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p.000060:
p.000060: GLOSSARY
p.000060:
p.000060: GLOSSARY
p.000060:
p.000060:
p.000060: Alzheimer’s disease – A degenerative brain disorder common in the elderly, characterised by progressive deterioration
p.000060: of mental functions leading to impaired cognition and increased reliance on others for daily activities.
p.000060:
p.000060: Assisted reproductive (AR) technologies – The use of clinical and laboratory techniques to increase the chances of
p.000060: conceiving a baby. An example is in vitro fertilization, or IVF.
p.000060:
p.000060: Chimera – An organism whose body contains cells from another organism of the same or a different species.
p.000060:
p.000060: Cytoplasmic hybrid embryo – An embryo created by the transfer of the nucleus of a somatic cell from one species
p.000060: into an egg of another species from which the nucleus has been removed.
p.000060:
p.000060: Embryo – The earliest stage of development of an organism.
p.000060:
p.000060: Embryonic germ cell – An unspecified cell derived from primordial reproductive cells of developing foetuses
p.000060: that is able to replicate itself indefinitely and develop into all types of cells.
p.000060:
p.000060: Embryonic stem cell – An unspecialised cell derived from an embryo that is able to replicate itself indefinitely and
p.000060: develop into all types of cells.
p.000060:
p.000060: Foetus – The stage of development of an organism beyond the embryo and before birth, when tissues and organs have
p.000060: started to differentiate.
p.000060:
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000049: Fertilisation and Embryology (Mitochondrial Donation) Regulations31 in early 2015 to allow
p.000049: mitochondrial donation for prevention of serious mitochondrial diseases, with UK being the first country to
p.000049: do so.
p.000049:
p.000049: 6.6 In 2005 BAC Genetics Report, the Committee had recommended that the clinical practice of
p.000049: germline modification be prohibited, pending scientific evidence that techniques to prevent or eliminate
p.000049: serious genetic disorders have been proven effective. In light of recent international deliberations on
p.000049: germline modification techniques for the treatment of serious diseases, the BAC appointed a Germline
p.000049: Modification Working Group in October 2014 to review these developments and its current recommendations on the matter.
p.000049:
p.000049: 6.7 Information obtained from genetic research could be financially valuable. For example,
p.000049: research involving individuals who have genetic resistance to certain diseases, or whose genome might be found
p.000049: to contain genes relevant to understanding superior human athletic performance, could potentially be very valuable to
p.000049: researchers and institutions able to develop and commercially exploit such research findings. There is also
p.000049: much interest in pharmacogenomics, the aim of which is to create optimal drug treatments that are
p.000049: tailored to the genetic makeup of the patient, or a subset of patients, classified by (for example)
p.000049: ethnic group, in order to maximise
p.000049:
p.000049: 29 Nuffield Council on Bioethics, Novel Techniques for the Prevention of Mitochondrial DNA Disorders: an Ethical
p.000049: Review, June 2012.
p.000049: 30 The HFEA licenses and monitors all fertility clinics and research involving human embryos in the UK. Its
p.000049: report, Mitochondria Replacement Consultation: Advice to Government, was published in March 2013.
p.000049: 31 The National Archives, Human Fertilisation and Embryology (Mitochondrial Donation) Regulations, Available at:
p.000049: http://www.legislation.gov.uk/ukdsi/2015/9780111125816/contents.
p.000049:
p.000050: 50
p.000050:
p.000050: HUMAN GENETIC RESEARCH
p.000050:
p.000050: efficacy and minimise adverse effects. For this and other reasons, economic exploitation has been
p.000050: the subject of some controversy, and it is correspondingly important that all research participants be well
p.000050: aware of the implications.
p.000050:
p.000050: 6.8 Genetic information refers to any information about the genetic makeup of an individual. It can
p.000050: be derived from genetic testing in either a clinical or research setting, or from any other sources,
p.000050: including details of an individual’s family history of genetic diseases.
p.000050:
p.000050: 6.9 Genetic information is often seen as an exceptional kind of personal information. There are
p.000050: several reasons for this:
p.000050:
p.000050: (a) Genetic information is seen as a determining aspect of a person, yet many people are reluctant to
p.000050: countenance the role of genetic influences in considering human potential and conduct, lest it undermine the autonomy
p.000050: that we attribute to individuals;
...
p.000072: proven to be acceptably safe and effective, it would be ethical for families to use them, if they choose
p.000072: to, but a continuing debate on these issues is important. The Human Fertilisation & Embryology
p.000072: Authority (HFEA), which licenses and monitors all fertility clinics and research involving human embryos in the
p.000072: UK, will take a lead in continuing the debate by launching a public consultation in September 2012, and report
p.000072: its findings in Spring 2013. The clinical use of such techniques is currently prohibited in the UK. In its 2005
p.000072: Genetics Report, the BAC had similarly recommended that the clinical practice of germ-line modification be
p.000072: prohibited and its position remains, pending evidence from research that clinical procedures to prevent or
p.000072: eliminate serious genetic disorders has been proven effective.
p.000072: 6.5 Genetic research can also be viewed to be financially valuable, for example research involving individuals
p.000072: who have genetic resistance to certain diseases, or whose genome might be found to contain genes
p.000072: relevant to understanding superior human athletic performance, could potentially be very valuable to researchers and
p.000072: institutions able to develop and commercially exploit the research. Thus pharmacogenomics depends on the
p.000072: presumption that optimal drug treatments may be tailored to the genetic makeup of the patient, or a subset of
p.000072: patients, for example classified by ethnic group. For this and other reasons, economic exploitation has been the
p.000072: subject of some controversy, and it is correspondingly important that all parties to research be well aware
p.000072: of the implications.
p.000072: 6.6 Genetic information refers to any information about the genetic makeup of an individual. It can
p.000072: be derived from genetic testing in either a clinical or research setting, or from any other sources,
p.000072: including details of an individual’s family history of genetic diseases.
p.000072: 6.7 Genetic information is often seen as an exceptional kind of personal information. There are
p.000072: several reasons for this:
p.000072:
p.000072: 56 The report Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review was published
p.000072: in June 2012.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A43
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) Genetic information is seen as a determining aspect of a person, yet many people are reluctant to
p.000072: countenance the role of genetic influences in considering human potential and conduct, as well as when considering
p.000072: genetic diseases, lest it undermine the autonomy that we attribute to individuals;
p.000072: (b) Genetic information can be socially sensitive because it can convey information about others. Even though an
p.000072: individual genome is unique, it may also provide information about family members. This can be highly sensitive, since
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000060: of mental functions leading to impaired cognition and increased reliance on others for daily activities.
p.000060:
p.000060: Assisted reproductive (AR) technologies – The use of clinical and laboratory techniques to increase the chances of
p.000060: conceiving a baby. An example is in vitro fertilization, or IVF.
p.000060:
p.000060: Chimera – An organism whose body contains cells from another organism of the same or a different species.
p.000060:
p.000060: Cytoplasmic hybrid embryo – An embryo created by the transfer of the nucleus of a somatic cell from one species
p.000060: into an egg of another species from which the nucleus has been removed.
p.000060:
p.000060: Embryo – The earliest stage of development of an organism.
p.000060:
p.000060: Embryonic germ cell – An unspecified cell derived from primordial reproductive cells of developing foetuses
p.000060: that is able to replicate itself indefinitely and develop into all types of cells.
p.000060:
p.000060: Embryonic stem cell – An unspecialised cell derived from an embryo that is able to replicate itself indefinitely and
p.000060: develop into all types of cells.
p.000060:
p.000060: Foetus – The stage of development of an organism beyond the embryo and before birth, when tissues and organs have
p.000060: started to differentiate.
p.000060:
p.000060: Gamete – Sperm or egg.
p.000060:
p.000060: Genome – The complete set of genetic information in an organism.
p.000060:
p.000060: Huntington’s disease – A neurodegenerative genetic disorder that causes the progressive breakdown of nerve
p.000060: cells in the brain and impacts the individual’s movement, cognition and behaviour. The disease is caused by an
p.000060: autosomal dominant mutation.
p.000060:
p.000060: Hybrid – An organism whose cells contain genetic material from organisms of different species.
p.000060:
p.000060: In vitro fertilisation (IVF) – A clinical and laboratory procedure whereby the eggs and sperm from a couple are
p.000060: extracted and fertilised outside their bodies. Such a procedure is a form of assisted reproduction aimed at increasing
p.000060: the chances of a couple conceiving a baby.
p.000060:
p.000060: Induced pluripotent stem cell – An adult somatic cell, such as a human skin cell, that has been
p.000060: reprogrammed (or induced) into an embryonic pluripotent state.
p.000060:
p.000060: Institutional review board (IRB) – A committee appointed by an institution to review the ethical standards
p.000060: of biomedical research proposals.
p.000060:
p.000060:
p.000061: 61
p.000061:
p.000061: GLOSSARY
p.000061:
p.000061: Oocyte – An egg cell.
p.000061:
p.000061: Pluripotent – The ability to differentiate into cells of the three germ layers in the body, namely the
p.000061: ectoderm, mesoderm and endoderm.
p.000061:
p.000061: Reproductive cloning – Process of creating a genetically identical copy of a human being or animal.
p.000061:
...
Searching for indicator foetuses:
(return to top)
p.000004: collected (unless the re-consent requirement is waived by an IRB);
p.000004:
p.000004: (b) If the biological material was collected from a minor below 21 years of age, who did not at the time of collection
p.000004: possess decision-making capacity and therefore did not personally, or jointly together with his/her parent, consent to
p.000004: the donation. In the event that re-consent is not practicable, the IRB should generally have the discretion to waive
p.000004: the requirement in accordance with the relevant criteria for waiver of consent, where appropriate; or
p.000004:
p.000004: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000004: combinations.
p.000004:
p.000004: 31. Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000004: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000004: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000004: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000004: immediately before death.
p.000004:
p.000004: 32. For research using foetal tissues, consent for the termination of pregnancy should be separate from the
p.000004: consent for obtaining foetal tissue or any tissue related to the pregnancy for research. Where possible, an
p.000004: attending physician should not also seek consent for research participation from a patient in this situation. Consent
p.000004: for the use of foetal tissue for research could be obtained from either parent, as provided for in the Medical
p.000004: (Therapy, Education and Research) Act.
p.000004:
p.000004: 33. Specific and personal consent from the donors must be obtained before any gametes or embryos are to be
p.000004: used for research. Potential donors should be provided with sufficient information to make an informed decision
p.000004: and be given at least a week to decide.
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: EXECUTIVE SUMMARY
p.000005:
p.000005:
p.000005: 34. For women undergoing fertility treatment, consent for the donation of surplus oocytes or embryos for
p.000005: research should be separate from the consent for treatment. The treating physician should not also be the
...
p.000038:
p.000038: (d) Individual privacy and confidentiality of the personal information are assured.
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039: PERSONAL INFORMATION IN RESEARCH
p.000039:
p.000039: 4.20 Personal health information derived from research should not be disclosed or used for other purposes.
p.000039: Research information may not be definitive, and research participants are entitled to expect that their data will not
p.000039: be used for purposes other than those for which they have given consent. Thus, such information should not be disclosed
p.000039: to any third party, including employers or insurance companies.
p.000039:
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p.000040: 40
p.000040:
p.000040: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000040:
p.000040: V. BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000040:
p.000040:
p.000040: 5.1 Human biological materials are a valuable resource in biomedical research. These materials could be
p.000040: obtained from living or dead persons, or foetuses. It includes blood and other body fluids, solid body tissues and
p.000040: organs, gametes and embryos, as well as their derivatives. Even biological materials that have been stored for many
p.000040: years may be useful. The ethical issues concerning the use of human biological materials for research
p.000040: relate to the collection, storage, access, and use of these materials; and to the use of personal information
p.000040: generated from research using these materials. Such information may be of central importance to the research or
p.000040: merely incidental, may also have health implications for the donors of biological materials or their
p.000040: genetic relatives, and be of relevance to their employers or insurers.
p.000040:
p.000040: 5.2 Biological materials for research may be newly obtained specifically for the purpose of research or they
p.000040: may come from pre-existing stored specimens. They may be specifically requested for research or they may be
p.000040: surplus from a clinical procedure. They may also be identified or de-identified.
p.000040:
p.000040: 5.3 Human biological materials taken for clinical or research use may be stored in repositories
p.000040: called tissue banks. Tissue banks may be set up specifically for research, but many exist primarily for
p.000040: clinical use in transplantation. Clinical tissue repositories, which consist of samples that have been
p.000040: collected and used for clinical diagnosis, such as blood or tumours that have been surgically removed, are
p.000040: also potentially useful for research. Some repositories consist of accumulated and archived biological materials that
...
p.000043: obtained if research is to be conducted on the previously collected material or personal information related to the
p.000043: sample, or at the least notified of his or her right to withdraw the biological material from research or storage for
p.000043: research. In the event that re-consent is not practicable, the IRB should generally have the discretion to waive the
p.000043: requirement in accordance with the relevant criteria for waiver of consent, where appropriate; or
p.000043:
p.000043: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000043: combinations.
p.000043:
p.000043: 5.17 When any clinically significant findings are discovered in the process of research using human
p.000043: biological materials, researchers should ensure that donors of these materials are informed, if they have
p.000043: indicated their desire to know of such findings.
p.000043:
p.000043: 5.18 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000043: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000043: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000043: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000043: immediately before death, if there is no actual notice of contrary indications by the deceased person, or actual notice
p.000043: of opposition of another legally authorised person of the same or prior class.
p.000043:
p.000043: Foetal Tissues
p.000043:
p.000043: 5.19 Foetal tissues include membranes, amniotic fluid, placenta and umbilical cord. Foetal tissues for research
p.000043: should only be taken from dead or non-viable foetuses. Abortion should not be induced for the purpose of obtaining
p.000043: materials for research.
p.000043:
p.000043: 5.20 Consent for the termination of pregnancy should be separate from the consent for obtaining foetal
p.000043: tissue or any tissue related to the pregnancy for research. Where possible, an attending physician
p.000043: should not also seek consent for research participation from a patient in this situation.
p.000043:
p.000043: 5.21 Consent for the use of foetal tissue for research could be obtained from either parent, as provided in the
p.000043: Medical (Therapy, Education and Research) Act.
p.000043:
p.000043: 5.22 Any research intention to propagate foetal cells in vitro and/or to transplant these cells into a human
p.000043: recipient should be disclosed when consent is sought.
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000044:
p.000044: Human Gametes and Embryos
p.000044:
p.000044: 5.23 The creation of human embryos specifically for research can only be justified when there is strong
p.000044: scientific merit in and potential medical benefit from such research. The Human Cloning and Other Prohibited
p.000044: Practices Act prohibits the development of a human embryo created other than by fertilisation of human egg by human
...
p.000051: know.
p.000051:
p.000051: 6.14 In whole-genome research, participants should be provided with as much detailed information as
p.000051: possible that is specific to such research, during the consent taking process. They should be informed of the
p.000051: mechanisms for data security, and given an explanation on the nature of whole-genome research, highlighting the
p.000051: difficulty in guaranteeing their anonymity with complete certainty. As the dissemination of information in
p.000051: whole-genome research is likely to be rapid and wide, there will also be practical limitations on withdrawal from
p.000051: such research. Participants should be informed of these limitations and the implications of their withdrawal.
p.000051:
p.000051: 6.15 For clinical trials involving gene-based therapies, regulatory approval from HSA is required, in
p.000051: addition to ethics approval from an IRB.
p.000051:
p.000051:
p.000051:
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p.000052: 52
p.000052:
p.000052: HUMAN STEM CELL RESEARCH
p.000052:
p.000052: VII. HUMAN STEM CELL RESEARCH
p.000052:
p.000052:
p.000052: 7.1 Stem cells are undifferentiated cells that have the potential to develop into specialised cell types. They
p.000052: may be derived from early embryos (embryonic stem cells), the germ cells of foetuses (embryonic germ cells)
p.000052: or from the human body at a later developmental stage (somatic or adult stem cells).
p.000052:
p.000052: 7.2 Since the discovery in 2007 that human skin cells can be reprogrammed into an embryonic state,
p.000052: research in this area has progressed rapidly. Researchers have been studying the characteristics of these
p.000052: reprogrammed cells, called induced pluripotent stem cells, creating disease models to further understand the
p.000052: pathophysiology of specific diseases, as well as creating patient-specific stem cells and finding ways to transform
p.000052: these stem cells into desired cells, which could then be used for treatment. Researchers are also trying to find
p.000052: more efficient ways to convert somatic cells directly into lineage-specific stem/progenitor cells,
p.000052: bypassing the intermediate pluripotent stage.
p.000052:
p.000052: 7.3 Stem cell research can be classified into two major categories:
p.000052:
p.000052: (a) Basic research to understand physiological cellular processes and disease mechanisms; and
p.000052:
p.000052: (b) Research into new therapies, including pre-clinical and clinical trials involving stem cells or their
p.000052: derivatives.
p.000052: 7.4 The unique capacity of stem cells to develop into various specialised cell types makes them of potential
...
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p.000060: 60
p.000060:
p.000060: GLOSSARY
p.000060:
p.000060: GLOSSARY
p.000060:
p.000060:
p.000060: Alzheimer’s disease – A degenerative brain disorder common in the elderly, characterised by progressive deterioration
p.000060: of mental functions leading to impaired cognition and increased reliance on others for daily activities.
p.000060:
p.000060: Assisted reproductive (AR) technologies – The use of clinical and laboratory techniques to increase the chances of
p.000060: conceiving a baby. An example is in vitro fertilization, or IVF.
p.000060:
p.000060: Chimera – An organism whose body contains cells from another organism of the same or a different species.
p.000060:
p.000060: Cytoplasmic hybrid embryo – An embryo created by the transfer of the nucleus of a somatic cell from one species
p.000060: into an egg of another species from which the nucleus has been removed.
p.000060:
p.000060: Embryo – The earliest stage of development of an organism.
p.000060:
p.000060: Embryonic germ cell – An unspecified cell derived from primordial reproductive cells of developing foetuses
p.000060: that is able to replicate itself indefinitely and develop into all types of cells.
p.000060:
p.000060: Embryonic stem cell – An unspecialised cell derived from an embryo that is able to replicate itself indefinitely and
p.000060: develop into all types of cells.
p.000060:
p.000060: Foetus – The stage of development of an organism beyond the embryo and before birth, when tissues and organs have
p.000060: started to differentiate.
p.000060:
p.000060: Gamete – Sperm or egg.
p.000060:
p.000060: Genome – The complete set of genetic information in an organism.
p.000060:
p.000060: Huntington’s disease – A neurodegenerative genetic disorder that causes the progressive breakdown of nerve
p.000060: cells in the brain and impacts the individual’s movement, cognition and behaviour. The disease is caused by an
p.000060: autosomal dominant mutation.
p.000060:
p.000060: Hybrid – An organism whose cells contain genetic material from organisms of different species.
p.000060:
p.000060: In vitro fertilisation (IVF) – A clinical and laboratory procedure whereby the eggs and sperm from a couple are
p.000060: extracted and fertilised outside their bodies. Such a procedure is a form of assisted reproduction aimed at increasing
p.000060: the chances of a couple conceiving a baby.
p.000060:
p.000060: Induced pluripotent stem cell – An adult somatic cell, such as a human skin cell, that has been
p.000060: reprogrammed (or induced) into an embryonic pluripotent state.
p.000060:
p.000060: Institutional review board (IRB) – A committee appointed by an institution to review the ethical standards
p.000060: of biomedical research proposals.
p.000060:
...
p.000072:
p.000072: (d) Obtaining consent is not possible or practicable;
p.000072:
p.000072: (e) Individual privacy and confidentiality of the personal information are assured; and
p.000072:
p.000072: (f) In the event that clinically significant findings are discovered, affected individuals who
p.000072: have indicated their wish to know will be informed in a timely manner, if reasonably possible.
p.000072:
p.000072: 4.20 Personal health information obtained or used for research purposes should not be released for
p.000072: other purposes. Research information may not be definitive, and research participants are entitled to expect that their
p.000072: data will not be used for purposes other than those for which they have given consent. Thus such information should not
p.000072: be disclosed to any third party, including employers or insurance companies.
p.000072:
p.000072:
p.000072:
p.000072:
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p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A33
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: V. HUMAN TISSUE RESEARCH AND BIOBANKING
p.000072:
p.000072: 5.1 The term “human tissue” refers to any kind of human biological material from living or dead individuals. It
p.000072: includes blood and other body fluids and their derivatives, as well as solid body tissues, organs, foetuses, gametes
p.000072: and embryos, and is a valuable resource for biomedical research. Even tissue that has been stored for many years may be
p.000072: useful. The ethical issues concerning the use of human tissue for research relate to the collection, storage,
p.000072: access, and actual usage of the tissue (the purpose of the research); and to the use of information generated
p.000072: from research. Such information, may be central to the research or incidental, and may also have health implications
p.000072: for tissue donors or for their genetic relatives, and relevance for their employers or insurers.
p.000072: 5.2 Tissues for research may be newly obtained specifically for the purpose of research or they may come from
p.000072: pre-existing stored specimens. They may be specifically requested for research or they may be surplus
p.000072: tissue, consequent to a clinical procedure. They may also be identified or de-identified.
p.000072: 5.3 Human tissue banks are repositories, where human biospecimens taken for clinical or research use are stored.
p.000072: Tissue banks can be set up specifically for research, but many tissue banks exist primarily for clinical
p.000072: use in transplantation. Clinical tissue repositories, which consist of samples, such as blood or a
p.000072: tumour that has been surgically removed, that have been collected and used for clinical diagnosis, are also
p.000072: potentially useful for research. Some such repositories consist of accumulated and archived biospecimens that
p.000072: may have been acquired over a period of many years and can be described as legacy tissues.
...
p.000072: (b) If the tissue was collected when the individual was a child, such that consent from a parent or
p.000072: guardian was required, and there is ongoing contact. Once the child attains the age of 21, his or her consent should be
p.000072: obtained if research is to
p.000072:
p.000072:
p.000072: A36
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: be conducted on the previously collected tissue or information related to this tissue specimen. In the event
p.000072: re-contact is not practicable, the IRB should have the discretion to determine whether or not the stored material or
p.000072: information can be used without re-consent; and
p.000072: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000072: combinations.
p.000072:
p.000072: 5.17 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000072: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000072: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000072: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000072: immediately before death, if there are no actual notice of contrary indications by the deceased person, or actual
p.000072: notice of opposition of another legally authorised person of the same or prior class.
p.000072: Foetal Tissues
p.000072:
p.000072: 5.18 Foetal tissues include membranes, amniotic fluid, placenta and umbilical cord. Foetal tissues for research
p.000072: should only be taken from dead or non-viable foetuses. Abortion should not be induced for the purpose of obtaining
p.000072: material for research.
p.000072: 5.19 Consent for the termination of pregnancy should be separate from the consent for obtaining foetal
p.000072: tissue or any tissue related to the pregnancy for research. Provisions for ensuring that where possible an attending
p.000072: physician should not also seek consent for research participation from a patient apply mutatis mutandis in this
p.000072: situation.
p.000072: 5.20 Consent for the use of foetal tissue for research could be obtained from either parent, as indicated in the
p.000072: Medical (Therapy, Education and Research) Act.
p.000072: 5.21 Any intention to propagate foetal cells in vitro and/or to transplant these cells into a human recipient
p.000072: should be disclosed when consent is sought.
p.000072: Human Gametes and Embryos
p.000072:
p.000072: 5.22 The creation of human embryos specifically for research can only be justified when there is strong
p.000072: scientific merit and potential medical benefit from such research. Under the Human Cloning and Other Prohibited
p.000072: Practices Act, the development of a human embryo created other than by fertilisation of human egg by human sperm, for a
p.000072: period of more than 14 days, excluding any period when the development of the embryo is suspended, is
...
p.000072: 6.12 In whole-genome research, participants should be provided with as much detailed information as
p.000072: possible that is specific to such research, during the consent process. They should be provided with information on
p.000072: mechanisms for data security, and an explanation on the nature of whole-genome research, with its
p.000072: difficulty in guaranteeing their anonymity with complete certainty. As the dissemination of information in
p.000072: whole-genome research is likely to be rapid and wide, there will be practical limitations on withdrawal from
p.000072: research. Participants should be informed of these limitations and the implications of their withdrawal.
p.000072:
p.000072: 6.13 Approval from MOH is required for research involving germ-line modification. Such research is only allowed
p.000072: for purposes of preventing or treating serious genetic conditions.
p.000072:
p.000072: 6.14 For clinical trials involving gene-based therapies, approval from HSA is required.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A45
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: VII. HUMAN STEM CELL RESEARCH
p.000072:
p.000072: 7.1 Stem cells are unspecialised cells that have the potential to develop into specialised cell types. They may
p.000072: be derived from early embryos (embryonic stem cells), or from the germ cells of foetuses (embryonic germ cells) or from
p.000072: the human body at a later developmental stage (somatic or adult stem cells).
p.000072: 7.2 Since the discovery in 2007 that human skin cells can be reprogrammed into an embryonic state,
p.000072: research in this area has progressed rapidly. Researchers have been studying the characteristics of the
p.000072: reprogrammed cells, called induced pluripotent stem cells, creating disease models to further understand
p.000072: the pathophysiology of specific diseases, as well as creating patient-specific stem cells and finding ways to
p.000072: transform these stem cells into desired cells, which could be used for treatment. Researchers are also
p.000072: trying to find more efficient ways to convert somatic cells directly into lineage-specific
p.000072: stem/progenitor cells, bypassing the intermediate pluripotent stage.
p.000072: 7.3 Stem cell research can be classified into two major categories:
p.000072:
p.000072: (a) Basic research into the understanding of physiological cellular processes and disease mechanisms; and
p.000072:
p.000072: (b) Research into new therapies, including pre-clinical and clinical trials involving stem cells or their
p.000072: derivatives.
p.000072:
p.000072: 7.4 The unique capacity of stem cells to develop into various specialised cell types makes them of potential
p.000072: use for the regeneration or reconstruction of diseased or injured tissue. Stem cell research may thus lead to
...
Social / Incarcerated
Searching for indicator restricted:
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p.000048: biological materials and associated biodata. These allow detailed long-term genetic studies to take place.
p.000048: Technological advances have also led to an increase in pre-clinical and clinical trials of gene-based therapies in
p.000048: recent years. Gene transfer in combination with stem cell therapy is also being studied in more detail. In
p.000048: addition, whole human genome sequencing can now be done in a relatively short period and at a lower cost. All these
p.000048: advances, together with advances in information technology, have resulted in new ethical challenges in the
p.000048: conduct and governance of genetic research.
p.000048:
p.000048: 6.3 Whole-genome research is likely to continue to advance and intensify. It involves the collection of
p.000048: biological materials, genome sequencing, data analysis, and, possibly, the use of the biological materials and
p.000048: data for future research projects that may not be contemplated when the materials are taken. In addition, the
p.000048: data may also be submitted to easily accessible scientific databases in order to facilitate research. Thus, the
p.000048: implications of whole genome studies and the use of very large data sets of potentially or actually
p.000048: identifiable genetic information raise ethical concerns. Research using these data sets is often
p.000048: international and is facilitated by increasing acceptance of the concept of open access. Moreover, very extensive
p.000048: analysis can be performed by cross-referencing genomic data with demographic or other information. The possibility of
p.000048: inadvertent identification is thus higher than it would be with more restricted data and more limited analysis.
p.000048: Specifically, therefore:
p.000048:
p.000048: (a) Research participants may also need to be informed if and why whole-genome studies make it harder to guarantee
p.000048: their anonymity with complete certainty;
p.000048:
p.000048: (b) Researchers may discover new patterns or relationships, and may feel there is considerable potential for
p.000048: detecting findings that may be suggestive or prove clinically significant in future. It should be made clear in
p.000048: advance as to when the obligation of the researcher to a research participant or tissue donor ceases in
p.000048: relation an incidental finding made during the conduct of research; and
p.000048:
p.000048: (c) The potential commercial value of large-scale genomic studies makes issues of research integrity and data
p.000048: ownership especially important.
p.000048:
p.000048: 6.4 Genetic interventions also raise ethical and moral issues, with germline genetic modification being
p.000048: the most contentious. Any intervention that alters the germline of
p.000048:
p.000049: 49
p.000049:
p.000049: HUMAN GENETIC RESEARCH
p.000049:
p.000049: an individual will lead to a change in the genetic makeup of that individual’s descendants. At present,
p.000049: there is insufficient knowledge of the potential long-term consequences of such interventions, as they are still
p.000049: in the experimental stage. Many countries, such as Australia, Canada, and Finland therefore have laws that
p.000049: prohibit germline modification.
p.000049:
p.000049: 6.5 With the emergence of assisted reproductive techniques to prevent the transmission of mitochondrial disease,
p.000049: such as ooplasmic transfer, pronuclear transfer and maternal spindle transfer, the Nuffield Council on
...
p.000072: susceptibility of diseases, with numerous biobanks set up all over the world, to store biospecimens and associated
p.000072: biodata. These allow detailed long-term genetic studies to take place. Technological advances have led to an increase
p.000072: in pre-clinical and clinical trials of gene-based therapies in recent years. Gene transfer in combination with
p.000072: stem cell therapy is also being studied in more detail. In addition, whole human genome sequencing can now be
p.000072: done in a relatively short period and at a lower cost. All these advances, together with advances in
p.000072: information technology, have resulted in new ethical challenges in the conduct and governance of genetic
p.000072: research.
p.000072: 6.3 Whole-genome research is likely to continue to advance and intensify. It involves the collection of
p.000072: biospecimens, genome sequencing, data analysis, and, possibly, the use of the biospecimens and data for future research
p.000072: projects that may not be known when the biospecimens are taken. In addition, the data may also be submitted
p.000072: to easily accessible scientific databases, to facilitate research. Thus, the implications for whole genome studies
p.000072: and the use of very large data sets of potentially or actually identifiable genetic information raise
p.000072: ethical concerns. Research using these data sets is often international and is facilitated by a research culture of
p.000072: relatively open access. Moreover, very extensive analysis can be performed by cross-referencing genomic data
p.000072: with demographic or other information. The possibility of inadvertent identification is thus higher
p.000072: than it would be with more restricted data and more limited analysis. Specifically, therefore:
p.000072: (a) Participants may need to be informed if and why whole-genome studies make it harder to guarantee their
p.000072: anonymity with complete certainty;
p.000072: (b) Researchers may discover new patterns or relationships, and may feel there is considerable potential for
p.000072: detecting findings that may be suggestive or prove clinically significant in future. Parties should be clear in
p.000072: advance as to when the obligation of the researcher ceases; and
p.000072: (c) The potential commercial value of large-scale genomic studies makes issues of research integrity and data
p.000072: ownership especially important.
p.000072:
p.000072:
p.000072:
p.000072: A42
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 6.4 Genetic interventions also raise ethical and moral issues, with germ-line genetic modification
p.000072: being the most contentious. Any intervention that alters the germ-line of an individual will lead to a change in
p.000072: the genetic makeup of that individual’s descendants. At present, there is insufficient knowledge of the
p.000072: potential long-term consequences of such interventions, as they are still in the experimental stage. Many countries,
p.000072: such as Australia, Canada, and Finland have laws that prohibit germline modification. With emerging
p.000072: assisted reproductive techniques such as ooplasmic transfer, pronuclear transfer and maternal spindle transfer, to
p.000072: prevent the transmission of mitochondrial disease, the Nuffield Council on Bioethics conducted a public
p.000072: consultation early this year. The Council recently published a report, which explores the ethical issues concerning
...
Social / Infant
Searching for indicator infant:
(return to top)
p.000067: Opinion No. 16/2009. March 2009.
p.000067:
p.000067:
p.000068: 68
p.000068:
p.000068: BIBLIOGRAPHY
p.000068:
p.000068: Uganda. Uganda National Council for Science and Technology. National Guidelines for Research Involving Humans
p.000068: as Research Participants. March 2007.
p.000068:
p.000068: United Kingdom. Access to Health Records Act. 1990.
p.000068:
p.000068: United Kingdom. Association of the British Pharmaceutical Industry. Guidelines for Phase 1 Clinical Trials. 2007.
p.000068:
p.000068: United Kingdom. Data Protection Act. 1998.
p.000068:
p.000068: United Kingdom. Department of Health, Royal College of General Practitioners, British Medical Association.
p.000068: The Good Practice Guidelines for GP electronic patient records. 2011.
p.000068:
p.000068: United Kingdom. Department of Health. Innovative Genetic Treatment to Prevent Mitochondrial Disease
p.000068: (Press Release). 28 June 2013.
p.000068:
p.000068: United Kingdom. England and Wales Court of Appeal (Civil Division): Jonathan Yearworth & Ors v North Bristol NHS Trust
p.000068: [2009] 3 Weekly Law Reports 118, 4 February 2009.
p.000068:
p.000068: United Kingdom. General Medical Council. Confidentiality. 12 October 2009.
p.000068:
p.000068: United Kingdom. General Medical Council. Good Practice in Research and Consent to Research. April 2010.
p.000068:
p.000068: United Kingdom. House of Lords: S (An Infant, by her Guardian ad Litem the Official Solicitor) v. S
p.000068: [1972] Appeal Cases 24, 23 July 1970.
p.000068:
p.000068: United Kingdom. Human Fertilisation and Embryology Act. 2008.
p.000068:
p.000068: United Kingdom. Human Fertilisation and Embryology Authority. Mitochondria Replacement
p.000068: Consultation: Advice to Government. March 2013.
p.000068:
p.000068: United Kingdom. Human Fertilisation and Embryology Authority. Third Scientific Review of the Safety and Efficacy of
p.000068: Methods to Avoid Mitochondrial Disease through Assisted Conception: 2014 Update. June 2014.
p.000068:
p.000068: United Kingdom. Human Fertilisation and Embryology (Mitochondrial Donation) Regulations. 2015.
p.000068: United Kingdom. Human Genetics Commission. Inside Information: Balancing Interests in the Use of Personal Genetic Data.
p.000068: 2002.
p.000068:
p.000068: United Kingdom. Human Tissue Act. 2004.
p.000068:
p.000068: United Kingdom. Human Tissue Authority. Code of Practice 9: Research. September 2009.
p.000068:
p.000068: United Kingdom. Medical Research Council. Ethics Guide: Medical Research Involving Adults who Cannot Consent.
p.000068: 2007.
p.000068:
p.000068: United Kingdom. Medical Research Council. Ethics Guide: Medical Research Involving Children. 2004.
p.000068:
p.000069: 69
p.000069:
p.000069: BIBLIOGRAPHY
p.000069:
...
Social / Laboratory Staff
Searching for indicator research staff:
(return to top)
p.000063: participants. The Chairperson or other IRB delegate(s) may be empowered to conduct expedited reviews or grant
p.000063: exemptions.
p.000063:
p.000063: 5. Minimal risk refers to an anticipated level of harm and discomfort that is no greater than that ordinarily
p.000063: encountered in daily life, or during the performance of routine educational, physical, or psychological
p.000063: tasks.
p.000063:
p.000063: 6. In multi-centre research, a lead IRB could be designated that plays the main role in conducting a full
p.000063: ethics review. Multi-national research should be subject to review by the IRB of the local partner institution(s).
p.000063:
p.000063: 7. Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000063: carried out in their premises or facilities; or by their employees or
p.000063:
p.000001: 1
p.000001:
p.000001: EXECUTIVE SUMMARY
p.000001:
p.000001:
p.000001: on their patients; or involving access to or use of human biological materials, medical records or other personal
p.000001: information in their custody. They are also responsible for ensuring research integrity.
p.000001:
p.000001: 8. Every institution that conducts human biomedical research, or allows such research to be carried out in
p.000001: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000001: research staff have access to an IRB at another institution. Should a research proposal be rejected by an
p.000001: IRB, an appeal mechanism should be available in which a second committee must be able to exercise independent
p.000001: judgement.
p.000001:
p.000001: 9. The responsibilities of the researchers include ensuring that their research is
p.000001: conducted with integrity and complies with all relevant laws and other regulatory obligations and
p.000001: requirements; submitting annual (or more frequent) progress reports as required by the IRBs; reports of adverse events
p.000001: arising from the research should be submitted to the IRBs within 15 days of their occurrence, while serious adverse
p.000001: events should be reported immediately; not altering or modifying in any way any drug or other clinical
p.000001: regimen without the IRB’s and attending physician’s approval; and ensuring that participants are informed
p.000001: of clinically significant findings that are discovered in the process of research, if they have indicated
p.000001: their desire to know these.
p.000001:
p.000001: III. Consent
p.000001:
p.000001: 10. Consent for participation in research must be voluntary. There should be no coercion, deception or undue
p.000001: influence. Participants may be reimbursed for legitimate expenses. Any other payment, whether monetary or
...
p.000021: and may have an impact on their research. The IRB shall then decide on the appropriate steps to manage the conflict.
p.000021:
p.000021: 2.35 Threats to research integrity could arise when there is a conflict of interest between those who commission
p.000021: and fund research (including commercial organisations) and those who carry it out (the researchers).
p.000021: Routine checks and balances ensuring the integrity of the research process have been developed in
p.000021: universities and other research institutions with a commitment to research. When research is recruited to the service
p.000021: of commercial or institutional interests, researchers may be in a difficult position if their results are
p.000021: inconsistent with the expectations or hopes of their funders. IRBs need to consider how best to avoid such threats to
p.000021: integrity when considering applications in which they might arise.
p.000021:
p.000021: Responsibilities of Institutions
p.000021:
p.000021: 2.36 Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000021: carried out in their premises or facilities; or by their employees or on their patients; or involving access to or use
p.000021: of human biological materials, medical records or other personal information in their custody. They are also
p.000021: responsible for ensuring research integrity.
p.000021:
p.000021: 2.37 Every institution that conducts human biomedical research, or allows such research to be carried out in
p.000021: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000021: research staff have access to an IRB at another institution.
p.000021:
p.000021: 2.38 Institutions should set up clear policies for the operation of their IRBs. The
p.000021: composition of IRBs and specific operational details are provided for in the MOH Operational Guidelines for
p.000021: Institutional Review Boards.12
p.000021:
p.000021: 2.39 Institutions should ensure that there is an arrangement for receiving feedback from research
p.000021: participants.
p.000021:
p.000021:
p.000021: 12 MOH, Operational Guidelines for Institutional Review Boards. 2007.
p.000021:
p.000022: 22
p.000022:
p.000022: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000022:
p.000022: 2.40 It is the responsibility of institutions to provide adequate resources, including resources for the
p.000022: training and education of IRB members, and administrative support for the IRBs to discharge their responsibilities in
p.000022: an effective and timely manner.
p.000022:
p.000022: 2.41 Institutions should ensure that provisions are made to treat and compensate research participants for the
p.000022: adverse consequences resulting directly from their participation, where appropriate.
p.000022:
p.000022: 2.42 An institution must accept legal responsibility for the decisions of its IRB and must provide the IRB members
p.000022: with a full indemnity for actions resulting from decisions made by those members in good faith in the course of
p.000022: discharging their duties.
p.000022:
p.000022: 2.43 In view of the investment of time and effort in preparing for research, including the sourcing of funds, it
...
p.000072: manage the conflict.
p.000072:
p.000072: 2.38 Threats to research integrity could arise when there is a conflict of interest between those who commission
p.000072: and fund research (including commercial organisations) and those who carry it out (the researchers).
p.000072: Routine checks and balances ensuring the integrity of the research process have developed in universities
p.000072: and other research institutions with a commitment to research. When research is recruited to the service of
p.000072: commercial or institutional interests, researchers may be in a difficult position if their results are inconsistent
p.000072: with the expectations or hopes of their source of funds. IRBs need to consider how best to avoid such threats to
p.000072: integrity when considering applications in which they might arise.
p.000072:
p.000072: Responsibilities of Institutions
p.000072:
p.000072: 2.39 Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000072: carried out on their premises or facilities; or by their employees or on their patients; or involving access to or use
p.000072: of human tissue collections, medical records or other personal information in their custody. They are also responsible
p.000072: for ensuring research integrity.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A16
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 2.40 Every institution that conducts human biomedical research, or allows such research to be carried out on
p.000072: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000072: research staff have access to an IRB at another institution.
p.000072:
p.000072: 2.41 The institution should set up clear policies for the operation of IRBs. The composition of IRBs and
p.000072: specific operational details are provided in the MOH Operational Guidelines for Institutional Review Boards.47
p.000072:
p.000072: 2.42 It is the responsibility of institutions to provide adequate resources, including resources for the
p.000072: training and education of IRB members, and administrative support for the IRBs to discharge their responsibilities in
p.000072: an effective and timely manner.
p.000072:
p.000072: 2.43 Institutions should ensure that provisions are made to compensate or treat research participants
p.000072: for adverse consequences of their participation, where appropriate.
p.000072:
p.000072: 2.44 An institution must accept legal responsibility for the decisions of its IRB and must provide the IRB members
p.000072: with full indemnity against actions resulting from decisions made by those members in good faith in the course of their
p.000072: duties.
p.000072:
p.000072: 2.45 In view of the investment of time and effort in preparing for research, including the sourcing of funds, it
p.000072: would be proper for there to be in place some kind of mediation or appeals procedure, so that in the event that a
p.000072: research proposal is not approved by an IRB, the Principal Investigator has an opportunity to further justify the
p.000072: research, or if disagreement persists, to have available an appeal mechanism in which adjudication by some third party
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000024: good for them. An IRB should evaluate the provisions for obtaining consent whenever it considers a research
p.000024: proposal entailing work with human participants, the use of human biological materials or identifiable
p.000024: personal information.
p.000024:
p.000024: 3.2 There is a distinction between the legal and ethical obligations relating to consent. There are
p.000024: various situations where the law requires consent to be obtained, and where a research procedure done without consent
p.000024: could be subsequently challenged in court. Legal requirements thus constrain what can or cannot be enforced concerning
p.000024: ethical obligations in obtaining an individual’s consent. However, these Guidelines refer to consent issues as a
p.000024: matter of ethics – what ought to be done in obtaining informed consent – and are to be understood as presuming
p.000024: compliance with the law as it stands.
p.000024:
p.000024: Voluntary and Informed Consent
p.000024:
p.000024: 3.3 Consent must be voluntary and informed. Informed consent is not merely providing information, but
p.000024: requires that the person consenting does so with adequate understanding. The language, occasion and
p.000024: manner of explanation, the level of detail offered, and the process by which the consent is taken, should all be aimed
p.000024: at helping the potential research participant understand what consent is being asked for.
p.000024:
p.000024: 3.4 Obtaining the consent of prospective participants entails providing sufficient relevant information and
p.000024: explaining it in ways that allow them to make an informed decision with an appropriate level of
p.000024: understanding. The requirements vary somewhat depending on the nature of the research, such as whether
p.000024: the research involves biological materials or genetic information, and the likelihood of
p.000024: discovering clinically significant findings either directly or incidentally to the research. The consent
p.000024: process will also depend on the vulnerability of the participant. Anything in the nature of the research which
p.000024: the participant may find morally or culturally sensitive should entail some corresponding sensitivity in
p.000024: obtaining consent.
p.000024:
p.000024: 3.5 Therefore, valid consent should require that:
p.000024:
p.000024: (a) Research participants understand what is proposed, the nature of any entailed risks and benefits
...
p.000029: infants, children and young people: an update for researchers and research ethics committees” Arch Dis
p.000029: Child 2014 Oct; 99(10): 887-91.
p.000029:
p.000030: 30
p.000030:
p.000030: CONSENT
p.000030:
p.000030: the research risks involved are significantly greater than minimal, it would be prudent to assess capacity on an
p.000030: individual basis before enrolment.
p.000030:
p.000030: Engagement
p.000030:
p.000030: 3.26 For minors who lack sufficient decision-making capacity, it is still important to engage them as
p.000030: far as their intellectual abilities permit. This may involve, for example, explaining the nature of the
p.000030: research procedures and dealing with the minor’s concerns. Engagement serves to minimise the potential risks
p.000030: associated with participation, such as any distress experienced while undergoing research
p.000030: procedures.20 In every instance, including the obtaining of consent, IRBs and researchers should
p.000030: ensure that such engagement or explanation should be communicated effectively with age
p.000030: appropriate language and methods, and appropriately documented.
p.000030:
p.000030: Summary
p.000030:
p.000030: 3.27 The BAC is thus of the view that for research involving minors with decision-making capacity, consent from
p.000030: both the minor and a parent should be obtained; such a minor’s refusal of consent should be respected. Apart from this,
p.000030: it is still important to engage the minor in ways that respect his or her current level of understanding.
p.000030: Parents or guardians of minors lacking decision-making capacity are authorised to consent to their
p.000030: participation in research that involves no more than minimal risk and is not contrary to their best
p.000030: interests.
p.000030:
p.000030: Waiver of Parental Consent
p.000030:
p.000030: 3.28 For research that does not involve more than minimal risk, such as surveys seeking information relating only
p.000030: to the minor, the BAC is of the view that IRBs should be able to waive parental consent for minors who have
...
p.000072: the use of biospecimens or identifiable personal information.
p.000072:
p.000072: 3.2 There is a distinction between the legal and ethical obligations arising on matters of consent. There are
p.000072: various situations where the law requires consent to be obtained, and where a procedure done without consent
p.000072: could be challenged in court. Legal requirements thus constrain what can or cannot be enforced concerning
p.000072: ethical obligations on consent. For instance, short of recommending a change in the law, it would not be possible to
p.000072: recommend waiving consent in any situation where the law sets some standard of consent. However, these
p.000072: Guidelines refer to ethical consent issues – what ought to be done in obtaining informed consent – and
p.000072: are to be understood as presuming observance of the law as it stands.
p.000072:
p.000072: Voluntary and Informed Consent
p.000072:
p.000072: 3.3 Consent must be voluntary and informed.48 Informed consent is not a matter of merely providing information,
p.000072: but requires that the person giving consent does so with adequate understanding. The language, occasion and
p.000072: manner of explanation, the level of detail offered, and the process by which the consent is taken, should all be aimed
p.000072: at helping the potential research participant to understand what consent is being asked for.
p.000072:
p.000072: 3.4 Consent taking entails providing sufficient relevant information and explaining it to prospective
p.000072: participants in ways that allow them to make an informed decision at an appropriate level of understanding. The
p.000072: requirements vary somewhat depending upon the nature of the research; whether involving tissue or genetic information;
p.000072: whether or not there may be clinically significant findings either directly or incidentally to the research;
p.000072: and also on the vulnerability or ability of the participant. Anything in the nature of the research which the
p.000072: participant may find sensitive should entail some corresponding sensitivity in taking consent.
p.000072:
p.000072: 3.5 Therefore, valid consent should require that:
p.000072:
p.000072:
p.000072: 48 Consent in law has to be consent with understanding to be valid, so the term “informed consent” is
...
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p.000025: it is important that these positions are revisited, to ensure their relevance given scientific, regulatory and legal
p.000025: developments. This will facilitate in ensuring that human biomedical research in Singapore continues to be
p.000025: conducted in accordance with ethical standards that are recognised internationally. Ethical pronouncements on
p.000025: what is considered sensitive or unacceptable may change with time as a result of research and technological
p.000025: advances, or in accordance with social or cultural developments. Regular reviews are therefore important to
p.000025: remain in touch with the public’s sentiments and concerns, to ensure that there is adequate regulation for
p.000025: the protection of research participants, and not unduly impede potentially beneficial research. The BAC plays a
p.000025: crucial role in maintaining public trust so that biomedical sciences may flourish in Singapore.
p.000025:
p.000025: Judge (ret.) Richard Magnus and his committee members have done a commendable job in producing such a comprehensive
p.000025: ethical guidance document for all who are involved in human biomedical research in Singapore. They have
p.000025: thoroughly reviewed the BAC’s past recommendations, re-engaged the research community and public on pertinent
p.000025: issues arising from areas such as stem cell research and genetic research, and compiled the relevant
p.000025: recommendations into a single, concise volume. I am confident that the standards and recommendations
p.000025: advocated in the Guidelines will enhance the responsible and ethical conduct of human biomedical research in
p.000025: Singapore.
p.000025:
p.000025:
p.000025: Professor Lim Pin Emeritus Advisor
p.000025: Bioethics Advisory Committee June 2015
p.000025:
p.000025:
p.000025:
p.000025: PREFACE
p.000025:
p.000025:
p.000025: As the BAC celebrates its 15th anniversary this year, we have reviewed the recommendations that the committee has made
p.000025: in the seven reports issued since its inception in 2000. The BAC was set up with the aim of protecting the rights and
p.000025: welfare of individuals, while allowing the development of biomedical sciences for the benefit of mankind, and this
p.000025: continues to be the impetus guiding the BAC in its work.
p.000025:
p.000025: In accordance with our mandate, the BAC has examined a wide range of topics, including human stem cell research,
p.000025: reproductive and therapeutic cloning, human tissue research, human genetics research, personal
p.000025: information, egg donation, and human-animal combinations – with an overarching focus on the area of human
p.000025: biomedical research. Given the extensive subject matter that the BAC has covered over more than a decade, we decided to
p.000025: consolidate our past recommendations into a single volume. We hope that the Ethics Guidelines for Human
p.000025: Biomedical Research will be an accessible resource for researchers and members of ethics committees, or any
p.000025: interested individual who is seeking guidance on the best practices for the ethical conduct of human biomedical
p.000025: research in Singapore.
p.000025:
p.000025: During the course of preparing the Guidelines, we also took the opportunity to reflect on the BAC’s past
p.000025: recommendations, review our positions where appropriate after taking into account new scientific, regulatory
p.000025: and legal developments. This was done to ensure that we are up-to-date with both local practices and
p.000025: international best standards. We sought to reconcile any apparent discrepancies, and to clarify any uncertainties
p.000025: that have emerged since publication of our original reports. This resulting document therefore contains the
p.000025: most current views of the BAC, advocating the standards expected of researchers and research institutions
p.000025: in Singapore, and setting out a framework for the ethics review of human biomedical research. Furthermore,
p.000025: in the course of our review, we have also deliberated on recent emerging issues, such as incidental findings and whole
p.000025: genome sequencing, and have incorporated new ethical guidance on these issues into the Guidelines.
p.000025:
p.000025: The Guidelines was an ambitious project, and is the result of countless hours of deliberation and conversations. I
p.000025: would like to express my heartfelt gratitude to my dedicated committee members, and our distinguished panel of
...
p.000008:
p.000008: (g) The Human-Animal Combinations Report. Human-Animal Combinations in Stem Cell Research (2010).
