1. The Nuremberg Code established ethical guidelines for human experimentation after Nazi doctors were tried for war crimes for medical experiments without consent. It included requirements for voluntary and informed consent. 2. The Declaration of Helsinki expanded on informed consent and emphasized that subjects' welfare takes precedence over scientific interests. 3. The Belmont Report summarized ethical principles of respect for persons, beneficence, and justice in research involving human subjects. It addressed informed consent, risk-benefit assessment, and fair subject selection.

1. Ethical Principles: Nuremberg
code, declaration of Helsinki and
Belmonte report
Dr Urmila M. Aswar
Department of Pharmacology, SIOP, Narhe

2. Pre WWII
Edward Jenner (1789)
Smallpox Vaccine
Louis Pasteur (1885)
Rabies Vaccine
Walter Reed (1900)
Yellow Fever

3. Introduction
During the Nuremberg War Crimes Trials, 23
German doctors were charged with crimes
against humanity for “performing medical
experiments upon concentration camp inmates
and other living human subjects, without their
consent, in the course of which, the defendants
committed the
murders, brutalities, cruelties, tortures, atrocities,
and other inhuman acts.”
No law that differentiated between legal and
illegal experiments.

4. The Nuremberg Code (1947)
As part of the verdict, the Court enumerated
some rules for "Permissible Medical
Experiments", now known as the “Nuremberg
Code”. These rules include

5. 1. Consent
• The voluntary consent of the human subject is
absolutely essential.
• Able to exercise free power of choice, without the
intervention of any element of force.
• Should have sufficient knowledge and comprehension
of the elements of the subject matter involved.
• He should be made known the nature, duration, and
purpose of the experiment; the method and means by
which it is to be conducted.
• All inconveniences and hazards reasonable to be
expected; and the effects upon his health which may
possibly come from his participation in the experiment

6. 2. Benefit to society
The experiment should be such as to yield
fruitful results for the betterment of
society, unprocurable by other methods or
means of study, and not random and
unnecessary in nature.

7. 3. Previous base of study
The experiment should be so designed and
based on the results of animal
experimentation and a knowledge of the
natural history of the disease or other
problem under study that the anticipated
results will justify the performance of the
experiment

8. 4. Avoid sufferings
• The experiment should be so conducted as to
avoid all
unnecessary physical and mental suffering and
injury.

9. 5. No death
No experiment should be conducted where
there is a prior reason to believe that death or
disabling injury will occur.

10. 6. Humanity first
• The degree of risk to be taken should never
exceed the benefit.

11. 7. Facilities
• Proper preparations should be made and
adequate facilities provided to protect the
experimental subject against even remote
possibilities of injury, disability, or death.

12. 8. TEAM: Scientifically qualified
• The experiment should be conducted only by
scientifically qualified persons. The highest
degree of skill and care should be required
through all stages of the experiment of those
who conduct or engage in the experiment.

13. 9. Discontinuation by subject
During the course of the experiment the
human subject should be at liberty to bring
the experiment to an end if he has reached
the physical or mental state where
continuation of the experiment seems to him
to be impossible.

14. 10. Right to Physician
During the course of the experiment the
scientist in charge must be prepared to
terminate the experiment at any stage, if he
has probable cause to believe, in the exercise
of the good faith, superior skill and
careful judgment required of him that a
continuation of the experiment is likely to
result in injury, disability, or death to
the experimental subject.

15. Declaration of Helsinki
Recommendations Guiding Medical Doctors in
Biomedical Research Involving Human
Subjects
Adopted by the 18th World Medical
Assembly, Helsinki, Finland, 1964 and as revised by the World
Medical Assembly in Tokyo, Japan in 1975, in Venice, Italy in
1983, and in Hong Kong in 1989 and the 48th General
Assembly, Somerset West, Republic of South Africa, October
1996
“Concern for the interests of the subject must always
prevail over the interests of science and society.”

16. Declaration of Helsinki
• The Declaration of Helsinki is a set of ethical
principles regarding human
experimentation developed for the medical
community by the World Medical Association.
• Common document of human research ethics

17. • The Declaration is morally binding on
physicians, and that obligation overrides any
national or local laws or regulations.

18. The fundamental principle is respect for the
individual their right to self determination and the
right to make informed decisions regarding
participation in research, both initially and during the
course of the research.
The investigator's duty is solely to the patient or
volunteer, and while there is always a need for
research, the subject's welfare must always take
precedence over the interests of science and society.
Ethical considerations must always take precedence
over laws and regulations

19. Recognition of vulnerables
The recognition of the increased vulnerability of
individuals and groups calls for special vigilance.
It is recognized that when the research
participant is incompetent, physically or mentally
incapable of giving consent, or is a minor, then
allowance should be considered for surrogate
consent by an individual acting in the subjects
best interest.

20. Post WWII
• Willowbrook study (1950s)
mentally retarded children were deliberately infected with hepatitis virus
• Jewish Chronic Disease Hospital, Brooklyn
(1960s)
Live cancer cells were injected into 22 senile patients without telling them.
• Humphries (1970)
Tearoom Trade: Impersonal Sex in Public Places
• Questioned about identity

21. Henry K
Beecher Article
“Ethics and clinical research”
Henry K. Beecher
New Engl J Med 274 (1966):1354-60
• 22 published medical studies presenting risk to subjects without
their knowledge or approval
• Published in some of the most prestigious journals and conducted
at some of the most prestigious institutions
• Laid the foundation for current guidelines on
informed consent and human experimentation.

22. Public Health Service Policy
• NIH Director requested that the National Advisory Health
Council review human subject protections
• Council recommended prior institutional review for PHS
supported research to:
– Protect of the rights and welfare of the subjects
– Assure appropriate methods of informed consent
– Determine acceptable balance of risks and benefits
• Adopted as Public Health Service policy in 1966
• Beginnings of the Institutional Review Board (IRB)

23. Tuskegee Syphilis Study
American medical research
project conducted by the
U.S. Public Health Service
from 1932 to 1972,
examined the natural course
of untreated syphilis in black
American men.
The subjects, all impoverished
sharecroppers from Macon county,
Alabama, were unknowing participants
in the study; they were not told that they
had syphilis, nor were they offered
effective treatment.

24. National Research Act
• 1973 Kennedy Hearings befor health
committee at Washington “Quality of Health
Care - Human Experimentation”
• 1974 National Research Act (by US congress)
– Established the “National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research”
– Required IRBs at institutions

25. The Belmont Report
Ethical Principles and Guidelines for the Protection of
Human Subjects of Research
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research
April 18, 1979

26. The Belmont Report
Summarizes
• Ethical principles and guidelines for research
involving human subjects.
• Three core principles are identified: respect
for persons, beneficence, and justice.
• Three primary areas of application are also
stated: Informed consent, Assessment of risks
and benefits, and Selection of subjects