Asian J Beauty Cosmetol. 2014; 12(2): 141-146.
Series11. Ethics in Human Participants Research
In Jae Lee
ABSTRACT
This paper is to examine guidelines and ethics which researchers must know and obey in studies with human subjects. To the end, above all, I reviewed the basic ethical principles of Belmont Report and the purpose and contents of Bioethics Law of Korea launched 2013. 3. And finally I suggested some points which researchers should consider when they draw up research protocols. Any researcher who conducts research with human participants 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 are reasonable given the expected benefits; that the participants or their authorized representatives provide informed consent; that the investigator has informed participants of key elements of the study protocol; and that the privacy of participants and the confidentiality of data are maintained. All research involving human participants in Korea also must be reviewed and approved by independent committees known as Institutional Review 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. The IRB must conduct periodic reviews of research to ensure continued protection of the welfare of human subjects and with compliance with relevant regulations.
Keywords : Research involving human participant, IRB, Belmont report, Respect for persons, Informed consent, Beneficience, Minimal risk, Justice