초록 열기/닫기 버튼

현대 의생명과학의 진보와 이에 대한 연구는 인간유래물질과 임상정보의 접근에 의존하고 있으며 이것은 바이오뱅크의 형태로 결합되어 있다. 전 세계는 인종ㆍ민족ㆍ개인 간의 유전적 차이에 따라 치료를 달리하는 맞춤의학시대를 맞이하여 국가적 차원에서 인간유전체 및 역학연구의 기반이 되는 바이오뱅크의 필요성에 대한 논의를 활발히 진행하고 있다. 본고는 바이오뱅크를 이용한 연구에서 발생될 수 있는 개인정보보호문제와 동의확보의 문제에 대해서 살펴보고, 개정된 생명윤리 및 안전에 관한 법률의 주요내용을 검토한다.


Advance of biomedical-science and research depend on human material and clinical information. Human biobanks are collection of samples of human body substance(e.g. tissue, blood, DNA), which are electronically linked to personal data and in particular to health information on the donors. Indisputably, the most contentious aspect is implications for the governance of medical research. The government’s policy was that under no circumstance should tissue-based medical research take place without the consent of the person from whom the tissue was obtained. The core of biobank is consent of donors and should continue to be essential requirement for use of sample and data. However, donors should also have the possibility of making their samples and data available for scientific research for an indefinite period of time, without restriction to a specific research project or a specific field of research. And I shall examine the main provisions of the new Act and their relationship with other parts of the biomedical regulatory framework. In this paper, I seek to privacy and consent issues of biobank research and review on revision of Bioethics and Safety Act.