Su Lim is a senior mathematics major at Grinnell College and interested in biostatistics and clinical research.
The mid-20th century in the United States was a golden age of scientific advancements and medical discoveries. The rapid expansion of medical knowledge and techniques encouraged medical professionals to perform numerous experiments using human subjects either to better understand the human body or to test the efficacy of treatments in humans. Largely led and funded by the United States government, such human experiments were often performed unethically or illegally. Although the Nuremberg code and Declaration of Helsinki were introduced to protect the rights and welfare of human subjects in medical research, unethical experimentation continued for the next several decades in the United States. In 1972, the publicity about the Tuskegee syphilis study “raised alarms about the misuse of human subjects”. The study contributed to the enactment of the National Research Act by which the current U.S federal research systems are heavily influenced and significantly altered the way American physicians have viewed human subjects in their research .
Tuskegee Syphilis Study
The Tuskegee syphilis study is recognized as the most notorious human experimentation in the American history. The United States Public Health Service (USPHS) physicians led the study from 1932 to 1972 to examine the natural progress of untreated syphilis in African American men, diagnosed with syphilis, at the Tuskegee institute in Mason City, Alabama. The subjects were promised to receive “free special treatment” for a serious disease and enrolled without informed consent . Researchers supplied non-effective medicines to deceive the participants so that they believed they were being treated . Researchers believed that the “benefits of nontreatment outweighed the benefits of treatment,” even when penicillin became available as a treatment for syphilis, because they aimed to study the natural course of untreated syphilis . This study symbolizes disrespect for human rights and the lack of ethical consideration for human subjects.
Mustard Gas Experiments
The United States government conducted mustard gas experiments on American soldiers during World War II to test the efficacy of clothing and protective equipment in the event of mustard gas attacks . The soldiers were put in a gas chamber or directly exposed to mustard gas for hours without informed or voluntary consent. Since servicemen must obey any orders, they were forced to participate in the study and to take the vow of silence for the rest of their life while suffering from intense respiratory problems, skin burns, and cancers afterwards .
San Quentin Penitentiary
Dr. Leo Stanley, the chief surgeon at San Quentin State Penitentiary, conducted inhumane experiments on prisoners at the penitentiary from 1913 to 1951. As a eugenicist, he wanted to stop the reproduction of the “unfit,” so he sterilized more than 20,000 prisoners through voluntary consent, which consent was largely influenced by his persuasion and by their desire for better care and food provided by prison personnel . He also implanted testicular substances from young prisoners and even livestock – goats and boars – into aging men, who he believed had good genes, to rejuvenate them .
Guatemala Syphilis Study
The United States National Institute of Health funded the Guatemala syphilis study to examine the effects of various medications in the prevention of syphilis. The USPHS physicians recruited or/and deliberately injected syphilis to vulnerable populations – female sex workers, prisoners, soldiers, and mental health patients – in Guatemala without obtaining valid consent. Researchers believed that “it was acceptable in Guatemala to cross ethical lines that they would not have breached” in America . Furthermore, the Guatemalan government saw this study as a great opportunity to upgrade their public health infrastructure and import advanced medical knowledge and techniques from the United States, while they knew that they were harming their people .
The Nuremberg trials that prosecuted Nazi physicians from 1945 to 1946 for their unethical human experimentation during World War II initiated public discussion of research ethics involving human subjects. Established in 1947, the Nuremberg code differentiated between therapeutic and non-therapeutic experimentation, and this distinction heightened public awareness of the therapeutic intent of medical research . The Nuremberg code has ten provisions to protect the rights and welfare of human subjects . Its first provision, “the voluntary consent of the human subject is absolutely essential,” marked the beginning of modern discussions of voluntary and informed consent .
Unfortunately, the Nuremberg code had little impact in the United States. American physicians saw it as irrelevant to their research; for them, what separated American research from Nazi research was the promise of antibiotics and the increased federal funding and medical discoveries .
As Reverby Said, “The horrors of the experiments under the Nazi became thought of a Nazi science, not science. American medical researchers, flush with the excitement of the expanding funding and medical breakthroughs of the postwar period, did not think they needed such outside authority or that names of those doing problematic research could be given out because of the possibility of criminal prosecution”.
The linkage between American and Nazi experimentation was “illusive” to American physicians .
The first provision did not address the special case of obtaining consent from incompetent individuals such as children, illiterates or prisoners. Most human experimentation in the mid-20th century targeted vulnerable populations who lacked competence or power. Furthermore, the Nuremberg code did not appeal to American physicians because the terms “volunteers” and “subjects” were often used interchangeably, so research subjects were often seen as volunteers . This misunderstanding made it difficult to stop the unethical human experimentation in the United States that continued for the next several decades. Moreover, the Nuremberg code was just a guideline, so American physicians were not obligated to follow it .
