연구윤리위반행위에 대한 법적 규율

Abstract

Research misconduct in biomedical research attracts significant concern in Korea. Biomedical research usually use human subjects or biological materials which are originated from human bodies. Also, the products of biomedical research are applied to human bodies for the purposes of preventing, diagnosing or treating diseases. Because of theses reasons,biomedical research should be examined not only its scientific feasibility but its ethical appropriateness. Some types of the research misconduct are regulated by legal means, such as <Bioethics and Safety Act> in Korea. Research misconduct can be done through all the process of the research. When a researcher submits research proposal, The proposal should be scrutinized carefully by third party such as institutional review board on the aspects of scientific and ethical standard. Also, the selection of subjects and obtaining biological materials should be done according to the ethical process. Respect of autonomy is the main principle that should be followed in this process and researcher should obtain informed consent of subject. The performance of research also done ethically. Some types of research misconduct can be composed of fraud,embezzlement, or dereliction of duty. However, it should be very cautiously examined before criminally punishing certain research misconduct. Fabrication, falsification, or plagiarism are main problems that can be done in the publication process of the research products. When we regulate biomedical research, legal framework should be considered as the last means. Ethical guideline which is made according to the consensus of all the interested parties is the first choice to regulate biomedical research. There can be a lot of ethical or legal frameworks which aim to regulate biomedical research. The regulatory framework which is chosen by the society is influenced by ethical standard of that society and the standard is continuously changing. I argue that ethical or legal regulatory frameworks should not be the ruling means to control the biomedical research. Rather, they should be the means to adapt the products of the biomedical research to society without conflicts.