THE NUREMBERG CODE DECLARATION OF HELSINKI THE BELMONT REPORT

1. ANKITA PATEL

2.  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
Cosmetic Act
1964 Declaration of Helsinki

3.  1974 - National Research Act
1972 - Tuskeegee Study Exposed
1979 - Belmont Report

4.  THE Nuremberg Code is the most important
document in the history of the ethics of medical
research.
 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.

5.  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
experimentation
 Subject can terminate her/his involvement

6.  Purpose:
 It served as a blueprint for
today’s principles that ensure
the rights of subjects in medical
research.
 Because of its link with the
horrors of World War II and the
use of prisoners in Nazi
concentration camps for
medical experimentation,
debate continues today about
the authority of the Code, its
applicability to modern medical
research, and even its
authorship.

7.  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.

8.  The Declaration of Helsinki (DoH) is, indisputably, a
remarkable document. It is the mission of the
medical doctor to safeguard the health of the
people.
 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.

9.  Safeguarding research subjects
 Informed consent
 Minimizing risk
 Adhering to an approved research plan/protocol

10.  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.

11.  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
1983.
41st WMA General Assembly, Hong Kongng September,
1989
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.

12.  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.

13.  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.

14.  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.

15.  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.”

16. A. boundaries between practice and
research,
B. basic ethical principles,
C. applications.

17. Term Term Definition Outcome
Practice Interventions
designed solely to
enhance the well-
being of an
individual
Reasonable
expectation of
success
Research Activity designed to
test a hypothesis;
contributes to
generalized
knowledge
Permits a conclusion
to be drawn

18.  1.Respect for Persons
 2.Beneficence
 3. Justice

19.  Treat people as autonomous (having the right to
self-govern) agents.
 Protect those who have diminished autonomy
(vulnerable populations), e.g. children, prisoners,
elderly.

20.  Do no harm,
 Maximize benefits/minimize risks,
 NOT an act of kindness or charity, but a concrete
obligation

21.  Treat people fairly
 Do not exploit those who are readily available
or malleable
 Fair distribution of the risks and the benefits
of research based upon the problem/issue
under investigation

22.  Consideration of the three general principles
in the conduct of research lead to the
consideration of:
 Informed Consent process
 Risk/Benefits assessment
 Selection of research participants

23.  IRB
Members
should
consider the
following…

24.  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
reasoned decision?

25.  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
maximize benefit?
 What are the benefits (to the participant; to society)?

26.  Selection of Subjects
 Is the potential subject pool appropriate for the
research?
 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
situation?
 Are the recruitment procedures fair and impartial?
 Are the inclusion and exclusion criteria fair and
appropriate?

27.  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.