THE NUREMBERG CODEDECLARATION OF HELSINKITHE BELMONT REPORT
Tuskegee Syphilis Study 1940s
Radiation Experiments Begins - 1932
1940s - Nazi Experiments
1947- Nuremberg Code
1950s-1961 Thalidomide Tragedy
1962 Kefauver-Harris Amendments Food, Drug and
1964 Declaration of Helsinki
1974 - National Research Act
1972 - Tuskeegee Study Exposed
1979 - Belmont Report
THE Nuremberg Code is the most important
document in the history of the ethics of medical
The Code was formulated 50 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.
Voluntary informed consent
Experiment should be for the good of society, results not
obtainable by other means
Experiment should be based upon prior animal studies
Physical and mental suffering and injury should be avoided
There should be no expectation that death or disabling injury
will occur from the experiment
Risk vs. benefit
Protect subjects against injury, disability, or death
Only scientifically qualified individuals should conduct human
Subject can terminate her/his involvement
It served as a blueprint for
today’s principles that ensure
the rights of subjects in medical
Because of its link with the
horrors of World War II and the
use of prisoners in Nazi
concentration camps for
debate continues today about
the authority of the Code, its
applicability to modern medical
research, and even its
So, The Nuremberg code has no legal force behind it, and
it would be erroneous even to credit it as the framework
on which all future codes have been based.
The Declaration of Helsinki (DoH) is, indisputably, a
remarkable document. It is the mission of the
medical doctor to safeguard the health of the
The British Medical Journal announced the
emergence of the DoH in its 18 July 1964 edition
with the following words: ‘A draft code of ethics on
human experimentation was published in the
British Medical Journal of 27 October 1962.
Safeguarding research subjects
Adhering to an approved research plan/protocol
A revised version was accepted as the final draft at
the meeting of the World Medical Association in
Helsinki in June 1964, It is to be known as the
Declaration of Helsinki Attached to just over 700
words of the text of the original DoH.
In its 40-year lifetime the Declaration has been
revised five times and has risen to a position of
prominence as a guiding statement of ethical
principles for doctors involved in medical research.
Adopted by the 18th WMA General Assembly
Helsinki, Finland, June 1964 and amended by the 29th
WMA General Assembly, Tokyo, Japan, October 1975.
35th WMA General Assembly, Venice, Italy, October
41st WMA General Assembly, Hong Kongng September,
48th WMA General Assembly, Somerset West, Republic of
South Africa, October 1996 and the 52nd WMA General
Assembly, Edinburgh, Scotland, October 2000.
WMA General Assembly, Washington 2002.
Thus, Both the Nuremberg Code and the
Declaration of Helsinki served as models for the
current U.S. federal research regulations, which
require not only the informed consent of the
research subject (with proxy consent sometimes
acceptable, as for young children), but also prior
peer review of research protocols by a committee
(the institutional review board of the hospital or
research institution) that includes a representative
of the community.
The Nuremberg Code focuses on the human rights
of research subjects, the Declaration of Helsinki
focuses on the obligations of physician-investigators
to research subjects, and the federal regulations
emphasize the obligations of research institutions
that receive federal funds.
Due to the publicity from the Syphilis Study, the
National Research Act of 1974 was passed.
The National Research Act created the National
Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research.
The Commission charge was to identify the basic
ethical principles that should underlie the
conduct of biomedical and behavioral research
involving human participants and to develop
guidelines which should be followed to assure
that such research is conducted in accordance
with those principles.
Carrying out its charge, the Commission
prepared the Belmont Report in 1979.
The Belmont Report is a statement of basic
ethical principles and guidelines that provide
“an analytical framework to guide the
resolution of the ethical problems arising from
research with human subjects.”
A. boundaries between practice and
B. basic ethical principles,
Term Term Definition Outcome
designed solely to
enhance the well-
being of an
Research Activity designed to
test a hypothesis;
Permits a conclusion
to be drawn
1.Respect for Persons
Treat people as autonomous (having the right to
Protect those who have diminished autonomy
(vulnerable populations), e.g. children, prisoners,
Do no harm,
Maximize benefits/minimize risks,
NOT an act of kindness or charity, but a concrete
Treat people fairly
Do not exploit those who are readily available
Fair distribution of the risks and the benefits
of research based upon the problem/issue
Consideration of the three general principles
in the conduct of research lead to the
Informed Consent process
Selection of research participants
Informed Consent Process
Information - Does the consent form provide all the information
necessary for the individual to make a reasoned decision?
Comprehension - Is the consent form crafted in language
understandable to the potential participant?
Voluntariness - Does the consent form and clearly indicate that
participation in the research is voluntary?
What additional protections can be in place to protect those
with limited autonomy?
How to determine whether one lacks the autonomy to make a
Assessment of Risks and Benefits
Risk refers to the probability of harm; when considering risk,
one should consider both the probability and the severity of
the envisioned harm; while the term, benefit refers to
something that promotes health, well-being, or welfare.
What are the risks of harm to the participants (consider
physical, psychological, social, and economic harms)? Are the
risks justified? Can they be minimized?
Can the research design be improved to minimize risk and
What are the benefits (to the participant; to society)?
Selection of Subjects
Is the potential subject pool appropriate for the
Is it appropriate to involve vulnerable populations
(e.g., economically disadvantaged; limited
cognitive capacity) in the research or are they
being enrolled because it is convenient or because
they are easily manipulated as a result of their
Are the recruitment procedures fair and impartial?
Are the inclusion and exclusion criteria fair and
Thus, The Belmont Report attempts to summarize
the basic ethical principles identified by the
Commission in the course of its deliberations. It is
the outgrowth of an intensive four-day period of
discussions that were held in February 1976 at the
Smithsonian Institution’s Belmont Conference
Center supplemented by the monthly deliberations
of the Commission that were held over a period of
nearly four years. It is a statement of basic ethical
principles and guidelines that should assist in
resolving the ethical problems that surround the
conduct of research with human subjects.