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: INTRODUCTION
p.000009:
p.000009: What is Human Biomedical Research?
p.000009:
p.000009: 1.6 Biomedical research is important because it is a basic prerequisite for evidence-based medicine. Research,
p.000009: in this context, means “a systematic investigation, including research development, testing and evaluation,
p.000009: designed to develop or contribute to generalisable knowledge.”1 Although the observations and clinical
p.000009: experiences of medical practitioners and others have been vital in the history of medicine, the systematic
p.000009: scientific foundations are also essential. While good medical practice entails far more than the mechanical
p.000009: application of science, good biomedical research is fundamental to its success, and is a safeguard against
p.000009: unsubstantiated or harmful claims. Biomedical research in general is thus regarded by the BAC as a public good.
p.000009:
p.000009: 1.7 Biomedical research has been defined as research having as its purpose the enhancement
p.000009: or improvement of medical practice.2 This extends the scope of biomedical research beyond research
p.000009: that is clinical, and it could include research that does not use human participants at all. Much fundamental research
p.000009: in physiology and other disciplines has the goals of medicine as its ultimate aim. In a similar way, the goal of much
p.000009: bioengineering research is ultimately medical, though this is not true of the foundational disciplines in engineering.
p.000009: For these reasons, it is difficult to provide a single definition that covers all obvious examples of research
p.000009: that have a clearly medical goal, while not becoming over-inclusive with respect to basic research that might
p.000009: ultimately be important for medicine but is not done with the primary aim of furthering its goals.
p.000009:
p.000009: 1.8 The BAC therefore adopts the following definition of human biomedical research:
p.000009:
p.000009: Human Biomedical Research refers to any research done for the ultimate purpose of studying, diagnosing, treating
p.000009: or preventing, any disease, injury, disorder, or condition of the human mind or body, and which entails the
p.000009: involvement of humans, human biological materials or information derived from humans or human biological materials.
p.000009: Also included is research on human physiological processes.
p.000009:
p.000009: 1.9 The BAC takes the view that human biomedical research usually needs to be regulated because one
p.000009: or more of the following conditions will inevitably apply to any proposed human biomedical research:
p.000009:
p.000009: (a) The research involves intervention with respect to, interaction with, or observation of one
p.000009: or more human participants;
p.000009:
p.000009: (b) The research will use or manipulate human biological materials (e.g. human cells, tissues, organs and
p.000009: body fluids);
p.000009:
p.000009: (c) The research entails the systematic review, analysis, use or publication of previously compiled
p.000009: identifiable (identified or reversibly de-identified) medical or personal information or biodata;
p.000009:
p.000009:
p.000009: 1 Office for Human Research Protections, 45 Code of Federal Regulations 46.102(d).
...
p.000072: the BAC frequently receives enquiries about such matters, together with occasional requests for it to intervene or
p.000072: comment on issues.
p.000072: What is Human Biomedical Research?
p.000072:
p.000072: 1.7 Biomedical research is important because it is a basic prerequisite for evidence-based medicine. Research,
p.000072: in this context, means “a systematic investigation, including research development, testing and evaluation,
p.000072: designed to develop or contribute to generalisable knowledge.”36 Although the observations and clinical
p.000072: experiences of medical practitioners and others have been vital in the history of medicine, the systematic
p.000072: scientific foundations are also essential. While good medical practice entails far more than the mechanical
p.000072: application of science, good biomedical research is fundamental to its success, and is a safeguard against
p.000072: unsubstantiated or harmful claims. Biomedical research in general is thus regarded by the BAC as a public good.
p.000072: 1.8 Biomedical research has been defined as research having as its purpose the enhancement
p.000072: or improvement of medical practice.37 This extends the scope of biomedical research beyond research that is
p.000072: clinical, and it could include research that does not use human subjects at all. Much fundamental research in
p.000072: physiology and other disciplines has the eventual goals of medicine as its ultimate aim. In a similar way, the goal
p.000072: of much bioengineering is ultimately medical, though this is not true of the foundation disciplines in engineering. For
p.000072: such reasons it is difficult to provide a single definition that covers all obvious examples of research that
p.000072: have a clearly medical goal, while not becoming over-inclusive with respect to basic research that might ultimately
p.000072: be important for medicine but is not done with the aim of furthering its goals.
p.000072:
p.000072: 1.9 The BAC therefore adopts the following definition of human biomedical research:
p.000072:
p.000072: Human Biomedical Research refers to any research done for the ultimate purpose of studying, diagnosing, treating or
p.000072: preventing, any disease, injury or disorder of the human mind or body, and which entails the involvement of
p.000072: humans, human tissues or information derived from humans or human tissues.
p.000072:
p.000072: 1.10 The BAC takes the view that human biomedical research normally needs to be regulated because one
p.000072: or more of the following conditions will inevitably apply to any proposed human biomedical research:
p.000072:
p.000072:
p.000072: 36 US Department of Health and Human Services, 45 CFR 46.102(d).
p.000072: 37 Levine, RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al. (Eds.) The Oxford
p.000072: textbook of clinical research ethics. Oxford: OUP (2008), page 211.
p.000072:
p.000072:
p.000072:
p.000072: A3
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) The research involves intervention with respect to, interaction with, or observation of one
p.000072: or more human participants; or
p.000072: (b) The research will use or manipulate human biological materials (e.g. human cells, tissues, organs
...
p.000072: attitudes and practices of both patients and "normal" healthy individuals. In addition, clinical research requires
p.000072: "normal" subjects as a comparison group; etiological research using cohort studies starts with recruiting
p.000072: healthy subjects. A simple definition would encompass all research that involve human subjects/tissues/information
p.000072: with the aim of disease treatment, prevention and health promotion. I would like to propose that the following sentence
p.000072: be added the existing definition:
p.000072:
p.000072: "…..derived from humans or human tissues. Research on normal subjects and populations is also included in this
p.000072: definition."
p.000072:
p.000072: 2. Paras 4.7, 4.14
p.000072:
p.000072: The proposed Personal Data Protection Bill recognises the role of "data intermediaries" or "Trusted Third
p.000072: Parties" (TTPs). TTPs are fairly common in many non-biomedical sectors but need to be "popularized" in the biomedical
p.000072: sectors. With an efficient and trustworthy TTP, data owners and research subjects can have greater confidence
p.000072: that their reversibly de- identified data are well protected. Propose adding a short para after 4.7:
p.000072:
p.000072: "The use of 'data intermediaries' in the form of a 'Trusted Third Party' should be encouraged especially when data
p.000072: are kept in a reversibly de-identified form. Record linkages via TTP provide greater confidence to data
p.000072: owners and research participants that their data are adequately protected. Ideally for Singapore, either a
p.000072: single or a few large TTPs with the ability to conduct audits on the storage and use of reversibly
p.000072: de-identified data."
p.000072:
p.000072: Happy to provide further clarifications if required. Best regards
p.000072: Professor Chia Kee Seng Dean, School of Public Health
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C15
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Comments from SingHealth Tissue Repository
p.000072:
p.000072: 13 August 2012
p.000072:
p.000072:
p.000072: Background
p.000072:
p.000072: a. Incidental research findings (IF) are not limited to the disease area under study. A researcher
p.000072: looking into biomarkers for cancer may find that a sample of blood from a supposedly healthy volunteer
p.000072: actually shows hyperglycaemia whilst another researcher studying genetic predisposition for diabetes may instead
p.000072: discover that a patient sample shows BRCA1 mutation, which carries a high risk of breast and ovarian cancers.
p.000072:
p.000072: b. High-throughput interrogation of alterations at the genomic level is now widely performed, using
p.000072: donated patient samples removed during surgery. These samples are banked in research tissue biobanks or repositories,
p.000072: of which the two largest collections reside in the NUHS Tissue Repository and the SingHealth Tissue Repository (STR).
p.000072:
p.000072: c. Tissue repositories ensure that samples are collected ethically and legally. Processed and annotated samples
p.000072: with de-identified patient information are then distributed to Principal Investigators (PIs) after approval by an
...
p.000072: this risk should be disclosed to other family members who may also be at risk of developing the same
p.000072: condition. The individual may be additionally burdened with considerations for the family members who may or may not be
p.000072: affected by the condition and their wish to know or not to know. Family members who are not affected by the
p.000072: genetic condition may nevertheless be affected psychologically (such as the condition of “survivor guilt”). In view
p.000072: of these considerations, we emphasise the importance of pre- and post-test genetic counselling.” (para 4.25, Genetic
p.000072: testing and genetic research, Singapore Bioethics Advisory Committee, Nov 2005, pg.30)
p.000072:
p.000072: C18
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: One implication of the need to return IF is that there will be a need for pre- and post-test genetic
p.000072: counselling and there are simply insufficient resources and trained genetic counsellors for that
p.000072: matter.
p.000072:
p.000072: 3.19 No consensus on what constitutes significant incidental findings. The range of possible genetic and
p.000072: biochemical alterations that may emerge from tissue-based research are legion. Yet, it is near impossible to
p.000072: define which are sufficiently significant and should trigger a return of IF. A genetic predisposition
p.000072: towards low sperm count may not be significant to an 80-year-old single male but may well be very significant to
p.000072: the scion of a wealthy family. Placing on the researcher/biobank the duty to decide which of the numerous genetic
p.000072: alterations (which will include not only mutations but polymorphisms) to report will pose far too onerous a liability
p.000072: and may stop all human genomic research in its tracks. For that matter, it is impossible to conduct any
p.000072: meaningful genetic counselling when the implications of the IF can range from bilateral ovarian cancers
p.000072: at the age of 40 to a polymorphism that may render one less likely to win a marathon race.
p.000072:
p.000072: Concluding remarks
p.000072:
p.000072: 4. Return of incidental research data is a hotly debated issue with many angles that need to be considered
p.000072: and for that reason, there is currently no consensus in the research community. Whilst I fully appreciate
p.000072: the arguments to return significant incidental findings, the implications may well sound the death knell for biobanks
p.000072: and human tissue research.
p.000072:
p.000072: 5. I take the position that, for the moment, the earlier BAC recommendations of Feb 2002 should
p.000072: stand. Research tissue samples should be acquired as donations or absolute gifts and the act of donation be separated
p.000072: from the research intention3. Patient donors should not expect any material benefits in making the gift for the
p.000072: advancement of knowledge and the benefit of humankind in general. Similarly, biobanks and researchers should
p.000072: not have an obligation to return research results, incidental or otherwise to patient donors.
p.000072:
p.000072:
...
p.000072: 'advertise' around and ask if their friends, families or spouses are willing to donate their time for research
p.000072: purposes. Many fear reprisals. Even when there was an assurance that it is not true, there were rumours that it could
p.000072: turn up in other ways such as a delay in promotion, or lower bonuses or getting marked down or denied opportunities
p.000072: later.
p.000072:
p.000072: In reality, it is quite difficult to even get independent third parties. Presently, many researchers
p.000072: already have difficulties to get people to be the controls for their research. To get independent third parties will be
p.000072: an additional obstacle. It is necessary but in reality, it will be hard to implement on the ground level.
p.000072:
p.000072: In addition, many researchers are not even familiar with the various Acts and ethical guidelines proposed
p.000072: by BAC. Especially for visiting investigators, genuine safety lapses may occur as they may not be well-versed in the
p.000072: guidelines. Unless they are forced to attend some courses in this area, it is likely that they may not know what the
p.000072: boundaries are until they are scrutinised by their IRBs or have infringed the guidelines.
p.000072:
p.000072: Having a one-stop centre may help solve this problem. This one-stop centre could oversee all the research
p.000072: institutions. This one-stop centre could help to disseminate information to researchers and research
p.000072: participants and form a bridge of understanding while at the same time, enforce the guidelines in the research. All
p.000072: guidelines or Acts will not achieve its full effect if there is no concerted effort to implement or enforce it through
p.000072: a single body.
p.000072:
p.000072: In addition, this one-stop centre could be the independent third parties. Many research participants are
p.000072: scattered all over and a researcher will usually have difficulty finding suitable candidates.
p.000072:
p.000072: For example, the CHIP trial in 2008- (http://www.chip.sg/) "CHloroquine for Influenza Prevention" - is a new
p.000072: drug trial in which chloroquine, a simple and well-known medicine, might prevent flu. It was advertised widely in the
p.000072: press which costs more than S$10K to have a coverage in Straits Times. This money could have been saved if there was a
p.000072: one-stop centre to help disseminate the information through their established network.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
...
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p.000025: research in public healthcare, tertiary and research institutions are reviewed, and there are ethics governance
p.000025: frameworks in place to ensure that research participants are properly protected.
p.000025:
p.000025: The BAC strives to make recommendations that are aligned with international best practices, but also sensitive to and
p.000025: applicable in our local context. As some of the recommendations that BAC had made were issued more than a decade ago,
p.000025: it is important that these positions are revisited, to ensure their relevance given scientific, regulatory and legal
p.000025: developments. This will facilitate in ensuring that human biomedical research in Singapore continues to be
p.000025: conducted in accordance with ethical standards that are recognised internationally. Ethical pronouncements on
p.000025: what is considered sensitive or unacceptable may change with time as a result of research and technological
p.000025: advances, or in accordance with social or cultural developments. Regular reviews are therefore important to
p.000025: remain in touch with the public’s sentiments and concerns, to ensure that there is adequate regulation for
p.000025: the protection of research participants, and not unduly impede potentially beneficial research. The BAC plays a
p.000025: crucial role in maintaining public trust so that biomedical sciences may flourish in Singapore.
p.000025:
p.000025: Judge (ret.) Richard Magnus and his committee members have done a commendable job in producing such a comprehensive
p.000025: ethical guidance document for all who are involved in human biomedical research in Singapore. They have
p.000025: thoroughly reviewed the BAC’s past recommendations, re-engaged the research community and public on pertinent
p.000025: issues arising from areas such as stem cell research and genetic research, and compiled the relevant
p.000025: recommendations into a single, concise volume. I am confident that the standards and recommendations
p.000025: advocated in the Guidelines will enhance the responsible and ethical conduct of human biomedical research in
p.000025: Singapore.
p.000025:
p.000025:
p.000025: Professor Lim Pin Emeritus Advisor
p.000025: Bioethics Advisory Committee June 2015
p.000025:
p.000025:
p.000025:
p.000025: PREFACE
p.000025:
p.000025:
p.000025: As the BAC celebrates its 15th anniversary this year, we have reviewed the recommendations that the committee has made
p.000025: in the seven reports issued since its inception in 2000. The BAC was set up with the aim of protecting the rights and
p.000025: welfare of individuals, while allowing the development of biomedical sciences for the benefit of mankind, and this
p.000025: continues to be the impetus guiding the BAC in its work.
p.000025:
p.000025: In accordance with our mandate, the BAC has examined a wide range of topics, including human stem cell research,
p.000025: reproductive and therapeutic cloning, human tissue research, human genetics research, personal
p.000025: information, egg donation, and human-animal combinations – with an overarching focus on the area of human
...
Social / Police Officer
Searching for indicator officer:
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p.000025: international experts, for their tireless commitment to the development of these Guidelines. I would also like to thank
p.000025: members of the research community and the general public, who participated in our public consultation sessions and
p.000025: provided us with valuable comments on the 2012 draft. Their thoughtful feedback spurred further debate, and
p.000025: helped us to refine our consideration of pertinent issues. While our views may not always be compatible, we are
p.000025: nevertheless grateful for all the inputs we have received.
p.000025:
p.000025:
p.000025: Judge (ret.) Richard Magnus Chairman
p.000025: Bioethics Advisory Committee June 2015
p.000025:
p.000025:
p.000025:
p.000025: BIOETHICS ADVISORY COMMITTEE (MARCH 2011 TO DECEMBER 2015)
p.000025:
p.000025: Emeritus Advisor
p.000025: Professor Lim Pin
p.000025: University Professor, National University of Singapore (NUS)
p.000025:
p.000025: Chairman
p.000025: Mr Richard Magnus
p.000025: Judge (ret.)
p.000025:
p.000025: Members
p.000025: Professor Alastair Campbell
p.000025: Director, Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, NUS
p.000025:
p.000025: Associate Professor Chin Jing Jih
p.000025: Senior Consultant Geriatrician, Department of Continuing and Community Care, Tan Tock Seng Hospital
p.000025:
p.000025: Professor Kon Oi Lian
p.000025: Head, Division of Medical Sciences, National Cancer Centre Singapore
p.000025:
p.000025: Mr Alfian Yasrif Bin Kuchit
p.000025: Deputy Director, Community Relations Muslim Matters, Ministry of Culture, Community and Youth
p.000025:
p.000025: Mr Charles Lim Aeng Cheng
p.000025: Parliamentary Counsel (Special Projects) and Chief Knowledge Officer, Attorney-General's Chambers
p.000025:
p.000025: Associate Professor Lim Tit Meng
p.000025: Chief Executive, Science Centre Singapore
p.000025:
p.000025: Professor Ng Soon Chye
p.000025: Director, O & G Partners Fertility Centre, Gleneagles Hospital; and Medical Director, Sincere IVF Center, Novena
p.000025: Specialist Center, Singapore
p.000025:
p.000025: Associate Professor Ngiam Tee Liang
p.000025: Associate Professorial Fellow, Department of Social Work, Faculty of Arts and Social Sciences, NUS
p.000025:
p.000025: Associate Professor Nuyen Anh Tuan (till March 2013)
p.000025: Associate Professor (ret.), Department of Philosophy, Faculty of Arts and Social Sciences, NUS
p.000025:
p.000025: Professor Kandiah Satkunanantham
p.000025: Senior Consultant, Division of Hip & Knee Surgery, University Orthopaedics, Hand and Reconstructive Microsurgery
p.000025: Cluster, National University Hospital
p.000025:
p.000025: Professor Patrick Tan Boon Ooi
p.000025: Duke-NUS Graduate Medical School; and Group Leader, Genome Institute of Singapore
p.000025:
p.000025: Dr Mary Anne Tsao (from March 2014)
p.000025: President & Director, Tsao Foundation
p.000025:
p.000025: Mr Gregory Vijayendran
p.000025: Equity Partner, Rajah & Tann LLP
p.000025:
p.000025:
p.000025: INTERNATIONAL PANEL OF EXPERTS
p.000025:
p.000025: Professor Martin Bobrow (till March 2014)
p.000025: Emeritus Fellow, University of Cambridge, United Kingdom
p.000025: Professor Peter Braude (from June 2014)
p.000025: Emeritus Professor of Obstetrics and Gynaecology, King’s College London
p.000025:
p.000025: Dr Christine Grady (from November 2014)
p.000025: Chief, Department of Bioethics, National Institutes of Health
p.000025:
p.000025: Professor Bartha Maria Knoppers (till March 2012)
...
p.000027:
p.000027: (d) Employees, junior collaborators, or students.
p.000027:
p.000027:
p.000027:
p.000027: 14 For example, the courts have permitted a simple paternity blood test for a child where this was not clearly
p.000027: against the interests of the child, notwithstanding there was no direct benefit to the child: S v S [1972] AC 24 (House
p.000027: of Lords). Nothing in the Mental Capacity Act (Chap 177A) expressly overrules the common law, except by necessary
p.000027: implication.
p.000027: 15 World Medical Association, Declaration of Helsinki (rev. 2013), article 28; Council for
p.000027: International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research
p.000027: Involving Human Subjects (2002), Articles 9 and 15.
p.000027:
p.000028: 28
p.000028:
p.000028: CONSENT
p.000028:
p.000028: 3.18 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000028: prospective participants reassured that they have nothing to fear in declining research participation or
p.000028: in contributing biological materials or personal information for research. Thus, consent from uniformed
p.000028: personnel, for example, should not be taken by a senior officer, and preferably not by uniformed personnel.
p.000028:
p.000028: 3.19 When it is not possible for consent to be taken by an independent third party, the IRB may give directions for
p.000028: the consent to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000028: sufficient safeguards to protect the welfare and interests of the participant.
p.000028:
p.000028: 3.20 A further issue of vulnerability arises in societies where social proxy arrangements are widespread, for
p.000028: example, where a village headman might be thought to have the authority to give consent on behalf of a
p.000028: village, or a husband on behalf of a wife. Not all societies treat their individual members as autonomous. This can
p.000028: become an issue if researchers based in Singapore seek to conduct research in places where social proxy
p.000028: arrangements are widespread. In such cases, while local customs are to be respected, they cannot supersede a
p.000028: requirement for individual consent.
p.000028:
p.000028: Consent for Research Involving Patients
p.000028:
p.000028: 3.21 It is important to note the differences between a patient’s consent for medical treatment and
...
p.000072: Consent from Vulnerable Persons not Lacking Capacity
p.000072:
p.000072: 3.16 Vulnerable adult research participants not only include those who are of diminished capacity, but also
p.000072: those whose autonomy might be prejudiced by being under the influence of, or the control of, or
p.000072: obligated to, third parties. Potentially vulnerable participants might include, but are not limited to:
p.000072:
p.000072: (a) Prisoners;
p.000072:
p.000072: (b) Serving uniformed personnel, especially junior ranks;
p.000072:
p.000072: (c) Patients, especially if the intending researcher is their attending physician; and
p.000072:
p.000072: (d) Employees, junior collaborators, or students.
p.000072:
p.000072: 3.17 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000072: prospective participants reassured that they have nothing to fear in declining research participation or
p.000072: in contributing tissue for research. Thus consent among uniformed personnel, for example, should not be taken by
p.000072: a senior officer, and preferably not by uniformed personnel at all.
p.000072:
p.000072: 3.18 When it is not possible for consent to be taken by an independent third party, the IRB may give directions for
p.000072: the consent to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000072: sufficient safeguards to protect the welfare and interests of the participant.
p.000072:
p.000072:
p.000072:
p.000072: A22
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 3.19 A further issue of vulnerability arises in societies where social proxy arrangements are widespread, for
p.000072: example, where a village headman might be felt to have authority to give consent on behalf of a village, or a husband
p.000072: on behalf of a wife. Not all societies treat their individual members as autonomous. This can become
p.000072: an issue if researchers based in Singapore seek to conduct research in places where social proxy arrangements are
p.000072: widespread. In such cases, while local customs are to be respected, they cannot supersede a requirement for individual
p.000072: consent.
p.000072:
p.000072: Consent from Patients
p.000072:
...
Social / Presence of Coercion
Searching for indicator coerced:
(return to top)
p.000014: Research (1979);
p.000014:
p.000014: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000014:
p.000014: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000014: Declaration on Bioethics and Human Rights (2005).
p.000014:
p.000014: General Ethical Principles that have Guided the BAC
p.000014:
p.000014: 2.3 A review of the five foundational documents above reveals that participants need to be protected and their
p.000014: autonomy in matters of research participation recognised. Although these documents do not agree on every
p.000014: particular matter, they appear to be in accord in their fundamentals. Based on these, the BAC has formulated
p.000014: the following five guiding principles reflecting their local application, first summarised in its Egg Donation Report.
p.000014:
p.000014: 5 The BAC used the term “subject” in its earlier reports, but more recently has used the term “participant”. The
p.000014: latter is preferred as it implicitly acknowledges that research participants choose to participate, and
p.000014: should not be merely the passive subjects of research.
p.000014:
p.000015: 15
p.000015:
p.000015: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000015:
p.000015: Respect for persons
p.000015:
p.000015: 2.4 Individuals are to be respected as human beings and treated accordingly. This includes respecting
p.000015: their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC
p.000015: refers to as autonomy.6 Their welfare and interests are to be protected, especially when their autonomy is
p.000015: impaired or lacking. This principle mandates the need for informed consent to participation in research,
p.000015: respect for privacy, safeguarding confidentiality, and minimising harm to research participants. It also
p.000015: requires a proper regard for religious and cultural diversity.
p.000015:
p.000015: 2.5 This principle integrates with many other aspects of life in societies that could be described
p.000015: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000015: Ideals of this democratic society include all citizens being equal under the law, or having rights to
p.000015: privacy in the management of their affairs, to the enjoyment of security and public health and safety,
p.000015: with rights over their own bodies, and many others. All of these, in the final analysis, come down to the principle
p.000015: that individuals should be accorded certain basic rights or entitlements arising from their existence in society.
...
p.000072:
p.000072: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000072: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000072: Declaration on Bioethics and Human Rights (2005).
p.000072:
p.000072: General Ethical Principles that have Guided the BAC
p.000072:
p.000072: 2.5 A review of the five foundation documents above reveals that participants need to be protected and their
p.000072: autonomy in matters of research participation recognised. Although these documents do not agree in
p.000072: every particular, they appear to be in accord in their fundamentals. Based on these, the BAC formulated
p.000072: five guiding principles reflecting their local application, first summarised in its Egg Donation Report. In
p.000072: particular, as enjoined by the UNESCO Declaration, the BAC expects researchers to be aware of and respect the
p.000072: cultural and religious diversity of Singapore society. The BAC also indicated that respect for individuals can be
p.000072: subordinate to the public interest in certain cases, as in some kinds of public health research.
p.000072: 2.6 The five principles the BAC endorses are as follows:
p.000072:
p.000072: Respect for persons
p.000072:
p.000072: 2.7 Individuals are to be respected as human beings and treated accordingly. This includes respecting
p.000072: their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC
p.000072: refers to as autonomy.41 Their welfare and interests are to be protected, especially when their autonomy is
p.000072: impaired or lacking. This principle mandates the need for informed consent to participation in research;
p.000072: respect for privacy; for safeguarding confidentiality; for protecting vulnerable participants; and it
p.000072: also requires a proper regard for religious and cultural diversity.
p.000072: 2.8 This principle integrates with many other aspects of life in societies that could be described
p.000072: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000072: Ideals such as all citizens being equal under the law, or having rights to privacy and the management of their
p.000072: affairs, to the enjoyment of security and public health and safety, with rights over their own bodies,
p.000072: and many others, all, in the last analysis, come down to the principle that individuals should be accorded certain
p.000072: basic rights or entitlements arising from their existence in society. These entitlements exist notwithstanding
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000002: participants should be allowed to decide whether or not to be informed of such findings, during the consent-taking
p.000002: process.
p.000002:
p.000002: 20. If a clinically significant finding is discovered, but the preference of the research participant
p.000002: for receiving such information is unknown, researchers should refer to their IRBs for advice on the
p.000002: appropriate handling of such information.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: EXECUTIVE SUMMARY
p.000003:
p.000003:
p.000003: IV. Personal Information in Research
p.000003:
p.000003: 21. All biomedical research involving personal information, whether identified or de- identified, should
p.000003: be reviewed by an IRB and approved, or granted an exemption from review, before it commences. IRBs should have
p.000003: the discretion to decide whether specific consent is required or general consent is sufficient for the particular
p.000003: project.
p.000003:
p.000003: 22. It is not practicable to give research participants a right to view, amend, delete or otherwise
p.000003: control data they have provided for research purposes. Information created through research should be managed in
p.000003: ways that respect the need to observe confidentiality and care in use. It should remain in the care of and for
p.000003: the use of the researcher, subject to ethics governance procedures, rather than being treated as the continued property
p.000003: of the research participant or ‘donor’.
p.000003:
p.000003: 23. Personal information used for research should be de-identified as early as possible, and stored
p.000003: and managed as de-identified information. The principle of proportionality applies, such that the level of care and
p.000003: urgency regarding de-identification and data protection should be consistent with the sensitivity of the data. IRBs
p.000003: should consider the suitability of the extent and means of the de-identification in proportion to the
p.000003: risk.
p.000003:
p.000003: 24. To maximise the value of data and biological materials collected in cohort or follow- up studies, where a
p.000003: large amount of data is collected for analysis, it should be managed as reversibly de-identified data.
p.000003: Under the Personal Data Protection Act 2012 (PDPA), an organisation that collects and de-identifies
p.000003: personal data for processing and storage is still considered to hold personal data if it retains the ability to
p.000003: re-identify the data. Thus, in the re-identification of reversibly de-identified data, the management of the key to
p.000003: any code or encryption can and generally should be separated from the management of the data.
p.000003:
p.000003: 25. Should an individual be identified inadvertently from de-identified information, the confidentiality
p.000003: and privacy rights of this individual should not be regarded as abrogated by such identification, and
p.000003: steps should be taken to reinstate and secure them.
p.000003:
...
p.000035: Thus identifiable information includes identified information and reversibly de-identified information.
p.000035:
p.000035: 4.3 Personal information used in research may be obtained through various sources, such as through interviewing
p.000035: or testing individuals, from the course of medical diagnosis or treatment, analysis of biological materials contributed
p.000035: for research, and registries or databases. Such data may be stored electronically or as physical records, and managed
p.000035: by healthcare or research institutions, or government or non-government registries. Data that are routinely
p.000035: collected or submitted to national registries may be immensely valuable for human biomedical research. To enhance its
p.000035: value, it may be necessary to link the records of individuals from multiple databases.
p.000035:
p.000035: 4.4 In research, information can be used in many unforeseen ways, and it is not practicable to give
p.000035: research participants a right to view, amend, delete or otherwise control data they have provided for research
p.000035: purposes. Moreover, the information may have been, in a sense, created by the researcher through his or her
p.000035: observation and interventions – for instance a measure of memory, or an assessment of genetic potential,
p.000035: which might otherwise have been unknown. Information created through research should be managed in ways that
p.000035: respect the need to observe confidentiality and care in use. It should remain in the care of and for the
p.000035: use of the researcher, subject to ethics governance procedures; rather than being treated as the
p.000035: continued property of the research participant or ‘donor’.
p.000035:
p.000035: 4.5 Research data, which may include personal information, should be retained for future use, re-analysis, or
p.000035: re-investigation in the light of fresh developments. Many journals also require that research data be made
p.000035: available to other researchers who wish to replicate and build upon a publication. Thus,
p.000035: destruction of research data is discouraged but the protection of participants’ privacy must be maintained.
p.000035:
p.000035: Protection of Personal Information
p.000035:
p.000035: 4.6 Protecting the privacy of research participants and the confidentiality of their personal information
p.000035: obtained or derived from research is based on the principle of respect for
p.000035:
p.000036: 36
p.000036:
p.000036: PERSONAL INFORMATION IN RESEARCH
p.000036:
p.000036: persons. Thus, personal information should be stored and managed in ways that provide proper security and
p.000036: confidentiality. While a researcher collecting data from consenting individuals will know their identities, such
p.000036: information should be stored and managed as de-identified information as soon as is practicable. The principle of
p.000036: proportionality applies, such that the level of care and urgency regarding de- identification and data
p.000036: protection should be consistent with the sensitivity of the data.
p.000036:
p.000036: 4.7 To maximise the value of data and biological materials collected in cohort or follow- up studies, where a
p.000036: large amount of data is collected for analysis, it should be managed as reversibly de-identified data.
...
p.000040: collected and used for clinical diagnosis, such as blood or tumours that have been surgically removed, are
p.000040: also potentially useful for research. Some repositories consist of accumulated and archived biological materials that
p.000040: have been acquired over a period of many years without specific or adequate donor consent for research use.
p.000040: These collections are referred to as legacy tissues.
p.000040:
p.000040: 5.4 Biobanks are collections of human biological materials that are linked to personal information,
p.000040: which may include medical information of individuals from whom the biological material originate. The individuals may
p.000040: or may not be identifiable by the biobank. Biobanks may be created for research purposes or be part of a
p.000040: clinical service, such as a health screening programme. As they consist of biological materials and data
p.000040: systematically collected from a large number of individuals, they are very valuable for research that may lead to a
p.000040: better understanding of diseases.
p.000040:
p.000040: 5.5 Many countries have created tissue banks and biobanks, some of which are national while others are
p.000040: institution-based. Several initiatives have also involved international collaborations. For such initiatives, all
p.000040: parties involved should agree to a common set of ethical guidelines and standards for the collection, storage, use and
p.000040: disposal of the biological materials collected.
p.000040:
p.000040: 5.6 It is still uncertain in Singapore whether a person, or a body corporate, can legally own human
p.000040: biological materials or whether the donor can have any property rights over his or her biological materials
p.000040: after it is contributed for research. However, there is gradual international legal recognition that individuals have
p.000040: at least some property
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000041:
p.000041: type rights of control in respect of their excised tissues.23 The question of ownership applies not only to the
p.000041: physical forms of human biological materials but also to their derivatives - whether in the form of data, discoveries
p.000041: or biological products. However, it is generally accepted that the human body or any of its parts, should not be used
p.000041: as a means for financial gain. The donation of biological materials for use in research should thus be
p.000041: considered as an altruistic gift. An altruistic donor does not have intellectual property rights in any
p.000041: commercially valuable development arising from the research, and donations should be made and accepted on that
p.000041: understanding. Also, tissue banks and biobanks have been referred to as custodians of the biological
p.000041: materials that they are responsible for.24 The ‘gift’ model for the altruistic donation of biological materials for
p.000041: research is also appropriate for the provision and management of research data, as this would allow it to be shared or
p.000041: re-analysed in other contexts or for other research purposes, subject to appropriate safeguards.
p.000041:
p.000041: 5.7 As the use of human biological material is critical for biomedical research, both the public and research
p.000041: participants should have confidence that the biological materials that they contribute are handled and used
p.000041: sensitively and responsibly. Researchers should always ensure that the collection and use of human biological
p.000041: materials will not compromise the safety, welfare and interests of donors, which should be of paramount
p.000041: consideration.
p.000041:
p.000041: Guidelines on Biobanking and Research Involving Human Biological Materials
p.000041:
p.000041: General
p.000041:
p.000041: 5.8 All research involving human biological materials, whether identified or de-identified, should be reviewed
p.000041: and approved by an IRB, or granted an exemption from review, before it commences.
p.000041:
p.000041: 5.9 It is essential to protect the privacy and confidentiality of donors of biological materials and
p.000041: their personal information, as well as personal information given by donors about others. All the
...
p.000072:
p.000072: 4.1 Personal information is any identifiable information about an individual, living or dead. It not
p.000072: only includes personal particulars, but also details of medical conditions, as well as information disclosed or derived
p.000072: in the process of healthcare management. In the research context, it will include any information collected, used or
p.000072: generated as part of the research process. Personal information varies widely in its sensitivity, as a function of use
p.000072: and context.
p.000072: 4.2 In research, information can be used in many unforeseen ways, and it is not practicable to give
p.000072: research participants a right to view, amend, delete or otherwise control data they have provided for research
p.000072: purposes. Moreover, the information may be such that it was in a sense created by the researcher, who by his or her
p.000072: procedures and interventions may have created the information – for instance a measure of memory, or an
p.000072: assessment of genetic potential – that might otherwise have been unknown. The ‘gift’ model for the
p.000072: altruistic donation of tissue for research might therefore be appropriate for the provision and management of
p.000072: research data, as this would allow it to be shared or re-analysed in other contexts or for other research
p.000072: purposes, subject to safeguards. Information created through research should be managed in ways that respect
p.000072: the need to observe confidentiality and care in use. It should remain in the care of and for the use of the
p.000072: researcher, subject to ethics governance procedures; rather than being treated as the continued property
p.000072: of the research participant or ‘donor’.
p.000072: 4.3 In particular, it is often valuable, and customary, to retain research data, which may include personal
p.000072: information, for future use, re-analysis, or re-investigation in the light of fresh developments. Many
p.000072: journals also require that research data be made available to other researchers who wish to replicate and
p.000072: build upon a publication. Thus destruction of research data is discouraged, but the protection of
p.000072: participant privacy must be maintained.
p.000072: 4.4 Personal information used in research may be obtained through various sources, such as through interviewing
p.000072: or testing individuals, information submitted to registries or databases, and information provided or obtained
p.000072: during the course of medical diagnosis or treatment. Such data may be stored as physical records, as in
p.000072: medical records, or stored electronically, and managed by healthcare institutions, research institutions, and
p.000072: government and non-government registries. Data that are routinely collected or submitted to registries,
p.000072: public and private agencies may be immensely valuable for biomedical research. To enhance its value, it may be
p.000072: necessary to link records of individuals from multiple databases.
p.000072: 4.5 Personal information in research may be identified or de-identified. Identified information
p.000072: is information where identifying particulars are included, such that the identity of the individual is
p.000072: known, for example, in a medical record. De-identified information is information whereby the identity of the
p.000072: individual is not known. If it is
p.000072:
p.000072:
...
p.000072: Tissue banks can be set up specifically for research, but many tissue banks exist primarily for clinical
p.000072: use in transplantation. Clinical tissue repositories, which consist of samples, such as blood or a
p.000072: tumour that has been surgically removed, that have been collected and used for clinical diagnosis, are also
p.000072: potentially useful for research. Some such repositories consist of accumulated and archived biospecimens that
p.000072: may have been acquired over a period of many years and can be described as legacy tissues.
p.000072: 5.4 Biobanks are collections of human biospecimens that are linked to personal information,
p.000072: which may include medical information of individuals from whom the specimens originate. The individuals may or may not
p.000072: be identifiable by the biobank. They may be created for research purposes or be part of a clinical service, such as a
p.000072: health screening programme. As they consist of biospecimens and data systematically collected from a large number of
p.000072: individuals, they are very valuable for research that may lead to better understanding of diseases.
p.000072: 5.5 Many countries, including Singapore, have created tissue banks and biobanks, some of which are national,
p.000072: while others are institution-based. Several initiatives have also involved international collaborations. For such
p.000072: initiatives, all parties involved should agree to a common set of ethical guidelines and standards for the collection,
p.000072: storage, use and disposal of the biospecimens collected.
p.000072: 5.6 It is unclear whether a person, or a body corporate, can legally own human tissue samples or
p.000072: whether an individual can have any property rights over his or her tissue after it is contributed for research. The
p.000072: question of ownership applies not only to the physical forms of human biological materials but also to their
p.000072: derivatives - whether in the form of data, discoveries or biological products. For this reason, the term
p.000072: of
p.000072:
p.000072:
p.000072: A34
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: custodianship has been used to refer to the relationship of tissue banks to the tissues they contain.53 However, it is
p.000072: generally accepted that the human body or any of its parts, should not be used as a means for financial gain. The
p.000072: donation of tissue for use in research should thus be considered as an altruistic gift. An altruistic donor does not
p.000072: retain rights in the donated tissue, or an intellectual property right in any commercially
p.000072: valuable development arising from the research, and donations should be made and accepted on that understanding.
p.000072: 5.7 As the use of human tissue is critical for biomedical research, both the public and research
p.000072: participants should have confidence that the biospecimens that they contribute are handled and used
p.000072: sensitively and responsibly. Researchers should always ensure that their collection and use of human tissue will
p.000072: not compromise the safety, welfare and interests of donors, which should be of paramount consideration.
p.000072: Guidelines on Human Tissue Research and Biobanking
p.000072:
p.000072: General
p.000072:
p.000072: 5.8 All research involving human tissue, whether identified or de-identified, should be reviewed by an
p.000072: IRB, and approved before it commences.
p.000072: 5.9 It is essential to protect the privacy of tissue donors and the confidentiality of their personal
p.000072: information, including personal information given by donors about individuals who are not themselves
p.000072: donors. All the requirements for the use of personal information in research in Part IV of these Guidelines will
p.000072: apply.
p.000072: 5.10 Donors should not be offered any financial incentives for their donation, although reasonable
p.000072: reimbursement of expenses incurred may be given.
p.000072: 5.11 Researchers and those managing tissue banks and biobanks need to be sensitive to religious and
...
p.000072: interest or the general public interest. I understand that this is already the view taken by some local IRBs.
p.000072:
p.000072: (3) In short, more detailed guidelines are necessary on such an important issue as waiver of parental consent, which
p.000072: the law considers as a first line of defence in protection of a child’s interests.
p.000072:
p.000072: Finally, I have written in some detail on these issues in the context of minors and biomedical research. I attach these
p.000072: articles if they have not already been referred to, and might be of some use to the BAC. The relevant portions in the
p.000072: Singapore Academy of Law Journal article are 44- 50.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C38
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: Comments from member of the public (2)
p.000072:
p.000072: 21 and 29 July 2012
p.000072:
p.000072:
p.000072: Summary of Main Revisions
p.000072:
p.000072: "The BAC recognises this importance and is of the view that research institutions have a responsibility
p.000072: to ensure that the requirements of research integrity are observed. The BAC has recommended that there be an appeal
p.000072: mechanism, to allow the Principal Investigator to make an appeal for reconsideration of their proposals if they
p.000072: are not approved by an IRB. Institutions would be responsible for ensuring that such a mechanism is in place."
p.000072:
p.000072: Question: Drawing along the same parallels, property agents in Singapore used to be unlicensed and if they
p.000072: misconduct themselves, it is up to the companies to decide their own disciplinary action. Sometimes, these companies
p.000072: mete out different standards of punishment such as dismissal, suspension or a written warning letter.
p.000072: In addition, the so-called 'disciplinary committee' usually consist of a more senior staff who will have the
p.000072: unfeterred sole decision to do what he/she prefers while the rest will usually be the silent majority.
p.000072:
p.000072: After several complaints from members of public, a new statutory board Council for Estate Agencies was set up to hear
p.000072: grievances and allow them to investigate complaints while at the same time, help be a bridge of communication
p.000072: and to increase public trust between consumers and property agents.
p.000072:
p.000072: They also help to standardise the system by having a demerit point systems for each property agent so that the process
p.000072: will be clear and transparent.
p.000072:
p.000072: IRBs in Singapore usually consist of members who have full time day jobs. Quite a lot of them may not have enough
p.000072: training or time to fully assess the merits of each projects.
p.000072:
p.000072: Research institutions are may not be truly capable of having a good IRB in place. Having a centralised IRB with full
p.000072: time staff with adequate training allows more transparency and accountability while at the same time, maps out
p.000072: the common similarities between researchers and research participants. Moreover, it disallows researchers and PIs from
p.000072: shopping around any research institution in Singapore.
p.000072:
p.000072: For example, HSA Singapore already regulates and enforces clinical trials in Singapore and metes out punitive action to
p.000072: manufacturers or importers of poorly made medical devices or harmful pharmaceuticals. In UK, HRA Health Research
p.000072: Authority was set up in 2011 Dec to look into this issue.
p.000072:
p.000072: HRA UK allows the blowing of whistle from research participants but at the same time, it helps gather patient advocacy
p.000072: groups as a one-stop service so that research institutions can forward to having a more cohesive adequately informed
p.000072: patient advocacy groups rather than having to hunt or source for research participants.
p.000072: May I know if there is a consideration along this line?
p.000072:
p.000072: C39
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: In your ethical guidelines that "3.17 In such cases, consent should be taken by independent third parties, whenever
p.000072: possible, and prospective participants reassured that they have nothing to fear in declining research
...
Social / Racial Minority
Searching for indicator minority:
(return to top)
p.000072: 15;341(3):198-203. What's the price of a research subject? Approaches to payment for research participation.) In this
p.000072: model, a research subject is paid a pre-determined stipend, in accordance with the duration of his participation in the
p.000072: study. This payment is submitted to the Ethical Review Board for approval, and provided to the subject at the time of
p.000072: informed consent for entry into a study. It should be noted that such payments are fixed, and not based on
p.000072: reimbursement of the subject’s expenses or loss of earnings. I seek clarification from the committee as to whether it
p.000072: is their intent to disallow such payments.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C13
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: I do feel the BAC’s position on this need to be clarified to researchers and IRBs. As to the question as to whether
p.000072: non‐patient volunteer research in general will suffer impact if ‘loss of time’ payments were discontinued, I think
p.000072: the answer is self-evident. One needs to be circumspect when using terms such as ‘vulnerable persons’ and
p.000072: ‘risky research’. It needs to be clear that the vast majority of healthy volunteer research subjects in our experience,
p.000072: are educated and with gainful employment. We have our own safeguards to prevent subjects from
p.000072: over‐volunteering in Lilly studies, and if the concern is around a small minority of the economically disadvantaged
p.000072: who may look upon these payments as a major source of income, then for further protection, I have
p.000072: proposed in the past that some form of central tracking of non‐patient research volunteers be administered by a
p.000072: coordinating body. Such a system already exists in the UK:
p.000072: .
p.000072:
p.000072: On the question of risk, it also needs to be clear to payment to volunteers are calculated mainly on
p.000072: the time spent on study, with degree of discomfort factored in if appropriate. There is no payment on the basis of
p.000072: ‘risk’ incurred. Further, any discussion of ‘risk’ is not complete without consideration of risk mitigation. In the
p.000072: phase 1 clinical protocols that are put forth to the IRB and HSA, a large measure of clinical monitoring is often in
p.000072: place. Also, not clinical pharmacology research is in novel therapeutics.
p.000072:
p.000072: Last, I am quite concerned that there was not more of an effort to engage with stakeholders on this discussion. I was
p.000072: only made aware of the proposed changes when I chanced upon it in a press report, and a couple of investigators in
p.000072: other institutions I spoke with who conduct healthy volunteer research, were not aware of these proposals at all. I
p.000072: would urge a nuanced approach to this matter from the BAC.
...
Searching for indicator race:
(return to top)
p.000015: refers to as autonomy.6 Their welfare and interests are to be protected, especially when their autonomy is
p.000015: impaired or lacking. This principle mandates the need for informed consent to participation in research,
p.000015: respect for privacy, safeguarding confidentiality, and minimising harm to research participants. It also
p.000015: requires a proper regard for religious and cultural diversity.
p.000015:
p.000015: 2.5 This principle integrates with many other aspects of life in societies that could be described
p.000015: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000015: Ideals of this democratic society include all citizens being equal under the law, or having rights to
p.000015: privacy in the management of their affairs, to the enjoyment of security and public health and safety,
p.000015: with rights over their own bodies, and many others. All of these, in the final analysis, come down to the principle
p.000015: that individuals should be accorded certain basic rights or entitlements arising from their existence in society.
p.000015: These entitlements exist notwithstanding individual differences in endowment of race, character, gender or talent,
p.000015: and without requirement that individuals justify them. However, an individual’s autonomy can be curtailed under certain
p.000015: circumstances, for the public good, such as when quarantined during disease epidemics.
p.000015:
p.000015: Solidarity
p.000015:
p.000015: 2.6 The BAC earlier advocated a principle of reciprocity between the individual and wider society, as
p.000015: a way to capture the well-established idea that there is some measure of mutual obligation that regulates the
p.000015: relationship between the two. However, the underlying principle is perhaps better expressed as solidarity. The
p.000015: essential principle is not one of individual exchange, but of a wider vision in which common interest is invoked as a
p.000015: reason for the subordination of individual interest to that of a group in specified circumstances. Solidarity
p.000015: reflects the importance of general altruism as a basis for participation in biomedical research.
p.000015:
p.000015: 2.7 In biomedical research, agreed social benefits – considered as a public good – carry an implication that, if
p.000015: accepted, they inherently reflect an in-principle willingness to consider participation in research of the kind
p.000015: yielding the accepted benefits. This means that there is a balance to be struck between the interests of the public
p.000015: and the rights of individual participants; and that incompatible and irreconcilable ethical perspectives
p.000015: should be resolved with some regard to public interest. The BAC is therefore of the view that that certain
...
p.000072: refers to as autonomy.41 Their welfare and interests are to be protected, especially when their autonomy is
p.000072: impaired or lacking. This principle mandates the need for informed consent to participation in research;
p.000072: respect for privacy; for safeguarding confidentiality; for protecting vulnerable participants; and it
p.000072: also requires a proper regard for religious and cultural diversity.
p.000072: 2.8 This principle integrates with many other aspects of life in societies that could be described
p.000072: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000072: Ideals such as all citizens being equal under the law, or having rights to privacy and the management of their
p.000072: affairs, to the enjoyment of security and public health and safety, with rights over their own bodies,
p.000072: and many others, all, in the last analysis, come down to the principle that individuals should be accorded certain
p.000072: basic rights or entitlements arising from their existence in society. These entitlements exist notwithstanding
p.000072: individual differences in endowment of race, character, gender or talent, and without requirement that individuals
p.000072: justify them. An individual’s autonomy can be curtailed under certain circumstances, such as when quarantined
p.000072: in disease epidemics.
p.000072:
p.000072:
p.000072:
p.000072: 41 NMEC similarly referred to autonomy as “the right of individuals to decide for themselves what
p.000072: is good for them.” Paragraph 2.3.1, Ethical Guidelines on Research Involving Human Subjects (1997).
p.000072:
p.000072:
p.000072:
p.000072: A9
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Solidarity
p.000072:
p.000072: 2.9 The BAC earlier advocated a principle of reciprocity between the individual and the wider society, as a way
p.000072: to capture the well-established idea that there is some measure of mutual obligation that regulates the relationship
p.000072: between the individual and society. In biomedical research where there is minimal risk of harm to
p.000072: participants, agreed social benefits – considered as a public good – carry an implication that, if accepted, they
p.000072: inherently reflect an in-principle willingness to consider participation in research of the kind yielding the
p.000072: accepted benefits. This means that there is a balance to be struck between the interests of the public and
p.000072: the rights of individual participants; and that incompatible and irreconcilable ethical perspectives should be
p.000072: resolved with some regard to the public interest.
