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)

SVHM uses St Vincent's Hospital Application for Governance and Ethics (SAGE), as a one-stop portal for all High and Low Risk Ethics/Governance application submission and post-approval management of research projects.

Quick reference guides and video tutorials on how to navigate SAGE is available here.

To be eligible for Low Risk Review, the project MUST NOT INCLUDE:

Women who are pregnant
Children or young people under the age of 18
Persons with an intellectual disability or mental impairment of any kind
Persons highly dependent on medical care
Persons incompetent to provide informed consent
People involved in illegal activities
Prisoners or people on parole
Research specifically recruiting Aboriginal and / or Torres Strait Islander people
Persons not usually considered to be vulnerable but would be considered vulnerable in the context of this research project
Additional clinical interventions and/or therapies

Human genetic research or gene technology

Derivation or use of human stem cells
Discomfort or risk beyond that of routine care
Deception of participants, concealment or covert observation
Examining potentially sensitive or contentious issues
Additional Radioactive substances / ionizing radiation
Assisted reproductive technology (ART)
Xenotransplantation
Toxins / mutagens / teratogens / carcinogens
Collection, use or disclosure of identifiable information

The HREC reserves the right to promote projects to high risk at any time.

Site-Specific Guidelines

Please ensure the SVHM Site Specific Guidelines for submissions are followed when submitting your application
SVHM Research Collaboration Agreement (RCA) with SVHM details inserted can be found under our Forms Tab.
Please ensure standard DHHS templates and formatting are used for submissions
Please ensure the Low and Negligible Risk Requirements are met

Chief Principal Investigator / Principal Investigator Responsibilities in Trials

New Low Risk Ethics Applications

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:

Please first complete the HREA form via Ethical Review Manager (ERM ), then submit the application form by uploading it to the SAGE portal.

*Please note: the RGU does not accept hard copy submission, only submissions via SAGE will be accepted. Please refer to SAGE Reference Guides here.

Legal documents: please adhere to the SVHM Digital Signature Guidelines.

1. Cover Letter and Checklist - Ethics – Mandatory

1x e-copy

2. Fee Form – Mandatory

Please include remittance advice when paying with EFT

1x e-copy

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.

1x e-copy

4. Victorian Specific Module (VSM) – Mandatory if Victorian Sites are involved

1x e-copy

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:

Multi-Site – Master PICF
Single-Site with only SVHM Participating – SVHM site-specific PICF

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	Patient Liaison Officer at St Vincent’s Hospital Melbourne
Telephone	(03) 9231 1954
Email	PLO@svhm.org.au

Reviewing HREC Approving this Research and HREC Executive Officer Details

Reviewing HREC Name	St. Vincent’s Hospital Melbourne HREC
Position	HREC Executive Officer
Telephone	(03) 9231 6970
Email	Research.ethics@svhm.org.au

*Please note: these details must appear exactly as it is shown below

1x e-copy

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

1x e-copy

7. Budget – as per sponsor or institution guidelines

1x e-copy

8. Patient-Facing Materials – if participants are enrolled in the study

Such as surveys, brochures, advertisements or questionnaires

1x e-copy

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)

1x e-copy (either scanned wet ink signature or docu-sign signature)

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.

1x e-copy

11. Certificate of Insurance – for all commercially sponsored studies

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

1x e-copy

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

1x e-copy

New Low Risk Governance Applications

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:

Please first complete the SSA form via Ethical Review Manager (ERM ), then submit the application form by uploading it to the SAGE portal.

*Please note: the RGU does not accept hard copy submission, only submissions via SAGE will be accepted. Please refer to SAGE Reference Guides here.

Legal documents: please adhere to the SVHM Digital Signature Guidelines.

1. Cover Letter and Checklist - Governance – Mandatory

1x e-copy

2. Fee Form – Mandatory

Please include remittance advice when paying with EFT

1x e-copy

3. HREC Approval Letter (including any amendment approval) – Mandatory

1x e-copy

4. Original Human Research Ethics Application (HREA) Form – Mandatory

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.

1x e-copy

6. Victorian Specific Module (VSM) – Mandatory if Victorian Sites are involved

1x e-copy

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.

