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KMID : 0986720010090020051
Korean Journal of Medicine and Law
2001 Volume.9 No. 2 p.51 ~ p.70
The Legal Perspective of Research with Human Subjects
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Abstract
The first issue to be brought into attention, dealing with research with human subjects (Medizinische Versuche am Menschen) in Korea, was the experimentations by army medical team during the Japanese colonial days. Often called ¡®731 military unit human experiments¡¯, Japanese army performed experiments using Korean and Chinese people. In 1970 a research on a newly developed oral contraceptive, whose pharmaceutical effectiveness was unknown at the time, was made an issue because those subjects were unaware that they were being used as human subjects.

Through these historical events bioethical issues such as cruelty against human subjects and informed consent have been brought to attention. But still, more attention must be paid upon the details of the context and the procedure of human researches. There are laws regulating human experimentation in Korea but the specific ethical codes are not available. We must clarify the ethical requirements for human researches and legislation of those requirements is pressing.

We always come to risk benefit evaluation of the matter as human research will eventually be help for promoting human health and medical development as well as it is harmful to the subjects. To acknowledge a research we must ask for proper observation of the law, the best method to be taken, transparency of the results and evaluation by the review board. Other issues that must be taken into consideration are as follow. The consent between the researcher and the subjects should be always fully autonomous. The ways to evaluate the level of autonomousness are also required. The researchers are fully liable for the reparation. The privacy and the human dignity of the subject must be respected.
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