...
p.000072: of these considerations, we emphasise the importance of pre- and post-test genetic counselling.” (para 4.25, Genetic
p.000072: testing and genetic research, Singapore Bioethics Advisory Committee, Nov 2005, pg.30)
p.000072:
p.000072: C18
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: One implication of the need to return IF is that there will be a need for pre- and post-test genetic
p.000072: counselling and there are simply insufficient resources and trained genetic counsellors for that
p.000072: matter.
p.000072:
p.000072: 3.19 No consensus on what constitutes significant incidental findings. The range of possible genetic and
p.000072: biochemical alterations that may emerge from tissue-based research are legion. Yet, it is near impossible to
p.000072: define which are sufficiently significant and should trigger a return of IF. A genetic predisposition
p.000072: towards low sperm count may not be significant to an 80-year-old single male but may well be very significant to
p.000072: the scion of a wealthy family. Placing on the researcher/biobank the duty to decide which of the numerous genetic
p.000072: alterations (which will include not only mutations but polymorphisms) to report will pose far too onerous a liability
p.000072: and may stop all human genomic research in its tracks. For that matter, it is impossible to conduct any
p.000072: meaningful genetic counselling when the implications of the IF can range from bilateral ovarian cancers
p.000072: at the age of 40 to a polymorphism that may render one less likely to win a marathon race.
p.000072:
p.000072: Concluding remarks
p.000072:
p.000072: 4. Return of incidental research data is a hotly debated issue with many angles that need to be considered
p.000072: and for that reason, there is currently no consensus in the research community. Whilst I fully appreciate
p.000072: the arguments to return significant incidental findings, the implications may well sound the death knell for biobanks
p.000072: and human tissue research.
p.000072:
p.000072: 5. I take the position that, for the moment, the earlier BAC recommendations of Feb 2002 should
p.000072: stand. Research tissue samples should be acquired as donations or absolute gifts and the act of donation be separated
p.000072: from the research intention3. Patient donors should not expect any material benefits in making the gift for the
p.000072: advancement of knowledge and the benefit of humankind in general. Similarly, biobanks and researchers should
p.000072: not have an obligation to return research results, incidental or otherwise to patient donors.
p.000072:
p.000072:
p.000072: A/Prof Tan Soo Yong
p.000072: Director, SingHealth Tissue Repository Singapore Health Services
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 3 “Another way of simplifying consent is to have a system in which consent is completely delinked from the research
p.000072: purpose. In this system, the donor makes an absolute gift of tissue to a specified tissue bank. But it is made clear to
p.000072: the donor that the consent to the gift is not to be linked to or conditional upon any particular approved research use
...
Social / Religion
Searching for indicator faith:
(return to top)
p.000021: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000021: research staff have access to an IRB at another institution.
p.000021:
p.000021: 2.38 Institutions should set up clear policies for the operation of their IRBs. The
p.000021: composition of IRBs and specific operational details are provided for in the MOH Operational Guidelines for
p.000021: Institutional Review Boards.12
p.000021:
p.000021: 2.39 Institutions should ensure that there is an arrangement for receiving feedback from research
p.000021: participants.
p.000021:
p.000021:
p.000021: 12 MOH, Operational Guidelines for Institutional Review Boards. 2007.
p.000021:
p.000022: 22
p.000022:
p.000022: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000022:
p.000022: 2.40 It is the responsibility of institutions to provide adequate resources, including resources for the
p.000022: training and education of IRB members, and administrative support for the IRBs to discharge their responsibilities in
p.000022: an effective and timely manner.
p.000022:
p.000022: 2.41 Institutions should ensure that provisions are made to treat and compensate research participants for the
p.000022: adverse consequences resulting directly from their participation, where appropriate.
p.000022:
p.000022: 2.42 An institution must accept legal responsibility for the decisions of its IRB and must provide the IRB members
p.000022: with a full indemnity for actions resulting from decisions made by those members in good faith in the course of
p.000022: discharging their duties.
p.000022:
p.000022: 2.43 In view of the investment of time and effort in preparing for research, including the sourcing of funds, it
p.000022: would be proper to have some kind of re-evaluation or appeal procedure in the event that a research proposal
p.000022: is not approved by an IRB. The principal investigator should then have an opportunity to further justify the
p.000022: research, or if disagreement persists, to make available an appeal mechanism in which adjudication by a
p.000022: third party is possible. Institutions are responsible for ensuring that such a mechanism is put in place.
p.000022: Appeals should be considered by another committee, whose members should not include any member of the IRB that
p.000022: initially reviewed the proposal. This committee must be able to exercise independent judgement,
p.000022: free from bias or a conflict of interests.
p.000022:
p.000022: Responsibilities of IRBs
p.000022:
p.000022: 2.44 The functions of an IRB include the following:
p.000022:
p.000022: (a) The ethics review and approval of proposed human biomedical research projects;
p.000022:
p.000022: (b) Ensuring that research proposals have been scientifically evaluated and have scientific merit, as it
p.000022: would be unethical to subject human participants to any risk or research that is so poorly designed that it
p.000022: could not yield generalisable knowledge. The IRB is not expected to undertake such scientific review itself;
p.000022:
...
p.000072: of human tissue collections, medical records or other personal information in their custody. They are also responsible
p.000072: for ensuring research integrity.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A16
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 2.40 Every institution that conducts human biomedical research, or allows such research to be carried out on
p.000072: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000072: research staff have access to an IRB at another institution.
p.000072:
p.000072: 2.41 The institution should set up clear policies for the operation of IRBs. The composition of IRBs and
p.000072: specific operational details are provided in the MOH Operational Guidelines for Institutional Review Boards.47
p.000072:
p.000072: 2.42 It is the responsibility of institutions to provide adequate resources, including resources for the
p.000072: training and education of IRB members, and administrative support for the IRBs to discharge their responsibilities in
p.000072: an effective and timely manner.
p.000072:
p.000072: 2.43 Institutions should ensure that provisions are made to compensate or treat research participants
p.000072: for adverse consequences of their participation, where appropriate.
p.000072:
p.000072: 2.44 An institution must accept legal responsibility for the decisions of its IRB and must provide the IRB members
p.000072: with full indemnity against actions resulting from decisions made by those members in good faith in the course of their
p.000072: duties.
p.000072:
p.000072: 2.45 In view of the investment of time and effort in preparing for research, including the sourcing of funds, it
p.000072: would be proper for there to be in place some kind of mediation or appeals procedure, so that in the event that a
p.000072: research proposal is not approved by an IRB, the Principal Investigator has an opportunity to further justify the
p.000072: research, or if disagreement persists, to have available an appeal mechanism in which adjudication by some third party
p.000072: is possible. Institutions are responsible for ensuring that such a mechanism is in place.
p.000072:
p.000072: Responsibilities of IRBs
p.000072:
p.000072: 2.46 The functions of an IRB include the following:
p.000072:
p.000072: (a) The ethics review and approval of proposed human biomedical research projects;
p.000072:
p.000072: (b) Ensuring that research proposals have been scientifically evaluated and have scientific merit. The IRB
p.000072: is not expected to undertake the review itself, but has to be satisfied that it has been competently done;
p.000072:
p.000072: (c) Evaluating the provisions for the consent process to ensure that valid consent that is appropriate
p.000072: for the study to be undertaken is obtained;
p.000072:
p.000072: (d) The continuing review and oversight of the research projects approved by them;
p.000072:
p.000072: 47 Ministry of Health, Singapore, Operational Guidelines for Institutional Review Boards. 2007.
p.000072:
p.000072:
p.000072:
p.000072: A17
p.000072:
p.000072: ANNEX A
p.000072:
...
Searching for indicator religious:
(return to top)
p.000014: particular matter, they appear to be in accord in their fundamentals. Based on these, the BAC has formulated
p.000014: the following five guiding principles reflecting their local application, first summarised in its Egg Donation Report.
p.000014:
p.000014: 5 The BAC used the term “subject” in its earlier reports, but more recently has used the term “participant”. The
p.000014: latter is preferred as it implicitly acknowledges that research participants choose to participate, and
p.000014: should not be merely the passive subjects of research.
p.000014:
p.000015: 15
p.000015:
p.000015: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000015:
p.000015: Respect for persons
p.000015:
p.000015: 2.4 Individuals are to be respected as human beings and treated accordingly. This includes respecting
p.000015: their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC
p.000015: refers to as autonomy.6 Their welfare and interests are to be protected, especially when their autonomy is
p.000015: impaired or lacking. This principle mandates the need for informed consent to participation in research,
p.000015: respect for privacy, safeguarding confidentiality, and minimising harm to research participants. It also
p.000015: requires a proper regard for religious and cultural diversity.
p.000015:
p.000015: 2.5 This principle integrates with many other aspects of life in societies that could be described
p.000015: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000015: Ideals of this democratic society include all citizens being equal under the law, or having rights to
p.000015: privacy in the management of their affairs, to the enjoyment of security and public health and safety,
p.000015: with rights over their own bodies, and many others. All of these, in the final analysis, come down to the principle
p.000015: that individuals should be accorded certain basic rights or entitlements arising from their existence in society.
p.000015: These entitlements exist notwithstanding individual differences in endowment of race, character, gender or talent,
p.000015: and without requirement that individuals justify them. However, an individual’s autonomy can be curtailed under certain
p.000015: circumstances, for the public good, such as when quarantined during disease epidemics.
p.000015:
p.000015: Solidarity
p.000015:
p.000015: 2.6 The BAC earlier advocated a principle of reciprocity between the individual and wider society, as
p.000015: a way to capture the well-established idea that there is some measure of mutual obligation that regulates the
p.000015: relationship between the two. However, the underlying principle is perhaps better expressed as solidarity. The
p.000015: essential principle is not one of individual exchange, but of a wider vision in which common interest is invoked as a
...
p.000041: re-analysed in other contexts or for other research purposes, subject to appropriate safeguards.
p.000041:
p.000041: 5.7 As the use of human biological material is critical for biomedical research, both the public and research
p.000041: participants should have confidence that the biological materials that they contribute are handled and used
p.000041: sensitively and responsibly. Researchers should always ensure that the collection and use of human biological
p.000041: materials will not compromise the safety, welfare and interests of donors, which should be of paramount
p.000041: consideration.
p.000041:
p.000041: Guidelines on Biobanking and Research Involving Human Biological Materials
p.000041:
p.000041: General
p.000041:
p.000041: 5.8 All research involving human biological materials, whether identified or de-identified, should be reviewed
p.000041: and approved by an IRB, or granted an exemption from review, before it commences.
p.000041:
p.000041: 5.9 It is essential to protect the privacy and confidentiality of donors of biological materials and
p.000041: their personal information, as well as personal information given by donors about others. All the
p.000041: requirements for the use of personal information in research in Part IV of these Guidelines should be observed.
p.000041:
p.000041: 5.10 Donors of biological materials should not be offered any financial incentives for their donation, although
p.000041: reasonable reimbursement of expenses incurred may be given.
p.000041:
p.000041: 5.11 Researchers and those managing tissue banks and biobanks need to be sensitive to religious and
p.000041: cultural perspectives and traditions relating to human tissue. These vary considerably amongst various religions and
p.000041: cultures, especially when whole cadavers or gross organ parts are involved.
p.000041:
p.000041:
p.000041:
p.000041: 23 See for e.g., Jonathan Yearworth v. North Bristol NHS Trust [2009] 3 WLR 118, where the English Court of Appeal
p.000041: held that patients who stored their gametes in a hospital storage facility retained an ownership interest
p.000041: in the stored tissue. The patients possessed some rights to control the use of the stored tissue, and could sue for
p.000041: damages arising from the destruction of the stored tissue as a result of the hospital’s negligence.
p.000041: 24 Medical Research Council, UK. Human tissue and biological samples for use in research: Operational and Ethical
p.000041: Guidelines (2005), paragraph 2.1.
p.000041:
p.000042: 42
p.000042:
p.000042: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000042:
p.000042: Consent in research with human biological materials
p.000042:
p.000042: 5.12 Informed consent must be obtained before any biological materials are taken for use in research. If the
p.000042: materials are intended for storage and future use in research, consent should also be obtained for this
p.000042: purpose.
p.000042:
...
p.000055: position is that while feelings of repugnance cannot be ignored, the process of paying heed to them should involve an
p.000055: evaluation of actual or likely harms and benefits.
p.000055:
p.000055: 7.18 Slippery slope arguments. A concern is sometimes expressed that research with human-animal
p.000055: combinations risks a ‘slippery slope’ that will open the way to unacceptable research or applications.
p.000055: This was one reason for public concern over research cloning – it raised in the public mind the possibility of
p.000055: human reproductive cloning occurring if cloning techniques became widespread. The BAC takes the view that cases should
p.000055: be considered on their merits, and any danger of this kind should be considered when a case is reviewed.
p.000055:
p.000055: 7.19 Human dignity – maintaining a distinction between human and animals. There is and should be no intention,
p.000055: in research, to try and produce animals that have been rendered human in some important and essential
p.000055: mental, physical or existential characteristic. Human consciousness is the most fundamental of such characteristics.
p.000055: The BAC is of the view that acceptable research must preclude procedures that risk this consequence, and should
p.000055: certainly never have it as an explicit aim.
p.000055:
p.000055: 7.20 The risk of hubris and ‘playing God’. The expression ‘playing God’ is often heard in connection with
p.000055: research or practice at the boundaries of medicine, and the exact meaning to be attributed to it may depend
p.000055: on the speaker. Religious critics may mean by it that interference with the process of creating and destroying life is
p.000055: interference with divine prerogative. In its secular form, this criticism can imply that we may suffer
p.000055: from scientific or ethical hubris, a pride in power that blinds us to limitations or unforeseen risks. Such concerns
p.000055: should not be lightly dismissed, but they are not without answers. Whatever we do will affect future
p.000055: generations. It is thus also ‘playing God’ if we prohibit research that might help patients.
p.000055:
p.000055: 7.21 The BAC’s view is that the problem of slippery slope, hubris, and other ethical concerns
p.000055: discussed above present a powerful case for ethical and legal regulation, rather than a case for outright
p.000055: prohibition. Regulation is an assurance that change will be introduced without abrupt and radical challenges to the
p.000055: fundamental values, beliefs and practices in society, and only when the key ethical issues arising from research
p.000055: involving human-animal combinations have been considered in each case.
p.000055:
p.000055: 7.22 The possibility of creating humanised animals. Most of the concerns just discussed are related to
p.000055: the possibility of allowing actual independent living entities to develop from human-animal combinations. It seems to
p.000055: the BAC that the main ethical hazard lies in the possibility of inadvertently creating an animal with human
p.000055: characteristics, especially, but not exclusively, mental attributes. The risks can be seen most clearly in the
p.000055: specific case of human neural stem cells grafted into the brains of non-human
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
...
p.000072: Research (1979);
p.000072:
p.000072:
p.000072: 40 The BAC used the term “subject” in its earlier reports, but more recently has used the term
p.000072: “participant”. The latter is increasingly used in many jurisdictions as it implicitly acknowledge the fact that
p.000072: research participants choose to participate, and should not be merely the passive subjects of research.
p.000072: These terms are however treated as interchangeable in these Guidelines.
p.000072:
p.000072:
p.000072:
p.000072: A8
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000072: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000072: Declaration on Bioethics and Human Rights (2005).
p.000072:
p.000072: General Ethical Principles that have Guided the BAC
p.000072:
p.000072: 2.5 A review of the five foundation documents above reveals that participants need to be protected and their
p.000072: autonomy in matters of research participation recognised. Although these documents do not agree in
p.000072: every particular, they appear to be in accord in their fundamentals. Based on these, the BAC formulated
p.000072: five guiding principles reflecting their local application, first summarised in its Egg Donation Report. In
p.000072: particular, as enjoined by the UNESCO Declaration, the BAC expects researchers to be aware of and respect the
p.000072: cultural and religious diversity of Singapore society. The BAC also indicated that respect for individuals can be
p.000072: subordinate to the public interest in certain cases, as in some kinds of public health research.
p.000072: 2.6 The five principles the BAC endorses are as follows:
p.000072:
p.000072: Respect for persons
p.000072:
p.000072: 2.7 Individuals are to be respected as human beings and treated accordingly. This includes respecting
p.000072: their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC
p.000072: refers to as autonomy.41 Their welfare and interests are to be protected, especially when their autonomy is
p.000072: impaired or lacking. This principle mandates the need for informed consent to participation in research;
p.000072: respect for privacy; for safeguarding confidentiality; for protecting vulnerable participants; and it
p.000072: also requires a proper regard for religious and cultural diversity.
p.000072: 2.8 This principle integrates with many other aspects of life in societies that could be described
p.000072: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000072: Ideals such as all citizens being equal under the law, or having rights to privacy and the management of their
p.000072: affairs, to the enjoyment of security and public health and safety, with rights over their own bodies,
p.000072: and many others, all, in the last analysis, come down to the principle that individuals should be accorded certain
p.000072: basic rights or entitlements arising from their existence in society. These entitlements exist notwithstanding
p.000072: individual differences in endowment of race, character, gender or talent, and without requirement that individuals
p.000072: justify them. An individual’s autonomy can be curtailed under certain circumstances, such as when quarantined
p.000072: in disease epidemics.
p.000072:
p.000072:
p.000072:
p.000072: 41 NMEC similarly referred to autonomy as “the right of individuals to decide for themselves what
p.000072: is good for them.” Paragraph 2.3.1, Ethical Guidelines on Research Involving Human Subjects (1997).
p.000072:
p.000072:
p.000072:
p.000072: A9
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Solidarity
p.000072:
p.000072: 2.9 The BAC earlier advocated a principle of reciprocity between the individual and the wider society, as a way
...
p.000072: valuable development arising from the research, and donations should be made and accepted on that understanding.
p.000072: 5.7 As the use of human tissue is critical for biomedical research, both the public and research
p.000072: participants should have confidence that the biospecimens that they contribute are handled and used
p.000072: sensitively and responsibly. Researchers should always ensure that their collection and use of human tissue will
p.000072: not compromise the safety, welfare and interests of donors, which should be of paramount consideration.
p.000072: Guidelines on Human Tissue Research and Biobanking
p.000072:
p.000072: General
p.000072:
p.000072: 5.8 All research involving human tissue, whether identified or de-identified, should be reviewed by an
p.000072: IRB, and approved before it commences.
p.000072: 5.9 It is essential to protect the privacy of tissue donors and the confidentiality of their personal
p.000072: information, including personal information given by donors about individuals who are not themselves
p.000072: donors. All the requirements for the use of personal information in research in Part IV of these Guidelines will
p.000072: apply.
p.000072: 5.10 Donors should not be offered any financial incentives for their donation, although reasonable
p.000072: reimbursement of expenses incurred may be given.
p.000072: 5.11 Researchers and those managing tissue banks and biobanks need to be sensitive to religious and
p.000072: cultural perspectives and traditions, as these vary considerably amongst various religions and cultures, especially
p.000072: when whole cadavers or gross organ parts are involved.
p.000072: Consent in research with human tissues
p.000072:
p.000072: 5.12 Informed consent must be obtained from the donor or the legal guardian or proxy (or the next-of-kin if the
p.000072: donor has died), before any tissue is used for research. If there is intention for storage and future use of the tissue
p.000072: for research, consent should also be obtained.
p.000072:
p.000072: 5.13 Consent may be general or specific. General consent is consent that does not limit the use of the tissue for
p.000072: any particular research project. It includes consent for future use
p.000072:
p.000072: 53 Medical Research Council, UK. Human tissue and biological samples for use in research: Operational and
p.000072: Ethical Guidelines (2005), paragraph 2.1.
p.000072:
p.000072:
p.000072:
p.000072: A35
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: of the tissue or information generated from the research using the tissue, without a requirement for
p.000072: re-consent. In a general consent, the donor may seek to limit the uses to which the tissue and any information derived
...
p.000072: animal tissues are not normally thought of as something that can or should be mixed. It is seen as unnatural. The BAC’s
p.000072: position is that while feelings of repugnance cannot be ignored, the process of paying heed to them should involve an
p.000072: evaluation of actual likely harms and benefits.
p.000072: 7.17 Slippery slope arguments. A concern is sometimes expressed that research with human-animal
p.000072: combinations risks a ‘slippery slope’ that will open the way to unacceptable research or applications.
p.000072: This was one reason for public concern over research cloning – it raised in the public mind the possibility of
p.000072: human reproductive cloning occurring if cloning techniques became widespread. The BAC takes the view that cases should
p.000072: be considered on their merits, and any danger of this kind should be considered when a case is reviewed.
p.000072: 7.18 Human dignity – maintaining a distinction between human and animals. There is and should be no intention,
p.000072: in research, to try and produce animals that have been rendered human in some important and essential
p.000072: mental, physical or existential characteristic. Human consciousness is the most fundamental of such characteristics.
p.000072: The BAC is of the view that acceptable research must preclude procedures that risk this consequence, and should
p.000072: certainly never have it as an explicit aim.
p.000072: 7.19 The risk of hubris and ‘playing God’. The expression ‘playing God’ is often heard in connection with
p.000072: research or practice at the boundaries of medicine, and the exact meaning to be read into it may depend on
p.000072: the speaker. Religious critics may mean by it that interference with the process of creating and destroying life is
p.000072: interference with divine prerogative. In its secular form, this criticism can imply that we may suffer from
p.000072: scientific or ethical hubris, a pride in power that blinds us to limitations or unforeseen risks. Such
p.000072: concerns are not to be lightly dismissed, but they are not without answers. Whatever we do will affect
p.000072: future generations. It is thus also ‘playing God’ if we prohibit research that might help patients.
p.000072: 7.20 The BAC’s view is that the problem of slippery slopes, hubris, and other ethical concerns
p.000072: discussed above present a powerful case for ethical and legal regulation, rather than a case for outright
p.000072: prohibition. Regulation is an assurance that change will be introduced without abrupt and radical challenge to the
p.000072: fundamental values, beliefs and practices that underlie society, and only when the key ethical issues arising from
p.000072: research involving human-animal combinations have been considered in each case.
p.000072:
p.000072:
p.000072: A49
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 7.21 The possibility of creating humanised animals. Most of the concerns just discussed are related to the
p.000072: possibility of allowing actual independent living entities to develop from human-animal combinations. It seems to the
p.000072: BAC that the main ethical hazard lies in the possibility of inadvertently creating an animal with human
p.000072: characteristics, especially, but not exclusively, mental attributes. The risks can be seen most clearly in the
p.000072: specific case of human neural stem cells grafted into the brains of non-human primate foetuses57, which
...
p.000072: Distribution List for Consultation Paper on
p.000072: “Ethics Guidelines for Human Biomedical Research – for comments” (Public Consultation Period: 20 June 2012 to 15 August
p.000072: 2012)
p.000072:
p.000072: 1. Academy of Medicine
p.000072: 2. Agency for Integrated Care
p.000072: 3. Alice Lee Centre for Nursing Studies
p.000072: 4. Alzheimer’s Disease Association
p.000072: 5. Association of Muslim Professionals
p.000072: 6. Autism Association (Singapore)
p.000072: 7. Bioinformatics Institute
p.000072: 8. Biomedical Research Council
p.000072: 9. Bioprocessing Technology Institute
p.000072: 10. Buddhist Fellowship
p.000072: 11. Cardiovascular Research Institute
p.000072: 12. The Catholic Medical Guild of Singapore
p.000072: 13. Changi General Hospital
p.000072: 14. College of Family Physicians Singapore
p.000072: 15. Defence Medical & Environmental Research Institute @ DSO National Laboratories
p.000072: 16. Department of Biological Sciences, National University of Singapore
p.000072: 17. Duke-NUS Graduate Medical School
p.000072: 18. ES Cell International
p.000072: 19. Experimental Therapeutics Centre
p.000072: 20. Genome Institute of Singapore
p.000072: 21. Graduates’ Christian Fellowship (Singapore)
p.000072: 22. Health Sciences Authority
p.000072: 23. Hindu Advisory Board
p.000072: 24. Institute of Bioengineering and Nanotechnology
p.000072: 25. Institute of Medical Biology
p.000072: 26. Institute of Mental Health
p.000072: 27. Institute of Molecular and Cell Biology
p.000072: 28. Inter-Religious Organisation Singapore
p.000072: 29. Jewish Welfare Board
p.000072: 30. John Hopkins Singapore International Medical Centre
p.000072: 31. Khoo Teck Puat Hospital
p.000072: 32. KK Women’s and Children’s Hospital
p.000072: 33. Khoo Teck Puat - National University Children's Medical Institute
p.000072: 34. Law Reform Committee, Singapore Academy of Law
p.000072: 35. The Law Society of Singapore
p.000072: 36. Majlis Ugama Islam Singapura (Islamic Religious Council of Singapore)
p.000072: 37. Muscular Dystrophy Association Singapore
p.000072: 38. Nanyang Polytechnic
p.000072:
p.000072: B1
p.000072:
p.000072: ANNEX B
p.000072:
p.000072: 39. Nanyang Technological University
p.000072: 40. National Arthritis Foundation
p.000072: 41. National Cancer Centre
p.000072: 42. National Council of Churches of Singapore
p.000072: 43. National Council of Social Service
p.000072: 44. National Dental Centre
p.000072: 45. National Healthcare Group
p.000072: 46. National Heart Centre
p.000072: 47. National Neuroscience Institute
p.000072: 48. National Skin Centre
p.000072: 49. National University Cancer Institute, Singapore
p.000072: 50. Ngee Ann Polytechnic
p.000072: 51. NUHS Research Office
p.000072: 52. Parkway Hospitals Singapore
p.000072: 53. The Parsi Zoroastrian Association of Singapore
p.000072: 54. Raffles Hospital
p.000072: 55. Republic Polytechnic
p.000072: 56. Saw Swee Hock School of Public Health, National University of Singapore
p.000072: 57. Sikh Advisory Board
p.000072: 58. SIM University
p.000072: 59. Singapore Association For Mental Health
p.000072: 60. Singapore Bioimaging Consortium
p.000072: 61. Singapore Buddhist Federation
p.000072: 62. Singapore Cancer Society
p.000072: 63. Singapore Children's Society
p.000072: 64. Singapore Chinese Buddhist Association
p.000072: 65. Singapore Clinical Research Institute
p.000072: 66. Singapore Epilepsy Foundation
p.000072: 67. Singapore Eye Research Institute
p.000072: 68. Singapore General Hospital
p.000072: 69. Singapore Health Services
p.000072: 70. Singapore Heart Foundation
p.000072: 71. Singapore Immunology Network
...
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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p.000072:
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p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C10
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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p.000072:
p.000072:
p.000072: C11
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: Comments from Humanist Society (Singapore)
p.000072:
p.000072: 13 August 2012
p.000072:
p.000072:
p.000072: To: Bioethics Advisory Committee, Singapore
p.000072: We, the Humanist Society (Singapore), a registered society representing the non-religious in Singapore, would like
p.000072: to express our support for the draft “Ethics Guidelines for Human Biomedical Research”.
p.000072:
p.000072: We believe that research is vital to understanding nature and holds great potential for extending human
p.000072: lifespans and improving quality of life. In particular, we agree with the committee’s stand that stem cell
p.000072: research should not be prohibited, but instead regulated with guidelines based on our current understanding of Science.
p.000072:
p.000072: Yours sincerely,
p.000072: Humanist Society (Singapore)
p.000072: Guided by reason, informed by evidence, driven by compassion
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C12
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: Comments from Lily-NUS Centre for Clinical Pharmacology
p.000072:
p.000072: 16 and 21 August 2012
p.000072:
p.000072:
p.000072: Greetings,
p.000072:
p.000072: I am responding to the call for comments from the BAC on the proposed Draft Guidelines for Human Biomedical Research.
p.000072: Please allow me a short introduction. I am Dr Danny Soon, and currently the Managing Director of the Lilly-NUS Centre
p.000072: for Clinical Pharmacology, located at MD11 in NUS. We have been in operation for 14 years, and have
p.000072: conducted over 130 studies, in the field of clinical pharmacology research, including
...
Social / Soldier
Searching for indicator military:
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p.000069:
p.000069: United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human Rights.
p.000069: 2005.
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000070: BIBLIOGRAPHY
p.000070:
p.000070: United States of America. Office for Human Research Protections, Department of Health and Human Services. Protection of
p.000070: Human Subjects, Title 45 Code of Federal Regulations, Part
p.000070: 46. Revised 2009.
p.000070:
p.000070: United States of America. National Bioethics Advisory Commission. Research Involving Human Biological
p.000070: Materials: Ethical Issues and Policy Guidance. August 1999.
p.000070:
p.000070: United States of America. National Commission for the Protection of Human Subjects of Biomedical and
p.000070: Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human
p.000070: Subjects of Research. 1979.
p.000070:
p.000070: United States of America. National Institutes of Health. Guidelines for the Conduct of Research Involving
p.000070: Human Subjects at the National Institutes of Health. August 2004.
p.000070:
p.000070: United States of America. National Institutes of Health. NIH Guidelines for Research Involving Recombinant
p.000070: DNA Molecules. October 2011.
p.000070:
p.000070: United States of America. Nuremberg Code. In: Trials of War Criminals before the Nuremberg Military
p.000070: Tribunals under Control Council. Law No. 10, Vol. 2: 181-182. 1949.
p.000070:
p.000070: United States of America. Office for Civil Rights HIPAA Privacy. Research. 3 April 2003. World Health Organization. A
p.000070: Practical Guide for Health Researchers. 2004.
p.000070: World Health Organization. Genetic Databases Assessing the Benefits and the Impact on Human and Patient
p.000070: Rights. 2003.
p.000070:
p.000070: World Health Organization. Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells
p.000070: and Fluids in Research. 2003.
p.000070:
p.000070: World Health Organization. Handbook for Good Clinical Research Practice. 2005. World Health Organization. Review of
p.000070: Ethical Issues in Medical Genetics. 2003.
p.000070: World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research
p.000070: with Human Participants. 2011.
p.000070:
p.000070: World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving
p.000070: Human Subjects. Revised 2013.
p.000070:
p.000070: World Medical Association. WMA Declaration on Ethical Considerations Regarding Health Databases. October 2002.
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071:
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p.000071:
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p.000071:
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p.000071:
p.000071:
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p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
...
p.000072:
p.000072: Ministry of Health. Licensing Terms and Conditions on Assisted Reproduction Services. Singapore, 2011.
p.000072:
p.000072: Ministry of Health. Operational Guidelines for Institutional Review Boards. Singapore, December 2007.
p.000072:
p.000072: Ministry of Information and the Arts. Public Consultation Paper on Proposed Data Protection Bill. Singapore,
p.000072: 2012.
p.000072:
p.000072: National Advisory Committee for Laboratory Animal Research. Guidelines on the Care and Use of Animals for
p.000072: Scientific Purposes. Singapore, 2004.
p.000072:
p.000072: National Health and Medical Research Council, National Statement on Ethical Conduct in Human Research.
p.000072: Australia, 2007.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A54
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: National Healthcare Group. Investigator Manual: All that an Investigator Needs to Know. Singapore, August
p.000072: 2009.
p.000072:
p.000072: National Medical Ethics Committee. Ethical Guidelines for Gene Technology. Singapore, 2001.
p.000072:
p.000072: National Medical Ethics Committee. Ethical Guidelines on Research Involving Human Subjects, Singapore, 1997.
p.000072:
p.000072: National Medical Ethics Committee. Recommendations on Clinical Trials: Update Focusing on Phase I Trials,
p.000072: Singapore, 2007.
p.000072:
p.000072: National Registry of Diseases Act (Cap. 201). Singapore, 2007.
p.000072:
p.000072: Nuremberg Code. In: Trials of War Criminals before the Nuremberg Military Tribunals under Control Council.
p.000072: U.S. Government Printing Office, Washington D.C. Law No. 10, Vol. 2: 181-182 (1949).
p.000072:
p.000072: Ourednik V and 10 others. Segregation of Human Neural Stem Cells in the Developing Primate
p.000072: Forebrain. Science. 293 (2001): 1820-1824.
p.000072:
p.000072: Personal Data Protection Bill. Singapore, 2012.
p.000072:
p.000072: Private Hospitals and Medical Clinics Act (Cap. 248). Singapore, 1999. Singapore Medical Council. Ethical Code and
p.000072: Ethical Guidelines (nd).
p.000072: United Nations Educational, Scientific and Cultural Organization (UNESCO)
p.000072: Universal Declaration on Bioethics and Human Rights, 2005.
p.000072:
p.000072: Wilfond BS and Diekema DS. Engaging children in genomics research: decoding the meaning of assent in research, Genetics
p.000072: in Medicine.14 (2012): 437-443.
p.000072:
p.000072: World Medical Association. Declaration of Helsinki:Ethical Principles for Medical Research Involving Human
p.000072: Subjects (revised 2008).
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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p.000072:
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p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A55
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: List of Abbreviations
p.000072:
p.000072:
p.000072: BAC Bioethics Advisory Committee
...
Social / Threat of Stigma
Searching for indicator threat:
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p.000017: necessary to ensure patients participating in research are not victims of therapeutic misconception, or
p.000017: mis- estimation – the fallacy of overestimating the benefits they may gain from participating in
p.000017: the research. Research is a process designed to yield a contribution to generalisable knowledge, which is practically
p.000017: useful or theoretically important, and is therefore a public good. This is not the same as beneficence. Indeed, many
p.000017: researchers would argue that a spirit of intellectual curiosity often impels valid research that is
p.000017: difficult to evaluate in any practical way. The importance of respect for persons seems to us to better capture
p.000017: the essential aspects of beneficence and non-maleficence insofar as these concepts apply to research
p.000017: participants, and we have thus framed the principle of respect for persons as, in effect, incorporating them.
p.000017:
p.000017: Research Integrity
p.000017:
p.000017: 2.14 Research integrity is the term used to refer to the integrity or validity of the research process. Anything
p.000017: which undermines the objectivity of the research and the validity of
p.000017:
p.000017: 10 In the US, for example, the regulatory requirements of minimising risks to participants and ensuring that the
p.000017: risks are acceptable in light of the anticipated benefits have been grounded in beneficence as a basic ethical
p.000017: principle in the Belmont Report, which subsumes non-maleficence under beneficence.
p.000017:
p.000018: 18
p.000018:
p.000018: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000018:
p.000018: the results can be regarded as a threat to research integrity; for example, if there is plagiarism, selectivity in
p.000018: the publication of results, or if the independence of researchers is undermined by their obligations to their
p.000018: employers or to the funders of their research.
p.000018:
p.000018: 2.15 The BAC’s view is that research integrity is essential. It is not a simple concept, but to some extent, the
p.000018: presumptive integrity of research and of researchers is already implicit in adherence to the BAC’s general
p.000018: ethical principles outlined above, and its importance is made explicit wherever appropriate in these
p.000018: Guidelines. Further guidance is available in the Singapore Statement on Research Integrity, developed by the 2nd
p.000018: World Conference on Research Integrity, which was the first international effort to encourage the
p.000018: development of unified policies, guidelines and codes of conduct, with the long-term goal of fostering greater
p.000018: integrity in research globally.11
p.000018:
p.000018: 2.16 The BAC is also of the view that research institutions have a responsibility to ensure that the
p.000018: requirements of research integrity are observed, and IRBs have a responsibility to check that
p.000018: research integrity, as well as research merit, has been considered.
p.000018:
p.000018: 2.17 The principles described above are general in nature and fundamental to ethics governance of
p.000018: biomedical research involving human participants, the use of the biological materials that they have
p.000018: contributed, and information about persons obtained or derived from the research process. In practice,
p.000018: these principles are engaged in a number of specific guidelines, considered below.
...
p.000072: however, the participants may not be patients, and even if they are, there is often no direct benefit
p.000072: for the patient from participation in the research. Indeed, it is necessary to ensure patients
p.000072: participating in research are not victims of therapeutic mis-estimation
p.000072: – the fallacy of overestimating the benefits they may gain from participating in the research. Research is a process
p.000072: designed to yield a general contribution to knowledge, which is practically useful or theoretically important, and is
p.000072: therefore a public good. This is not the same as beneficence. Indeed, many researchers would argue that a
p.000072: spirit of intellectual curiosity often impels valid research that is difficult to evaluate in any practical way. The
p.000072: importance of respect for persons seems to us to capture better the essential aspects of beneficence and
p.000072: non-maleficence insofar as these concepts apply to research participants, and we have thus framed the principle of
p.000072: respect for persons as, in effect, incorporating them.
p.000072: Research Integrity
p.000072:
p.000072: 2.17 It may be noted that the BAC principles do not include an explicit mention of research integrity. This is
p.000072: because the integrity of process in all aspects has to be a given for ethical governance of research, including
p.000072: judicial process and IRB decisions on research proposals. Research integrity is the term used to refer
p.000072: to the integrity or validity of the research process. Anything which undermines the objectivity of the
p.000072: research and the validity of the results can be regarded as a threat to research integrity. As can be seen from, for
p.000072: example, the Singapore Statement on Research Integrity put up by the 2nd World Conference on Research
p.000072: Integrity,46 research integrity is not a simple concept. Essentially it is thought of in terms of the following
p.000072: components:
p.000072: (a) The trustworthiness of the research product, as manifest in attention to the details of the
p.000072: scientific process in ways that maximise objectivity and minimise bias or selectivity by researchers. Research
p.000072: should be reported in ways that allow others to replicate it and test the research conclusions;
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 45 In the US, for example, the regulatory requirements of minimising risks to participants and ensuring that
p.000072: the risks are acceptable in light of the anticipated benefits have been grounded in beneficence as a basic ethical
p.000072: principle in the Belmont Report, which subsumes non-maleficence under beneficence.
p.000072: 46 More information on the World Conference on Research Integrity can be found at:
p.000072: http://www.singaporestatement.org/
p.000072:
p.000072:
p.000072:
p.000072: A12
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (b) The ethics of the research environment, as manifest for instance in institutional practice, the regulation of
p.000072: research, the sensitivity of the research to the social context in which it occurs, and the measures taken to ensure
p.000072: that professional standards are respected; and
p.000072:
p.000072: (c) The avoidance by researchers of any plagiarism or fabrication of data.
p.000072:
...
Social / Victim of Abuse
Searching for indicator trauma:
(return to top)
p.000030:
p.000030: Waiver of Consent
p.000030:
p.000030: 3.29 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000030: typically in epidemiological or public health research carried out with medical records or with data from national
p.000030: registries, when the following conditions are met:
p.000030:
p.000030: (a) The research is justified and poses no more than minimal risk to research participants;
p.000030:
p.000030: (b) The waiver will not adversely affect the welfare and interests of research participants;
p.000030: (c) The research could not practicably proceed without the waiver;
p.000030:
p.000030: 20 This is addressed by the concept of assent in some jurisdictions like the US. However, as assent is a procedure that
p.000030: lacks clear legal recognition in Singapore, and may be confused with consent to research, it is best to focus on
p.000030: engagement with the minor participant.
p.000030:
p.000031: 31
p.000031:
p.000031: CONSENT
p.000031:
p.000031: (d) Obtaining consent is not possible or practicable; and
p.000031:
p.000031: (e) Individual privacy and confidentiality of the personal information are assured.
p.000031:
p.000031: 3.30 Exceptionally, valuable research might require the recruitment of highly compromised patients, such as
p.000031: accident trauma victims, who are unable to give consent and for whom no proxy is practically available to
p.000031: give consent within the timeframe required for the research procedures to be administered. In such cases, always
p.000031: subject to the treatment of the patient remaining the priority, and subject to the provisions of the
p.000031: Mental Capacity Act, it may be appropriate for an IRB to authorise the research, if it involves no more than
p.000031: minimal risk. Consent must be sought, directly or from a proxy, as soon as is practicable, and with the clear
p.000031: understanding that a patient shall have every right to withdraw or decline with retrospective effect (which will
p.000031: require removing earlier collected data from the study).
p.000031:
p.000031: Clinically Significant Incidental Findings
p.000031:
p.000031: 3.31 A clinically significant incidental finding occurs when, in the course of research done for some other
p.000031: purposes, a finding is made that has a clear implication for the health of the participant to whom it relates. Research
p.000031: findings are by their nature provisional and not definitive. Where research data suggests the presence of a clinical
p.000031: condition that would require a confirmation and possible treatment, there is some duty on the part of the researcher to
p.000031: ensure that the research participant is informed of the possible condition with advice to follow up on the matter with
p.000031: a medical practitioner.
p.000031:
p.000031: 3.32 If there is reasonable possibility that incidental findings may occur in a research, research
...
p.000072: typically epidemiological or public health research carried out with medical records or with data from national
p.000072: registries, when the following conditions are met:
p.000072:
p.000072: (a) The research is justified and poses no more than minimal risk to research participants;
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 51 For a discussion on the meaning of assent in research see Wilfond, BS & Diekema, DS. Engaging
p.000072: children in genomics research: decoding the meaning of assent in research, Genetics in Medicine (2012), 14
p.000072: (4): 437-443.
p.000072:
p.000072:
p.000072:
p.000072: A24
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (b) The waiver will not adversely affect the welfare and interests of research participants;
p.000072:
p.000072: (c) The research could not practicably proceed without the waiver;
p.000072:
p.000072: (d) Obtaining consent is not possible or practicable;
p.000072:
p.000072: (e) Individual privacy and confidentiality of the personal information are assured; and
p.000072:
p.000072: (f) In the event that clinically significant findings are discovered, affected individuals who
p.000072: have indicated their wish to know will be informed in a timely manner, if reasonably possible.
p.000072:
p.000072: 3.28 Exceptionally, valuable research might require the recruitment of highly compromised patients, such as
p.000072: accident trauma victims, who are unable to give consent and for whom no proxy is available to give
p.000072: consent. In such cases, always subject to the treatment of the patient remaining the priority, and
p.000072: subject to the provisions of the Mental Capacity Act, it may be appropriate for an IRB to authorise the research,
p.000072: with patient consent being sought (directly or from a proxy) as soon as is practicable, and with the clear
p.000072: understanding that a patient shall have every right to withdraw or decline with retrospective effect (which
p.000072: will require removing earlier collected data from the study).52
p.000072:
p.000072: Clinically Significant Incidental Findings
p.000072:
p.000072: 3.29 A clinically significant incidental finding occurs when, in the course of research done for some other
p.000072: purposes, a finding is made that has a clear implication for the health of the participant to whom it relates. Research
p.000072: findings are by their nature provisional and not definitive. Where research data suggests the presence of a clinically
p.000072: important condition that would require a confirmation and possible treatment, there is some duty on the part of the
p.000072: researcher to ensure that the research participant is informed of the possible condition with advice to follow up the
p.000072: matter with a medical practitioner.
p.000072: 3.30 Research participants should be given the choice of whether to be informed about such findings,
p.000072: prior to the commencement of the research, if the research is such that there is some reasonable possibility that
...
Social / Women
Searching for indicator women:
(return to top)
p.000004: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000004: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000004: immediately before death.
p.000004:
p.000004: 32. For research using foetal tissues, consent for the termination of pregnancy should be separate from the
p.000004: consent for obtaining foetal tissue or any tissue related to the pregnancy for research. Where possible, an
p.000004: attending physician should not also seek consent for research participation from a patient in this situation. Consent
p.000004: for the use of foetal tissue for research could be obtained from either parent, as provided for in the Medical
p.000004: (Therapy, Education and Research) Act.
p.000004:
p.000004: 33. Specific and personal consent from the donors must be obtained before any gametes or embryos are to be
p.000004: used for research. Potential donors should be provided with sufficient information to make an informed decision
p.000004: and be given at least a week to decide.