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	Patient Liaison Officer at St Vincent’s Hospital Melbourne
Telephone	(03) 9231 1954
Email	PLO@svhm.org.au

Local HREC Officer Contact

Reviewing HREC Name	St. Vincent’s Hospital Melbourne HREC
Position	HREC Executive Officer
Telephone	(03) 9231 6970
Email	Research.ethics@svhm.org.au

*Please note: these details must appear exactly as it is shown below

1x e-copy

9. Protocol or Research Plan – Mandatory

Submit the original Protocol approved by the reviewing HREC.

1x e-copy

10. Budget – as per sponsor or institution guidelines

1x e-copy

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.

1x e-copy

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

1x e-copy (either scanned wet ink signature or docu-sign signature)

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:

Name of Institution: St Vincent's Hospital (Melbourne) Limited
Address: 41 Victoria Parade, Fitzroy VIC 3065
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.

Data Transfer Agreements & Material Transfer Agreements – for investigator initiated, multi-site clinical trials where there is a transfer of data or materials between SVHM and an external institution

1x e-copy (either scanned wet ink signature or docu-sign signature)

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.

1x e-copy

16. Certificate of Insurance – for commercially sponsored studies

Submit the original Certificate of Insurance approved by the reviewing HREC.

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

1x e-copy

18. Research Team Curriculum Vitae (CVs) – Mandatory

Provide a Curriculum Vitae for the following study personnel:

SVHM Principal Investigator
SVHM Associate Investigators / Research Coordinators

1x e-copy

Post Approval Amendments

To Submit a Study Amendment:

Please submit the application by uploading it to SAGE, see Quick Reference Guide here

*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)

1. Amendment Request Form	1x e-copy
2. Fee Form - please include remittance advice when paying with EFT	1x e-copy
3. Change/Addition of Coordinating or Principal Investigator Form	1x e-copy (either scanned wet ink signature or docu-sign signature)
4. CV of the new CPI/PI	1x e-copy
5. GCP Certificate of the new CPI/PI	1x e-copy
6. Research Collaboration Agreement (RCA) - if applicable	1x e-copy (either scanned wet ink signature or docu-sign signature)

Change of Principal Investigator (Temporary - less than 6 months)

1. Amendment Request Form	1x e-copy
2. Fee Form - please include remittance advice when paying with EFT	1x e-copy
3. Change/Addition of Coordinating or Principal Investigator Form	1x e-copy (either scanned wet ink signature or docu-sign signature)
4. CV of the new CPI/PI	1x e-copy
5. GCP Certificate of the new CPI/PI	1x e-copy
6. Letter Specifying dates of the temporary change to PI	1x e-copy

Changing Members of a Research Team (Associate Researcher or Research Coordinator)

1. Changing Members of a Research Team Form	1x e-copy (either scanned wet ink signature or docu-sign signature)
2. CV of the new Research Team Member	1x e-copy
3. GCP Certificate of the new Research Team Member	1x e-copy

Updated Protocol

1. Amendment Request Form *Explaining the nature of the amendment and whether the changes/updates warrants an updated PICF	1x e-copy
2. Fee Form - please include remittance advice when paying with EFT	1x e-copy
3. Updated Protocol/ Investigator Brochure – including updated version numbers and dates	1x e-copy
4. Tracked Changes of the Protocol/Investigator Brochure	1x e-copy
5. Summary of Changes	1x e-copy

Updated Participant Information and Consent Form (PICF)

1. Amendment Request Form *Explaining the nature of the PICF changes	1x e-copy
2. Fee Form- please include remittance advice when paying with EFT	1x e-copy
3. Updated Participant Information and Consent Form (PICF) – including updated version numbers and dates	1x e-copy
4. Tracked Changes of the PICF	1x e-copy

Updated Patient-Facing Documents

1. Amendment Request Form	1x e-copy
2. Fee Form - please include remittance advice when paying with EFT	1x e-copy
3. Updated patient-facing documents	1x e-copy
4. Tracked Changes to the patient-facing documents	1x e-copy

