Changhua County Public Health & National Taiwan University Violated Ethics Laws Starting COVID-19 Study Prior to IRB Approval

Changhua County Public Health & National Taiwan University Violated Ethics Laws Starting COVID-19 Study Prior to IRB Approval

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.

Background

According to a piece in Focus Taiwan authored by Chen Wei-ting and Chiang Yi-ching, the Changhua Public Heal...

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