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Ethics in research involving

human subjects

presented by:
Celia M Poon-King
medical epidemiologist
lecturer in epidemiology

Public Health & Primary Care Unit
Paraclinical Sciences

Faculty of Medical Sciences
UWI, St Augustine, T&T



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what do you know?

what do you think you need to know?

why?
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Outline
history

knowledge - principles, IRB

attitude
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Outline
skills - application framework of
principles

practice - learning objectives,
research project
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History

1947 - Nuremberg code

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History

1964 - Helsinki declaration

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History

1979 - Belmont report
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History

1993 - CIOMS

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History
2005 - UNESCO
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Knowledge
ethics

principles

professional conduct
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What are the ethical principles
in research involving humans?
beneficence - promotion of well being
maximize benefit

non-maleficence - do no harm
(commission or omission)
minimize harm
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What are the ethical principles
in research involving humans?
respect for persons
privacy, confidentiality
autonomy - make own decisions
informed consent

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What are the ethical principles
in research involving humans?
justice - fairness

risks and benefits

is it justifiable to .
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Attitude
what are the attitudes that are
needed?
ethics is essential to research and
clinical practice
research should be a part of
everyday clinical practice
know when to ask for help
see it, do it, teach it
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Issue
HIV It is 1970; developing world; vertical
transmission: mother to child; clinical trials
showing gain for intense Antiviral Treatment
Regimes; A trial for a less intense regime
ethical issues
beneficence
non-maleficence
autonomy
justice
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Beneficence
maximize benefits
individual
family
community
researcher
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Non-Maleficence
minimize risk of harm
physical
psychological
social

individual vs community
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Autonomy
informed consent

sufficient information
Belmont Report
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Autonomy
capacity
understand
appreciate consequences of
participation

free power
Belmont Report
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Autonomy
actions:
ethics committee - community
investigators
participants
Paddi Ohara
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Vulnerable populations
(sufficient knowledge, capacity, free power)

children (assent)
mentally disabled

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Vulnerable populations
(sufficient knowledge, capacity, free power)

prisoners

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Justice
fairness

share risks share benefits

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Role of EC/IRB
ethics committee (EC)
institutional review board (IRB)

safeguard - dignity rights, safety and
well being
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Ethics committee
Institutional review board

review & approval

beneficence, autonomy, justice,
non-maleficence
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Ethics committee
Institutional review board
membership

non-scientist, community participant
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Ethics committee
Institutional review board
scientifically sound research?

scientific review board
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Responsible conduct of research
scientific misconduct
to maintain honesty & integrity
examples of failure - plagiarism,
fabrication, falsification
regulation: professions, legal
outcome of failure:
damage science, society
credibility
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Learning objectives
principles

beneficence, non-maleficence, justice,
respect for persons (including
autonomy)
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Learning objectives

informed consent
components, deception - procedures
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Learning objectives
institutional review board/ethics
committee
responsibilities, composition

responsible conduct of research
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Implication - research project
protocol
undertaking study
interpretation
making recommendations
presenting your findings
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Summary
ethical conduct of research with
human subjects

responsible conduct of research
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Issue
use of statins
diabetics
your country
2007
a clinical trial to examine the efficacy of
statins in the treatment regimes in
diabetics
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the end

thank you