Clinical trials ultimately aim to develop medicine, treat diseases through it, and physical well-being of humans and clinical trials on humans should take ethical conditions into account. Since humans do experiments on humans as the subject of the stu...
Clinical trials ultimately aim to develop medicine, treat diseases through it, and physical well-being of humans and clinical trials on humans should take ethical conditions into account. Since humans do experiments on humans as the subject of the study, there is room for danger to occur to the subjects during its process. Hence starting with the enactment of the Nuremberg Code as a result of numerous tragic experiments in which human dignity has not been preserved, it has consistently emphasized the protection of subjects by enacting ethical guidelines for clinical trials.
According to international ethical guidelines, research on human subjects must be reviewed in advance by the Institutional Review Board. The Institutional Review Board has the primary responsibility for the research carried out by each institution and recommends that researchers affiliated with the institution follow the ethical guidelines that must be followed.
In this study, each research institutions that conducts research on humans in Korea and Mongolia was selected and Standard Operating Procedure for clinical trial were compared and reviewed. It also examined the main contents of international ethical guidelines and analyzed the Standard Operating Procedure to see how much the institution's regulations reflects ethical principles centering on clauses related to the study subjects, researchers and governance.
The results of the study are as follows. First, Mongolia has tried to establish proper research ethics in Mongolia since the concept of research ethics was first introduced in 1997, but the operation regulations of the Institutional Review Board of a medical school in Mongolia are mixed with guidelines for clinical experiments and rules for the role and rights of the Board, which required improved Standard Operating Procedure to protect the research subjects, strengthen the responsibility of the researchers, and present ethical guidelines.
Second, it was deemed necessary to prepare institution-specific regulations for vulnerable subjects, including the consent of legal representatives, and to provide proper treatment and compensation methods if damaged by research.
Third, it is expected to be needed to strengthen the qualification of curriculum as the responsible researcher of the trial by legislating education content and duration including Good Clinical Practice education.
This study has the limitation that it was hard to take an in-depth approach, such as identifying gaps between actual operations by comparing and analyzing them based on data research and literature research. However, there is significance in that the rules on the regulations of the Institutional Review Board in Mongolia that has not been studied could be studied based on international ethical standards.