Advice about the ExpeditedReview process[1]

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 participantsare 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 viaexpedited 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.

  • 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?

  • Research about parentingYesNo
  • Research investigating sensitive personal issuesYesNo
  • Research investigating sensitive cultural issuesYesNo
  • Explorations of grief, death or serious/traumatic lossYesNo
  • Depression, mood states, anxietyYesNo
  • GamblingYesNo
  • Eating disordersYesNo
  • Illicit drug takingYesNo
  • Substance abuseYesNo
  • Self report of criminal behaviourYesNo
  • Any psychological disorderYesNo
  • SuicideYesNo
  • Gender identityYesNo
  • SexualityYesNo
  • Race or ethnic identityYesNo
  • Any disease or health problemYesNo
  • FertilityYesNo
  • Termination of pregnancyYesNo

Will any of the procedures to be involve?

  • Use of personal data obtained from Commonwealth

or State Government Department/AgencyYesNo

  • Deception of participantsYesNo
  • Concealing the purposes of the researchYesNo
  • Covert ObservationYesNo
  • Audio or visual recording without consentYesNo
  • Recruitment via a third party or agencyYesNo
  • Withholding from one group specific treatments or

methods of learning, from which they may ‘benefit’

eg. In medicine or teachingYesNo

  • Any psychological interventions or treatmentsYesNo
  • Administration of physical stimulationYesNo
  • Invasive physical proceduresYesNo
  • Infliction of pain YesNo
  • Physical exercise causing fatigueYesNo
  • Administration of drugsYesNo
  • Administration of other substancesYesNo
  • Administration of ionizing radiationYesNo
  • Tissue sampling or blood takingYesNo
  • Collecting body fluidYesNo
  • Genetic testingYesNo
  • Use of medical records where participants

can be identified or linkedYesNo

  • Drug trials and other clinical trialsYesNo
  • Administration of drugs or placebosYesNo
  • Exposure to shocking images/words etc YesNo
  • Extreme violation of cultural norms YesNo
  • Deprivation of basic needs (sleep,food, etc.) YesNo
  • More than 3 hours of continuous participation YesNo

Other Risks

  • Are there any risks to the researcher

Eg. Research undertaken in unsafe environments

or trouble spotsYesNo

  • 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 communityYesNo

  • Conflict of interests YesNo

Do any of the participants fall within the following targeted categories?

  • Suffer a psychological disorderYesNo
  • Suffering a physical vulnerabilityYesNo
  • Children without parental or Guardian consent YesNo
  • Resident of a custodial institutionYesNo
  • Unable to give free informed consent due to difficulties in

understanding the information statementYesNo

  • Members of socially identifiable group with special

Cultural or religious needs or political vulnerabilitiesYesNo

  • Those in dependent relationships with the researcher

Eg. Doctor/Patient, Teacher/PupilYesNo

  • Participants are able to be identified in any final report when

specific consent for this has not been givenYesNo

Actions

  • 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.
  • 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:

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[1] Adapted from Queensland Health Low Risk Ethical Review Application.