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: EXECUTIVE SUMMARY
p.000005:
p.000005:
p.000005: 34. For women undergoing fertility treatment, consent for the donation of surplus oocytes or embryos for
p.000005: research should be separate from the consent for treatment. The treating physician should not also be the
p.000005: researcher seeking consent for the donation of oocytes or embryos for research. Donors should confirm in writing that
p.000005: they do not require the oocytes or embryos for future use.
p.000005:
p.000005: 35. Women wishing to donate eggs specifically for research must be interviewed by an independent panel. The panel
p.000005: must be satisfied that they are of sound mind, clearly understand the nature and consequences of the donation,
p.000005: and have freely given explicit consent, without any inducement, coercion or undue influence.
p.000005:
p.000005: 36. If complications occur as a direct and proximate result of the egg donation, the donor should be provided
p.000005: with prompt and full medical care. This provision is the responsibility of the researchers and their
p.000005: institutions.
p.000005:
p.000005: 37. Trans-species fertilisation involving human gametes is not allowed for the purpose of reproduction unless
p.000005: done to assess or diagnose sub-fertility, in which case, the resultant hybrid must be terminated at the
p.000005: two-cell stage, and must have written approval from the Director of Medical Services.
p.000005:
p.000005: 38. Human embryos created for research through in vitro fertilisation of human eggs by human sperm, or created
p.000005: through any form of cloning technology, should not be allowed to develop beyond 14 days in vitro, or to be
p.000005: implanted into the body of any human or animal.
p.000005:
p.000005: 39. Human cytoplasmic hybrid embryos created for research should not be allowed to develop beyond 14
p.000005: days in vitro, or to be implanted into the body of any human or animal.
p.000005:
p.000005: 40. Every effort should be made to obtain consent for the use of surplus biological materials for
...
p.000044: sperm, for a period of more than 14 days, excluding any period when the development of the embryo is
p.000044: suspended. Commercial trading in human eggs, human sperm and human embryos is also prohibited.
p.000044:
p.000044: 5.24 The supply and use of human gametes and embryos is governed by the Human Cloning and Other
p.000044: Prohibited Practices Act (Cap. 131B). Researchers should also comply with the requirements stipulated in
p.000044: MOH’s 2011 Licensing Terms and Conditions (LTC) on Assisted Reproduction (AR) Services imposed under
p.000044: Section 6(5) of the Private Hospitals and Medical Clinics Act.
p.000044:
p.000044: 5.25 Under the LTC,25 written approval from the Director of Medical Services must be obtained for all
p.000044: research involving human embryos and human oocytes (including those obtained from excised ovarian tissue).
p.000044: This requirement extends to human- animal combination gametes or embryos, which are those containing both human
p.000044: and animal genetic or non-genetic material and includes an embryo created by the fertilisation of human and
p.000044: animal gametes.
p.000044:
p.000044: 5.26 Specific and personal consent from the donors must be obtained before any gametes or embryos are to be
p.000044: used for research. Potential donors should be provided with sufficient information to make an informed decision
p.000044: and be given at least a week to decide.
p.000044:
p.000044: 5.27 For women undergoing fertility treatment, consent for the donation of surplus oocytes or embryos for
p.000044: research should be separate from the consent for treatment. The treating physician should not also be the
p.000044: researcher seeking consent for the donation of oocytes or embryos for research. Donors should confirm in writing that
p.000044: they do not require the oocytes or embryos for future use.
p.000044:
p.000044: 5.28 As the process of donating eggs for research is time-consuming, invasive and associated with a
p.000044: certain degree of discomfort and risk, women wishing to donate eggs specifically for research i.e. those
p.000044: who are not undergoing fertility treatment, must be interviewed by an independent panel. The panel must be
p.000044: satisfied that they are of sound mind, clearly understand the nature and consequences of the donation, and have
p.000044: freely given explicit consent, without any inducement, coercion or undue influence.
p.000044:
p.000044: 5.29 All egg donors should be informed if their eggs will be used to create embryos, including
p.000044: human-animal combination embryos, which will be destroyed in the process of research, and if any derived cells
p.000044: from the embryos so created will be kept for future research or possible clinical use. They should be
p.000044: assured that any embryos
p.000044:
p.000044:
p.000044:
p.000044: 25 At paragraphs 9.1-9.11.
p.000044:
p.000045: 45
p.000045:
p.000045: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000045:
p.000045: created for research will not be implanted or allowed to develop in vitro beyond 14 days.
p.000045:
p.000045: 5.30 Donors of eggs obtained specifically for research, and not as a result of clinical treatment,
p.000045: may be reimbursed for legitimate expenses incurred, such as cost of transport and childcare services, and
p.000045: actual loss of earnings, as a result of the procedures required to obtain the eggs. Any other payment, whether
p.000045: monetary or in kind, should not amount to an inducement and should be approved by an IRB. If
p.000045: complications occur as a direct and proximate result of the donation, the donor should be provided with prompt and full
...
p.000072: period of more than 14 days, excluding any period when the development of the embryo is suspended, is
p.000072: prohibited. Commercial trading in human eggs, human sperm and human embryos is also not allowed.
p.000072: 5.23 The use of human gametes or embryos for research is governed by the requirements of the law, as given in the
p.000072: MOH’s 2011 Licensing Terms and Conditions on Assisted Reproduction Services imposed under Section 6(5) of the
p.000072: Private Hospitals and
p.000072:
p.000072:
p.000072: A37
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Medical Clinics Act and by the Human Cloning and Other Prohibited Practices Act (Cap. 131B).
p.000072: 5.24 Under the Licensing Terms and Conditions on Assisted Reproduction Services, written approval from
p.000072: the Director of Medical Services must be obtained for all research involving human embryos and human
p.000072: oocytes (including those obtained from excised ovarian tissue). This requirement extends to human-animal combination
p.000072: gametes or embryos, which are those containing both human and animal genetic or non-genetic material and includes an
p.000072: embryo created by the fertilisation of human and animal gametes.
p.000072: 5.25 Consent from the donors must be obtained before any gametes or embryos are to be used for research.
p.000072: Individuals from whom the gametes or embryos are derived, should be provided with sufficient information to make an
p.000072: informed decision and be given at least a week to decide.
p.000072: 5.26 For women undergoing fertility treatment, consent for the donation of oocytes or embryos for
p.000072: research should be separate from the consent for treatment. The treating physician should not also be the
p.000072: researcher seeking consent for the donation of oocytes and embryos for research. Donors should confirm in writing
p.000072: that they do not require the oocytes or embryos for future use.
p.000072: 5.27 As the process of donating eggs for research is time-consuming, invasive and associated with a
p.000072: certain degree of discomfort and risks, women wishing to donate eggs specifically for research i.e. who are
p.000072: not also undergoing any fertility treatment, must be interviewed by an independent panel. The panel must be satisfied
p.000072: that they are of sound mind, clearly understand the nature and consequences of the donation, and have freely given
p.000072: explicit consent, without any inducement, coercion or undue influence.
p.000072: 5.28 All egg donors should be informed if their eggs will be used to create embryos, including
p.000072: human-animal combination embryos, which will be destroyed in the process of research, and if any derived cells
p.000072: from the embryos so created will be kept for future research or possible clinical use. They should be
p.000072: assured that any embryos created for research will not be implanted or allowed to develop in vitro beyond 14 days.
p.000072:
p.000072: 5.29 Donors of eggs obtained specifically for research, and not as a result of clinical treatment,
p.000072: may be reimbursed for legitimate expenses incurred, such as cost of transport and childcare services, and
p.000072: actual loss of earnings, as a result of the procedures required to obtain the eggs. Any additional payment to
p.000072: be given, whether monetary or in kind, should not amount to an inducement. If complications occur as a direct and
p.000072: proximate result of the donation, the donor should be provided with prompt and full medical care. The cost of this
p.000072: provision is the responsibility of the researchers and their institutions.
p.000072:
p.000072:
p.000072:
p.000072: A38
p.000072:
p.000072: ANNEX A
p.000072:
...
p.000072: 3. Alice Lee Centre for Nursing Studies
p.000072: 4. Alzheimer’s Disease Association
p.000072: 5. Association of Muslim Professionals
p.000072: 6. Autism Association (Singapore)
p.000072: 7. Bioinformatics Institute
p.000072: 8. Biomedical Research Council
p.000072: 9. Bioprocessing Technology Institute
p.000072: 10. Buddhist Fellowship
p.000072: 11. Cardiovascular Research Institute
p.000072: 12. The Catholic Medical Guild of Singapore
p.000072: 13. Changi General Hospital
p.000072: 14. College of Family Physicians Singapore
p.000072: 15. Defence Medical & Environmental Research Institute @ DSO National Laboratories
p.000072: 16. Department of Biological Sciences, National University of Singapore
p.000072: 17. Duke-NUS Graduate Medical School
p.000072: 18. ES Cell International
p.000072: 19. Experimental Therapeutics Centre
p.000072: 20. Genome Institute of Singapore
p.000072: 21. Graduates’ Christian Fellowship (Singapore)
p.000072: 22. Health Sciences Authority
p.000072: 23. Hindu Advisory Board
p.000072: 24. Institute of Bioengineering and Nanotechnology
p.000072: 25. Institute of Medical Biology
p.000072: 26. Institute of Mental Health
p.000072: 27. Institute of Molecular and Cell Biology
p.000072: 28. Inter-Religious Organisation Singapore
p.000072: 29. Jewish Welfare Board
p.000072: 30. John Hopkins Singapore International Medical Centre
p.000072: 31. Khoo Teck Puat Hospital
p.000072: 32. KK Women’s and Children’s Hospital
p.000072: 33. Khoo Teck Puat - National University Children's Medical Institute
p.000072: 34. Law Reform Committee, Singapore Academy of Law
p.000072: 35. The Law Society of Singapore
p.000072: 36. Majlis Ugama Islam Singapura (Islamic Religious Council of Singapore)
p.000072: 37. Muscular Dystrophy Association Singapore
p.000072: 38. Nanyang Polytechnic
p.000072:
p.000072: B1
p.000072:
p.000072: ANNEX B
p.000072:
p.000072: 39. Nanyang Technological University
p.000072: 40. National Arthritis Foundation
p.000072: 41. National Cancer Centre
p.000072: 42. National Council of Churches of Singapore
p.000072: 43. National Council of Social Service
p.000072: 44. National Dental Centre
p.000072: 45. National Healthcare Group
p.000072: 46. National Heart Centre
p.000072: 47. National Neuroscience Institute
p.000072: 48. National Skin Centre
p.000072: 49. National University Cancer Institute, Singapore
p.000072: 50. Ngee Ann Polytechnic
p.000072: 51. NUHS Research Office
p.000072: 52. Parkway Hospitals Singapore
p.000072: 53. The Parsi Zoroastrian Association of Singapore
p.000072: 54. Raffles Hospital
p.000072: 55. Republic Polytechnic
p.000072: 56. Saw Swee Hock School of Public Health, National University of Singapore
p.000072: 57. Sikh Advisory Board
p.000072: 58. SIM University
p.000072: 59. Singapore Association For Mental Health
p.000072: 60. Singapore Bioimaging Consortium
p.000072: 61. Singapore Buddhist Federation
p.000072: 62. Singapore Cancer Society
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000002: it is not possible for consent to be taken by an independent third party, the IRB may give directions for the consent
p.000002: to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000002: sufficient safeguards to protect the welfare and interests of the participants.
p.000002:
p.000002: 15. For research involving patients, consent for participating in research should be clearly separated from
p.000002: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000002: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000002: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000002: and sufficient safeguards to protect the welfare and interests of the patient.
p.000002:
p.000002: 16. For research involving minors with decision-making capacity, consent from both the minor and a parent should
p.000002: be obtained; such a minor’s refusal of consent should be respected. Apart from this, it is still important to
p.000002: engage the minor in ways that respect his or her current level of understanding. Parents or guardians
p.000002: of minors lacking decision-making capacity are authorised to consent to their participation in research
p.000002: that involves no more than minimal risk and is not contrary to their best interests. For research that
p.000002: does not involve more than minimal risk, such as surveys seeking information relating only to the minor, IRBs should be
p.000002: able to waive parental consent for minors who have decision-making capacity, where there is otherwise no prohibition
p.000002: by law and parental consent is not a reasonable requirement for the protection of the minor’s interests.
p.000002:
p.000002: 17. IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000002: typically in epidemiological or public health research carried out with medical records or with data from national
p.000002: registries.
p.000002:
p.000002: 18. For research involving recruitment of highly compromised patients who are unable to give consent and for whom
p.000002: no proxy is available to give consent, and subject to the treatment of the patient remaining the priority, IRBs may
p.000002: authorise the research if it involves no more than minimal risk. Consent must be sought, directly or from
p.000002: a proxy, as soon as is practicable. The patient or proxy shall have every right to withdraw or decline
p.000002: with retrospective effect (which will require removing earlier collected data or biological material from the
p.000002: study).
p.000002:
p.000002: 19. Where there is a possibility that the research may yield clinically significant incidental findings,
p.000002: participants should be allowed to decide whether or not to be informed of such findings, during the consent-taking
p.000002: process.
p.000002:
p.000002: 20. If a clinically significant finding is discovered, but the preference of the research participant
p.000002: for receiving such information is unknown, researchers should refer to their IRBs for advice on the
p.000002: appropriate handling of such information.
p.000002:
p.000002:
p.000002:
p.000002:
...
p.000003:
p.000003: (b) The research could not practicably proceed without the waiver;
p.000003:
p.000003: (c) Obtaining consent is not possible or practicable; and
p.000003:
p.000004: 4
p.000004:
p.000004: EXECUTIVE SUMMARY
p.000004:
p.000004:
p.000004: (d) Individual privacy and confidentiality of the personal information are assured.
p.000004:
p.000004: 28. Research information may not be definitive, and research participants are entitled to expect that their data
p.000004: will not be used for purposes other than those for which they have given consent. Thus, such information should not be
p.000004: disclosed to any third party, including employers or insurance companies.
p.000004:
p.000004: V. Biobanking and Research Involving Human Biological Materials
p.000004:
p.000004: 29. Informed consent must be obtained before any human biological materials are taken for use in research. If the
p.000004: materials are intended for storage and future use in research, consent should also be obtained for this purpose.
p.000004:
p.000004: 30. Re-consent is required in the following situations:
p.000004:
p.000004: (a) When the proposed research is not covered by the consent that was given when the biological materials were
p.000004: collected (unless the re-consent requirement is waived by an IRB);
p.000004:
p.000004: (b) If the biological material was collected from a minor below 21 years of age, who did not at the time of collection
p.000004: possess decision-making capacity and therefore did not personally, or jointly together with his/her parent, consent to
p.000004: the donation. In the event that re-consent is not practicable, the IRB should generally have the discretion to waive
p.000004: the requirement in accordance with the relevant criteria for waiver of consent, where appropriate; or
p.000004:
p.000004: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000004: combinations.
p.000004:
p.000004: 31. Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000004: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000004: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000004: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000004: immediately before death.
p.000004:
...
p.000029:
p.000029: Consent for Research Involving Minors
p.000029:
p.000029: Respect for the developing autonomy of minors
p.000029:
p.000029: 3.23 In Singapore, under the common law, the age of majority is 21 years. This age is generally
p.000029: taken as the age at which a person is considered an adult and thus able to make all decisions for oneself. The category
p.000029: of minors thus spans a wide range, from children of tender years who lack any capacity to give consent, to young
p.000029: persons who have acquired the capacity to understand and make decisions on research participation.
p.000029: Parents generally have the authority to make decisions on behalf of minors, and this would include research
p.000029: participation. However, the welfare and best interests of the child or young person is the paramount consideration and
p.000029: parents must discharge their responsibilities to promote these.16 Unless research participation offers direct benefit
p.000029: to the minor, the authority of parents or guardians to consent to research without direct benefit is constrained
p.000029: in a similar fashion to proxy decisions for incapacitated adults as discussed in para. 3.16 above. Participation
p.000029: in research without direct benefit should involve no more than minimal risk and not be contrary to the best
p.000029: interests of the minor.
p.000029:
p.000029: 3.24 It is nevertheless ethically important to give due respect to the developing capacity of minors to be involved
p.000029: in, and make their own decisions about research participation. This consideration is reinforced in the case of research
p.000029: without direct benefit, where the minor should appreciate its altruistic nature. Respect for a minor’s
p.000029: developing autonomy is thus recognised by the Medicines (Clinical Trials) Regulations, which require both the
p.000029: minor who has sufficient understanding and a parent or guardian to consent to participation in a clinical
p.000029: trial.17 Similarly, the common law will not subject a child with sufficient understanding to a
p.000029: non-therapeutic procedure against his/her will.18
p.000029:
p.000029: Determining decision making capacity
p.000029:
p.000029: 3.25 In order to give a valid consent, the minor must have sufficient maturity and intelligence to
p.000029: understand the relevant information relating to the proposed research, and use that information to arrive at a reasoned
p.000029: decision. This capacity is, however, not easily linked to fixed ages, as it varies from minor to minor, and depends on
p.000029: the nature and complexity of the research. None of the current legal age thresholds bear immediate relevance to
p.000029: determining when a minor develops sufficient decision- making capacity to consent to research participation,
p.000029: although children between the ages of 12-14 may acquire near adult decision-making capacity.19 We therefore
p.000029: recommend that IRBs set suitable age thresholds for obtaining minors’ consent based on the relevant minors’
p.000029: developmental abilities, the context of the particular research protocol and the complexity of its procedures and
p.000029: risks. However, if researchers hold a reasonable doubt whether a particular minor possesses capacity to give consent,
p.000029: or if
p.000029:
p.000029: 16 Children and Young Persons Act (Cap. 38), s.3A; Guardianship of Infants Act (Cap 122), s.3
p.000029: 17 Medicines (Clinical Trials) Regulations, r.11(2).
p.000029: 18 S v S [1972] AC 24 at 45 (House of Lords).
p.000029: 19 Working Party of the Royal College of Paediatrics and Child Health, “Guidance on clinical research involving
p.000029: infants, children and young people: an update for researchers and research ethics committees” Arch Dis
p.000029: Child 2014 Oct; 99(10): 887-91.
p.000029:
p.000030: 30
p.000030:
p.000030: CONSENT
p.000030:
p.000030: the research risks involved are significantly greater than minimal, it would be prudent to assess capacity on an
p.000030: individual basis before enrolment.
p.000030:
p.000030: Engagement
p.000030:
p.000030: 3.26 For minors who lack sufficient decision-making capacity, it is still important to engage them as
p.000030: far as their intellectual abilities permit. This may involve, for example, explaining the nature of the
p.000030: research procedures and dealing with the minor’s concerns. Engagement serves to minimise the potential risks
p.000030: associated with participation, such as any distress experienced while undergoing research
p.000030: procedures.20 In every instance, including the obtaining of consent, IRBs and researchers should
p.000030: ensure that such engagement or explanation should be communicated effectively with age
p.000030: appropriate language and methods, and appropriately documented.
p.000030:
p.000030: Summary
p.000030:
p.000030: 3.27 The BAC is thus of the view that for research involving minors with decision-making capacity, consent from
p.000030: both the minor and a parent should be obtained; such a minor’s refusal of consent should be respected. Apart from this,
p.000030: it is still important to engage the minor in ways that respect his or her current level of understanding.
p.000030: Parents or guardians of minors lacking decision-making capacity are authorised to consent to their
p.000030: participation in research that involves no more than minimal risk and is not contrary to their best
p.000030: interests.
p.000030:
p.000030: Waiver of Parental Consent
p.000030:
p.000030: 3.28 For research that does not involve more than minimal risk, such as surveys seeking information relating only
p.000030: to the minor, the BAC is of the view that IRBs should be able to waive parental consent for minors who have
p.000030: decision-making capacity, where there is otherwise no prohibition by law and parental consent is not a
p.000030: reasonable requirement for the protection of the minor’s interests.
p.000030:
p.000030: Waiver of Consent
p.000030:
p.000030: 3.29 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000030: typically in epidemiological or public health research carried out with medical records or with data from national
p.000030: registries, when the following conditions are met:
p.000030:
p.000030: (a) The research is justified and poses no more than minimal risk to research participants;
p.000030:
p.000030: (b) The waiver will not adversely affect the welfare and interests of research participants;
p.000030: (c) The research could not practicably proceed without the waiver;
p.000030:
p.000030: 20 This is addressed by the concept of assent in some jurisdictions like the US. However, as assent is a procedure that
p.000030: lacks clear legal recognition in Singapore, and may be confused with consent to research, it is best to focus on
p.000030: engagement with the minor participant.
p.000030:
p.000031: 31
p.000031:
p.000031: CONSENT
p.000031:
p.000031: (d) Obtaining consent is not possible or practicable; and
p.000031:
p.000031: (e) Individual privacy and confidentiality of the personal information are assured.
p.000031:
p.000031: 3.30 Exceptionally, valuable research might require the recruitment of highly compromised patients, such as
p.000031: accident trauma victims, who are unable to give consent and for whom no proxy is practically available to
p.000031: give consent within the timeframe required for the research procedures to be administered. In such cases, always
p.000031: subject to the treatment of the patient remaining the priority, and subject to the provisions of the
p.000031: Mental Capacity Act, it may be appropriate for an IRB to authorise the research, if it involves no more than
p.000031: minimal risk. Consent must be sought, directly or from a proxy, as soon as is practicable, and with the clear
p.000031: understanding that a patient shall have every right to withdraw or decline with retrospective effect (which will
p.000031: require removing earlier collected data from the study).
p.000031:
p.000031: Clinically Significant Incidental Findings
p.000031:
p.000031: 3.31 A clinically significant incidental finding occurs when, in the course of research done for some other
...
p.000033: 33
p.000033:
p.000033: CONSENT
p.000033:
p.000033: be taken by the researcher so long as there are provisions to manage the conflict of interest and sufficient safeguards
p.000033: to protect the welfare and interests of the participant.
p.000033:
p.000033: 3.43 For research involving patients, consent for participating in research should be clearly separated from
p.000033: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000033: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000033: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000033: and sufficient safeguards to protect the welfare and interests of the patient.
p.000033:
p.000033: 3.44 While local customs should be respected when conducting research in places where social proxy arrangements
p.000033: are widespread, individual consent from the prospective participant is nevertheless essential.
p.000033:
p.000033: 3.45 For research involving minors with decision-making capacity, consent from both the minor and a parent should
p.000033: be obtained; such a minor’s refusal of consent should be respected. Apart from this, it is still important to
p.000033: engage the minor in ways that respect his or her current level of understanding. Parents or guardians
p.000033: of minors lacking decision-making capacity are authorised to consent to their participation in research
p.000033: that involves no more than minimal risk and is not contrary to their best interests.
p.000033:
p.000033: 3.46 For research that does not involve more than minimal risk, such as surveys seeking information relating only
p.000033: to the minor, IRBs should be able to waive parental consent for minors who have decision-making capacity,
p.000033: where there is otherwise no prohibition by law and parental consent is not a reasonable requirement
p.000033: for the protection of the minor’s interests.
p.000033:
p.000033: 3.47 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000033: typically epidemiological or public health research carried out with medical records or with data from national
p.000033: registries, when the following conditions are met:
p.000033:
p.000033: (a) The research is justified and poses no more than minimal risk to research participants;
p.000033:
p.000033: (b) The waiver will not adversely affect the welfare and interests of research participants;
p.000033:
p.000033: (c) The research could not practicably proceed without the waiver;
p.000033:
p.000033: (d) Obtaining consent is not possible or practicable; and
p.000033:
p.000033: (e) Individual privacy and confidentiality of the personal information are assured.
p.000033:
p.000033: 3.48 For research involving recruitment of highly compromised patients who are unable to give consent and for
p.000033: whom no proxy is available to give consent, subject to the treatment of the patient remaining the priority,
p.000033: IRBs may authorise the research, if it involves no more than minimal risk. Consent must be sought, directly
p.000033: or from a proxy, as soon as is practicable. The patient or proxy shall have every right to
p.000033:
p.000034: 34
p.000034:
...
p.000042: share in the commercial gain derived from the research;
p.000042:
p.000042: (d) Whether the biological materials may be stored and used for future research, and for how long;
p.000042:
p.000042: (e) The potential types of research for which the biological materials may be used;
p.000042:
p.000042: (f) Whether there is any possibility of being re-contacted for future research, or to be informed about clinically
p.000042: significant incidental findings, if they so wish;
p.000042:
p.000042: (g) Whether the biological materials will be identified and the applicable privacy and confidentiality
p.000042: safeguards for personal information derived from research involving the materials; and
p.000042:
p.000042: (h) That it is possible for donors to withdraw consent from the research, as long as the biological materials
p.000042: have not yet been used, and in any case without prejudice to any treatment they may be undergoing, and of the
p.000042: procedures and implications of the withdrawal.
p.000042:
p.000043: 43
p.000043:
p.000043: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000043:
p.000043: 5.16 Re-consent is required in the following situations:
p.000043:
p.000043: (a) When the proposed research is not covered by the consent that was given when the biological materials were
p.000043: collected (unless the re-consent requirement is waived by an IRB);
p.000043:
p.000043: (b) If the biological material was collected from a minor below 21 years of age, who did not at the time of
p.000043: collection possess decision-making capacity and therefore did not personally, or jointly together with his/her
p.000043: parent, consent to the donation. Once the minor attains the age of 21, his or her consent should be
p.000043: obtained if research is to be conducted on the previously collected material or personal information related to the
p.000043: sample, or at the least notified of his or her right to withdraw the biological material from research or storage for
p.000043: research. In the event that re-consent is not practicable, the IRB should generally have the discretion to waive the
p.000043: requirement in accordance with the relevant criteria for waiver of consent, where appropriate; or
p.000043:
p.000043: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000043: combinations.
p.000043:
p.000043: 5.17 When any clinically significant findings are discovered in the process of research using human
p.000043: biological materials, researchers should ensure that donors of these materials are informed, if they have
p.000043: indicated their desire to know of such findings.
p.000043:
p.000043: 5.18 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000043: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000043: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
...
p.000072: involving children (we have advocated above that there should not be such a requirement), we suggest that it should be
p.000072: the consent of the child that is waivable, rather than parental consent. Otherwise, there may an inadvertent
p.000072: displacement of the authority of the parent over the child, where the child may agree to participate, but where the
p.000072: parent may not. For example, it is likely that a parent would still need to be involved in the child’s participation in
p.000072: the research (such as arranging for the parent to be present for the research or tests to be carried
p.000072: out, etc). The parent’s wishes should be respected in such a case. This position would also be consistent with the
p.000072: position articulated in paragraph 3.45 and therefore does not run the risk of creating many different layer of consents
p.000072: (for invasive research, for non-invasive research, and for clinical research).
p.000072:
p.000072: As important as it is to take into consideration the views of the minor who will be subject to the
p.000072: research, an approach requiring both consent from the minor and parent may pose a potential problem in situations
p.000072: where the parent consents to the research and the minor does not.
p.000072:
p.000072: In the event of a deadlock, would the parents’ decision trump that of the minor, and if so, what purpose would there be
p.000072: in having both the minor and parent give consent to the research?
p.000072:
p.000072:
p.000072: C35
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 11. 4.12, 4.13
p.000072: and 4.18
p.000072:
p.000072: Use of Medical Records for Research
p.000072: Use of Personal Information
p.000072: We note that the BAC has recommended that appropriate access be given to suitably qualified professionals
p.000072: for the purpose of research. We note that the BAC Guidelines are silent on whether there is a need to obtain consent
p.000072: from patients before the release of such medical information. Whilst the BAC does advocate that the Healthcare
p.000072: Institutions and the IRBs formulate clear procedures for the release of such medical records and other
p.000072: personal information, we suggest that the Guidelines should make clear that all such access must be subject
p.000072: to IRB approval (similar to the need to obtain IRB approvals for other forms of research and which would be in
p.000072: line with paragraph 4.15 of the Guidelines).
p.000072: Tissue Banking
p.000072:
p.000072: 12. 5.8 Guidelines on Human Tissue Research
p.000072: We note that the Guidelines provide that all research involving human tissue, whether identified or de-identified,
p.000072: should be reviewed by an IRB and approved before it commences.
p.000072:
p.000072: At present, we understand that tissue banks are required to be licensed under the PHMC Act. We note that under the
...
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p.000004: materials are intended for storage and future use in research, consent should also be obtained for this purpose.
p.000004:
p.000004: 30. Re-consent is required in the following situations:
p.000004:
p.000004: (a) When the proposed research is not covered by the consent that was given when the biological materials were
p.000004: collected (unless the re-consent requirement is waived by an IRB);
p.000004:
p.000004: (b) If the biological material was collected from a minor below 21 years of age, who did not at the time of collection
p.000004: possess decision-making capacity and therefore did not personally, or jointly together with his/her parent, consent to
p.000004: the donation. In the event that re-consent is not practicable, the IRB should generally have the discretion to waive
p.000004: the requirement in accordance with the relevant criteria for waiver of consent, where appropriate; or
p.000004:
p.000004: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000004: combinations.
p.000004:
p.000004: 31. Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000004: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000004: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000004: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000004: immediately before death.
p.000004:
p.000004: 32. For research using foetal tissues, consent for the termination of pregnancy should be separate from the
p.000004: consent for obtaining foetal tissue or any tissue related to the pregnancy for research. Where possible, an
p.000004: attending physician should not also seek consent for research participation from a patient in this situation. Consent
p.000004: for the use of foetal tissue for research could be obtained from either parent, as provided for in the Medical
p.000004: (Therapy, Education and Research) Act.
p.000004:
p.000004: 33. Specific and personal consent from the donors must be obtained before any gametes or embryos are to be
p.000004: used for research. Potential donors should be provided with sufficient information to make an informed decision
p.000004: and be given at least a week to decide.
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: EXECUTIVE SUMMARY
p.000005:
p.000005:
p.000005: 34. For women undergoing fertility treatment, consent for the donation of surplus oocytes or embryos for
p.000005: research should be separate from the consent for treatment. The treating physician should not also be the
p.000005: researcher seeking consent for the donation of oocytes or embryos for research. Donors should confirm in writing that
p.000005: they do not require the oocytes or embryos for future use.
p.000005:
p.000005: 35. Women wishing to donate eggs specifically for research must be interviewed by an independent panel. The panel
p.000005: must be satisfied that they are of sound mind, clearly understand the nature and consequences of the donation,
p.000005: and have freely given explicit consent, without any inducement, coercion or undue influence.
p.000005:
p.000005: 36. If complications occur as a direct and proximate result of the egg donation, the donor should be provided
...
p.000010: of that Report.
p.000010:
p.000011: 11
p.000011:
p.000011: INTRODUCTION
p.000011:
p.000011: The Legislative and Regulatory Framework of Human Biomedical Research in Singapore
p.000011:
p.000011: 1.14 All research in Singapore, like any other activity, is bound by the laws of Singapore, comprising a
p.000011: combination of statute and case law. A number of statutes and regulations made under them are relevant
p.000011: to the conduct of human biomedical research.
p.000011:
p.000011: Statutes and Subsidiary Legislation
p.000011:
p.000011: 1.15 Relevant statutes and subsidiary legislation are as follows. The list is not exhaustive, but covers all the
p.000011: principal sources of legislation impinging on human biomedical research practice:
p.000011:
p.000011: (a) Medicines (Clinical Trials) Regulations (Cap. 176, Rg 3) made under Sections 18 and 74 of the Medicines Act
p.000011: (Cap. 176) (1985 Ed.), which is an Act to make provisions with respect to medicinal products and medical
p.000011: advertisements and matters connected therewith;
p.000011:
p.000011: (b) Health Products Act (Cap. 122D) (2008 Ed.): An Act to regulate the manufacture, import,
p.000011: supply, presentation and advertisement of health products and of active ingredients used in the manufacture of health
p.000011: products and provide for matters connected therewith;
p.000011:
p.000011: (c) Private Hospitals and Medical Clinics Act (Cap. 248) (1999 Ed.): An Act to provide for the
p.000011: control, licensing and inspection of private hospitals, medical clinics, clinical laboratories and
p.000011: healthcare establishments, and for purposes connected therewith;
p.000011:
p.000011: (d) Medical (Therapy, Education and Research) Act (Cap. 175) (1985 Ed.) (amended vide Act 4/2010):
p.000011: This is an Act to make provision for the use of the bodies of deceased persons or parts thereof for purposes
p.000011: of medical or dental education, research, advancement of medical or dental science, therapy and
p.000011: transplantation, and for other purposes connected therewith;
p.000011:
p.000011: (e) Human Cloning and other Prohibited Practices Act (Cap. 131B) (2005 Ed.): An Act to prohibit the placing of a
p.000011: human embryo clone in the body of a human or an animal and certain other practices associated with reproductive
p.000011: technology;
p.000011:
p.000011: (f) National Registry of Diseases Act (Cap. 201) (2007 Ed.) (amended vide Act 56/2007): An Act to
p.000011: establish the National Registry of Diseases and to provide for the compilation of information on the incidence of
p.000011: certain diseases for use as a basis for the direction of programmes for disease prevention and control, and for
p.000011: purposes connected therewith. This Act regulates the release of data from disease registries for public
p.000011: health and research purposes;
p.000011:
p.000011: (g) Infectious Diseases Act (Cap 137) (amended 2010): An Act relating to quarantine and the
p.000011: prevention of infectious diseases. Section 59A of the Act relates to National Public Health Research;
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: INTRODUCTION
p.000012:
p.000012: (h) Mental Capacity Act (Cap. 177A) (revised 2010): This Act reformed the law governing decisions
p.000012: made on behalf of persons lacking decision-making capacity. The Act governs decision-making on
...
p.000021:
p.000021: 2.36 Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000021: carried out in their premises or facilities; or by their employees or on their patients; or involving access to or use
p.000021: of human biological materials, medical records or other personal information in their custody. They are also
p.000021: responsible for ensuring research integrity.
p.000021:
p.000021: 2.37 Every institution that conducts human biomedical research, or allows such research to be carried out in
p.000021: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000021: research staff have access to an IRB at another institution.
p.000021:
p.000021: 2.38 Institutions should set up clear policies for the operation of their IRBs. The
p.000021: composition of IRBs and specific operational details are provided for in the MOH Operational Guidelines for
p.000021: Institutional Review Boards.12
p.000021:
p.000021: 2.39 Institutions should ensure that there is an arrangement for receiving feedback from research
p.000021: participants.
p.000021:
p.000021:
p.000021: 12 MOH, Operational Guidelines for Institutional Review Boards. 2007.
p.000021:
p.000022: 22
p.000022:
p.000022: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000022:
p.000022: 2.40 It is the responsibility of institutions to provide adequate resources, including resources for the
p.000022: training and education of IRB members, and administrative support for the IRBs to discharge their responsibilities in
p.000022: an effective and timely manner.
p.000022:
p.000022: 2.41 Institutions should ensure that provisions are made to treat and compensate research participants for the
p.000022: adverse consequences resulting directly from their participation, where appropriate.
p.000022:
p.000022: 2.42 An institution must accept legal responsibility for the decisions of its IRB and must provide the IRB members
p.000022: with a full indemnity for actions resulting from decisions made by those members in good faith in the course of
p.000022: discharging their duties.
p.000022:
p.000022: 2.43 In view of the investment of time and effort in preparing for research, including the sourcing of funds, it
p.000022: would be proper to have some kind of re-evaluation or appeal procedure in the event that a research proposal
p.000022: is not approved by an IRB. The principal investigator should then have an opportunity to further justify the
p.000022: research, or if disagreement persists, to make available an appeal mechanism in which adjudication by a
p.000022: third party is possible. Institutions are responsible for ensuring that such a mechanism is put in place.
p.000022: Appeals should be considered by another committee, whose members should not include any member of the IRB that
p.000022: initially reviewed the proposal. This committee must be able to exercise independent judgement,
p.000022: free from bias or a conflict of interests.
p.000022:
p.000022: Responsibilities of IRBs
p.000022:
p.000022: 2.44 The functions of an IRB include the following:
p.000022:
...
p.000043: collection possess decision-making capacity and therefore did not personally, or jointly together with his/her
p.000043: parent, consent to the donation. Once the minor attains the age of 21, his or her consent should be
p.000043: obtained if research is to be conducted on the previously collected material or personal information related to the
p.000043: sample, or at the least notified of his or her right to withdraw the biological material from research or storage for
p.000043: research. In the event that re-consent is not practicable, the IRB should generally have the discretion to waive the
p.000043: requirement in accordance with the relevant criteria for waiver of consent, where appropriate; or
p.000043:
p.000043: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000043: combinations.
p.000043:
p.000043: 5.17 When any clinically significant findings are discovered in the process of research using human
p.000043: biological materials, researchers should ensure that donors of these materials are informed, if they have
p.000043: indicated their desire to know of such findings.
p.000043:
p.000043: 5.18 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000043: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000043: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000043: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000043: immediately before death, if there is no actual notice of contrary indications by the deceased person, or actual notice
p.000043: of opposition of another legally authorised person of the same or prior class.
p.000043:
p.000043: Foetal Tissues
p.000043:
p.000043: 5.19 Foetal tissues include membranes, amniotic fluid, placenta and umbilical cord. Foetal tissues for research
p.000043: should only be taken from dead or non-viable foetuses. Abortion should not be induced for the purpose of obtaining
p.000043: materials for research.
p.000043:
p.000043: 5.20 Consent for the termination of pregnancy should be separate from the consent for obtaining foetal
p.000043: tissue or any tissue related to the pregnancy for research. Where possible, an attending physician
p.000043: should not also seek consent for research participation from a patient in this situation.
p.000043:
p.000043: 5.21 Consent for the use of foetal tissue for research could be obtained from either parent, as provided in the
p.000043: Medical (Therapy, Education and Research) Act.
p.000043:
p.000043: 5.22 Any research intention to propagate foetal cells in vitro and/or to transplant these cells into a human
p.000043: recipient should be disclosed when consent is sought.
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000044:
p.000044: Human Gametes and Embryos
p.000044:
p.000044: 5.23 The creation of human embryos specifically for research can only be justified when there is strong
p.000044: scientific merit in and potential medical benefit from such research. The Human Cloning and Other Prohibited
p.000044: Practices Act prohibits the development of a human embryo created other than by fertilisation of human egg by human
p.000044: sperm, for a period of more than 14 days, excluding any period when the development of the embryo is
p.000044: suspended. Commercial trading in human eggs, human sperm and human embryos is also prohibited.
p.000044:
p.000044: 5.24 The supply and use of human gametes and embryos is governed by the Human Cloning and Other
p.000044: Prohibited Practices Act (Cap. 131B). Researchers should also comply with the requirements stipulated in
p.000044: MOH’s 2011 Licensing Terms and Conditions (LTC) on Assisted Reproduction (AR) Services imposed under
p.000044: Section 6(5) of the Private Hospitals and Medical Clinics Act.
p.000044:
p.000044: 5.25 Under the LTC,25 written approval from the Director of Medical Services must be obtained for all
p.000044: research involving human embryos and human oocytes (including those obtained from excised ovarian tissue).
...
p.000065:
p.000065: Philippines. Philippine Council for Health Research and Development. National Ethical Guidelines for Health
p.000065: Research. 2006.
p.000065:
p.000065: 2nd World Conference on Research Integrity. Singapore Statement on Research Integrity. 22 September 2010.
p.000065:
p.000065: Singapore. Animals and Birds Act (Cap. 7). Revised 2002.
p.000065:
p.000065:
p.000066: 66
p.000066:
p.000066: BIBLIOGRAPHY
p.000066:
p.000066: Singapore. Bioethics Advisory Committee. Donation of Human Eggs for Research. 2008.
p.000066:
p.000066: Singapore. Bioethics Advisory Committee. Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and
p.000066: Therapeutic Cloning. 2002.
p.000066:
p.000066: Singapore. Bioethics Advisory Committee. Genetic Testing and Genetic Research. 2005.
p.000066:
p.000066: Singapore. Bioethics Advisory Committee. Human-Animal Combinations in Stem Cell Research. 2010.
p.000066:
p.000066: Singapore. Bioethics Advisory Committee. Human Tissue Research. 2002.
p.000066:
p.000066: Singapore. Bioethics Advisory Committee. Personal Information in Biomedical Research. 2007.
p.000066:
p.000066: Singapore. Bioethics Advisory Committee. Research Involving Human Subjects: Guidelines for IRBs. 2004.
p.000066:
p.000066: Singapore. Children and Young Persons Act (Cap. 38). Amended 2001. Singapore. Guardianship of Infants Act (Cap. 122).
p.000066: Amended 1985.
p.000066: Singapore. Health Products Act (Cap. 122D). 2008.
p.000066:
p.000066: Singapore. Human Cloning and other Prohibited Practices Act (Cap. 131B). 2005. Singapore. Infectious Diseases Act (Cap.
p.000066: 137). Amended 2010.
p.000066: Singapore. Medical (Therapy, Education and Research) Act (Cap. 175). Amended 2010. Singapore. Medicines (Clinical
p.000066: Trials) Regulations (Cap. 176). Amended 2000.
p.000066: Singapore. Medicines Act (Cap. 176). 1985.
p.000066:
p.000066: Singapore. Mental Capacity Act (Cap. 177A). Revised 2010.
p.000066:
p.000066: Singapore. Ministry of Health. Code of Ethical Practice in Human Biomedical Research. 2009.
p.000066:
p.000066: Singapore. Ministry of Health. Governance Framework for Human Biomedical Research.
p.000066: December 2007.
p.000066:
p.000066: Singapore. Ministry of Health. Licensing Terms and Conditions on Assisted Reproduction Services. 2011.
p.000066:
p.000066: Singapore. Ministry of Health. Operational Guidelines for Institutional Review Boards. December 2007.
p.000066:
p.000066:
p.000066:
p.000067: 67
p.000067:
p.000067: BIBLIOGRAPHY
p.000067:
p.000067: Singapore. Ministry of Health. Singapore Guideline for Good Clinical Practice. Revised 1999.
p.000067:
p.000067: Singapore. National Advisory Committee for Laboratory Animal Research. Guidelines on the Care and Use of Animals for
p.000067: Scientific Purposes. 2004.
p.000067:
p.000067: Singapore. National Healthcare Group. Investigator Manual: All that an Investigator Needs to Know. August 2009.
p.000067:
p.000067: Singapore. National Medical Ethics Committee. Ethical Guidelines for Gene Technology. 2001.
p.000067:
p.000067: Singapore. National Medical Ethics Committee. Ethical Guidelines on Research Involving Human Subjects. 1997.
p.000067:
p.000067: Singapore, National Medical Ethics Committee. Recommendations on Clinical Trials: Update Focusing on
...
p.000072:
p.000072: 1.15 All research in Singapore, like any other activity, is bound by the laws of Singapore, comprising a
p.000072: combination of case and statute law. A number of statutes and regulations made under them are relevant to the
p.000072: conduct of biomedical research.
p.000072: Statutes and Subsidiary Legislation
p.000072:
p.000072: 1.16 Relevant statutes and subsidiary legislation are as follows. The list is not exhaustive, but covers all the
p.000072: principal sources of legislation impinging on biomedical research practice:
p.000072: (a) Medicines (Clinical Trials) Regulations (Cap. 176, Rg 3) made under Sections 18 and 74 of the Medicines Act
p.000072: (Cap. 176) (1985 Ed.), which is an Act to make provisions with respect to medicinal products and medical advertisements
p.000072: and matters connected therewith;
p.000072: (b) Health Products Act (Cap. 122D) (2008 Ed.): An Act to regulate the manufacture, import,
p.000072: supply, presentation and advertisement of health products and of active ingredients used in the manufacture of health
p.000072: products and provide for matters connected therewith;
p.000072: (c) Ministry of Health (MOH), Licensing Terms and Conditions on Assisted Reproduction Services (2011)
p.000072: imposed under Section 6(5) of the Private Hospitals and Medical Clinics Act (Cap. 248) (1999 Ed.),
p.000072: which is an Act to provide for the control, licensing and inspection of private hospitals, medical
p.000072: clinics, clinical laboratories and healthcare establishments, and for purposes connected therewith. Sections 9
p.000072: and 10 of the Licensing Terms and Conditions relate to research;
p.000072: (d) Medical (Therapy, Education and Research) Act (Cap. 175) (1985 Ed.) (amended vide Act 4/2010):
p.000072: This is an Act to make provision for the use of the bodies of deceased persons or parts thereof for purposes
p.000072: of medical or dental education, research, advancement of medical or dental science, therapy and
p.000072: transplantation, and for other purposes connected therewith;
p.000072:
p.000072:
p.000072:
p.000072: A5
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (e) Human Cloning and other Prohibited Practices Act (Cap. 131B) (2005Ed.): An Act to prohibit the placing of a
p.000072: human embryo clone in the body of a human or an animal and certain other practices associated with reproductive
p.000072: technology;
p.000072: (f) National Registry of Diseases Act (Cap. 201) (2007 Ed.) (amended vide Act 56/2007): An Act to
p.000072: establish the National Registry of Diseases and to provide for the compilation of information on the incidence of
p.000072: certain diseases for use as a basis for the direction of programmes for disease prevention and control, and for
p.000072: purposes connected therewith. This Act regulates the release of data from disease registries for public
p.000072: health and research purposes;
p.000072: (g) Infectious Diseases Act (Cap 137), amended 2010: An Act relating to quarantine and the prevention of
p.000072: infectious diseases. Section 59A of the Act relates to National Public Health Research;
p.000072: (h) Mental Capacity Act (Cap. 177A), revised 2010: This Act reformed the law where decisions need to be
p.000072: made on behalf of persons lacking capacity. The Act governs decision-making on behalf of persons lacking
p.000072: capacity in specified conditions, both where they lose mental capacity at some point in their lives (for example as
...
p.000072: with the expectations or hopes of their source of funds. IRBs need to consider how best to avoid such threats to
p.000072: integrity when considering applications in which they might arise.
p.000072:
p.000072: Responsibilities of Institutions
p.000072:
p.000072: 2.39 Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000072: carried out on their premises or facilities; or by their employees or on their patients; or involving access to or use
p.000072: of human tissue collections, medical records or other personal information in their custody. They are also responsible
p.000072: for ensuring research integrity.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A16
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 2.40 Every institution that conducts human biomedical research, or allows such research to be carried out on
p.000072: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000072: research staff have access to an IRB at another institution.
p.000072:
p.000072: 2.41 The institution should set up clear policies for the operation of IRBs. The composition of IRBs and
p.000072: specific operational details are provided in the MOH Operational Guidelines for Institutional Review Boards.47
p.000072:
p.000072: 2.42 It is the responsibility of institutions to provide adequate resources, including resources for the
p.000072: training and education of IRB members, and administrative support for the IRBs to discharge their responsibilities in
p.000072: an effective and timely manner.
p.000072:
p.000072: 2.43 Institutions should ensure that provisions are made to compensate or treat research participants
p.000072: for adverse consequences of their participation, where appropriate.
p.000072:
p.000072: 2.44 An institution must accept legal responsibility for the decisions of its IRB and must provide the IRB members
p.000072: with full indemnity against actions resulting from decisions made by those members in good faith in the course of their
p.000072: duties.
p.000072:
p.000072: 2.45 In view of the investment of time and effort in preparing for research, including the sourcing of funds, it
p.000072: would be proper for there to be in place some kind of mediation or appeals procedure, so that in the event that a
p.000072: research proposal is not approved by an IRB, the Principal Investigator has an opportunity to further justify the
p.000072: research, or if disagreement persists, to have available an appeal mechanism in which adjudication by some third party
p.000072: is possible. Institutions are responsible for ensuring that such a mechanism is in place.
p.000072:
p.000072: Responsibilities of IRBs
p.000072:
p.000072: 2.46 The functions of an IRB include the following:
p.000072:
p.000072: (a) The ethics review and approval of proposed human biomedical research projects;
p.000072:
p.000072: (b) Ensuring that research proposals have been scientifically evaluated and have scientific merit. The IRB
p.000072: is not expected to undertake the review itself, but has to be satisfied that it has been competently done;
p.000072:
...
p.000072: is no clear legal standing for assent as a procedure – unlike the case of consent – the BAC retains the use of the term
p.000072: consent for children as well as adults, but on the understanding that a child’s consent can be informed only to the
p.000072: extent that is reasonable given the child’s age, and that a combination of parental and child consent is
p.000072: the normal requirement. The older the child and the more mature his or her understanding, the more important it is to
p.000072: engage them in ways that respect their level of understanding and their right to refuse.
p.000072:
p.000072: 3.23 In Singapore, under the common law, the age of majority is 21 years. This age is generally
p.000072: taken as the age at which a person is considered an adult and thus able to make all decisions for oneself.
p.000072:
p.000072: 3.24 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000072: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy. The gift
p.000072: will take effect upon death.
p.000072:
p.000072: 3.25 Under the Medicines (Clinical Trials) Regulations, consent for participation in clinical trials must be
p.000072: obtained from the parent, guardian or legal representative of an individual below the age of 21.
p.000072:
p.000072: 3.26 The BAC is of the view that for research involving individuals less than 21 years of age and presenting more
p.000072: than minimal risk, such as those with invasive procedures, consent from parents should be obtained, in addition to
p.000072: consent from the child. For research that does not involve more than minimal risk, such as surveys, IRBs should be able
p.000072: to waive parental consent.
p.000072:
p.000072: Waiver of Consent
p.000072:
p.000072: 3.27 IRBs may consider a waiver of the consent requirement for research done in the public interest,
...
p.000072: implications of the withdrawal.
p.000072: 5.16 Re-consent is required in the following situations:
p.000072:
p.000072: (a) When the proposed research is not covered by the consent that was given when the tissue was collected
p.000072: (unless the re-consent requirement is waived by an IRB);
p.000072: (b) If the tissue was collected when the individual was a child, such that consent from a parent or
p.000072: guardian was required, and there is ongoing contact. Once the child attains the age of 21, his or her consent should be
p.000072: obtained if research is to
p.000072:
p.000072:
p.000072: A36
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: be conducted on the previously collected tissue or information related to this tissue specimen. In the event
p.000072: re-contact is not practicable, the IRB should have the discretion to determine whether or not the stored material or
p.000072: information can be used without re-consent; and
p.000072: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000072: combinations.
p.000072:
p.000072: 5.17 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000072: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000072: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000072: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000072: immediately before death, if there are no actual notice of contrary indications by the deceased person, or actual
p.000072: notice of opposition of another legally authorised person of the same or prior class.
p.000072: Foetal Tissues
p.000072:
p.000072: 5.18 Foetal tissues include membranes, amniotic fluid, placenta and umbilical cord. Foetal tissues for research
p.000072: should only be taken from dead or non-viable foetuses. Abortion should not be induced for the purpose of obtaining
p.000072: material for research.
p.000072: 5.19 Consent for the termination of pregnancy should be separate from the consent for obtaining foetal
p.000072: tissue or any tissue related to the pregnancy for research. Provisions for ensuring that where possible an attending
p.000072: physician should not also seek consent for research participation from a patient apply mutatis mutandis in this
p.000072: situation.
p.000072: 5.20 Consent for the use of foetal tissue for research could be obtained from either parent, as indicated in the
p.000072: Medical (Therapy, Education and Research) Act.
p.000072: 5.21 Any intention to propagate foetal cells in vitro and/or to transplant these cells into a human recipient
p.000072: should be disclosed when consent is sought.
p.000072: Human Gametes and Embryos
p.000072:
p.000072: 5.22 The creation of human embryos specifically for research can only be justified when there is strong
p.000072: scientific merit and potential medical benefit from such research. Under the Human Cloning and Other Prohibited
p.000072: Practices Act, the development of a human embryo created other than by fertilisation of human egg by human sperm, for a
p.000072: period of more than 14 days, excluding any period when the development of the embryo is suspended, is
p.000072: prohibited. Commercial trading in human eggs, human sperm and human embryos is also not allowed.
p.000072: 5.23 The use of human gametes or embryos for research is governed by the requirements of the law, as given in the
p.000072: MOH’s 2011 Licensing Terms and Conditions on Assisted Reproduction Services imposed under Section 6(5) of the
p.000072: Private Hospitals and
p.000072:
p.000072:
p.000072: A37
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Medical Clinics Act and by the Human Cloning and Other Prohibited Practices Act (Cap. 131B).
p.000072: 5.24 Under the Licensing Terms and Conditions on Assisted Reproduction Services, written approval from
p.000072: the Director of Medical Services must be obtained for all research involving human embryos and human
p.000072: oocytes (including those obtained from excised ovarian tissue). This requirement extends to human-animal combination
...
p.000072: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS, 2002.
p.000072:
p.000072: Department of Health and Human Services. The Belmont Report: Ethical Principles and Guidelines for the Protection of
p.000072: Human Subjects of Research. United States of America, 1979.
p.000072:
p.000072: Department of Health and Human Services. Protection of Human Subjects, Title 45 Code of Federal Regulations, Part 46,
p.000072: 102(d). United States of America, 1980.
p.000072:
p.000072: Greene M and 21 others. Moral Issues of Human-Non-Human Primate Neural Grafting. Science. 309 (2005):
p.000072: 385-386.
p.000072:
p.000072: Harris B. Disciplinary and Regulatory Proceedings. 6th Ed. London: Wiley & Sons, 2011.
p.000072:
p.000072: Health Products Act (Cap. 122D). Singapore, 2008.
p.000072:
p.000072: Human Cloning and other Prohibited Practices Act (Cap. 131B). Singapore, 2005.
p.000072:
p.000072: Human Fertilisation and Embryology Act 2008. United Kingdom: HMSO.
p.000072:
p.000072:
p.000072: A53
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Human Tissue Act 2004. United Kingdom: HMSO.
p.000072:
p.000072: Infectious Diseases Act (Cap. 137). Singapore, Amended 2010.
p.000072:
p.000072: Levine RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al. (Eds.) The Oxford
p.000072: textbook of clinical research ethics. Oxford: OUP (2008) page 211.
p.000072:
p.000072: Medical (Therapy, Education and Research) Act (Cap. 175). Singapore, amended 2010.
p.000072:
p.000072: Medical Research Council. Human tissue and biological samples for use in research: Operational and Ethical Guidelines.
p.000072: United Kingdom, 2005.
p.000072:
p.000072: Medical Research Council. Ethics Guide: Medical research involving adults who cannot consent. United Kingdom,
p.000072: 2007.
p.000072:
p.000072: Medical Research Council. Ethics Guide: Medical research involving children. United Kingdom, 2004.
p.000072:
p.000072: Medicines Act (Cap. 176). Singapore, 1985.
p.000072:
p.000072: Mental Capacity Act 2005. United Kingdom: HMSO.
p.000072:
p.000072: Mental Capacity Act. Singapore, 2010.
p.000072:
p.000072: Ministry of Health. Code of Ethical Practice in Human Biomedical Research. Singapore, 2009.
p.000072:
p.000072: Ministry of Health. Governance Framework for Human Biomedical Research. Singapore, December 2007.
p.000072:
p.000072: Ministry of Health. Guideline for Good Clinical Practice. Singapore, Revised 1999.
p.000072:
p.000072: Ministry of Health. Licensing Terms and Conditions on Assisted Reproduction Services. Singapore, 2011.
p.000072:
p.000072: Ministry of Health. Operational Guidelines for Institutional Review Boards. Singapore, December 2007.
p.000072:
p.000072: Ministry of Information and the Arts. Public Consultation Paper on Proposed Data Protection Bill. Singapore,
p.000072: 2012.
p.000072:
...
p.000072: include: (i) a detailed explanation of what genetic testing is and what it can be used for (paragraphs 2.1 to 2.11);
p.000072: (ii) general and specific ethical considerations in genetic testing including the 20 recommendations given by
p.000072: the BAC with regards to how genetic testing should be conducted (paragraphs 4.1 to 4.80); and (iii) genetic
p.000072: counseling (paragraphs 4.81 to 4.89). The information set out in the Guidelines seem to provide a very broad summary of
p.000072: genetic testing and only appear to touch on the surface when it comes to content-specific information.
p.000072:
p.000072: (ii) The portion on Stem Cell research in the Guidelines is covered in paras 7.1 to 7.32. However the BAC Report on
p.000072: Human-Animal Combinations in Stem Cell Research (“BAC Stem Cell Research Guidelines”) spans 34 pages. Similar
p.000072: to the BAC Genetic Testing Guidelines, the Guidelines does not include large portions of the BAC Stem Cell
p.000072: Research Guidelines. These include: (i) the detailed explanation on
p.000072:
p.000072: C28
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: chimeras and hybrids as at out in paragraphs 2.1 to 2.15; (ii) the regulatory practices adopted by different countries
p.000072: set out at paragraphs 4.1 to 4.11; and (iii) the table of regulatory approaches adopted by different countries at pages
p.000072: 27 to 34 of the BAC Stem Cell Research Guidelines.
p.000072:
p.000072: (iii) Other omissions from the Guidelines include important principles such as the one stated in paragraph 8.7 of
p.000072: the Human Tissue Research Report “…the governing common law principle that informs the letter of the law of both
p.000072: the Human Organ Transplant Act, and of the Medical (Treatment, Education and Research) Act: no person may enter into
p.000072: a contract for the sale of his body or any part thereof, including organs, tissue or blood. No person is
p.000072: under any compulsion to give. Nor is any person under an obligation to accept a gift…”.
p.000072:
p.000072: Our view is that these background information can be very helpful in understanding the background and BAC’s
p.000072: thinking in relation to the relevant guidelines and recommendations. We therefore suggest that
p.000072: the Guidelines be expressed as being complementary to the previous Reports, and to also include references to the
p.000072: previous Reports, where helpful, within the Guidelines. This will also aid readers to navigate the BAC’s Reports.
p.000072:
p.000072: On another level, we also propose that there should be an effort in consolidating other relevant guidelines to human
p.000072: biomedical research. Particularly, we note that other than the BAC (which guidelines do not have the force of
p.000072: law), there are also a number of other guidelines issued by various bodies, including the Ministry of Health, the
p.000072: National Medical Ethics Committee, and the Singapore Medical Council. Whilst the guidelines issued by these
p.000072: bodies are presumably drafted with the specific target audience (such as the healthcare institutions licensed under the
p.000072: Private Hospitals and Medical Clinics Act (“PHMC Act”) in the case of the MOH guidelines), there may be a need to
p.000072: review and to consider whether there are any inconsistencies or ambiguities amongst these various guidelines, as a
p.000072: plethora of guidelines can lead to confusion as to the applicable ethical codes. In particular (see our comments to
...
