Debated in Parliament on 17 Aug 2015.
Order for Second Reading read.
Mdm Speaker, I beg to move, "That the Bill be now read a Second time."
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.
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.
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. 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.
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.
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.
Page: 99
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.
MOH has been monitoring developments in other advanced countries that have well-established biomedical research sectors, such as the United Kingdom, the United States of America (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 proactive measure to help ensure that Singapore maintains its reputation as a biomedical hub of international standing.
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.
This Bill incorporates provisions for two separate but related regulatory frameworks, namely, (a) the HBR regulatory framework, and (b) the human tissue regulatory framework. These frameworks also apply to the activities of the Government.
The principal objective of these frameworks is to protect the safety and welfare of research subjects and tissue donors, ensuring that their health and well-being are not compromised, and their privacy and autonomy are respected.
This 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
Page: 100
(d) prohibiting the commercial trading of human tissue.
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.
Let me now describe the provisions of these two regulatory frameworks.
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: the first area refers to any research for clinical or medical-related purposes, involving a human subject, while the second area covers any research involving human embryos, eggs, sperm or human-animal combinations.
In regulating the research environment, the Bill defines the roles and responsibilities of three 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.
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.
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.
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.
Page: 101
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.
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.
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, and 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 prerequisites 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.
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.
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.
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.
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
Page: 102
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 only be given by a family member, such as a spouse, an adult child or a parent.
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.
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.
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.
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.
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.
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.
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
Page: 103
and Other Prohibited Practices Act.
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.
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.
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.
The clauses in Part 8 of the Bill deal with MOH's powers to administer and enforce the provisions in 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.
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.
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 these research subjects and tissue donors.
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. Mdm Speaker, I beg to move.
Page: 104
*Question proposed.*
Dr Chia Shi-Lu.
Mdm Speaker, this is an important Bill, and I would also say a timely one, building upon a process of public and professional consultation that was begun over 10 years ago. However, and particularly as a researcher in the biomedical sciences myself – and I herein declare my interest in this area – I am acutely aware that the pace of scientific discovery is so rapid and the scope so broad that it is challenging to construct comprehensive and durable legislation.
This is an important Bill because without biomedical research there will be no progress in the development of therapies that cure human disease, alleviate human suffering, or make our lives more active and fulfilling. Where we are today, and where we will be in the foreseeable future, the noble search for the next magic drug, the next miracle cure, cannot happen without the use of human tissues and the participation of human subjects. The development of new cures for cancer, new implants to replace worn-out body parts, vaccines for diseases like dengue fever and Ebola, all these cannot happen without the use of human tissues and the participation of human subjects.
Further to this, there is also an increasing number of therapies that involve the use of human cells and tissues, and although the concerns may not be as great or as complex as those that surround organ donation and transplantation, nonetheless many of the same issues regarding the procurement, storage and usage of these biological materials need close scrutiny.
This is an important Bill because although biomedical research in Singapore occurs within a closely regulated ethical and safety framework that is supported by related legislation, such as the Medicines Act, Human Organ Transplant Act, Human Cloning Act and so on, we do not as yet, have a formal legislative framework that covers the conduct of biomedical research in Singapore.
I am reassured, however, that this Bill strengthens the existing ethical and regulatory framework that safeguards the rights of the patient. This is critical, as it will increase the confidence of the public in the conduct of medical research in Singapore and encourage the participation of the public in medical research.
Page: 105
When a patient or a member of the public is invited to participate or contribute to a medical research study, many greet such an offer with a degree of distrust and trepidation. This should not be the case. In many developed nations, patients often compete to be eligible to participate in such research, either because it allows them the opportunity to contribute to the greater good, or because it gains them expedited access to advanced therapies which may otherwise not be open to them. In these countries, a comprehensive legal and regulatory framework sustains this environment by affording greater peace of mind to these research participants. Mdm Speaker, in Mandarin, please.
(In Mandarin): [Please refer to Vernacular Speech.] Mdm Speaker, I support the Human Biomedical Research Bill.
MOH has provided a set of guidelines by the Ethics Review Committee to all public and private hospitals and research institutions. Generally, the ethics committee of most organisations will follow these guidelines. The problem is that these guidelines are not mandatory in nature and are not legally abiding.
In recent years, there are more and more biomedical research projects in Singapore and they are getting more complicated in nature as well. This is driving and promoting the development of the biomedical research industry in Singapore.
