임상시험 대상자 보호를 위한 규제 동향에 관한 연구 ─ 피해자 보상 관련 제도를 중심으로─

This study examines the damage compensation system among systems to protect the rights of clinical trial subjects. It can be said that the system for preventing damage has been somewhat standardized in many countries, following the standards of the ICH GCP guidelines, but the damage compensation system, which provides ex post facto relief for damage, varies depending on the conditions of each country. It is designed and operated in a relatively unique way in accordance with laws and guidelines of any given country. Therefore, in order to properly understand the unique characteristics of each country's system related to the protection of clinical trial subjects, it is necessary to understand the damage compensation system. Specifically, this study will conduct research and analysis on related laws and guidelines in four countries, including the UK, Japan, the US, and the EU. Since these countries have a leading status in the fields of the pharmaceutical industry and medical research which are related to clinical trials of drugs, research targeting them can serve as basic data that can help improve Korea's related system of norms in the future. The ultimate goal of this study is to derive and present such implications.