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p.000063:
p.000063: II. Ethics Governance of Human Biomedical Research
p.000063:
p.000063: 3. An IRB should review all human biomedical research and the composition of the IRB should combine
p.000063: appropriate expertise with some lay representation to reinforce the objectivity and impartiality of the
p.000063: process. The composition of IRBs and specific functional and operational details are provided for
p.000063: in the MOH Operational Guidelines for Institutional Review Boards.
p.000063:
p.000063: 4. The level of detail required in a research protocol submitted for IRB review should vary in proportion to
p.000063: the identifiable risk or sensitivity of the research. IRBs may conduct either full or expedited reviews, or
p.000063: grant exemptions from ethics review. An expedited review is permissible for research that involves no more than minimal
p.000063: risk to research participants while exemptions from review must involve no likelihood of harm to research
p.000063: participants. The Chairperson or other IRB delegate(s) may be empowered to conduct expedited reviews or grant
p.000063: exemptions.
p.000063:
p.000063: 5. Minimal risk refers to an anticipated level of harm and discomfort that is no greater than that ordinarily
p.000063: encountered in daily life, or during the performance of routine educational, physical, or psychological
p.000063: tasks.
p.000063:
p.000063: 6. In multi-centre research, a lead IRB could be designated that plays the main role in conducting a full
p.000063: ethics review. Multi-national research should be subject to review by the IRB of the local partner institution(s).
p.000063:
p.000063: 7. Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000063: carried out in their premises or facilities; or by their employees or
p.000063:
p.000001: 1
p.000001:
p.000001: EXECUTIVE SUMMARY
p.000001:
p.000001:
p.000001: on their patients; or involving access to or use of human biological materials, medical records or other personal
p.000001: information in their custody. They are also responsible for ensuring research integrity.
p.000001:
p.000001: 8. Every institution that conducts human biomedical research, or allows such research to be carried out in
p.000001: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000001: research staff have access to an IRB at another institution. Should a research proposal be rejected by an
p.000001: IRB, an appeal mechanism should be available in which a second committee must be able to exercise independent
p.000001: judgement.
p.000001:
p.000001: 9. The responsibilities of the researchers include ensuring that their research is
p.000001: conducted with integrity and complies with all relevant laws and other regulatory obligations and
...
p.000014: patients, when commercial value or scientific prestige may be attached to the outcomes of research, or
p.000014: when findings may not support the hopes of those who provide funding.
p.000014:
p.000014: 2.2 Ethics governance of research seeks to ensure the protection and assurance of the safety, health,
p.000014: dignity, welfare and privacy of research participants, and to safeguard against unethical practices. There have been a
p.000014: number of international documents and declarations that form the foundation of ethical biomedical research
p.000014: governance as practised in major research jurisdictions. They have also formed the basis for the ethical
p.000014: principles that have guided the BAC. The following foundational documents and declarations are key:
p.000014:
p.000014: (a) The Nuremberg Code (1949);
p.000014:
p.000014: (b) The World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.000014: Subjects (1964, revised 2013);
p.000014:
p.000014: (c) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
p.000014: Research (1979);
p.000014:
p.000014: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000014:
p.000014: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000014: Declaration on Bioethics and Human Rights (2005).
p.000014:
p.000014: General Ethical Principles that have Guided the BAC
p.000014:
p.000014: 2.3 A review of the five foundational documents above reveals that participants need to be protected and their
p.000014: autonomy in matters of research participation recognised. Although these documents do not agree on every
p.000014: particular matter, they appear to be in accord in their fundamentals. Based on these, the BAC has formulated
p.000014: the following five guiding principles reflecting their local application, first summarised in its Egg Donation Report.
p.000014:
p.000014: 5 The BAC used the term “subject” in its earlier reports, but more recently has used the term “participant”. The
p.000014: latter is preferred as it implicitly acknowledges that research participants choose to participate, and
p.000014: should not be merely the passive subjects of research.
p.000014:
p.000015: 15
p.000015:
p.000015: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000015:
p.000015: Respect for persons
p.000015:
p.000015: 2.4 Individuals are to be respected as human beings and treated accordingly. This includes respecting
p.000015: their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC
...
p.000020:
p.000020: Guidelines on Ethics Governance of Human Biomedical Research
p.000020:
p.000020: Ethics Review
p.000020:
p.000020: 2.26 All human biomedical research as defined in paragraph 1.8 should be reviewed by a properly constituted IRB.
p.000020: The composition of an IRB should combine appropriate expertise with some lay representation to reinforce the
p.000020: objectivity and impartiality of the process, so that there can be no room for any public perception that
p.000020: it is not independent of those who are required to submit research for its review.
p.000020:
p.000020: 2.27 The level of detail required in a research protocol submitted for an IRB review should vary in proportion
p.000020: to the identifiable risk or sensitivity of the research. IRBs may conduct either full or expedited reviews,
p.000020: or grant exemptions from ethics review. Each institution should determine for itself, after due deliberation and
p.000020: consultation with its IRB, the categories of research that could be expedited or exempted from ethics
p.000020: review. Such research must present no more than minimal risks to research participants, where
p.000020: minimal risk refers to an anticipated level of harm and discomfort that is no greater than that ordinarily
p.000020: encountered in daily life, or during the performance of routine educational, physical, or psychological tasks.
p.000020:
p.000020: 2.28 A less formal process of review than that of a standard full review is permissible for research that
p.000020: involves no more than minimal risk to research participants. The Chairperson or other IRB delegate(s) may be
p.000020: empowered to conduct such expedited reviews.
p.000020:
p.000020: 2.29 In the case of exemption from review, there must be no likelihood of harm to research participants, for
p.000020: example, when irreversibly de-identified data or commercialised human cell lines are used. Researchers
p.000020: seeking exemption from review would accordingly need to make a request with an abbreviated protocol,
p.000020: and obtain endorsement from the IRB before commencing the research. The Chairperson or other IRB delegate(s) may be
p.000020: empowered to grant such exemptions.
p.000020:
p.000020: Multi-Centre and Multi-National Research
p.000020:
p.000020: 2.30 For multi-centre research, a lead IRB could be designated. The choice of the lead IRB should be dictated by
p.000020: considerations such as the primary institution of affiliation of the principal investigator, the location where the
p.000020: greater part of the research is carried out, the expertise of the IRBs, or the place where the largest number of
p.000020: participants is located. The lead IRB will play the main role in conducting a full ethics review, in coordinating the
p.000020: research programme, and in keeping the other participating IRBs informed of any decisions or amendments,
p.000020: including those made during the entire research period.
p.000020:
...
p.000069: Information Sheets & Consent Forms: Guidance for Researchers & Reviewers. March 2011.
p.000069:
p.000069: United Kingdom. National Health Services, National Patient Safety Agency, National Research Ethics Service.
p.000069: Standard Operating Procedures for Research Ethics Committees. May 2010.
p.000069:
p.000069: United Kingdom, Nuffield Council on Bioethics. Novel Techniques for the Prevention of Mitochondrial DNA
p.000069: Disorders: An Ethical Review. June 2012.
p.000069:
p.000069: United Kingdom. Nuffield Council on Bioethics. Report on Human Tissue: Ethical and Legal Issues. April 1995.
p.000069:
p.000069: United Kingdom. Nuffield Council on Bioethics. The Ethics of Research Related to Healthcare in
p.000069: Developing Countries. 2002.
p.000069:
p.000069: United Kingdom. Royal College of Paediatrics and Child Health: Ethics Advisory Committee.
p.000069: Guidelines for the Ethical Conduct of Medical Research Involving Children. 2000.
p.000069:
p.000069: United Kingdom. The Health Service (Control of Patient Information) Regulations. 2002. United Kingdom. The Medicines
p.000069: for Human Use (Clinical Trials) Regulations. 2004.
p.000069: United Kingdom. UK Biobank Ethics and Governance Framework. October 2007.
p.000069:
p.000069: United Nations Educational, Scientific and Cultural Organisation. Report of the IBC on Pre- implantation Genetic
p.000069: Diagnosis and Germ-line Intervention. 24 April 2003.
p.000069:
p.000069: United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human Rights.
p.000069: 2005.
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000070: BIBLIOGRAPHY
p.000070:
p.000070: United States of America. Office for Human Research Protections, Department of Health and Human Services. Protection of
p.000070: Human Subjects, Title 45 Code of Federal Regulations, Part
p.000070: 46. Revised 2009.
p.000070:
p.000070: United States of America. National Bioethics Advisory Commission. Research Involving Human Biological
p.000070: Materials: Ethical Issues and Policy Guidance. August 1999.
p.000070:
p.000070: United States of America. National Commission for the Protection of Human Subjects of Biomedical and
p.000070: Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human
p.000070: Subjects of Research. 1979.
p.000070:
p.000070: United States of America. National Institutes of Health. Guidelines for the Conduct of Research Involving
p.000070: Human Subjects at the National Institutes of Health. August 2004.
p.000070:
p.000070: United States of America. National Institutes of Health. NIH Guidelines for Research Involving Recombinant
p.000070: DNA Molecules. October 2011.
p.000070:
p.000070: United States of America. Nuremberg Code. In: Trials of War Criminals before the Nuremberg Military
p.000070: Tribunals under Control Council. Law No. 10, Vol. 2: 181-182. 1949.
p.000070:
...
p.000072: of scientists is undermined by their obligations to their employers or to the funders of their research.
p.000072:
p.000072: 2.4 As a consequence of such considerations there have been a number of international documents and declarations
p.000072: that form the foundations of ethical biomedical research governance as practised in major jurisdictions. They have
p.000072: also formed the basis for the ethical principles that have guided the BAC. Of these foundation documents and
p.000072: declarations the following are key:
p.000072:
p.000072: (a) The Nuremberg Code (1947), reported in 1949;
p.000072:
p.000072: (b) The Declaration of Helsinki: Ethical Principles for Research Involving Human Subjects (1964, Revised 2008);
p.000072:
p.000072: (c) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
p.000072: Research (1979);
p.000072:
p.000072:
p.000072: 40 The BAC used the term “subject” in its earlier reports, but more recently has used the term
p.000072: “participant”. The latter is increasingly used in many jurisdictions as it implicitly acknowledge the fact that
p.000072: research participants choose to participate, and should not be merely the passive subjects of research.
p.000072: These terms are however treated as interchangeable in these Guidelines.
p.000072:
p.000072:
p.000072:
p.000072: A8
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000072: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000072: Declaration on Bioethics and Human Rights (2005).
p.000072:
p.000072: General Ethical Principles that have Guided the BAC
p.000072:
p.000072: 2.5 A review of the five foundation documents above reveals that participants need to be protected and their
p.000072: autonomy in matters of research participation recognised. Although these documents do not agree in
p.000072: every particular, they appear to be in accord in their fundamentals. Based on these, the BAC formulated
p.000072: five guiding principles reflecting their local application, first summarised in its Egg Donation Report. In
p.000072: particular, as enjoined by the UNESCO Declaration, the BAC expects researchers to be aware of and respect the
p.000072: cultural and religious diversity of Singapore society. The BAC also indicated that respect for individuals can be
p.000072: subordinate to the public interest in certain cases, as in some kinds of public health research.
p.000072: 2.6 The five principles the BAC endorses are as follows:
p.000072:
p.000072: Respect for persons
p.000072:
p.000072: 2.7 Individuals are to be respected as human beings and treated accordingly. This includes respecting
p.000072: their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC
...
p.000072: during which the IRB system has been implemented.
p.000072:
p.000072: Guidelines on Ethics Governance of Biomedical Research
p.000072:
p.000072: Ethics Review
p.000072:
p.000072: 2.29 All human biomedical research as defined in paragraph 1.10 should be reviewed by a properly constituted IRB.
p.000072: The composition of an IRB should combine appropriate expertise with some lay representation to reinforce the
p.000072: objectivity and impartiality of the process, and so that there can be no room for any public perception that it is not
p.000072: independent of those who are required to submit to its review.
p.000072:
p.000072: 2.30 The level of detail required in a research protocol submitted for an IRB review should vary in proportion
p.000072: to the identifiable risk or sensitivity of the research. IRBs may conduct either full or expedited reviews,
p.000072: or grant exemptions from ethics review. Each institution should determine for itself, after due deliberation and
p.000072: consultation with its IRB, the categories of research that could be expedited or exempted from ethics
p.000072: review. Such research must present no more than minimal risks to the research participants, where minimal
p.000072: risk refers to an anticipated level of harm and discomfort that is no greater than that ordinarily encountered
p.000072: in daily life, or during the performance of routine educational, physical, or psychological tasks.
p.000072:
p.000072: 2.31 A less formal process of review than that of a standard full review is permissible for research that involves
p.000072: minimal risk. The Chairperson, or other IRB delegate(s) may be empowered to conduct such expedited reviews.
p.000072:
p.000072: 2.32 In the case of exemption from review, there should be no likelihood of harm, for example, when
p.000072: irreversibly de-identified data is used.. Researchers seeking exemption from review would need to make a request with
p.000072: an abbreviated protocol accordingly, and obtain endorsement from the IRB, before commencing the research.
p.000072:
p.000072: Multi-Centre and Multi-National Research
p.000072:
p.000072: 2.33 For multi-centre research, a lead IRB could be designated. The choice of the lead IRB should be dictated by
p.000072: considerations such as the principal institution of affiliation of the Principal Investigator, the location where the
p.000072: greater part of the research is carried out, the expertise of the constituted IRB, or the location where the largest
p.000072: number of subjects is located. The lead IRB will play the main role in conducting a full ethics
p.000072:
p.000072:
p.000072:
p.000072: A15
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: review, in coordinating the research programme, and in keeping other participating IRBs informed of any
p.000072: decisions or amendments, including those made during the whole research period.
p.000072:
p.000072: 2.34 For multi-national research, the local portion should be subject to review by the IRB of the local partner
...
p.000072: Australia, 2007.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A54
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: National Healthcare Group. Investigator Manual: All that an Investigator Needs to Know. Singapore, August
p.000072: 2009.
p.000072:
p.000072: National Medical Ethics Committee. Ethical Guidelines for Gene Technology. Singapore, 2001.
p.000072:
p.000072: National Medical Ethics Committee. Ethical Guidelines on Research Involving Human Subjects, Singapore, 1997.
p.000072:
p.000072: National Medical Ethics Committee. Recommendations on Clinical Trials: Update Focusing on Phase I Trials,
p.000072: Singapore, 2007.
p.000072:
p.000072: National Registry of Diseases Act (Cap. 201). Singapore, 2007.
p.000072:
p.000072: Nuremberg Code. In: Trials of War Criminals before the Nuremberg Military Tribunals under Control Council.
p.000072: U.S. Government Printing Office, Washington D.C. Law No. 10, Vol. 2: 181-182 (1949).
p.000072:
p.000072: Ourednik V and 10 others. Segregation of Human Neural Stem Cells in the Developing Primate
p.000072: Forebrain. Science. 293 (2001): 1820-1824.
p.000072:
p.000072: Personal Data Protection Bill. Singapore, 2012.
p.000072:
p.000072: Private Hospitals and Medical Clinics Act (Cap. 248). Singapore, 1999. Singapore Medical Council. Ethical Code and
p.000072: Ethical Guidelines (nd).
p.000072: United Nations Educational, Scientific and Cultural Organization (UNESCO)
p.000072: Universal Declaration on Bioethics and Human Rights, 2005.
p.000072:
p.000072: Wilfond BS and Diekema DS. Engaging children in genomics research: decoding the meaning of assent in research, Genetics
p.000072: in Medicine.14 (2012): 437-443.
p.000072:
p.000072: World Medical Association. Declaration of Helsinki:Ethical Principles for Medical Research Involving Human
p.000072: Subjects (revised 2008).
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A55
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: List of Abbreviations
p.000072:
p.000072:
p.000072: BAC Bioethics Advisory Committee
p.000072: HFEA Human Fertilisation and Embryology Authority
p.000072: HSA Health Sciences Authority
p.000072: IRB Institutional Review Board
p.000072: LPA Lasting power of attorney
p.000072: MOH Ministry of Health
p.000072: NMEC National Medical Ethics Committee
p.000072: SGGCP Singapore Guideline for Good Clinical Practice
p.000072: UNESCO United Nations Educational, Scientific and Cultural Organization
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A56
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: ANNEX B
p.000072:
p.000072: CONSULTATION PAPER DISTRIBUTION LIST
p.000072:
p.000072:
p.000072:
p.000072: ANNEX B
p.000072:
p.000072: Distribution List for Consultation Paper on
p.000072: “Ethics Guidelines for Human Biomedical Research – for comments” (Public Consultation Period: 20 June 2012 to 15 August
p.000072: 2012)
p.000072:
p.000072: 1. Academy of Medicine
p.000072: 2. Agency for Integrated Care
p.000072: 3. Alice Lee Centre for Nursing Studies
p.000072: 4. Alzheimer’s Disease Association
p.000072: 5. Association of Muslim Professionals
p.000072: 6. Autism Association (Singapore)
p.000072: 7. Bioinformatics Institute
p.000072: 8. Biomedical Research Council
p.000072: 9. Bioprocessing Technology Institute
p.000072: 10. Buddhist Fellowship
p.000072: 11. Cardiovascular Research Institute
p.000072: 12. The Catholic Medical Guild of Singapore
...
Social / embryo
Searching for indicator embryo:
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p.000011: principal sources of legislation impinging on human biomedical research practice:
p.000011:
p.000011: (a) Medicines (Clinical Trials) Regulations (Cap. 176, Rg 3) made under Sections 18 and 74 of the Medicines Act
p.000011: (Cap. 176) (1985 Ed.), which is an Act to make provisions with respect to medicinal products and medical
p.000011: advertisements and matters connected therewith;
p.000011:
p.000011: (b) Health Products Act (Cap. 122D) (2008 Ed.): An Act to regulate the manufacture, import,
p.000011: supply, presentation and advertisement of health products and of active ingredients used in the manufacture of health
p.000011: products and provide for matters connected therewith;
p.000011:
p.000011: (c) Private Hospitals and Medical Clinics Act (Cap. 248) (1999 Ed.): An Act to provide for the
p.000011: control, licensing and inspection of private hospitals, medical clinics, clinical laboratories and
p.000011: healthcare establishments, and for purposes connected therewith;
p.000011:
p.000011: (d) Medical (Therapy, Education and Research) Act (Cap. 175) (1985 Ed.) (amended vide Act 4/2010):
p.000011: This is an Act to make provision for the use of the bodies of deceased persons or parts thereof for purposes
p.000011: of medical or dental education, research, advancement of medical or dental science, therapy and
p.000011: transplantation, and for other purposes connected therewith;
p.000011:
p.000011: (e) Human Cloning and other Prohibited Practices Act (Cap. 131B) (2005 Ed.): An Act to prohibit the placing of a
p.000011: human embryo clone in the body of a human or an animal and certain other practices associated with reproductive
p.000011: technology;
p.000011:
p.000011: (f) National Registry of Diseases Act (Cap. 201) (2007 Ed.) (amended vide Act 56/2007): An Act to
p.000011: establish the National Registry of Diseases and to provide for the compilation of information on the incidence of
p.000011: certain diseases for use as a basis for the direction of programmes for disease prevention and control, and for
p.000011: purposes connected therewith. This Act regulates the release of data from disease registries for public
p.000011: health and research purposes;
p.000011:
p.000011: (g) Infectious Diseases Act (Cap 137) (amended 2010): An Act relating to quarantine and the
p.000011: prevention of infectious diseases. Section 59A of the Act relates to National Public Health Research;
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: INTRODUCTION
p.000012:
p.000012: (h) Mental Capacity Act (Cap. 177A) (revised 2010): This Act reformed the law governing decisions
p.000012: made on behalf of persons lacking decision-making capacity. The Act governs decision-making on
p.000012: behalf of persons lacking capacity in specified conditions, both where they lose mental capacity at some point in
p.000012: their lives (for example as a result of dementia or brain injury) and where the incapacitating condition
p.000012: has been present since birth. It covers a wide range of decisions relating to personal welfare and financial
...
p.000043: should only be taken from dead or non-viable foetuses. Abortion should not be induced for the purpose of obtaining
p.000043: materials for research.
p.000043:
p.000043: 5.20 Consent for the termination of pregnancy should be separate from the consent for obtaining foetal
p.000043: tissue or any tissue related to the pregnancy for research. Where possible, an attending physician
p.000043: should not also seek consent for research participation from a patient in this situation.
p.000043:
p.000043: 5.21 Consent for the use of foetal tissue for research could be obtained from either parent, as provided in the
p.000043: Medical (Therapy, Education and Research) Act.
p.000043:
p.000043: 5.22 Any research intention to propagate foetal cells in vitro and/or to transplant these cells into a human
p.000043: recipient should be disclosed when consent is sought.
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000044:
p.000044: Human Gametes and Embryos
p.000044:
p.000044: 5.23 The creation of human embryos specifically for research can only be justified when there is strong
p.000044: scientific merit in and potential medical benefit from such research. The Human Cloning and Other Prohibited
p.000044: Practices Act prohibits the development of a human embryo created other than by fertilisation of human egg by human
p.000044: sperm, for a period of more than 14 days, excluding any period when the development of the embryo is
p.000044: suspended. Commercial trading in human eggs, human sperm and human embryos is also prohibited.
p.000044:
p.000044: 5.24 The supply and use of human gametes and embryos is governed by the Human Cloning and Other
p.000044: Prohibited Practices Act (Cap. 131B). Researchers should also comply with the requirements stipulated in
p.000044: MOH’s 2011 Licensing Terms and Conditions (LTC) on Assisted Reproduction (AR) Services imposed under
p.000044: Section 6(5) of the Private Hospitals and Medical Clinics Act.
p.000044:
p.000044: 5.25 Under the LTC,25 written approval from the Director of Medical Services must be obtained for all
p.000044: research involving human embryos and human oocytes (including those obtained from excised ovarian tissue).
p.000044: This requirement extends to human- animal combination gametes or embryos, which are those containing both human
p.000044: and animal genetic or non-genetic material and includes an embryo created by the fertilisation of human and
p.000044: animal gametes.
p.000044:
p.000044: 5.26 Specific and personal consent from the donors must be obtained before any gametes or embryos are to be
p.000044: used for research. Potential donors should be provided with sufficient information to make an informed decision
p.000044: and be given at least a week to decide.
p.000044:
p.000044: 5.27 For women undergoing fertility treatment, consent for the donation of surplus oocytes or embryos for
p.000044: research should be separate from the consent for treatment. The treating physician should not also be the
p.000044: researcher seeking consent for the donation of oocytes or embryos for research. Donors should confirm in writing that
p.000044: they do not require the oocytes or embryos for future use.
p.000044:
p.000044: 5.28 As the process of donating eggs for research is time-consuming, invasive and associated with a
p.000044: certain degree of discomfort and risk, women wishing to donate eggs specifically for research i.e. those
p.000044: who are not undergoing fertility treatment, must be interviewed by an independent panel. The panel must be
p.000044: satisfied that they are of sound mind, clearly understand the nature and consequences of the donation, and have
...
p.000045: through any form of cloning technology, should not be implanted into the body of any human or animal.
p.000045:
p.000045: 5.34 Human cytoplasmic hybrid embryos26 created for research should not be allowed to develop beyond 14 days in
p.000045: vitro, or to be implanted into the body of any human or animal.
p.000045:
p.000045: 5.35 No one should be under a duty to participate in any manner of research involving human gametes
p.000045: or embryos, including human-animal combination embryos, to which he or she has a conscientious objection.
p.000045:
p.000045: Surplus Biological Materials from Clinical Procedures
p.000045:
p.000045: 5.36 Biological materials, such as blood, biopsy samples or even whole organs, may be left over after clinical
p.000045: procedures that may be therapeutic or diagnostic in nature. Such materials can be very useful for research.
p.000045: However, when these materials are being taken primarily for a therapeutic or diagnostic purpose, this purpose must be
p.000045: fulfilled before any surplus materials may be used for research.
p.000045:
p.000045: 5.37 Every effort should be made to obtain consent for the use of surplus biological materials for
p.000045: research. As the primary objective for removing such materials is clinical, consent for the clinical procedure
p.000045: should be separate from the consent for the use of left over materials for research. To avoid any conflict
p.000045: of interest and to
p.000045:
p.000045: 26 A human cytoplasmic hybrid embryo is an embryo that is created by the fusion of the nucleus of a human somatic
p.000045: cell with that of an enucleated animal ovum. The nuclear DNA is human. The mitochondrial DNA and ooplasm are of
p.000045: predominantly animal origin. It is not known if human cytoplasmic hybrid embryos are viable, and it is not considered
p.000045: ethical to determine viability by allowing development to proceed.
p.000045:
p.000046: 46
p.000046:
p.000046: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000046:
p.000046: safeguard the patient’s welfare, consent for research should only be taken after consent has been given for
p.000046: any clinical procedure and it should be taken by a different person. Ideally, the attending physician should obtain the
p.000046: consent for the diagnostic or therapeutic procedure, while the researcher should seek consent for the
p.000046: research. If this is not possible when the researcher is also the attending physician, the IRB may give directions for
p.000046: the consent to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000046: and sufficient safeguards to protect the welfare and interests of the patient. Patients should be assured
p.000046: that refusal to consent for research will not affect the quality of care that will be given to them.
p.000046:
...
p.000053: conditions, and subject to observance of provisions for laboratory animal welfare, the BAC does not
p.000053: foresee any ethical difficulty in the continued use of such animals.
p.000053:
p.000053: 7.8 The objectives of using human-animal combinations in stem cell research include:
p.000053:
p.000053: (a) To study stem cell integration and differentiation;
p.000053:
p.000053: (b) To test the developmental potential of human stem cells or their derivatives;
p.000053:
p.000053: (c) To evaluate the potential usefulness and safety of transplanting human stem cells for clinical
p.000053: treatment; and
p.000053:
p.000053: (d) To study the possibility of growing human tissues and organs in animals for transplantation into
p.000053: humans.
p.000053:
p.000053: 7.9 The unique nature of stem cells also sometimes risks uncontrolled growth and differentiation
p.000053: whether used clinically, or in experiments involving animals. Thus research involving the use of human
p.000053: pluripotent stem cells requires particularly careful attention if it is to be ethically conducted and monitored.
p.000053:
p.000053: Legislation
p.000053:
p.000053: 7.10 There is no specific legislation that governs stem cell research in Singapore. The Human Cloning
p.000053: and Other Prohibited Practices Act (Cap. 131B) was enacted in 2004 primarily to prohibit human reproductive
p.000053: cloning. This Act does not prohibit therapeutic cloning (research cloning), but it limits the
p.000053: development of a human embryo that is created by any process other than the fertilisation of a human egg by a human
p.000053: sperm, to not more than 14 days (excluding any period when the development of the embryo is suspended). It also
p.000053: prohibits the commercial trading of human gametes and embryos.
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054: HUMAN STEM CELL RESEARCH
p.000054:
p.000054: 7.11 The MOH’s LTC for AR Centres (2011) imposed under regulation 6(5) of the Private Hospitals and Medical
p.000054: Clinics Regulations (Cap 248, Rg 2), provides the requirements for the use of human gametes and embryos
p.000054: for research, including the use of human-animal combination gametes and embryos for research.
p.000054:
p.000054: 7.12 The Medicines (Clinical Trials) Regulations (Cap. 176, Rg 3) made under sections 18 and 74 of the Medicines
p.000054: Act (Cap. 176), govern all clinical trials, including first-in- human trials and trials of cell- and tissue-based
p.000054: therapeutic products.
p.000054:
p.000054: Ethical and Social Issues
p.000054:
p.000054: Moral status of the human embryo
p.000054:
p.000054: 7.13 The main controversy in embryonic stem cell research concerns the moral status of the human embryo, and
p.000054: arises from the fact that the human embryo is destroyed in the process of stem cell derivation. There is a wide
p.000054: spectrum of views concerning the human embryo. At one end, it is considered to be a human being from
p.000054: the time of fertilisation, while at the other, the view is that it is a mass of cells, no different from any other
p.000054: biological material used for research.
p.000054:
p.000054: 7.14 After public consultation, the BAC adopted an intermediate position, whereby a human embryo is
p.000054: considered to have the status of a potential human being, but not the same status as a living child or adult. As a
p.000054: measure of respect and protection for the human embryo, the BAC recommended that human embryonic stem cell
p.000054: research, including the creation of human embryos specifically for research, should be allowed only when there is
p.000054: strong scientific merit in and potential medical benefit from such research. In addition, only embryos less than
p.000054: 14 days old should be used for the derivation of stem cells. At around this threshold, the primitive
p.000054: streak appears, signalling the onset of cell differentiation and development of organ systems, including
p.000054: the nervous system. As for the use of surplus embryos donated from fertility treatment by consenting parents, the BAC
p.000054: was of the view that rather than allow them to perish, their use in research would serve a greater good. The BAC’s
p.000054: position on this issue remains unchanged.
p.000054:
p.000054: 7.15 With the increasing possibility of alternative means of generating pluripotent stem cells, such as
p.000054: induced pluripotent stem cells, it is more likely that cloning technology would be less frequently used for the
p.000054: creation of embryos. The BAC welcomes such diversity in research methodologies, but continues to regard
p.000054: research cloning (or therapeutic cloning) as defensible under strict regulation, if the scientific question
p.000054: addressed cannot reasonably be investigated using other methods.
p.000054:
p.000054: Cloning and Respect for Individuals
p.000054:
p.000054: 7.16 Respect for human dignity forms the basis for the prohibition of human reproductive cloning in many
p.000054: countries, including Singapore. In particular, there are serious concerns about the safety of the technology
...
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p.000058: Cells (2008), online: .
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p.000060:
p.000060: GLOSSARY
p.000060:
p.000060: GLOSSARY
p.000060:
p.000060:
p.000060: Alzheimer’s disease – A degenerative brain disorder common in the elderly, characterised by progressive deterioration
p.000060: of mental functions leading to impaired cognition and increased reliance on others for daily activities.
p.000060:
p.000060: Assisted reproductive (AR) technologies – The use of clinical and laboratory techniques to increase the chances of
p.000060: conceiving a baby. An example is in vitro fertilization, or IVF.
p.000060:
p.000060: Chimera – An organism whose body contains cells from another organism of the same or a different species.
p.000060:
p.000060: Cytoplasmic hybrid embryo – An embryo created by the transfer of the nucleus of a somatic cell from one species
p.000060: into an egg of another species from which the nucleus has been removed.
p.000060:
p.000060: Embryo – The earliest stage of development of an organism.
p.000060:
p.000060: Embryonic germ cell – An unspecified cell derived from primordial reproductive cells of developing foetuses
p.000060: that is able to replicate itself indefinitely and develop into all types of cells.
p.000060:
p.000060: Embryonic stem cell – An unspecialised cell derived from an embryo that is able to replicate itself indefinitely and
p.000060: develop into all types of cells.
p.000060:
p.000060: Foetus – The stage of development of an organism beyond the embryo and before birth, when tissues and organs have
p.000060: started to differentiate.
p.000060:
p.000060: Gamete – Sperm or egg.
p.000060:
p.000060: Genome – The complete set of genetic information in an organism.
p.000060:
p.000060: Huntington’s disease – A neurodegenerative genetic disorder that causes the progressive breakdown of nerve
p.000060: cells in the brain and impacts the individual’s movement, cognition and behaviour. The disease is caused by an
p.000060: autosomal dominant mutation.
p.000060:
p.000060: Hybrid – An organism whose cells contain genetic material from organisms of different species.
p.000060:
p.000060: In vitro fertilisation (IVF) – A clinical and laboratory procedure whereby the eggs and sperm from a couple are
p.000060: extracted and fertilised outside their bodies. Such a procedure is a form of assisted reproduction aimed at increasing
p.000060: the chances of a couple conceiving a baby.
p.000060:
p.000060: Induced pluripotent stem cell – An adult somatic cell, such as a human skin cell, that has been
p.000060: reprogrammed (or induced) into an embryonic pluripotent state.
p.000060:
p.000060: Institutional review board (IRB) – A committee appointed by an institution to review the ethical standards
p.000060: of biomedical research proposals.
p.000060:
p.000060:
p.000061: 61
p.000061:
p.000061: GLOSSARY
p.000061:
p.000061: Oocyte – An egg cell.
p.000061:
p.000061: Pluripotent – The ability to differentiate into cells of the three germ layers in the body, namely the
p.000061: ectoderm, mesoderm and endoderm.
p.000061:
p.000061: Reproductive cloning – Process of creating a genetically identical copy of a human being or animal.
p.000061:
p.000061: Research cloning (also known as therapeutic cloning) – The use of cloning technology for research purposes that
...
p.000063: – How Are We Going to Get “Gen-Ethics” just in time?. 1999.
p.000063:
p.000063: Denmark. Danish National Committee on Biomedical Research Ethics. Guidelines about Notification etc. Of a
p.000063: Biomedical Research Project to the Committee System on Biomedical Research Ethics. 5 May 2011.
p.000063:
p.000063: European Commission. Opinion on Ethical Aspects of Clinical Research in Developing Countries. 4 February
p.000063: 2003.
p.000063:
p.000063: European Commission. Seventh Framework Programme. Guidance for Applicants: Informed Consent. (n.d.).
p.000063:
p.000063: Finland. Medical Research Act. Revised 2010.
p.000063:
p.000063: Finland. National Advisory Board on Health Care Ethics. Perspectives on Medical Research Conducted on Children. 2003.
p.000063:
p.000063: France. Civil Code. 1994.
p.000063:
p.000063: France. Comite Consultatif National d’Ethique. Opinion on Gene Therapy. 13 December 1990.
p.000063:
p.000063: France. Comite Consultatif National d’Ethique. Opinion on the Ethics of Research in the Sciences of Human
p.000063: Behaviour. 14 October 1993.
p.000063:
p.000063: Germany. Act for Protection of Embryos - The Embryo Protection Act. 13 December 1990.
p.000063:
p.000063: Greece. National Bioethics Commission. Template of Code of Research Ethics for Biological Sciences. 2009.
p.000063:
p.000063: Greene M et al. Moral Issues of Human-Non-Human Primate Neural Grafting. Science. 309 (2005): 385-386.
p.000063:
p.000064: 64
p.000064:
p.000064: BIBLIOGRAPHY
p.000064:
p.000064: Harris B. Disciplinary and Regulatory Proceedings. 6th Ed. London: Wiley & Sons, 2011. Human Genome Organisation.
p.000064: Statement on Human Genomic Databases. 2002.
p.000064: Human Genome Organisation. Statement on The Principled Conduct of Genetics Research. 21 March 1996.
p.000064:
p.000064: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000064: Human Use. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice. 10 June 1996.
p.000064:
p.000064: International Society for Stem Cell Research. Guidelines for the Conduct of Human Embryonic Stem Cell
p.000064: Research. 21 December 2006.
p.000064:
p.000064: International Society for Stem Cell Research. Guidelines for the Clinical Translation of Stem Cells. 3 December 2008.
p.000064:
p.000064: Ireland. Irish Council for Bioethics. Report on Human Biological Material: Recommendations
p.000064: for Collection, Use and Storage in Research. 29 June 2005.
p.000064:
p.000064: Israel. Ministry of Health. Guidelines for Clinical Trials in Human Subjects. 2006.
p.000064:
p.000064: Israel. The Prohibition of Genetic Intervention (Human Cloning and Genetic Manipulation of Reproductive Cells) Law Num.
p.000064: 5759/1999. 29 December 1998.
p.000064:
...
p.000072: (Cap. 176) (1985 Ed.), which is an Act to make provisions with respect to medicinal products and medical advertisements
p.000072: and matters connected therewith;
p.000072: (b) Health Products Act (Cap. 122D) (2008 Ed.): An Act to regulate the manufacture, import,
p.000072: supply, presentation and advertisement of health products and of active ingredients used in the manufacture of health
p.000072: products and provide for matters connected therewith;
p.000072: (c) Ministry of Health (MOH), Licensing Terms and Conditions on Assisted Reproduction Services (2011)
p.000072: imposed under Section 6(5) of the Private Hospitals and Medical Clinics Act (Cap. 248) (1999 Ed.),
p.000072: which is an Act to provide for the control, licensing and inspection of private hospitals, medical
p.000072: clinics, clinical laboratories and healthcare establishments, and for purposes connected therewith. Sections 9
p.000072: and 10 of the Licensing Terms and Conditions relate to research;
p.000072: (d) Medical (Therapy, Education and Research) Act (Cap. 175) (1985 Ed.) (amended vide Act 4/2010):
p.000072: This is an Act to make provision for the use of the bodies of deceased persons or parts thereof for purposes
p.000072: of medical or dental education, research, advancement of medical or dental science, therapy and
p.000072: transplantation, and for other purposes connected therewith;
p.000072:
p.000072:
p.000072:
p.000072: A5
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (e) Human Cloning and other Prohibited Practices Act (Cap. 131B) (2005Ed.): An Act to prohibit the placing of a
p.000072: human embryo clone in the body of a human or an animal and certain other practices associated with reproductive
p.000072: technology;
p.000072: (f) National Registry of Diseases Act (Cap. 201) (2007 Ed.) (amended vide Act 56/2007): An Act to
p.000072: establish the National Registry of Diseases and to provide for the compilation of information on the incidence of
p.000072: certain diseases for use as a basis for the direction of programmes for disease prevention and control, and for
p.000072: purposes connected therewith. This Act regulates the release of data from disease registries for public
p.000072: health and research purposes;
p.000072: (g) Infectious Diseases Act (Cap 137), amended 2010: An Act relating to quarantine and the prevention of
p.000072: infectious diseases. Section 59A of the Act relates to National Public Health Research;
p.000072: (h) Mental Capacity Act (Cap. 177A), revised 2010: This Act reformed the law where decisions need to be
p.000072: made on behalf of persons lacking capacity. The Act governs decision-making on behalf of persons lacking
p.000072: capacity in specified conditions, both where they lose mental capacity at some point in their lives (for example as
p.000072: a result of dementia or brain injury) and where the incapacitating condition has been present since birth. It
p.000072: covers a wide range of decisions, on personal welfare and financial matters and substitute
p.000072: decision-making by attorneys or court-appointed “deputies”, and clarifies the position where no such formal process
...
p.000072: Foetal Tissues
p.000072:
p.000072: 5.18 Foetal tissues include membranes, amniotic fluid, placenta and umbilical cord. Foetal tissues for research
p.000072: should only be taken from dead or non-viable foetuses. Abortion should not be induced for the purpose of obtaining
p.000072: material for research.
p.000072: 5.19 Consent for the termination of pregnancy should be separate from the consent for obtaining foetal
p.000072: tissue or any tissue related to the pregnancy for research. Provisions for ensuring that where possible an attending
p.000072: physician should not also seek consent for research participation from a patient apply mutatis mutandis in this
p.000072: situation.
p.000072: 5.20 Consent for the use of foetal tissue for research could be obtained from either parent, as indicated in the
p.000072: Medical (Therapy, Education and Research) Act.
p.000072: 5.21 Any intention to propagate foetal cells in vitro and/or to transplant these cells into a human recipient
p.000072: should be disclosed when consent is sought.
p.000072: Human Gametes and Embryos
p.000072:
p.000072: 5.22 The creation of human embryos specifically for research can only be justified when there is strong
p.000072: scientific merit and potential medical benefit from such research. Under the Human Cloning and Other Prohibited
p.000072: Practices Act, the development of a human embryo created other than by fertilisation of human egg by human sperm, for a
p.000072: period of more than 14 days, excluding any period when the development of the embryo is suspended, is
p.000072: prohibited. Commercial trading in human eggs, human sperm and human embryos is also not allowed.
p.000072: 5.23 The use of human gametes or embryos for research is governed by the requirements of the law, as given in the
p.000072: MOH’s 2011 Licensing Terms and Conditions on Assisted Reproduction Services imposed under Section 6(5) of the
p.000072: Private Hospitals and
p.000072:
p.000072:
p.000072: A37
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Medical Clinics Act and by the Human Cloning and Other Prohibited Practices Act (Cap. 131B).
p.000072: 5.24 Under the Licensing Terms and Conditions on Assisted Reproduction Services, written approval from
p.000072: the Director of Medical Services must be obtained for all research involving human embryos and human
p.000072: oocytes (including those obtained from excised ovarian tissue). This requirement extends to human-animal combination
p.000072: gametes or embryos, which are those containing both human and animal genetic or non-genetic material and includes an
p.000072: embryo created by the fertilisation of human and animal gametes.
p.000072: 5.25 Consent from the donors must be obtained before any gametes or embryos are to be used for research.
p.000072: Individuals from whom the gametes or embryos are derived, should be provided with sufficient information to make an
p.000072: informed decision and be given at least a week to decide.
p.000072: 5.26 For women undergoing fertility treatment, consent for the donation of oocytes or embryos for
p.000072: research should be separate from the consent for treatment. The treating physician should not also be the
p.000072: researcher seeking consent for the donation of oocytes and embryos for research. Donors should confirm in writing
p.000072: that they do not require the oocytes or embryos for future use.
p.000072: 5.27 As the process of donating eggs for research is time-consuming, invasive and associated with a
p.000072: certain degree of discomfort and risks, women wishing to donate eggs specifically for research i.e. who are
p.000072: not also undergoing any fertility treatment, must be interviewed by an independent panel. The panel must be satisfied
p.000072: that they are of sound mind, clearly understand the nature and consequences of the donation, and have freely given
p.000072: explicit consent, without any inducement, coercion or undue influence.