In order to ensure that all biomedical research activities relating to human bodies are conducted in accordance with the research and ethical standards, and to protect the safety, privacy and welfare of patients and donors of human tissues for research purposes, the enactment of this new legislation is necessary.
The Bill clearly spells out the role and responsibility of the individuals and organisations involved in these research projects and imposes strict controls on some restricted items of research. These include:
Firstly, collection of the patients' human tissue can only be conducted with the prior consent of the patient.
Secondly, regulation of research involving the combination of human and animal stem cells.
Thirdly, prohibition of the commercial trading of human tissues.
May I ask the Minister, in order to ensure that the research institutions abide by the regulations, what kind of audit process does the MOH have? Can the Minister disclose what
Page: 106
are the audit institution and details of the audit process?
Upon implementation of this new law, our legislative framework will comply with the standards of the leading countries in this area, such as the US, UK and Australia. I believe this will help to raise Singapore's status in the international scientific research field.
(In English): I have three further questions for the Minister. First, and I accept that this may not be within this Bill's remit, it is not entirely clear what manner of redress and compensation would be available to research participants should they suffer adverse effects, whether directly or indirectly, from their involvement in the said research.
Second, on the other hand, particularly when cell or tissue samples are obtained from subjects, whether the said subject has any rights to additional remuneration should the results of the research lead to clinically and commercially viable therapies.
Finally, in the hopefully unlikely event that research or tissue banking activities have to be suspended, as spelt out in Part 8 of the Bill, could the Minister elaborate on the process by which the suspension order will be reviewed and then either rescinded or perhaps lead to a permanent cancellation of the study? Although professionals in the field of biomedical research do appreciate the generally light touch adopted by this Bill, some remain concerned about the process of review and appeal should issues arise that could lead to a suspension of their research study. With that, I support the Bill.
Mr Pritam Singh.
Mdm Speaker, the MOH's public consultation on the Human Biomedical Research Bill carried out from November to December 2014 states that the Bill is light-touch with minimal regulatory intervention. It envisages a system of self-accountability, underpinned by risk-based audits and checks.
The Bill covers two major issues. Firstly, the biomedical research framework, while the second aspect regulates the framework governing the use and banking of human tissue. Mdm Speaker, I am concerned that with the light-touch regulatory approach, Parliament and Singaporeans will not be sufficiently informed about the nature of biomedical research carried out under the auspices of this Bill, leaving this House in little control over what Members agree to once this Bill passes muster.
Page: 107
I am also of the view that this Bill provides a unique opportunity to nudge Members into exploring and expanding Parliament's role in our society through additional scrutiny to operationalise Parliament's educative role in society.
At the outset, a vibrant biomedical research scene is in Singapore's interest. The prospects of a cure for cancer, human immunodeficiency virus (HIV), Parkinson's disease, correcting congenital defects and a host of other medical breakthroughs are exciting. I certainly hope many Singaporeans, and young Singaporeans in particular, dedicate themselves to being at the forefront of these breakthroughs.
What does this Bill allow, albeit under restricted conditions? Under the human biomedical research framework, and under the conditions established in clause 3, it allows for: (a) research involving human embryos; (b) human-animal combination embryos created by the incorporation of human genetic material, or human cells or entities created as a result of the introduction of human cells into an animal foetus; and (c) the introduction into human neural cells of a post-natal animal and the introduction of human cells into the brain of a living post-natal animal.
Under the Bill, the MOH's approval is required should the introduction of human genes into an animal embryo result in an entity that has human consciousness. These prospects can either cause the layman to look forward towards the future of human biomedical research with keen anticipation or with an acute sense of dread.
The self-accountability framework underpinning this Bill allows for an RI or a bio-technology company or even a small and medium enterprise (SME) to potentially set up IRB to review and assess the work that is carried out by its researchers. Consent from subjects is an integral aspect of this Bill, before biomedical research is carried out, and rightfully so. However, the Bill gives extraordinarily wide powers to the chairman of an IRB, as exemplified by Part 2 of the Fifth Schedule, to waive the requirement for appropriate consent to be obtained for human biomedical research involving biological material or health information, should the research be reasonably considered to contribute to "the greater public good", a term that would only be determined affirmatively and not without controversy – in a Court of law?
