SBREC Office Use Only
Flinders University
SOCIAL AND BEHAVIOURAL RESEARCH ETHICS COMMITTEE
Risk Level
To be reviewed by:
Project No.
Low or Negligible Risk Assessment
For Social and Behavioural Research involving Humans
Project Title
Applicant / Principal Researcher Information
Title:
First Name:
Status:
Family Name:
Staff:
Flinders Uni Student No.
(Principal researcher only)
Flinders Uni Student:
Associate:
Degree enrolled in:
(please do not use acronyms)
Supervisor(s)
Flinders Uni School/Department or Organisation:
Postal Address:
Phone:
Fax:
Email:
National Statement
The National Statement on Ethical Conduct in Human Research (NS) recognises that human research involves a wide range of studies that
have different levels of risks and potential benefits. The NS states that, based on the degree of risk involved in a study, the University can
develop different Human Research Ethics Committee (HREC) mechanisms for assessing and approving research ethics applications.
Researchers and HRECs are required to determine the existence, likelihood and severity of these risks based on the research methodology and
design, participant population and research activity. The NS identifies three levels of risk outlined below. New ethics applications that fulfill any
of the three risk definitions may not need to be reviewed by the full SBREC committee.
1. Exempt Research 5.1.22 (page 79).
Research is deemed to be exempt from any ethical review if (a) it is negligible risk (as defined in paragraph 2.1.7, page 18) and involves the
use of existing collections of data or records that contain only non-identifiable data about human beings.
2. Negligible Risk Research 2.1.7 (page 18).
Research is ‘negligible risk’ where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is not more than
inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk’
3. Low Risk Research
2.1.6 (page 18). 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.
Research that does not fulfill any of the above definitions must be reviewed by the full SBREC.
If you believe (and can make a convincing argument) that your study involves only negligible (No.2) or low risk (No.3) research, the SBREC
Chair will consider expediting the HREC process. For applicants whereby the first named applicant is in the School of Psychology, this may
mean that your application will be assessed by the School of Psychology Ethics Sub-Committee (SPESC). For applicants elsewhere in the
University, this may mean your application being assessed by the SBREC Low Risk Sub-Committee or SBREC Executive. In all three instances,
the process will lead to a quicker decision for you.
If you want your application to be considered by either the SPESC or the SBREC low-risk sub-committee, you need to answer the questions
below. These will be assessed by the Chair of SBREC and s/he will decide whether or not you have provided sufficient justification for your
research being low or negligible risk. If so, your application will be emailed to the relevant sub-committee and will be assessed in a timely
fashion.
Please answer ALL of the questions below:
RISK ASSESSMENT
1. Research Topics
Please indicate whether any of the following topics will be covered in part or in whole?
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Yes
No
Yes
No
Yes
No
research about parenting
research investigating sensitive personal issues
research investigating sensitive cultural issues
explorations of grief, death or serious/traumatic loss
depression, mood states, anxiety
gambling
eating disorders
illicit drug taking
substance abuse
self-report of criminal behaviour
any other psychological disorder
suicide
gender identity
sexuality
race or ethnic identity
any disease or health problem
fertility
termination of pregnancy
2. Procedures
Are the following procedures to be employed?
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deception of participants
use of data or records from which individuals can be identified
covert observation
audio or visual recording without consent
recruitment via a third party or agency
withholding from one group specific treatments or methods or
learning, from which they may ‘benefit’ (e.g., medicine or teaching)
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any psychological interventions or treatments
administration of physical stimulation (e.g., light treatment in eyes)
administration of devices to be swallowed (e.g., capsules)
infliction of pain
administration of ionising radiation
collecting bodily fluid
Conflict of Interest
 conflict of interest may exist (e.g., financial or other relationship)
3. Participant Vulnerability Assessment
Do any of the participants fall within the following categories?
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suffering a psychological disorder
suffering a physical vulnerability
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people highly dependent on medical care
minors (0 – 18 years)
minors (School of Psychology students aged 17)
people whose ability to give consent is impaired
resident of a custodial institution
unable to give free and informed consent because of difficulties in
understanding information statement (e.g, language difficulties)
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members of a socially identifiable group with special cultural or
religious needs or political vulnerabilities
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those in a dependent relationship with the researchers (e.g., student/lecturer,
doctor/patient, service provider/client, employer/employee)
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participants able to be identified in any final report or publication when
specific consent for this has not been given
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Indigenous Australians
4. Research in Overseas Settings Assessment
Will any of your research be conducted overseas? If yes, please specify which country or countries.
Does the research involve any of the following:
Yes
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No
research being undertaken in a politically unstable area
research involving sensitive cultural issues
research in countries where criticism of government and
institutions might put participants and/or researchers at risk
ETHICAL PRINCIPLES
If you believe your research is low or negligible risk, please provide a convincing argument below. We have provided the four ethical principles
that underpin the National Statement on Ethical Conduct in Human Research (refer to Section 1 of the NS for a definition of these ethical
principles) – in no more than 100 words per ethical principle, provide detail of why your proposed study is low or negligible risk. In each of these
sections, make specific reference to the definitions of low or negligible risk outlined above.
1.
Research Merit and Integrity (no more than 100 words justification)
2.
Justice (no more than 100 words justification)
3.
Beneficence (no more than 100 words justification)
4.
Respect (no more than 100 words justification)