...
p.000072: human-animal combination embryos, which will be destroyed in the process of research, and if any derived cells
p.000072: from the embryos so created will be kept for future research or possible clinical use. They should be
p.000072: assured that any embryos created for research will not be implanted or allowed to develop in vitro beyond 14 days.
p.000072:
p.000072: 5.29 Donors of eggs obtained specifically for research, and not as a result of clinical treatment,
p.000072: may be reimbursed for legitimate expenses incurred, such as cost of transport and childcare services, and
p.000072: actual loss of earnings, as a result of the procedures required to obtain the eggs. Any additional payment to
p.000072: be given, whether monetary or in kind, should not amount to an inducement. If complications occur as a direct and
p.000072: proximate result of the donation, the donor should be provided with prompt and full medical care. The cost of this
p.000072: provision is the responsibility of the researchers and their institutions.
p.000072:
p.000072:
p.000072:
p.000072: A38
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 5.30 Trans-species fertilisation involving human gametes is not allowed for the purpose of reproduction unless
p.000072: done to assess or diagnose sub-fertility, in which case, the resultant hybrid must be terminated at the
p.000072: two-cell stage, and in any case must have written approval from the Director of Medical Services.
p.000072: 5.31 No human embryos created for research, including human cytoplasmic hybrid embryos54 and other
p.000072: embryos created through any form of cloning technology, should be allowed to develop beyond 14 days in vitro.
p.000072: 5.32 No human embryo created for research, including any human cytoplasmic embryo or other embryo created through
p.000072: any form of cloning technology, should be implanted into the body of any human or animal.
p.000072: 5.33 Research involving human germline modification for purposes other than the prevention or
p.000072: treatment of serious genetic conditions should not be allowed.
p.000072: 5.34 No one should be under a duty to participate in any manner of research involving human gametes
p.000072: or embryos, including human-animal combination embryos, to which he or she has a conscientious objection.
p.000072: Surplus Tissues from Clinical Procedures
p.000072:
p.000072: 5.35 Tissues, such as blood, biopsy samples or even whole organs, may be left over after clinical procedures, which
p.000072: may be therapeutic or diagnostic. Such tissues can be very useful for research. However, when tissue is being taken
p.000072: primarily for a therapeutic or diagnostic purpose, this purpose must be fulfilled before any surplus tissue
p.000072: may be used for research.
p.000072: 5.36 Every effort should be made to obtain consent for the use of surplus tissue for research. As the
p.000072: primary objective for removing such specimens is clinical, consent for the clinical procedure should be separate from
p.000072: the consent for the use of left over tissues for research. To avoid any conflict of interest and to safeguard the
p.000072: patient’s welfare, consent for research should only be taken after consent has been given for any clinical procedure
p.000072: and it should be taken by a different person. Ideally, the attending physician should obtain the consent
p.000072: for the diagnostic or therapeutic procedure, while the researcher should seek consent for the research. In the
p.000072: case that the researcher is also the attending physician, the IRB may give directions for the consent to
p.000072: be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000072: and sufficient safeguards to protect the welfare and interests of the patient. Patients should be assured
p.000072: that refusal to consent will not affect the quality of care that will be given to them.
p.000072:
p.000072: 54 A human cytoplasmic hybrid embryo is an embryo that is created by the fusion of the nucleus of a
p.000072: human somatic cell with that of an enucleated animal ovum. The nuclear DNA is human. The mitochondrial
p.000072: DNA and ooplasm are of predominantly animal origin. It is not known if human cytoplasmic hybrid embryos
p.000072: are viable, and it is not considered ethical to determine viability by allowing development to proceed.
p.000072:
p.000072:
p.000072:
p.000072: A39
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 5.37 If consent could not be obtained for the use of surplus tissue for research, IRBs should have the discretion
p.000072: to waive the consent requirement if the patient is not identifiable, since the research protocol would not have
p.000072: influenced the procedures used in obtaining the biospecimens. Healthcare institutions should inform patients that
p.000072: there is a possibility that their surplus biospecimens may be used for research, and assure them that only research
p.000072: with the necessary safeguards in place will be allowed to proceed after approval from an IRB.
p.000072: 5.38 It is current practice to use patients’ biospecimens that are surplus to clinical requirements for
p.000072: validating laboratory tests or for purposes of clinical audit without consent of the originators and without IRB
p.000072: approval, if the specimens are irreversibly de-identified. Although this practice is ethically acceptable, since it is
p.000072: not possible for individuals to be identified, it is good practice for healthcare institutions to inform
...
p.000072: provisions for laboratory animal welfare, the BAC does not foresee any ethical difficulty in the continued use
p.000072: of such animals.
p.000072:
p.000072: 7.7 The objectives of using human-animal combinations in stem cell research include:
p.000072:
p.000072: (a) To study stem cell integration and differentiation;
p.000072:
p.000072: (b) To test the developmental potential of human stem cells or their derivatives;
p.000072:
p.000072: (c) To evaluate the potential usefulness and safety of transplanting human stem cells for clinical
p.000072: treatment; and
p.000072:
p.000072: (d) To study the possibility of growing human tissues and organs in animals for transplantation into
p.000072: humans.
p.000072:
p.000072: 7.8 The unique nature of stem cells also sometimes risks uncontrolled growth and differentiation
p.000072: whether used clinically, or in experiments involving animals. Thus research involving the use of human
p.000072: pluripotent stem cells requires particularly careful attention if it is to be ethically conducted and monitored.
p.000072: Legislation
p.000072:
p.000072: 7.9 There is no specific legislation that governs stem cell research in Singapore. The Human Cloning
p.000072: and Other Prohibited Practices Act (Cap. 131B) was enacted in 2004 primarily to prohibit human reproductive
p.000072: cloning. This Act does not prohibit
p.000072:
p.000072:
p.000072: A47
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: therapeutic cloning (research cloning). It limits the development of a human embryo that is created by a process other
p.000072: than the fertilisation of a human egg by a human sperm, to not more than 14 days, excluding any period when the
p.000072: development of the embryo is suspended. It also prohibits the commercial trading of human gametes and embryos.
p.000072: 7.10 The MOH’s Licensing Terms and Conditions imposed under regulation 6(5) of the Private Hospitals
p.000072: and Medical Clinics Regulations (Cap 248, Rg 2), provides the requirements for the use of human gametes and
p.000072: embryos for research, including the use of human-animal combination gametes and embryos for research.
p.000072: 7.11 The Medicines (Clinical Trials) Regulations (Cap. 176, Rg 3) made under sections 18 and 74 of the Medicines
p.000072: Act (Cap. 176), govern all clinical trials, including first-in- man trials and trials of cell- and tissue-based
p.000072: therapeutic products.
p.000072: Ethical and Social Issues
p.000072:
p.000072: Moral status of the human embryo
p.000072:
p.000072: 7.12 The main controversial issue in embryonic stem cell research concerns the moral status of the
p.000072: human embryo, and arises from the fact that the human embryo is destroyed in the process of stem cell
p.000072: derivation. There is a wide spectrum of views concerning the human embryo. At one end, it is considered to be a human
p.000072: being from the time of fertilisation, while at the other end, the view is that it is a mass of cells, no different from
p.000072: any other biological material used for research.
p.000072: 7.13 After public consultation, the BAC adopted an intermediate position, whereby a human embryo is
p.000072: considered as having the status of a potential human being, but not the same status as a living child or adult. As a
p.000072: measure of respect and protection for the human embryo, the BAC recommended that human embryonic stem cell research,
p.000072: including the creation of human embryos specifically for research, should be allowed only when there is strong
p.000072: scientific merit in and potential medical benefit from such research. In addition, only embryos less than 14
p.000072: days old should be used for the derivation of stem cells, as at around day 14, the primitive streak appears,
p.000072: signaling the onset of cell differentiation and development of organ systems, including the nervous system.
p.000072: As for the use of surplus embryos donated from fertility treatment by consenting parents, the BAC was of the view that
p.000072: rather than allow them to perish, their use in research would serve a greater good. This remains the BAC position on
p.000072: this issue.
p.000072: 7.14 With the increasing possibility of alternative means of generating pluripotent stem cells, such as
p.000072: induced pluripotent stem cells, it is increasingly less likely that cloning technology would be used for the
p.000072: creation of embryos. The BAC welcomes such diversity in research methodologies, but regards research
p.000072: cloning (or therapeutic cloning) as defensible under strict regulation, if the scientific question
p.000072: addressed cannot reasonably be investigated using other methods.
p.000072:
p.000072:
p.000072: A48
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Cloning and Respect for Individuals
p.000072:
p.000072: 7.15 Respect for human dignity forms the basis for the prohibition of human reproductive cloning in many
...
p.000072: approved by a scientific committee, and that the biological materials to be used have been obtained ethically,
p.000072: with appropriate consent, and without any inducement or coercion, especially when vulnerable people are involved.
p.000072: 7.26 In human-animal combinations research involving live animals or resulting in the creation of live
p.000072: animals, the IRB should also ensure that the proposal has been approved by the institutional animal care and
p.000072: use committee, whose remit covers the welfare of laboratory animals.
p.000072: 7.27 Where human embryonic stem cells, induced pluripotent stem cells, or any other kind of pluripotent stem
p.000072: cells are introduced into non-human animals at any stage of development, particular attention should be paid
p.000072: to the need to avoid the creation of entities in which human sentience or consciousness might be expected to occur.
p.000072: 7.28 Animals into which human embryonic stem cells, induced pluripotent stem cells, or any other kind of
p.000072: pluripotent stem cells have been introduced should not be allowed to breed.
p.000072: 7.29 Human cytoplasmic hybrid embryos should not be allowed to develop beyond 14 days
p.000072: in vitro.
p.000072:
p.000072: 7.30 No human cytoplasmic embryo should be implanted into the body of any human or animal.
p.000072: 7.31 If the research involves introducing human embryonic stem cells or any pluripotent cells, or products derived
p.000072: from these cells, into humans, or any novel applications of any stem cells that are outside the scope of established
p.000072: standards of medical care, it should be conducted in accordance with the requirements and standards of a clinical trial
p.000072: for cell-based product, as specified by the HSA, and approval from HSA must be obtained. IRBs must ensure that:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A51
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) The proposal is reviewed and approved by a scientific review committee with the relevant expertise;
p.000072:
p.000072: (b) There is strong evidence of the safety and efficacy of the cells from pre-clinical studies;
p.000072:
p.000072: (c) The research participants have been provided with sufficient information, in particular information on
p.000072: the nature and risks of the research, and the source of the cells, so that their values and beliefs are respected; and
p.000072:
p.000072: (d) Appropriate and informed consent has been obtained, without any inducement, coercion or undue influence.
p.000072:
p.000072: 7.32 No clinical or research personnel should be under a duty to conduct or assist in human embryonic stem cell or
p.000072: induced pluripotent stem cell research, or research involving human-animal combinations, to which they have a
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p.000063:
p.000063: 4. The level of detail required in a research protocol submitted for IRB review should vary in proportion to
p.000063: the identifiable risk or sensitivity of the research. IRBs may conduct either full or expedited reviews, or
p.000063: grant exemptions from ethics review. An expedited review is permissible for research that involves no more than minimal
p.000063: risk to research participants while exemptions from review must involve no likelihood of harm to research
p.000063: participants. The Chairperson or other IRB delegate(s) may be empowered to conduct expedited reviews or grant
p.000063: exemptions.
p.000063:
p.000063: 5. Minimal risk refers to an anticipated level of harm and discomfort that is no greater than that ordinarily
p.000063: encountered in daily life, or during the performance of routine educational, physical, or psychological
p.000063: tasks.
p.000063:
p.000063: 6. In multi-centre research, a lead IRB could be designated that plays the main role in conducting a full
p.000063: ethics review. Multi-national research should be subject to review by the IRB of the local partner institution(s).
p.000063:
p.000063: 7. Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000063: carried out in their premises or facilities; or by their employees or
p.000063:
p.000001: 1
p.000001:
p.000001: EXECUTIVE SUMMARY
p.000001:
p.000001:
p.000001: on their patients; or involving access to or use of human biological materials, medical records or other personal
p.000001: information in their custody. They are also responsible for ensuring research integrity.
p.000001:
p.000001: 8. Every institution that conducts human biomedical research, or allows such research to be carried out in
p.000001: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000001: research staff have access to an IRB at another institution. Should a research proposal be rejected by an
p.000001: IRB, an appeal mechanism should be available in which a second committee must be able to exercise independent
p.000001: judgement.
p.000001:
p.000001: 9. The responsibilities of the researchers include ensuring that their research is
p.000001: conducted with integrity and complies with all relevant laws and other regulatory obligations and
p.000001: requirements; submitting annual (or more frequent) progress reports as required by the IRBs; reports of adverse events
p.000001: arising from the research should be submitted to the IRBs within 15 days of their occurrence, while serious adverse
p.000001: events should be reported immediately; not altering or modifying in any way any drug or other clinical
p.000001: regimen without the IRB’s and attending physician’s approval; and ensuring that participants are informed
...
p.000001: ignorant of a research hypothesis should be disclosed and justified to the satisfaction of an IRB. It is also best
p.000001: ethical practice to highlight to the participant the fact that, for methodological reasons, not
p.000001: all information concerning the research hypothesis and protocol will be revealed.
p.000001:
p.000001: 12. Prospective research participants or their legally authorised representatives should be provided with
p.000001: sufficient information in an understandable form and appropriate manner, to enable them to make an informed
p.000001: decision.
p.000001:
p.000001: 13. Consent could be specific to a particular research project, or general for the storage and future use of
p.000001: biological materials or personal information in research. In any general consent, donors should be allowed to
p.000001: impose some limits to the use of their biological materials or personal information. IRBs should have the
p.000001: discretion to decide, when considering a research proposal, whether specific consent is required or general consent is
p.000001: sufficient, if previously given.
p.000001:
p.000001:
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: EXECUTIVE SUMMARY
p.000002:
p.000002:
p.000002: 14. For research involving vulnerable persons not lacking mental capacity (for example, prisoners, uniformed
p.000002: personnel, and employees), consent should be taken by independent third parties, whenever possible. When
p.000002: it is not possible for consent to be taken by an independent third party, the IRB may give directions for the consent
p.000002: to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000002: sufficient safeguards to protect the welfare and interests of the participants.
p.000002:
p.000002: 15. For research involving patients, consent for participating in research should be clearly separated from
p.000002: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000002: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000002: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000002: and sufficient safeguards to protect the welfare and interests of the patient.
p.000002:
...
p.000021: disqualify him- or herself from any consideration of the case, and he or she should refrain from offering his or
p.000021: her opinion to the IRB on the particular research under review. The member should make full disclosure
p.000021: of such an actual, potential or apparent conflict of interest to the IRB.
p.000021:
p.000021: 2.34 Researchers should disclose any actual, potential or perceived individual conflicts of interest, when
p.000021: submitting their research proposals to the IRB, as well as any institutional conflicts that they are aware of
p.000021: and may have an impact on their research. The IRB shall then decide on the appropriate steps to manage the conflict.
p.000021:
p.000021: 2.35 Threats to research integrity could arise when there is a conflict of interest between those who commission
p.000021: and fund research (including commercial organisations) and those who carry it out (the researchers).
p.000021: Routine checks and balances ensuring the integrity of the research process have been developed in
p.000021: universities and other research institutions with a commitment to research. When research is recruited to the service
p.000021: of commercial or institutional interests, researchers may be in a difficult position if their results are
p.000021: inconsistent with the expectations or hopes of their funders. IRBs need to consider how best to avoid such threats to
p.000021: integrity when considering applications in which they might arise.
p.000021:
p.000021: Responsibilities of Institutions
p.000021:
p.000021: 2.36 Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000021: carried out in their premises or facilities; or by their employees or on their patients; or involving access to or use
p.000021: of human biological materials, medical records or other personal information in their custody. They are also
p.000021: responsible for ensuring research integrity.
p.000021:
p.000021: 2.37 Every institution that conducts human biomedical research, or allows such research to be carried out in
p.000021: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000021: research staff have access to an IRB at another institution.
p.000021:
p.000021: 2.38 Institutions should set up clear policies for the operation of their IRBs. The
p.000021: composition of IRBs and specific operational details are provided for in the MOH Operational Guidelines for
p.000021: Institutional Review Boards.12
p.000021:
p.000021: 2.39 Institutions should ensure that there is an arrangement for receiving feedback from research
p.000021: participants.
p.000021:
p.000021:
p.000021: 12 MOH, Operational Guidelines for Institutional Review Boards. 2007.
p.000021:
p.000022: 22
p.000022:
p.000022: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000022:
p.000022: 2.40 It is the responsibility of institutions to provide adequate resources, including resources for the
p.000022: training and education of IRB members, and administrative support for the IRBs to discharge their responsibilities in
p.000022: an effective and timely manner.
p.000022:
...
p.000027: court deputy or donee of a lasting power of attorney to enrol an incapacitated adult in minimal risk
p.000027: research where this is consistent with the incapacitated person’s beliefs and values, and not contrary
p.000027: to the person’s present wishes and feelings.
p.000027:
p.000027: Consent for Research Involving Vulnerable Persons Not Lacking Mental Capacity
p.000027:
p.000027: 3.17 Vulnerable research participants not only include those who are lacking mental capacity, but also
p.000027: those whose autonomy might be prejudiced by being under the influence or control of, or by being obligated to,
p.000027: third parties. Potentially vulnerable participants might include, but are not limited to:
p.000027:
p.000027: (a) Prisoners;
p.000027:
p.000027: (b) Uniformed personnel, especially junior ranks;
p.000027:
p.000027: (c) Patients, especially if the intending researcher is their attending physician; and
p.000027:
p.000027: (d) Employees, junior collaborators, or students.
p.000027:
p.000027:
p.000027:
p.000027: 14 For example, the courts have permitted a simple paternity blood test for a child where this was not clearly
p.000027: against the interests of the child, notwithstanding there was no direct benefit to the child: S v S [1972] AC 24 (House
p.000027: of Lords). Nothing in the Mental Capacity Act (Chap 177A) expressly overrules the common law, except by necessary
p.000027: implication.
p.000027: 15 World Medical Association, Declaration of Helsinki (rev. 2013), article 28; Council for
p.000027: International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research
p.000027: Involving Human Subjects (2002), Articles 9 and 15.
p.000027:
p.000028: 28
p.000028:
p.000028: CONSENT
p.000028:
p.000028: 3.18 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000028: prospective participants reassured that they have nothing to fear in declining research participation or
p.000028: in contributing biological materials or personal information for research. Thus, consent from uniformed
p.000028: personnel, for example, should not be taken by a senior officer, and preferably not by uniformed personnel.
p.000028:
...
p.000032:
p.000032: (e) The procedures and implications for withdrawal from the research; and
p.000032:
p.000032: (f) Any other information specific to the type of research, as given in the parts on research involving human
p.000032: biological materials, genetic research and stem cell research in these Guidelines.
p.000032:
p.000032: 3.39 Prospective participants should be given adequate time to decide whether or not to participate in
p.000032: the research and the opportunity to clarify any doubts that they may have.
p.000032:
p.000032: 3.40 Consent to participation in research should be documented in writing.
p.000032:
p.000032: 3.41 Consent could be specific to a particular research project, or general for the storage and future use of
p.000032: biological materials or personal information. In any general consent, donors should be allowed to impose some
p.000032: limits to the use of their biological materials or personal information. IRBs should have the discretion
p.000032: to decide, when considering a research proposal, whether specific consent is required or general consent is
p.000032: sufficient, if previously given.
p.000032:
p.000032: 3.42 For research involving vulnerable persons not lacking mental capacity (for example, prisoners, uniformed
p.000032: personnel, and employees), consent should be taken by independent third parties, whenever possible.
p.000032: Prospective participants should be reassured that they have nothing to fear in declining research
p.000032: participation or in contributing biological materials for research. When it is not possible for consent to be taken
p.000032: by an independent third party, the IRB may give directions for the consent to
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: CONSENT
p.000033:
p.000033: be taken by the researcher so long as there are provisions to manage the conflict of interest and sufficient safeguards
p.000033: to protect the welfare and interests of the participant.
p.000033:
p.000033: 3.43 For research involving patients, consent for participating in research should be clearly separated from
p.000033: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000033: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000033: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
...
p.000072: his or her opinion to the IRB on the particular research under review. The member should make full disclosure of such
p.000072: an actual, potential or apparent conflict of interest to the IRB.
p.000072:
p.000072: 2.37 Researchers should disclose any real, potential or perceived individual conflicts of interest, when
p.000072: submitting their research proposals to the IRB, as well as any institutional conflicts which they are
p.000072: aware of, that may have an impact on their research. The IRB shall then decide on the appropriate steps to
p.000072: manage the conflict.
p.000072:
p.000072: 2.38 Threats to research integrity could arise when there is a conflict of interest between those who commission
p.000072: and fund research (including commercial organisations) and those who carry it out (the researchers).
p.000072: Routine checks and balances ensuring the integrity of the research process have developed in universities
p.000072: and other research institutions with a commitment to research. When research is recruited to the service of
p.000072: commercial or institutional interests, researchers may be in a difficult position if their results are inconsistent
p.000072: with the expectations or hopes of their source of funds. IRBs need to consider how best to avoid such threats to
p.000072: integrity when considering applications in which they might arise.
p.000072:
p.000072: Responsibilities of Institutions
p.000072:
p.000072: 2.39 Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000072: carried out on their premises or facilities; or by their employees or on their patients; or involving access to or use
p.000072: of human tissue collections, medical records or other personal information in their custody. They are also responsible
p.000072: for ensuring research integrity.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A16
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 2.40 Every institution that conducts human biomedical research, or allows such research to be carried out on
p.000072: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000072: research staff have access to an IRB at another institution.
p.000072:
p.000072: 2.41 The institution should set up clear policies for the operation of IRBs. The composition of IRBs and
p.000072: specific operational details are provided in the MOH Operational Guidelines for Institutional Review Boards.47
p.000072:
p.000072: 2.42 It is the responsibility of institutions to provide adequate resources, including resources for the
p.000072: training and education of IRB members, and administrative support for the IRBs to discharge their responsibilities in
p.000072: an effective and timely manner.
p.000072:
p.000072: 2.43 Institutions should ensure that provisions are made to compensate or treat research participants
p.000072: for adverse consequences of their participation, where appropriate.
p.000072:
p.000072: 2.44 An institution must accept legal responsibility for the decisions of its IRB and must provide the IRB members
...
p.000072: (b) Those whose autonomy might be prejudiced by being under the influence of, or the control of, or obligated to,
p.000072: third parties; and
p.000072:
p.000072: (c) Infants or children. In the case of under-aged research participants issues of consent primarily
p.000072: involve parent or guardians.
p.000072:
p.000072: Consent from Vulnerable Persons not Lacking Capacity
p.000072:
p.000072: 3.16 Vulnerable adult research participants not only include those who are of diminished capacity, but also
p.000072: those whose autonomy might be prejudiced by being under the influence of, or the control of, or
p.000072: obligated to, third parties. Potentially vulnerable participants might include, but are not limited to:
p.000072:
p.000072: (a) Prisoners;
p.000072:
p.000072: (b) Serving uniformed personnel, especially junior ranks;
p.000072:
p.000072: (c) Patients, especially if the intending researcher is their attending physician; and
p.000072:
p.000072: (d) Employees, junior collaborators, or students.
p.000072:
p.000072: 3.17 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000072: prospective participants reassured that they have nothing to fear in declining research participation or
p.000072: in contributing tissue for research. Thus consent among uniformed personnel, for example, should not be taken by
p.000072: a senior officer, and preferably not by uniformed personnel at all.
p.000072:
p.000072: 3.18 When it is not possible for consent to be taken by an independent third party, the IRB may give directions for
p.000072: the consent to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000072: sufficient safeguards to protect the welfare and interests of the participant.
p.000072:
p.000072:
p.000072:
p.000072: A22
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 3.19 A further issue of vulnerability arises in societies where social proxy arrangements are widespread, for
p.000072: example, where a village headman might be felt to have authority to give consent on behalf of a village, or a husband
p.000072: on behalf of a wife. Not all societies treat their individual members as autonomous. This can become
...
p.000072: participants should be allowed to decide whether or not to be informed of the result, prior to the commencement of the
p.000072: research. Participants should also have an opportunity to express their preferences about the sharing of such
p.000072: information with biological relatives, or others.
p.000072:
p.000072: 3.38 Prospective participants should be given adequate time to decide whether or not to participate in
p.000072: the research and the opportunity to clarify any doubts that they may have.
p.000072:
p.000072: 3.39 Consent to participation in research should be documented in writing.
p.000072:
p.000072: 3.40 Consent could be specific to a particular research project, or general for the storage and future use of
p.000072: tissue or personal information. In any general consent, donors should be allowed to impose some limits
p.000072: to the use of their tissue or information. IRBs should have the discretion to decide, when considering
p.000072: a research proposal, whether specific consent is required or general consent is sufficient, if previously
p.000072: given.
p.000072:
p.000072: 3.41 For research involving vulnerable adults not lacking capacity (for example, prisoners, serving uniformed
p.000072: personnel, and employees), consent should be taken by independent third parties, whenever possible.
p.000072: Prospective participants should be reassured that they have nothing to fear in declining research
p.000072: participation or in contributing tissue for research. When it is not possible for consent to be taken by an
p.000072: independent third party, the IRB may give directions for the consent to be taken by the researcher so long as there are
p.000072: provisions to manage the conflict of interest and sufficient safeguards to protect the welfare and interests of the
p.000072: participant.
p.000072:
p.000072: 3.42 For research involving patients, consent for participating in research should be clearly separated from
p.000072: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000072: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000072: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000072: and sufficient safeguards to protect the welfare and interests of the patient.
p.000072:
...
Social / gender
Searching for indicator gender:
(return to top)
p.000015: refers to as autonomy.6 Their welfare and interests are to be protected, especially when their autonomy is
p.000015: impaired or lacking. This principle mandates the need for informed consent to participation in research,
p.000015: respect for privacy, safeguarding confidentiality, and minimising harm to research participants. It also
p.000015: requires a proper regard for religious and cultural diversity.
p.000015:
p.000015: 2.5 This principle integrates with many other aspects of life in societies that could be described
p.000015: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000015: Ideals of this democratic society include all citizens being equal under the law, or having rights to
p.000015: privacy in the management of their affairs, to the enjoyment of security and public health and safety,
p.000015: with rights over their own bodies, and many others. All of these, in the final analysis, come down to the principle
p.000015: that individuals should be accorded certain basic rights or entitlements arising from their existence in society.
p.000015: These entitlements exist notwithstanding individual differences in endowment of race, character, gender or talent,
p.000015: and without requirement that individuals justify them. However, an individual’s autonomy can be curtailed under certain
p.000015: circumstances, for the public good, such as when quarantined during disease epidemics.
p.000015:
p.000015: Solidarity
p.000015:
p.000015: 2.6 The BAC earlier advocated a principle of reciprocity between the individual and wider society, as
p.000015: a way to capture the well-established idea that there is some measure of mutual obligation that regulates the
p.000015: relationship between the two. However, the underlying principle is perhaps better expressed as solidarity. The
p.000015: essential principle is not one of individual exchange, but of a wider vision in which common interest is invoked as a
p.000015: reason for the subordination of individual interest to that of a group in specified circumstances. Solidarity
p.000015: reflects the importance of general altruism as a basis for participation in biomedical research.
p.000015:
p.000015: 2.7 In biomedical research, agreed social benefits – considered as a public good – carry an implication that, if
p.000015: accepted, they inherently reflect an in-principle willingness to consider participation in research of the kind
p.000015: yielding the accepted benefits. This means that there is a balance to be struck between the interests of the public
p.000015: and the rights of individual participants; and that incompatible and irreconcilable ethical perspectives
p.000015: should be resolved with some regard to public interest. The BAC is therefore of the view that that certain
p.000015: rights such as informed consent, derived from the principle of respect for individuals, may be subordinate to the
...
p.000072: refers to as autonomy.41 Their welfare and interests are to be protected, especially when their autonomy is
p.000072: impaired or lacking. This principle mandates the need for informed consent to participation in research;
p.000072: respect for privacy; for safeguarding confidentiality; for protecting vulnerable participants; and it
p.000072: also requires a proper regard for religious and cultural diversity.
p.000072: 2.8 This principle integrates with many other aspects of life in societies that could be described
p.000072: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000072: Ideals such as all citizens being equal under the law, or having rights to privacy and the management of their
p.000072: affairs, to the enjoyment of security and public health and safety, with rights over their own bodies,
p.000072: and many others, all, in the last analysis, come down to the principle that individuals should be accorded certain
p.000072: basic rights or entitlements arising from their existence in society. These entitlements exist notwithstanding
p.000072: individual differences in endowment of race, character, gender or talent, and without requirement that individuals
p.000072: justify them. An individual’s autonomy can be curtailed under certain circumstances, such as when quarantined
p.000072: in disease epidemics.
p.000072:
p.000072:
p.000072:
p.000072: 41 NMEC similarly referred to autonomy as “the right of individuals to decide for themselves what
p.000072: is good for them.” Paragraph 2.3.1, Ethical Guidelines on Research Involving Human Subjects (1997).
p.000072:
p.000072:
p.000072:
p.000072: A9
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Solidarity
p.000072:
p.000072: 2.9 The BAC earlier advocated a principle of reciprocity between the individual and the wider society, as a way
p.000072: to capture the well-established idea that there is some measure of mutual obligation that regulates the relationship
p.000072: between the individual and society. In biomedical research where there is minimal risk of harm to
p.000072: participants, agreed social benefits – considered as a public good – carry an implication that, if accepted, they
p.000072: inherently reflect an in-principle willingness to consider participation in research of the kind yielding the
p.000072: accepted benefits. This means that there is a balance to be struck between the interests of the public and
p.000072: the rights of individual participants; and that incompatible and irreconcilable ethical perspectives should be
p.000072: resolved with some regard to the public interest.
p.000072: 2.10 However, the underlying principle is perhaps better expressed as one of solidarity. The essential
...
Social / parents
Searching for indicator parent:
(return to top)
p.000002: it is not possible for consent to be taken by an independent third party, the IRB may give directions for the consent
p.000002: to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000002: sufficient safeguards to protect the welfare and interests of the participants.
p.000002:
p.000002: 15. For research involving patients, consent for participating in research should be clearly separated from
p.000002: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000002: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000002: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000002: and sufficient safeguards to protect the welfare and interests of the patient.
p.000002:
p.000002: 16. For research involving minors with decision-making capacity, consent from both the minor and a parent should
p.000002: be obtained; such a minor’s refusal of consent should be respected. Apart from this, it is still important to
p.000002: engage the minor in ways that respect his or her current level of understanding. Parents or guardians
p.000002: of minors lacking decision-making capacity are authorised to consent to their participation in research
p.000002: that involves no more than minimal risk and is not contrary to their best interests. For research that
p.000002: does not involve more than minimal risk, such as surveys seeking information relating only to the minor, IRBs should be
p.000002: able to waive parental consent for minors who have decision-making capacity, where there is otherwise no prohibition
p.000002: by law and parental consent is not a reasonable requirement for the protection of the minor’s interests.
p.000002:
p.000002: 17. IRBs may consider a waiver of the consent requirement for research done in the public interest,
...
p.000004:
p.000004: 28. Research information may not be definitive, and research participants are entitled to expect that their data
p.000004: will not be used for purposes other than those for which they have given consent. Thus, such information should not be
p.000004: disclosed to any third party, including employers or insurance companies.
p.000004:
p.000004: V. Biobanking and Research Involving Human Biological Materials
p.000004:
p.000004: 29. Informed consent must be obtained before any human biological materials are taken for use in research. If the
p.000004: materials are intended for storage and future use in research, consent should also be obtained for this purpose.
p.000004:
p.000004: 30. Re-consent is required in the following situations:
p.000004:
p.000004: (a) When the proposed research is not covered by the consent that was given when the biological materials were
p.000004: collected (unless the re-consent requirement is waived by an IRB);
p.000004:
p.000004: (b) If the biological material was collected from a minor below 21 years of age, who did not at the time of collection
p.000004: possess decision-making capacity and therefore did not personally, or jointly together with his/her parent, consent to
p.000004: the donation. In the event that re-consent is not practicable, the IRB should generally have the discretion to waive
p.000004: the requirement in accordance with the relevant criteria for waiver of consent, where appropriate; or
p.000004:
p.000004: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000004: combinations.
p.000004:
p.000004: 31. Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000004: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000004: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000004: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000004: immediately before death.
p.000004:
p.000004: 32. For research using foetal tissues, consent for the termination of pregnancy should be separate from the
p.000004: consent for obtaining foetal tissue or any tissue related to the pregnancy for research. Where possible, an
p.000004: attending physician should not also seek consent for research participation from a patient in this situation. Consent
p.000004: for the use of foetal tissue for research could be obtained from either parent, as provided for in the Medical
p.000004: (Therapy, Education and Research) Act.
p.000004:
p.000004: 33. Specific and personal consent from the donors must be obtained before any gametes or embryos are to be
p.000004: used for research. Potential donors should be provided with sufficient information to make an informed decision
p.000004: and be given at least a week to decide.
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: EXECUTIVE SUMMARY
p.000005:
p.000005:
p.000005: 34. For women undergoing fertility treatment, consent for the donation of surplus oocytes or embryos for
p.000005: research should be separate from the consent for treatment. The treating physician should not also be the
p.000005: researcher seeking consent for the donation of oocytes or embryos for research. Donors should confirm in writing that
p.000005: they do not require the oocytes or embryos for future use.
p.000005:
p.000005: 35. Women wishing to donate eggs specifically for research must be interviewed by an independent panel. The panel
p.000005: must be satisfied that they are of sound mind, clearly understand the nature and consequences of the donation,
p.000005: and have freely given explicit consent, without any inducement, coercion or undue influence.
p.000005:
...
p.000029: to the minor, the authority of parents or guardians to consent to research without direct benefit is constrained
p.000029: in a similar fashion to proxy decisions for incapacitated adults as discussed in para. 3.16 above. Participation
p.000029: in research without direct benefit should involve no more than minimal risk and not be contrary to the best
p.000029: interests of the minor.
p.000029:
p.000029: 3.24 It is nevertheless ethically important to give due respect to the developing capacity of minors to be involved
p.000029: in, and make their own decisions about research participation. This consideration is reinforced in the case of research
p.000029: without direct benefit, where the minor should appreciate its altruistic nature. Respect for a minor’s
p.000029: developing autonomy is thus recognised by the Medicines (Clinical Trials) Regulations, which require both the
p.000029: minor who has sufficient understanding and a parent or guardian to consent to participation in a clinical
p.000029: trial.17 Similarly, the common law will not subject a child with sufficient understanding to a
p.000029: non-therapeutic procedure against his/her will.18
p.000029:
p.000029: Determining decision making capacity
p.000029:
p.000029: 3.25 In order to give a valid consent, the minor must have sufficient maturity and intelligence to
p.000029: understand the relevant information relating to the proposed research, and use that information to arrive at a reasoned
p.000029: decision. This capacity is, however, not easily linked to fixed ages, as it varies from minor to minor, and depends on
p.000029: the nature and complexity of the research. None of the current legal age thresholds bear immediate relevance to
p.000029: determining when a minor develops sufficient decision- making capacity to consent to research participation,
p.000029: although children between the ages of 12-14 may acquire near adult decision-making capacity.19 We therefore
...
p.000029:
p.000030: 30
p.000030:
p.000030: CONSENT
p.000030:
p.000030: the research risks involved are significantly greater than minimal, it would be prudent to assess capacity on an
p.000030: individual basis before enrolment.
p.000030:
p.000030: Engagement
p.000030:
p.000030: 3.26 For minors who lack sufficient decision-making capacity, it is still important to engage them as
p.000030: far as their intellectual abilities permit. This may involve, for example, explaining the nature of the
p.000030: research procedures and dealing with the minor’s concerns. Engagement serves to minimise the potential risks
p.000030: associated with participation, such as any distress experienced while undergoing research
p.000030: procedures.20 In every instance, including the obtaining of consent, IRBs and researchers should
p.000030: ensure that such engagement or explanation should be communicated effectively with age
p.000030: appropriate language and methods, and appropriately documented.
p.000030:
p.000030: Summary
p.000030:
p.000030: 3.27 The BAC is thus of the view that for research involving minors with decision-making capacity, consent from
p.000030: both the minor and a parent should be obtained; such a minor’s refusal of consent should be respected. Apart from this,
p.000030: it is still important to engage the minor in ways that respect his or her current level of understanding.
p.000030: Parents or guardians of minors lacking decision-making capacity are authorised to consent to their
p.000030: participation in research that involves no more than minimal risk and is not contrary to their best
p.000030: interests.
p.000030:
p.000030: Waiver of Parental Consent
p.000030:
p.000030: 3.28 For research that does not involve more than minimal risk, such as surveys seeking information relating only
p.000030: to the minor, the BAC is of the view that IRBs should be able to waive parental consent for minors who have
p.000030: decision-making capacity, where there is otherwise no prohibition by law and parental consent is not a
p.000030: reasonable requirement for the protection of the minor’s interests.
p.000030:
...
p.000033:
p.000033: be taken by the researcher so long as there are provisions to manage the conflict of interest and sufficient safeguards
p.000033: to protect the welfare and interests of the participant.
p.000033:
p.000033: 3.43 For research involving patients, consent for participating in research should be clearly separated from
p.000033: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000033: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000033: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000033: and sufficient safeguards to protect the welfare and interests of the patient.
p.000033:
p.000033: 3.44 While local customs should be respected when conducting research in places where social proxy arrangements
p.000033: are widespread, individual consent from the prospective participant is nevertheless essential.
p.000033:
p.000033: 3.45 For research involving minors with decision-making capacity, consent from both the minor and a parent should
p.000033: be obtained; such a minor’s refusal of consent should be respected. Apart from this, it is still important to
p.000033: engage the minor in ways that respect his or her current level of understanding. Parents or guardians
p.000033: of minors lacking decision-making capacity are authorised to consent to their participation in research
p.000033: that involves no more than minimal risk and is not contrary to their best interests.
p.000033:
p.000033: 3.46 For research that does not involve more than minimal risk, such as surveys seeking information relating only
p.000033: to the minor, IRBs should be able to waive parental consent for minors who have decision-making capacity,
p.000033: where there is otherwise no prohibition by law and parental consent is not a reasonable requirement
p.000033: for the protection of the minor’s interests.
p.000033:
...
p.000042:
p.000042: (f) Whether there is any possibility of being re-contacted for future research, or to be informed about clinically
p.000042: significant incidental findings, if they so wish;
p.000042:
p.000042: (g) Whether the biological materials will be identified and the applicable privacy and confidentiality
p.000042: safeguards for personal information derived from research involving the materials; and
p.000042:
p.000042: (h) That it is possible for donors to withdraw consent from the research, as long as the biological materials
p.000042: have not yet been used, and in any case without prejudice to any treatment they may be undergoing, and of the
p.000042: procedures and implications of the withdrawal.
p.000042:
p.000043: 43
p.000043:
p.000043: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000043:
p.000043: 5.16 Re-consent is required in the following situations:
p.000043:
p.000043: (a) When the proposed research is not covered by the consent that was given when the biological materials were
p.000043: collected (unless the re-consent requirement is waived by an IRB);
p.000043:
p.000043: (b) If the biological material was collected from a minor below 21 years of age, who did not at the time of
p.000043: collection possess decision-making capacity and therefore did not personally, or jointly together with his/her
p.000043: parent, consent to the donation. Once the minor attains the age of 21, his or her consent should be
p.000043: obtained if research is to be conducted on the previously collected material or personal information related to the
p.000043: sample, or at the least notified of his or her right to withdraw the biological material from research or storage for
p.000043: research. In the event that re-consent is not practicable, the IRB should generally have the discretion to waive the
p.000043: requirement in accordance with the relevant criteria for waiver of consent, where appropriate; or
p.000043:
p.000043: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000043: combinations.
p.000043:
p.000043: 5.17 When any clinically significant findings are discovered in the process of research using human
p.000043: biological materials, researchers should ensure that donors of these materials are informed, if they have
p.000043: indicated their desire to know of such findings.
p.000043:
p.000043: 5.18 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000043: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000043: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000043: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000043: immediately before death, if there is no actual notice of contrary indications by the deceased person, or actual notice
p.000043: of opposition of another legally authorised person of the same or prior class.
p.000043:
p.000043: Foetal Tissues
p.000043:
p.000043: 5.19 Foetal tissues include membranes, amniotic fluid, placenta and umbilical cord. Foetal tissues for research
p.000043: should only be taken from dead or non-viable foetuses. Abortion should not be induced for the purpose of obtaining
p.000043: materials for research.
p.000043:
p.000043: 5.20 Consent for the termination of pregnancy should be separate from the consent for obtaining foetal
p.000043: tissue or any tissue related to the pregnancy for research. Where possible, an attending physician
p.000043: should not also seek consent for research participation from a patient in this situation.
p.000043:
p.000043: 5.21 Consent for the use of foetal tissue for research could be obtained from either parent, as provided in the
p.000043: Medical (Therapy, Education and Research) Act.
p.000043:
p.000043: 5.22 Any research intention to propagate foetal cells in vitro and/or to transplant these cells into a human
p.000043: recipient should be disclosed when consent is sought.
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000044:
p.000044: Human Gametes and Embryos
p.000044:
p.000044: 5.23 The creation of human embryos specifically for research can only be justified when there is strong
p.000044: scientific merit in and potential medical benefit from such research. The Human Cloning and Other Prohibited
p.000044: Practices Act prohibits the development of a human embryo created other than by fertilisation of human egg by human
p.000044: sperm, for a period of more than 14 days, excluding any period when the development of the embryo is
p.000044: suspended. Commercial trading in human eggs, human sperm and human embryos is also prohibited.
p.000044:
p.000044: 5.24 The supply and use of human gametes and embryos is governed by the Human Cloning and Other
p.000044: Prohibited Practices Act (Cap. 131B). Researchers should also comply with the requirements stipulated in
p.000044: MOH’s 2011 Licensing Terms and Conditions (LTC) on Assisted Reproduction (AR) Services imposed under
p.000044: Section 6(5) of the Private Hospitals and Medical Clinics Act.
p.000044:
p.000044: 5.25 Under the LTC,25 written approval from the Director of Medical Services must be obtained for all
...
p.000072: been assigned to, does not amount to deception in the sense intended here. It is well recognised that
p.000072: the requirements of research may be inconsistent with full disclosure of the research purpose or hypothesis to
p.000072: intended participants, and there are procedures for managing this matter. The important
p.000072: consideration is that subjects cannot be deceived as to the risks or benefits of the research, or such
p.000072: things as the affiliation of the researcher, the uses or value of the research, or their rights in respect of
p.000072: participation.
p.000072:
p.000072:
p.000072:
p.000072: A20
p.000072:
p.000072: ANNEX A
p.000072:
p.000072:
p.000072:
p.000072: 3.10 In any general consent for future research, donors may wish to impose some limits to the use of their tissue
p.000072: or information. If the donation is accepted, any such conditions must be observed. If the conditions are
p.000072: unacceptable or impractical, the donation should be declined. In general, the intention should be to seek a
p.000072: completely general consent without restriction, given that the tissue or information will be used only if the research
p.000072: is approved by an IRB.
p.000072:
p.000072: The Mental Capacity Act
p.000072:
p.000072: 3.11 Under the Mental Capacity Act, decisions in matters affecting day-to-day living of a person lacking capacity
p.000072: may be taken by a proxy, such as a parent, caregiver or legal guardian, or a “donee”, who is a proxy appointed
p.000072: with a lasting power of attorney (LPA). The Act is silent with regards to whether or not next-of-kin can assume
p.000072: the responsibility for seeking and giving consent for medical treatment, including clinical trials. However, a donee
p.000072: who has been specifically given authority under the LPA to give or refuse consent to the carrying out or continuation
p.000072: of medical treatment by a health care provider, may also decide on the conduct of clinical trials.
p.000072:
p.000072: 3.12 In making such decisions, the donee must follow the statutory principles under the Act, viz., act
p.000072: in the donor’s best interests,50 have regard to the guidance in the Codes of Practice, carry out the donor’s
p.000072: instructions and make decisions within the scope of authority specified in the LPA. To give consent for the
p.000072: person lacking capacity to participate in clinical trials, the donee must be satisfied that:
p.000072:
p.000072: (a) The individual has previously indicated a willingness to participate; or
p.000072:
p.000072: (b) Consent would, in the judgement of the donee, have been given had the individual (not being a
p.000072: child), been able to make an informed choice.
p.000072:
...
p.000072:
p.000072: behalf of a non-competent person cannot be defended as in the person’s best interest if no clinical trial is involved.
p.000072:
p.000072: Consent Involving Vulnerable Persons
p.000072:
p.000072: 3.15 While it is usual to treat the individual as an autonomous agent for purposes of taking consent, provision has
p.000072: to be made when considering research participants who might be considered vulnerable. Such participants include:
p.000072:
p.000072: (a) Adults with diminished mental powers (such as the intellectually disabled or patients with dementia
p.000072: or others who lack mental capacity as defined in the Mental Capacity Act) or because they are incapacitated
p.000072: through accident, injury or illness;
p.000072:
p.000072: (b) Those whose autonomy might be prejudiced by being under the influence of, or the control of, or obligated to,
p.000072: third parties; and
p.000072:
p.000072: (c) Infants or children. In the case of under-aged research participants issues of consent primarily
p.000072: involve parent or guardians.
p.000072:
p.000072: Consent from Vulnerable Persons not Lacking Capacity
p.000072:
p.000072: 3.16 Vulnerable adult research participants not only include those who are of diminished capacity, but also
p.000072: those whose autonomy might be prejudiced by being under the influence of, or the control of, or
p.000072: obligated to, third parties. Potentially vulnerable participants might include, but are not limited to:
p.000072:
p.000072: (a) Prisoners;
p.000072:
p.000072: (b) Serving uniformed personnel, especially junior ranks;
p.000072:
p.000072: (c) Patients, especially if the intending researcher is their attending physician; and
p.000072:
p.000072: (d) Employees, junior collaborators, or students.
p.000072:
p.000072: 3.17 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000072: prospective participants reassured that they have nothing to fear in declining research participation or
p.000072: in contributing tissue for research. Thus consent among uniformed personnel, for example, should not be taken by
...
p.000072: extent that is reasonable given the child’s age, and that a combination of parental and child consent is
p.000072: the normal requirement. The older the child and the more mature his or her understanding, the more important it is to
p.000072: engage them in ways that respect their level of understanding and their right to refuse.
p.000072:
p.000072: 3.23 In Singapore, under the common law, the age of majority is 21 years. This age is generally
p.000072: taken as the age at which a person is considered an adult and thus able to make all decisions for oneself.
p.000072:
p.000072: 3.24 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000072: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy. The gift
p.000072: will take effect upon death.
p.000072:
p.000072: 3.25 Under the Medicines (Clinical Trials) Regulations, consent for participation in clinical trials must be
p.000072: obtained from the parent, guardian or legal representative of an individual below the age of 21.
p.000072:
p.000072: 3.26 The BAC is of the view that for research involving individuals less than 21 years of age and presenting more
p.000072: than minimal risk, such as those with invasive procedures, consent from parents should be obtained, in addition to
p.000072: consent from the child. For research that does not involve more than minimal risk, such as surveys, IRBs should be able
p.000072: to waive parental consent.
p.000072:
p.000072: Waiver of Consent
p.000072:
p.000072: 3.27 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000072: typically epidemiological or public health research carried out with medical records or with data from national
p.000072: registries, when the following conditions are met:
p.000072:
p.000072: (a) The research is justified and poses no more than minimal risk to research participants;
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 51 For a discussion on the meaning of assent in research see Wilfond, BS & Diekema, DS. Engaging
...
p.000072:
p.000072: (b) The type and amount of tissue to be collected, and the procedures and risks involved in taking it;
p.000072: (c) That the tissue will be considered a gift and they will not have the right to any commercial gain from the
p.000072: research;
p.000072: (d) Whether the tissue may be stored and used for future research, and for how long;
p.000072:
p.000072: (e) The potential types of research for which the tissue may be used;
p.000072:
p.000072: (f) Any possibility of being re-contacted for future research;
p.000072:
p.000072: (g) Whether the tissue sample will be identified and the applicable privacy and confidentiality
p.000072: safeguards;
p.000072: (h) The safeguards for protecting their privacy and the confidentiality of their personal information; and
p.000072: (i) That it is possible for them to withdraw consent from the research, as long as the specimens have not been
p.000072: used, and in any case without prejudice to any treatment they may be undergoing, and of the procedures and
p.000072: implications of the withdrawal.
p.000072: 5.16 Re-consent is required in the following situations:
p.000072:
p.000072: (a) When the proposed research is not covered by the consent that was given when the tissue was collected
p.000072: (unless the re-consent requirement is waived by an IRB);
p.000072: (b) If the tissue was collected when the individual was a child, such that consent from a parent or
p.000072: guardian was required, and there is ongoing contact. Once the child attains the age of 21, his or her consent should be
p.000072: obtained if research is to
p.000072:
p.000072:
p.000072: A36
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: be conducted on the previously collected tissue or information related to this tissue specimen. In the event
p.000072: re-contact is not practicable, the IRB should have the discretion to determine whether or not the stored material or
p.000072: information can be used without re-consent; and
p.000072: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000072: combinations.
p.000072:
p.000072: 5.17 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000072: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000072: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000072: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000072: immediately before death, if there are no actual notice of contrary indications by the deceased person, or actual
p.000072: notice of opposition of another legally authorised person of the same or prior class.
p.000072: Foetal Tissues
p.000072:
p.000072: 5.18 Foetal tissues include membranes, amniotic fluid, placenta and umbilical cord. Foetal tissues for research
p.000072: should only be taken from dead or non-viable foetuses. Abortion should not be induced for the purpose of obtaining
p.000072: material for research.
p.000072: 5.19 Consent for the termination of pregnancy should be separate from the consent for obtaining foetal
p.000072: tissue or any tissue related to the pregnancy for research. Provisions for ensuring that where possible an attending
p.000072: physician should not also seek consent for research participation from a patient apply mutatis mutandis in this
p.000072: situation.
p.000072: 5.20 Consent for the use of foetal tissue for research could be obtained from either parent, as indicated in the
p.000072: Medical (Therapy, Education and Research) Act.
p.000072: 5.21 Any intention to propagate foetal cells in vitro and/or to transplant these cells into a human recipient
p.000072: should be disclosed when consent is sought.
p.000072: Human Gametes and Embryos
p.000072:
p.000072: 5.22 The creation of human embryos specifically for research can only be justified when there is strong
p.000072: scientific merit and potential medical benefit from such research. Under the Human Cloning and Other Prohibited
p.000072: Practices Act, the development of a human embryo created other than by fertilisation of human egg by human sperm, for a
p.000072: period of more than 14 days, excluding any period when the development of the embryo is suspended, is
p.000072: prohibited. Commercial trading in human eggs, human sperm and human embryos is also not allowed.
p.000072: 5.23 The use of human gametes or embryos for research is governed by the requirements of the law, as given in the
p.000072: MOH’s 2011 Licensing Terms and Conditions on Assisted Reproduction Services imposed under Section 6(5) of the
p.000072: Private Hospitals and
p.000072:
p.000072:
p.000072: A37
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Medical Clinics Act and by the Human Cloning and Other Prohibited Practices Act (Cap. 131B).
p.000072: 5.24 Under the Licensing Terms and Conditions on Assisted Reproduction Services, written approval from
p.000072: the Director of Medical Services must be obtained for all research involving human embryos and human
...
p.000072: a concept of either assent or consent of children below the age of majority.
p.000072:
p.000072: As noted under the Guidelines, “in Singapore, there is no clear legal standing for assent
p.000072:
p.000072: C33
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: as a procedure…”. Such a procedure may therefore be confusing to a researcher who is tasked to obtain such assent.
p.000072: In the case of consent from children, it is similarly submitted that such a concept may not be that
p.000072: clear under Singapore law. Whilst common law recognises the concept of “Gillick” competency, there does not appear
p.000072: to be very clear guidelines for consent by minors for participation in clinical trials or research
p.000072: involving human subjects, since, as is noted in the BAC’s general principles, there may not be actual benefit to
p.000072: the child in consenting to the trial, as opposed to consent for treatment.
p.000072:
p.000072: Further, Regulation 11 of the Medicines (Clinical Trials) Regulations (“Clinical Trials Regulations”) provides that
p.000072: that a person under the age of 21 shall not be a subject in a clinical trial unless consent is obtained from the
p.000072: subject’s parent, guardian or legal representative. There is no corresponding requirement for consent (or
p.000072: assent) to be obtained for the trial.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 10. 3.44 and 3.45
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: Consent from child in addition to consent from parent for research
p.000072: Whilst we do not advocate that consent or assent be a requirement, we agree that it is important that proper
p.000072: explanation be given to the child and that the IRB should ensure that such a requirement is set out in the protocol and
p.000072: the form of informed consent to provide that whilst ultimately it is the parent, guardian or legal representative who
p.000072: gives the consent, efforts should be made by the researcher to involve the child in the informed consent, but it should
p.000072: stop short of requiring consent or assent.
p.000072: We also note that the BAC has recommended that for research on subjects below 21 years and involving
p.000072: more than minimal risks, such as those with invasive procedures, consent from parents should be obtained, in
p.000072: addition to consent from the child. However, for research on subjects below 21 years that does not involve more than
p.000072: minimum risk, the IRB should be able to waive parental consent. The Guidelines however are silent as to whether child
p.000072: consent is still required, and the implication may be that whilst the IRB may be able to waive the need for parental
p.000072: consent, the consent from the child may still be required.
p.000072:
...
p.000072: C34
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: consent, if the parents give consent.
p.000072:
p.000072: We have two suggestions:
p.000072: (a) First, we suggest that the Guidelines make clear that such waivers by the IRB in paragraph 3.44 can only
p.000072: apply in the case where the research is not regulated under the Clinical Trials Regulations. Otherwise, an
p.000072: anomaly may arise in a case where there may be a clinical trial which may not involve more than minimal
p.000072: risks (i.e. a non-invasive clinical trial), and IRB may waive a requirement for parental consent, which is
p.000072: required under Clinical Trials Regulations.
p.000072:
p.000072: (b) Secondly, on the assumption that consent of the child is a requirement in all research
p.000072: involving children (we have advocated above that there should not be such a requirement), we suggest that it should be
p.000072: the consent of the child that is waivable, rather than parental consent. Otherwise, there may an inadvertent
p.000072: displacement of the authority of the parent over the child, where the child may agree to participate, but where the
p.000072: parent may not. For example, it is likely that a parent would still need to be involved in the child’s participation in
p.000072: the research (such as arranging for the parent to be present for the research or tests to be carried
p.000072: out, etc). The parent’s wishes should be respected in such a case. This position would also be consistent with the
p.000072: position articulated in paragraph 3.45 and therefore does not run the risk of creating many different layer of consents
p.000072: (for invasive research, for non-invasive research, and for clinical research).
p.000072:
p.000072: As important as it is to take into consideration the views of the minor who will be subject to the
p.000072: research, an approach requiring both consent from the minor and parent may pose a potential problem in situations
p.000072: where the parent consents to the research and the minor does not.
p.000072:
p.000072: In the event of a deadlock, would the parents’ decision trump that of the minor, and if so, what purpose would there be
p.000072: in having both the minor and parent give consent to the research?
p.000072:
p.000072:
p.000072: C35
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 11. 4.12, 4.13
p.000072: and 4.18
p.000072:
p.000072: Use of Medical Records for Research
p.000072: Use of Personal Information
p.000072: We note that the BAC has recommended that appropriate access be given to suitably qualified professionals
p.000072: for the purpose of research. We note that the BAC Guidelines are silent on whether there is a need to obtain consent
p.000072: from patients before the release of such medical information. Whilst the BAC does advocate that the Healthcare
p.000072: Institutions and the IRBs formulate clear procedures for the release of such medical records and other
p.000072: personal information, we suggest that the Guidelines should make clear that all such access must be subject
p.000072: to IRB approval (similar to the need to obtain IRB approvals for other forms of research and which would be in
p.000072: line with paragraph 4.15 of the Guidelines).
p.000072: Tissue Banking
p.000072:
p.000072: 12. 5.8 Guidelines on Human Tissue Research
p.000072: We note that the Guidelines provide that all research involving human tissue, whether identified or de-identified,
p.000072: should be reviewed by an IRB and approved before it commences.
p.000072:
p.000072: At present, we understand that tissue banks are required to be licensed under the PHMC Act. We note that under the
p.000072: Guidelines for Healthcare Institutions promulgated pursuant to Regulation 4 of the Private Hospitals and
...
