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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 SciencesUWI, St Augustine, T&T
04/19/23 ethics in research involving human subjects
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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 beingmaximize 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, confidentialityautonomy - make own decisionsinformed 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 regimeethical 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 O’hara
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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 consentcomponents, deception - procedures
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Learning objectives
institutional review board/ethics committeeresponsibilities, 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