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

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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