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 the BHS Research Ethics and Governance Unit via ResearchEthics@bhs.org.au.

Information links

All progress reports must be submitted by the April 30 each year. 

Completed Annual Reports must be submitted via ERM.

 

BHS & SJGBH HREC Research Governance Fees* - Effective 1 June 2019

*All fees are inclusive of GST

For queries contact the BHS Research Ethics and Governance Unit via researchethics@bhs.org.au

Fees apply for studies submitted for ethical oversight or research governance assessment and are categorised in the table following. This fee will be charged to studies whether they are reviewed under the centralised multi-site system or as a single site study.

 

 

Research amendments

Research amendments

Administrative changes and updated investigator brochures

 

b (major)

b (minor)

c

Clinical trials - sponsored

$880

$440

$220


Commercial clinical trial - sub-studies - additional site - sponsored

$440

$220

$220


Clinical trials - sponsored (eg grants/collaborative group)

$440

$220

$220


Study - sponsored (eg grants/collaborative group)

$440

$220

$220


Study - sponsored (eg not-for-profit organisations)

$220

$220

$220


Internal BHS and SJoG initiated - non-sponsored

No fee

No fee

No fee


Internal BHS/SJoG quality improvement projects - non-sponsored

No fee

No fee

No fee


University studies ie. student/post-graduate projects

$110

$55

No fee


Independent expert review

Case-by-case

Case-by-case

Case-by-case

1. Low Negligible Risk Research Application Form (LNRR VIC) Form

Please refer to the ERM User Guide for Detailed Instructions on how to create a LNRR application on ERM

Low Negligible Risk Research Application Form

 

 

ERM User Guide

2. Victorian Specific Module (VSM)

* The VSM is only applicable if:

- Study is seeking a Waiver of Consent

- for Multi-site studies

Victorian Specific Module

3. Pre-submission (peer) review of research proposal  

Download Form 

4. Participant Information and Consent Form

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

-          Multi-Site – Master PICF

-          Single site with only BHS participating – BHS site-specific PICF

 

There are different templates available on the Department of Health website. Please use the template(s) that are appropriate for the type of research you are conducting

 

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

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

Reviewing HREC Approving this Research and HREC Executive Officer Details

 

Reviewing HREC Name

BHS SJOG HREC

Position

HREC Executive Officer

Telephone

(03) 5320 8661

Email

ResearchEthics@bhs.org.au

Participant Information and Consent Form (PICF)

 

5. Protocol or Research Plan

Protocol Template

6. Budget as per sponsor or institution guidelines

 

7. Patient-facing Materials

such as surveys, brochures, advertisements or questionnaires

 

8. Research Collaboration Agreement – if applicable

* An RCA should be used if:

- The study is multi-site

- Involves any external investigator

 

9. Research Team Curriculum Vitae (CVs)

 

 

1. Low Negligible Risk Research Application Form (LNRR VIC) Form

Please refer to the ERM User Guide for Detailed Instructions on how to create a LNRR application on ERM

Low Negligible Risk Research Application Form

 

 

ERM User Guide

2. HREC Approval Letter

 

3. Site-Specific (SSA) Form

 

Please refer to the ERM User Guide for Detailed Instructions on how to create an SSA application on ERM

Site-Specific (SSA) Form

 

ERM User Guide

 

4. Pre-submission (peer) review of research proposal  

Download Form 

5. Victorian Specific Module (VSM)

* The VSM is only applicable if:

- Study is seeking a Waiver of Consent

- for Multi-site studies

Victorian Specific Module

6. Participant Information and Consent Form

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

-          Multi-Site – Master PICF

-          Single site with only BHS participating – BHS site-specific PICF

 

There are different templates available on the Department of Health website. Please use the template(s) that are appropriate for the type of research you are conducting

 

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

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

Reviewing HREC Approving this Research and HREC Executive Officer Details

 

Reviewing HREC Name

BHS SJOG HREC

Position

HREC Executive Officer

Telephone

(03) 5320 8661

Email

ResearchEthics@bhs.org.au

Participant Information and Consent Form (PICF)

 

7. Protocol or Research Plan

Protocol Template

8. Budget as per sponsor or institution guidelines

 

9. Patient-facing Materials

such as surveys, brochures, advertisements or questionnaires
 

10. Standard Form of Indemnity – for commercially sponsored studies where BHS is providing premises for the conduct of the study

Standard Form of Indemnity

11. Research Collaboration Agreement – if applicable

* An RCA should be used if:

- The study is multi-site

- Involves any external investigator
 
12. Research Team Curriculum Vitae (CV's)
 
   

From time to time, Amendments to research projects are required. These are usually initiated by either the researchers or by external project sponsors.

