Korean Regulations of Clinical Trials and Research with Human Subjects
Clinical trials and research with human subjects are conducted throughout the world including both the developed and the developing countries. Clinical trials and research with human subjects have the common concerns on how to protect the rights, safety, and welfare of the human subjects properly and adequately. In this article, I examined government regulations of Korea that formulate the basic frame and minimal requirement for the researchers to comply with when they conduct clinical trials and research with human subjects. Especially, I explored Constitutional Law, the Bioethics and Safety Act, the Pharmaceutical Affairs Act, the Medical Device Act, and Korea Good Clinical Practice. As a result, I found some defaults in our laws and regulations in protecting human subjects. In case of Constitutional law, there is no principle of beneficence necessary for researchers to protect human subjects by analyzing the risk and benefit of making them participate in clinical trials and research unlike the global standards. In case of BEASA, it has limited jurisdiction in research with human subjects in the specific life science areas such as human embryonic research, genetic testing, and gene therapy. In addition, BEASA is not applied to human behavioral research and does not have a definition on research. As to PAA, it has a “swiss cheese” syndrome in three ways: no provision on vulnerable populations, no provisions on Informed Consent and IRBs, and no provision on the research participants’ protected health information. Finally, KGCP also needs to insert some provisions such as much more specified kinds of vulnerable populations, types of conflict of interest, and the use of placebo, to protect human subjects in accordance with the global standards.