On 2 March 2017, the Ministry of Health released a draft amendment to the Fifth Schedule to the Human Biomedical Research Act 2015 (the “HBRA”), which supplements the existing waiver framework under the HBRA.
The amendment will introduce a new waiver process which will enable institutional review boards (“IRBs”) to waive the consent requirement for the use of legacy health information for research purposes, where, among other conditions, such information is collected prior to the impending commencement of the consent requirement under the HBRA and the process of obtaining such consent involves a disproportionate amount of effort and resources (the “New Legacy Health Information Waiver”).
This Update examines the New Legacy Health Information Waiver against the existing HBRA framework and discusses two immediate concerns that the New Legacy Health Information Waiver may raise:
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The scope of the New Legacy Health Information Waiver and the existing HBRA framework as well as a possible lacuna in the waiver framework; and
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How IRBs will determine whether one of the conditions under the New Legacy Health Information Waiver has been met – namely that the process of obtaining consent will involve a disproportionate amount of effort and resources relative to the research requirements.
If you have any queries or would like to know more about how these changes may impact you, please contact:
LAM Chung Nian
Head – Intellectual Property, Technology
and Media, Telecommunications and Data Protection Practices
d +65 6416 8271
e chungnian.lam@wongpartnership.com
Click here to see Chung Nian’s CV.