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 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:
Where to submit
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
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:
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.
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:
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
*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.