Logo Western Health Logo Western Health Western Health logo Emergency

Getting started with research and ethics review pathways

Before submitting a new project, you will need to determine the level of risk and which criteria your project will fall under.
OfficeOfResearch.png

Involve a Western Health investigator 

To be approved to conduct research at Western Health: 

  • A WH employee with research experience must be involved in every project.
  • That person must be listed as the Principal Investigator (PI) at the WH site. 

The nominated PI must:  

  • have expertise in a discipline relevant to the project 
  • have more than 2 research publications, or demonstrate equivalent research experience if no publications exist (to be detailed in their curriculum vitae) 
  • act as a liaison between the external researchers and Western Health 
  • provide local knowledge to support the conduct of the research 
  • be kept regularly updated on the project’s progress and by the external researchers.  

 

Student researchers 

Postgraduate students with some research experience and 2 or more publications may be eligible to be nominated as the PI. Undergraduate students, however, with limited research experience or fewer than 2 publications should not be listed as the PI on a project.  

For those who are ineligible, their supervisor or a senior colleague involved in the project and who has the appropriate research experience should take on the role of PI and be responsible for managing the project.  

This helps ensure that all research projects have the necessary leadership and oversight.  

 

Investigator qualifications 

  • All researchers must submit a CV using the Western Health CV Template or a signed and dated full CV with accompanying WH Code of Conduct (2023) declaration.
  • It is mandatory for all PIs and study coordinators to have completed GCP training – please provide certificate of completion (within last 3 years).
  • An Honorary Researcher Appointment is required for all external researchers who have contact with patients, access data or use our resources/facilities. 

 

Research oversight at Western Health

The Office for Research provides ethics and governance oversight for research projects carried out at Western Health sites.  

At Western Health, we do not have a Human Research Ethics Committee (HREC) and cannot review higher risk research. 

However, as outlined in the NHMRC National Statement on Ethical Conduct in Research 2025, we do have an alternate organisational review body that can: 

  • provide ethics review and approval of low risk research projects
  • provide review and approval of minimal risk research, evaluation projects, quality assurance and clinical audit projects. 

 

Choosing the right ethics review pathway 

The type of ethics review your project needs depends on the level of risk involved. 

Before you start preparing your research ethics application for submission to Western Health, it’s important to first work out the risk level of your project. 

The National Statement on Ethical Conduct in Human Research 2025 (Section 2, Chapter 2.1, page 13) explains the different risk categories in human research. 

 

Site-Specific Assessment (SSA) at Western Health 

Before you can start your research project at Western Health, you must obtain Site-Specific Assessment (SSA) Authorisation from us. 

We can grant SSA Authorisation only after we complete a research governance review and confirm that all requirements have been met. 

You can submit your SSA application at the same time as your ethics application, or after you’ve received ethics approval. 

For details on how to submit an SSA application, please visit our Research Governance page. 

 

Research risk profiles 

Figure 1: Risk profiles of research (NHMRC National Statement on Ethical Conduct in Human Research 2025, Section 2, Ch 2.1, pg.13) 

LOWER RISK 

HIGHER RISK 

Minimal 

Low 

Greater than Low 

High 

No risk of harm or discomfort*; potential for minor burden or inconvenience 

No risk or harm; risk of discomfort* 

(+/- foreseeable burden)  

Risk of harm** 

(+/- foreseeable burden) 

Risk of significant harm** 

(+/- foreseeable burden) 

 

*Potential discomforts in research can affect the body and/or mind and may include:  

  • mild side effects from a medication
  • slight pressure or irritation when measuring blood pressure
  • feeling anxious during an interview.  

If a person’s reaction goes beyond discomfort – for example, if they become distressed – this is considered a harm. 

**Potential harms in research may include: 

  • physical harms, including injury, illness, pain or death
  • psychological harms, including feelings of worthlessness, distress, guilt, anger, fear or anxiety
  • devaluation of personal worth, including being humiliated, manipulated or in other ways treated disrespectfully or unjustly
  • social harms, including damage to social networks or relationships with others; discrimination in access to benefits, services, employment or insurance; social stigmatisation; and unauthorised disclosure of personal information
  • economic harms, including the imposition of direct or indirect costs on participants
  • legal harms, including discovery and prosecution of criminal conduct. 

 

Higher risk research 

This is research where the risk to participants (or others) goes beyond discomfort. Research in this category carries risk of harm and is therefore considered higher risk research that requires review by a Human Research Ethics Committee. Most clinical interventional research involving drugs and/or devices is higher risk research.  

If your higher risk research project will only take place at Western Health, you must get ethics review approval from an HREC that is registered and certified with the NHMRC. 

If your higher risk research project involves multiple sites, including Western Health, the ethics review must be done by an HREC that is: 

  • registered and certified by the NHMRC
  • participating in the National Mutual Acceptance (NMA) scheme. 

Note: By agreement, Western Health may accept ethics reviews conducted by registered and certified HRECs that are not part of the NMA scheme. 

If the HREC you plan to use is not part of the NMA scheme, please contact the Office for Research before submitting your application. We will advise you whether the selected HREC is acceptable for review. 

