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Ethics Review

Ethics Review. Tom Smith. Research on Human Subjects. A useful starting point is the presumption that research on Human subjects is not allowed unless ethical concerns are satisfied You can think of the University’s Human Ethics Process as the Gateway to Human research

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Ethics Review

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  1. Ethics Review Tom Smith

  2. Research on Human Subjects • A useful starting point is the presumption that research on Human subjects is not allowed unless ethical concerns are satisfied • You can think of the University’s Human Ethics Process as the Gateway to Human research • New National Statement on Ethical Conduct in Human Research http://www.anu.edu.au/ro/ORI/NHMRC_Human_Ethics_National_Statement_2007.pdf • See also ANU’s website http://www.anu.edu.au/ro/ORI/human.php

  3. New Ethics System • Low-Risk Protocol E1 • Low-Risk Protocol E2 • High-Risk Protocol E3

  4. New Ethics System • Low-Risk E1 – human subjects engaged only in activities they would be likely to encounter in normal life. Reviewed and approved by Chair of ANU Human Research Ethics Committee (approx 5 days) • Low-Risk E2 – human subjects who are fully competent and not vulnerable engaged in research settings in a relatively benign way not what they would encounter in everyday life. Considered by Delegated Ethics Review Committee (DERC) • High-Risk E3 – human subjects who are very vulnerable, or research settings that are particularly unusual or uncomfortable. Considered by ANU Human Research Ethics Committee

  5. Delegated Ethics Review Committee (DERC) • DERCs review E2 Protocols • There are two DERCs: • Humanities and Social Sciences (includes CBE) • Science, Medicine, and Engineering • Most of CBE’s protocols are expected to be E1 and will gain quick approval • For those that are classified as E2, they need to go to DERC • DERC meets every 2 weeks • CBE will continue it’s Local Area Ethics Committee in the form of a Shadow Ethics committee and you can submit you protocol to it and get a speedy review before sending it to DERC

  6. What is Low Risk • Research is low risk when the only foreseeable risk is one of discomfort • Discomfort is defined as “less serious than harm … which can involve body and/or mind. Discomforts include, eg, minor side effects of medication, discomforts of measuring blood pressure and anxiety induced by an interview” National Statement p 16

  7. What is Negligible Risk • Research is negligible risk where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. • Inconvenience is defined as less serious than discomfort egs filling in a form, participating in a street interview, or giving up time to participate in research. National Statement p 16

  8. How to Apply • Log-in to ARIES (ANU Research Information Enterprise System) and follow the steps outlined in the Quick Guidehttp://www.anu.edu.au/ro/ORI/HumanEthicsQuickGuide.pdf • See also the Human Ethics User Manual http://www.anu.edu.au/ro/ORI/HEManual.pdf

  9. ARIES Questions • Third Party Identification • Children or Young People • Dependent or Unequal Relationship • Membership of a Group or Related Issues • Physical Harm • Psychological Harm • Social Harm • Economic Harm • Legal Harm • Covert Observation • Deception • Sensitive Person Information • Overseas Research • Privacy Legislation/Regulation

  10. Third Party Identification • Is it possible for third parties to identify participants • Would this identification have an impact on the participant

  11. Children or Young People • Does the research involve the participation of children or young people

  12. Dependent or Unequal Relationship • Does a pre existing relationship exist between participants and researchers, or • Does a pre existing relationship exist between participants and others involved in facilitating or implementing the research

  13. Membership of a Group or Related Issues • Does the research involve the recruitment of members of a group, a significant coincidental recruitment of a group, or • Does the research involve issues likely to be considered significant to the group

  14. Physical Harm • Does the research involve a risk of physical harm, which may include • Injury • Illness,or • Pain • This may include being humiliated, manipulated or in other ways treated disrespectfully or unjustly

  15. Psychological Harm (including Devaluation of Personal Worth) • Does the research involve a risk of psychological harm which may include feelings of: • Worthlessness • Distress, • Guilt • Anger, or • Fear

  16. Social Harm • Could the research result in a significant negative impact upon the personal relations • For example, could the research damage the relationship between the participant and another family member

  17. Economic Harm • Could the research expose participants to potential loss of: • Professional reputation • Market standing • Health Insurance or • Employability

  18. Legal Harm • Could the research expose participants to potential litigation • Could the research lead to the the possibility for documents to be subpoenaed

  19. Covert Observation • Does the research involve covert observation • Will the research involve the observation of others without their knowledge • This does not apply to the observation of legal behaviour in a public place

  20. Deception • Does the research involve active concealment • Does the research involve planned deception

  21. Sensitive Personal Information • Does the research involve sensitive personal information

  22. Overseas Research • Will the research be conducted overseas

  23. Privacy Legislation/Regulation • Does the research proposal involve the collection, use or disclosure of personal information

  24. High Risk (E3) Questions • Is this a clinical trial • Does this research involve the intentional recruitment or issues involving Aboriginal and Torres Strait Islander Peoples • Does the research involve: • Human genetics • Human stem cells • Women who are pregnant and the human foetus • People who are highly dependent on medical care who may be unable to give consent • People with a cognitive impairment, an intellectual disability or a mental illness • An intention to study or expose or is likely to discover illegal activity

  25. Summary • New National Statement http://www.anu.edu.au/ro/ORI/NHMRC_Human_Ethics_National_Statement_2007.pdf • New ANU Ethics Clearance System http://www.anu.edu.au/ro/ORI/human_changes.php • Most of CBE’s protocols are expected to be E1 and will have quick approval • For those that are E2, the will need to go to the Delegated Ethics Review Committee (DERC) • CBE provides a Shadow Ethics Review Panel which gives speedy review to help you get through DERC

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