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Research Ethics
Office for ResearchGary Allen
Chris Rose’Meyer
Rhiannon CampbellResearch Ethics Administrator
ph: 3735 4855 fax: 07 3735 7994 email: r.campbell@griffith.edu.au
Education Research Ethic AdvisorsDr Leonie Rowan
Dr Sue Whatman
Dr Christine McDonald
Photo: Australian HES 11/11/09
Office for Research - 2012
Overview
1. What is human research?
2. Why research ethics matters?
3. History of the governance of human research ethics – Response to international scandals
4. Governance in Australia
5. Using the National Statement (2007)
6. Griffith University
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What is Human Research?Examples of human
research
Interviews
Surveys
Focus Groups
Observations
Chat rooms
Testing
Identified personal information not on the public record.
Human research is conducted with or about people, or their data or their tissue.
Persons Born Overseas (Percent)*
Census Year 2001Local Government AreaASGC Version
http://maps.oesr.qld.gov.au/thematics/index.jsp?p_usertype_id=2
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Office for Research | g.allen@griffith.edu.au | © Griffith University 2012
Why research ethics matters?
Responsibility to participants
Reputation of the University
Requirements of research funding bodies, state, federal and international
Requirements of the University’s insurer – indemnification of researchers
Future access to populations and sites
Use of public funds carries with it obligations to the community
Professional obligations
Requirements of many journals
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History of the governance of human research ethics
Response to international scandals
Why Human Research Ethics?
World War II See Unit 731 (Japanese) for biological
and chemical warfare Mengele – 1500 sets of imprisoned twins Luftwaffe – freezing experiments Dachau – Malaria treatment And many more well documented
episodes of inhumanity.
Following the Doctors’ Trials at Nuremberg the
Tribunal delivered their opinion on medicalexperimentation on human beings – The Nuremberg Code (1947).
History of Research Ethics
1.Nuremberg Code
http://www.ushmm.org/research/doctors
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Nuremberg Codehttp://ohsr.od.nih.gov/guidelines/nuremberg.htm
1.The voluntary consent of the human subject is absolutely essential
2.The experiment should be such as to yield fruitful results for the good of society
3.The experiment should be so designed and based on the results of animal experimentation
4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury
5.No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur;
6.The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7.Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8.The experiment should be conducted only by scientifically qualified persons
9.During the course of the experiment the human subject should be at liberty to bring the experiment to an end
10.During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage
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Nuremberg Codehttp://ohsr.od.nih.gov/guidelines/nuremberg.htm
1.The voluntary consent of the human subject is absolutely essential
2.The experiment should be such as to yield fruitful results for the good of society
3.The experiment should be so designed and based on the results of animal experimentation
4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury
5.No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur;
6.The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7.Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8.The experiment should be conducted only by scientifically qualified persons
9.During the course of the experiment the human subject should be at liberty to bring the experiment to an end
10.During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage
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Beneficence
Voluntary participation
Informed Consent
Scandals – Deception / Consent
Watch Queen Observation of homosexual acts in
public toilets.
Recorded car licence plates.
Learned of names and addresses from friendly policemen while pretending to be a market researcher.
As a public health surveyor interviewed men he had observed.
Most men married and secretive about homosexual activity.
3. Laud Humphreys – The Watch Queen in the Tea Room (1967)
http://bioethics.net/
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International research ethics frameworks for human research
World Medical Association developed a set of ethical
principles for the medical community regarding Human experimentation – Declaration of Helsinki
1966.http://www.wma.net/en/30publications/
10policies/b3/index.html
1. Self – determination2. Informed Consent
Ethical Principals and the Guidelines for the Protection of Human Subjects of Research –
Belmont Report (1979) http://ohsr.od.nih.gov/guidelines/belmont.html
1. Respect for Persons2. Beneficence3. Justice
2. UN Declaration of Human Rights
3. Declaration of Helsinki (WMA)
4. Belmont Report
http://www.mcmaster.ca/ors/ethics/tutorial/define.htm
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Personal responsibility: Reflective practice John Hopkins Hospital Baltimore
Office of Human Research Protection suspended supported medical research projects involving humans.
» 2400 federally funded human experiments
» 15 000 patients and volunteers
» $419M for research ($277 in experiments involving humans)
Death of volunteer at university’s asthma and allergy centre.
Use of unapproved drug (hexamethonium) without informing IRB
Lack of reflective practice as earlier volunteers were also incapacitated – this should have been reported as an adverse event.
