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KMID : 1011120080020020105
Bioethics Policy Studies
2008 Volume.2 No. 2 p.105 ~ p.122
Framework for the Regulation of Human Biotechnology
Kim Ho-Ki

Abstract
The risks resulting from human biotechnology are not different from the usual type of risk, so the risk assessment and management system which has been developed in other areas can be used in assessing and managing the risks of human biotechnology.
In accessing and managing the risk of human biotechnology, especially the following two principles should be observed. Firstly, the risk must be reduced as low as reasonably practicable, and secondly, the autonomy of related persons ought to be respected. To keep the risks of human biotechnology as low as possible, researchers must be qualified and properly trained. Moreover, it should be institutionally guaranteed that sufficient attention would be paid to protect the life and health of the people during research. Research process should be in consistent with universally or generally accepted scientific method, and authorities should be in a position to adopt appropriate measures to prevent the risks involved with human biotechnology from being realized. Obtaining informed consent is indispensible to guarantee the autonomy of the participants of research . It is also of importance that the autonomy of those who are not directly influenced should be respected, even if the possible harm to their health is negligibly small compared to that which the participants could suffer.
KEYWORD
Biotechnology, Human biotechnology, Risk assessment, Risk management
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