A clinical trial investigating COVID-19 antibodies conducted by the Changhua County Public Health Bureau and National Taiwan University in Taiwan violated the Human Subjects Research Act in that island nation. The head of the Department of Medical Affairs at the Ministry of Health and Welfare (MOHW), Liu Yueh-ping, recently told reporters that the study violated the rules because the researchers failed to submit their research plans to an Institutional Review Board (IRB) and obtain approvals prior to commencement of research. Rather, the investigators started the clinical trial before the National Taiwan University’s IRB actually approved the study plan, leading to the legal violation. The violation of this law in Taiwan carries a fine between NT$100,000 (US$3,475) to NT$1million. A fine will be announced by MOHW, which maintains jurisdiction over Changhua County Health Bureau, within two weeks. Importantly, this is a reminder to all trial site organizations to keep organized, aligned with partners, and within the boundaries of ethics, guidelines and rules.
According to a piece in Focus Taiwan authored by Chen Wei-ting and Chiang Yi-ching, the Changhua Public Health Bureau was conducting a clinical trial investigating neutralizing antibodies targeting COVID-19 patients. They declared the study start date on June 11 with the goal of offering a snapshot of the prevalence of COVID-19 during peak time of the pandemic in Taiwan back in February and March, reported Yeh Yen-po at a press conference on Aug. 27 upon sharing the results.
The investigational team collected 4,841 samples from study subjects with high risk of COVID-19 exposure, including contacts of confirmed cases and those that had returned from abroad and were then in quarantine. The study also included in this pool of subjects healthcare workers and other frontline staff during the period of June 11 to Aug 12.
The study team discovered that neutralizing antibodies for SARS-CoV-2, the virus behind COVID-19 were represented in just four subjects equaling a positivity rate of 8.3 per 10,000 people in Taiwan. That such a low rate of exposure found in high risk populations was deemed “extremely good news,” reported Wei-ting and Yi-ching.
Study Started Two Months Prior to IRB Approval
But during the study, somehow questions surfaced as to the legitimacy of the study. That is, was it legal in the first place? That’s because questions were raised about the procedures leading up to the study. As it turns out, although the study started back on June 11, National Taiwan University professor Chan Chang-chuan acknowledged that the study actually received IRB approval on August 11.
Disputes between the Two Sponsors
Consequently, the MOHW initiated an investigation into the study and with that action commenced a probe of the participants, including Changhua Public Health Bureau. The Focus Taiwan piece shared that apparently a dispute broke out between National Taiwan University’s College of Public Health and the Changhua Public Health Bureau as the study got under way.
According to the perspective of National Taiwan University College of Public Health, the county health bureau actually violated Central Epidemic Command Center (CECC) protocol while testing subjects while in home quarantine with no COVID-19 symptoms. This dispute actually led to the ethics investigation.
After this investigation, it was determined that the Changhua health bureau had breached public health laws, however these laws included no stipulated penalties. On the other hand, the National Taiwan University College of Public Health was in dispute with the CECC about testing all arrivals returning to the country for COVID-19 infection.
It is apparent that bureaucratic tensions appeared to build as these two organizations started executing the study. In the midst of the worst pandemic in a century, the tension, confusion and possibly a proclivity toward acting with urgency, along with what appears to be sloppy record-keeping led to this violation of law. Research must be run ethically, which among other things includes sign off by IRB before the trial kicks off.