In fact, clause 57 affords the Minister even greater powers by permanently exempting any biomedical research activity from this Bill. Equally of concern, clause 62 gives the Minister power to amend any of the Schedules to this Bill, effectively delegating all Parliamentary oversight on the Bill to the Minister after its passage in this House, as the five Schedules cover the essence of what this Bill seeks to legislate, namely: (a) human biological material excluded from the definition of human tissue; (b) research studies and methods excluded from the definition of human biomedical research; (c) prohibited human
Page: 108
biomedical research; (d) restricted human biomedical research; and (e) waiver of requirements for appropriate consent by IRBs.
Should the Minister choose to exercise his powers by virtue of clause 62, Parliament would have, in effect, completely delegated its powers to the Minister to fundamentally alter the Bill in operation should the scope of the Schedules, as listed in the Bill, be modified without having to go through Parliament. At the very least, should Parliament not place greater reporting requirements on the exercise of such extensive powers even as we seek to allow our researchers and RI as much latitude as possible to produce cutting-edge research work?
Clause 62 would make Parliament little more than a mere rubber stamp with regard to human biomedical research in Singapore as this Bill gives complete latitude to the Minister to change the parameters and scope of biomedical research in Singapore without an amendment Bill and without Members having an opportunity to debate any gazetted changes in Parliament.
Mdm Speaker, I recognise that clause 5 of the Bill allows the Minister to establish an advisory committee to advise the Minister on any matter arising out of the administration of this Act. In effect, the existence of this clause reinforces the point that we are heading into uncharted waters even for the Minister who oversees this legislation. Parliament and the general public should be kept well-apprised of the research and controversies carried out under the auspices of this Bill should Parliament decide to pass this Bill.
I make this suggestion because in researching for this Bill, I perused the newly released Ethics Guidelines for Biomedical Research released in late June this year by the Cabinet-appointed Bioethics Advisory Committee (BAC), and found it disconcerting that in the written response received during the public consultation period for these guidelines, the Managing Director of the Lilly-NUS Centre for Clinical Pharmacology noted, "I am quite concerned that there was not more of an effort to engage with stakeholders on this discussion. I was only made aware of the proposed changes when I chanced upon it in the press report, and a couple of investigators in other institutions I spoke to who conduct healthy volunteer research were not aware of these proposals at all. I would urge a nuanced approach to this matter from the BAC."
Unsurprisingly, the public consultation on these BAC Ethics Guidelines revealed that different groups have different views on the conduct of biomedical research. In particular, the comments of the Buddhist Fellowship and the Catholic Medical Guild of Singapore revealed the difficulties in answering the fundamental question of when life begins and at what point consciousness starts – questions that are central to specific aspects of human
Page: 109
biomedical research.
Mdm Speaker, in view of the unique nature of this Bill and the significant powers that it confers, not just on the Minister, biomedical researchers and institutions and their review boards, it is helpful that clause 63 on regulations provides extensive powers to the Minister to make regulations requiring the submission of information, returns and reports as the Director of Medical Services may require. I would like the Ministry to consider publishing through the media or through Parliament at regular intervals the details of research projects rejected by the various IRB and the reasons for their rejection.
This is in addition to the details of projects that are submitted to MOH for special approval, including details of serious adverse events, as identified in clause 2. This is chiefly to keep the public informed and aware of the workings of the self-regulation framework, particularly since this is a highly specialised area that requires significant intervention for the effects of this Bill to be understood by the layman.
More specifically, in view of the importance of clause 63 as a regulatory tool for the Bill, I would like to ask the Minister how the penalty threshold of a $20,000 fine and a two-year imprisonment term was derived which, in my view, is set at a rather low threshold.
Mdm Speaker, the Workers' Party is of the view that Parliament ought to form a Select Committee to holistically scrutinise the clauses that confer significant powers to various entities in addition to a detailed primer into the research this Bill legislates.
Secondly, it recommends that the Government commit to publishing details of human biomedical research that will be carried out under this Bill's auspices and recommends that reporting regulations to Parliament be placed upon research institutions and review boards that seek to carry out restricted research. As Members have not had the opportunity to scrutinise this Bill closely and in the event a Select Committee is not formed, the Workers' Party will abstain from voting in favour of this Bill.
Mrs Lina Chiam.
Mdm Speaker, this Bill seeks to control and provide the regulatory framework to scientists as well as research subjects to ensure that the two parties on the opposing side know their boundaries.
Page: 110
The Bill is a timely initiative by MOH to address scientific breakthroughs that may have ethical, legal and religious repercussions in controversial unproven research experiments.
