Minors and biomedical research in Singapore



This paper examines the challenges of enrolling minors in biomedical research that does not offer participants any prospect of direct benefit. It does so in the context of the current Singapore regime for the protection of research subjects, and seeks to evaluate if this is adequate for the task. In the process, it reviews appropriate Commonwealth and US precedents, regulatory instruments and guidelines that bear on three main issues raised by such research, and makes some recommendations on how they might be better addressed: first, the protective ceilings of risk prescribed beyond which minors may not be exposed to. Secondly, the allocation of decision-making authority and processes employed before a minor is permitted to enrol in such research. Finally, the particular regulatory oversight mechanisms that are needed to improve ethical and legal compliance.