'첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률' 개정에 따른 '기관생명윤리위원회(Institutional Review Board)' 역할 및 '임상시험 및 대상자보호프로그램(Human Research Protections Program)' 강화의 중요성

The Importance of Strengthening the Role of the Institutional Review Board and the Human Research Protections Program following the Revision of the Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals

The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.