Low Risk Research and Quality Assurance

Low Risk Research

The Low Risk Research Sub-committee provides an expedited review pathway for all projects which are considered as “low risk”.

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 HREC-A for full HREC review at any time.
 

For further information, please contact Ms Leanne Clinch, Senior Administrative Officer HREC-a on 03 9288 3924 or e-mail research.ethics@svhm.org.au


The Research Governance Unit will no longer review Quality Assurance Applications.
The review of all Quality Assurance Applications will be undertaken by:

Quality & Risk

Building C - Healy Wing - Level 2
Hours: 8.00am-4.30pm

 

For further details on how to submit your application please click on the following link:

Quality Assurance Submission Audit

All new submissions can be sent via email to: qisubmissions@svha.org.au


Quick links

New Ethics Applications

There are no submission deadlines applications made to the Low Risk Subcommittee

Please ensure the following guidelines are consulted when completing your application:

Please submit 1 electronic copy of the application to research.ethics@svhm.org.au and the following in hard copy for review:



  • Fee Form - Payment is required upon submission


Master Participant Information and Consent From  - This needs to submitted for Multi-Site Studies

Documentation of Version and Date

Participant Information and Consent Form Footer needs to include the Version and Date . Please see below for recommendation:

Site Specific        -   [Protocol No.] [Site] Specific PICF [type eg. Main / Optional genetic] Ver x.x Date dd/mm/yyyy 

Master Template -   [Protocol No.] National Mutual Acceptance PICF  [type eg. Main / Optional genetic] Ver x.x Date dd/mm/yyyy 


  • Protocol or Research Plan - 1 hard copy

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 following link for guidance on developing a protocol:

http://www.spirit-statement.org/publications-downloads/


  • Victoria Specific Module - 1 hard copy

The Victoria Specific Module is only applicable if study is seeking a Waiver of Consent


  • Budget - 1 hard copy

  • Surveys/Questionnaires/Study Material - 1 hard copy



  • Letter of Acknowledgement from participating site (if Multisite) - 1 signed copy

  • CV's of the Research Team - 1 hard copy

 

Multi-site studies involving interstate sites

Mulit-site studies invovling an interstate site requires a National Ethics Application (NEAF) Form to be submitted instead of the Low and Neglible Risk Form and a Victorian Specific Module (VSM) to be submitted in addition to the documents listed above.

 

Applications should be submitted to:

Office Location:

Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065

Mailing Address:

St Vincent's Hospital Melbourne
Research Governance Unit
PO Box 2900 Fitzroy VIC 3065

 

For further information, please contact Ms Leanne Clinch, Senior Administrative Officer on 03 9231 3924 or e-mail research.ethics@svhm.org.au

New Governance Applications

After ethics approval has been obtained from an accredited HREC for your project, governance authorisation must be obtained before conducting your research at St Vincent's Hospital Melbourne. Research must not commence until governance authorisation has been granted. 

Applications can be submitted at any time (no closing date), however applications must be complete at the time of submission.

For governance applications, please submit 1 electronic copy of ALL documentation to research.ethics@svhm.org.au and the following in hard copy:


Cover Sheet - 1 signed hard copy


Fee Form - 1 signed hard copy


HREC Approval Letter - 1 hard copy


Low and Neglible Risk (LNR) Form  - 1 signed original 


LNR Site Specifc Assessment Form - 1 signed original


Participant information and Consent Form Non-Interventional (as required) - 1 hard copy

The approved master version (clean) and a SVHM site-specific version (tracked & clean) is required.


Protocol or Research Plan - 1 hard copy


Budget - 1 hard copy


Surveys/Questionnaires/Study Material - 1 hard copy


Research Collaboration Agreement - 3 signed originals

For investigator initiated, multi-site non-clinical trials


CV's of the Research Team - 1 hard copy


 

Applications should be submitted to:

Office Location:

Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065

Mailing Address:

St Vincent's Hospital Melbourne
Research Governance Unit
PO Box 2900 Fitzroy VIC 3065

 

For further information, please contact the Research Governance Unit on 03 9231 3924 or email research.ethics@svhm.org.au

Post Approval Amendments

All amendments must be reviewed and approved by the HREC before they are undertaken.

