This article examines how ethical standards for human experimentation have evolved, with the backdrop of medical advances gained through unethical biomedical experimentation by the Nazis and the Japanese Empire during World War II. It discusses how to balance ethical standards with scientific progress, and includes historical examples and contemporary perspectives on clinical trials.
The Nazis and the Japanese Empire. Most people have a negative reaction to the names of these two groups. This is partly because they are war criminal nations that started World War II, but also because they were responsible for ruthless biotechnology experiments on Jews and Asians, respectively. Paradoxically, Germany and Japan gained a great deal of medical knowledge in a short period of time through these experiments and are now among the world’s leading medical powers. So what can we do to weigh the light and darkness of clinical trials? What if we had to choose between the victims of irresponsible experiments and patients with unresearched diseases? The answer comes from the ethical standards of clinical trials.
Clinical trials are the process of testing unconfirmed medical knowledge on real human subjects for medical purposes or to advance science. Because they test incomplete knowledge on living beings, they must be repeatedly checked for safety. However, until the standards for clinical trials were clearly established, the rights of human subjects were not respected at all. Over time, human rights have evolved and the well-being of individual patients has become more important. As a result, human experimentation, which has a high risk of abuse, is strictly regulated in many countries today. This is because, although the ambition of researchers and the interests of the pharmaceutical industry are powerful drivers of scientific progress, without legal protections for subjects or patients during the experimental process, it would lead to inhumane results.
So how can clinical trials be conducted ethically? In this article, we will look at the history and development of clinical trials, the unethical behaviors that have occurred, the evolution of clinical trial ethics regulations, and consider the future direction of biotechnology that respects human beings.
The vivisection of executed prisoners by Herophilus and Erastrastus in the 2nd century BC was a major contribution to modern medicine, but it still provokes ethical debate because the knowledge was gained at the expense of a living human being. In Alexandria at the time, vivisection was supported by the state. It was seen as an inevitable way to gain medical knowledge. Human experimentation was justified by the utilitarian idea of sacrificing guilty condemned prisoners to save the lives of many innocent citizens. In the 18th century, germs were forcibly injected into patients, prisoners, and the intellectually challenged in order to discover new germs, and the results were recorded. Medical experiments also included the unauthorized autopsies of deceased patients, with a complete disregard for human rights. Of course, there is no denying the tremendous advances in life sciences that have been made in this process, but questions remain about its legitimacy.
In the name of scientific advancement, reckless experiments that violated human rights led to a movement against clinical trials in the late 19th century, centered on religious people. The movement grew in the 20th century in Europe and the United States as the public became more concerned about human rights. After the end of World War II, in October 1945, legislation was passed through international conventions to punish war criminals. On October 25, 1946, a trial was held at the Nuremberg Court of Justice to try German doctors and scientists for human experimentation, and 23 people were indicted, 20 of whom were doctors. The trial emphasized the irresponsible, unethical, and anti-human experimentation that violated the Hippocratic Oath. The question of the standards of human experimentation was raised throughout the trial. The defendants argued that their actions were justified and that they were innocent due to the special circumstances of war, as no clear principles of human experimentation existed until the early 20th century. In response, the prosecution called Dr. Leo Alexander and Dr. Andrew Ivy as witnesses. Based on their testimony, ten articles were included in the final judgment of the trial, which became known as the Nuremberg Code. The Code was intended to establish solid standards for human experimentation internationally.
So far, we’ve described the development of ethical standards for clinical trials. However, the ultimate goal of clinical trials is to prevent subjects from being harmed by poor standards, while also preventing overly stringent standards from stalling medical advances and leaving patients untreated. As always, what one side gains, the other side gives up. The gains and losses for the two groups of subjects and patients mentioned above are two sides of the same coin, and it’s not easy to draw the line.
Clinical trials conducted on human subjects can be broadly categorized into two types: those for academic purposes and those for therapeutic purposes. I believe that the criteria for these two types of clinical trials should be significantly different. In academic experiments, i.e., experiments that do not benefit the subject, there is no reason for the subject to take great risks. Sure, they may feel that they can sacrifice themselves for the greater good of medical advancement, but it’s not worth their life. For patients, on the other hand, it depends on the severity of the disease, but basically, the criteria should be more flexible than in the former case. This is because the patient directly benefits from the outcome of the clinical trial. However, when considering whether a patient should consent to a clinical trial, it’s also important to consider situations where the patient is in critical condition or mentally unable to express their wishes. In this case, a surrogate will be appointed, and the interests of the patient and the surrogate will need to be weighed against the circumstances.
Current clinical trial standards are too general and not detailed enough. Law, especially civil and criminal law, can be complemented by the dignity of numerous precedents and judgments, even if they are not universal and detailed. However, bioethical standards for dealing with human life are different. There are fewer precedents, and the standards cannot be more dignified than life itself. Historically, there have been efforts to create laws that are clear and can cover all cases, but now, from the perspective of the human subjects, we need to be unbound by standards. Clinical trial technology needs to move in the direction of maintaining flexibility in the pursuit of good.
