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

• 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

New Ethics System

• Low-Risk Protocol E1

• Low-Risk Protocol E2

• High-Risk Protocol E3

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

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

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

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

How to Apply

• Log-in to ARIES (ANU Research Information Enterprise System) and follow the steps outlined in the Quick Guide http://www.anu.edu.au/ro/ORI/HumanEthicsQuickGuide.pdf

• See also the Human Ethics User Manual http://www.anu.edu.au/ro/ORI/HEManual.pdf

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

Third Party Identification

• Is it possible for third parties to identify participants

• Would this identification have an impact on the participant

Children or Young People

• Does the research involve the participation of children or young people

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

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

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

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

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

Economic Harm

• Could the research expose participants to potential loss of:– Professional reputation– Market standing– Health Insurance or– Employability

Legal Harm

• Could the research expose participants to potential litigation

• Could the research lead to the the possibility for documents to be subpoenaed

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

Deception

• Does the research involve active concealment

• Does the research involve planned deception

Sensitive Personal Information

• Does the research involve sensitive personal information

Overseas Research

• Will the research be conducted overseas

Privacy Legislation/Regulation

• Does the research proposal involve the collection, use or disclosure of personal information

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

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