Research Ethics & Integrity:
An Introduction
Presentation by
Kristie
Westerlaken
Policy Officer,
Research Ethics and Integrity
Human Research: What is it?
•
Interviews
•
Surveys
•
Focus Groups
•
Observations
•
Chat rooms
•
Psychological, physiological,
medical testing or treatment
•
Body organs, tissues, fluids or
exhaled breath
•
Data mining
-
identifiable, re
-
or non
-
identifiable
information
–
published or
unpublished
http://consumerist.co
m/227155
Background to
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
•
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).
1.
Nuremberg Code
http://www.ushmm.org/research/doct
ors
Background cont’d
World Medical Association developed a set of ethical
principles for the medical community regarding human
experimentation
–
Helsinki 1966.
1.
Self
–
determination
2.
Informed Consent
Ethical Principals and the Guidelines for the Protection
of Human Subjects of Research
–
Belmont Report
(1979)
1.
Respect for Persons
2.
Beneficence
3.
Justice
2.
UN Declaration of
Human Rights
3.
Declaration of
Helsinki (WMA)
4.
Belmont Report
http://www.mcmaster.ca/ors/ethics/
tutorial/define.htm
Background cont’d:
Scandals
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.
–
Necessity of informed consent
–
Communication of diagnosis
–
Accurate reporting of results
–
Federal legislation following Belmont report
into Institutional Review Boards.
1.
Tuskegee Study of
Untreated Syphilis
in the Negro Male
http://www.cdc.gov/tuskegee/timeli
ne.htm
Background cont’d:
Scandals
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.
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
/
Background cont’d:
Scandals
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.
Laud Humphreys
–
The Watch Queen in
the
Tea Room
(1967)
http://bioethics.net/
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
•
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
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
Design
Quality
Conduct
http://commons.wikimedia.org/wiki/File:P
rologue_Hammurabi_Code_Louvre_AO10
237.jpg
Office for Research
-
2013
Office for Research
-
2013
Human Ethics
Research Ethics &
Integrity
Human Research
Ethics Manual
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
Expedited Review 2
Low Risk
Expedited Review 1
Negligible Risk
Variation
Change to approved protocol
Prior Review
Approval by multiple HREC
Office for Research
-
2013
Expedited review
National Statement Section 5.1.18
-
23
•
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
Office for Research
-
2013
Portal
Research
My Ethics
New
Application
Submit
Online
Full HREC review
National Statement Section 5.1.6
•
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
Office for Research
-
2013
NHMRC
Human
Research
Ethics Portal
National
Ethics
Application
Form
Submit
NEAF PDF
to Office for
Research
Reviewed by
Office for
Research
(possible
expedited?)
Referred to
next HREC
meeting
Ethical Review Results
•
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
.
•
PROVISIONAL
: gaps
and flaws so
a range of conditions is set by
HREC
that must be addressed before the research can start.
•
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.
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
Good
Training
Good
Records
Publication
&
Presentation
Peer Review
Office for Research
-
2013
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?
•
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/research
-
services/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
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