Number of Migrant Workers Enrolled into COVID-19 Clinical Trials Since Start of Pandemic and Measures to Ensure Appropriate Informed Consent Obtained Without Duress
Ministry of HealthSpeakers
Summary
This question concerns the enrollment of migrant workers in COVID-19 clinical trials and the measures taken to ensure informed consent without duress. Dr Tan Wu Meng asked for the number of enrolled workers and details on safeguards, while Minister for Health Ong Ye Kung replied that 4,257 workers participated in one HSA-approved trial. He explained that trials require regulatory and ethical approvals under the Health Products (Clinical Trials) Regulations, which criminalize causing participation via coercion, intimidation, or deception. Minister for Health Ong Ye Kung stated that Principal Investigators must document written consent, ensure participants understand the trial, and allow withdrawal at any time without penalty. These procedures include providing participants with ample opportunities for clarification before and during the recruitment process.
Transcript
45 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.
Mr Ong Ye Kung: 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.