Most research involving human participants will require ethics oversight of some kind, the level of which will be dependent on the risk of research being undertaken.
An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a QA activity. Terms such as ‘peer review’, ‘quality assurance’, ‘quality improvement’, ‘quality activities’, ‘quality studies’ and ‘audit’ are often used interchangeably.
All Quality Assurance (QA) projects including clinical audit, evaluation activities, service redesign and quality improvement projects must be submitted for ethics review if intention is to publish or present the findings beyond SWH.
If the duration of the project is beyond two years or the risk is beyond the routine care/ business than the project will not qualify as QA or negligible risk.
Research is broad and includes the creation of new knowledge and/or the use of existing knowledge in a new and creative way so as to generate new concepts, methodologies, inventions and understandings. This could include synthesis and analysis of previous research to the extent that it is new and creative.
In the health field research can be defined as the systematic investigation of a problem, issue or question which increases knowledge and understanding of health and the provision of care.
Refer to Ethical Considerations in Quality Assurance and Evaluation Activities (NHMRC, 2014) and National Statement on Ethical Conduct in Human Research (NHMRC, 2007) for more information.
The NHMRC’s advice outlined below, states that where one or more of the triggers below apply, ethical review should be sought:
The South West Healthcare Centre for Research Education and Teaching (CREATe) unit has one review process for all research projects for the ethics and governance oversight. All research applications including negligible, low and greater than low risk are submitted to SWH HREC for ethical review and approval, and recommendations are made to the CEO for Site Specific Authorisation.
SWH HREC reviews all single-site negligible risk, low risk and greater than low risk projects involving patients, staff and resources.
It is advisable to discuss your research project at least six weeks prior to HREC meeting. The risk level of the research determines the application type – Low and Negligible Risk (LNR VIC) form or Human Research Ethics Application (HREA).
It is advisable to have your project peer reviewed if you are a novice researcher and submitting application for the first time.
Please refer to further information below
South West Healthcare is a participating health service in the National Mutual Acceptance (NMA) scheme. This process streamlines the single scientific and ethical review of multi-centre human research, including clinical trials and low risk projects.
This means that for project that has been granted ethical approval by a certified HREC needs to undergo Site Specific Assessment only. For queries related to ethics application for multi-site study, Investigators should contact the Coordinating office for Clinical Trial Research at firstname.lastname@example.org.
Site specific assessment (SSA) is conducted for all multi-site and single-site research projects. The form is available on ERM.
It is the Principal Investigator’s responsibility to complete the application and obtain the necessary signatures from Head of Department or supporting departments.
For the detailed SSA information refer to SWH site specific assessment procedure
|Protocol or project description|
|Participant information and consent form(s)
Several PICF templates for health and medical research projects are available on Victorian Clinical Trials Research webpage. Please use the one suitable for your research.
Depending on the research type alternative options to ‘Consent’ including –waiver of consent, or an opt-out approach are available for low risk research. Kindly discuss with us for details.
Participant Information and Consent Form (PICF) (Section 5)
SWH specific information must be added on PICF, including:
|Participant-specific documents – advertising documents (email, flyer, text message, transcript for phone call), brochures, letter of invitation|
|Data Collection tools –survey, questionnaire|
|Investigator Curriculum Vitae (CV)|
|Investigators GCP certificate and registration evidence|
|Research Collaboration Agreement|
|Certificate of Insurance|
SWH HREC will conduct ethical review of proposal in accordance with the National Statement on Ethical Conduct in Human Research and the Australian Code for the Responsible Conduct of Research. HREC can – approve, request amendment for proposals that require further development or reject a proposal.
The Principal Investigator is required to address all queries and resubmit through ERM.