임상시험 대상자의 건강상 피해에 대한 배상 및 보상에 관한 소고

The system of compensation or indemnification for health damage or harm of clinical trial subjects has a very important meaning as a protection system for subjects in clinical trials. Therefore, in order for the compensation/ indemnification system to function properly as a protection system for the target person, there should be no contradiction, so the current system need to be improved in some ways. First of all, the current law stipulates the insurance subscription obligation only in the case of drug clinical trials, but it is necessary to regulate the insurance subscription obligation in the case of other clinical trials related to medical devices or medical practices. In addition, it is necessary to regulate the training of experts or the establishment of a committee to review the adequacy of subscription insurance. Next, it is necessary to provide information to the clinical trial subject regarding not only the compensation procedure but also the indemnification procedure, and in the case of the indemnification procedure, it is necessary to prepare a simple procedure like the compensation procedure. On the other hand, it is necessary to clarify the basis of the subject's right to claim compensation to eliminate the potential for dispute. And it is necessary to clearly organize the parts that may be interpreted unfavorably to the subject due to unclear regulations in the 「Guidelines for Establishing Regulations and Procedures for Compensation for Victims of Clinical Trials」. In addition, it is necessary to establish an objective and neutral investigation and appraisal body, a compensation/indemnification review committee, and introduce a causal relationship presumption system to protect subjects who are in a relatively inferior position compared to sponsors or investigators in clinical trials.