Human Biomedical Research Bill
With the intention of conforming to the above principles, on 18 August 2015 the Singapore Parliament passed the Human Biomedical Research Bill (the “Bill“). The introduction of the Bill will provide overdue clarity on the legal frameworks for (a) the conduct of human biomedical research, and (b) the handling of human tissue in Singapore.
Human Biomedical Research Regulatory Framework
All human biomedical research will be subject to general controls. Additionally, there are two different categories which warrant separate treatment, namely:-
- “prohibited research [i] which cannot be conducted; and
- restricted research [ii] which is subject to stricter rules than the general controls.
Human Tissue Regulatory Framework
The human tissue regulatory framework provides that commercial trading of human tissue is prohibited. However, a live donor may be reimbursed for reasonable expenses incurred by him and arising out of the removal of his tissue. Nonetheless, tissues whose functional, structural and biological characteristics have been substantially manipulated are outside the scope of the Bill and, as such, may be commercially exploited.
Appropriate consent must be obtained from donors for the removal, storage, supply and use of their tissue. Where human tissue has been imported from outside Singapore, there should be documentary evidence that the consent has been given in accordance with the legal or ethical requirements of that place. Tissues donated prior to the enactment of the Bill may be used in research if they have been obtained with appropriate consent and the potential benefits outweigh the risks.
The Bill also requires controls to be put in place to protect the confidentiality of tissue donors and to prevent the unauthorised disclosure of their personal information. Tissue banks are required to develop internal policies, standards and systems for the proper conduct of their operations.
- Human Biomedical Research Bill
- Human Biomedical Research Bill – Consultation Document (Nov – Dec 2014)