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進入《TAIPEI TIMES》 Vaccine trial recruitment questioned
Deputy Minister of Health and Welfare Hsueh Jui-yuan, left, responds to questions during a meeting of the legislature’s Social Welfare and Environmental Hygiene Committee in Taipei yesterday. Photo: CNA Photo: CNA
COVID-19: An online registration program to recruit participants for clinical trials may be illegal, as it does not provide warnings about the risks, a KMT legislator said
By Lin Hui-chin / Staff reporter
Lawmakers yesterday questioned the legality of an online platform set up by the government to recruit participants for COVID-19 vaccine clinical trials.
The Central Epidemic Command Center （CECC） launched the online platform on Wednesday last week, and said people can sign up until Nov. 30.
Minister of Health and Welfare Chen Shih-chung （陳時中）, who heads the center, said at the time that three domestic manufacturers that are developing COVID-19 vaccine candidates would soon complete phase 1 clinical trials and as phase 2 vaccine trials would need more participants, the CECC launched the platform to help shorten the recruitment process and speed up the trials.
As of yesterday, more than 19,000 people had registered, close to the center’s target of 20,000.
At a meeting of the legislature’s Social Welfare and Environmental Hygiene Committee yesterday, Chinese Nationalist Party （KMT） Legislator Chiang Wan-an （蔣萬安） said that the online registration could be illegal, as it does not provide warnings in accordance with regulations on clinical trial recruitment for volunteers, the advert has not received approval from the Institutional Review Board and it likely breached other regulations.
“The trial advert must not have provisions stating that participants will receive free medical treatment or a financial subsidy, or that it is available for a limited time only to push people to sign up before the deadline,” Chiang said.
“It must not contain words, graphics, photos or illustrations to entice or force people into signing up,” he added.
In the past, the ministry would issue regulations warning people about the risks associated with clinical trials, “but now [the trials] were publicized through a press conference, which was also circulated through online platforms such as Line, Facebook and others, and only presented the potentially good points. We did not see any warnings about possible side effects and associated risks,” he added.
“The government has set a bad example, skirting around possible illegalities. In the future, can pharmaceutical firms and companies making medical vaccines do the same? That is, they can first publicize on an online platform to collect the personal data of volunteers, then claim it was not an open call for participants,” Chiang said.
Democratic Progressive Party Legislator Lin Shu-fen （林淑芬） also questioned the program.
“The trials would involve more than 20,000 people, but if something goes wrong, can the victims receive compensation, and what if the vaccine company cannot pay?” she asked. “Our government led the way in publicizing the trials, but not in shouldering the responsibility for compensation. Is this proper?”
Deputy Minister of Health and Welfare Hsueh Jui-yuan （薛瑞元） clarified that it was only a platform for registration, and not an official recruitment for clinical trial participants.
“The platform is a means for people to register, and asking them if they are willing to take part in the clinical trials, to provide their personal information. When the trial program is approved, then the official recruitment can start, and the vaccine company can select suitable volunteers,” Hsueh said.
As to whether the advert conforms to the law, it will have to be judged on a case-by-case basis, he added.
新聞來源：TAIPEI TIMES
