Speeches
Opening Speech for Second Reading of Human Biomedical Research Bill by Minister of State for Health Dr Lam Pin Min
17 August 2015
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Madam Speaker, I beg to move that the Bill be now read a second time.
Background – Biomedical Research in Singapore
2 Research in biomedical sciences has led to important advances in knowledge and technology that have improved the health, life expectancy and quality of life of people around the world. In Singapore, despite the relatively short history of research, we have already seen benefits from biomedical research.
3 In the area of cancer research, a team at our National University Hospital developed a novel genetic screening programme that provides more accurate diagnosis of acute lymphoblastic leukaemia in children. This new technology has increased the success rate for the treatment of such cases to over 80%, with fewer side effects and better quality of life. It has also lowered the cost of treatment and reduced the period of hospitalisation.
4 Beyond the benefits to the health of our people, research in the biomedical sciences has the potential to create good jobs for our young people and become one of the key pillars of the economy.
5 However, good quality human biomedical research (HBR) needs to be underpinned by strong ethics governance and protection for people who are subjects of such research.
Current Controls
6 Today, we have laws that cover specific areas of research. For example, the Medicines (Clinical Trials) Regulations only apply to clinical trials for pharmaceuticals. Besides legislation, the Ministry of Health (MOH) has issued guidelines on the conduct of HBR, but these apply mainly to research by public sector bodies or researchers using public research funds. The Singapore Medical Council also has issued ethics guidelines on clinical research, but these apply only to registered doctors.
7 With the growth of HBR activity beyond the public sector, and with more non-doctor researchers involved in clinical research, it is timely to bring all types of HBR under a formal legislative framework. This is the key impetus for this Bill. We want to build strong legislative foundations to facilitate research while ensuring high ethical standards and protection for human subjects.
8 In addition, there has been increased demand for human tissue as biomedical research often involves the use of such tissue. With more human tissue being collected and stored in tissue banks and tissue collections of varying sizes in Singapore, it is important to formalise the ground rules for handling human tissue. This will help ensure protection for tissue donors, ethical conduct in the collection of tissue, and good stewardship of this valuable resource for biomedical research.
9 MOH has been monitoring developments in other advanced countries that have well-established biomedical research sectors such as the UK, the USA and Australia. MOH has taken bearing from their regulatory frameworks and legislation governing HBR and handling of human tissue. The introduction of this Bill is a pro-active measure to help ensure that Singapore maintains its reputation as a biomedical research hub of international standing.
10 MOH has also consulted widely with stakeholders, including the research community and the public throughout the development of this Bill. A formal online public consultation was conducted between November 2014 and January 2015. The feedback received supported having a Bill that would protect the safety and welfare of research subjects and tissue donors, and provide clarity to the roles and responsibilities of those engaged in HBR and tissue banking.
Scope and Objectives of Bill
11 This Bill incorporates provisions for two separate but related regulatory frameworks, namely (i) the HBR regulatory framework, and (ii) the human tissue regulatory framework. These frameworks also apply to the activities of the Government.
12 The principal objective of both these frameworks is to protect the safety and welfare of research subjects and tissue donors, ensuring that their health and well-being is not compromised, and their privacy and autonomy is respected.
13 The Bill does this by :
a) regulating the conduct of HBR, with stricter rules for certain types of restricted research;
b) prohibiting certain other types of HBR;
c) regulating tissue banking activities; and
d) prohibiting the commercial trading of human tissue.
14 The Bill includes many elements that should be familiar to researchers and those who handle human tissue, such as the concept of informed consent and the requirement for independent ethics review. Some of these are reflected in the existing laws and guidelines, and are already in practice. This Bill will make transparent a set of standards and requirements that apply uniformly across the board.
15 Let me now describe the provisions of these two regulatory frameworks.
HBR Regulatory Framework
Definition of HBR
16 In relation to the HBR regulatory framework, the scope of the framework is defined by the term “human biomedical research”. This is described in clause 3 of the Bill, and it covers two main areas :
a) The first area refers to any research for clinical or medical-related purposes, involving a human subject.
b) The second area covers any research involving human embryos, eggs, sperm, or human-animal combinations.
Role of research institutions, institutional review boards and researchers in HBR
17 In regulating the research environment, the Bill defines the roles and responsibilities of three key entities. They are the “research institution” (RI), the “institutional review board” (IRB), and the individual “researcher”. Together, they form an interlinked system with checks and oversight to ensure that the research is conducted ethically, and that there is accountability for the safety and welfare of the research subjects. Let me elaborate on this.
18 Under the HBR framework, every individual researcher must conduct HBR under the supervision and control of an RI. He can either be an employee of the RI, or enter into some form of contractual or collaborative agreement to conduct the research under the auspices of that RI. No researcher is allowed to conduct HBR on his own outside this framework, without any oversight or supervision.
19 Before starting any HBR, the researcher must have his research proposal reviewed and approved by an IRB appointed by his RI. He must then ensure that appropriate consent is obtained for each research subject involved in the HBR. When conducting the HBR, the researcher must not deviate materially from the approved protocol without further approval from the IRB.
20 The IRB plays an important role in ensuring the ethical conduct of research and protecting the safety and welfare of research subjects. The IRB reviews HBR proposals of the researchers under its RI, assessing, among other things, the ethics of the study, the researchers’ qualifications, and the adequacy of the safety measures put in place to protect research subjects.
21 Even though it is appointed by the RI, the IRB is obliged to make an independent assessment whether to approve or reject the proposed HBR, with the safety and welfare of research subjects being its paramount consideration. The IRB must include a scientific member and a lay person who are not related to the RI.
