Risk Assessment
Checklist
Human Research Ethics Committee
About this Form
This checklist should be used to assess the level of ethical risk your human research project
presents to its participants. Projects presenting minimal ethical risk or less to participants are
eligible to apply for HREC approval via the ‘expedited review’ process.
If after completing this checklist you determine that your project presents minimal risk or less, you
are eligible to complete an Application for HREC Approval (Expedited). Please note that if you are
applying for expedited review, you must attach this completed checklist to your application form.
Expedited review cannot take place without the checklist.
If you determine that your project presents more than minimal ethical risk, it is ineligible for
expedited review and you must apply for standard HREC approval using the Application for HREC
Approval (Standard).
Student researchers must review the completed checklist with supervisors before submitting an
application.
Please note that timing constraints are not an acceptable reason for seeking expedited review
where projects are of more than everyday risk.
Completing the Form
This form can be completed on your computer. Use the tab key to move to areas in the form that
require a response and enter your response. The response area will expand to fit the content you
are entering. Click inside a checkbox to record a Yes/No response. Signatures can be applied in
required spaces once the completed form is printed.
Do not commence research until written approval has been received from the HREC.
Contact Details
Principal Researcher’s Name:
Student/Other Researcher’s
Name/s:
School/Section:
External Funding Requirements
Is the research being funded by an agency outside the University that
Yes
No
requires the approval of a full committee meeting of the HREC?
If Yes, your research is ineligible for expedited review, and you must apply for approval via
the standard HREC process.
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Risk Assessment
Checklist
Human Research Ethics Committee
Risk Assessment
A. Research Topics
Are any of the following topics to be covered in part or in whole?
Parenting
Sensitive personal issues
Sensitive cultural issues
Grief, death or serious/traumatic loss
Depression, mood states, anxiety
Gambling
Eating disorders
Illicit drug taking
Substance abuse
Self-report of criminal behaviour
Any psychological disorder
Suicide
Gender identity
Sexuality
Race or ethnic identity
Any disease or health problem
Fertility
Termination of pregnancy
B. Research Procedures
Are any of the following procedures to be employed?
Use of personal data obtained from Commonwealth/State gov’t dept/agency
Deception of participants
Concealing the purposes of the research
Covert observation
Audio-/video-recording without consent
Recruitment via a third party or agency
Withholding from one group specific ‘beneficial’ treatments/learning methods
Any psychological interventions or treatments
Administration of physical stimulation
Invasive physical procedures
Infliction of pain
Administration of drugs
Administration of other substances
Administration of ionising radiation
Tissue sampling or blood-taking
Collecting body fluid
Genetic testing
Use of medical records where participants can be identified/ linked
Drug trials and other clinical trials
Administration of drugs or placebos
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Yes
Yes
No
No
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Risk Assessment
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Human Research Ethics Committee
C. Other Risks
Are there researcher risks (e.g., unsafe environments or troublespots)?
Assessment of Participant Vulnerability
Do any of the participants fall within the following targeted categories?
Suffering from a psychological disorder
Suffering from a physical vulnerability
Highly dependent on medical care
Minors without parental or guardian consent
Impaired ability to give consent
Resident of a custodial institution
Unable to give free informed consent because of difficulties in understanding
information statement (e.g., language difficulties)
Member of a socially identifiable group with special cultural or religious needs or
political vulnerabilities
In a pre-existing (e.g. friend, family member) or dependent/unequal relationship with
researcher/s (e.g., lecturer/student, doctor/patient, teacher/pupil, professional/client,
employer/employee, supervisor/staff member)
Identifiable in any final report when specific consent for this has not been given
Indigenous Australians
Researcher Conflict of Interest
Are any of the researchers affiliated with any of the external organisations involved
in your research?
Are any of the researchers in receipt of any financial benefit from any of the external
organisations involved in your research?
Research in Overseas Settings
Does the research involve any of the following:
Research being undertaken in a politically unstable area
Research involving sensitive cultural issues
Research in countries where criticism of government and institutions may put
participants and/or researchers at risk
Yes
No
Yes
No
Yes
No
Yes
No
Ethical Risk Assessment
If you answered NO to all questions on this checklist, your project is ‘low risk’ and is eligible to be
considered for HREC approval via the expedited review process. To do this, complete an
Application for HREC Approval (Expedited) and submit it together with this signed checklist to the
Ethics Officer for review at a sub-committee meeting of the HREC.
If you answered YES to any items on this form, your project is not ‘low risk’ and is not eligible to be
considered via expedited review. You must apply for HREC approval by completing an Application
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Risk Assessment
Checklist
Human Research Ethics Committee
for HREC Approval (Standard) and submit it to the Ethics Officer for review at a full committee
meeting of the HREC.
Student researchers must review the completed checklist with supervisors before submitting any
application.
Special Case Argument
If you have answered YES to any items on this form but believe that your project may still be
eligible for expedited review because of the particular nature of the project and the participants,
please provide reasons below (or attach an additional sheet) and submit this form to the HREC
Executive for consideration of your special case by the HREC Chair.
Researcher(s) Signatures
……………………………………………………
Principal Researcher
………………………………………………………………..
Print name in block letters
Date: …..../…...../….....
……………………………………………
Other Researcher
……………………………………………
Other Researcher
………………………………………………
Print name in block letters
………………………………………………
Print name in block letters
Date: …..../…...../….....
Date: Date: …..../…...../….....
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Risk Assessment
Checklist
Human Research Ethics Committee
HREC Use Only
Special Case Approval
The Chair of the Human Research Ethics Committee has considered the particular circumstances
of this project as outlined above and agrees/does not agree that this project should be submitted
for approval via the expedited review process.
Other comments:
Signature:
____________________________________________________
Chair, Human Research Ethics Committee
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