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10.3The Principles of Bioethics

The starting point of the principles of bioethics comes from profound remorse related to human experiments: particularly, inhuman experiments on human bodies, such as infection experiments with pathogenic bacteria, ultralow pressure and freezing experiments conducted in concentration camps in Nazi Germany during the Second World War. This historical fact greatly influenced debates on clinical studies. The Universal Declaration of Human Rights adopted by the UN General Assembly in 1948 is a declaration that bases the dignity of human beings upon the negative history of society. Additionally, the Declaration of Helsinki (see Column at the bottom) adopted by the World Medical Association in 1964 furnished the fundamental principles of clinical research with specific expressions describing those principles.
Until the 1960s, clinical research was believed to be conducted ethically in the United States. However, various examples of inappropriate human experiments were detected. The weak individuals of society such as African-Americans, mentally-disabled persons, and children were, without their consent, being implanted with cancer cells or made the subject of observation with no further treatment. In 1973, the federal government established a "national committee for the protection of human subjects in biomedical and behavioral research" and carried out an investigation on the protection of human subjects in clinical research. In 1979, based on this investigation, a report called the Belmont Report was summarized and this report laid out the following four bioethical principles: (1) reverence for the autonomy of human subjects, (2) the principle of good deed to help achieve an overall maximum benefit, (3) the fairness to consider the autonomy of others and the interest of future generations, and (4) the principle to avoid causing safety hazards. Ethical decisions are to be made in the actual practice of clinical research with these principles mutually kept in balance. Yet, before the discussion of these principles, it is imperative to verify the major premise that research on human subjects is of scientific importance.

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Declaration of Helsinki

For advancement of science, experiments involving humans are indispensable at a certain stage. The principle by which such experiments are humanely performed is called the Nuremberg Code, which was originally defined in the verdict of an American occupation court over human experiments conducted in concentration camps during the Second World War in Nazi Germany. This principle was later systematized into specific rules for clinical practice and adopted as the Declaration of Helsinki at the World Medical Association in 1964. Thereafter, multiple revisions were made, and currently, it is acknowledged worldwide as the most fundamental and comprehensive basic principle in clinical research.
More specifically, the Helsinki declaration states that the privacy and dignity of test subjects or patients must be preserved, informed consent must be obtained in a non-intimidating atmosphere, and the test subject should have the freedom to withdraw his or her consent at any time. The declaration attaches importance particularly to the consideration of people in vulnerable positions, indicating that scientific and social benefits must not outweigh consideration of the test subject. In recent years, some revisions have been made in order to define specific considerations protecting test subjects not only for clinical research in general but also for the fields of medical products and epidemiological studies.

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