Notifications of protocol Amendments must be processed via the ERM on line data base.

Documents sent to the BHS Research Ethics and Governance Unit via email cannot be accepted.

Requirements:

Amendment requests must be submitted vie Ethical Review Manager (ERM)
Applications for amendment should include background of the amendment, amended sections of the protocol, and any other relevant documentation. Changes should be highlighted for ease of review.

If the Patient Information and Consent Form (PICF) is to be amended, please utilize “tracked changes” or underline all additions and changes to the text and strikethrough any deleted original text. One approved copy is to be provided, along with one tracked copy and a final 'clean' copy. A new version number and date is required in the footer of each page of the PICF. If new researchers are to be included, their names and contact details are required on the PICF.

Confirmation of payment. Please refer to the Research Fees Schedule

Monitoring of research at Ballarat Health Services is undertaken through a number of different means:

1. HREC-Initiated Monitoring of Research Projects: where the HREC requests information from researchers about a project, e.g. annual project reports (or more frequent if required), final reports, safety reports, etc. All reports must be submitted to BHS Research and Ethics Service via ERM by the Principal Investigator.

Annual Progress Report/Final Report

It is a condition of approval by the HREC that the Principal Investigator should submit a Progress Report via Ethical Review Manager (ERM) for the study annually. If the study has been completed please use the same form to submit a Final Report along with any publications arising from the project.
Please refer to the attached “Flow Chart” to ensure compliance of the Annual /Final Progress Reports requirement for the continuation of your approved research project.

*Annual Reports for projects that have been approved in January – April in any year do not need to be submitted until 30 April the following year

Completed Annual Reports must be submitted via ERM

 

All progress reports must be submitted by the April 30 each year. 

Requirement to report- amendments, adverse events, other relevant safety information or other matters which may impact the conduct of the project.

2. Researcher-Initiated Monitoring of Research Projects: where researchers provide information to the HREC in a timely manner as the requirement to report arises, i.e. serious adverse events (SAEs) and other safety information, requests for amendment of approved protocol/documents, other correspondence.

In accordance with the National Statement Chapter 5.5.3, researchers also have a significant responsibility to monitor their research activity and must submit the following to the HREC, in relation to a given project:

Reports of Adverse/Serious Adverse Events/Suspected Unexpected Serious Adverse Reactions- and advise the HREC if the event has resulted in an amendment to the protocol and/or to the informed consent document.

Protocol amendments, updates to Investigator Brochures or changes to informed consent documents- from time to time, amendments to research projects are required. These are usually initiated by either the researchers or by external project sponsors (such as pharmaceutical companies) and may also require a change to the informed consent process.

Correspondence- notification of start of recruitment, project closed to accrual, protocol deviations or project suspended for a period of time, or any other matters that need to be reported to the HREC (including reason or discussion where appropriate).

Annual Site Progress Report/Final Report

It is a condition of approval by the HREC that the Principal Investigator should submit a site progress report for the study annually. If the study has been completed please use the same form to submit a Final Report along with any publications arising from the project. Post approval reporting is made via ERM.
Please refer to the attached “Flow Chart” to ensure compliance of the Annual /Final Progress Reports requirement for the continuation of your approved research project.

*Annual Reports for projects that have been approved in January – April in any year do not need to be submitted until 30 April the following year

Completed Annual Reports must be submitted via ERM

 

3. Office for Research-initiated: where the Office for Research requests further information about research staff or approved research projects, including auditing of research project

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.” 

Terms such as ‘peer review’, ‘quality assurance’, ‘quality improvement’, ‘quality activities’, ‘quality studies’ and ‘audit’ are often used interchangeably. In this document the term ‘quality assurance’ is used to include all of these terms. Please read the attached document to confirm that you research project meets the NS QA definition.

Ballarat Health Services Research Ethics and Governance Unit (REGU) 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 BHS 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 following essential documents are required for ethical review.

  1. QA Application 2019 to be downloaded and submitted via ERM
  2. Protocol Template
  3. Supporting Documentation

Upload the completed /signed above documents into ERM

 

 

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