Changhua Ten Thousand People Serum Test Condemned for Illegal Human Experiments by Ministry of Health and Welfare

(Recently added: Statement from the National Taiwan University School of Public Health)

NTU Public Health College and Changhua County Health Bureau cooperated with the serum antibody testing program for 10,000 people. The suspect process and consent form were not reviewed by the Research Ethics Review Board (IRB), which generated controversy. Liu Yueping, director of the Department of Medical Affairs of the Ministry of Health and Welfare, said today that the investigation procedure to interview relevant personnel has been completed and that it is determined that the Changhua County Health Office is essentially conducting investigations into the human body, but has not submitted an IRB plan. Violation of the Human Body Investigation Law can be fined 10,000 to 1 million yuan, and the results of the arbitration are expected to be announced in two weeks.

Related news:Department of Teaching of Illegal Human Experiments, National Taiwan University School of Public Health – Intends to fine the school or the host of the project

The Changhua County Health Bureau believes that serum antibody research is carried out in cooperation with the National Taiwan University School of Public Health. Of course, there is no IRB data, and the National Taiwan University School of Public Health advocates only data analysis. This dispute was jointly investigated by the Ministry of Health and Welfare, the Ministry of Science and Technology, and the Ministry of Education, and interviewed relevant personnel in Changhua County, the National Taiwan University School of Public Health, and the inspection From first line.

Liu Yueping noted that the Special Investigation Committee of the Ministry of Health and Welfare completed the investigation and made recommendations. You consider that you are essentially conducting human research, but have not completed the required procedures for human research and have not written a research plan to submit to the Ethics Review Board (IRB) for review. Zhang County Health National Taiwan University Public Health Bureau and Agency both violated the “Human Body Research Law”, and the competent authority may impose a fine of 100,000 to 1 million yuan in accordance with the law. However, the amount of the fines depends on the circumstances of the violation and has yet to be determined and is expected to be announced in two weeks.

The Zhang County Health Bureau will be responsible for fines imposed by the Department of Medical Affairs of the Ministry of Health and Welfare, and the Ministry of Education will be the competent authority of the School of Public Health of National Taiwan University.

Changhua County Health Director Ye Yanbo did not respond today, only pointed out through the press office that the office has not yet officially received the official document and will explain it to the public after the official document is officially received. . Changhua County Magistrate Wang Huimei said that if he receives an official letter from the Ministry of Health and Welfare two weeks later, he will respond formally when he understands the content of the letter.

It is understood that in relation to the second issue of the serum antibody screening test for 10,000 people, the Health Bureau noted that the National Taiwan University Public Health Bureau was directing the work and the Health Bureau was helping in part to organize the detection work. Therefore, the basis for the sanction is unclear.

Zheng Shouxia, dean of the National Taiwan University School of Public Health, said it is regrettable that the Ministry of Health and Welfare has determined that the Changhua County Health Office and the University Public Health Research Team National Taiwan have violated the Human Research Act. The school has not yet received the official document and the details are unclear. After receiving the official document, if sanctioned The subject is a Zhan Changquan individual and will respect the opinions of Zhan Changquan. If the Institute of Public Health is sanctioned, internal discussions will take place and the parties involved will be asked for Zhan Changquan’s opinion before deciding on follow-up actions.

“Apple News” repeatedly called Zhan Changquan’s mobile phone, but the other party did not answer the phone.

(Reported by Lin Fangru, Xu Minrong, Sun Yingzhe / Taipei-Changhua Online)