Taking risks is an inevitable necessity when trying to achieve a breakthrough in modern science, technology, or human understanding. A moral dilemma, however, emerges when the risks threaten human lives and well-being. One must ask: can the well-being of one human be sacrificed in order to achieve a greater potential benefit for the larger population?
Human clinical trials have occurred throughout history, particularly in the fields of medicine and psychology. When comparing different periods, it is evident that over time, society has set more rigid and condition-based standards on what type of tests can be applied on people, as well as the necessary qualifications of the testers themselves. However, the issue itself has always been controversial, and the standards are constantly changing on the basis of legal, religious, and moral arguments. It is common sense that forcing someone to partake in a clinical study against their will, performing experiments on subjects without their knowledge of it, instigating unnecessary pain and torture, or not allowing someone to withdraw from the experiment, are unacceptable and morally, legally, and religiously unjustifiable. But such easy answers make it seem that there are strict regulations that are implemented when human clinical trials are carried out, and that there is an organized system that determines such issues. The reality is, even these “common sense” ground rules can be compromised in various situations where infringing upon one or more of the rules is pivotal to the success of the experiment.
There is a blatant discrepancy between the protocol that is implemented when handling vulnerable people, such as the mentally disabled, certain prisoners, or children, and those who are actually capable of making conscious decisions for themselves. Vulnerable people can be characterized by their inability to comprehend or, in some cases have a say in, the conditions they are subject to and the repercussions of a particular action that is carried out upon or on behalf of them. For instance, a child is considered “vulnerable” because he or she doesn’t have the experience or comprehension necessary to make a decision for him or herself, which leaves the responsibility up to the parent or legal guardian.
Another example is a prisoner of war, whose self-autonomy is completely lost. A prisoner can be forced or bribed (usually with certain ration privileges, or in some cases even freedom) into participating in experimental trials. Certain events, such as the Syphilis Studies in the 1930s, Nazi experiments of the mid 1940s, and the Willowbrook Study in the 1960s, where vulnerable people were exploited and subject to various trials, triggered the application of moral and legal restrictions that are recognized as “Ethical Milestones” (Henry 2012).
In a proper trial, the subjects involved in particular experiments would be informed of the treatments they were undergoing and would not be exposed to unbearable or unconsented agony. The trials themselves would provide a significant benefit to the greater good, and the patients would not be exposed to highly risky and life-compromising situations. Unfortunately, all of these basic humanitarian considerations were neglected in the aforementioned scenarios, as well as in many other instances when vulnerable people have been exploited.
The Syphilis Study
This study took place between 1932 and 1972 and was administered by the Public Health Service, with connections to the Tuskegee Institute. The “Tuskegee Study of Untreated Syphilis in the Negro Male” aimed to analyze the natural development of untreated syphilis in underprivileged black males. The PHS would oversee the injection of the syphilis virus into the males, who were told that they were being tested for “bad blood” and were provided free medical exams, meals, and burial insurance as compensation for participating in the procedure (CDCP 2016). Essentially, the subjects were completely unaware that they were becoming hosts for the disease, and were thus unaware that they needed proper treatment. The researchers went as far as not offering penicillin, the primary treatment at the time for syphilis, to the subjects, as they wanted to monitor the long-term effects of the disease and accumulate the highest possible amount of information for their study.
The Study was (rightfully) deemed “ethically unjustified,” and a series of class-action legal disputes ensued. The Tuskegee Syphilis Study is a prime example of unwarranted and unpardonable human clinical trials. Not only did it take advantage of a vulnerable population, which was in this case an impoverished racial minority, but it also failed to provide basic information, treatment, and awareness to its subjects, who were under the assumption that they were receiving medical assistance rather than medical injustice.
