19 November, 2015
According to the Council for International Organisations of Medical Sciences' International Ethical Guidelines for Biomedical Research Involving Human Subjects, all research and storage of human tissue should be conducted in accordance with three basic ethical principles, namely, respect for persons, beneficence and justice.
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.
The Bill envisages an interlinked system of checks and oversight involving:-
- the research institution;
- the international review board (appointed by the research institution); and
- the individual researcher.
Under the Bill, every individual researcher is required to conduct human biomedical research under the supervision and control of a research institution. Additionally, before embarking on any research, the researcher must have his proposal reviewed and approved by an international review board appointed by his research institution.
Appropriate consent is required to be obtained for each research subject involved in the human biomedical research. More stringent consent requirements apply for vulnerable subject groups (such as those lacking mental capacity or minors) or in respect of restricted research areas.
The Bill also imposes a general requirement to (a) protect the confidentiality of individually-identifiable information collected for human biomedical research, and (b) prohibit any attempt to re-identify the individual from whom information that is not individually-identifiable is obtained.
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.
[i] Prohibited human biomedical research comprises human biomedical research involving:-
(a) the development of the certain types of human-animal combination embryos (namely, cytoplasmic hybrid embryos and human-animal combination embryos created in-vitro by using (i) human gametes and animal gametes, or (ii) one human pronucleus and one animal pronucleus) beyond 14 days or the appearance of the primitive streak, whichever is the earlier;
(b) the implantation of any human-animal combination embryo into the uterus of an animal or human;
(c) the introduction of human stem cells (including induced pluripotent stem cells) or human neural cells into the brain of living great apes whether prenatal or postnatal; or
(d) the breeding of animals which have had any kind of pluripotent stem cells (including induced pluripotent stem cells) introduced into them.
[ii] Restricted human biomedical research comprises human biomedical research involving:-
(a) human eggs or human embryos;
(b) the following types of human-animal combination embryos (namely, (i) cytoplasmic hybrid embryos, (ii) human-animal combination embryos created by the incorporation of human stem cells (including induced pluripotent stem cells), and (iii) human-animal combination embryos created in-vitro by using (1) human gametes and animal gametes, or (2) one human pronucleus and one animal pronucleus);
(c) the introduction of human stem cells (including induced pluripotent stem cells) into a prenatal animal foetus or animal embryos;
(d) the introduction of human pluripotent stem cells (including induced pluripotent stem cells) into a living postnatal animal;
(e) the introduction of human stem cells (including induced pluripotent stem cells) or human neural cells into the brain of a living postnatal animal; or
(f) any entity created as a result of any process referred to in sub-paragraphs (c), (d) and (e).
For further information, please contact:
Marcus Chow, Partner, Bird & Bird
marcus.chow@twobirds.com
