Low risk research is research in which the only foreseeable risk to the participant is one of discomfort.
In accordance with Chapter 5 of the NHMRC National Statement on Ethical Conduct in Human Research (2007) and sections 5.1.18 to 5.1.21 in particular, the MH HREC has established a Low Risk Research Sub-Committee for the review of research involving no more than low risk.
The Low Risk Research Sub-Committee is an informal sub-committee of the HREC, which meets in the week prior to the monthly meeting of the full HREC.
The minutes of the meetings of the Low Risk Research Sub-Committee are incorporated into the agenda of the main HREC meeting and then the minutes of the next scheduled meeting of the HREC and the decisions of the Low Risk Research Sub-Committee must be endorsed and adopted by the HREC before any correspondence is forwarded to the researchers involved.
What makes a 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. (NS Chapter 2.1)
To be eligible for Low Risk Review, the project must not include:
- Women who are pregnant
- Children or young people under the age of 18
- Persons with an intellectual disability or severe mental impairment
- Persons highly dependent on medical care
- Persons incompetent to provide informed consent
- People involved in illegal activities
- Persons not usually considered to be vulnerable but would be considered vulnerable in the context of this research project
- Additional clinical interventions and/or therapies (such as an application of a drug or device)
- Human genetic research or gene technology or use of human stem cells
- Deception of participants, concealment or covert observation
- Exposure to ionising radiation, such as x-rays and DEXA
- Invasive procedures (such as blood samples or obtaining biopsies outside of standard care)These are generally not considered to meet the criteria for low risk because they are deemed to be invasive and may constitute a level of risk, which even if unlikely, is more serious than discomfort. (Please see the further explanation below, and/ or contact the Office for Research for further information)
In order to measure the level of risk associated with your planned project, you should take the following into account:
- the kinds of harm, discomfort or inconvenience that may occur;
- the likelihood of these occurring; and
- the severity of any harm that may occur.
Often research studies will involve the collection of blood or tissue samples for the purpose of research, in addition to the collection of the samples for standard of care purposes. Whilst these research purposed samples may be collected at the same time, and via the same procedure as the collection of samples for standard of care purposes, the collection of new samples or any variation to the collection process poses additional risks for participants. As such applications of this nature automatically constitute a ‘greater than low risk’ application, which should be submitted on the NEAF for the review of the full ethics committee.
If you are unsure whether your project is low risk, contact the Office for Research.
The Low Risk Research Sub-committee reserves the right to refer projects to full HREC review at any time. They also reserve the right to request that a full National Ethics Application Form (NEAF) be submitted rather than a Low and Negligible Risk (LNR) form. This is because the NEAF does not cover many of the ethical issues that may arise in medium to high risk research projects.
If you are confident your project is low risk, you can start the HREC ethical review application process.
Find out how to apply for ethical review.
Note that you are required to submit an application for Ethics and an application for Governance approval.