Number of Migrant Workers Enrolled into COVID-19 Clinical Trials Since Start of Pandemic and Measures to Ensure Appropriate Informed Consent Obtained Without Duress

Dr Tan Wu Meng asked the Minister for Health (a) since the start of the COVID-19 pandemic, how many migrant workers in Singapore have been enrolled into COVID-19 clinical trials; and (b) what measures are implemented to ensure that appropriate informed consent took place without duress.

A clinical trial is a research study of a health product to discover or verify its effects and ascertain its safety or efficacy in trial participants. Since the beginning of the COVID-19 pandemic, the Health Sciences Authority (HSA) has approved one COVID-19 clinical trial on migrant workers. The trial recruited 4,257 migrant workers to assess whether existing treatments could reduce the spread of SARS-CoV-2 infection.

Institutions who wish to conduct clinical trials are required to obtain regulatory approval from HSA under the Health Product (Clinical Trials) Regulations based on prevailing requirements. The principal investigator (PI) for the study is also required to seek ethical approval from the relevant Institutional Review Board (IRB) and ensure that written informed consent is obtained from trial participants in accordance with the requirements under the Health Products (Clinical Trials) Regulations. It is an offence under the Regulations for any person to cause, compel or induce another person to give consent or to participate in a clinical trial by coercion, intimidation, deception or misrepresentation.

As necessary, PIs should document informed consent by means of a written, signed and dated informed consent form. During consent-taking, PIs should also ensure that participants understand the contents of the form, provide ample opportunities for clarification, and inform participants that they may choose to withdraw from the trial at any time without penalty.