연재11. 인간 대상 연구에서의 윤리

Abstract

This paper is to examine guidelines and ethics which researchers must know and obey in studies with humansubjects. To the end, above all, I reviewed the basic ethical principles of Belmont Report and the purpose andcontents of Bioethics Law of Korea launched 2013. 3. And finally I suggested some points which researchersshould consider when they draw up research protocols. Any researcher who conducts research with humanparticipants needs to protect the interest of research subjects by complying with relevant codes or regulations. These provisions are designed to ensure that risks to human participants are minimized; that risks arereasonable given the expected benefits; that the participants or their authorized representatives provideinformed consent; that the investigator has informed participants of key elements of the study protocol; andthat the privacy of participants and the confidentiality of data are maintained. All research involving humanparticipants in Korea also must be reviewed and approved by independent committees known as InstitutionalReview Boards (IRBs). The IRB is responsible for approving or disapproving all covered research activity,requiring for instance that subjects are given enough information to be able to provide informed consent. TheIRB must conduct periodic reviews of research to ensure continued protection of the welfare of human subjectsand with compliance with relevant regulations.