Ethical & legal implications of new law governing human biomedical research

Sumytra Menon1

1 Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore

The conduct of human biomedical research will enter a new phase as Singapore transitions from advisory guidelines to legal regulation. The Human Biomedical Research Act (HBRA) heralds a landmark change that will impact research institutions, institutional review boards, researchers and research subjects. The Singapore government has announced a “sunrise period” so the affected parties can prepare for compliance. The purpose of the HBRA is to protect research subjects and tissue donors, and to provide a legal foundation to facilitate research studies that meets high ethical standards. This talk will focus on consent, researchers responsibilities and incidental findings. It will address some of the ethical and legal implications on researchers and research subjects, and reflect on the repercussions of such regulation on the conduct of human biomedical research.


Sumytra Menon is a Senior Assistant Director at the Centre for Biomedical Ethics (CBmE), Yong Loo Lin School of Medicine, National University of Singapore. She is a lawyer by training and in conjunction with the National Ethics Capability Committee, is developing a national competency and accreditation framework for clinical ethics and research ethics training. She is also the Programme Director of the CENTRES project (Clinical Ethics Network + Research Ethics Support), which offers training programmes for clinical ethics committees, research ethics committees and transplant ethics committees.

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