I would like to touch on a few points presented in this Bill.
Under Part 4, sections 15 and 16 on Appointment of IRBs and by Multiple Research Institutions, one critical point to note is that, under this Bill, the IRB is vested with the power to approve its budget, experiment protocol and research programme. Currently, all research institutes have their own accredited IRBs, but that itself is not fully independent.
Although this Bill addresses that all IRB members must declare conflicts of interest, one cannot expect an IRB to be fully independent when the IRB member is from the same research institution itself. In addition, since biomedical researchers are a closely-knit community in Singapore, many scientists who are also IRB members may also have relationship ties with other scientists who are submitting their research proposal to IRB.
If a scientist gets a red light at one IRB committee, would there still be a scenario if the scientist were to shop around other IRBs in other RIs to green light their research? Having accredited IRBs in each RI may not be a way to promote good corporate governance.
With too many research experiments being conducted, it will just take one or two major slip-ups to hurt Singapore's reputation as a healthcare research hub. There could one day be so many complaints by research subjects until MOH has to step in to micro-manage IRBs. By then, public confidence will be damaged and MOH will lose credibility.
In the USA, there have been many complaints to the US Bioethics Committee about harassment from researchers who stalk and target human research subjects.
Mdm Speaker, having this Human Biomedical Research Bill is a first step. But the law is meaningless if it is not effective in its application.
I would like to ask the Minister for Health if there are similar plans to set up another Statutory Board to help administer this Human Biomedical Research Act, such as the Casino Regulatory Authority and the Council for Estate Agencies.
Having an IRB that is from a Statutory Board with full-time commitment from the staff will ensure true independence from any RI that may unduly influence their deliberation process. Having a new Statutory Board allows research participants a good channel to lodge their complaints should there be a cause for investigation rather than go to an IRB committee
Page: 111
in an RI.
As new scientific knowledge is discovered every day, having a vigorous centralised training for full-time committed IRB staff will promote a fairer and consistent assessment of each research proposal submitted. In addition, many scientists and principal investigators need a lot of volunteers to conduct their clinical trials and research experiments. By setting up a new Statutory Board, perhaps it will be a good way to provide a one-stop service to allow scientists to publicise their needs for volunteers, just like how the Blood Bank of Singapore promotes their need for blood donation. Even Blood Bank opens their outlets in Woodlands, Jurong on weekends because people do see a need to donate blood. Perhaps MOH may even task Blood Bank to open up more channels so that people can also opt in to participate in experiments.
Germline Embryo Modification and Human-Genome Editing to Eradicate Heritable Diseases. In the Third and Fourth Schedules, this Bill touched on human-animal combination embryos, human stem cells, hybrid embryos, induced pluripotent stem cells but is silent on germline embryo modification and human-genome editing in a human adult.
MOH should take a standpoint on Germline Embryo Modification and Human-Genome Editing to eradicate human heritable diseases. But this Bill is silent on this issue. But if MOH fails to address this, it will lead to fear, hesitation and uncertainty among the scientist community and may be open for abuse among researchers and over-zealous kiasu parents if there is no clear legislation on this.
Germline Embryo Modification is aimed at preventing the transmission of mitochondrial DNA mutations from mother to child. In the USA and the UK, the trend to use human-genome editing using a technique called CRISPR has put a moral and religious dilemma among their lawmakers as well because their technique has caused unintended mutations and the long-term effects have not been studied.
I feel that in Singapore, as a secular nation, we should try to approve research techniques that aim to improve and eliminate heritable diseases, such as diabetes or asthma, regardless of religious objections. It is always human nature to want the best out of ourselves and that includes having a baby who is disease-free.
But I am aware of that, since genome editing techniques in embryos and living adults still carry some risks. Rather than ban them completely in the Third Schedule as Prohibited Human Biomedical Research, I am calling for a moratorium on such research until there is enough evidence to be proven relatively safe by IRBs.
Page: 112
The future of biotechnologies is so difficult to accurately predict that policies based on these predictions will not effectively reduce risks. I might like to add that MOH should make it a point to debate this list of prohibited research again every year or so, so that the Act can be up to date with the fast moving research.
Nanoethics and Synthetic Ethics and Third Schedule – Prohibited Human Biomedical Research. This Bill does not address nanotechnology and synthetic technologies in human biomedical research.