22 The RI is the overarching entity under which HBR is conducted. It is responsible for the supervision and control of its researchers, including monitoring their HBR to ensure compliance with the regulatory requirements. It must also appoint the IRB to review the HBR of its researchers, and it is responsible for providing the necessary resources and support to ensure the proper functioning of the IRB. It is worthwhile to note that, in this system, it is the RI that will ultimately be accountable in the event that its appointed IRB fails to perform its review functions properly.
23 An RI bears heavy responsibilities, and it is a role that should not be taken lightly. An RI must be a body of persons or an organisation – an individual cannot be an RI. The RI must also have a place of business in Singapore, with at least two individuals who are ordinarily resident in Singapore responsible for the supervision and control of the HBR it conducts. These pre-requisites help to ensure that only bona fide organisations, which have adequate resources and personnel capable of performing the responsibilities of an RI, conduct HBR in Singapore.
24 This system of researchers, IRBs and RIs that I have described is covered in the clauses in Part 4, and in clauses 22, 23 and 24.
Requirement for appropriate consent
25 One important aspect of the HBR framework is the requirement to obtain appropriate consent from research subjects. This upholds the principle of voluntary, informed participation, which is an important cornerstone of ethical HBR.
26 In general, before a person is enrolled as research subject, he should have:
a) the right to know what is expected of him, and what risks he will likely be exposed to, as a research subject; and
b) the right to decide whether or not to be a research subject, including the right to change his mind and discontinue being a research subject.
27 There will be standards set for the consent-taking process to ensure that prospective subjects are adequately informed and understand the nature of their participation in the research. There will also be additional safeguards for ‘vulnerable’ groups, such as minors below 21 years of age, and those without the mental capacity to give their own consent. For example, for persons without mental capacity, consent can be given by a donee or deputy authorised under the Mental Capacity Act to give consent on such matters. If there is no such donee or deputy, consent can be given by a family member, such as a spouse, an adult child or a parent.
28 However, as a safeguard, those who are unable to give their own personal consent can only be enrolled in research where their participation is essential because research of comparable effectiveness cannot be carried out without the participation of that class of persons. An example of such research may involve patients with late stage Alzheimer’s disease who have lost their mental capacity. In such a case, an IRB will also scrutinise the research proposal and consider whether the enrolment of these patients is indeed scientifically necessary and ethically acceptable.
29 The requirements for appropriate consent are covered in detail in Part 3 and clause 25 of the Bill. Furthermore, clause 26 makes it an offence to coerce, intimidate, deceive or mislead a person into becoming a research subject, or to stop him from discontinuing his participation as a research subject.
Protection of confidentiality
30 The HBR framework also includes controls and requirements to protect the confidentiality of research subjects against accidental loss or unauthorised access or disclosure. These are covered in clauses 27, 28 and 29.
Additional controls for restricted research and prohibited research
31 Clauses 30 and 31 of the Bill provide for certain specified subcategories of HBR to be subjected to tighter controls. These are research that are “restricted” as they are considered ‘sensitive’, such as those using human embryos, and research that are “prohibited” as they are deemed ethically unacceptable and are disallowed completely.
Human Tissue Regulatory Framework
32 Related to the HBR framework is the human tissue framework in Part 6 of the Bill. This regulates the removal of tissue from the human body as well as the procurement, storage, supply and use of human tissue in research.
Definition of human tissue
33 The definition of “human tissue” in clause 2 generally includes any biological material obtained from the human body that consists of, or includes, human cells.
Prohibition against commercial trading
34 The human tissue framework prohibits commercial trading of human tissue, upholding the principle that human tissue should be obtained only through altruistic donations. Clauses 32 and 33 make it an offence to buy or sell, or to advertise the buying or selling of, human tissue. These are aligned with similar prohibitions against 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
35 Similar to the HBR framework, the requirement to obtain appropriate consent from tissue donors is an important aspect of the human tissue framework. Tissues may only be removed, stored, supplied and used for research with the donor’s consent, and the donated tissue must be used in accordance with the donor’s wishes. Additionally, it will be an offence to coerce, intimidate, deceive or mislead a person into providing his tissue.
36 The requirement for appropriate consent and the controls on the removal, storage, supply and use of the tissue, are covered in clauses 37 and 38.
Confidentiality of tissue donors
37 The human tissue framework also includes controls and requirements to protect the confidentiality of tissue donors and prevent unauthorised disclosure of their personal information. This is covered in clause 39 of the Bill.
MOH’s Regulatory and Enforcement Powers
38 The clauses in Part 8 of the Bill deal with MOH’s powers to administer and enforce this Bill. RIs and tissue banks are required to formally notify MOH before they commence operations, and have to periodically declare their compliance with the regulatory requirements while they continue operating. MOH will not license them, but will have the necessary powers to inspect and audit them, to ensure compliance with regulatory requirements.
Offences and Penalties
39 Regarding offences and penalties, the offences in the Bill fall into four ‘tiers’ according to the nature and seriousness of the offence. The most serious offences, such as commercial trading in human tissue, conducting “prohibited research” or forcing a person to become a research subject against his will, carry the highest maximum penalties, which is a fine of up to $100,000 or imprisonment for up to 10 years or both.
Conclusion
40 The ultimate objective of HBR is to improve human health and well-being. HBR is essential to understanding the causes and progression of diseases, and to the development of new and improved therapies, diagnostics and preventive interventions. Those who donate their tissue or participate as research subjects play an indispensable part in HBR. It is only right that their safety and welfare be protected. This Bill will put in place regulatory frameworks that will protect those research subjects and tissue donors.
41 I hope that Members will show their support for this Bill, as a demonstration of Singapore’s commitment towards ethical and responsible biomedical research and handling of human tissue.
Madam Speaker, I beg to move.