Between 1945 and 1949, a series of thirteen trials known as the
“Nuremberg Trials” was held in Nuremberg, Germany to dissect the crimes of
World War II. (History Channel). One of these
trials, the “Doctors’ Trial”, uncovered the horrific details of the research
endeavors of its defendants: medical professionals and scientists (Shuster). These individuals
performed a spectrum of torturous experiments that often resulted in the death
of prisoners in the concentration camps (Shuster).
Sixteen of the twenty-three defendants were found guilty, and seven of them
were put to death as punishment (Shuster).
The Nazi doctors and scientists under
scrutiny were responsible for neglecting the humanity of the human subjects. To
justify their actions, the defendants emphasized their responsibility to follow
orders from their superiors; their goal was to aid the German military effort
through discovery, which included finding cures for diseases (McNeill). However, the grave
nature of the experiments overshadowed the attempt to reason the efforts of
these medical professionals.
Because the camps were flooded with easily
accessible and vulnerable inmates, they quickly became the source of the human
subjects for research during the war. The prisoners were forced to participate
in many of the studies without consent; they were ill-informed and unaware. The
Nazi doctors and scientists dehumanized the prisoners, treating them merely as
objects for data. The victims were exposed to frigid temperatures of water and
effective revival methods for military pilots, infected with various diseases
such as typhus and malaria to test experimental drugs, and forced to endure
low-pressure chambers to evaluate the exposure limit for high-altitude flying (McNeill). Methods of mass extermination and
“racial hygiene” were also conducted on the prisoners. These included
procedures such as castration and sterilization. (McNeill)
The International Military Tribunal
identified the outcomes of these experiments as a crime against humanity, and the
defendants were accused of violating the Hippocratic
Oath’s duty to “do no harm” (Shuster). Notably, the Hippocratic Oath served as the only
means by which to evaluate these actions at the time of the trial. As a result,
the imperative need for further ethical guidance became imminent. Thus, the Nuremberg Code was written in 1947 by
the judges overseeing the trial to establish foundational ethics for research (Shuster).
Code was pivotal in the foundation of ethical concern for human research.
The document outlines ten ethical guidelines to protect human subjects.
Foremost, the Nuremberg Code
establishes the principle of informed consent, which involves the awareness of
the research subject on all aspects of the experiment prior to his or her
voluntary consent (Friedmann and Sprecher). Notably, the
individual should have the legal capacity to give consent to ensure validity.
In addition, the Nuremberg Code
discusses the purpose of experimentation and experimental design, with the
emphasis on the utility of the study for both the subject and society (Friedmann and
Moreover, the document identifies the need for qualified individuals to conduct
the study with both skill and care, as well as a safe environment for the
participants. During the course of the experiment, both the professional in
charge and the subject have a right to cease the study at any time (Friedmann and
Overall, the essential message articulated in the Nuremberg Code is the protection of human rights, specifically with
respect to research.
With the development of the Nuremberg Code, the need for international institutions to
uphold utility around the world became evident (Dodd). Thus, the code
triggered the development of key international organizations, including NATO in
1949 and the Agency for International Development in 1961 (NATO; USAID). The ethical dialogue surrounding
Nuremberg, Germany stimulated collaboration among nations, which has since
fostered the protection and advocacy of human rights
However, several ambiguities of the document propelled the development of
more recent, concrete regulations. Foremost, the Nuremberg Code is only a set of guidelines, so it lacks legal
authority. Thus, the document itself is overly simplistic and therefore inadequately
addresses several crucial concepts. The importance of voluntary consent is mentioned,
yet it is not considered contextually, such as in the case of a legal surrogate
or guardian serving as the authority over another individual. In addition, the
code insists that the experiments must yield “fruitful results for the good of
society”, yet it does not explain what is considered to be “fruitful” (Friedmann and
The Nuremberg Code avoids the
discussion of both therapeutic research and post-research care of participants
altogether. While “humanitarian importance” is emphasized, the code does not
provide a means by which to calculate or gauge this concept when weighing the
benefits and risks (Friedmann and Sprecher). The last guidelines
of the code mention the ability of both the participant and the researcher to
cease the study at any time, but the interpretable nature of these points is evident.
