Ethics & governance

All research involving human participants must receive:

1. Ethical approval from a registered Human Research Ethics Committee (HREC), and

2. Organisational governance authorisation from the Research Governance Officer/Chief Executive delegate

Quality assurance vs research – what’s the difference?

The difference between quality assurance (QA) activities and research can be confusing as they often use similar research methods. Furthermore, QA and research exist on a continuum, and work that begins as one form of activity can evolve into another over time.

Irrespective of whether an activity is QA or research, those conducting the activity must consider whether the people involved will be exposed to any risk, burden, inconvenience or possible breach of privacy.

Triggers for consideration of ethical review

The NHMRC has a list of examples where ethical review should be considered:

• Where the activity potentially infringes the privacy or professional reputation of participants, providers or organisations
• Secondary use of data – that is, using data or analysis from QA or evaluation activities for another purpose
• Gathering information about the participant beyond that which is collected routinely (in other words, collecting information that does not come up or about as part of standard care)
• Information may include biospecimens or additional investigations or outcome measures
• Testing of non-standard (innovative) models of care, protocols or equipment
• Comparing two or more cohorts to one another
• Randomisation or the use of control groups or placebos
• Targeted analysis of data involving minority/vulnerable groups whose data is to be separated out of that data collected or analysed as part of the main QA/evaluation activity

Don’t forget, if there is any doubt as to whether the project is QA or research, please contact your local research office! (see contact details below).

Levels of ethics oversight

The level of risk associated with your project will determine which ethics application you will need to apply for:

Human Research Ethics Application (HREA) – more than low risk application

• Any research that is considered greater than ‘low risk’.

Low/Negligible Risk Application (LNR)

• ‘Low risk research’ describes research where the only foreseeable risk is one of discomfort.

Quality Assurance Application (QA)

Preparing and submitting an ethics application

In addition to your ethics application, you will need to provide some supporting documentation. This may vary but commonly requested documents include:

• Protocol/project proposal
• Participant Information and Consent Form (PICF)
• A CV for the researchers involved
• Good Clinical Practice completion certificate (check with your ethics office)
• Budget
• Questionnaires
• Brochures/fliers
• Invitation emails
• Interview guides
• Other relevant documents

If you work for a public health organisation, you will be asked to complete your ethics application via ERM (Ethical Review Manager). Some private health organisations partner with public health services for their ethics and governance processes and therefore may use the ERM also. ERM is an online portal that enables users to complete their research ethics applications electronically.

You can access the ERM portal here: https://au.forms.ethicalreviewmanager.com/Account/Login

Key contacts

Three health service HRECs registered with the National Health and Medical Research Council (NHMRC) are located within the western region. 

We strongly encourage you to seek advice from your local research office prior to submitting an application.

Codes and Policies for Research Ethics

All health and medical research is governed by State and national guidelines and regulations, including:

The National Statement on Ethical Conduct in Human Research

The purpose of The National Statement is:​

• To promote ethically sound human research​
• To ensure that participants are accorded the respect ​ and protection that is due to them​
• To foster research that is of benefit to the community

The Australian Code for the Responsible Conduct of Research, 2018

The Code covers:​

• Management of research data​
• Supervision of research​
• Publication and dissemination of research findings​
• Authorship​
• Peer review​
• Conflicts of interest​
• Collaborations across research institutions

Ethical considerations quality assurance and evaluation activities

• Provides guidance for the consideration of ethical issues in quality assurance and evaluation activities
• Assists organisations in developing QA policy and appropriate oversight

ICH Good Clinical Practice guideline

• Internationally accepted standard for the designing, conducting, recording and reporting of clinical trials
• Compliance with the Guideline is a condition of approval for the conduct of a clinical trial