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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?

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ethics in research involving human subjects

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

slide2
what do you know?
  • what do you think you need to know?
  • why?

ethics in research involving human subjects

outline
Outline
  • history
  • knowledge - principles, IRB
  • attitude

ethics in research involving human subjects

outline4
Outline
  • skills - application framework of principles
  • practice - learning objectives, research project

ethics in research involving human subjects

history
History
  • 1947 - Nuremberg code

ethics in research involving human subjects

history6
History
  • 1964 - Helsinki declaration

ethics in research involving human subjects

history7
History
  • 1979 - Belmont report

ethics in research involving human subjects

history8
History
  • 1993 - CIOMS

ethics in research involving human subjects

history9
History
  • 2005 - UNESCO

ethics in research involving human subjects

knowledge
Knowledge
  • ethics
  • principles
  • professional conduct

ethics in research involving human subjects

what are the ethical principles in research involving humans
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

ethics in research involving human subjects

what are the ethical principles in research involving humans12
What are the ethical principles in research involving humans?
  • respect for persons
    • privacy, confidentiality
    • autonomy - make own decisions
    • informed consent

ethics in research involving human subjects

what are the ethical principles in research involving humans13
What are the ethical principles in research involving humans?
  • justice -fairness
    • risks and benefits
    • is it justifiable to …….

ethics in research involving human subjects

attitude
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

ethics in research involving human subjects

issue
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

ethics in research involving human subjects

beneficence
Beneficence
  • maximize benefits
  • individual
  • family
  • community
  • researcher

ethics in research involving human subjects

non maleficence
Non-Maleficence
  • minimize risk of harm
  • physical
  • psychological
  • social
  • individual vs community

ethics in research involving human subjects

autonomy
Autonomy
  • informed consent
  • sufficient information

Belmont Report

ethics in research involving human subjects

autonomy19
Autonomy
  • capacity
    • understand
    • appreciate consequences of participation
  • free power

Belmont Report

ethics in research involving human subjects

autonomy20
Autonomy
  • actions:
  • ethics committee - community
  • investigators
  • participants

Paddi O’hara

ethics in research involving human subjects

vulnerable populations sufficient knowledge capacity free power
Vulnerable populations(sufficient knowledge, capacity, free power)
  • children (assent)
  • mentally disabled

ethics in research involving human subjects

vulnerable populations sufficient knowledge capacity free power22
Vulnerable populations(sufficient knowledge, capacity, free power)
  • prisoners

ethics in research involving human subjects

justice
Justice
  • fairness
  • share risks → share benefits

ethics in research involving human subjects

role of ec irb
Role of EC/IRB

ethics committee (EC)

institutional review board (IRB)

  • safeguard - dignity rights, safety and well being

ethics in research involving human subjects

ethics committee institutional review board
Ethics committee Institutional review board
  • review & approval
    • beneficence, autonomy, justice, non-maleficence

ethics in research involving human subjects

ethics committee institutional review board26
Ethics committee Institutional review board
  • membership
    • non-scientist, community participant

ethics in research involving human subjects

ethics committee institutional review board27
Ethics committee Institutional review board
  • scientifically sound research?
    • scientific review board

ethics in research involving human subjects

responsible conduct of research scientific misconduct
Responsible conduct of researchscientific misconduct
  • to maintain honesty & integrity
  • examples of failure - plagiarism, fabrication, falsification
  • regulation: professions, legal
  • outcome of failure:
    • damage science, society
    • credibility

ethics in research involving human subjects

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

ethics in research involving human subjects

learning objectives30
Learning objectives
  • informed consent
    • components, deception - procedures

ethics in research involving human subjects

learning objectives31
Learning objectives
  • institutional review board/ethics committee
    • responsibilities, composition
  • responsible conduct of research

ethics in research involving human subjects

implication research project
Implication - research project
  • protocol
  • undertaking study
  • interpretation
  • making recommendations
  • presenting your findings

ethics in research involving human subjects

summary
Summary
  • ethical conduct of research with human subjects
  • responsible conduct of research

ethics in research involving human subjects

issue34
Issue
  • use of statins
  • diabetics
  • your country
  • 2007
    • a clinical trial to examine the efficacy of statins in the treatment regimes in diabetics

ethics in research involving human subjects

slide35
the end

thank you

ethics in research involving human subjects