Searching for indicator parents:
(return to top)
p.000002:
p.000002: 15. For research involving patients, consent for participating in research should be clearly separated from
p.000002: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000002: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000002: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000002: and sufficient safeguards to protect the welfare and interests of the patient.
p.000002:
p.000002: 16. For research involving minors with decision-making capacity, consent from both the minor and a parent should
p.000002: be obtained; such a minor’s refusal of consent should be respected. Apart from this, it is still important to
p.000002: engage the minor in ways that respect his or her current level of understanding. Parents or guardians
p.000002: of minors lacking decision-making capacity are authorised to consent to their participation in research
p.000002: that involves no more than minimal risk and is not contrary to their best interests. For research that
p.000002: does not involve more than minimal risk, such as surveys seeking information relating only to the minor, IRBs should be
p.000002: able to waive parental consent for minors who have decision-making capacity, where there is otherwise no prohibition
p.000002: by law and parental consent is not a reasonable requirement for the protection of the minor’s interests.
p.000002:
p.000002: 17. IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000002: typically in epidemiological or public health research carried out with medical records or with data from national
p.000002: registries.
p.000002:
p.000002: 18. For research involving recruitment of highly compromised patients who are unable to give consent and for whom
p.000002: no proxy is available to give consent, and subject to the treatment of the patient remaining the priority, IRBs may
...
p.000028: always possible. In such situations, the IRB may give directions for the consent to be taken by the
p.000028: researcher-physician so long as there are provisions to manage the conflict of interest and sufficient safeguards to
p.000028: protect the welfare and interests of the patient.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: CONSENT
p.000029:
p.000029: Consent for Research Involving Minors
p.000029:
p.000029: Respect for the developing autonomy of minors
p.000029:
p.000029: 3.23 In Singapore, under the common law, the age of majority is 21 years. This age is generally
p.000029: taken as the age at which a person is considered an adult and thus able to make all decisions for oneself. The category
p.000029: of minors thus spans a wide range, from children of tender years who lack any capacity to give consent, to young
p.000029: persons who have acquired the capacity to understand and make decisions on research participation.
p.000029: Parents generally have the authority to make decisions on behalf of minors, and this would include research
p.000029: participation. However, the welfare and best interests of the child or young person is the paramount consideration and
p.000029: parents must discharge their responsibilities to promote these.16 Unless research participation offers direct benefit
p.000029: to the minor, the authority of parents or guardians to consent to research without direct benefit is constrained
p.000029: in a similar fashion to proxy decisions for incapacitated adults as discussed in para. 3.16 above. Participation
p.000029: in research without direct benefit should involve no more than minimal risk and not be contrary to the best
p.000029: interests of the minor.
p.000029:
p.000029: 3.24 It is nevertheless ethically important to give due respect to the developing capacity of minors to be involved
p.000029: in, and make their own decisions about research participation. This consideration is reinforced in the case of research
p.000029: without direct benefit, where the minor should appreciate its altruistic nature. Respect for a minor’s
p.000029: developing autonomy is thus recognised by the Medicines (Clinical Trials) Regulations, which require both the
p.000029: minor who has sufficient understanding and a parent or guardian to consent to participation in a clinical
...
p.000030: far as their intellectual abilities permit. This may involve, for example, explaining the nature of the
p.000030: research procedures and dealing with the minor’s concerns. Engagement serves to minimise the potential risks
p.000030: associated with participation, such as any distress experienced while undergoing research
p.000030: procedures.20 In every instance, including the obtaining of consent, IRBs and researchers should
p.000030: ensure that such engagement or explanation should be communicated effectively with age
p.000030: appropriate language and methods, and appropriately documented.
p.000030:
p.000030: Summary
p.000030:
p.000030: 3.27 The BAC is thus of the view that for research involving minors with decision-making capacity, consent from
p.000030: both the minor and a parent should be obtained; such a minor’s refusal of consent should be respected. Apart from this,
p.000030: it is still important to engage the minor in ways that respect his or her current level of understanding.
p.000030: Parents or guardians of minors lacking decision-making capacity are authorised to consent to their
p.000030: participation in research that involves no more than minimal risk and is not contrary to their best
p.000030: interests.
p.000030:
p.000030: Waiver of Parental Consent
p.000030:
p.000030: 3.28 For research that does not involve more than minimal risk, such as surveys seeking information relating only
p.000030: to the minor, the BAC is of the view that IRBs should be able to waive parental consent for minors who have
p.000030: decision-making capacity, where there is otherwise no prohibition by law and parental consent is not a
p.000030: reasonable requirement for the protection of the minor’s interests.
p.000030:
p.000030: Waiver of Consent
p.000030:
p.000030: 3.29 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000030: typically in epidemiological or public health research carried out with medical records or with data from national
p.000030: registries, when the following conditions are met:
p.000030:
...
p.000031:
p.000031: Clinically Significant Incidental Findings
p.000031:
p.000031: 3.31 A clinically significant incidental finding occurs when, in the course of research done for some other
p.000031: purposes, a finding is made that has a clear implication for the health of the participant to whom it relates. Research
p.000031: findings are by their nature provisional and not definitive. Where research data suggests the presence of a clinical
p.000031: condition that would require a confirmation and possible treatment, there is some duty on the part of the researcher to
p.000031: ensure that the research participant is informed of the possible condition with advice to follow up on the matter with
p.000031: a medical practitioner.
p.000031:
p.000031: 3.32 If there is reasonable possibility that incidental findings may occur in a research, research
p.000031: participants should be given the choice of whether to be informed about such findings, during the consent-taking
p.000031: process, prior to the commencement of the research. Researchers should ensure that research participants,
p.000031: who so choose, are informed and advised to seek medical attention and confirmation of the research result in a
p.000031: clinical laboratory.
p.000031:
p.000031: 3.33 Communication of clinically significant findings to research participants could be done directly by
p.000031: the researcher, or through a healthcare provider or other party authorised to receive the information,
p.000031: and who is appropriately qualified and in a better position to advise and discuss the implications of the
p.000031: findings.
p.000031:
p.000031: 3.34 Parents who have indicated a wish to know, should be informed of clinically significant
p.000031: incidental findings affecting their children’s health, when they are discovered. Upon reaching the
p.000031: age of 21 and if the research is still on-going, the individuals concerned will then be in a position to make
p.000031: their own decisions regarding whether or not to be contacted in the event that such findings are uncovered.
p.000031:
p.000031: 3.35 If a clinically significant finding is discovered, but the preference of the research participant
p.000031: for receiving such information is unknown, researchers should refer to their IRBs for advice on the
p.000031: appropriate handling of such information.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: CONSENT
p.000032:
p.000032: Guidelines on Consent
p.000032:
p.000032: 3.36 Consent for participation in research must be voluntary. There should be no coercion or undue influence.
p.000032: Participants may be reimbursed for legitimate expenses. Any other payment, whether monetary or in kind,
p.000032: should not amount to an inducement, and should be approved by an IRB.
p.000032:
p.000032: 3.37 Participants should be allowed to withdraw from the research at any time without any explanation, and without
p.000032: penalty or prejudice to any treatment they may be receiving.
p.000032:
...
p.000033: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000033: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000033: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000033: and sufficient safeguards to protect the welfare and interests of the patient.
p.000033:
p.000033: 3.44 While local customs should be respected when conducting research in places where social proxy arrangements
p.000033: are widespread, individual consent from the prospective participant is nevertheless essential.
p.000033:
p.000033: 3.45 For research involving minors with decision-making capacity, consent from both the minor and a parent should
p.000033: be obtained; such a minor’s refusal of consent should be respected. Apart from this, it is still important to
p.000033: engage the minor in ways that respect his or her current level of understanding. Parents or guardians
p.000033: of minors lacking decision-making capacity are authorised to consent to their participation in research
p.000033: that involves no more than minimal risk and is not contrary to their best interests.
p.000033:
p.000033: 3.46 For research that does not involve more than minimal risk, such as surveys seeking information relating only
p.000033: to the minor, IRBs should be able to waive parental consent for minors who have decision-making capacity,
p.000033: where there is otherwise no prohibition by law and parental consent is not a reasonable requirement
p.000033: for the protection of the minor’s interests.
p.000033:
p.000033: 3.47 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000033: typically epidemiological or public health research carried out with medical records or with data from national
p.000033: registries, when the following conditions are met:
p.000033:
p.000033: (a) The research is justified and poses no more than minimal risk to research participants;
p.000033:
...
p.000054: arises from the fact that the human embryo is destroyed in the process of stem cell derivation. There is a wide
p.000054: spectrum of views concerning the human embryo. At one end, it is considered to be a human being from
p.000054: the time of fertilisation, while at the other, the view is that it is a mass of cells, no different from any other
p.000054: biological material used for research.
p.000054:
p.000054: 7.14 After public consultation, the BAC adopted an intermediate position, whereby a human embryo is
p.000054: considered to have the status of a potential human being, but not the same status as a living child or adult. As a
p.000054: measure of respect and protection for the human embryo, the BAC recommended that human embryonic stem cell
p.000054: research, including the creation of human embryos specifically for research, should be allowed only when there is
p.000054: strong scientific merit in and potential medical benefit from such research. In addition, only embryos less than
p.000054: 14 days old should be used for the derivation of stem cells. At around this threshold, the primitive
p.000054: streak appears, signalling the onset of cell differentiation and development of organ systems, including
p.000054: the nervous system. As for the use of surplus embryos donated from fertility treatment by consenting parents, the BAC
p.000054: was of the view that rather than allow them to perish, their use in research would serve a greater good. The BAC’s
p.000054: position on this issue remains unchanged.
p.000054:
p.000054: 7.15 With the increasing possibility of alternative means of generating pluripotent stem cells, such as
p.000054: induced pluripotent stem cells, it is more likely that cloning technology would be less frequently used for the
p.000054: creation of embryos. The BAC welcomes such diversity in research methodologies, but continues to regard
p.000054: research cloning (or therapeutic cloning) as defensible under strict regulation, if the scientific question
p.000054: addressed cannot reasonably be investigated using other methods.
p.000054:
p.000054: Cloning and Respect for Individuals
p.000054:
p.000054: 7.16 Respect for human dignity forms the basis for the prohibition of human reproductive cloning in many
p.000054: countries, including Singapore. In particular, there are serious concerns about the safety of the technology
p.000054: used for this purpose, and any unforeseen problems for those born as a result of the technology.
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: HUMAN STEM CELL RESEARCH
p.000055:
p.000055: Human-Animal Combinations
p.000055:
p.000055: 7.17 Repugnance. Many people express repugnance or disgust at the idea of human-animal combinations, as human and
p.000055: animal tissues are not normally thought of as something that can or should be mixed. It is seen as unnatural. The BAC’s
p.000055: position is that while feelings of repugnance cannot be ignored, the process of paying heed to them should involve an
p.000055: evaluation of actual or likely harms and benefits.
...
p.000072: in research. When a researcher is also the attending physician, the researcher-physician should be aware of
p.000072: a potential conflict of interest and of the fact that his or her patients may feel obliged to give consent.
p.000072: Ideally, the consent for research should be taken by an independent third person, though this is not
p.000072: always possible. In such situations, the IRB may give directions for the consent to be taken by the
p.000072: researcher-physician so long as there are provisions to manage the conflict of interest and sufficient safeguards to
p.000072: protect the welfare and interests of the patient.
p.000072:
p.000072: Consent for Research Involving Children
p.000072:
p.000072: 3.22 Children present certain consent issues if involved in research, and they are
p.000072: categorised as a vulnerable class of research participants. In some jurisdictions a distinction is made
p.000072: between consent and assent, such that if parents consent, research can proceed provided children assent, i.e.
p.000072: agree. The assent of a child is not comparable to the informed consent of an adult. It is perhaps
p.000072: better regarded as a mechanism for engaging the child in the research process, in such a way as to respect the
p.000072: child’s right to object, and to entitle them to as reasonable an explanation as may be reasonable, consistent with
p.000072: the child’s level of understanding, but without an
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A23
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: implication that the child is giving informed consent.51 In clinical research that has a reasonable expectation of
p.000072: benefitting a child, the research might be allowed to proceed even without the child’s assent, if the
p.000072: parents give consent, but in general, researchers should respect refusal by a child. Because, in Singapore, there
p.000072: is no clear legal standing for assent as a procedure – unlike the case of consent – the BAC retains the use of the term
p.000072: consent for children as well as adults, but on the understanding that a child’s consent can be informed only to the
p.000072: extent that is reasonable given the child’s age, and that a combination of parental and child consent is
p.000072: the normal requirement. The older the child and the more mature his or her understanding, the more important it is to
p.000072: engage them in ways that respect their level of understanding and their right to refuse.
p.000072:
p.000072: 3.23 In Singapore, under the common law, the age of majority is 21 years. This age is generally
p.000072: taken as the age at which a person is considered an adult and thus able to make all decisions for oneself.
p.000072:
p.000072: 3.24 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000072: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy. The gift
p.000072: will take effect upon death.
p.000072:
p.000072: 3.25 Under the Medicines (Clinical Trials) Regulations, consent for participation in clinical trials must be
p.000072: obtained from the parent, guardian or legal representative of an individual below the age of 21.
p.000072:
p.000072: 3.26 The BAC is of the view that for research involving individuals less than 21 years of age and presenting more
p.000072: than minimal risk, such as those with invasive procedures, consent from parents should be obtained, in addition to
p.000072: consent from the child. For research that does not involve more than minimal risk, such as surveys, IRBs should be able
p.000072: to waive parental consent.
p.000072:
p.000072: Waiver of Consent
p.000072:
p.000072: 3.27 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000072: typically epidemiological or public health research carried out with medical records or with data from national
p.000072: registries, when the following conditions are met:
p.000072:
p.000072: (a) The research is justified and poses no more than minimal risk to research participants;
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 51 For a discussion on the meaning of assent in research see Wilfond, BS & Diekema, DS. Engaging
p.000072: children in genomics research: decoding the meaning of assent in research, Genetics in Medicine (2012), 14
p.000072: (4): 437-443.
p.000072:
p.000072:
p.000072:
p.000072: A24
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (b) The waiver will not adversely affect the welfare and interests of research participants;
p.000072:
p.000072: (c) The research could not practicably proceed without the waiver;
p.000072:
...
p.000072: matter with a medical practitioner.
p.000072: 3.30 Research participants should be given the choice of whether to be informed about such findings,
p.000072: prior to the commencement of the research, if the research is such that there is some reasonable possibility that
p.000072: incidental findings may occur. Researchers should ensure that research participants, who so choose, are informed and
p.000072: advised to seek medical attention and confirmation of the research result in a clinical laboratory.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 52 This contingency has been considered by the UK MRC Ethics Guide: Medical research involving
p.000072: adults who cannot consent, 2007 (section 4.3).
p.000072:
p.000072:
p.000072:
p.000072: A25
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 3.31 Communication of clinically significant findings to research participants could be directly by the
p.000072: researcher, or through a healthcare provider or other party authorised to receive the information and in a
p.000072: better position to advise and discuss the implications of the findings.
p.000072:
p.000072: 3.32 Communication of clinically significant incidental findings to biological relatives should be
p.000072: encouraged. This, including the question of who will do it and taking into account the participant’s preference, should
p.000072: be discussed and agreed upon at the time of obtaining consent
p.000072:
p.000072: 3.33 Parents who have indicated a wish to know, should be informed of clinically significant research
p.000072: results affecting their children’s health, when they are discovered. Upon reaching the age of 21 and if the
p.000072: research is still on-going, the individuals concerned will then be in a position to make their own decisions
p.000072: regarding whether or not to be contacted in the event that clinically significant incidental findings are
p.000072: uncovered.
p.000072:
p.000072: Guidelines on Consent
p.000072:
p.000072: 3.34 Consent for participation in research must be voluntary. There should be no coercion or undue influence.
p.000072: Participants may be reimbursed for legitimate expenses, such as cost of transport and child care services, and actual
p.000072: loss of earnings. Any additional payment to be given, whether monetary or in kind, should not amount to an
p.000072: inducement.
p.000072:
p.000072: 3.35 Participants should be allowed to withdraw from the research at any time without any explanation, and without
p.000072: penalty or prejudice to any treatment they may be receiving.
p.000072:
p.000072: 3.36 Prospective research participants or authorised third parties should be provided with sufficient information
p.000072: in an understandable form and appropriate manner, to enable them to make an informed decision. Such information
p.000072: include:
p.000072:
p.000072: (a) The nature and purpose of the research;
p.000072:
...
p.000072: provisions to manage the conflict of interest and sufficient safeguards to protect the welfare and interests of the
p.000072: participant.
p.000072:
p.000072: 3.42 For research involving patients, consent for participating in research should be clearly separated from
p.000072: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000072: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000072: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000072: and sufficient safeguards to protect the welfare and interests of the patient.
p.000072:
p.000072: 3.43 While local customs should be respected when conducting research in places where social proxy arrangements
p.000072: are widespread, individual consent from prospective participant is nevertheless essential.
p.000072:
p.000072: 3.44 For research involving individuals less than 21 years of age and presenting more than minimal risk, such as
p.000072: those involving invasive procedures, consent from parents
p.000072:
p.000072: A27
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: should be obtained, in addition to consent from the child. Researchers should respect a child’s right to refuse to
p.000072: participate in research, and their entitlement to such explanation as may be reasonable, consistent with the
p.000072: child’s level of understanding. For research that does not involve more than minimal risk, such as surveys,
p.000072: IRBs should be able to decide to waive parental consent.
p.000072:
p.000072: 3.45 Clinical research that has a reasonable expectation of benefitting a child might be allowed to
p.000072: proceed even without the child’s consent, if the parents give consent.
p.000072:
p.000072: 3.46 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000072: typically epidemiological or public health research carried out with medical records or with data from national
p.000072: registries, when the following conditions are met:
p.000072:
p.000072: (a) The research is justified and poses no more than minimal risk to research participants;
p.000072:
p.000072: (b) The waiver will not adversely affect the welfare and interests of research participants;
p.000072:
p.000072: (c) The research could not practicably proceed without the waiver;
p.000072:
p.000072: (d) Obtaining consent is not possible or practicable;
p.000072:
p.000072: (e) Individual privacy and confidentiality of the personal information are assured; and
p.000072:
p.000072: (f) In the event that clinically significant findings are discovered, affected individuals who
p.000072: have indicated their wish to know will be informed in a timely manner, if reasonably possible.
p.000072:
p.000072: 3.47 For valuable research involving recruitment of highly compromised patients who are unable to give consent and
p.000072: for whom no proxy is available to give consent, subject to the treatment of the patient remaining the priority, IRBs
...
p.000072: human embryo, and arises from the fact that the human embryo is destroyed in the process of stem cell
p.000072: derivation. There is a wide spectrum of views concerning the human embryo. At one end, it is considered to be a human
p.000072: being from the time of fertilisation, while at the other end, the view is that it is a mass of cells, no different from
p.000072: any other biological material used for research.
p.000072: 7.13 After public consultation, the BAC adopted an intermediate position, whereby a human embryo is
p.000072: considered as having the status of a potential human being, but not the same status as a living child or adult. As a
p.000072: measure of respect and protection for the human embryo, the BAC recommended that human embryonic stem cell research,
p.000072: including the creation of human embryos specifically for research, should be allowed only when there is strong
p.000072: scientific merit in and potential medical benefit from such research. In addition, only embryos less than 14
p.000072: days old should be used for the derivation of stem cells, as at around day 14, the primitive streak appears,
p.000072: signaling the onset of cell differentiation and development of organ systems, including the nervous system.
p.000072: As for the use of surplus embryos donated from fertility treatment by consenting parents, the BAC was of the view that
p.000072: rather than allow them to perish, their use in research would serve a greater good. This remains the BAC position on
p.000072: this issue.
p.000072: 7.14 With the increasing possibility of alternative means of generating pluripotent stem cells, such as
p.000072: induced pluripotent stem cells, it is increasingly less likely that cloning technology would be used for the
p.000072: creation of embryos. The BAC welcomes such diversity in research methodologies, but regards research
p.000072: cloning (or therapeutic cloning) as defensible under strict regulation, if the scientific question
p.000072: addressed cannot reasonably be investigated using other methods.
p.000072:
p.000072:
p.000072: A48
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Cloning and Respect for Individuals
p.000072:
p.000072: 7.15 Respect for human dignity forms the basis for the prohibition of human reproductive cloning in many
p.000072: countries, including Singapore. In particular, there are serious concerns about the safety of the
p.000072: technology used for this purpose, and about any unforeseen problems for those born as a result of the
p.000072: technology.
p.000072: Human-Animal Combinations
p.000072:
p.000072: 7.16 Repugnance. Many people express repugnance or disgust at the idea of human-animal combinations, as human and
p.000072: animal tissues are not normally thought of as something that can or should be mixed. It is seen as unnatural. The BAC’s
p.000072: position is that while feelings of repugnance cannot be ignored, the process of paying heed to them should involve an
p.000072: evaluation of actual likely harms and benefits.
...
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 10. 3.44 and 3.45
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: Consent from child in addition to consent from parent for research
p.000072: Whilst we do not advocate that consent or assent be a requirement, we agree that it is important that proper
p.000072: explanation be given to the child and that the IRB should ensure that such a requirement is set out in the protocol and
p.000072: the form of informed consent to provide that whilst ultimately it is the parent, guardian or legal representative who
p.000072: gives the consent, efforts should be made by the researcher to involve the child in the informed consent, but it should
p.000072: stop short of requiring consent or assent.
p.000072: We also note that the BAC has recommended that for research on subjects below 21 years and involving
p.000072: more than minimal risks, such as those with invasive procedures, consent from parents should be obtained, in
p.000072: addition to consent from the child. However, for research on subjects below 21 years that does not involve more than
p.000072: minimum risk, the IRB should be able to waive parental consent. The Guidelines however are silent as to whether child
p.000072: consent is still required, and the implication may be that whilst the IRB may be able to waive the need for parental
p.000072: consent, the consent from the child may still be required.
p.000072:
p.000072: We also note that under paragraph 3.45, clinical research that has a reasonable expectation of benefiting a
p.000072: child might be allowed to proceed even without the child’s
p.000072: C34
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: consent, if the parents give consent.
p.000072:
p.000072: We have two suggestions:
p.000072: (a) First, we suggest that the Guidelines make clear that such waivers by the IRB in paragraph 3.44 can only
p.000072: apply in the case where the research is not regulated under the Clinical Trials Regulations. Otherwise, an
p.000072: anomaly may arise in a case where there may be a clinical trial which may not involve more than minimal
p.000072: risks (i.e. a non-invasive clinical trial), and IRB may waive a requirement for parental consent, which is
p.000072: required under Clinical Trials Regulations.
p.000072:
p.000072: (b) Secondly, on the assumption that consent of the child is a requirement in all research
p.000072: involving children (we have advocated above that there should not be such a requirement), we suggest that it should be
p.000072: the consent of the child that is waivable, rather than parental consent. Otherwise, there may an inadvertent
p.000072: displacement of the authority of the parent over the child, where the child may agree to participate, but where the
p.000072: parent may not. For example, it is likely that a parent would still need to be involved in the child’s participation in
p.000072: the research (such as arranging for the parent to be present for the research or tests to be carried
p.000072: out, etc). The parent’s wishes should be respected in such a case. This position would also be consistent with the
p.000072: position articulated in paragraph 3.45 and therefore does not run the risk of creating many different layer of consents
p.000072: (for invasive research, for non-invasive research, and for clinical research).
p.000072:
p.000072: As important as it is to take into consideration the views of the minor who will be subject to the
p.000072: research, an approach requiring both consent from the minor and parent may pose a potential problem in situations
p.000072: where the parent consents to the research and the minor does not.
p.000072:
p.000072: In the event of a deadlock, would the parents’ decision trump that of the minor, and if so, what purpose would there be
p.000072: in having both the minor and parent give consent to the research?
p.000072:
p.000072:
p.000072: C35
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 11. 4.12, 4.13
p.000072: and 4.18
p.000072:
p.000072: Use of Medical Records for Research
p.000072: Use of Personal Information
p.000072: We note that the BAC has recommended that appropriate access be given to suitably qualified professionals
p.000072: for the purpose of research. We note that the BAC Guidelines are silent on whether there is a need to obtain consent
p.000072: from patients before the release of such medical information. Whilst the BAC does advocate that the Healthcare
p.000072: Institutions and the IRBs formulate clear procedures for the release of such medical records and other
p.000072: personal information, we suggest that the Guidelines should make clear that all such access must be subject
p.000072: to IRB approval (similar to the need to obtain IRB approvals for other forms of research and which would be in
p.000072: line with paragraph 4.15 of the Guidelines).
p.000072: Tissue Banking
p.000072:
p.000072: 12. 5.8 Guidelines on Human Tissue Research
p.000072: We note that the Guidelines provide that all research involving human tissue, whether identified or de-identified,
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000020: 2.30 For multi-centre research, a lead IRB could be designated. The choice of the lead IRB should be dictated by
p.000020: considerations such as the primary institution of affiliation of the principal investigator, the location where the
p.000020: greater part of the research is carried out, the expertise of the IRBs, or the place where the largest number of
p.000020: participants is located. The lead IRB will play the main role in conducting a full ethics review, in coordinating the
p.000020: research programme, and in keeping the other participating IRBs informed of any decisions or amendments,
p.000020: including those made during the entire research period.
p.000020:
p.000020: 2.31 For multi-national research, the local portion should be subject to review by the IRB of the local partner
p.000020: institution(s), and the local IRB(s) should have a final say on matters affecting local participants.
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000021:
p.000021: Conflicts of Interest
p.000021:
p.000021: 2.32 Institutions, IRBs, members of IRBs and researchers should take special care to avoid conflicts of interest,
p.000021: whether actual, potential, or only the appearance of conflict. Institutions should develop policies and
p.000021: procedures to identify, eliminate, minimise or manage conflicts of interest that may affect research.
p.000021:
p.000021: 2.33 Should an IRB member have a personal interest in the research under review, that member should
p.000021: disqualify him- or herself from any consideration of the case, and he or she should refrain from offering his or
p.000021: her opinion to the IRB on the particular research under review. The member should make full disclosure
p.000021: of such an actual, potential or apparent conflict of interest to the IRB.
p.000021:
p.000021: 2.34 Researchers should disclose any actual, potential or perceived individual conflicts of interest, when
p.000021: submitting their research proposals to the IRB, as well as any institutional conflicts that they are aware of
p.000021: and may have an impact on their research. The IRB shall then decide on the appropriate steps to manage the conflict.
p.000021:
p.000021: 2.35 Threats to research integrity could arise when there is a conflict of interest between those who commission
p.000021: and fund research (including commercial organisations) and those who carry it out (the researchers).
p.000021: Routine checks and balances ensuring the integrity of the research process have been developed in
p.000021: universities and other research institutions with a commitment to research. When research is recruited to the service
p.000021: of commercial or institutional interests, researchers may be in a difficult position if their results are
p.000021: inconsistent with the expectations or hopes of their funders. IRBs need to consider how best to avoid such threats to
p.000021: integrity when considering applications in which they might arise.
p.000021:
p.000021: Responsibilities of Institutions
p.000021:
p.000021: 2.36 Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000021: carried out in their premises or facilities; or by their employees or on their patients; or involving access to or use
...
p.000063:
p.000063: Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000063: Application of Biology and Medicine: Convention on Human Rights and Biomedicine. 4 April 1997.
p.000063:
p.000063: Council of Europe. Guide for Research Ethics Committee Members. April 2012.
p.000063:
p.000063: Council of Europe. Recommendation No. R (97) 5 on the Protection of Medical Data. 13 February 1997.
p.000063:
p.000063: Council of Europe. Recommendation Rec (2006) 4 of the Committee of Ministers to member states on research on biological
p.000063: materials of human origin. 15 March 2006.
p.000063:
p.000063: Denmark. Act on a Biomedical Research Ethics Committee System and the Processing of Biomedical Research
p.000063: Projects. 2009.
p.000063: Denmark. Act on Research Ethics Review of Health Research Projects. 11 January 2012. Denmark. Danish Council of Ethics.
p.000063: Humans and Genetic Engineering in the New Millenium
p.000063: – How Are We Going to Get “Gen-Ethics” just in time?. 1999.
p.000063:
p.000063: Denmark. Danish National Committee on Biomedical Research Ethics. Guidelines about Notification etc. Of a
p.000063: Biomedical Research Project to the Committee System on Biomedical Research Ethics. 5 May 2011.
p.000063:
p.000063: European Commission. Opinion on Ethical Aspects of Clinical Research in Developing Countries. 4 February
p.000063: 2003.
p.000063:
p.000063: European Commission. Seventh Framework Programme. Guidance for Applicants: Informed Consent. (n.d.).
p.000063:
p.000063: Finland. Medical Research Act. Revised 2010.
p.000063:
p.000063: Finland. National Advisory Board on Health Care Ethics. Perspectives on Medical Research Conducted on Children. 2003.
p.000063:
p.000063: France. Civil Code. 1994.
p.000063:
p.000063: France. Comite Consultatif National d’Ethique. Opinion on Gene Therapy. 13 December 1990.
p.000063:
p.000063: France. Comite Consultatif National d’Ethique. Opinion on the Ethics of Research in the Sciences of Human
p.000063: Behaviour. 14 October 1993.
p.000063:
p.000063: Germany. Act for Protection of Embryos - The Embryo Protection Act. 13 December 1990.
p.000063:
p.000063: Greece. National Bioethics Commission. Template of Code of Research Ethics for Biological Sciences. 2009.
p.000063:
p.000063: Greene M et al. Moral Issues of Human-Non-Human Primate Neural Grafting. Science. 309 (2005): 385-386.
p.000063:
p.000064: 64
p.000064:
p.000064: BIBLIOGRAPHY
p.000064:
p.000064: Harris B. Disciplinary and Regulatory Proceedings. 6th Ed. London: Wiley & Sons, 2011. Human Genome Organisation.
p.000064: Statement on Human Genomic Databases. 2002.
p.000064: Human Genome Organisation. Statement on The Principled Conduct of Genetics Research. 21 March 1996.
p.000064:
p.000064: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
p.000064: Human Use. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice. 10 June 1996.
p.000064:
p.000064: International Society for Stem Cell Research. Guidelines for the Conduct of Human Embryonic Stem Cell
p.000064: Research. 21 December 2006.
p.000064:
p.000064: International Society for Stem Cell Research. Guidelines for the Clinical Translation of Stem Cells. 3 December 2008.
p.000064:
p.000064: Ireland. Irish Council for Bioethics. Report on Human Biological Material: Recommendations
p.000064: for Collection, Use and Storage in Research. 29 June 2005.
p.000064:
...
p.000067:
p.000067: Singapore, National Medical Ethics Committee. Recommendations on Clinical Trials: Update Focusing on
p.000067: Phase I Trials. 2007.
p.000067:
p.000067: Singapore. National Registry of Diseases Act (Cap. 201). Amended 2007. Singapore. Personal Data Protection Act (No.
p.000067: 26). 2012.
p.000067: Singapore. Private Hospitals and Medical Clinics Act (Cap. 248). 1999.
p.000067:
p.000067: Singapore. Singapore Medical Council. Ethical Code and Ethical Guidelines. (n.d.).
p.000067:
p.000067: South Africa. Health Professional Council of South Africa. Confidentiality: Protecting and Providing Information. May
p.000067: 2008.
p.000067:
p.000067: South Africa. Health Professional Council of South Africa. Guidelines on the Keeping of Patient Records. 29
p.000067: May 2007.
p.000067:
p.000067: South Africa. Human Tissue Act. 1983.
p.000067:
p.000067: South Africa. Medical Research Council. Guidelines on Ethics for Medical Research – General Principles.
p.000067: (n.d.).
p.000067:
p.000067: South Korea. Bioethics and Biosafety Act. 1 January 2005. Spain. Law 14/2007, of 3 July, on Biomedical Research.
p.000067: Sweden. Act concerning the Ethical Review of Research Involving Humans. 5 June 2003. Sweden. Genetic Integrity Act.
p.000067: 2006.
p.000067: Sweden. Swedish Research Council. Good Research Practice. 2006.
p.000067:
p.000067: Switzerland. Swiss National Advisory Commission on Biomedical Ethics. Research Involving Children,
p.000067: Opinion No. 16/2009. March 2009.
p.000067:
p.000067:
p.000068: 68
p.000068:
p.000068: BIBLIOGRAPHY
p.000068:
p.000068: Uganda. Uganda National Council for Science and Technology. National Guidelines for Research Involving Humans
p.000068: as Research Participants. March 2007.
p.000068:
p.000068: United Kingdom. Access to Health Records Act. 1990.
p.000068:
p.000068: United Kingdom. Association of the British Pharmaceutical Industry. Guidelines for Phase 1 Clinical Trials. 2007.
p.000068:
p.000068: United Kingdom. Data Protection Act. 1998.
p.000068:
p.000068: United Kingdom. Department of Health, Royal College of General Practitioners, British Medical Association.
p.000068: The Good Practice Guidelines for GP electronic patient records. 2011.
p.000068:
p.000068: United Kingdom. Department of Health. Innovative Genetic Treatment to Prevent Mitochondrial Disease
p.000068: (Press Release). 28 June 2013.
p.000068:
p.000068: United Kingdom. England and Wales Court of Appeal (Civil Division): Jonathan Yearworth & Ors v North Bristol NHS Trust
p.000068: [2009] 3 Weekly Law Reports 118, 4 February 2009.
p.000068:
p.000068: United Kingdom. General Medical Council. Confidentiality. 12 October 2009.
p.000068:
p.000068: United Kingdom. General Medical Council. Good Practice in Research and Consent to Research. April 2010.
p.000068:
p.000068: United Kingdom. House of Lords: S (An Infant, by her Guardian ad Litem the Official Solicitor) v. S
p.000068: [1972] Appeal Cases 24, 23 July 1970.
p.000068:
p.000068: United Kingdom. Human Fertilisation and Embryology Act. 2008.
p.000068:
...
p.000072:
p.000072: 2.33 For multi-centre research, a lead IRB could be designated. The choice of the lead IRB should be dictated by
p.000072: considerations such as the principal institution of affiliation of the Principal Investigator, the location where the
p.000072: greater part of the research is carried out, the expertise of the constituted IRB, or the location where the largest
p.000072: number of subjects is located. The lead IRB will play the main role in conducting a full ethics
p.000072:
p.000072:
p.000072:
p.000072: A15
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: review, in coordinating the research programme, and in keeping other participating IRBs informed of any
p.000072: decisions or amendments, including those made during the whole research period.
p.000072:
p.000072: 2.34 For multi-national research, the local portion should be subject to review by the IRB of the local partner
p.000072: institution(s), and the local IRB(s) should have a final say on matters affecting local participants.
p.000072:
p.000072: Conflicts of Interest
p.000072:
p.000072: 2.35 Institutions, IRBs and members of IRBs, and researchers should take special care to avoid conflicts of
p.000072: interest, whether actual conflict, potential conflict, or only the appearance of conflict. Institutions should
p.000072: develop policies and procedures to identify, eliminate, minimise or manage conflicts of interest that may affect
p.000072: research.
p.000072:
p.000072: 2.36 Should an IRB member have a personal interest in the research under review, that member should
p.000072: disqualify himself or herself from any consideration of the case by the IRB, and he or she should refrain from offering
p.000072: his or her opinion to the IRB on the particular research under review. The member should make full disclosure of such
p.000072: an actual, potential or apparent conflict of interest to the IRB.
p.000072:
p.000072: 2.37 Researchers should disclose any real, potential or perceived individual conflicts of interest, when
p.000072: submitting their research proposals to the IRB, as well as any institutional conflicts which they are
p.000072: aware of, that may have an impact on their research. The IRB shall then decide on the appropriate steps to
p.000072: manage the conflict.
p.000072:
p.000072: 2.38 Threats to research integrity could arise when there is a conflict of interest between those who commission
p.000072: and fund research (including commercial organisations) and those who carry it out (the researchers).
p.000072: Routine checks and balances ensuring the integrity of the research process have developed in universities
p.000072: and other research institutions with a commitment to research. When research is recruited to the service of
p.000072: commercial or institutional interests, researchers may be in a difficult position if their results are inconsistent
p.000072: with the expectations or hopes of their source of funds. IRBs need to consider how best to avoid such threats to
p.000072: integrity when considering applications in which they might arise.
p.000072:
p.000072: Responsibilities of Institutions
p.000072:
p.000072: 2.39 Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000072: carried out on their premises or facilities; or by their employees or on their patients; or involving access to or use
...
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: WRITTEN RESPONSES RECEIVED DURING THE PUBLIC CONSULTATION
p.000072:
p.000072:
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Written Responses Received During the Public Consultation on Ethics Guidelines for Human Biomedical Research
p.000072:
p.000072:
p.000072: Organisations / Institutions
p.000072:
p.000072: C1 Alice Lee Centre for Nursing Studies C2 Buddhist Fellowship
p.000072: C7 Cancer Science Institute of Singapore C8 Catholic Medical Guild of Singapore C12 Humanist Society
p.000072: (Singapore)
p.000072: C13 Lily-NUS Centre for Clinical Pharmacology
p.000072: C15 School of Public Health, National University of Singapore C16 SingHealth Tissue Repository
p.000072: C20 The Law Society of Singapore
p.000072:
p.000072:
p.000072: Individuals
p.000072:
p.000072: C28 Mr Benjamin Gaw and Ms Keow Mei Yen C38 Member of the Public (1)
p.000072: C39 Member of the Public (2)
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Comments from Alice Lee Centre for Nursing Studies
p.000072:
p.000072: 14 August 2012
p.000072:
p.000072:
p.000072: Many thanks for the draft Ethics Guidelines for Human Biomedical Research.
p.000072:
p.000072: We welcome the Guidelines and are very supportive to its recommendations. We believe this document will be a valuable
p.000072: resource for researchers in our department. We are pleased to see that an appeal mechanisms has been implemented for
p.000072: those who have proposals rejected. The variability in review process and opinion makes this a valuable inclusion.
p.000072:
p.000072: We also noted the concerns raised regarding monetary coercion of participants. We support that every effort should be
p.000072: made to resists ‘tempting’ participation in research via monetary incentives (other than reasonable loss of time and
p.000072: costs).
p.000072:
p.000072: Warmest regards Professor Sally Chan
p.000072: Professor and Head, Alice Lee Centre for Nursing Studies
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C1
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Comments from Buddhist Fellowship
p.000072:
p.000072: 26 July 2012
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C2
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
...
