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10.2Background of the Establishment of Bioethics

At the end of the Second World War, there was a prevailing, naïve belief in the world that with increasing development of science and technology, a more prosperous and equal society could be realized. However, at the beginning of the 1960s, the problems of environmental pollution were realized along with other social issues such as anti-Vietnam war, civil-right and consumer movements, and university disputes. In the midst of all these, a critical view regarding science and technology became widespread.
In 1962, R. Carson wrote the book Silent Spring, in which she warned of the unlimited use of chemicals, pointing out the importance of ecological judgement, and also, in part, urged a reflective viewpoint about the rapid development of the life sciences. By the 1960s, molecular biology was established, and life phenomena were to be described at the molecular level. In 1973, recombinant DNA techniques were introduced. Introducing recombinant DNA techniques brought a whirlpool of debate because it meant that the possibility of manipulation of life became reality.
Moreover, in the field of medicine, new technologies attracting ethical interests appeared one after another. At the beginning of the 1960s, artificial dialysis was put into practical use, and since the device was not easily available, a "God Committee" in Seattle, Washington, was set up for selecting subjects to undergo this procedure. It is believed that this was the first organization that ever dealt with bioethical issues. In 1967, the first heart transplantation had been performed in South Africa, and shortly thereafter, a heart transplantation boom occurred in North America. Since at that time heart transplantations were still at an experimental stage, great emphasis was placed on the importance of obtaining patient consent. Furthermore, for heart transplantations, it is indispensable to remove the heart from a body considered "dead," although the heart is still beating. Then, the concept of "brain death" was proposed. This concept stirred up social debates about what defines the death of human beings.
These circumstances helped introduce to clinical practice the idea of informed consent (see Column at the bottom), which was originally a procedure needed for experimental research involving human subjects. The introduction of informed consent to clinical practice in fact brought about some structural changes in the physician-patient relationships: in the past, the relationship mainly had centered around medical care for infectious or acute diseases, but it moved to the type of relationship suited for medical care necessary for the current mature society where chronic diseases have spread in society. In other words, this was a transformation from the paternalistic physician-patient relationship, in which the decision of the course of treatment was left to the physician who is a medical specialist, to a modernized physician-patient relationship, in which the patients themselves decide the course of treatment upon having received adequate information.
In the 1960s feminism gained power, and movements for the liberalization of abortion progressed. Until then, abortion had been considered a crime in Christian countries. With Christian churches involved, there were scores of heated discussions regarding the pros and cons of abortion. Along with these heated discussions, the question of "from what stage is an embryo considered a human being" became an important issue. Around this time, embryo diagnosis was put into practical use, which then led to the debate on the rights and wrongs of "selective abortion" based on the diagnosis. In 1978, the first baby to have been conceived through in vitro fertilization in the world was born in England. This led to various debates on the control of reproductive technologies in many countries, particularly nations following Christianity. These various issues mutually affected each other leading to the formation of "bioethics."

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Informed Consent

The most important criterion of ethical principles in clinical practice is informed consent. It is translated as consent given by a subject after obtaining sufficient information before beginning a study. It has two origins. One concept derives from a judicial trial case in the Unites States, which ruled that the physician had the obligation to provide information to the patient. However, because this practice had such a mechanical nature that the physician just provides the patient instructions for the purpose of treatment, it did not follow the premise of an equal relationship between the two of them. The other one derives from the Nuremberg Code (see Column Section 3 of Chapter 10), which states that the human subject must be informed in a non-intimidating atmosphere about the purpose of the study, its benefits, and all of its risks that are believed to be involved, and that based on these items of information, the subject must be allowed to give voluntary consent and should be able to withdraw from the study at any time. Presently, this is a basic procedure that applies to all experimental research involving humans, and requires a written consent of the person in question followed by easy-to-understand explanations provided.
In the Unites States, since the 1970s, the concept of informed consent has also become widespread in the setting of health care. This is because the country's national healthcare coverage for the public at large does not exist, and health care is more of a consumer product in nature that is being purchased on an individual basis. Furthermore, because the United States holds its logic on the standpoint of consumer sovereignty, all options must be presented to the consumers so that they can make their choice independently. In contrast, in Europe, where social welfare states have been in existence, people in the region have the viewpoint that a patient in a critical condition is not capable of making a rational judgment, and thus, they tend to outweigh the physician's decision on the course of treatment. As far as Japan is concerned, informed consent is virtually pursued in the health care setting, but the healthcare system itself is similar to that in Europe.

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