Ethics in research involving human subjects

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Ethics in research involving human subjects
Public Health Primary Care Unit
Paraclinical Sciences Faculty of Medical
Sciences UWI, St Augustine, TT

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

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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