“NUREMBERG CODE OF ETHICS AND DECLARATION OF HELSINKI”

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“NUREMBERG CODE OF ETHICS
AND DECLARATION OF HELSINKI”

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“NUREMBERG
CODE OF ETHICS”

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Set of guidelines, standards, and principles of a
Company which must be followed by its
employees.
usually in a written form.
often determined by the professional
body, company management or the
association.
CODE OF
ETHICS

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 The Code was formulated 74 years ago, in August 1947, in Nuremberg, Germany,
 By American judges sitting in judgment of Nazi doctors accused of conducting
murderous and torturous human experiments in the concentration camps.
 Due to the horrible Nazis experiment, Nuremberg trial was held which resulted in the
form of Nuremberg code of medical ethics.
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INTRODUCTION

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BACKGROUND -
NUREMBERG TRIAL
1. On December 9, 1946, an American military
tribunal opened criminal proceedings against 23
leading German physicians and administrators for
their willing participation in war crimes and crimes
against humanity.
2. It was held at the Palace of Justice in Nuremberg,
Germany.
3. Four American judges presided - The trial
described and documented some of the most
gruesome and painful medical experiments carried
out by Nazi Doctors.

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1) On trial were 22 men and one woman for their
participation in these experiments. Most were doctors,
though three were not. Some had been eminent
physicians
2) The defendants in this case are charged with murders,
tortures, and other atrocities committed in the name
of medical science
3) The victims of these crimes are numbered in the
hundreds of thousands.
4) A handful were alive; a few of the survivors appeared
in the courtroom.

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5) After hearing 85 witnesses and examining 1,471 documents that were presented, judgment
was pronounced on August 19, 1947 with sentencing following on the next day.
6) Of the 23 defendants, 7 were sentenced the death by hanging, 9 were given prison terms, and
7 were found not guilty.
7) The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to which
physicians must confirm when carrying out experiments on human subjects in a new code that
is now accepted worldwide.
8) This judgment established a new standard of ethical medical behavior for the post World War II
human rights era.

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A set of research ethics principles for human experimentation
set as a result of the Subsequent Nuremberg Trials at the end of
the Second World War.
NUREMBERG CODE

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1
• Voluntary consent is
essential
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• The results of any
experiment must be for the
greater good of society
3
• Human experiments based
on previous animal
experimentation
BASIC
PRINCIPLES

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• Adequate facilities used to protect
subjects
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• Experiments conducted only by
qualified scientists
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• Subjects should be able to end their
participation at any time
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• The scientist in charge must be
prepared to terminate the experiment
when injury, disability, or death is likely
to occur
BASIC
PRINCIPLES

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• Experiments should be conducted
by avoiding physical/mental
suffering and injury
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• No experiments should be
conducted if it is believed to cause
death/disability
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• The risks should never exceed
the benefits
BASIC
PRINCIPLES

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 The principles established by this code for medical
practice now have been extended into general
codes of medical ethics.
 It served as a blueprint for today’s principles that
ensure the rights of subjects in medical research.
PURPOSE
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13. CONCLUSION
 The Nuremberg Code has served as a foundation for ethical clinical research.
 Focused attention on the fundamental rights of research participants and on the
responsibilities of investigators.
 Resulted in the development of other initiatives- e.g. the Declaration of Helsinki
and the Belmont Report - to ensure the rights and safety of human beings taking
part in medical research
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DECLARATION
OF HELSINKI

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 Set of ethical principles
 Created in 1964
 Developed by WMA(World Medical Association)
 Followed Nuremberg code(1947)
 Document of Human research ethics
 not legally binding
 Recognized moral value & widely accepted
 Handle the growing unethical medical practice
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DOH gave answer to the dilemma (problem) associated with research
involving human subjects and stresses the protection of the participants
on the one hand and medicine's need for research on the other.
IMPORTANCE OF DOH

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The World Medical Association has developed the Declaration of
Helsinki as a statement of ethical principles to provide guidance to
physicians and other participants in medical research involving
human subjects.
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• Conform to accepted scientific
principles.
2
• Obtain true informed consent
in writing
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• Conducted by qualified and
trained persons..
BASIC
PRINCIPLES

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• Importance in proportion to
inherent risk
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• Assessment of risks
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• Safeguard subject's integrity
(privacy).
BASIC
PRINCIPLES

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• Preserve accuracy when
publishing
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• Adequately inform or right
to withdraw.
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• Design formulated in
experimental protocol,
reviewed by IEC.
BASIC
PRINCIPLES

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• Reliance on legal guardian
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• State compliance with
Declaration
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• Abstain unless hazard are
predictable
BASIC
PRINCIPLES

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7 ETHICAL PRINCIPLES IN CLINICAL
RESEARCH
1. Declaration of Helsinki Confidentiality — respect the privacy
2. Declaration of Helsinki Justice — equality and fairness
3. Declaration of Helsinki Autonomy — consent or self rule
4. Declaration of Helsinki Beneficence — do good
5. Declaration of Helsinki Non Maleficence — do no harm
6. Declaration of Helsinki Fidelity — duty of care
7. Declaration of Helsinki Truthfulness - Honesty

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o heavily influenced by the Nuremberg Code.
o provided guidance for physicians who were conducting
clinical research and focused on researchers' roles and
responsibilities when it comes to protecting human
subjects.
o seen as the first major attempt of the medical
community to police itself.
CONCLUSION

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