Low Risk Research and Quality Assurance

The Research Governance Office will be closed from 23 December 2019 to 06 January 2020. Please see submission dates below for new applications during this time period. 

Low Risk Research

The Low Risk Research Sub-committee 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:

  • 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 e.g. X-rays, DEXA

  • Assisted reproductive technology (ART)

  • Xenotransplantation

  • Toxins / mutagens / teratogens / carcinogens

  • Collection, use or disclosure of identifiable information

The Low Risk Research Sub-committee reserves the right to refer projects to a full HREC review at any time.
 

For further information, please contact Ms Lily Woods, Low Risk Officer on 03 9231 3924 or e-mail research.ethics@svhm.org.au


Low Risk Ethics, Governance or Amendment Submissions

  • Please ensure the SVHM Site Specific Guidelines for submissions are followed when submitting your application

  • Please ensure standard templates and formatting are used for submissions

  • Please ensure the Low and Negligible Risk Requirements are met

Collation of Documents

  • Please ensure applications are collated prior to submission to allow distribution to HREC members.

  • 1x hard copy and 1x e-copy should be submitted for review

  • The hard copy of each document should be clipped together in one bundle using a bulldog clip or similar; these will be kept on file.

Hard Copies of Applications must be delivered to:

Office Location: Level 5, Aikenhead Building, Building E

41 Victoria Parade, Fitzroy, 3065

 

Mailing Address: St. Vincent’s Hospital Melbourne

Research Governance Unit (RGU), PO Box 2900

Fitzroy, 3065

Electronic Copies of Applications must be delivered to:

Email: Research.Ethics@svhm.org.au

Subject: Low Risk Project ID# and CPI Name

New Low Risk Ethics Applications

The Research Governance Office will be closed from 23 December 2019 to 06 January 2020. Please see submission dates below for new applications during this time period. 

For any questions regarding submission, please contact the Research Governance Unit on ph: 03 9231 2394 or email: research.ethics@svhm.org.au

1. Low Risk Ethics Cover Letter and Checklist

1x hard copy

2. Fee Form- please include remittance advice when paying with EFT

1x hard copy

1x e-copy

3. Human Research Ethics Application (HREA) Form

*Please refer to the ERM User Guide for detailed instructions on how to create a HREA application on the ERM

*As of 01 January 2020, we will no longer accept LNR Forms. Low Risk Applications MUST complete a HREA.

1x hard copy

1x e-copy

4. Victorian Specific Module (VSM)

*The VSM is only applicable if:

  • study is seeking a Waiver of Consent

  • for Multi-site studies

1x hard copy

1x e-copy

5. Participant Information and Consent Form (PICF)

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 needsto includethe 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

Patient Information and Consent Form Contact Information

Clinical Contact Person

Position

Patient Liaison Officer at St Vincent’s Hospital Melbourne

Telephone

(03) 9231 1945

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 2394

Email

Research.ethics@svhm.org.au

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

1x hard copy

1x e-copy

6. Protocol or Research Plan

*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 hard copy

1x e-copy

7. Budgetas per sponsor or institution guidelines

1x hard copy

1x e-copy

8. Patient-Facing Materials

Such as surveys, brochures, advertisements or questionnaires

1x hard copy

1x e-copy

9. HREC Only Form of Indemnity – 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, Victoria 3065, ABN 22 052 110 755

 

9. Research Collaboration Agreement if applicable

*An RCA is applicable if:

  • The study is multi-site

  • Involves any external investigator

3x hard copies – all signed originals

10. 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 signed hard copy

1x e-copy

11. Research Team Good Clinical Practice (GCP) Certificates

GCP Certificates will need to be submitted when making an Ethics or Governance Application to SVHM RGU for the following study personnel:

  • Multi-Site Submission without SVHM as a study site– GCP Certificate of the Coordinating Principal Investigator only

  • St Vincent’s Hospital Melbourne as a study site–GCP Certificate of the Principal and all Associate Investigators

1x hard copy

1x e-copy

12. Research Team Curriculum Vitae (CVs)

1x hard copy

1x e-copy

  

New Low Risk Governance Applications

For any questions regarding submission, please contact the Research Governance Unit on ph: 03 9231 2394 or email: research.ethics@svhm.org.au

1. Low Risk Ethics Cover Letter and Checklist

1x hard copy

2. Fee Form - please include remittance advice when paying with EFT

1x hard copy

1x e-copy

3. Human Research Ethics Application (HREA) Form

1x hard copy

1x e-copy

4. HREC Approval Letter

1x hard copy

1x e-copy

5.Site-Specific (SSA) Form

*Please refer to the ERM User Guide for detailed instructions on how to create an SSA application on the ERM

1x hard copy

1x e-copy

6. Victorian Specific Module (VSM)

*The VSM is only applicable if:

  • study is seeking a Waiver of Consent

  • for Multi-site studies

1x hard copy

1x e-copy

7. Site-Specific Participant Information and Consent Form (PICF)

The following PICFs will need to be submitted for HREC Review:

  • Master PICF

  • SVHM Site-Specific PICF

Based on the Reviewing HREC Approved Master Participant Information and Consent Form.