Addition of Sites

1. Amendment Request Form	1x e-copy
2. Fee Form - please include remittance advice when paying with EFT	1x e-copy
3. Change/Addition of Coordinating or Principal Investigator Form	1x e-copy (either scanned wet ink signature or docu-sign signature)
4. Master PICF – if changing from a single to multi-site study a master PICF will be required	1x e-copy
5. CV of the new CPI/PI	1x e-copy
6. GCP Certificate of the new CPI/PI	1x e-copy
7. Updated Form of Indemnity - HREC Review Only – if commercially sponsored -or- 8. Research Collaboration Agreement (RCA)– if investigator initiated, unsponsored	1x e-copy (either scanned wet ink signature or docu-sign signature)

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	1x e-copy
2. Fee Form - please include remittance advice when paying with EFT	1x e-copy
3. SVHM Addition of Satellite/Recruitment/Service Site Form	1x e-copy
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	1x e-copy (either scanned wet ink signature or docu-sign signature)
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	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.

1. Amendment Request Form	1x e-copy
2. Fee Form - please include remittance advice when paying with EFT	1x e-copy
3. SVHM Addition of Satellite/Recruitment/Service Site Form	1x e-copy
4. Letter of Support from Site	1x e-copy
4. CV & GCP Certificate for PI/AI - if applicable	1x e-copy
5. Patient docs - documents that be used for recruitment of participants from this site (eg. flyers)	1x e-copy
6. Updated Form of Indemnity - HREC Review Only – if commercially sponsored	1x e-copy (either scanned wet ink signature or docu-sign signature)

Addition of Service Site

Please view this document for addition information as to whether your request qualifies under this category of site addition.

1. Amendment Request Form	1x e-copy
2. Fee Form - please include remittance advice when paying with EFT	1x e-copy
3. SVHM Addition of Satellite/Recruitment/Service Site Form	1x e-copy
4. Letter of Support from Site	1x e-copy
4. Service Agreement	1x e-copy (either scanned wet ink signature or docu-sign signature)

All Other Changes (Administrative)

1. Amendment Request Form	1x e-copy
2. Fee Form - please include remittance advice when paying with EFT	1x e-copy
3. Documents requiring review	1x e-copy

Annual Reporting Requirements

Annual Safety Reports

Due on the anniversary of study approval

The completion and submission of an annual report is part of the conditions of ethical approval for all projects.
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.
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.
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.
For further information, please contact Research Integrity and Compliance Assistance on 03 9231 6987 or email: svhm.ResearchAnnualR@svha.org.au
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.

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
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
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

New Case Study Report Applications

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	Please submit your case study abstract using our template as a guide
2. CV of Researcher(s)	Please submit CVs of all researchers involved in the Case Study Report
3. Consent Form	Please use the template provided here
4. Support from Head of Department	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.

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	Submit the completed audit report.
2. Corrective Actions	Include details of corrective actions taken in response to audit findings.

New Quality Assurance & Internal Audit Applications

Please submit all QA applications to qisubmissions@svha.org.au

There are no closing dates for QA activities.

The use of ERM is not required for QA activities.
ONLY ELECTRONIC SUBMISSIONS will be accepted 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.

1. QA Cover Sheet
2. Quality Assurance/Audit Application Form	Electronic signature is accepted for this form
3. QA Participant Information/Consent Form (PICF) – if applicable
4. Participant Facing Documents - if applicable	Such as surveys, questionnaires, etc.
5. Fee Form – if applicable	Required for all QA activities that are intended to be published

Quality Assurance Post-Approval Amendments

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

Please complete for any changes to the activity including:

Request for extension of the project
Addition of sites

2. Updated Documents – if applicable

PICF (tracked and clean) with updated version numbers and dates
Protocol (tracked and clean) with updated version numbers and dates
Surveys, questionnaires, etc.
Change of Associate Investigator Form (CMORT)
Change of Principal Investigator Letter
If Publishing - Please email us with QA number, QA cover sheet and a Fee Form (for publishing approval)

Quality Assurance Annual Reporting Requirements

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:

QA Cover Sheet (if your study is continuing past the proposed completion date)
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