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 include the following information in the email and subject:

  • Project ID
  • HREC number (if possible)
  • Documents for review (including fee form)
  • Detail regarding the submission (eg. "new ethics submission, new governance submission)

*Please note: the RGU does not accept hard copy submission.

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. 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 include the following information in the email and subject:

  • Project ID
  • HREC number (if possible)
  • Documents for review (including fee form)
  • Detail regarding the submission (eg. "new ethics submission, new governance submission)

*Please note: the RGU does not accept hard copy submission.

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.

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 include the following information in the email and subject:

  • Project ID
  • HREC number (if possible)
  • Documents for review (including fee form)
  • detail regarding the submission (eg. "amendment (protocol and PICF)

*Please note: the RGU does not accept hard copy submission.

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

  

  • 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

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.

New Case Study Report Applications

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

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 & Internal Audits

Quality Assurance is defined by the NHMRC as:

“An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation.”

QA and internal audit are terms used interchangeably to refer to activities that fall under the auspice of Quality Assurance review. St. Vincent’s Hospital Research Governance Unit (RGU) aims to encourage and facilitate the process of Quality Assurance activities, as it is an essential process for improving health services and patient outcomes. QA aims to gain information on specific services to create better outcomes and more effective processes.

QA activities may involve patients or staff of SVHM and SVHM affiliated facilities. Therefore, it is equally important for Quality Assurance activities to be conducted with ethical consideration of those involved. 

Quality Assurance activities must be initiated by a St. Vincent’s Hospital Principal Investigator and focused on an SVHM department specifically. Any applications initiated by an external principal investigator are not considered Quality Assurance. SVHM does not approve multisite QA activity, nor QA activity for other institutions. 

QA must not be conducted with intent to publish. If publication is the aim of the project, please submit a low risk ethics application. 

Quality Improvement projects are not reviewed as Quality Assurance activity. If your application aims to implement changes within a department for improvement purposes, please submit a low risk ethics application. 

To be eligible for Quality Assurance, the project MUST NOT:

  • Aim to generate new generalizable knowledge

  • Involve any significant departure from the routine clinical care provided to patients

  • Involve randomisation, control groups, or use of placebo

  • Seek to gather information about the participant beyond that collected as part of routine care

  • Involve additional testing, blood or tissue collection

  • Involve the assessment of safety/efficacy of a new intervention/device

  • Impose any additional burden, harm or risk, beyond those associated with routine care

Please proceed with a Low Risk Application if your activity involves any of the above.

Research Using a Database

Any research using a database MUST:

  • Receive ethical approval, and is therefore, not considered a Quality Assurance activity. If the research involves vulnerable populations it may need to be reviewed by the full HREC
  • Use a waiver of consent or opt out approach
  • Hold only deidentified information

If the database is intended to be used for further data analysis than stated in the initial application, an additional ethics application must be submitted.

Process of Review

The Research Governance Unit (RGU) will be reviewing incoming Quality Assurance/Internal Audit applications as of 01 December 2019.

The RGU will determine whether applications are within the scope of quality assurance activities, or advise escalation of the project to Low-Risk Research if determined to be outside of the scope of QA.

Once reviewed, an e-mail approval will be issued to the investigator permitting the commencement of the QA activity. For QA activities which have paid an administration fee for publication, a separate formal letter of approval will be issued to the investigator detailing permission for the activity to be published.

The RGU will endeavour to have a response to your application in approximately 7-10 business days.

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

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