임상시험과 피험자보호에 관한 연구

In today' society, it is necessary to take a clinical trial on humans in order to carry out scientific and medicinal research. In the event that subjects participate clinical trial, additional measures should be taken to protect subjects' right, safety and welfare. Especially in the sphere of medicinal research, some parts of doctors and researchers, possibly, oppose to legal regulations. But appropriate regulations play an important role to protect not only subjects but also doctors and researchers. By collaborating with the related Ministry, we can secure excellent human and material resources to take a clinical trial, and at the same time, provide fair and damage-preventing system and informed consent for the subjects. At the first glance, clinical trial on the subjects have damaging interests to the subjects individuals. In fact, clinical trial are carried out by the sacrifice of the subjects individuals. On the other hand, doctors who carry out clinical testings have the duty to contribute to the development of medical science and to protect subjects' interests. Doctors who carry out experiments should make a good adjustment these two conflicting interests. These two's interests are conflicting each other, so it is not easy to coordinate interests between them. If damages occur to the subjects, we should prepare to take perfect legal remedy measures to compensate for the damaged subjects. Clinical trial on humans should lay down administrative and legal regulations and pass the judgement of Institutional Review Board, and so on. Because of these reasons we should modify various laws and regulations to protect the subjects. As taken effect to the foreign countries it is desirable to introduce insurance system and take measures to advance science and medicine. Substantially, as every country has different clinical trial system, we should make a greater effort to protect the subjects.