24 June, 2015
1. On 23 June 2015, the Bioethics Advisory Committee (BAC) issued its Ethics Guidelines for Human Biomedical Research (Guidelines).
2. The issuance of the Guidelines follows a thorough process of deliberation by the BAC on a range of ethical issues concerning human biomedical research, including consideration of feedback received during the BAC’s public consultation on the draft Guidelines in June 2012.
3. The Guidelines are intended to set out a framework for the ethics review of human biomedical research. They provide guidance on the ethical, legal and social rights and responsibilities of all stakeholders in human biomedical research, especially research participants, on topics such as the following:
(a) the role of institutional review boards (IRBs) in human biomedical research;
(b) consent requirements for human biomedical research;
(c) the protection of personal information;
(d) biobanking and research involving human biological materials;
(e) human genetic research; and
(f) human stem cell research.
4. Pertinently, the Guidelines continue to emphasise the importance of voluntary informed consent and independent oversight procedures to protect the rights of research participants, including those who are mentally incapacitated and minors. This is reflected in the BAC’s new recommendations in relation to, amongst others:
(a) research participants’ rights to be informed of clinically significant incidental findings if they had indicated a wish to know;
(b) research participants’ rights to compensation for adverse consequences resulting from their participation;
(c) research participants’ rights to reimbursement for legitimate expenses incurred as a result of their participation;
(d) respecting a minor’s refusal of consent to participate in research.
5. The BAC has expressed that the Guidelines contain the BAC’s current views on the standards expected of researchers and research institutions in Singapore.
6. In preparing the Guidelines, the BAC reviewed its past reports and consolidated its earlier recommendations as expressed in those reports. The earlier BAC reports that form the basis of the Guidelines remain available as primary sources of information. These reports are:
(a) The Stem Cell Report. Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning (2002);
(b) The Tissue Report. Human Tissue Research (2002);
(c) The IRB Report. Research Involving Human Subjects: Guidelines for IRBs (2004);
(d) The Genetics Report. Genetic Testing and Genetic Research (2005);
(e) The Personal Information Report. Personal Information in Biomedical Research (2007);
(f) The Egg Donation Report. Donation of Human Eggs for Research (2008); and
(g) The Human-Animal Combinations Report. Human-Animal Combinations in Stem Cell Research (2010).
7. In addition, the Guidelines have taken into account new scientific, regulatory, social and legal developments since the publication of the BAC’s earlier reports, and incorporated the BAC’s recommendations on recent emerging issues such as whole genome sequencing and the management of incidental findings. In the course of its review, the BAC also considered existing international practices and guidelines on the ethical conduct of human biomedical research, and sought expert opinion on the various issues.
8. The BAC was established by the Singapore Government in December 2000 to examine the ethical, legal and social issues arising from human biomedical research. Its role is to develop and recommend policies to the Government on these issues, with the aim of protecting the rights and welfare of the public, while allowing biomedical sciences to develop and realise their full potential for the benefit of humankind.
9. For reference, the Guidelines and all earlier reports published by the BAC may be accessed here.
For further information, please contact:
Tony Yeo, Director, Drew & Napier
tony.yeo@drewnapier.com
Benjamin Gaw, Director, Drew & Napier
benjamin.gaw@drewnapier.com
