Determining Ethical Review Pathway
Before submitting a new project, you will need to determine the level of risk and which criteria your project will fall under.
High risk research
High risk research is research in which there is any possibility of harms greater than discomfort, or research which is ineligible for low or negligible risk review (NHMRC National Statement on Ethical Conduct in Human Research (2023 and updates), Chapter 2.1). Most clinical interventional research involving drugs or devices is high risk.
Potential harms in research may include:
- Physical harms: including injury, illness, pain
- Psychological harms: including feelings of worthlessness, distress, guilt, anger or fear related, for example, to disclosure of sensitive or embarrassing information, or learning about a genetic possibility of developing an untreatable disease
- 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 findings of previously unknown paternity status
- Economic harms: including the imposition of direct or indirect costs on participants
- Legal harms: including discovery and prosecution of criminal conduct
Where to submit
- Project involves Western Health site/s only:
- Multi-centre project:
Low Risk Research
Low risk research is 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. (NHMRC National Statement on Ethical Conduct in Human Research (2023 and updates) Chapter 2.1).
Discomfort can involve the body and/or mind. Discomforts include, for example, minor side-effects of medication, the discomforts related to measuring blood pressure, and anxiety induced by an interview. Where a person's reactions exceed discomfort and become distress, they should be viewed as harms.
There are a number of populations that may be vulnerable or require special consideration due to the circumstances and context of the research. Research involving these groups may not be eligible for low or minimal risk review, and should be assessed with reference to the NHMRC National Statement on Ethical Conduct in Human Research (2023 and updates) and the Health Records Act 2001 (Vic) – Statutory Guidelines on Research, and in collaboration with the Research Office, prior to submitting a low risk application.
Where to submit
- Project involves Western Health site/s only:
- Western Health Low Risk Ethics Panel (LREP) for ethics and governance approvals here.
- Multi-centre project:
Clinical Audits, Quality Assurance and Minimal Risk Research
In some circumstances, attempts to clearly separate Quality Assurance (QA) from research are unhelpful. Moreover, QA, evaluation and research exist on a continuum of activity, and work that begins as one form of activity can evolve into another over time. Importantly, QA and evaluation commonly involve minimal risk, burden or inconvenience to participants, and, while some level of oversight is necessary, HREC or LREP review processes are often not the optimal pathway for review of these activities. While HREC review is required for Research, as per NHMRC guidance, QA activities and/or evaluation projects can undergo ethical review via an alternate pathway, or in some cases be exempt from ethical review.
Accordingly, applications that meet the QA, clinical audit or evaluation activity criteria will undergo an organisational review at Office for Research level and will be granted organisational oversight approval (indicating the activity fulfils the criteria for exemption from a formal ethical review and has been authorised at WH). Researchers are able to commence once any ethical issues have been considered and resolved.
Key considerations of the organisational review aim to ensure:
- Participants in QA/evaluation projects are afforded appropriate protections and respect.
- QA and/or evaluation projects are undertaken to generate outcomes that are used to assess and/or improve service provision.
- Those who undertake QA/evaluation projects adhere to relevant ethical principles and state, territory and Commonwealth legislation.
- Organisations provide guidance and oversight to ensure activities are conducted ethically including a pathway to address concerns.
Submissions received via the QA pathway that are identified as Minimal Risk Research (MRR) will be reviewed via an expedited pathway by the Office for Research to identify any ethical issues.
The following definitions apply and should help you to determine the level of risk of your intended activity.
Minimal Risk*
The NHMRC National Statement on Ethical Conduct in Human Research (2023 updates) (Chapter 2.1), defines Mimimal 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* is research where there is no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience (NHMRC National Statement on Ethical Conduct in Human Research (2023 and updates) Chapter 2.1).
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.
For example:
- 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; or
- Project using surveys or basic short interviews, filling in a form, participating in a street survey, or giving up time to participate in research.
- And examples of burden and inconvenience may include the time that will need to be given up to participate in the research, filling in forms and costs related to travel.
- *Previously known as Negligible Risk Research- name changed by NHMRC in 2023 with launch of the new National Statement on Ethical Conduct in Human Research (2023 and updates)
Quality Assurance, Clinical Audit and Evaluation Activity
The NHMRC: Ethical Considerations in Quality Assurance and Evaluation Activities (2014), state 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 research. Furthermore, evaluation is a term that generally encompasses the systematic collection and analysis of information to make judgements, usually about the effectiveness, efficiency and/or appropriateness of an activity for example
- clinical audits;
- quality improvement activity; or
- health service delivery evaluation
Where to submit
- Project involves Western Health site/s only:
- Western Health Office for Research/Western Health Low Risk Ethics Panel (LREP) see webpage page here.
- Multi-centre project (Low Risk SSA):
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*All projects where there is the possibility of the level of risk escalating from inconvenience to discomfort (even if unlikely) should be submitted via the Low Risk Research pathway to obtain the higher level of review. For example: participant completing survey/questionnaire and there is the potential for the questions to induce anxiety or psychological discomfort.
Projects that are determined to only have a risk profile of inconvenience may be submitted via the Clinical Audits, Quality Assurance and Minimal Risk Research.
This level of risk should be discussed with the Office for Research to assist in determining the correct review pathway before commencing the application.