Please note that when submitting and amendment, 1 hard copy and 1 electronic copy must be submitted to the Research Governance Unit at the following:

Email: research.ethics@svhm.org.au

Location/address:

Office Location:

Level 5, Building E (Aikenhead Wing)
27 Victoria Parade
Fitzroy VIC 3065

Mailing Address:

St Vincent's Hospital Melbourne
Research Governance Unit
PO Box 2900 Fitzroy VIC 3065

 

The following documents are required when submitting an amendment. The number of hard copy documents are listed below as some cases require 3 copies of legal documents must be submitted.

 

Changing Members of a Research Team

To remove or add a researcher to the Research team please submit the following via email to research.ethics@svhm.org.au

If the Participant Information Sheet and Consent Form has been amended, please include one tracked copy and one clean copy. Please note a fee is chargeable if there is a PICF update to this request.
 
For further information, please contact The Research Governance Unit on 03 9231 2394 or email research.ethics@svhm.org.au


 

Updated Protocol 

Cover Sheet  - 1 original hard copy

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


Fee Form - 1 original hard copy

Payment required upon submission


Protocol and/or Investigator's Brochure - 1 hard tracked and clean copy


Summary of Changes - 1 hard copy


 

Updated Participant Information and Consent Form (PICF)

Cover Sheet - 1 original hard copy

Explaining the nature of the amendment.


Fee Form - 1 original hard copy

Payment required upon submission


Participant Information and Consent Form - 1 hard tracked and clean copy


 

Addition of Sites

Cover Sheet - 1 original hard copy

Explaining the nature of the amendment.


Fee Form - 1 original hard copy

Payment required upon submission


Acknowledgment Letter - 1 signed original

A letter from the Principle Investigator from the new site acknowledging their participation (This should be on the additional site's letter head)

OR

National Ethics Application Form - 1 signed original 

Only required if recruiting interstate sites.


Master Participant Information and Consent Form - 1 hard copy

If converting from a single-site study to a multi site, a master PICF is required


Curriculum Vitae of the Principal Investigator from the participating site - 1 hard copy


Research Collaboration Agreement - 3 signed originals 


If the study is currently a single site study, but is converting to a multi-site trial under the SERP process, you will need to contact the Central Allocation System (03 9096 7395) to obtain a SERP HREC Reference Number.


When converting a single site to a multi-site:

  • If adding a Victorian site only under the existing LNR process only a a letter of acknowledgement from the Principal Investigator of that site is require.
  • If adding both interstate and Victorian sites in one submission a NEAF is required.

When adding a site to an already approved Multi-site study:

  • Only an acknowledgement letter is required

 

Change of Principle Investigator

Cover Sheet - 1 original hard copy

Explaining the nature of the amendment.


Fee Form - 1 original hard copy

Payment required upon submission


Acknowledgment Letter - 1 signed original

A letter from the new Principle Investigator of the site acknowledging their participation (This should be on the additional site's letter head)


Curriculum Vitae of the new Principle Investigator - 1 hard copy


Research Collaboration Agreement- 3 signed originals 


 

For further information, please contact the Research Governance Unit on 03 9231 2394 or email research.ethics@svhm.org.au

Annual Reporting Requirements

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.

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.

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

Documents

  • Progress Report - Project Form (HREC)

  • Project Final Report/Site Closure Report (HREC)

  • Progress Report - Site Form (RGO)

    These documents can be downloaded from the Department of Health website

    How to Submit

    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.

    For further information, please contact Dr Trixie Shinkel, Senior Administrative Officer on 03 9231 3915 or email svhm.ResearchAnnualR@svha.org.au

    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.

Resources

Resources / News / Training

Resources

St Vincent's Hospital Certificates of Currency 2012-2013

  • Professional Indemnity
  • Public and Products Liability

News

Training Manuals



Contact Us

For more information visit the Research Governance Unit Contact Page