The Human Biomedical Research Bill (the “Bill”) was passed in Parliament on 18 August 2015, following a public consultation conducted from 6 November 2014 to 18 December 2014. The Bill has yet to come into force.
At present, limited legislation and guidelines govern specific areas of human biomedical research (“HBR”). For example, the Medicines (Clinical Trials) Regulations apply to clinical trials for pharmaceuticals and guidelines issued by the Singapore Medical Council apply to clinical research conducted by registered doctors. The Singapore Bioethics Advisory Committee has also issued various reports on biomedical research in Singapore with recommendations for the adoption of certain ethical principles in biomedical research although these recommendations have no legally binding effect. The Bill was introduced in the context of growing HBR activity in the private sector and increasing HBR undertaken by non-doctor researchers; it will bring all types of HBR under a formal legislative framework. The Bill also makes related amendments to the Health Products Act, Medicines Act and Mental Capacity Act.
The Bill seeks to promote Singapore’s international standing as a biomedical research hub, by providing clear ethical guidelines for the conduct of HBR and the collection of human tissue, as well as establishing safeguards for the safety and welfare of research subjects and tissue donors.
Scope of the Bill
The Bill sets out two separate but related regulatory frameworks:
- HBR Framework: The HBR Framework will protect the safety and welfare of human research subjects, regulate the conduct of HBR and certain restricted HBR and prohibit certain types of HBR.
- Human Tissue Regulatory Framework: This framework will protect the safety and welfare of tissue donors and prohibit the commercial trading of human tissue.
The following are the key features of the HBR Framework:
- Key entities: The Bill envisions a tripartite relationship involving:
- Institutional Review Boards (“IRBs”): An IRB is a board or committee appointed by a research institution in accordance with the Bill to conduct an ethics review of proposed HBR. The Bill sets out the functions and duties of IRBs and also provides for regulations to be made governing the composition, quorum and proceedings of an IRB.
- Research Institutions (“RIs”): An RI is any public healthcare institution, private clinic/hospital, biotech start-up, small or medium enterprise or other research organisation that has notified the Ministry of Health (the “MOH”) of its intention to conduct HBR. An RI is the overarching entity under which HBR is conducted. It is responsible for, among other things, supervising and controlling the activities of its HBR researchers in order to ensure compliance with the approved HBR proposals and regulatory requirements.
- Researchers: Researchers must conduct their research in accordance with the HBR proposal approved by the IRBs (as well as any other rules and regulations under the Bill).
- Requirement for appropriate consent: The Bill introduces requirements for obtaining consent for the conduct of HBR and sets standards for the consent-taking process to ensure that potential subjects are adequately informed and understand the nature of their participation in the research. More stringent requirements apply for “vulnerable” persons (such as those lacking mental capacity or minors) or in respect of restricted research involving sensitive tissues.
- Protection of confidentiality: The Bill also seeks to protect the confidentiality of research subjects against accidental loss or unauthorised access or disclosure of individually‑identifiable information or human biological material.
Human Tissue Regulatory Framework
The following are key features of the Human Tissue Regulatory Framework.
- Prohibition against commercial trading: The commercial trading of human tissue is prohibited. It is an offence to buy or sell, or advertise the buying or selling of, human tissue. This prohibition is in line with similar prohibitions against the commercial trading of organs (in the Human Organ Transplant Act) and of embryos, eggs and sperm (in the Human Cloning and Other Prohibited Practices Act).
- Controls on removal, storage, supply and use of human tissue: Tissues may only be removed, stored, supplied and used for research with the donor’s consent, and in accordance with the donor’s wishes. The Bill also makes it an offence to coerce, intimidate, deceive or mislead a person into providing his tissue.
- Confidentiality of tissue donors: The Bill also seeks to protect the confidentiality of tissue donors and prevent unauthorised disclosure of their personal information.
MOH’s regulatory and enforcement powers
RIs and tissue banks are subject to regulatory requirements for as long as they continue operating. The MOH will not license RIs and tissue banks, but will have the necessary powers to inspect and audit them in order to ensure compliance with such regulatory requirements.
Offences and penalties
The offences in the Bill are categorised into four “tiers”, according to their nature and seriousness. The most serious offences (such as commercial trading in human tissue) will carry the highest maximum penalties, which are a fine of up to S$100,000 or imprisonment for up to 10 years or both.
An article about the Bill when it was introduced in Parliament on 13 July 2015 was featured in a previous issue of the Allen & Gledhill Legal Bulletin (July 2015). To read the article entitled “Human Biomedical Research Bill 2015 introduced in Parliament: Regulating human biomedical research, tissue banks and tissue banking activities”, please click here