The World Medical Association (WMA) issued the Declaration of Helsinki in 1964 to provide a more specific and stringent code of research ethics involving human subjects, such as the requirement to obtain consent from the legal guardian in the case of incompetent research subjects . The Declaration shifted the focus from the protection of human rights of research subjects to the protection of patient welfare through physician responsibility . The WMA condemned its members who had ignored the “humanitarian motives” as medical professionals and committed inhumane acts against human subjects for research purposes
. However, it also consistently protected its members who had violated ethical principles .
Despite the efforts to secure the rights and welfare of research participants in the mid-20th century, unethical human experimentation continued in the United States until the media covered the Tuskegee Syphilis study. The United States Congress then passed the National Research Act in 1974, establishing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . Since the Nuremberg code and the Declaration of Helsinki often were “inadequate to cover complex situations”, the Commission “[addressed] the fundamental ethical principles that should underlie the conduct of biomedical and behavioral research involving subjects”. Published by the Commission in 1978, the Belmont Report discussed these three basic principles of ethics and their applications.
The first principle is respect for persons that comes with two moral statements: “the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy” . People should make a deliberate decision that should not be influenced by those in a position of power. People with diminished autonomy should be protected, as it is difficult for them to make valid informed and voluntary consent. Most of the victims of unethical experimentation were African American who did not have human rights in the 20th century, soldiers who must obey orders, or prisoners who were often denied fair and just treatment in prison. This principle had great impact on how American physicians should treat their research subjects and respect them for their participation in their study.
The second principle, beneficence, conveys two moral statements: the requirement to do no harm and the requirement to maximize benefits and minimize harm . The Hippocratic oath – “to do no harm” – that had underlain Western medical ethics was not enough to protect human rights, as it was not an enforceable regulation . Rather, this second principle is an obligation that enabled American physicians to prioritize patient welfare and health over their research purposes and to maximize benefits and minimize risks of research on participants.
The third principle, justice, stresses the fair distribution of the benefits and risks of research . It allowed American physicians to be thoughtful when deciding who should be included and excluded from their research and whether participants are selected through fair procedures. It helped researchers think twice about the welfare and health of research participants when they designed their study.
Numerous unethical human experiments, particularly the Tuskegee Syphilis study, raised alarms about the misuse of human subjects in the mid-20th century in the United States. The current American federal research regulations for protection of human research subjects are heavily influenced by the three principles of ethics discussed in the Belmont Report. The National Research Act also contributed to the push for protection of vulnerable populations in addition to informed and voluntary consent and patient welfare, thus discouraging medical abuses in biomedical research.
 Susan Reverby, Examining Tuskegee: the infamous syphilis study and its legacy, (Chapel Hill: University of North Carolina Press, 2009), 189.
 Ankita Patel, “The Nuremberg Code, Declaration of Helsinki, The Belmont Report,” http://www.slideshare.net/ANKITAPATEL45/belmont-report-48291712.
 Allan Brandt, “Racism and Research: The Case of the Tuskegee Syphilis Study,” http://www.med.navy.mil/bumed/Documents/Healthcare%20Ethics/Racism-And-Research.pdf, 7.
 Ibid., 9.
 Carol A. Heintzelman, “The Tuskegee Syphilis Study and Its Implications for the 21 century,” The New Social Worker, Last modified 2003, http://www.socialworker.com/feature-articles/ethics-articles/The_Tuskegee_Syphilis_Study_and_Its_Implications_for_the_21st_Century/.
 Carol Vento, “America’s Mustard Gas Experiments and World War II,” Defense Media Network, Sep. 14, 2013.
 Ethan Blue, “The Stranger Career of Leo Stanley: Remaking Manhood and Medicine at San Quentin State Penitentiary, 1913-1951,” Pacific Historical Review, no. 2 (2009): 220.
 Ibid., 228.
 Matthew Walter, “First, Do Harm,” Nature, vol. 482 (2012): 152.
 Ibid., 150.
 Reverby. Examining Tuskegee, 189.
 Robert Baker, The American Medical Ethics Revolution: How the AMA’s Code of Ethics Has Transformed Physicians’ relationships to patients, professional, and society, Maryland: Johns Hopkins University Press, 1999: 301.
 Reverby, Examining Tuskegee, 66.
 Ibid., 189
 Dianne Irving, “Need to know: Nuremberg Code, Declaration of Helsinki, Belmont Report, OHRP,” Lifeissues.net: Clear Thinking About Crucial Issues, Last modified June 27, 2014. http://www.lifeissues.net/writers/irv/irv_214needtoknow.html.
 Robert Baker, The American Medical Ethics Revolution, 303.
 Irving, “Need to know.”
 Reverby, Examining Tuskegee, 189.
 Irving, “Need to know.”
Schwartz, Marie. Birthing a Slave: Motherhood and Medicine in the Antebellum South. Harvard University Press, 2010.
Steinberg, Jonathan. “The Ethical Use of Unethical Human Research.” http://bioethics.as.nyu.edu/docs/IO/30171/Steinberg.HumanResearch.pdf.
Washington, Harriet. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present. New York: The Doubleday Broadway Publishing Group, 2006.