This blog post examines whether bioequivalence testing can be ethical and whether we are overlooking any issues when balancing money and human dignity.
Maruta means “peeled log” in Japanese, but for us, it evokes the memory of cruel human experimentation. During World War II, Japan established a special unit called ‘Unit 731’. This unit was notorious not for military operations, but for human experimentation bordering on torture. From 1936 onwards, for about a decade, Unit 731 conducted bacterial experiments, freezing experiments, and poison gas experiments on prisoners from neighboring countries like Korea, China, and Russia. Approximately 3,000 innocent lives were sacrificed in these heinous experiments, which included freezing living hands until they broke and performing dissections on people while they were still alive and without anesthesia. Japan could not escape condemnation from countries around the world, including the victim nations. The human experiments of Unit 731 are considered crimes born of wartime desperation, acts that are absolutely unthinkable in modern society.
Yet even today, human experiments persist in our midst. A prime example is the bioequivalence test, also known as the bioavailability test. This experiment involves administering a drug with identical ingredients to a third party—the test subject—to verify whether its biological response matches that of an existing drug currently on the market. Participants take the medication and undergo various tests afterward. Among young people, this is known as “Maruta part-time work.” Primarily, men aged 19 to 30 in good physical condition participate. Despite the potential for side effects, there is an overflow of applicants. In fact, several websites have been established that specialize in recruiting subjects for bioequivalence studies.
Of course, bioequivalence studies are conducted legally. To ensure these studies do not become like the Maruta experiments of Unit 731, they must adhere to the Nuremberg Code, a fundamental medical ethics code. The Nuremberg Code reflects moral, ethical, and legal concepts regarding medical experiments and specifies ten basic principles that must be followed. Among these, the most crucial principle is the voluntary consent of the subject. The relevant party must possess the legal capacity to decide whether to consent and must be able to make a reasonable decision. The subject must be informed of the nature, duration, and purpose of the experiment; the methods and means of the experiment; all anticipated discomforts and risks; and the potential effects on health or personal circumstances that participation in the experiment may cause. All these obligations imply that the subject and the experimenter are on equal footing; the experimenter cannot coerce the subject into participating.
While these standards and principles are taken for granted in modern ethical standards, the relationship between subjects and experimenters in actual bioequivalence trials is, strictly speaking, not equal. A survey of 1,531 male and female university students conducted by a part-time job brokerage site revealed that 58.3% of men, 40.6% of women, and an average of 48.3% responded that they would consider participating in Maruta-style part-time work if paid sufficiently. A monetary transaction condition intervenes between the subject and the experiment planner. The subject participates in the experiment for financial gain, while the experiment planner assumes the role of an employer paying wages. Within this monetary snare, the experiment planner and subject can easily transform into dominant and subordinate positions.
However, this is not an argument to exclude monetary elements from experiments involving humans. As dignified as humans are, subjects should receive appropriate compensation for their participation, and money provides the most objective standard for this. Rather, what is needed to resolve this issue is for experiment designers to clearly understand their relationship with subjects and maintain a sense of crisis that problems could arise. Experiment designers must recognize that in modern society, the tool of money can intrude into human experimentation, potentially undermining human dignity. The experiment designer’s sound ethical principles act as a shield, ensuring subjects recognize their own dignity and that experiments involving precious human life are conducted solely for the common good. If laws exist to uphold what we judge to be right, ethical consciousness can be maintained through self-reflection.
Such arguments may seem somewhat distant during peaceful times. However, a proper ethical view of human dignity functions as a crucial safeguard, preserving a minimum level of humanity during crises. In post-war interviews with Japanese members of Unit 731, they responded that they did not consider the brutal human experiments of that time to be cruel at all. They believed using prisoners for military purposes was simply their normal duty. Their ethical framework became distorted in wartime, resulting in a tragic event that severely undermined human dignity.
Consider this verse from Korean poet Lee Wol-ran’s ‘Maruta Part-timer’:
In a dead-end alley, the lone card left
A body as smooth as a test tube
Will become a Maruta for Unit 731
Before those permitted white-coated war criminals
The vulgar blood being passed down Is being recorded on noble charts.
To avoid becoming those permitted white-coated war criminals, we must always remember we are dignified human beings.