The lesson of John Hopkins (2001)
http://www.hopkinsmedicine.org/
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Governance in AustraliaImplementation of international standards and expansion beyond
clinical work
Australian national framework
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NHMRC Statement on Human Experimentation and Supplementary Notes (First published 1966, multiple revisions, last revised 1992)
National Statement on Ethical Conduct in Research Involving Humans (1999)
National Statement on Ethical Conduct in Human Research (2007)
Australian Code for the Responsible Conduct of Research (2007) – Research Integrity not research ethics, but an important document for your research
National Statement on Ethical Conduct in Human Research (2007)
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Office for Research | g.allen@griffith.edu.au | © Griffith University 2012
Principles of ethical conduct
• Merit and integrityo Genuine search for knowledgeo Based on literature, prior research and / or
established problemo Sufficient expertise and resourceso Any conflicts of interest addressed
• Respect for personso Intrinsic value of humans, rather than
resourceso Welfare, beliefs, perceptions, customs and
cultural heritageo Privacy, confidentiality and cultural
sensitivitieso Honour assurances providedo Respect the capacity for self determination
Office for Research | g.allen@griffith.edu.au | © Griffith University 2012
Principles of ethical conduct
• Beneficenceo Responsibility to minimise harmso Not non-maleficenceo Not overstating the benefitso Benefits must justify the riskso Fair flow of benefits versus burdenso Genuinely informed consent
• Justiceo Fair selection and inclusiono Distributive justiceo No unfair burdeno Fair flow of / access to benefitso No exploitationo Impact on prejudice and discrimination
In the National Statement (2007) Different research methods and
disciplines:» Qualitative research» Human tissues» Clinical trials» Databanks
Different types of participants» Children» Overseas» Aboriginal and Torres Strait Island people
Ethical review» Membership and role of HRECs» Low risk and negligible risk» Duplication of review
Researcher responsibilities Institutional responsibilities
Since the 1999’s first edition explicitly expanded the scope beyond clinical to all human research.
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Using the National Statement (2007)Research ethics in practice
Office for Research | g.allen@griffith.edu.au | © Griffith University 2012
Risks in human researchA common mistake researchers make is to describe a project as involving no risks
When what they actually mean is that there are strategies in place to negate or minimise the risks
Risks in Human Research What are some of the risks of
Human Research.» Physical (Injury, illness, harm)
» Psychological (significant distress)
» Social (impact on social networks, access to services and support)
» Economic (loss of income, earnings and cost to participants)
» Legal (exposure to civil or criminal proceedings)
» Humiliation (devaluation of worth)
» Environment (see Code not NS)
Recognition of burden on participants.
Another common mistake is to assume that risks only refers to physical or perhaps also significant psychological harms.
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Risks in Human Research
Assessing RisksTo whom do the risks apply?
» Participants, potential participants, third parties, environment, and / or researchers.
Addressing risks» Are there alternatives?» Can risks be negated or
minimised?» Can risks be managed?
Can the risks be justified?
Disclosure to potential participants
Yet another common mistake is to focus only on the risks to the participants.
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Justifying the risks in Human ResearchAssessing BenefitsWhat are the benefits?To whom do the benefits flow?
» Directly to participants and/or participant community (people like the participants)
» Other stakeholders / wider society» Sponsors / Griffith University» Researchers
Recognising uncertainty in research
Justifying research with minimal benefit
Describing benefits to potential participants
As we know, there are known knowns. There are things we know we know. We also know there are known unknowns. That is to say we know there are some things we do not know. But there are also unknown unknowns, the ones we don't know we don't know.
Donald Rumsfeld
http://www.wisdomquotes.com/003223.html
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Have you “Done” ethics yet? Research ethics is first and
foremost a personal responsibility
It is a design, conduct and quality issue
Researchers should engage with the ethical principles and review process
See the process as a continuing professional responsibility until the research is completed
Not form filling – someone else’s problem
Objective is to help you improve design and quality of the research
This is not an expression we like to hear because…
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LimitationsClinical Research Precedents and scandals relate
primarily to medical research. More easily quantifiable risks
Quantitative Assumptions Sample size Consent (verbal)
Western Liberal – Democratic expectations
Consent Attitudes towards personal
burdens vs collective benefits Standard of care
It is important to recognise that the National Statement has its limitations
Office for Research - 2012
Office for Research - 2012
Human research ethics at Griffith University
Proportional, transparent and collegiate
Office for Research | g.allen@griffith.edu.au | © Griffith University 2012
Sources of guidance, information and resources
Research Ethics Manual
Office for Research – Process and system questions
Office for Research – Responding to ethical review feedback
Psychology REA(s)
HDR Supervisor
Office for Research – Application of ethical principles to your work and / or policy questions
Griffith University – Levels of Ethical review
Full ReviewMore than low risk
Allow approximately 40 days for the initial review
Full ReviewMore than low risk
Allow approximately 40 days for the initial review
Expedited Review 2Low Risk + Significant ethical issues
Allow approximately 15 days for the initial review
Expedited Review 2Low Risk + Significant ethical issues
Allow approximately 15 days for the initial review
Expedited Review 1Low Risk + Minimal ethical issues
Allow approximately 7 days for the initial review
Expedited Review 1Low Risk + Minimal ethical issues
Allow approximately 7 days for the initial review
Expedited Review 1 (NR)Negligible Risk
Allow approximately 5 days for the initial review
Expedited Review 1 (NR)Negligible Risk
Allow approximately 5 days for the initial review
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How to Apply
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Recruitment – see also Booklet 21
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Impacts on Recruitment
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Steps to Success
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General Tips
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Other issues to be considered
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Contacts
Office for Research - 2012
•Chris Rose’Meyer x 27227
•Gary Allen (x 27226)
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