Overall, the subjectivity of the document presents a broad list of ambiguous
guidelines which are highly circumstantial and thus reliant on interpretation;
ethical thinking is not effectively addressed on a personal level.
To combat the shortcomings of the Nuremberg
Code, further regulations were introduced in the United States. Several
unfortunate research incidents again involving human subjects ignited the
movement for the development of more specific regulations to ensure the
protection of human rights. Such studies as the “Thalidomide Incident” and the
“Tuskegee Syphilis Study” propelled the creation of several key documents,
including the Declaration of Helsinki,
the National Research Act, and The Common Rule (Curators of
the University of Missouri).
Written in 1964, the Declaration of
Helsinki considered several shortcomings of the Nuremberg Code, including the distinction between therapeutic and
non-therapeutic research. However, the Declaration
of Helsinki, although updated over time, provided only recommendations (Curators of
the University of Missouri). Ten years later,
the National Research Act created the
“National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research”, and it became the first attempt at concrete regulations
in public policy for research ethics in the United States. The Commission
authored the Belmont Report in 1979 to
emphasize respect for individuals, beneficence, and justice in light of
informed consent, the assessment of risks and benefits, and subject selection
in research (Curators of the University of
Missouri). In 1991, The Common
Rule provided additional mandates, such as informed consent documentation,
Institutional Review Board requirements, and protections for vulnerable
research subjects including children, the disabled, and pregnant women (Curators of
the University of Missouri).
Each of these documents was derived from the basic principles of the Nuremberg Code. They collectively present
an encompassing set of regulations to foster the protection of human rights in
research. These current guidelines and regulations arise from the basic
principles of ethics: justice, beneficence, non-maleficence, and autonomy. As a
result, they are consistent in the foundations for the ethics of research.
Notably, the perpetual challenge of
aligning the diverse ethical perspectives of each culture on a global scale is
omnipresent. Furthermore, there is no international enforcement system
currently in place to regulate an international policy of ethics, which further
complicates the development of additional regulations on the international
level. As a result, conflicting opinions of ethics and the lack of an
international system of enforcement complicate the evolution of regulations, even
though history rightfully suggests the need for increasing policy to prevent
future abuses within the scientific community.
Nonetheless, because the basic elements of justice, beneficence,
non-maleficence, and autonomy are consistent themes in the guidelines and
regulations that do exist, such documentation fosters reason and practicality. It
is seemingly impossible to have universal regulations for the obvious conflicts
in cultural values, norms, and legal systems, yet the guidelines and
regulations that currently govern society empower the protection of human
rights amidst scientific advancement. As research evolves, it is imperative to
consider the foundational principles of ethics; by applying justice,
beneficence, non-maleficence, and autonomy to unique, advancing scenarios as a
means of justification, human rights will be promoted.
Curators of the University of
Missouri. Research & Economic Development. 2018. 18 January
Dodd, Christopher J. “Nuremberg:
Past, Present, and Future.” Washington University Global
Law Review VI.3 (2007): 645-652.
Friedmann, W and Drexel A Sprecher.
“Trials of War Criminals before the Nuremberg Military
under Control Council Law No. 10.” Harvard Law Review II (1949):
History Channel. “Nuremberg
Trials.” 2010. History.com. A+E Networks. 27 January 2018
McNeill, Paul M. “A History of
Unethical Experimentation on Human Subjects.” The Ethics and
Politics of Human Experimentation. Cambridge:
Cambridge University Press, 1993. 22.
NATO. What is NATO? 18 January
Shuster, Evelyne. “Fifty Years
Later: The Significance of the Nuremberg Code.” The New
Journal of Medicine (1997): 1436-1440.
USAID. USAID History. 8
September 2017. 18 January 2018