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 (2007 updated 2018), 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 & Negligible 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 (2007 updated 2018) 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.
Negligible risk research* is research in which 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 (2007 updated 2018) Chapter 2.1). Examples of inconvenience may include filling in a form, participating in a street survey, or giving up time to participate in research.
Negligible 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.
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 negligible risk review, and should be assessed with reference to the NHMRC National Statement on Ethical Conduct in Human Research (2007 updated 2018) and the Health Records Act 2001 (Vic) – Statutory Guidelines on Research, and in collaboration with the Research Office, prior to submitting a low or negligible 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 Negligible 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 Negligible Risk Research (NRR) will require an ethical review and will therefore be reviewed by a member of the LREP via an expedited pathway.
The following definitions apply and should help you to determine the level of risk of your intended activity.
Negligible Risk*
The NHMRC National Statement on Ethical Conduct in Human Research (2007 updated 2018) (Chapter 2.1), defines negligible risk as "when there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk". 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
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 & Negligible 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 Negligible 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.
