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Research Ethical Clearance 2010
1. Ethical clearance for
Research
at
Zayed University
March 2010
Brigitte Howarth: Chair ZU Committee on the use of Human Subjects in Research
Janet Martin: Office of Research
3. January 29 2010
“acted dishonestly
and irresponsibly in
carrying out
research on
children against
their best interests
and without official
permission”
4. January 29 2010
“did not have the
ethical approval or
qualifications to
oversee the study,
which involved
children undergoing
colonoscopies,
lumbar punctures,
barium meals and
brain scans.”
5. January 29 2010
“he received 55,000
UKP to carry out the
research on behalf of
solicitors acting for
parents who believed
that their children had
been harmed by
MMR… He did not
declare any conflict of
interest to the Lancet
medical journal.”
6. January 29 2010
“The study prompted
a massive drop in the
number of children
being vaccinated
against measles,
mumps and rubella.
Subsequent studies
involving millions of
children found no
evidence of a link
between MMR and
autism.”
7. UN apology after flawed climate study
Times Online January 21, 2010
8. 21 January 2010
“The IPPC said
that the
prediction in its
landmark 2007
report was
‘poorly
substantiated’
and resulted
from a lapse in
standards”
9. 21 January 2010
“The UN’s top
climate change
body issued an
unprecedented
apology
yesterday over
its flawed
prediction that
Himalayan
glaciers were
likely to
disappear by
2035.”
10. ZU investigators would know all about ethical
clearance …
… this is straightforward stuff that
hardly needs to be covered!
“I’m only doing a pilot
study”
11. ZU investigators would know all about ethical
clearance …
… this is straightforward stuff that
hardly needs to be covered!
“I don’t need clearance
because I’m only surveying
ZU students”
12. ZU investigators would know all about ethical
clearance …
… this is straightforward stuff that
hardly needs to be covered!
“my supervisor said that
not to worry. It’s ok.”
13. ZU investigators would know all about ethical
clearance …
… this is straightforward stuff that
hardly needs to be covered!
“I already have ethical
clearance from another
collaborative institution”
14. ZU investigators would know all about ethical
clearance …
… this is straightforward stuff that
hardly needs to be covered!
“I received my research
grant before this ethics
committee got going”
15. Recent examples from faculty have assisted the Committee
in determining what is not recommended for the quality of
ethics consideration at ZU:
Obtaining informed consent:
“a relevant statement will be included in the
instructions given prior to data collection”
“Questionnaire aimed to know your opinion on
the [subject] in terms of the level of
satisfaction, as well as in terms of information
and since I … would like to know”
17. Ethical clearance is part of
Research Integrity:
This embodies a range of good research practice and
conduct which can include
•intellectual honesty
•accuracy
•fairness
•intellectual property
•protection of human and animal subjects involved
in the conduct of research.
Responsibilities for research integrity are shared by
individual researchers and the institution.
18. Ethical clearance in Research
The ‘Belmont’ ethical principles are to ensure:
• Respect for persons (the research consent process
ensures autonomy for individuals – “informed”
consent, confidentiality of data etc)
• Beneficence (the intention to do no harm – to
maximize possible benefits and minimize possible risks
to people involved in research)
• Justice (fairness in distribution of research inclusion
and exclusion)
19. What should we do about
understanding ethical
clearance
in research?
24. Who is your Research Ethics Committee?
Dr. Brigitte Howarth (Chair)
Dr. Eric Breton
Dr. Usama AlAlami
Dr. Gaelle Duthler
Dr. Sharon Parker
Dr. Grant Regan (ex-officio for ICE)
Dr. Chet Jablonski
Janet Martin (ex-officio for the Office of Research)
External representative (yet to appoint)
25. Recent feedback from faculty:
Considering the Committee responses:
“…don’t you and your committee think that I will be able to
present a professional research study”
“This is not the first time I’m working on research that requires
ethical clearance…. You are underestimating my skills and
potential as a researcher openly and very rudely.”
“I am a highly educated person, and I don’t need another person
to speak to me about conducting research professionally.”
“I should have received a quick reply from you”
26. Recent feedback from faculty:
Considering the Committee responses:
“Thank you very much for your prompt reply and considerations.
I greatly appreciate it!”
“Thank you very much to the Committee for processing my
application in such an efficient manner.”
“I do hope this clarifies some of our statements and I thank you
again for your valuable help.”
“Thanks for this feedback, will make changes as recommended
and pre test.”
27. Ethical Training for Research
All faculty and students will soon have access to an
internationally recognized online training resource:
CITI: Collaborative Institutional Training Initiative
https://www.citiprogram.org
Committee members will also hopefully have access to SRA
certification from the US, such as
“Human Research Protections Certificate Program”
A HELPFUL process?
HITTING your head against a wall … or something!!?
What are your past experiences?
