Human Ethics FAQs

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Research involving the participation of humans at QUT (conducted by staff and/or students) must be undertaken in accordance with the National Statement on Ethical Conduct in Research Involving Humans (National Statement). The following information is based on the new requirements of the National Statement (released March 2007) and should be read in conjunction with that document.

• Am I conducting research involving human participation?
• Do I need human ethics clearance?
• I’m doing human research, and it isn’t exempt from review, what do I do now?
• How do I submit an application for ethical clearance?
• How long does the ethical review process take?

Am I conducting research involving human participation?

Human research is conducted with or about people, or their data or tissue. Human participation in research is therefore to be understood broadly, to include the involvement of human beings through:

• taking part in surveys, interviews or focus groups
• undergoing psychological, physiological or medical testing or treatment; being observed by researchers
• researchers having access to their personal documents or other materials
• the collection and use of their body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath
• access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.

The term ‘participants’ is therefore used very broadly in this National Statement to include those who may not even know they are the subjects of research; for example, where the need for their consent for the use of their tissue or data has been waived by a Human Research Ethics Committee (HREC).

In addition, the conduct of human research often has an impact on the lives of others who are not participants. When this impact is reasonably foreseeable, it may raise ethical questions for researchers and for those ethically reviewing research.

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Do I need human ethics clearance?

It is possible for a limited range of research to be exempted from review. However, in exempting this research, the Institute (QUT) needs to be satisfied that the research meets the requirements of the National Statement and is ethically acceptable.

Therefore, a researcher must still provide some level of information to allow this determination to be made and recorded.  In general, this can be achieved with a simple email to the Research Ethics Unit outlining the nature of your work, and why you believe it to be exempt.

In general, the following research can be exempted from review:

• Research that is negligible risk and that involves the use of existing collections of data or records that contain only non-identifiable data about human beings

Decisions on levels of risk should be made with reference to Chapter 2.1 of the National Statement.

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I’m doing human research, and it isn’t exempt from review, what do I do now?

You will now need to determine what level of review will be required for your research proposal. Broadly, your research will require review by one of two processes dependant on the level of risk and/or category of research. The following information will help you determine the type of review required.

What is a Designated Chapter?

Section 5.1.6 of the National Statement states that the following types of research require review by a Human Research Ethics Committee (HREC) (except where research on collections of non-identifiable data under these chapters satisfies the conditions for exemption from review):

• Chapter 3.3: Interventions and therapies, including clinical and non-clinicaltrials, and innovations
• Chapter 3.5: Human genetics,
• Chapter 3.6: Human stem cells,
• Chapter 4.1: Women who are pregnant and the human foetus,
• Chapter 4.4: People highly dependent on medical care who may be unable to give consent,
• Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness,
• Chapter 4.7: Aboriginal and Torres Strait Islander Peoples,
• Chapter 4.6: People who may be involved in illegal activities (Where research is intended to study or expose illegal activity or that is likely to discover it must be reviewed and approved by a Human Ethics Research Committee (HREC), except where that research uses collections of non-identifiable data and involves negligible risk, and may therefore be exempted from ethical review.)

Note: Section 5.1.6 also stipulates that research which is more than low risk be reviewed by a HREC.

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What is Low Risk?

Chapter 2.1 of the National Statement on Ethical Conduct in Human Research (2007) provides fuller guidance on determining risks and benefits in your research, and should also be consulted in your decision making, along with your supervisor, research team peers or Faculty Research Ethics Advisor.

The following serves as a simple checklist to some of the issues that can arise in research which may impact on determining the level of risk, and subsequent level of review required for your research

Research may lead to harms, discomforts and/or inconveniences for participants and/or others. No list of harms can be exhaustive, but one helpful classification identifies the following kinds of potential harms in research

• 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

Research is ‘low risk’ where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk. Discomforts include, for example, minor side-effects of medication, the discomforts related to measuring blood pressure, and anxiety induced by an interview. Decisions on levels of risk should be made with reference to Chapter 2.1 of the National Statement.

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How do I submit an application for ethical clearance?

Once you have determined the type of application you will need to submit (Low Risk or Committee) the general process for applying can be found in the Applications section of the website. All applications for ethical clearance must be submitted to the Research Ethics Unit for processing.

Please note we would like to receive both an electronic copy and hard copy of your application. The electronic copy should be placed within a compressed ZIP folder and emailed to ethicscontact@qut.edu.au. General information on compressed ZIP folders.

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How long does the ethical review process take?

It is important to note that compiling your ethics application may take many weeks, and it is important that you are considering ethical implications from the outset of formulating a research proposal. This is to ensure that not only is the project designed with ethical considerations in place, but also to minimise "surprises" over the length of time approval may take - which may impact on your ability to conduct the project.

Once your application is received the following timeframes are usual for the review itself:

• Low Risk Applications are considered by the Chairperson, UHREC. You should receive feedback on your application in approximately 3-4 weeks following receipt of your application by the research ethics unit.
• Committee Applications are considered at a meeting of UHREC. You should receive feedback on your application in approximately 2-3 weeks after the meeting date. Note - UHREC meets every two months - check submission dates

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