Exempt from HREC review | Eligible for low risk review | Requiring full review

Levels of Ethical Review

References to 'NS' are to the National Statement on Ethical Conduct in Human Research (2007).

Researchers who are involved in a human research project must ensure that the project has undergone the appropriate level of ethical review before it can commence.

The following information and the Ethical Issues Checklist for Human Research is provided to assist researchers to determine the appropriate level of review required for the project.

Note: the checklist is a general guide only and does not replace the need for researchers to do their own thorough review against the NS. The checklist has been created to assist researchers to meet their requirement for keeping an auditable record of any research undertaken that is exempt from HREC (i.e. low risk or full) review.

Research projects with different levels of risk to participants are subject to different requirements for review.

A risk is a potential for harm, discomfort or inconvenience. It involves:

• the likelihood that any harm (or discomfort or inconvenience) will occur; and
• the severity of the harm (or discomfort or inconvenience), including its consequences.

Guidance on different levels of risk, and the differences between 'inconvenience', 'discomfort' and risks that are 'more serious than discomfort' is contained in NS 2.1. Researchers should be familiar with these definitions when considering the level of review required for the research project.

There are 3 review categories:

• research exempt from HREC review;
• research eligible for low risk review; and
• research requiring full review.

Exempt from HREC review

Research that has undergone a thorough NS review by the researchers and is considered to be 'negligible risk research', is exempt from HREC (i.e. low risk or full) review.

Research that satisfies both of the following conditions is exempt from ethical review:

• It is ‘negligible risk’ research: there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.
• It involves the use of existing collections of data or records that contain only non-identifiable data about human beings.

This can include anonymous surveys/questionnaires where the intention is to gather factual information and people’s perceptions and does not involve personally sensitive or contentious issues or use any form of concealment or deception.

Research that uses qualitative methods e.g. face-to-face interactions between participant and researcher; personal interviews; focus groups; oral histories; observation; and on-line research that identifies participants, carries more than negligible risk and requires either low risk or full review (NS 3.1).

Researchers are to keep an auditable record of any research that has been exempted from HREC review (NS 5.2.9).

Eligible for low risk review

'Low risk research' describes research which satisfies both of the following conditions:

• There is no forseeable risk of any harm to participants and others; and any foreseeable risk is no more than discomfort. Discomfort can include, for example, minor side-effects of medication, the discomfort related to measuring blood pressure, and anxiety induced by an interview (NS 2.1).
• It is not included in the following categories:
  • the use without consent of personal information in medical research, or personal health information (NS 2.3.5)
  • interventions and therapies; including clinical and non-clinical trials and innovations (NS 3.3)
  • human genetics (NS 3.5)
  • human stem cells (NS 3.6)
  • women who are pregnant and the human fetus (NS 4.1)
  • children and young people (with some exceptions) (NS 4.2)
  • people highly dependent on medical care who may be unable to give consent (NS 4.4)
  • people with a cognitive impairment, an intellectual disability, or a mental illness (NS 4.5)
  • people who may be involved in illegal activities (NS 4.6)
  • Aboriginal and Torres Strait Islander peoples (NS 4.7)
  • people in other countries (with some exceptions) (NS 4.8).

Where the risk, even if unlikely, is more serious than discomfort, the project will require full review (refer below).

Low risk research may be reviewed by a sub-committee of the HREC or executively approved by the HREC Convener. Applications for low risk review may be submitted to the HREC Secretariat at any time. The outcome of the application will normally be advised 3-4 weeks after receipt.

Research timetables should allow for the possibility that a project submitted as a low risk application may be deemed to involve more than low risk, or to raise other issues, therefore requiring full review. Researchers may be requested to provide additional information.

Psychology research applications in this category should be submitted to the School of Psychology Human Ethics Subcommittee.

Requiring full review

Research that requires full review, is research which satisfies any of the following conditions:

• It is included in the NS categories listed above
• The level of risk to participants and others is more serious than discomfort i.e. harm. Harm includes physical, psychological, devaluation of personal worth, social, economic and legal harm (NS 2.1)
• The use without consent of personal information in medical research, or personal health information
• It involves concealment or deception of any kind. Research where the true purpose, or the collection of data itself, is concealed or where participants are deceived, is not considered ethical unless compelling reasons are given for its use.

Applications for full review must be submitted to the HREC according to its annual schedule of meeting deadlines.