Is it still needed? … examples
Nuremberg Trials (1947); Milgram Study (1974); Thalidomide Study (late 1950’s); untreated syphilis in negro males (1952-)
Is it still needed? … examples
Nuremberg Trials (1947); Milgram Study (1974); Thalidomide Study (late 1950’s); untreated syphilis in negro males (1952-)
Is it still needed? … examples
Nuremberg Trials (1947); Milgram Study (1974); Thalidomide Study (late 1950’s); untreated syphilis in negro males (1952-)
Is it still needed? … examples
Nuremberg Trials (1947); Milgram Study (1974); Thalidomide Study (late 1950’s); untreated syphilis in negro males (1952-)
Is it needed at ZU now?
International protocol dictates that quality research all over the world undergoes a systematic evaluation of ethical appropriateness of research involving either human or animal subjects
Anyone “surveyed out” here sometimes?
When research which is not well designed (and likely to not deliver sound outcomes) but widely circulated to avoid the hassle of good sampling design, everyone is more likely to delete quality research requests when they come along. Not in anyone’s interest.
Is it needed at ZU now?
International protocol dictates that quality research all over the world undergoes a systematic evaluation of ethical appropriateness of research involving either human or animal subjects
Anyone “surveyed out” here sometimes?
When research which is not well designed (and likely to not deliver sound outcomes) but widely circulated to avoid the hassle of good sampling design, everyone is more likely to delete quality research requests when they come along. Not in anyone’s interest.
Is it needed at ZU now?
International protocol dictates that quality research all over the world undergoes a systematic evaluation of ethical appropriateness of research involving either human or animal subjects
Anyone “surveyed out” here sometimes?
When research which is not well designed (and likely to not deliver sound outcomes) but widely circulated to avoid the hassle of good sampling design, everyone is more likely to delete quality research requests when they come along. Not in anyone’s interest.
Is it needed at ZU now?
International protocol dictates that quality research all over the world undergoes a systematic evaluation of ethical appropriateness of research involving either human or animal subjects
Anyone “surveyed out” here sometimes?
When research which is not well designed (and likely to not deliver sound outcomes) but widely circulated to avoid the hassle of good sampling design, everyone is more likely to delete quality research requests when they come along. Not in anyone’s interest.
Is it needed at ZU now?
International protocol dictates that quality research all over the world undergoes a systematic evaluation of ethical appropriateness of research involving either human or animal subjects
Anyone “surveyed out” here sometimes?
When research which is not well designed (and likely to not deliver sound outcomes) but widely circulated to avoid the hassle of good sampling design, everyone is more likely to delete quality research requests when they come along. Not in anyone’s interest.
Examples of what not to do…
These were the TOTAL information responses provided to the Committee at ZU.
University of Arizona example with permission from Sarah Trainer, Fulbright student at ZU undertaking research in 2009/10
Ethical consideration for human or animal subjects used in research
The Belmont Report” (http://en.wikipedia.org/wiki/Belmont_Report) – shapes research principles world-wide
It is in the interests of both the institution and all researchers that research projects are reviewed and conducted ethically, both to protect the right and welfare of research subjects, as well as to enable international recognition for creditable institutional procedures in research being supported and followed at ZU.
Society entrusts investigators with the privilege of using other humans to advance knowledge, but the research community as a whole suffers when even a few investigators ignore basic principles of ethics.
Many options …
It is no time to HIDE and IGNORE research ethics!
Future grants will depend on it.
UAE organizations like HAAD and the EF will insist on it.
Our research credibility depends on it.
This Committee will:
Establish protocol and procedures during 2009/10
Review and approve all applications for ethical clearance during 2009/10
Communicate with faculty and students undertaking research to educate, learn and develop
4. Review all policies, procedures and committee structures for future recommendation…. Live and learn!
Comparison to the past – thanks to Richard Mapstone
Is it an easy/fun job? Road to popularity? No.
The Committee is simply working within principles that we believe in to do the best by the researcher AND the institution.
The process for ethical clearance should improve research design, not hinder the research process.
Examples of what not to do…
The Committee have and will make every attempt to support all research applications with constructive and diplomatic feedback.
Don’t take issues personally. In truth many of us do not like criticism or interference with our work.
The Committee would greatly appreciate support of less experienced researchers by more experienced people in such situations, and a mob of volunteers next time the call for Committee membership (and the heavy workload involved) comes up from those unhappy with the current arrangements!
The Committee is attempting to ensure that the respect, beneficence and justice is upheld for all ZU research, for the benefit of researchers and the institution. That’s all.
A philosophy to work together. The spirit of our decisions …
Discuss and debate, rather than become offended or offensive
Membership for CITI in progress
Certification or course completion will become a pre-requisite for grant funding and ethical clearances
Sometimes learning new things seems daunting.
As Stephen Abrams said: “Learning is incremental and you can grow a little bit at a time and suddenly realize that you’re competent in something new.”
At ZU we have the beginnings of policies and procedures
We have a hard-working and very positive team (our ZU Committee) working together with a solid philosophical view
We have new training initiatives imminent – available to everyone
We are listening and learning
We are establishing a credible ethical research clearance procedure at ZU, one-step-at-a-time!