Research Ethics & Integrity:
An Introduction
Presentation by
Kristie Westerlaken
Policy Officer,
Research Ethics and Integrity
Human Research: What is it?
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http://consumerist.co
m/227155
Interviews
Surveys
Focus Groups
Observations
Chat rooms
Psychological, physiological,
medical testing or treatment
• Body organs, tissues, fluids or
exhaled breath
• Data mining - identifiable, reor non-identifiable
information – published or
unpublished
Background to
Human Research
Ethics
1. Nuremberg Code
http://www.ushmm.org/research/doct
ors
World War II
• See Unit 731 (Japanese) for biological and
chemical warfare
• Mengele – 1500 sets of imprisoned twins
• Luftwaffe – freezing experiments
• Dachau – Malaria treatment
• Etc, well documented episodes of
inhumanity.
Following the Doctors’ Trials at Nuremberg the
Tribunal delivered their opinion on medical
experimentation on human beings – The
Nuremberg Code (1947).
Background cont’d
2. UN Declaration of
Human Rights
3. Declaration of
Helsinki (WMA)
4. Belmont Report
World Medical Association developed a set of ethical
principles for the medical community regarding human
experimentation – Helsinki 1966.
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Ethical Principals and the Guidelines for the Protection
of Human Subjects of Research – Belmont Report
(1979)
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3.
http://www.mcmaster.ca/ors/ethics/
tutorial/define.htm
Self – determination
Informed Consent
Respect for Persons
Beneficence
Justice
Background cont’d:
Scandals
1. Tuskegee Study of
Untreated Syphilis
in the Negro Male
Tuskegee Alabama 1932 - 1972
• Clinical study that recruited 399 African
Americans with syphilis.
• Research into the natural progression of
the untreated disease in hopes of
justifying treatment programs.
• Investigators failed to treat patients
appropriately after the validation of
penicillin as an effective cure.
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http://www.cdc.gov/tuskegee/timeli
ne.htm
Necessity of informed consent
Communication of diagnosis
Accurate reporting of results
Federal legislation following Belmont report
into Institutional Review Boards.
Background cont’d:
Scandals
2. Stanford Prison
Experiment
3. Milgram Experiment
(Yale)
Obedience to Authority
– an experimental
view (1974)
"The social psychology of this
century reveals a major lesson:
often it is not so much the kind of
person a man is as the kind of
situation in which he finds himself
that determines how he will act."
(1974)
http://www.stanleymilgram.com
/
Philip Zimbardo – 1971
• 24 undergraduates were selected to play
the roles of prisoners and guards in a
mock prison.
• Role play – but went beyond the
boundaries.
• One-third of guards judged to exhibit
‘sadistic’ tendencies.
Stanley Milgram – 1963
• How much pain an individual would
inflict on another simply because s/he
were ordered to by a scientist.
• Obedience of authority v individual
morality
• Replicated Nazi criminality.
Background cont’d:
Scandals
Laud Humphreys –
The Watch Queen in
the Tea Room (1967)
http://bioethics.net/
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.
Social scientists do not have an
inalienable right to conduct
research involving other people
(Oakes, 2002).
Principles of Ethical Conduct in
Human Research – 4 values
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Research merit & integrity
Respect for persons
Beneficence
Justice
RELEVANT TO ALL HUMAN RESEARCH
Governance of Research Ethics
in Australia & Griffith University
• National Statement on Ethical Conduct in Human Research
(2007)
– Australian Gov’t National Health and Medical
Research Council/Australian Research Council and
Australian Vice-Chancellors’ Committee
• Australian Code for the Responsible Conduct of Research
(2007)
• Griffith University Code for the Responsible Conduct of
Research
Design
Quality
Conduct
http://commons.wikimedia.org/wiki/File:P
rologue_Hammurabi_Code_Louvre_AO10
237.jpg
Office for Research 2013
Practical Ethics
• Engage with ethics - NOT just
form filling
• Not someone else’s problem
• A continuing dialogue until
research is completed
• Intent is to improve research
design and quality of results
 Human Ethics
 Research Ethics &
Integrity
 Human Research
Ethics Manual
Office for Research 2013
Key Considerations Prior to
Applying for Ethics
• Specific participants: children & young people,
women who are pregnant & human foetus,
dependent or unequal relationships; highly
dependent on medical care; cognitive impairment,
intellectual disability, mental illness, illegal activity,
Aboriginal & Torres Strait Islander Peoples, other
countries
• Recruitment – Identification, first contact, incentives and risk
• Informed consent – voluntary, informed and understood
• Potential benefits – flow and description
• Potential risks – burden, balance, addressing and description
• Confidentiality – consent, identification, legislation and storage
• Other issues – use of third parties, phone-based, online and overseas
Applying for Ethics
Full Review
More than low risk
Variation
Change to approved protocol
Expedited Review 2
Low Risk
Prior Review
Approval by multiple HREC
Expedited Review 1
Negligible Risk
Office for Research 2013
Expedited review
National Statement Section 5.1.18-23
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All research that involves no more than low risk
Expedited Ethical Review Level 1 (Negligible Risk) E1(NR). Submitted online and reviewed by the
Office for Research (≈5 working days)
Expedited Ethical Review Level 1 – E1: more than
negligible risk, but no more than a low risk and no
major ethical issues. Submitted online and reviewed
by HREC Chair or Deputy Chair (≈ 10 working days)
Expedited Ethical Review Level 2 – E2: risks and/or
ethical issues may be present but addressed by
research design. Submitted online and reviewed by
HREC Panel (≈ 15 working days).
