Jaseng Hospital of Korean Medicine (Medical Director Jinho Lee) was designated by the Ministry of Food and Drug Safety as a “Training Institution for Clinical Trial Workers’ for the first time in the field of Korean medicine. It was also first accredited for the ‘Human Research Protection Program (HRPP)’ in Korean medicine.
All domestic clinical trial workers must complete the training of training institution for clinical trial designated by the Ministry of Food and Drug Safety to develop their professionalism and protect human research subjects. Its curriculum is of great importance in clinical trials as it affects the safety and quality of human research subjects.
In order to be designated as a training institution for clinical trial workers, it is necessary to meet various requirements set by the Ministry of Food and Drug Safety such as ▲organization, ▲manpower, ▲facilities, ▲program, and ▲career that are necessary for education. In particular, high professionalism and independence are required, such as the establishment of a department exclusively for the training of clinical trial workers within the institution. Even if the institution meets the requirements for designation, it has to go through a strict process, such as having to undergo an on-site survey by the Ministry of Food and Drug Safety.
Obtaining appropriate determination for ‘Human Research Protection Program (HRPP)’ for the first time in Korean medicine
Jaseng Hospital of Korean Medicine also obtained appropriate determination for the Human Research Protection Program (HRPP). This means that as a medical institution conducting clinical trials, it has been recognized from the country for its ethically and scientifically conducting research through a systematic system and proven regulations.
Jaseng Hospital of Korean Medicine have built the infrastructure by establishing the ‘Designated Clinical Trial Review Board (Designated IRB)’ early and concluding business consignment agreements with Gwangju, Daejeon, Bucheon, Bundang, Ulsan, and Haeundae Jaseng Hospital of Korean Medicine, which are specialized training Korean medicine hospitals for residents. In addition, 4 branches of Jaseng Hospitals (Gangnam, Daejeon, Bucheon, and Haeundae) have been designated as clinical trial institutions for pharmaceuticals and medical devices, and has been conducting various studies to date.
As Jaseng Hospital of Korean Medicine was designated as a training institution for clinical trial workers, it is now possible to develop a variety of educational programs tailored to the characteristics of clinical trials in Korean medicine having infrastructure for the protection of Korean medicine research, education, and research subjects. It is also possible to provide trainings for employees working for another institution and for institutions that have not yet been designated. Through this, Jaseng Hospital of Korean Medicine laid the foundation for a more specialized and systematic multi-institutional joint Korean medicine clinical trials.
The fact that a Korean medicine institution has been listed as a training institution for clinical trial workers has a special meaning in terms of the development of Korean medicine. Currently, the field of Korean medicine is conducting various clinical trials for the scientification and standardization of Korean medicine. However, there have been some institutional and policy difficulties due to the lack of training programs optimized for clinical trials of Korean medicine.
As a result, as the first training institution for clinical trial workers in the field of Korean medicine, Jaseng Hospital of Korean Medicine is plans to develop training programs for clinical trial workers in Korean medicine in the future to focus on cultivation specialists in Korean medicine clinical trials.
“As it was designated as the first training institution for clinical trials in the field of Korean medicine, we will continue to make efforts to protect the safety of human research subjects and maintain the every environment,” says Dr. JinHo Lee, Medical Director of Jaseng Hospital of Korean Medicine. “We will play a leading role in the frontline of cultivating specialists as a core research center representing Korean medicine clinical trials.”