Important: A Site-Specific Assessment application is also required for all higher risk research and can be submitted to Western Health at the same time as your ethics review submission, or after you receive ethics approval. 

Please ensure you list all the Western Health sites involved on the ethics application, so it is reflected on the HREC Approval letter; for example, Western Health: Footscray Hospital, Sunshine Hospital and Williamstown Hospital. 

Getting ethics review and approval for higher risk research  

 

Low risk research 

Low risk research is research where the only possible risk to participants is discomfort. If there’s a chance of greater harm – like pain or serious emotional distress – then the project is not considered low risk. 

Research involving vulnerable groups 

Some groups may be vulnerable or require special consideration due to their circumstances or the context of the research. 

If your project involves one of these groups, it may not qualify for low or minimal risk review. 

Before submitting a low risk application, you should: 

Getting ethics review and approval for low risk research 

 

When HREC review is not required 

According to the NHMRC, formal ethics review by an HREC is only required for research that involves more than low risk to participants. 

If your project only poses minimal burden or inconvenience, it may: 

  • meet the definition of a quality assurance, clinical audit, evaluation, or minimal risk research activity
  • fulfil the NHMRC’s criteria for exemption from formal ethics review
  • be reviewed instead through an organisational review by Western Health’s Office for Research. 

 

Fast-tracked submission pathway 

If your project is exempt: 

  • It will be reviewed via the expedited QA/MRR pathway at Western Health.
  • You will receive Organisational Approval, confirming:
  • The project is authorised by Western Health.
  • It meets the NHMRC exemption criteria. 

This process still checks for ethical issues, but without requiring full HREC review. 

You can start your project once ethical issues have been addressed and your application has been approved. 

 

What the organisational review looks at 

The Office for Research will review your project to ensure: 

  • participants are treated with respect and protected appropriately
  • the activity is genuinely designed to improve or evaluate service delivery
  • there are no ethical issues or risks that would require full HREC review
  • organisations provide guidance and oversight to ensure the activity is conducted ethically, including a pathway to address concerns
  • anyone conducting the activity follows relevant laws and ethical standards. 

Researchers can commence their projects once any ethical issues have been considered and resolved, and the project issued approval.  

Key considerations of the organisational review (via the expedited QA pathway) aim to ensure: 

  • Participants in these projects are afforded appropriate protections and respect.
  • Projects are undertaken to generate outcomes that are used to assess and/or improve service provision.
  • There are no ethical issues or risk levels that would elevate the activity to formal ethical review.
  • Organisations provide guidance and oversight to ensure activities are conducted ethically including a pathway to address concerns.
  • Those who undertake these projects adhere to relevant ethical principles and state, territory and Commonwealth legislation. 

The following definitions for activities exempt from formal ethics review apply and should help you determine the risk level of your intended activity. 

 

Clinical audits, quality assurance and minimal risk research 

Minimal risk research 

The NHMRC National Statement 2025 (Chapter 2.1) defines minimal risk as: 

  • no risk of harm or discomfort; potential for minor burden or inconvenience
  • neither burden nor inconvenience should be considered a type of harm or discomfort and therefore should not be viewed as a risk. 

Minimal risk research generally aims to establish new knowledge about a disease by review of information that has already been collected and is stored at the local site only, or by collection of information via surveys or interviews. 

Examples of minimal risk research include: 

  • use of existing de-identified clinical data with no foreseeable risk to the participants
  • use of existing research data for which consent has been provided for the secondary use
  • project using surveys or basic short interviews, filling in a form, participating in a street survey, or giving up time to participate in research. 

Examples of burden and inconvenience may include: 

  • filling in forms
  • the time required to participate in the research
  • costs related to travel. 

Please note: If there’s any chance that your project’s risks could increase from being a minor inconvenience to causing discomfort (even if it’s unlikely), you should submit the project through the Low Risk Research pathway. This ensures the project receives a higher level of review.  

For example, your survey or questionnaire might include questions that make participants feel anxious or emotionally uncomfortable.  

Quality assurance, clinical audit and evaluation activity 

The NHMRC: Ethical Considerations in Quality Assurance and Evaluation Activities (2014) states that the primary purpose of these studies “is to monitor or improve the quality of service delivered by an individual or an organisation”.  

Audits form part of standard hospital monitoring processes and are not considered research.  

The term ‘evaluation’ usually refers to the collection and analysis of information to assess the effectiveness, efficiency and appropriateness of an activity.  

Examples of evaluation activities include:  

  • clinical audits
  • quality improvement activity
  • health service delivery evaluation. 

Projects with only a risk profile of inconvenience and which use re-identifiable or non-identifiable data may be submitted via the Clinical Audits, Quality Assurance and Minimal Risk Research pathway. 

Before starting your application, it’s a good idea to discuss the level of risk with the Office for Research. This can help you choose the correct review pathway.  

 

Where to submit 

 

Related resources 

National Health and Medical Research Council (NHMRC) 

National Statement on Ethical Conduct in Human Research 2025 

NHMRC: Ethical Considerations in Quality Assurance and Evaluation Activities (2014) 

In the case of a life threatening emergency, call 000.
Emergency