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Singapore – Public Consultation On Human Biomedical Research Bill.

18 November, 2014

The Ministry of Health (“MOH“) will conduct an online public consultation exercise on the Human Biomedical Research Bill, which will be enacted in 2015.


Currently, there is no local legislation on human biomedical research. Researchers undertaking studies involving human subjects presently require only ethical approval from the Institutional Review Boards, which will then refer to MOH’s operational guidelines. 


The proposed Bill seeks to clarify the roles and responsibilities of organisations and individuals involved in human biomedical research. 


Further, it aims to enhance the protection of research participants’ and tissue donors’ welfare and prohibit the commercial trading of human tissues, regardless of whether these are used in research. This is to ensure that such research, tissue collection and storage are carried out under sound research and ethical practices and principles. 


Regulations included under the proposed Bill will apply to the following two research areas:


1. Restricted 


(a) MOH’s approval is required for the introduction of human genes into an animal embryo.


2. Prohibited 


(a) The development of human-animal embryos beyond 14 days; and
(b) The insertion of human stem cells into the brains of apes.


Under the proposed Bill, anyone found in breach of these rules could be jailed up to ten years or fined up to SGD 100k (about USD 80k), or both.

 

The proposed Bill will also include rules on the use of donated tissues, such as:


(a) A written consent form is needed before the donor’s tissue is removed;
(b) Donors can elect to give their tissues for generic or specific research use;
(c) A tissue bank must notify the Health Ministry before banking any tissue to ensure that the donors’ tissues are handled safely;
(d) A Person-in-Charge must also be appointed to develop clear policies to monitor, supervise and review the conduct of banking tissues; and
(e) For vulnerable groups such as young donors or adult donors who lack the mental capacity to provide consent, a guardian or parent can give their consent for them, provided that the removed tissue is primarily used for diagnostic or therapeutic purposes.


The online public consultation will close on 18 December 2014.


All interested parties may give feedback to MOH by email. More details of the public consultation are available on MOH’s website, which can be accessed at this link.

 

Baker McKenzie

 

For further information, please contact:

 

Andy Leck, Principal, Baker & McKenzie.Wong & Leow

andy.leck@bakermckenzie.com

 

Lim Ren Jun, Baker & McKenzie.Wong & Leow

ren.jun.lim@bakermckenzie.com

 
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