임상시험,의학적 연구와 관련한 국가,기관위원회 구성의 적정성 및 시험자,의뢰자에 대한 실효적 형사처벌필요성

According to the Korea Food and Drug Administration (KFDA) on July 4, 2018, 82 people were killed in five years due to the clinical trial damage. As a countermeasure, from October this year, the correct information on possible side effects should be mandatory released. KFDA hat also decided to increase the level of punishment if the test results are falsely reported, such as in cases in which the test side effects are reduced and the efficiency oder effect are inflated. If the information on the clinical participant, the adverse reaction occurred in the test process, and the test drug management record and the contract are falsely stated, the clinical trial institution may be canceled or suspended, or sentenced to one year in prison or fined up to 10 million won. It is doubtful whether such a punishment can be a balanced, appropriate punishment in accordance with the nature of the offense. It is doubtful whether this punishment will prevent the recidivism or perform the functions for prevention of future criminals. In this article, we first examine whether the organization and operation of the Institutional Reviwe Borad and the National Ethic Committee are appropriate, and whether the current organization is legitimate and seems to be a proper form to guarantee the human rights and autonomy of the subjects in clinical trials. And we examine what needs to be done in the field of criminal law in order to meet the basic requirements of such as the human dignity, the fundamental rights of subjects, the respect of rights for self-determination and the informed consent of subjects based on sufficient explanation.