Both tracked and clean SVHM Specific Participant Information and Consent Form Version are required for submission.

Participant Information and Consent Form Footer needs to include the 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

Patient Information and Consent Form Contact Information

Clinical Contact Person

Position

Patient Liaison Officer at St Vincent’s Hospital Melbourne

Telephone

(03) 9231 1945

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 2394

Email

Research.ethics@svhm.org.au

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

1x hard copy

1x e-copy

8. Protocol or Research Plan

1x hard copy

1x e-copy

9. Budget – as per sponsor or institution guidelines

1x hard copy

1x e-copy

10. Patient-Facing Materials

Such as surveys, brochures, advertisements or questionnaires

1x hard copy

1x e-copy

11. Standard Form of Indemnity – 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, Victoria 3065, ABN 22 052 110 755

 3x hard copies – all signed originals

12. Clinical Trial Research Agreement (CTRA) – for commercially sponsored, multi-site studies

-or-

13. Research Collaboration Agreement (RCA) – for investigator initiated, multi-site studies

*Please insert following SVHM details in the Research Agreement

  • Name of Institution: St Vincent's Hospital (Melbourne) Limited

  • Address: 41 Victoria Parade, Fitzroy VIC 3065

  • ABN: 22 052 110 755

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.

 

3x hard copies – all signed originals

14. 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 signed hard copy

1x e-copy

15. Research Team Good Clinical Practice (GCP) Certificates

GCP Certificates will need to be submitted when making an Ethics or Governance Application to SVHM RGU for the following study personnel:

  • St Vincent’s Hospital Melbourne as a study site–GCP Certificate of the Principal and all Associate Investigators

1x hard copy

1x e-copy

16. Research Team Curriculum Vitae (CVs)

1x hard copy

1x e-copy

Post Approval Amendments

Change of Principal Investigator (Permanent)

1. Low Risk Cover Sheet

1x hard copy

1x e-copy

2. Fee Form - please include remittance advice when paying with EFT

1x hard copy

1x e-copy

3. Change/Addition of Coordinating or Principal Investigator Form

1x hard copy

1x e-copy

4. CV of the new CPI/PI

1x hard copy

1x e-copy

5. GCP Certificate of the new CPI/PI

1x hard copy

1x e-copy

6. Research Collaboration Agreement (RCA) - if applicable

3x hard copies – all signed originals


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

1. Low Risk Cover Sheet

1x hard copy

1x e-copy

2. Fee Form - please include remittance advice when paying with EFT

1x hard copy

1x e-copy

3. Change/Addition of Coordinating or Principal Investigator Form

1x hard copy

1x e-copy

4. CV of the new CPI/PI

1x hard copy

1x e-copy

5. GCP Certificate of the new CPI/PI

1x hard copy

1x e-copy

6. Letter Specifying dates of the temporary change to PI

1x hard copy

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

2. CV of the new Research Team Member

1x e-copy

3. GCP Certificate of the new Research Team Memberonly for SVHM employees

1x e-copy

  

Updated Protocol 

1. Low Risk Cover Sheet

*Explaining the nature of the amendment and whether the changes/updates warrants an updated PICF

1x hard copy

1x e-copy

2. Fee Form - please include remittance advice when paying with EFT

1x hard copy

1x e-copy

3. Updated Protocol/ Investigator Brochureincluding updated version numbers and dates

1x hard copy

1x e-copy

4. Tracked Changes of the Protocol/Investigator Brochure

1x hard copy

1x e-copy

5. Summary of Changes

1x hard copy

1x e-copy

 

Updated Participant Information and Consent Form (PICF)

1. Low Risk Cover Sheet

*Explaining the nature of the PICF changes

1x hard copy

1x e-copy

2. Fee Form - please include remittance advice when paying with EFT

1x hard copy

1x e-copy

3. Updated Participant Information and Consent Form (PICF)including updated version numbers and dates

1x hard copy

1x e-copy

4. Tracked Changes of the PICF

1x hard copy

1x e-copy

 

