University Ethics Policy - Griffith University

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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unpublished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