University and Hospital Mobile Research Teams Approaching Residents for Blood Samples for Research into Vector-borne Diseases
Ministry of HealthSpeakers
Summary
This question concerns Ms Sylvia Lim’s inquiry regarding the regulation and oversight of mobile research teams seeking blood samples from residents for research into vector-borne diseases. Minister for Health Gan Kim Yong explained that such proposals must be approved by an Institutional Review Board (IRB) to ensure participant safety and ethical compliance. The Minister highlighted the requirement for voluntary informed consent and the implementation of measures to protect the confidentiality of residents' health information. Under the Human Biomedical Research Act (HBRA), research activities and IRBs are formalised under Research Institutions, which are subject to statutory supervision. The Ministry of Health further ensures participant protection by conducting regular audits of these institutions to maintain compliance with the HBRA’s systems and governance.
Transcript
36 Ms Sylvia Lim asked the Minister for Health (a) whether the Ministry approves or condones mobile research teams from universities or hospitals approaching residents at their homes to request blood samples for research into vector-borne diseases such as dengue and Zika; (b) if so, what approvals must be sought before carrying out such exercises; (c) what oversight role does the Ministry play to ensure that residents are not exploited; and (d) how are residents' health, safety and confidential information protected during such research.
Mr Gan Kim Yong: Research is important to help us better understand the distribution, causes and effects of diseases so as to strengthen the detection, prevention, control and management of these diseases.
Approaching residents at their homes to seek consent for participation in such research is one way of reaching out to participants. It provides greater convenience for the research participants.
Prior to embarking on any research involving human subjects, the research proposal would have to be approved by an Institutional Review Board (IRB). IRBs play an important role in carrying out an independent ethical review of the need for research and ensuring that there are adequate safety measures to protect research volunteers, including obtaining their informed consent.
Informed consent should be sought from participants in an appropriate and voluntary manner, prior to commencement of the research. The benefits and risks of the research should be clearly explained, and measures put in place to protect the confidentiality of research participants against accidental loss, disclosure or unauthorised access of confidential health information.
Under the Human Biomedical Research Framework of the Human Biomedical Research Act (HBRA), the role of researchers and IRBs will be formalised, and they will come under the supervision and control of a Research Institution. The Ministry of Health will conduct regular audits of the Research Institutions to ensure that its systems and governance are in compliance with HBRA. This will further strengthen the measures to protect the welfare of participants in research studies.