Human Biomedical Research Act (HBRA)

Human Biomedical Research Act (HBRA)

Singapore’s Human Biomedical Research Act (HBRA) marked a significant milestone in Singapore’s biomedical research regulatory landscape involving human subjects. This Act was implemented in four phases:

a. Phase 1 in July 2016 involved the administrative provisions
b. Phase 2 in January 2017 activated the prohibition of commercial tissue trading
c. Phase 3 in November 2017 was for the Human Biomedical Research (HBR) Framework including functions and duties of stakeholders
d. The final phase in November 2019 involved the Human Tissue Framework

Built on ethical principles and international standards, the HBRA aims to ensure the protection of individuals' rights, welfare, and dignity in biomedical research studies. It encompasses stringent guidelines and procedures to govern research practices, upholding ethical integrity and scientific credibility while fostering healthcare and medical innovation. The Act delineates responsibilities for various stakeholders, including researchers, institutional review boards (IRB), and regulatory authorities, to establish transparency and accountability. This framework enhances public confidence in Singapore’s biomedical research practices and underscores the nation's commitment to maintaining its international standing as a hub of biomedical research and innovation.

The Centre for Regulatory Excellence (CoRE) was collaborated with the Health Regulation Group, Ministry of Health (MOH) to undertake a landscape analysis project on Human Biomedical Research, which involved conducting comprehensive reviews of Singapore's current HBRA legislation. These reviews are compared with those from comparable jurisdictions to evaluate whether adjustments to Singapore's approach are necessary.

The project examined the following areas:

1. Scope of laws governing human biomedical research (HBR)
2. Governance of human tissue and tissue banking
3. Regulations concerning appropriate consent

The project concluded that while Singapore’s regulatory framework is robust, continuous adaptation to technological advancements and alignment with international legislations and guidelines are crucial in ensuring regulatory effectiveness and safeguarding the subjects’ safety as well as to not stifle research and innovation. By adopting a more nuanced approach, Singapore can reduce regulatory burdens and create a more balanced framework for HBR.