Advice about the Expedited Ethical Review process

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Advice about the Expedited Review process1
MQ HREC Expedited Ethical Review Checklist
(NHMRC ‘National Statement on Ethical Conduct in Human Research’ Sections 2.1.6, 5.1.6, 5.1.7, 5.1.18 – 5.1.21)
Low risk studies involve an activity where participants are unlikely to suffer burden or harm.
These studies must not present any more than what could be considered a minimal risk
and/or burden to participants. Risks to participants include not only physical risks, but also
psychological, spiritual, social harm or distress. Burdens may include research that is
intrusive, causes discomfort, inconvenience or embarrassment for the participants.
Research involving no more than low risk may be exempted from full ethics review and be
processed via expedited ethical review. Researchers are encouraged to complete the
checklist below. If the project includes any of the nine following types of research and/or
participants it will not be eligible for expedited ethical review.
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Interventions and therapies, including clinical and non-clinical trials and innovations
Human genetics
Human stem cells
Women who are pregnant and the human foetus
People who are highly dependent on medial care who may be unable to give consent
People with a cognitive impairment, an intellectual disability or a mental illness
People who may be involved in illegal activities
Research specifically targeting Aboriginal or Torres Strait Islanders.
If the project does not include the above, complete the checklist below to ascertain whether
the proposed research is eligible for consideration for low risk review by the expedited ethical
review process on ‘Distributor’. A ‘yes’ answer to any of the questions below does not
automatically preclude the research from being reviewed via the expedited review process. If,
however, you have multiple ‘yes’ answers, your research is not eligible for the expedited
ethical review.
Will the Research cover any of the following topics?
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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 psychological disorder
Suicide
Gender identity
Sexuality
Race or ethnic identity
Any disease or health problem
Fertility
Termination of pregnancy
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Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Adapted from Queensland Health Low Risk Ethical Review Application.
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Will any of the procedures to be involve?
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Use of personal data obtained from Commonwealth
or State Government Department/Agency
Deception of participants
Concealing the purposes of the research
Covert Observation
Audio or visual recording without consent
Recruitment via a third party or agency
Withholding from one group specific treatments or
methods of learning, from which they may ‘benefit’
eg. In medicine or teaching
Any psychological interventions or treatments
Administration of physical stimulation
Invasive physical procedures
Infliction of pain
Physical exercise causing fatigue
Administration of drugs
Administration of other substances
Administration of ionizing radiation
Tissue sampling or blood taking
Collecting body fluid
Genetic testing
Use of medical records where participants
can be identified or linked
Drug trials and other clinical trials
Administration of drugs or placebos
Exposure to shocking images/words etc
Extreme violation of cultural norms
Deprivation of basic needs (sleep, food, etc.)
More than 3 hours of continuous participation
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
Yes
No
Yes
Yes
No
No
Other Risks
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Are there any risks to the researcher
Eg. Research undertaken in unsafe environments
or trouble spots
Are there any risks to non participants in the research
Such as, participant family members and social community
Eg. Effects of biography on family and friends or
Infectious disease risk to the community
Conflict of interests
Do any of the participants fall within the following targeted categories?
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Suffer a psychological disorder
Suffering a physical vulnerability
Children without parental or Guardian consent
Resident of a custodial institution
Unable to give free informed consent due to difficulties in
understanding the information statement
Members of socially identifiable group with special
Cultural or religious needs or political vulnerabilities
Those in dependent relationships with the researcher
Eg. Doctor/Patient, Teacher/Pupil
Participants are able to be identified in any final report when
specific consent for this has not been given
Yes
Yes
Yes
Yes
No
No
No
No
Yes
No
Yes
No
Yes
No
Yes
No
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Actions
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If you answered ‘No’ to all questions, you can submit your application at any time for
expedited ethical review.
If you answered ‘Yes’ to one question, we recommend that you discuss your application
with your Faculty Ethics Advisor or contact the Ethics Secretariat ethics.secretariat@
mq.edu.au.
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If you answered ‘Yes’ multiple times your application will be reviewed by the Human
Research Ethics Committee. The meeting dates can be found at the following website:
http://www.research.mq.edu.au/for/researchers/how_to_obtain_ethics_approval/human_r
esearch_ethics/human_research_ethics_committe_meeting_dates
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