The Syphilis Study shamelessly infringed upon basic human rights, and caused a legal uproar, as evidenced by the title of a newspaper article, “Regulation Urged in Human Testing” (New York Times, Hicks, 1973). It violated the fundamental principle that each individual has the right to maintain his or her own life and well-being, and must thus be made aware of every, and any, procedure carried out on them by any sort of authority.
Two other major events shocked many people and led to stricter rules regulating tests on human subjects. They were the Nazi experiments and the Willowbrook State School experiments. In both of these tragic occurrences, all moral values and humanity were abandoned as malignant officials executed a variety of painful, invasive, and unwarranted measures on highly exposed and susceptible groups of people.
Everyone is aware of the horrors of the Holocaust, the mass genocide committed by the Nazis against millions of Jews, mentally disabled people, homosexuals, gypsies, and other minorities who were viewed as a threat to the purity of the “perfect Aryan race.” Fewer people are aware that the Holocaust also involved millions of brutal and inhumane experiments on people, with no justifiable scientific goal in mind. The primary aspiration of the Nazi physicians was to research and develop the tools, genes, and treatments necessary to ensure the advancement of the Aryan race and the sterilization of the supposedly “subordinate” races.
The most notorious doctor was Dr. Josef Mengele, at Auschwitz. He conducted a series of torturous procedures on primarily identical twins. During his assessments, he would specifically request twins and perform procedures like drawing enough blood that the children would bleed to death, injecting chloroform into their hearts, vivisecting their bodies, injecting chemicals into their eyes in hopes of changing their eye color (most likely to potentially achieve the highly sought-after Aryan blue eyes), sex change operations, incestuous impregnations, and even isolation endurance.
Perhaps the most gruesome and barbaric of all the procedures was the experiments on conjoining twins, where Dr. Mengele would sew the twins’ heads or limbs together to see how they would function. In other cases, he would attempt to separate pairs that were naturally conjoined (Bulow 2015).
In the case of the Willowbrook studies, a mental institution authorized the deliberate infection of their patients with Hepatitis to assess the growth and effects of the disease and to identify the effects of certain factors that prevent or slow the disease’s progression. Many of the subjects were disabled children, who were given “milkshakes laced with a live hepatitis virus” (Slepian 2012), and were either directly injected with the disease or fed fecal extracts of already afflicted patients. The majority of the parents and guardians who provided a written consent “didn’t know what they were signing” (Slepian 2012) because the document did not explicitly state that the children would be deliberately afflicted.
Further ethical questions were raised when it came out that the institution already had an extremely high number of patients getting the disease, and “P.I. Krugman argued that the risk was minimal - not greater than the children’s normal risk” (Henry 2012). Although the children would have most likely caught the disease anyway, it is essential to consider the possibility that some of the patients would have been otherwise immune to the factors that contributed to the spread of the ailment within the institution – and of course that it was still completely unjustifiable to have run such an unsanitary and deleterious institution in the first place, with no proper care given to the patients who were initially infected. Furthermore, that the parents were not made aware of the circumstances and were coerced into signing a document they couldn’t comprehend whilst being responsible for their child’s health was a severe moral infringement. It was, and is, completely unacceptable. The children under Willowbrook’s care obviously were not in a condition to take care of and make judgments for themselves, and for these “qualified” and “compassionate” officials to take advantage of innocent children and their families is beyond the ethical premises of human experimentation.
Modern scientific research
Unlike previous epochs in history, modern scientific research values preserving the liberties and safety of individuals involved in human experimentation trials. Several pieces of legislation and restrictions have been embedded into the process of implementing human studies at an assortment of facilities, ranging from universities to private clinics. Although there may still be cases where experiment administrators disregard the set humanitarian codes of human trial conduct, in general, people have been significantly more attentive to violations of any liberties during trials.
