e-copy
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5. Summary of Changes
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1x e-copy
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Updated Participant Information and Consent Form (PICF)
1. Amendment Request Form
*Explaining the nature of the PICF changes
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1x e-copy
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2. Fee Form- please include remittance advice when paying with EFT
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1x e-copy
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3. Updated Participant Information and Consent Form (PICF) – including updated version numbers and dates
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1x e-copy
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4. Tracked Changes of the PICF
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1x e-copy
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Updated Patient-Facing Documents
1. Amendment Request Form
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
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1x e-copy
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3. Updated patient-facing documents
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1x e-copy
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4. Tracked Changes to the patient-facing documents
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1x e-copy
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Addition of Sites
Addition of Satellite Site
Please view this document for addition information as to whether your request qualifies under this category of site addition.
1. Amendment Request Form
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
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1x e-copy
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3. SVHM Addition of Satellite/Recruitment/Service Site Form |
1x e-copy
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4. Letter of Support from Site |
1x e-copy |
5. CV & GCP Certificate for PI/AI responsible at the satellite site |
1x e-copy |
6. Form of Indemnity - HREC Review Only - for commercially sponsored studies
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1x e-copy (either scanned wet ink signature or docu-sign signature)
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7. Insurance Certificate - for commercially sponsored studies |
1x e-copy |
8. CTRA - for commercially sponsored trials adding a rural site not under the same legal entity as primary site
-or-
8. Research Collaboration Agreement (RCA) – if investigator initiated, unsponsored trials adding a rural site not under the same legal entity as primary site
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1x e-copy (either scanned wet ink signature or docu-sign signature) |
Addition of Recruitment Site
Please view this document for addition information as to whether your request qualifies under this category of site addition.
Addition of Service Site
Please view this document for addition information as to whether your request qualifies under this category of site addition.
All Other Changes (Administrative)
1. Amendment Request Form
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
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1x e-copy
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3. Documents requiring review
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1x e-copy
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Annual Safety Reports
Due on the anniversary of study approval
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The completion and submission of an annual report is part of the conditions of ethical approval for all projects.
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Failure to submit progress reports within 45 days following the 01 May submission deadline may lead to a suspension of the ethical approval for the study.
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Due 01 May - Annual Reports for projects that have been approved in January to April in any year do not need to be submitted until 01 May the following year.
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Acknowledgement of a submitted annual progress report will generally be provided within 2 months of submission - this timeline may be extended due to the significant volume of reports received.
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For further information, please contact Research Integrity and Compliance Assistance on 03 9231 6987 or email: svhm.ResearchAnnualR@svha.org.au
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All Annual Reports and Final Reports are to be submitted under the relevant projects on SAGE. Different report forms are required depending on the project types (Summary below). For more information regarding how to submit an annual report on SAGE, please refer to these Annual Report Submission Guides.
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Project Type |
Report Form Required |
Where to Submit |
Whose responsibility to submit |
Ethics only project
- no SVHM site is involved |
Progress/Final Report (HREC) |
Milestone tab under the SVH Project |
- Investigator-initiated study: CPI
- Commercially-sponsored study: Sponsor
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Governance only project
- study reviewed by an external HREC |
Site Report/Closure Form (RGO) -
one report for each site |
Milestone tab under the SSA Project for each site |
PI only |
Both Ethics and Governance project
- Single-site study where SVHM is both the HREC and the only participating site |
Site Report/Closure Form (RGO) |
Milestone tab under the SSA Project |
PI only |
Both Ethics and Governance project
- Multi-site study where SVHM is the HREC and one of the participating sites |
Both HREC and RGO report forms are required |
Milestone tab under the SVH Project for HREC Form;
and the SSA Project for each RGO Form/s |
HREC Report:
- Investigator-initiated study: CPI
- Commercially-sponsored study: Sponsor
RGO Report: PI only
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Ethics project with a closure of an external site
- Closure of a non-SVHM RGO site approved under SVHM HREC |
External Site Closure Form (HREC) |
Form tab under the SVH Project
How to submit an external site closure form |
- Investigator-initiated study: CPI
- Commercially-sponsored study: Sponsor
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Case Study Reports
A case study report is an article that describes a particular patient’s diagnosis and treatment plan. Often, a case study is used for the description of an unusual diagnosis or complications in treatment.
Process of Review
The Research Governance Unit (RGU) will be reviewing applications for case study reports.
Once reviewed, a formal letter of approval will be issued. The RGU will endeavour to have a response to your application in approximately 7-10 business days.
Please submit all Case Study Report applications to research.ethics@svhm.org.au
- There are no closing dates for Case Study reports
- ONLY ELECTRONIC COPIES are required. Please DO NOT submit hard copies to our office.
Please ensure the following documents are completed upon submitting to research.ethics@svhm.org.au
Document |
Instructions |
1. Case Study Report
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Please submit your case study abstract using our template as a guide
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2. CV of Researcher(s)
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Please submit CVs of all researchers involved in the Case Study Report
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3. Consent Form
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Please use the template provided here
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4. Support from Head of Department
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Please provide either a letter of support from Head of Department, or Chief Medical Officer if the Head of Department are directly involved in the case report.
*Please note: if the Head of Department/Chief Medical Officer signs the Case Study Report document, a separate letter is not required.
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Quality Assurance and Internal Audits
The Quality Assurance and Internal Audit processes are essential for ensuring compliance and quality in all research activities.
For more information, please contact quality.assurance@svhm.org.au
- Regular audits are conducted to ensure adherence to research protocols and guidelines.
- Feedback and recommendations are provided to researchers to improve research practices.
Please submit all required documentation to the Quality Assurance Office.
Document |
Instructions |
1. Audit Report
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Submit the completed audit report.
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2. Corrective Actions
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Include details of corrective actions taken in response to audit findings.
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Please submit all QA applications to qisubmissions@svha.org.au
- There are no closing dates for QA activities.
Please ensure the following documents are completed upon submitting to QA (qisubmissions@svha.org.au):
All necessary documents can be found in downloadable form by clicking here.
Amendments are required for any change to the approved project, including changes to the research plan, data collection, or change of investigators.
Please ensure the following documents are completed upon submitting amendments to QA (qisubmissions@svha.org.au):
All necessary documents can be found in downloadable form by clicking here.
1. QA Cover Sheet
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Please complete for any changes to the activity including:
- Request for extension of the project
- Addition of sites
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2. Updated Documents – if applicable
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A final report for QA projects will be due by the completion date proposed by the investigator on the QA application form.
The completion and submission of a final report is part of the conditions of approval for all projects. If the project has not been completed by the chosen date, please inform the Research Governance Unit.
Please submit QA final/progress reports to qisubmissions@svha.org.au using the following templates:
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QA Cover Sheet (if your study is continuing past the proposed completion date)
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Project Final Report (when your study has been completed) - this should be the finalised document created as part of your QA activity. This can be in whatever form your QA results are in (eg. PowerPoint Presentation, Poster, Flyer, Journal Article, etc.)
Please include “Final/Progress Report” and your QA study number in the email subject.
Contact Us
For more information visit the Research Governance Unit Contact Page