a plethora of “research studies” that involved the torture and murder of concentration camp inmates. One such study placed subjects in frigid water to observe how long it would take them to die of hypothermia. In another experiment, researchers inflicted simulated battle wounds and treated some subjects with experimental techniques while neglecting the “control” group (Tapalaga, 2020). In Nuremberg, Germany, beginning in December of 1946, in a series of military tribunals that became known as the Doctors’ Trials , prosecutors charged 20 Nazi physicians and three medical administrators who murdered and tortured concentration camp prisoners with horrific medical experiments. (Shuster, 2018). Historians have thoroughly documented the complete disregard for basic human rights that characterized some of the “research studies” performed in the camps by Joseph Mengele and others. As a result of these trials, the Nuremberg Code emerged as the first document to state the moral obligation of researchers to conduct legitimate research and protect human subjects who participate. Before this time, there had been no written or widely accepted standards for protecting human subjects in research, even when they consented to take part. Text Box 2 lists the mandates of the Nuremberg Code. In spite of recent memories of Nazi medical atrocities, dental investigators conducted what is now considered unethical
research at Sweden’s Vipeholm Mental Hospital from 1945 to 1953. In that series of studies, 436 patients were fed large quantities of sugars in an effort to observe the effect of carbohydrate type, frequency, and quantity of intake on the development of dental caries. The subjects of the study were residents of an institution for mentally challenged individuals who were never informed about their participation of the study and from whom informed consent was never sought. By the end of the study, subjects had 2,125 new dental cavities (Manjrekar, Do and Do, 2019). While research atrocities were occurring in Europe, the United States was not immune to transgressions of its own. For 40 years, from 1932 to 1972, the U.S. Public Health Service conducted the Tuskegee Syphilis Study, enrolling approximately 600 African-American men in the program. Because no cure for syphilis existed at the inception of the study, the purpose of the Tuskegee research was to observe the natural progression of the disease. However, even when penicillin became available in the 1940s, researchers never gave the drug to participants in the study. In fact, they never informed the subjects that syphilis was their diagnosis, telling them instead that they had “bad blood.” Therefore, the participants did not even seek treatment for syphilis on their own (Centers for Disease Control and Prevention [CDC], 2017; Alsan and Wanamaker, 2017; Tuskegee University, 2021).
Text Box 2: The Nuremberg Code 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility, which may not be delegated to another with impunity. 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. 3. 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. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted, where there is an appropriate reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. 8. 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. 9. 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 seemed to him to be impossible. 10. 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. Note . U.S. Department of Health and Human Services. (2016b [1949]). The Nuremberg Code. In Trials of war criminals before the Nuremberg military tribunals under Control Council Law No. 10 (Vol. 2). Washington, DC: U.S. Government Printing Office. Retrieved from http://www.hhs.gov/ ohrp/ archive/nurcode.html This study continued unchanged until an undercover investigation by the media brought the situation to the attention
In 1974, amid increasing outcries over the controversial research occurring in the United States, Congress appointed the National Commission for the Protection of Research Subjects of Biomedical and Behavioral Research. They charged the commission with defining the underlying ethical principles that should surround research involving human subjects as well as clarifying the definition of legitimate research. In 1979, the commission released the Belmont Report (Muscente, 2020; U.S. Department of Health and Human Services [HHS], 2016a). This document provided the basis for modern ethical principles that still guide healthcare ethics today.
of the public. When the story broke in 1972, only 74 of the original study participants were still alive (Lehman, 2021). Other research that caused similar ethical concerns during this period was taking place in U.S. prisons such as the Holmesburg Prison in Philadelphia and disabled children’s inpatient facilities such as the Willowbrook State School in Staten Island (Rosenbaum, 2020; Amramova, 2019).
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