Prior Review – already approved by another HREC.
Cover form plus approval. Reviewed by the Office
for Research (≈ 5 working days)
Office for Research 2013
Expedited Review - How to Apply
Portal
Research
My Ethics
Office for Research - 2013
New
Application
Submit
Online
Full HREC review
National Statement Section 5.1.6
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All research that involves more than low risk
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 highly dependent on medical care who may
be unable to give consent,
People with a cognitive impairment, an intellectual
disability, or a mental illness
Aboriginal and Torres Strait Islander People and
Communities
People who may be involved in illegal activities
Office for Research 2013
Full Review - How to Apply
NHMRC
Human
Research
Ethics Portal
National
Ethics
Application
Form
Submit
NEAF PDF
to Office for
Research
Office for Research - 2013
Reviewed by
Office for
Research
(possible
expedited?)
Referred to
next HREC
meeting
Ethical Review Results
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RE-SUBMIT: application has gaps and flaws that are so frequent and/or
serious that the application should not proceed without major revision. The
HREC provides detailed guidance on what should be included in a
resubmitted application.
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PROVISIONAL: gaps and flaws so a range of conditions is set by HREC
that must be addressed before the research can start.
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CONDITIONAL: very few or no gaps and flaws and a smaller range of
conditions is still set by HREC that must be addressed, but the research can
start from the date of the conditional approval. The conditions are
addressed while the research is under way.
Provisional becomes conditional when most of the conditions are
met. Provisional and conditional approvals become full approvals when all of
the conditions are met. All of the review pathways (E1, E2, Prior Review and
Full Review) utilise the provisional-conditional system.
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Office for Research 2013
What happens if the unexpected
happens?
• National Statement Chapter 5.5 requires
appropriate, adequate, regular monitoring and
reporting of approved research.
• Monitoring is institution and researcher
responsibility.
• Advise your supervisor, REA and the Office for
Research as soon as possible.
• Your first priority and ours is to:
– ensure immediate safety,
– minimise further risk, and
– protect future interests
• of participants, public, yourselves and the
institution.
Office for Research 2013
FAQs
• what are common mistakes made in the process?
– Failure to plan/review ethics manual
– Omitting informed consent materials
– Omitting detailed information (e.g. brief lit review) that
outlines the basis for the research aims/methodology
– Omitting detailed information relating to recruitment (e.g.
sample size, how will you identify, approach, etc.)
– Supervisor must be identified as contact/Chief Investigator –
Student = “Student Researcher”
– Lack of information relating to data storage, access,
destruction
• what happens if I need to change or modify my protocol?
– Request a variation – email to ethics team
Research Integrity – It is all
about you
Genuine
Search for
Knowledge
Peer Review
Publication
&
Presentation
Office for Research 2013
Good
Training
Good
Records
Research Integrity
Core Principles
• Honesty in all aspects of
research.
• Accountability in the
conduct of research.
• Professional courtesy and
fairness in working with
others
• Good Stewardship of
research on behalf of others
Research Misconduct
• human research conducted without ethics
approval
• conduct of human research inconsistent
with ethics approval
• failure to report and manage adverse events
• failure to protect participant safety, privacy,
confidentiality
• fabrication of results
• falsification or misrepresentation of results
• plagiarism
• misleading ascription of authorship
• failure to declare and manage serious
conflicts of interest
Office for Research 2013
Australian Code
Griffith Code
National Statement
GUREM Booklet 7
Conclusion: Why does research
ethics matter?
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Responsibility to participants – animal or human
Professional obligations
Use of public funds = obligation to community
University reputation
– Future access to populations & sites
• Requirements of research funding bodies (state, federal &
international)
• Requirements of many journals for publication
• Requirements of the University’s insurer (indemnification
of researchers)
Resources
• http://www.nhmrc.gov.au/
• http://www.griffith.edu.au/research/researchservices/research-ethics-integrity
• Griffith University Human Research Ethics
Manual
• Supervisor
• Research Ethics Advisor (REA)
Contacts
Systems Support Officer
• Rhiannon Campbell 373 54855
• Marnie Lawson 555 29251
Manager
• Rick Williams 373 54375
Policy Officer, Human Ethics
• Kristie Westerlaken 373 58043
Policy Officer, Animal Ethics
• Amanda Fernie 373 56618