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Public Health & Primary Care Unit Paraclinical Sciences Faculty of Medical Sciences UWI, St Augustine, T&T

Ethics in research involving human subjects


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

what

do you know?
do you think you need to know?

what

why?

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ethics in research involving human subjects

Outline
history

knowledge

- principles, IRB

attitude

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ethics in research involving human subjects

Outline
skills

- application framework of principles

practice

- learning objectives, research project

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ethics in research involving human subjects

History
1947

Nuremberg code

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ethics in research involving human subjects

History
1964

- Helsinki declaration

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History
1979

- Belmont report

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ethics in research involving human subjects

History
1993

- CIOMS

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History
2005

- UNESCO

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ethics in research involving human subjects

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

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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


conduct of research

responsible

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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
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