Changhua/NTU COVID-19 study found to have violated research laws

Taipei,  A study carried out earlier this year by the Changhua County Public Health Bureau and National Taiwan University (NTU), which involved testing people for COVID-19 antibodies, has been found to have violated research laws, a health official said on Monday.

Speaking to reporters, Liu Yueh-ping (劉越萍), head of the Department of Medical Affairs at the Ministry of Health and Welfare (MOHW), said the study was found to have violated the Human Subjects Research Act.

Under the act, researchers have to submit their research plans to an Institutional Review Board (IRB) and obtain board approval before they can begin the research process.

However, officials at the Changhua health bureau and researchers at NTU’s College of Public Health began their research process before NTU’s IRB approved of their plan, making the research illegal, Liu said.

Violators can be fined between NT$100,000 (US$3,475) to N$1 million.

The MOHW, which has jurisdiction over the Changhua County Health Bureau, will announce how much the bureau will be fined in two weeks, Liu said.

The amount of fines the NTU researchers have to pay will be decided by the Ministry of Education, she added.

The Changhua Public Health Bureau announced on June 11 that they had begun the study, which tested for neutralizing antibodies the body produces following exposure to COVID-19.

The aim was to offer a picture of how prevalent the disease was during its peak in Taiwan in February and March, the bureau’s director Yeh Yen-po (葉彥伯) said at a press conference on Aug. 27, when they released the results.

In total, researchers took samples from 4,841 subjects with a higher risk of COVID-19 exposure, including the contacts of confirmed cases and people in home quarantine after returning from abroad, as well as healthcare workers and other epidemic prevention staff from June 11 through Aug. 12, Yeh said at the time.

Neutralizing antibodies for COVID-19 were found in only four of the test subjects, equating to a positive rate of 8.3 per 10,000 people, he said, adding that such a low rate of exposure in a high-risk population was “extremely good news.”

As the study was ongoing, however, questions were raised regarding whether researchers had applied for approval to conduct the study in the first place. The head researcher, NTU professor Chan Chang-chuan (詹長權), had said that the study was approved by NTU’s IRB on Aug. 11, two months after it had already begun.

In response, the MOHW launched in investigation into the study and requested that the Changhua Public Health Bureau and Chan provide relevant information.

Both the bureau and NTU’s College of Public Health had disputes or disagreements with the Central Epidemic Command Center (CECC) when the study was under way.

The health bureau had violated CECC protocol and tested individuals in home quarantine with no symptoms for COVID-19, which lead to an ethics investigation.

The results of the investigation, released in September, were that while the Changhua health bureau had violated public health laws, the laws did not stipulate penalties for the types of violations it committed, so the bureau was not fined.

The NTU College of Public Health, on the other hand, had disagreements with the CECC regarding testing all arrivals in Taiwan for COVID-19, which the former supported but the latter found unnecessary.

 

Source: Focus Taiwan News Channel

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