Nanoparticles present possible dangers in human embryo or genome editing. Most of these are due to the high surface to volume ratio, which can make the particles very reactive or catalytic. They are also able to pass through cell membranes in organisms, and their interactions with biological systems are relatively unknown. With 3D Printing, it is also possible to synthesise artificial DNA and genes to be implanted inside an embryo or living adult.
Similar to my previous argument on genome editing technologies, I am calling for a moratorium on such research until there is enough evidence to be proven relatively safe by IRB.
Alternatively, I would propose nanotechnology and synthetic biology to be put under the Third Schedule first but with a light touch, and to only use this if it may not have a clear benefit to improve one's health.
One stumbling block is that it can be difficult to assess the effectiveness of ethics regulations. As each individual is unique in his genetic makeup, a human may respond differently to a treatment compared to another human. Rather than impose more "one-size-fits-all" restrictive rules that act as bans on using particular technologies, I suggest using "context-specific" regulations.
For example, in this Third Schedule, implanting human neural cells into the brain of living great apes is strictly prohibited. However, if a living great ape research subject has responded favourably to a treatment mixture of human-synthetic nano-neural cells and if a scientist were to have strong evidence that it can help Parkinsons' but is prohibited to do so due to this Schedule, delays caused by bioethical regulations can lead to loss of life because potential treatments are withheld from patients.
Reproducibility. Many researchers are under a lot of pressure to produce results and to publish their findings in renowned journals as part of their key performance indicators (KPIs). They may try to alter results to make it for scientific journal publications but when other peer
Page: 113
researchers try to follow their protocol in their scientific papers, the results may vary by a lot.
In the worst-case scenario, this scientist may publish fraud findings and innocent patients may be misled that they have cancer. It has happened in the USA, in Duke University by a cancer researcher Dr Anil Potti who fabricated his data and misled his patients. This is a clear waste of taxpayers' money and a breach of one's ethical duties.
This Bill should address the harmful effects of wilful suppression of negative results and false declaration of results by scientists and list down the penalties as such. One suggestion is to require companies or researchers to post all raw data and results to the Government website, even if the treatment being tested is never approved or if they cannot make it for scientific publishing. This promotes more vigorous scrutiny from MOH should there be any wilful suppression.
When a lot of dollars, time and volunteers are potentially putting themselves in a risk situation, we need to be sure the results of that are finding their way into view of the public.
Dr Benedict Tan.
Dr Benedict Tan (Nominated Member) : Mdm Speaker, as there are many grey areas in research ethics, the Human Biomedical Research Bill is a necessary and timely one. As I am directly involved in medical research and I work for an RI, I declare my interest. Mdm Speaker, I seek just three clarifications.
Firstly, the First Schedule of the Bill specifies human biological materials that are excluded from the definition of human tissue, presumably because such materials are not individually identifiable or viable for cloning. One such material listed is "naturally excreted bodily fluids and waste products, such as saliva, sweat, urine and faeces". As it is possible to extract genomic DNA from some of these materials, such as the commercially available kits designed to extract DNA from saliva, may I seek the Ministry's rationale behind the list?
Secondly, a common research scenario is one where the validation of new diagnostic tests, using residual biological specimens collected as part of routine clinical care. These residual specimens would otherwise have been discarded. In such research, there is no additional risk to the patient, as he or she is not required to undergo further procedures or tests for the research. Most often, these samples are selected after the diagnosis has been made using the current gold-standard method. Hence, it would be challenging to
Page: 114
retroactively obtain consent from the patient as he or she may have been discharged, be uncontactable or may have passed away. Though it is possible to obtain informed consent for every potential new case who might be enrolled into the study, this requires additional resources to be dedicated to patients who may eventually not be enrolled into the study after their diagnoses have been made.
With reference to the Fifth Schedule, Part 2, para 3(a), on the Waiver of Requirement for Appropriate Consent for Human Biomedical Research Involving Human Biological Material for Health Information, may I ask if the Ministry would clarify if the above scenario, which is a common one, would qualify as a research that "may not practicably be carried out unless there is a waiver".
Finally, Part 2, clause 5 empowers the Minister to establish advisory committees for the purpose of advising the Minister on any matter arising out of the administration of the Bill. Would the Ministry be able to give an indication as to whether representatives of the growing private sector or commercial biomedical companies will be invited to sit on such committees? Mdm Speaker, I stand in support of the Bill.
PAPERCUTS