YMID teams up with 6 organizations to develop ethical guidelines for research using human subjects

01/12/2020
          Yothi Medical Innovation District (YMID) and six strategic organizations under the YMID network have signed a memorandum of understanding on the Joint IRB YMID: Multicenter Medical Innovation Clinical Trial, which aims to create a collaborative network model for medical innovations. The signing ceremony was held on 16 November 2020 at the National Innovation Agency (Public Organization) or NIA. The Joint IRB (Institutional Review Board) will serve as a mechanism to approve critical trials. 
          The six participating organizations are the Department of Medical Services, the Royal Thai Army Medical Department, Mahidol University, Phyathai Hospital Group/Paolo Hospital Group, and the Thailand Center of Excellence for Life Sciences (TCELS) under the Ministry of Higher Education, Science, Research and Innovation.
          Mr. Suwit Wibulpolprasert, Chairman of YMID’s steering committee, noted that clinical trials represent the most critical stage of medical innovation development in ensuring that innovations are both effective and safe. However, the organizations in the YMID area have different IRBs looking into ethical research on human subjects and this causes delays in approval of clinical trials.
A multicenter for medical innovation clinical trials can therefore play an important role in speeding up such approvals while also meeting international standards and the YMID is considered the most suitable network to establish collaboration.
          The steering committee therefore gave the green light to the establishment of a mechanism for a joint operation to assess both clinical trials and ethical human research. The MOU signing on the Joint IRB YMID: Multicenter Medical Innovation Clinical Trial was held after the mechanism had been successfully tested.
          Prof. Banchong Mahaisavariya, President of Mahidol University, said that in the YMID area, the university provides 6 educational faculties and 3 medical services, namely Ramathibodi Hospital, the Hospital for Tropical Diseases, and dental services of the Faculty of Dentistry. The university carries out several clinical trials on medical innovations. A mechanism that unlocks obstacles to the quality and efficient review of human research ethics would make the multicenter operations easier.
All three units of the university are determined to support and drive the joint process towards success to serve the public interest.
          Dr. Somsak Akkasilp, Director-General of the Department of Medical Services, said that the department has a mission to create and transfer knowledge of technology and innovations, promote academic participation as well as provide medical services for all parties with the aim of developing the country's medical sector to meet international standards.
The department supervises 7 organizations in the YMID, namely Rajavithi Hospital, the Queen Sirikit National Institute of Child Health, the Institute of Dermatology, Prasat Neurological Institute, the National Cancer Institute, the Institute of Pathology, and Priest hospital. These organizations continuously conduct R&D into medical innovations.
          Dr. Somsak added that the joint approval process for human research ethics would result in closer collaboration between the YMID partners. Such unity would reinforce the potential of YMID and drive the growth and efficiency of the medical research and innovations.
Col. Assoc. Prof. Suthee Panichkul, a  researcher at the Royal Thai Army Medical Department, said that the Joint IRB YMID represented the first step in the development of a cross- functional model that would allow institutes to bridge the gap between R&D and bringing products to market quicker and more efficiently.
          “It will be of even more benefit if we can widen the Joint IRB YMID to serve more partners within the district because there are several institutes that do not have their own human research ethics committee. They could ask for review of their clinical trials by the joint body," said Assoc. Prof. Suthee.
          Dr. Sirasak Teparkum, Deputy CEO of TCELS, said that the Joint IRB YMID: Multicenter Medical Innovation Clinical Trial was one of the key tasks to be undertaken through the YMID Platform and had seen good cooperation from the organizations. The YMID has a working model through which operations related to policy development and guidelines are linked to the support and promotion of research into innovation in the district, allowing the end results to be translated into commercialization. In the future, the TCELS expects that the Joint IRB YMID will be expanded to the national level.
          Dr. Pun-Arj Chairatana, Executive Director of National Innovation Agency (NIA), said that the NIA has placed great importance on research within the YMID with an emphasis on the adoption of deep tech in the field of biomedical sciences and biotechnology both now and in the future.
The YMID development plan is divided into 3 phases. The first 5-year phase will focus on the development of high-potential innovations and research, in line with the government's policy. The second 10-year phase will focus on physical development of the YMID to promote R&D and clinical trials of medical innovations. A transportation network is under construction and this connects the organizations within the district systematically and efficiently. Finally, the last 20-year phase will continue the physical development to facilitate growing demand.
          Mr. Att Thongtang, CEO of Phyathai Hospital Group and Paolo Hospital Group, said that the hospitals are the only private facilities in the YMID. In addition, the Center of Private Research and Innovation Accelerator (CPRIA) has been established to create a learning culture and encourage research and innovation development in every operating process of the hospitals. The groups had also established an IRB to ensure that research would meet the standards.
          Participating in the Joint IRB YMID would be a crucial move to accelerate medical research. The groups expect that the Joint IRB YMID Model will be expanded to enhance medical innovation development of the country at large..
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