Updated Patient-Facing Documents

1. Low Risk Cover Sheet

1x hard copy

1x e-copy

2. Fee Form - please include remittance advice when paying with EFT

1x hard copy

1x e-copy

3. Updated patient-facing documents

1x hard copy

1x e-copy

4. Tracked Changes to the patient-facing documents

1x hard copy

1x e-copy


Addition of Sites

1. Low Risk Cover Sheet

1x hard copy

1x e-copy

2. Fee Form - please include remittance advice when paying with EFT

1x hard copy

1x e-copy

3. Change/Addition of Coordinating or Principal Investigator Form

1x hard copy

1x e-copy

4. Master PICFif changing from a single to multi-site study a master PICF will be required

1x hard copy

1x e-copy

5. CV of the new CPI/PI

1x hard copy

1x e-copy

6. GCP Certificate of the new CPI/PI

1x hard copy

1x e-copy

7. Updated HREC Review Form of Indemnity – if commercially sponsored

-or-

8. Research Collaboration Agreement (RCA) – if investigator initiated, unsponsored

3x hard copies – all signed originals

9. Letter of Acknowledgment from Participating Site(s)

1x hard copy

1x e-copy

 

Addition of Satellite/Service Sites

1. Low Risk Cover Sheet

1x hard copy

1x e-copy

2. Fee Form - please include remittance advice when paying with EFT

1x hard copy

1x e-copy

3. SVHM Addition of Satellite/Service Site Form

1x hard copy

1x e-copy

4. Research Collaboration Agreement (RCA)

-or-

5. Service Agreement

3x hard copies – all signed originals

 

All Other Changes (Administrative)

1. Low Risk Cover Sheet

1x hard copy

1x e-copy

2. Fee Form - please include remittance advice when paying with EFT

1x hard copy

1x e-copy

3. Documents requiring review

1x hard copy

1x e-copy

Annual Reporting Requirements

Due on 01 May

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

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.

  • In 2017 the Research Governance Unit (RGU) implemented a new system for the submission of annual progress reports that will save significant time and resources for research staff and RGU staff.

  • Annual progress reports for research projects will be due on a single date in the year instead of the anniversary of the HREC approval date. The date chosen is the 01 May.

  • The completion and submission of an annual report is part of the conditions of ethical approval for all projects.

  • For further information, please contact Lily Woods, Research Integrity and Compliance Assistance on 03 9231 3924 or email svhm.ResearchAnnualR@svha.org.au


Submitting Annual Reports

  • Once signed by the Sponsor/CRO, or the Coordinating Principal Investigator (CPI) for a multi-site project, or the Principal Investigator (PI) for a single-site project, forward electronically to the RGU.

  • ONLY E-COPIES are required for submission. Please submit to: svhm.ResearchAnnualR@svha.org.au

All annual reports should be submitted using one or more of the following templates as applicable:

Progress Report – Project Form

*Completed by the Sponsor

HREC

Due 01 May

Project Final Report/Site Closure Report

*Completed by the Sponsor

HREC/RGO

Due

  • Upon completion of the research project (single-site or multi-site)

-or-

  • Upon site closure (multi-site project)

Progress Report – Site Form

*Completed by the Principal Investigator

RGO

Due

  • Upon completion of the research project (single-site or multi-site)

    -or-

  • Upon site closure (multi-site project)

Quality Assurance

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, audit, and quality improvement 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, staff, or members of the community. 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. Any applications initiated by an external principal investigator are not considered Quality Assurance.


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.


Process of Review

The Research Governance Unit (RGU) will be reviewing incoming Quality Assurance/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 seeking to be published, a separate formal letter of approval will be issued to the investigator. This letter will detail permission for the activity to be published, and will incur a basic QA specific administration fee.

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

New Quality Assurance Applications

Please submit all QA applications to qisubmission@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 DO NOT submit hard copies to our office.

Please ensure the following documents are completed upon submitting to QA (qisubmission@svha.org.au):

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.

4. Research Collaboration Agreement (RCA) – if applicable

 

only for multi-site QA activities that will be published

5. Fee Form – if applicable

 

Only required for publishing approval

 

 

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 (qisubmission@svha.org.au):

1. QA Cover Sheet

 

 

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 qisubmission@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)

Please include “Final/Progress Report” and your QA study number in the email subject.

News/Resources/Training Manuals


Contact Us

For more information visit the Research Governance Unit Contact Page