On June 23, 2015, the Bioethics Advisory Committee (BAC) established by the Singapore government to recommend policies based on the ethical and legal issues arising from biomedical research released the Ethics Guidelines for Human Biomedical Research (Guidelines).
The Guidelines set out the framework for ethics committees or institutional review boards (IRBs), and aligns local clinical research practices with international standards expected of researchers and institutions in Singapore, including reproductive and therapeutic cloning, bio-banking, human genetic research and stem cell research. The Guidelines also provides guidance on emerging issues such as whole genome sequencing, and will certainly set the benchmark in the design of biomedical research in Singapore going forward.
The major revisions in the Guidelines address the following areas:
- Definition and scope of human biomedical research
- Research governance
- Data privacy
- Incidental findings
- Use of personal information
- Human stem cell research
In particular, the Guidelines emphasize the importance of voluntary informed consent of research participants. For example, for research involving minors (i.e., below the age of 21) with decision-making capacity, the informed consent of minors is required whereas previously only parental or a guardian’s consent was required. Whether a minor is able to give valid consent would depend on whether the minor has sufficient maturity and intelligence to understand the nature of the research participation and arrive at a reasoned decision. There are no age thresholds fixed for determining when a minor develops sufficient decision-making capacity to consent to research participation, although the Guidelines note that children between the ages of 12 to 14 may acquire near-adult decision-making capacity. Ultimately, in accepting minors for research participation, the ethics committees or institutional review boards should consider all factors such as the relevant minor’s developmental abilities, the context of the particular research protocol and the complexity of its procedures and risks in determining the age thresholds for obtaining a minor’s consent.
The Guidelines also reviewed the use of personal information in research due to the Personal Data Protection Act enacted in 2012, setting out clear and specific guidelines for healthcare institutions and researchers to ensure compliance with this Act. While the Guidelines are not legally binding, it is likely that the Singapore government will follow the Guidelines in the drafting of any legislation. Certainly for now, the Guidelines will set the benchmark in the design of biomedical research in Singapore going forward.