Online Consultation on Draft Subsidiary Legislation for Human Biomedical Research Act 

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UPDATE! Conclusion to the Consultation on Draft HBRA Subsidiary Legislation

           The summary of responses to feedback received during the public consultation on draft HBRA subsidiary legislation can be found here.

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Extension of Period of Consultation on Draft HBRA Subsidiary Legislation

            Due to a strong show of interest from stakeholders, we are pleased to inform you that the stakeholder consultation on draft HBRA subsidiary legislation will be extended for another 2 weeks, until 15 April.

Distinguishing Human Biomedical Research from Other HBR-like Studies

2          In addition, following certain earlier feedback through stakeholder engagement on the difficulties of distinguishing HBR from other HBR-like studies, MOH has drafted a table and decision tree to help distinguish HBR from other HBR-like studies, such as service evaluation, clinical audit and surveillance, which were not intended to be regulated under the HBRA (see Annex A here). You may wish to give your comments on the draft table in the feedback form here.

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        The Ministry of Health (MOH) is holding an online consultation from 1 March to 31 March 2017 on the draft subsidiary legislation relating to the research regulatory framework under the Human Biomedical Research Act (HBRA).

Human Biomedical Research Act

2      The HBRA was passed by Parliament on 18 August 2015, and it is being brought into operation gradually in phases. The provisions relating to the prohibition against commercial trading of human tissue were brought into operation on 1 January 2017.

3      For the next phase, the research regulatory framework will be brought into operation in the second half of 2017.  The research regulatory framework will :

  • regulate the conduct of HBR in general;
  • subject certain types of restricted HBR (e.g. research involving human eggs or embryos or human-animal combination embryos) to stricter controls; and
  • prohibit certain types of HBR that are considered to be ethically unacceptable in Singapore.

Proposed Subsidiary Legislation

4      The proposed set of Regulations will specify the technical details and elaborate on the various requirements and controls on HBR that are set out in the main Act.  This include matters such as the process of submitting annual declarations by research institutions, reporting of serious adverse events, composition of institutional review boards, and application for approval to conduct restricted research.

5      In particular, the proposed set of Regulations include the following : (click on links below)

        (a)  Regulations relating to Research Institutions (RI)
        (b)  Regulations relating to Institutional Review Board (IRB) 
        (c)  General Regulations 
        (d)  Regulations relating to Restricted Research 
        (e)  Regulations relating to collection and banking of certain tissues for research

6      Additionally, the Fifth Schedule of the Act will be amended to enable IRBs to waive the consent requirement for the use of health information for research purpose that had been collected in the past (i.e. before the research regulatory framework is brought into operation in the second half of 2017).

Stakeholder Consultation Sessions Held on March 13 and 14

7      The presentation slides relating to the draft regulations for RI, IRB and General Regulations are available here.

Industry Specific Dialogue Held on March 28

8      The presentation slides relating to the draft regulations for Restricted Research and the corresponding regulations relating to collection and banking of certain tissues for research are available here.

Feedback Sought

9      MOH invites interested parties to submit written comments on the draft subsidiary legislation and Annex A for table and decision tree that help to distinguish HBR from other HBR-like studies. For your convenience, you can use the feedback form here. Please send your views and comments to hbr_enquiries@moh.gov.sg.