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 (National Statement on Ethical Conduct in Human Research (2007), Chapter 2.1). Most clinical interventional research involving drugs or devices is high risk.
Potential harms in research may include:
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. 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 (National Statement on Ethical Conduct in Human Research (2007), 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. 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 National Statement on Ethical Conduct in Human Research (2007) 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.
Quality Assurance is an activity where the primary purpose is to monitor or evaluate the quality of a current service or practice provided by an individual or an organisation with the aim of improving that service or practice. Audits form part of standard hospital monitoring processes and are not research. Quality assurance and audit projects are usually retrospective, and evidence of ethical consideration is required prior to the publication of either. It is recommended that quality assurance and audit projects are discussed with the Research Office prior to submitting the appropriate application.
A waiver of consent may be requested for a project that satisfies all required criteria as listed in the National Statement on Ethical Conduct in Human Research (2007), Chapter 2.3.10. A request for waiver of consent must be submitted for full HREC review via the high risk research submission process. Only an HREC may grant waiver of consent for research using personal information in medical research, or personal health information. It is recommended that requests are discussed with the Research Office prior to submission.
The Western Health Low Risk Ethics Panel (LREP) is constituted according to the requirements of the National Health and Medical Research Council of Australia (NHMRC). The function of this panel is to consider the ethical implications of research applications submitted to the panel for review and to evaluate the ethical conduct of the research. The panel will be responsible for review of all quality assurance, negligible risk and low risk research from the Western Health Network.
Before submitting a new project, you will need to determine the level of risk and which criteria your project will fall under.
For the purpose of simplicity you should answer the following questions about your project:
Is this project undertaken for a valid purpose and does it aim to use the outcomes to improve delivery of health care?
Does this project seek to identify and/or quantify problems within, or impediments to, good health care delivery and to identify ways of improving those problems?
Does this project seek to evaluate current health practices or to monitor the introduction of a new practice?
Could this project infringe on ethical principles that guide human research?
If you answer yes to questions 1 to 3 your project may fit the definition of a low risk QA project. To seek approval for a QA project, you need to complete the QA Application Form and if applicable, complete the QA Participant Information and Consent Form. QA projects are reviewed by one member of the WH Low Risk Ethics Panel.
If you answered yes to question 4 your project may warrant ethical review and need to be submitted to the WH Low Risk Ethics Panel as a research project. The following table may assist you in determining whether your project falls in the QA, low risk or high risk category, if unsure contact the Office for Research to clarify.
For High Risk projects that do not fit under the Multi-centre Streamlined Ethical Review/Interstate Mutual Acceptance Process (website) are required to submit to Melbourne Health HREC for ethical review and approval.
For Paediatric single site studies (to be conducted at WH only), please submit toThe Royal Children's Hospital HREC for ethical review and approval.
Retrospective medical audit of current practice. No new information collected outside of standard care.
Prospective study comparing "standard of care"Impact on patients? If review will identify issues that will require patients to be contacted/treatment amended
Prospective study comparing "standard of care" vs intervention
Questionnaire based research
Questionnaires/survey of treatment group
Patients group - survey of patients outside "usual care"
7 years/ Clinical Trial 15 years/25 years for studies with children
Consent is not required
Participants able to consent for themselves
Patients unable to consent for themselves or waiver of consent (data use not related to purpose of collection)
Data re-identifiable or non-identifiable
Collect and use identifiable data
Collect, use and release of identifiable data. Databases. Tissues and Genetics Samples
Intervention & Impact risk to participants
Minimal or none
Participants - high impact, unable to consent and/or "vulnerable" group e.g. Children; Pregnant women; People with a cognitive impairment, an intellectual disability or a mental illness