The basis of this morality can be found in the Hippocratic Oath, which asserts that medical practitioners have an “ethical responsibility” to the advancement of their research and the subject involved in their research. A sample of the classical text clearly indicates the personal realization and obligation that a physician must assess before conducting an experiment: “I will apply dietic measures for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice” (Tyson 2001; originally written by Hippocrates). The Oath has even been modernized by medical professionals in the industry to adhere to the vastly different available technologies; the modern version of the Oath includes guidelines like, “I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person’s family and economic stability” (Lasagna 1964).
The Nuremberg Code is one of the primary pieces of legislation regulating experimental administrators and the morality of their procedures on human subjects. The Code blatantly outlines the strict regulations of involving people in the aims of scientific research. For instance, it makes statements like, “The voluntary consent of the human subject is absolutely essential”; “The experiment should be as such to yield fruitful results for the good of society unprocurable by other methods or means of study”; and “The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury” (Mitscherlich 1947). Other smaller milestones in legislation include the Food and Drug Act (1938), the Helsinki Declaration signed by the United States (1964), and the National Research Act Title II Public Law 93-348 (1974).
In summation, the constant ethical dilemma that many scientists are facing is the age-old problem of whether to sacrifice an individual’s well-being for the greater good, and whether that individual can be pushed beyond his or her limits in order to achieve the maximum result from the experiment. As the multiple historical instances and established legal and ethical guidelines presented in this article indicate, under any and all circumstances, the human subject must be considered before the fruit of the trial. Human experimentation is only truly ethical when the patient’s physical and mental state are protected, necessary preparations are made and scientifically qualified examiners are present, the experiment is only being conducted for the greater benefit of society, and there is no other possible form of experimentation (i.e. with animals). The patient may halt the experiment at any time and must be completely informed and aware of what the procedure will instigate.
When it comes to vulnerable people, like the mentally disabled, who are unable to make conscious decisions for themselves, they must have competent, experienced, and empathetic authorities to make decisions for them when it comes to their involvement in human clinical trials. However, the same ethical guidelines that are stated in the Nuremberg Code should be applied to the handicapped patient, and in some situations, even more legal restrictions should apply to the trial conductors and the people who are in charge of making decisions for the vulnerable individual. When it comes to children, the parents must be made aware of all of the procedures that will occur, they must ensure the comfort and safety of their child, they must consult with numerous scientific and legal authorities to ensure that they are not overstepping their boundaries, and the trial must be monitored by public officials and qualified experts to ensure the child’s safety. When it comes to prisoners, the trials must only be conducted on those who are either on death row or are serving life sentences with no possibility of parole; furthermore, the same guidelines listed in the Nuremberg Code must be applied, and the prisoners must not be compelled, guilted, or coerced into participation.
As long as a patient’s liberty, protection, and safety are assured and all legal, moral, and scientific principles and regulations are implemented, human experimentation is ethically justifiable and can even prove to be a great asset to modern technology and medicine.
Henry, David (Ph.D.). Hardy, Goldman, Bhatia. 2012. “Human Subjects Research with
Vulnerable Populations”. University of Illinois at Chicago, Institute for Health Research and Policy, School of Public Health. http://www.ihrp.uic.edu/files/Vulnerability_IHRP_041012.pdf
Centers for Disease Control and Prevention. 2016. “The Tuskegee Timeline”. U.S. Public Health
Service Syphilis Study at Tuskegee. http://www.cdc.gov/tuskegee/timeline.htm
Hicks, N. 1973. “Regulation Urged in Human Testing; Panel Calls for Controls on Federally
Aided Research Need for Protection Cited”. New York Times, pg. 30. http://www.ihrp.uic.edu/files/Vulnerability_IHRP_041012.pdf (I received the headline from a previous source, I couldn’t find the actual publication because it was published too long ago).
The Nuremberg Code (1947) In: Mitscherlich A, Mielke F. Doctors of infamy: the
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Tufts University. http://www.pbs.org/wgbh/nova/body/hippocratic-oath-today.html
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Slepian, S. 2012. “Recalling the horrors of Staten Island’s Willowbrook State School”. SILive