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. 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 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 1 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. 1 Will any of the procedures to be involve? 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 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? 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 2 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: http://www.research.mq.edu.au/for/researchers/how_to_obtain_ethics_approval/human_r esearch_ethics/human_research_ethics_committe_meeting_dates 3