의료기기 임상연구와 관련된 윤리문제

Abstract

Clinical investigations of medical devices are very important to verify its effectiveness, benefit, and safety. Therefore, preclinical trial established by ISO is essential to human clinical study. In Korea, 'clinical investigation guidelines for medical devices' was promulgated by KFDA with its applicable regulatory requirement in 2001, and clinical investigations have been supervised to be scientific and ethical. This guidelines are based on principle of biomedical and clinical research which is specified in 'Helsinki Declaration', and include duty, rights and responsibility of sponsor, IRB, inspector and subject for in scientific and ethical reasonability. Modern technology has lead to sophisticated medical devices and had much impact on medicine, but it has also produced ethical problems in the process of development Ethical problem in clinical research ranges from human to animal. However, animal experiment is essential in order to confirm that such alternative ways are comparable to animal subject. Clinical investigation is a developing stage for a future patient or human, and highest priority should be given to human rights. The training of ethical concerns to the experts who participate in development or manage medical devices is also necessary.