Ethics of biomedical research
After studying the fourth chapter, the student must:
• the history of the development of biomedical experiments on humans;
• the key requirements of the main international bioethical documents for scientific and medical research involving people;
• The rights of people - subjects of research;
• the basic moral norms governing the conduct of animal studies;
be able to
• apply the basic bioethical requirements for the organization and conduct of clinical trials in humans;
• Follow the basic moral standards associated with the conduct of experimental practice in practical medicine;
• apply the basic ethical principles of handling laboratory animals
• the basic moral principles of the behavior of a physician involved in clinical research;
• skills in analyzing moral conflicts associated with scientific medical research in humans.
The history of biomedical experiments on humans
The history of experimenting on humans
Little is known about experimenting in humans in ancient times. For example, there are reports that in ancient Egypt was allowed to conduct research on convicted criminals, and a representative of the Alexandrian science Erasistratus (about 300 262 BC) experimented on slaves. But it should be taken into account that experimentation as an informed scientific method appeared much later - only from the beginning of the New Time (the end of the 16th to the 17th century).
One of the first clinical experiments in the history of medicine put in the XVI century. famous French surgeon Ambroise Mare (1510-1590). But it is curious that this experiment took place by accident, in itself. At that time it was believed that gunshot wounds should be burned with boiling tar, in order to destroy the "powder poison". During one of the battles, A. Paré ended the pitch, and he simply applied a clean bandage. The next day he discovered the best condition of the newly treated wounds compared to those inflamed and painful wounds that were burned with resin. But, of course, before the emergence of the methodology for comparing the control and experimental groups was still very far.
In the era of modern times, the famous English philosopher F. Bacon advocates the scientific substantiation of medical practice. He criticizes the unproven nature of medical methods (because of what charlatans, for example, can acquire unjustified fame and honor). But at the same time Bacon recognizes the difficulties of developing experimentation on a person because of moral considerations.
In 1754 the British Navy doctor J. Lind conducted a special study, taking several groups of sailors with scurvy, and assigning each a different diet. The results were convincing: only in the group where patients received citrus fruits, recovery occurred, while the condition of other patients remained difficult. This proved the relationship between diet and health (although the vitamins were not yet known). Subsequently, the use of citrus fruits has become a mandatory practice of prevention and treatment of scurvy.
The first experiment that had a great impact on medical science and practice was the study of the English physician Edward Jenner (1749-1823), the founder of vaccination. Jenner noticed that rural milkmaids often get sick with cowpox, but their disease proceeds easily, and then they become immune to human smallpox. In 1796, Jenner conducted an experiment on the boy, introducing him material from a vial of a cow sick with smallpox. When the smallpox vaccination was later given to the boy, the disease did not develop. Jenner repeated the experiments on himself and other people. Vaccination began to be used in European countries, and later smallpox began to decline.
During the XIX century. the practice of experimentation is expanding; there are many cases of setting up the experiments of doctors on themselves or their relatives.
The German therapist I. Jörg (1779-1856) experience 17 different medicines in varying dosages to assess their effects on the body. Domestic infectious disease doctor GN Minh (1836-1896) with vaccinations on himself proved that the blood of patients with recurrent typhus is a source of infection. The famous German surgeon Werner Foreman (1904-1979), the Nobel Prize winner, developed a method for cardiac catheterization and in 1929 tested it on himself to prove his safety: he independently introduced himself a catheter through the ulnar vein into the right atrium.The founder of experimental medicine, the great French scientist Claude Bernard (1813-1878), in his works raises questions of the moral acceptability of experimentation in people and concludes that putting people at risk immorally and the needs of scientific progress can not justify violence against the well-being of an individual.
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