earticle

영어

It has been enacted since 2005 and completely amended in 2012 in Korea called Korean Bioethics & Safety Act("KBESA")' that is a general and basic statu te providing basic principles for researchers to protect human subjects by writi ng protocols and informed consent forms, and establishing Institutional Revie w Boards("IRBs") to protect rightsㆍsafetyㆍwelfare of human subjects. KBESA stipulates several provisons regarding how to deliberate national bioethics & s afety issues, IRBs, various types of researches, prohibition of reproductive clo ning & xenotransplantation, genetic test, administrative sanctions, and crimina l penalties, etc. as well as provisions regrading how to protect human subjects. However, there However, there are critical opinions on the current KBESA for not responding to the bioethics & safety issues properly caused by the outcomes of the rapid progress of biomedical science. Especially, the fact that the different topics, such as human subjects research, human materials research, human embryonic r esearch, gene therapy research, etc. are included in the one size fits all KBES A causes difficulties to regulate them reasonably. Also, there are many critical opinions on the matter of NBC, gene therapy research, using fresh eggs in hu man embryo research and donation for fresh eggs for research purpose, the sc ope of genetic test, etc. In order to answer these critical views, there are sugge stions as follows: 􀽰 to break KBESA into two separate statutes: KBESA as a general & basic statute describing states obligations and giving fundamental p rinciples on bioethics & safety, and KBESA as an individual statute regulating the specific topics features, to provide the real hammer powers such as su pporting staffs, office, and budgets for NBC to implement its functions properly, to set up multistage review mechanisms on protocols and add extra elements such as unique risk & benefit, longterm follow up, consideration on pregnancy, autopsy, and t he way to respond media, etc. in the informed consent form to protect human subjects in gene therapy research, to allow researchers to use fresh eggs in human embryo research and donate them for the purpose of research, to ex pand the categories of genetic test with the adequate & efficient monitoring sy stems.