Searching for indicator philosophy:
(return to top)
p.000025: Bioethics Advisory Committee June 2015
p.000025:
p.000025:
p.000025:
p.000025: BIOETHICS ADVISORY COMMITTEE (MARCH 2011 TO DECEMBER 2015)
p.000025:
p.000025: Emeritus Advisor
p.000025: Professor Lim Pin
p.000025: University Professor, National University of Singapore (NUS)
p.000025:
p.000025: Chairman
p.000025: Mr Richard Magnus
p.000025: Judge (ret.)
p.000025:
p.000025: Members
p.000025: Professor Alastair Campbell
p.000025: Director, Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, NUS
p.000025:
p.000025: Associate Professor Chin Jing Jih
p.000025: Senior Consultant Geriatrician, Department of Continuing and Community Care, Tan Tock Seng Hospital
p.000025:
p.000025: Professor Kon Oi Lian
p.000025: Head, Division of Medical Sciences, National Cancer Centre Singapore
p.000025:
p.000025: Mr Alfian Yasrif Bin Kuchit
p.000025: Deputy Director, Community Relations Muslim Matters, Ministry of Culture, Community and Youth
p.000025:
p.000025: Mr Charles Lim Aeng Cheng
p.000025: Parliamentary Counsel (Special Projects) and Chief Knowledge Officer, Attorney-General's Chambers
p.000025:
p.000025: Associate Professor Lim Tit Meng
p.000025: Chief Executive, Science Centre Singapore
p.000025:
p.000025: Professor Ng Soon Chye
p.000025: Director, O & G Partners Fertility Centre, Gleneagles Hospital; and Medical Director, Sincere IVF Center, Novena
p.000025: Specialist Center, Singapore
p.000025:
p.000025: Associate Professor Ngiam Tee Liang
p.000025: Associate Professorial Fellow, Department of Social Work, Faculty of Arts and Social Sciences, NUS
p.000025:
p.000025: Associate Professor Nuyen Anh Tuan (till March 2013)
p.000025: Associate Professor (ret.), Department of Philosophy, Faculty of Arts and Social Sciences, NUS
p.000025:
p.000025: Professor Kandiah Satkunanantham
p.000025: Senior Consultant, Division of Hip & Knee Surgery, University Orthopaedics, Hand and Reconstructive Microsurgery
p.000025: Cluster, National University Hospital
p.000025:
p.000025: Professor Patrick Tan Boon Ooi
p.000025: Duke-NUS Graduate Medical School; and Group Leader, Genome Institute of Singapore
p.000025:
p.000025: Dr Mary Anne Tsao (from March 2014)
p.000025: President & Director, Tsao Foundation
p.000025:
p.000025: Mr Gregory Vijayendran
p.000025: Equity Partner, Rajah & Tann LLP
p.000025:
p.000025:
p.000025: INTERNATIONAL PANEL OF EXPERTS
p.000025:
p.000025: Professor Martin Bobrow (till March 2014)
p.000025: Emeritus Fellow, University of Cambridge, United Kingdom
p.000025: Professor Peter Braude (from June 2014)
p.000025: Emeritus Professor of Obstetrics and Gynaecology, King’s College London
p.000025:
p.000025: Dr Christine Grady (from November 2014)
p.000025: Chief, Department of Bioethics, National Institutes of Health
p.000025:
p.000025: Professor Bartha Maria Knoppers (till March 2012)
p.000025: Director, Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University, Canada
p.000025: Professor Steven Hyman (from June 2012)
p.000025: Director, Stanley Center for Psychiatric Research, Broad Institute, United States of America
p.000025: Professor Bernard Lo (till March 2014)
p.000025: President, Greenwall Foundation and Emeritus Professor of Medicine, University of California, San Francisco, United
p.000025: States of America
p.000025: Dr Thomas H Murray (till March 2012)
p.000025: Senior Research Scholar and President Emeritus, The Hastings Center, United States of America
p.000025: Professor Onora O’Neill (till July 2013)
p.000025: Baroness O’Neill of Bengarve
p.000025: Emeritus Professor, University of Cambridge, United Kingdom
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000015:
p.000015:
p.000015: 6 NMEC similarly referred to autonomy as “the right of individuals to decide for themselves what is good for
p.000015: them.” Paragraph 2.3.1, Ethical Guidelines on Research Involving Human Subjects (1997).
p.000015:
p.000016: 16
p.000016:
p.000016: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000016:
p.000016: Justice
p.000016:
p.000016: 2.8 The concept of justice as applied to research includes the general principle of fairness and equality under
p.000016: the law. This concept implies that access to the benefits of research, and the burden of supporting
p.000016: it, should be equitably shared in society. It should not, for example, be considered ethical to exempt a class
p.000016: of otherwise suitable patients from participation in research by virtue of economic status.7 The concept of justice
p.000016: also implies that researchers and their institutions incur some responsibility for the welfare of participants, and
p.000016: their compensation and treatment in the event an adverse outcome results directly from their
p.000016: participation. It mandates careful consideration of the arrangements in place for ancillary care or follow-up in
p.000016: the case of research participants located in regions that may be resource-poor relative to the initiating country.
p.000016: Moreover, in the event research yields an immediate benefit that could apply to one of the participants in
p.000016: the research, justice would dictate that the benefit be offered.8
p.000016:
p.000016: 2.9 Although it is easy to defend the generic idea of justice as fundamental to the proper functioning of any
p.000016: society, both justifying and implementing a specific conception of justice is difficult, since research may
p.000016: entail compromises between competing interests. What different parties in a disagreement see as fair may depend
p.000016: upon widely different assumptions.
p.000016:
p.000016: Proportionality
p.000016:
p.000016: 2.10 The regulation of research should be in proportion to the possible threats to autonomy, individual welfare,
p.000016: or the public good. Proportionality is fundamental to the administration of any system of
p.000016: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000016: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000016: necessary regulation.9 It appeals to moderation and good sense in the determination of prohibited
p.000016: actions and the avoidance of micro-management and over-determination. The risk in any acceptable programme of
p.000016: research, and the stringency of its regulation, should not be disproportionate to any anticipated benefits.
p.000016: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
p.000016: decisions, which is in any case often impracticable in multicultural contexts.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: 7 “For example, during the 19th and early 20th centuries the burdens of serving as research
p.000016: subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to
p.000016: private patients.” Belmont Report, Part B(3), given as an example of manifest injustice. It would also breach the
p.000016: principle of solidarity.
p.000016: 8 An example would be a research participant assigned to a placebo control group.
p.000016: 9 See for example the discussion of proportionality in Harris, B. Disciplinary and Regulatory Proceedings, 6th
p.000016: Ed. London: Wiley & Sons (2011). The essential legal burden on the court was stated in de Freitas v. The Permanent
p.000016: Secretary of Ministry of Agriculture, Fisheries, Lands and Housing [1998] by Lord Clyde, that in deciding if a
p.000016: limitation imposed by an act, rule or decision is arbitrary or excessive, i.e. disproportionate, the
p.000016: court should ask itself “whether: (i) the legislative objective is sufficiently important to justify
p.000016: limiting a fundamental right; (ii) the measures designed to meet the legislative objective are rationally connected to
p.000016: it; and (iii) the means used to impair the right or freedom are no more than is necessary to
p.000016: accomplish the objective." http://www.bailii.org/uk/cases/UKPC/1998/30.html at section 25.
p.000016:
p.000017: 17
p.000017:
p.000017: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000017:
p.000017: Sustainability
p.000017:
p.000017: 2.11 The research process should be sustainable, in the sense that it should not jeopardise or prejudice the
...
p.000072: resolved with some regard to the public interest.
p.000072: 2.10 However, the underlying principle is perhaps better expressed as one of solidarity. The essential
p.000072: principle is not one of individual exchange, but of a wider vision in which a common interest is invoked as
p.000072: a reason for the subordination of individual interest to that of a group in specified circumstances. Expressing the
p.000072: idea as solidarity reflects the importance of general altruism as a basis for participation in biomedical research.
p.000072:
p.000072: Justice
p.000072:
p.000072: 2.11 The concept of justice as applied to research includes the general principle of fairness and equality under
p.000072: the law. This implies that access to the benefits of publicly funded research, and the burden of supporting it,
p.000072: should be equitably shared in society. It should not, for example, be considered ethical to exempt a class of
p.000072: otherwise suitable patients from participation in research by virtue of economic status.42 The concept of justice also
p.000072: implies that researchers and their institutions incur some responsibility for the welfare of participants and their
p.000072: possible compensation and treatment in the event of adverse outcomes arising directly from their participation.
p.000072: It mandates careful consideration of the arrangements in place for ancillary care or follow-up in the case of
p.000072: research participants located in regions that may be resource-poor relative to the initiating country. Moreover, in
p.000072: the event research yields an immediate benefit that could apply to one of the participants in the research,
p.000072: justice would dictate that the benefit be offered.43
p.000072: 2.12 Although it is easy to defend the generic idea of justice as fundamental to the proper functioning of any
p.000072: society, both justifying and implementing a specific conception of justice is difficult, since research may
p.000072: entail compromises between competing
p.000072:
p.000072:
p.000072: 42 “For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell
p.000072: largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private
p.000072: patients.” Belmont Report, Part B 3, given as an example of a manifest injustice. It would also breach the principle of
p.000072: solidarity.
p.000072: 43 An obvious example would be a participant in a placebo control group.
p.000072:
p.000072:
p.000072:
p.000072: A10
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: interests. What different parties in a disagreement see as fair may depend upon widely different assumptions.
p.000072: Proportionality
p.000072:
p.000072: 2.13 The regulation of research should be in proportion to the possible threats to autonomy, individual welfare,
p.000072: or public good. Proportionality is fundamental to the administration of any system of
p.000072: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000072: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000072: necessary regulation.44 It appeals to moderation and good sense in the determination of prohibited actions
p.000072: and the avoidance of micro-management and over-determination. The risk in any acceptable programme of research, and
p.000072: the strictness of its regulation, should not be disproportional to any anticipated benefits.
p.000072: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.000072: Act. A donee or other proxy is obligated under the Act to put the best interests of the participant first, yet
p.000072: participation in research is not usually a benefit to the participant. Consequently, consenting to
p.000072: participation in research on
p.000072:
p.000072: 50 With regard to best interests, Mental Capacity Act, section 6 (7) states: “He [the proxy] must consider, so
p.000072: far as is reasonably ascertainable –
p.000072: (a) the person’s past and present wishes and feelings (and, in particular, any relevant written statement made by him
p.000072: when he had capacity);
p.000072: (b) the beliefs and values that would be likely to influence his decision if he had capacity; and
p.000072: (c) the other factors that he would be likely to consider if he were able to do so.”
p.000072:
p.000072:
p.000072:
p.000072: A21
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: behalf of a non-competent person cannot be defended as in the person’s best interest if no clinical trial is involved.
p.000072:
p.000072: Consent Involving Vulnerable Persons
p.000072:
p.000072: 3.15 While it is usual to treat the individual as an autonomous agent for purposes of taking consent, provision has
p.000072: to be made when considering research participants who might be considered vulnerable. Such participants include:
p.000072:
p.000072: (a) Adults with diminished mental powers (such as the intellectually disabled or patients with dementia
p.000072: or others who lack mental capacity as defined in the Mental Capacity Act) or because they are incapacitated
p.000072: through accident, injury or illness;
p.000072:
p.000072: (b) Those whose autonomy might be prejudiced by being under the influence of, or the control of, or obligated to,
p.000072: third parties; and
p.000072:
p.000072: (c) Infants or children. In the case of under-aged research participants issues of consent primarily
p.000072: involve parent or guardians.
p.000072:
p.000072: Consent from Vulnerable Persons not Lacking Capacity
p.000072:
p.000072: 3.16 Vulnerable adult research participants not only include those who are of diminished capacity, but also
p.000072: those whose autonomy might be prejudiced by being under the influence of, or the control of, or
p.000072: obligated to, third parties. Potentially vulnerable participants might include, but are not limited to:
p.000072:
p.000072: (a) Prisoners;
p.000072:
p.000072: (b) Serving uniformed personnel, especially junior ranks;
p.000072:
p.000072: (c) Patients, especially if the intending researcher is their attending physician; and
p.000072:
p.000072: (d) Employees, junior collaborators, or students.
p.000072:
p.000072: 3.17 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000072: prospective participants reassured that they have nothing to fear in declining research participation or
p.000072: in contributing tissue for research. Thus consent among uniformed personnel, for example, should not be taken by
p.000072: a senior officer, and preferably not by uniformed personnel at all.
p.000072:
p.000072: 3.18 When it is not possible for consent to be taken by an independent third party, the IRB may give directions for
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000014: dignity, welfare and privacy of research participants, and to safeguard against unethical practices. There have been a
p.000014: number of international documents and declarations that form the foundation of ethical biomedical research
p.000014: governance as practised in major research jurisdictions. They have also formed the basis for the ethical
p.000014: principles that have guided the BAC. The following foundational documents and declarations are key:
p.000014:
p.000014: (a) The Nuremberg Code (1949);
p.000014:
p.000014: (b) The World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.000014: Subjects (1964, revised 2013);
p.000014:
p.000014: (c) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
p.000014: Research (1979);
p.000014:
p.000014: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000014:
p.000014: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000014: Declaration on Bioethics and Human Rights (2005).
p.000014:
p.000014: General Ethical Principles that have Guided the BAC
p.000014:
p.000014: 2.3 A review of the five foundational documents above reveals that participants need to be protected and their
p.000014: autonomy in matters of research participation recognised. Although these documents do not agree on every
p.000014: particular matter, they appear to be in accord in their fundamentals. Based on these, the BAC has formulated
p.000014: the following five guiding principles reflecting their local application, first summarised in its Egg Donation Report.
p.000014:
p.000014: 5 The BAC used the term “subject” in its earlier reports, but more recently has used the term “participant”. The
p.000014: latter is preferred as it implicitly acknowledges that research participants choose to participate, and
p.000014: should not be merely the passive subjects of research.
p.000014:
p.000015: 15
p.000015:
p.000015: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000015:
p.000015: Respect for persons
p.000015:
p.000015: 2.4 Individuals are to be respected as human beings and treated accordingly. This includes respecting
p.000015: their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC
p.000015: refers to as autonomy.6 Their welfare and interests are to be protected, especially when their autonomy is
p.000015: impaired or lacking. This principle mandates the need for informed consent to participation in research,
p.000015: respect for privacy, safeguarding confidentiality, and minimising harm to research participants. It also
p.000015: requires a proper regard for religious and cultural diversity.
p.000015:
p.000015: 2.5 This principle integrates with many other aspects of life in societies that could be described
p.000015: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000015: Ideals of this democratic society include all citizens being equal under the law, or having rights to
p.000015: privacy in the management of their affairs, to the enjoyment of security and public health and safety,
p.000015: with rights over their own bodies, and many others. All of these, in the final analysis, come down to the principle
p.000015: that individuals should be accorded certain basic rights or entitlements arising from their existence in society.
p.000015: These entitlements exist notwithstanding individual differences in endowment of race, character, gender or talent,
p.000015: and without requirement that individuals justify them. However, an individual’s autonomy can be curtailed under certain
p.000015: circumstances, for the public good, such as when quarantined during disease epidemics.
p.000015:
p.000015: Solidarity
p.000015:
p.000015: 2.6 The BAC earlier advocated a principle of reciprocity between the individual and wider society, as
p.000015: a way to capture the well-established idea that there is some measure of mutual obligation that regulates the
p.000015: relationship between the two. However, the underlying principle is perhaps better expressed as solidarity. The
p.000015: essential principle is not one of individual exchange, but of a wider vision in which common interest is invoked as a
p.000015: reason for the subordination of individual interest to that of a group in specified circumstances. Solidarity
p.000015: reflects the importance of general altruism as a basis for participation in biomedical research.
p.000015:
p.000015: 2.7 In biomedical research, agreed social benefits – considered as a public good – carry an implication that, if
p.000015: accepted, they inherently reflect an in-principle willingness to consider participation in research of the kind
p.000015: yielding the accepted benefits. This means that there is a balance to be struck between the interests of the public
p.000015: and the rights of individual participants; and that incompatible and irreconcilable ethical perspectives
p.000015: should be resolved with some regard to public interest. The BAC is therefore of the view that that certain
p.000015: rights such as informed consent, derived from the principle of respect for individuals, may be subordinate to the
p.000015: public interest based on the principle of solidarity. However, this should only be permitted in certain
p.000015: minimal risk research such as public health and epidemiological research, and subject to appropriate safeguards.
p.000015:
p.000015:
p.000015: 6 NMEC similarly referred to autonomy as “the right of individuals to decide for themselves what is good for
p.000015: them.” Paragraph 2.3.1, Ethical Guidelines on Research Involving Human Subjects (1997).
p.000015:
p.000016: 16
p.000016:
p.000016: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000016:
p.000016: Justice
p.000016:
p.000016: 2.8 The concept of justice as applied to research includes the general principle of fairness and equality under
p.000016: the law. This concept implies that access to the benefits of research, and the burden of supporting
p.000016: it, should be equitably shared in society. It should not, for example, be considered ethical to exempt a class
p.000016: of otherwise suitable patients from participation in research by virtue of economic status.7 The concept of justice
p.000016: also implies that researchers and their institutions incur some responsibility for the welfare of participants, and
p.000016: their compensation and treatment in the event an adverse outcome results directly from their
p.000016: participation. It mandates careful consideration of the arrangements in place for ancillary care or follow-up in
p.000016: the case of research participants located in regions that may be resource-poor relative to the initiating country.
p.000016: Moreover, in the event research yields an immediate benefit that could apply to one of the participants in
p.000016: the research, justice would dictate that the benefit be offered.8
p.000016:
p.000016: 2.9 Although it is easy to defend the generic idea of justice as fundamental to the proper functioning of any
p.000016: society, both justifying and implementing a specific conception of justice is difficult, since research may
p.000016: entail compromises between competing interests. What different parties in a disagreement see as fair may depend
p.000016: upon widely different assumptions.
p.000016:
p.000016: Proportionality
p.000016:
p.000016: 2.10 The regulation of research should be in proportion to the possible threats to autonomy, individual welfare,
p.000016: or the public good. Proportionality is fundamental to the administration of any system of
p.000016: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000016: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000016: necessary regulation.9 It appeals to moderation and good sense in the determination of prohibited
p.000016: actions and the avoidance of micro-management and over-determination. The risk in any acceptable programme of
p.000016: research, and the stringency of its regulation, should not be disproportionate to any anticipated benefits.
p.000016: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
p.000016: decisions, which is in any case often impracticable in multicultural contexts.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: 7 “For example, during the 19th and early 20th centuries the burdens of serving as research
p.000016: subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to
p.000016: private patients.” Belmont Report, Part B(3), given as an example of manifest injustice. It would also breach the
p.000016: principle of solidarity.
p.000016: 8 An example would be a research participant assigned to a placebo control group.
...
p.000025: biological materials or personal information. If the donation is accepted, any such conditions must be
p.000025: respected. If the conditions are unacceptable or
p.000025:
p.000026: 26
p.000026:
p.000026: CONSENT
p.000026:
p.000026: impractical, the donation should be declined. In general, the intention should be to seek a completely
p.000026: general consent without restriction, given that the biological materials or personal information will be used
p.000026: only if the research is approved by an IRB.
p.000026:
p.000026: Consent Involving Vulnerable Persons
p.000026:
p.000026: 3.12 While it is usual to treat the individual as an autonomous agent for purposes of taking consent, provision
p.000026: has to be made when considering research participants who are vulnerable. Such participants include:
p.000026:
p.000026: (a) Persons lacking mental capacity (such as the intellectually disabled, people who are incapacitated through
p.000026: accident, injury or illness, and others as defined in the Mental Capacity Act);
p.000026:
p.000026: (b) Those whose autonomy might be prejudiced by being under the influence of, or the control of, or obligated to,
p.000026: third parties; and
p.000026:
p.000026: (c) Minors.
p.000026:
p.000026: Consent for Research Involving Persons Lacking Mental Capacity
p.000026:
p.000026: The Mental Capacity Act
p.000026:
p.000026: 3.13 The Mental Capacity Act lays down the general framework under which decisions can be made on behalf of a
p.000026: person lacking capacity. As the Act states in Section 13(7) that treatment includes the conduct of a clinical
p.000026: trial, a deputy appointed by the court under the Act, or a donee who has been expressly given
p.000026: authority under a Lasting Power of Attorney (LPA) to give or refuse consent to the carrying out or continuation of
p.000026: medical treatment by a health care provider, may also decide on the person’s participation in clinical
p.000026: trials. But this is subject to the restrictions in Sections 13(8) and 25(3)(c), on both a deputy and a donee,
p.000026: concerning life-sustaining treatment or treatment necessary to prevent a serious deterioration in the patient’s
p.000026: condition.
p.000026:
p.000026: 3.14 In making such decisions on personal welfare, the deputy or the donee must follow the statutory principles
...
p.000027: benefit from the participation in research, the common law has not always interpreted the best
p.000027: interests test so narrowly.14 International guidelines on biomedical research also envisage the
p.000027: permissibility of research participation for incapacitated adults where (a) the research is intended to
p.000027: promote the health of the group represented by the potential participant, (b) the research cannot be
p.000027: conducted with participants who can give informed consent, and
p.000027: (c) the research participation entails only minimal risk or burden.15 It may thus be ethical for a
p.000027: court deputy or donee of a lasting power of attorney to enrol an incapacitated adult in minimal risk
p.000027: research where this is consistent with the incapacitated person’s beliefs and values, and not contrary
p.000027: to the person’s present wishes and feelings.
p.000027:
p.000027: Consent for Research Involving Vulnerable Persons Not Lacking Mental Capacity
p.000027:
p.000027: 3.17 Vulnerable research participants not only include those who are lacking mental capacity, but also
p.000027: those whose autonomy might be prejudiced by being under the influence or control of, or by being obligated to,
p.000027: third parties. Potentially vulnerable participants might include, but are not limited to:
p.000027:
p.000027: (a) Prisoners;
p.000027:
p.000027: (b) Uniformed personnel, especially junior ranks;
p.000027:
p.000027: (c) Patients, especially if the intending researcher is their attending physician; and
p.000027:
p.000027: (d) Employees, junior collaborators, or students.
p.000027:
p.000027:
p.000027:
p.000027: 14 For example, the courts have permitted a simple paternity blood test for a child where this was not clearly
p.000027: against the interests of the child, notwithstanding there was no direct benefit to the child: S v S [1972] AC 24 (House
p.000027: of Lords). Nothing in the Mental Capacity Act (Chap 177A) expressly overrules the common law, except by necessary
p.000027: implication.
p.000027: 15 World Medical Association, Declaration of Helsinki (rev. 2013), article 28; Council for
p.000027: International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research
p.000027: Involving Human Subjects (2002), Articles 9 and 15.
p.000027:
p.000028: 28
p.000028:
p.000028: CONSENT
p.000028:
...
p.000028: patient-participants fail to appreciate the difference between research and treatment, and believe that
p.000028: research participation is nonetheless offered to promote their medical interests.
p.000028:
p.000028: 3.22 Consent for treatment should therefore be clearly separated from consent for participation
p.000028: in research. When a researcher is also the attending physician, the researcher-physician should be aware of
p.000028: a potential conflict of interest and of the fact that his or her patients may feel obliged to give consent.
p.000028: Ideally, the consent for research should be taken by an independent third person, though this is not
p.000028: always possible. In such situations, the IRB may give directions for the consent to be taken by the
p.000028: researcher-physician so long as there are provisions to manage the conflict of interest and sufficient safeguards to
p.000028: protect the welfare and interests of the patient.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: CONSENT
p.000029:
p.000029: Consent for Research Involving Minors
p.000029:
p.000029: Respect for the developing autonomy of minors
p.000029:
p.000029: 3.23 In Singapore, under the common law, the age of majority is 21 years. This age is generally
p.000029: taken as the age at which a person is considered an adult and thus able to make all decisions for oneself. The category
p.000029: of minors thus spans a wide range, from children of tender years who lack any capacity to give consent, to young
p.000029: persons who have acquired the capacity to understand and make decisions on research participation.
p.000029: Parents generally have the authority to make decisions on behalf of minors, and this would include research
p.000029: participation. However, the welfare and best interests of the child or young person is the paramount consideration and
p.000029: parents must discharge their responsibilities to promote these.16 Unless research participation offers direct benefit
p.000029: to the minor, the authority of parents or guardians to consent to research without direct benefit is constrained
p.000029: in a similar fashion to proxy decisions for incapacitated adults as discussed in para. 3.16 above. Participation
p.000029: in research without direct benefit should involve no more than minimal risk and not be contrary to the best
p.000029: interests of the minor.
p.000029:
p.000029: 3.24 It is nevertheless ethically important to give due respect to the developing capacity of minors to be involved
p.000029: in, and make their own decisions about research participation. This consideration is reinforced in the case of research
p.000029: without direct benefit, where the minor should appreciate its altruistic nature. Respect for a minor’s
p.000029: developing autonomy is thus recognised by the Medicines (Clinical Trials) Regulations, which require both the
p.000029: minor who has sufficient understanding and a parent or guardian to consent to participation in a clinical
p.000029: trial.17 Similarly, the common law will not subject a child with sufficient understanding to a
p.000029: non-therapeutic procedure against his/her will.18
p.000029:
p.000029: Determining decision making capacity
p.000029:
p.000029: 3.25 In order to give a valid consent, the minor must have sufficient maturity and intelligence to
p.000029: understand the relevant information relating to the proposed research, and use that information to arrive at a reasoned
p.000029: decision. This capacity is, however, not easily linked to fixed ages, as it varies from minor to minor, and depends on
p.000029: the nature and complexity of the research. None of the current legal age thresholds bear immediate relevance to
p.000029: determining when a minor develops sufficient decision- making capacity to consent to research participation,
...
p.000036: ethics review, so long as the processes of data linkage or recording or dissemination of results will not generate
p.000036: identifiable information, and no attempt is made to re-identify the individual.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036: 21 Personal Data Protection Commission, “Advisory Guidelines on the Personal Data Protection Act for Selected Topics”
p.000036: (11 Sep 2014), at para. 3.18.
p.000036:
p.000037: 37
p.000037:
p.000037: PERSONAL INFORMATION IN RESEARCH
p.000037:
p.000037: 4.10 Given rapid technological advances that may allow re-identification through comparison of
p.000037: multiple de-identified data sets, it is no longer possible to promise absolute anonymity under all
p.000037: circumstances. However, researchers are expected to take proper security safeguards with all data. When
p.000037: provided with de-identified information for research, they should refrain from attempting to
p.000037: identify an individual, without IRB approval. Should an individual be identified inadvertently from
p.000037: de-identified information, the confidentiality and privacy rights of this individual should not be
p.000037: regarded as abrogated by such identification, and steps should be taken to reinstate and secure them.
p.000037:
p.000037: 4.11 The data collected by researchers may or may not be sensitive in nature, but researchers have a
p.000037: proportionate duty to maintain privacy and confidentiality. Under the principle of autonomy and respect for
p.000037: persons, healthcare practitioners and researchers alike have certain duties regarding the protection of confidential
p.000037: personal information that they collect or generate in the course of their work, whether or not such information forms
p.000037: or originally formed part of a medical record. This implies that storage and security of data should be
p.000037: secured in proportion to its sensitivity.
p.000037:
p.000037: Use of Medical Records for Research
p.000037:
p.000037: 4.12 Medical information and data collected or generated in the process of diagnosing and managing a person’s
p.000037: health condition form the individual’s medical records. These records may be stored electronically or as
p.000037: physical records. Most people regard their medical details as private and a matter for them and their physicians alone.
p.000037: Doctors are expected to respect the principle of medical confidentiality, as set out in the Ethical Code
p.000037: and Ethical Guidelines of the Singapore Medical Council. In a healthcare institution, all personnel
p.000037: who handle medical records are under legal and ethical obligation to observe the confidentiality of the information on
p.000037: the records and to safeguard the privacy of patients concerned.
p.000037:
p.000037: 4.13 Much valuable medical knowledge has resulted from the study of patients’ medical records. Further to the
p.000037: BAC’s recommendations in its 2005 Personal Information Report, the PDPA now affords an exemption under the Third
p.000037: Schedule allowing an organisation to use personal information for research without consent, provided that certain
...
p.000049:
p.000049: 29 Nuffield Council on Bioethics, Novel Techniques for the Prevention of Mitochondrial DNA Disorders: an Ethical
p.000049: Review, June 2012.
p.000049: 30 The HFEA licenses and monitors all fertility clinics and research involving human embryos in the UK. Its
p.000049: report, Mitochondria Replacement Consultation: Advice to Government, was published in March 2013.
p.000049: 31 The National Archives, Human Fertilisation and Embryology (Mitochondrial Donation) Regulations, Available at:
p.000049: http://www.legislation.gov.uk/ukdsi/2015/9780111125816/contents.
p.000049:
p.000050: 50
p.000050:
p.000050: HUMAN GENETIC RESEARCH
p.000050:
p.000050: efficacy and minimise adverse effects. For this and other reasons, economic exploitation has been
p.000050: the subject of some controversy, and it is correspondingly important that all research participants be well
p.000050: aware of the implications.
p.000050:
p.000050: 6.8 Genetic information refers to any information about the genetic makeup of an individual. It can
p.000050: be derived from genetic testing in either a clinical or research setting, or from any other sources,
p.000050: including details of an individual’s family history of genetic diseases.
p.000050:
p.000050: 6.9 Genetic information is often seen as an exceptional kind of personal information. There are
p.000050: several reasons for this:
p.000050:
p.000050: (a) Genetic information is seen as a determining aspect of a person, yet many people are reluctant to
p.000050: countenance the role of genetic influences in considering human potential and conduct, lest it undermine the autonomy
p.000050: that we attribute to individuals;
p.000050:
p.000050: (b) Genetic information can be socially sensitive because it can convey information about others. Even though an
p.000050: individual genome is unique, it may also provide information about family members. This can be highly sensitive, since
p.000050: genetic relatedness may not correspond to expected social relatedness. In particular, paternity information
p.000050: may be obtained through genetic testing;
p.000050:
p.000050: (c) The increasing ease with which the individual human genome can now be completely sequenced has
p.000050: created a situation in which incidental findings of genetic conditions or susceptibility might become easy
p.000050: to obtain. The sheer volume of genetic detail available from large-scale genomic studies also raises issues of
p.000050: data protection and privacy, since much of the value of genetic information in research, as in medicine,
p.000050: depends upon linking findings to individuals and their characteristics;
p.000050:
p.000050: (d) Genetic information may have predictive power for heritable disorders that develop later in life. Even
p.000050: when untreatable, knowledge of such disorders may still allow the individual to make decisions affecting their
p.000050: future, such as whether to refrain from having children. But it is not always the case that individuals
p.000050: wish to know the details of their own genetic makeup, and consequent prognosis in certain cases.
...
p.000072: declarations the following are key:
p.000072:
p.000072: (a) The Nuremberg Code (1947), reported in 1949;
p.000072:
p.000072: (b) The Declaration of Helsinki: Ethical Principles for Research Involving Human Subjects (1964, Revised 2008);
p.000072:
p.000072: (c) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
p.000072: Research (1979);
p.000072:
p.000072:
p.000072: 40 The BAC used the term “subject” in its earlier reports, but more recently has used the term
p.000072: “participant”. The latter is increasingly used in many jurisdictions as it implicitly acknowledge the fact that
p.000072: research participants choose to participate, and should not be merely the passive subjects of research.
p.000072: These terms are however treated as interchangeable in these Guidelines.
p.000072:
p.000072:
p.000072:
p.000072: A8
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000072: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000072: Declaration on Bioethics and Human Rights (2005).
p.000072:
p.000072: General Ethical Principles that have Guided the BAC
p.000072:
p.000072: 2.5 A review of the five foundation documents above reveals that participants need to be protected and their
p.000072: autonomy in matters of research participation recognised. Although these documents do not agree in
p.000072: every particular, they appear to be in accord in their fundamentals. Based on these, the BAC formulated
p.000072: five guiding principles reflecting their local application, first summarised in its Egg Donation Report. In
p.000072: particular, as enjoined by the UNESCO Declaration, the BAC expects researchers to be aware of and respect the
p.000072: cultural and religious diversity of Singapore society. The BAC also indicated that respect for individuals can be
p.000072: subordinate to the public interest in certain cases, as in some kinds of public health research.
p.000072: 2.6 The five principles the BAC endorses are as follows:
p.000072:
p.000072: Respect for persons
p.000072:
p.000072: 2.7 Individuals are to be respected as human beings and treated accordingly. This includes respecting
p.000072: their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC
p.000072: refers to as autonomy.41 Their welfare and interests are to be protected, especially when their autonomy is
p.000072: impaired or lacking. This principle mandates the need for informed consent to participation in research;
p.000072: respect for privacy; for safeguarding confidentiality; for protecting vulnerable participants; and it
p.000072: also requires a proper regard for religious and cultural diversity.
p.000072: 2.8 This principle integrates with many other aspects of life in societies that could be described
p.000072: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000072: Ideals such as all citizens being equal under the law, or having rights to privacy and the management of their
p.000072: affairs, to the enjoyment of security and public health and safety, with rights over their own bodies,
p.000072: and many others, all, in the last analysis, come down to the principle that individuals should be accorded certain
p.000072: basic rights or entitlements arising from their existence in society. These entitlements exist notwithstanding
p.000072: individual differences in endowment of race, character, gender or talent, and without requirement that individuals
p.000072: justify them. An individual’s autonomy can be curtailed under certain circumstances, such as when quarantined
p.000072: in disease epidemics.
p.000072:
p.000072:
p.000072:
p.000072: 41 NMEC similarly referred to autonomy as “the right of individuals to decide for themselves what
p.000072: is good for them.” Paragraph 2.3.1, Ethical Guidelines on Research Involving Human Subjects (1997).
p.000072:
p.000072:
p.000072:
p.000072: A9
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Solidarity
p.000072:
p.000072: 2.9 The BAC earlier advocated a principle of reciprocity between the individual and the wider society, as a way
p.000072: to capture the well-established idea that there is some measure of mutual obligation that regulates the relationship
p.000072: between the individual and society. In biomedical research where there is minimal risk of harm to
p.000072: participants, agreed social benefits – considered as a public good – carry an implication that, if accepted, they
p.000072: inherently reflect an in-principle willingness to consider participation in research of the kind yielding the
p.000072: accepted benefits. This means that there is a balance to be struck between the interests of the public and
p.000072: the rights of individual participants; and that incompatible and irreconcilable ethical perspectives should be
p.000072: resolved with some regard to the public interest.
p.000072: 2.10 However, the underlying principle is perhaps better expressed as one of solidarity. The essential
p.000072: principle is not one of individual exchange, but of a wider vision in which a common interest is invoked as
p.000072: a reason for the subordination of individual interest to that of a group in specified circumstances. Expressing the
p.000072: idea as solidarity reflects the importance of general altruism as a basis for participation in biomedical research.
p.000072:
p.000072: Justice
...
p.000072: the event research yields an immediate benefit that could apply to one of the participants in the research,
p.000072: justice would dictate that the benefit be offered.43
p.000072: 2.12 Although it is easy to defend the generic idea of justice as fundamental to the proper functioning of any
p.000072: society, both justifying and implementing a specific conception of justice is difficult, since research may
p.000072: entail compromises between competing
p.000072:
p.000072:
p.000072: 42 “For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell
p.000072: largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private
p.000072: patients.” Belmont Report, Part B 3, given as an example of a manifest injustice. It would also breach the principle of
p.000072: solidarity.
p.000072: 43 An obvious example would be a participant in a placebo control group.
p.000072:
p.000072:
p.000072:
p.000072: A10
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: interests. What different parties in a disagreement see as fair may depend upon widely different assumptions.
p.000072: Proportionality
p.000072:
p.000072: 2.13 The regulation of research should be in proportion to the possible threats to autonomy, individual welfare,
p.000072: or public good. Proportionality is fundamental to the administration of any system of
p.000072: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000072: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000072: necessary regulation.44 It appeals to moderation and good sense in the determination of prohibited actions
p.000072: and the avoidance of micro-management and over-determination. The risk in any acceptable programme of research, and
p.000072: the strictness of its regulation, should not be disproportional to any anticipated benefits.
p.000072: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
p.000072: decisions, which is in any case often impracticable in multicultural contexts.
p.000072: Sustainability
p.000072:
p.000072: 2.14 The research process should be sustainable, in the sense that it should not jeopardise or prejudice the
p.000072: welfare of later generations. For example, research leading to permanent change to the human genome might
p.000072: not be considered ethical, even if immediately beneficial, on the grounds that the long term
p.000072: implications are unforeseeable and could possibly be harmful.
p.000072: 2.15 The wider idea of sustainability has become an important aspect of contemporary thinking with
p.000072: increasing realisation of the finite nature of the earth and consequent need for thought regarding its
...
p.000072: when he had capacity);
p.000072: (b) the beliefs and values that would be likely to influence his decision if he had capacity; and
p.000072: (c) the other factors that he would be likely to consider if he were able to do so.”
p.000072:
p.000072:
p.000072:
p.000072: A21
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: behalf of a non-competent person cannot be defended as in the person’s best interest if no clinical trial is involved.
p.000072:
p.000072: Consent Involving Vulnerable Persons
p.000072:
p.000072: 3.15 While it is usual to treat the individual as an autonomous agent for purposes of taking consent, provision has
p.000072: to be made when considering research participants who might be considered vulnerable. Such participants include:
p.000072:
p.000072: (a) Adults with diminished mental powers (such as the intellectually disabled or patients with dementia
p.000072: or others who lack mental capacity as defined in the Mental Capacity Act) or because they are incapacitated
p.000072: through accident, injury or illness;
p.000072:
p.000072: (b) Those whose autonomy might be prejudiced by being under the influence of, or the control of, or obligated to,
p.000072: third parties; and
p.000072:
p.000072: (c) Infants or children. In the case of under-aged research participants issues of consent primarily
p.000072: involve parent or guardians.
p.000072:
p.000072: Consent from Vulnerable Persons not Lacking Capacity
p.000072:
p.000072: 3.16 Vulnerable adult research participants not only include those who are of diminished capacity, but also
p.000072: those whose autonomy might be prejudiced by being under the influence of, or the control of, or
p.000072: obligated to, third parties. Potentially vulnerable participants might include, but are not limited to:
p.000072:
p.000072: (a) Prisoners;
p.000072:
p.000072: (b) Serving uniformed personnel, especially junior ranks;
p.000072:
p.000072: (c) Patients, especially if the intending researcher is their attending physician; and
p.000072:
p.000072: (d) Employees, junior collaborators, or students.
p.000072:
p.000072: 3.17 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000072: prospective participants reassured that they have nothing to fear in declining research participation or
p.000072: in contributing tissue for research. Thus consent among uniformed personnel, for example, should not be taken by
p.000072: a senior officer, and preferably not by uniformed personnel at all.
p.000072:
p.000072: 3.18 When it is not possible for consent to be taken by an independent third party, the IRB may give directions for
p.000072: the consent to be taken by the researcher so long as there are provisions to manage the conflict of interest and
...
p.000072: re-identify the individual from the nature of the data content, it ceases to attract as strong a case
p.000072: for confidentiality. Therefore, research which relies exclusively on the secondary use of irreversibly de-identified
p.000072: information or human tissue may qualify for exemption from ethics review, so long as the processes of
p.000072: data linkage or recording or dissemination of results will not generate identifiable information, and no
p.000072: attempt is made to re-identify the individual.
p.000072:
p.000072:
p.000072: A30
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 4.9 Given rapid technological advances that may allow re-identification through comparison of
p.000072: multiple de-identified data sets, it is no longer possible to promise absolute anonymity under all
p.000072: circumstances. However, researchers are expected to take proper security safeguards with all data. When
p.000072: provided with de-identified information for research, they should refrain from attempting to
p.000072: identify an individual, without IRB approval. Should an individual be identified inadvertently from
p.000072: de-identified information, the confidentiality and privacy rights of this individual should not be
p.000072: regarded as abrogated by such identification, and steps should be taken to reinstate and secure them.
p.000072: 4.10 The data collected by researchers may or may not be sensitive, depending on the research, but
p.000072: researchers have a proportionate duty to maintain proper confidentiality. Under the principle of autonomy and respect
p.000072: for persons, healthcare practitioners and researchers alike have certain duties regarding the protection of
p.000072: confidential personal information that accrues to them in the course of their work, whether or not such
p.000072: information forms or originally formed part of a medical record. This implies that storage and security of
p.000072: data should be secured in proportion to its sensitivity.
p.000072: Use of Medical Records for Research
p.000072:
p.000072: 4.11 Medical information and data collected or generated in the process of diagnosing and managing a person’s
p.000072: health condition form the individual’s medical records. These records may be stored as physical records or
p.000072: electronic records. Most people regard their medical details as private and a matter for them and their
p.000072: physicians alone. Doctors are expected to respect the principle of medical confidentiality, as set out in the Ethical
p.000072: Code and Ethical Guidelines of the Singapore Medical Council. In a healthcare institution, all personnel
p.000072: who handle medical records (both physical and electronic) are under a legal and ethical obligation to observe the
p.000072: confidentiality of the information on the records and to safeguard the privacy of patients concerned.
p.000072: 4.12 Much valuable medical knowledge has, however, resulted from the study of patients’ medical records. Thus,
p.000072: the BAC is of the view that although the primary responsibility for access to medical records should
p.000072: remain with medical practitioners, appropriate access could be given to suitably qualified professionals for the
...
p.000072: institutions able to develop and commercially exploit the research. Thus pharmacogenomics depends on the
p.000072: presumption that optimal drug treatments may be tailored to the genetic makeup of the patient, or a subset of
p.000072: patients, for example classified by ethnic group. For this and other reasons, economic exploitation has been the
p.000072: subject of some controversy, and it is correspondingly important that all parties to research be well aware
p.000072: of the implications.
p.000072: 6.6 Genetic information refers to any information about the genetic makeup of an individual. It can
p.000072: be derived from genetic testing in either a clinical or research setting, or from any other sources,
p.000072: including details of an individual’s family history of genetic diseases.
p.000072: 6.7 Genetic information is often seen as an exceptional kind of personal information. There are
p.000072: several reasons for this:
p.000072:
p.000072: 56 The report Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review was published
p.000072: in June 2012.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A43
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) Genetic information is seen as a determining aspect of a person, yet many people are reluctant to
p.000072: countenance the role of genetic influences in considering human potential and conduct, as well as when considering
p.000072: genetic diseases, lest it undermine the autonomy that we attribute to individuals;
p.000072: (b) Genetic information can be socially sensitive because it can convey information about others. Even though an
p.000072: individual genome is unique, it may also provide information about family members. This can be highly sensitive, since
p.000072: genetic relatedness may not correspond to expected social relatedness. In particular, paternity information
p.000072: may be obtained through genetic testing;
p.000072: (c) The relative ease with which the individual human genome can now be comprehensively analysed has
p.000072: created a situation in which incidental findings of genetic conditions or susceptibility might become easy to obtain,
p.000072: and in which the sheer volume of genetic detail available for large-scale genomic studies raises issues of
p.000072: data protection and privacy, since much of the value of genetic information in research, as in medicine, depends
p.000072: upon linking findings to individuals and their characteristics;
p.000072:
p.000072: (d) Genetic information has predictive power, predicting heritable disorders that develop later in life.
p.000072: Even when untreatable, knowledge of such disorders may still allow the individual to make decisions affecting
p.000072: their future, such as whether to refrain from having children. But it is not always the case that
p.000072: individuals wish to know the details of their own genetic makeup, and consequent prognosis in
p.000072: certain cases. Especially if there is no current prospect of treatment, information about potentially disabling genetic
p.000072: conditions, such as Huntington’s disease, may not be something a person wishes to know; and
p.000072:
p.000072: (e) Genetic information may be of interest to others, such as relatives, who may also be affected, and insurers and
p.000072: employers.
p.000072:
p.000072: 6.8 For all these reasons, there has been a tendency to regard genetic research as somehow
p.000072: sensitive in much the same way as medical records are regarded as sensitive, because the information yielded
p.000072: by the research ought to be considered as private to the individual since its implications might be
p.000072: considerable, and because respect for the body is an important aspect of autonomy. In some cases, of
p.000072: course, genetic information is actual medical information, but in other cases it is just raw data that can be
p.000072: interpreted to yield a particular kind of personal information. The BAC is not of the view that genetic
p.000072: information is always and inherently special or exceptional. The BAC considered issues arising from the use
p.000072: of personal information generally in its Personal Information Report and in Part IV of these Guidelines.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A44
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Guidelines on Human Genetic Research
p.000072:
p.000072: 6.9 All human genetic research should be reviewed by an IRB and approved before it commences.
p.000072: 6.10 Participation in genetic research should be voluntary, whether directly or by contribution
p.000072: of biospecimens or personal information, and all the requirements of voluntary informed consent in
p.000072: Part III will apply. The requirements for the procurement and use of human tissue and personal
p.000072: information for such research in Parts IV and V respectively, will also apply.
p.000072: 6.11 When clinically significant findings are discovered in any genetic research, researchers
p.000072: should ensure that affected participants are informed, if they have indicated their desire to know.
p.000072: 6.12 In whole-genome research, participants should be provided with as much detailed information as
p.000072: possible that is specific to such research, during the consent process. They should be provided with information on
...
p.000072: de-identify or anonymize tissue samples.
p.000072:
p.000072:
p.000072: C17
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: 3.14 Bioresources are only released to researchers after all identifiable patient information (ID) has been
p.000072: detached from the sample, which is then given a random code. In this process of de-identification, the biobank
p.000072: functions as the trusted third party who holds the link between the patient’s identity and the code. This allows for
p.000072: valuable follow-up clinical data to be collected, de-identified and provided to the researcher whilst
p.000072: protecting patient confidentiality.
p.000072:
p.000072: 3.15 Alternatively, the link between the patient’s ID and the sample code can be irreversibly destroyed in the process
p.000072: of anonymization. Obviously, this precludes the collection of crucial clinical information such as the response to
p.000072: chemotherapy and survival data.
p.000072:
p.000072: 3.16 Some biobanks will provide de-identified samples for researchers who require follow- up data but anonymize
p.000072: samples for studies that do not require such information.
p.000072:
p.000072: 3.17 If researchers and biobanks have an obligation to return IF, one possible consequence is that biobanks will
p.000072: completely anonymize all patient samples. This will render it impossible to return IF and thereby protect the
p.000072: researcher from legal liabilities, but will also impede important and valuable scientific research.
p.000072:
p.000072: 3.18 Patient autonomy and the need for genetic counselling. Some patients cannot handle the devastating news that
p.000072: they suffer from a mutation that will result in breast cancer or early dementia. For example, patients have
p.000072: jumped off buildings immediately after receiving news that they have HIV infection. Inheritance of a mutation like
p.000072: BRCA1 also has implications for family members and the donor will be burdened with the responsibility of
p.000072: disclosure to relatives who may be affected. A patient may well NOT wish to receive data relating to
p.000072: significant genetic alterations. For this reason, the BAC has emphasized the need for pre- and post-test counselling in
p.000072: the context of genetic testing2. If return of IF is necessary, one would assume that the same requirements for genetic
p.000072: counselling will apply as part of the consent procedures:
p.000072:
p.000072: “… When the tissue samples provided for clinical use are intended also for research, informed consent for
p.000072: the research is required in addition to the consent for taking the tissue for clinical use. Consent is also required if
p.000072: there is an intention to store the tissue for future use.” (para 4.4, Genetic testing and genetic
p.000072: research, Singapore Bioethics Advisory Committee, Nov 2005)
p.000072:
p.000072: “The individual should be given appropriate genetic counselling and informed about the nature of the test
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000025: given general consent is sufficient.
p.000025:
p.000025: 3.11 In any general consent for future research, donors may wish to impose some limits to the use of their
p.000025: biological materials or personal information. If the donation is accepted, any such conditions must be
p.000025: respected. If the conditions are unacceptable or
p.000025:
p.000026: 26
p.000026:
p.000026: CONSENT
p.000026:
p.000026: impractical, the donation should be declined. In general, the intention should be to seek a completely
p.000026: general consent without restriction, given that the biological materials or personal information will be used
p.000026: only if the research is approved by an IRB.
p.000026:
p.000026: Consent Involving Vulnerable Persons
p.000026:
p.000026: 3.12 While it is usual to treat the individual as an autonomous agent for purposes of taking consent, provision
p.000026: has to be made when considering research participants who are vulnerable. Such participants include:
p.000026:
p.000026: (a) Persons lacking mental capacity (such as the intellectually disabled, people who are incapacitated through
p.000026: accident, injury or illness, and others as defined in the Mental Capacity Act);
p.000026:
p.000026: (b) Those whose autonomy might be prejudiced by being under the influence of, or the control of, or obligated to,
p.000026: third parties; and
p.000026:
p.000026: (c) Minors.
p.000026:
p.000026: Consent for Research Involving Persons Lacking Mental Capacity
p.000026:
p.000026: The Mental Capacity Act
p.000026:
p.000026: 3.13 The Mental Capacity Act lays down the general framework under which decisions can be made on behalf of a
p.000026: person lacking capacity. As the Act states in Section 13(7) that treatment includes the conduct of a clinical
p.000026: trial, a deputy appointed by the court under the Act, or a donee who has been expressly given
p.000026: authority under a Lasting Power of Attorney (LPA) to give or refuse consent to the carrying out or continuation of
p.000026: medical treatment by a health care provider, may also decide on the person’s participation in clinical
p.000026: trials. But this is subject to the restrictions in Sections 13(8) and 25(3)(c), on both a deputy and a donee,
p.000026: concerning life-sustaining treatment or treatment necessary to prevent a serious deterioration in the patient’s
p.000026: condition.
p.000026:
p.000026: 3.14 In making such decisions on personal welfare, the deputy or the donee must follow the statutory principles
p.000026: under the Act, viz., act in the incapacitated person’s (i.e. donor’s) best interests,13 have regard to the
p.000026: guidance in the Code of Practice of the Act, carry out the donor’s instructions and make decisions within the
p.000026: scope of authority specified in the LPA. To give consent for the person lacking capacity to participate
p.000026: in clinical trials, the deputy or the donee must be satisfied that:
p.000026:
p.000026: (a) The incapacitated individual has previously indicated a willingness to participate; or
p.000026:
p.000026: 13 With regard to best interests, Mental Capacity Act, section 6(7) states: “He [the deputy or
p.000026: donee] must consider, so far as is reasonably ascertainable –
p.000026: (a) the person’s past and present wishes and feelings (and, in particular, any relevant written statement made by him
p.000026: when he had capacity);
p.000026: (b) the beliefs and values that would be likely to influence his decision if he had capacity; and
p.000026: (c) the other factors that he would be likely to consider if he were able to do so.”
p.000026:
p.000027: 27
p.000027:
p.000027: CONSENT
p.000027:
p.000027: (b) Consent would, in the judgement of the deputy or donee, have been given had the incapacitated individual (not
p.000027: being a child), been able to make an informed choice.
p.000027:
p.000027: 3.15 Legal protection is offered to any individual acting in connection with the care or treatment of
p.000027: a person lacking capacity, provided certain requirements, as set out in Section 7(1) of the Act, are met.
p.000027: However, this statutory immunity does not apply to clinical trials, by virtue of an express exclusion in Section 7(3).
p.000027:
p.000027: 3.16 It should be stressed that biomedical research other than clinical trials is not expressly provided for or
p.000027: mentioned under the Act, unlike the specific provision made for research in the UK Mental Capacity Act 2005. A
p.000027: deputy or donee is obligated under the Act to make decisions on behalf of a potential participant in his best
p.000027: interests, yet participation in research, particularly non-clinical studies, does not usually benefit the participant
p.000027: directly. While an incapacitated person’s best interests would generally require that there be some direct
p.000027: benefit from the participation in research, the common law has not always interpreted the best
p.000027: interests test so narrowly.14 International guidelines on biomedical research also envisage the
p.000027: permissibility of research participation for incapacitated adults where (a) the research is intended to
p.000027: promote the health of the group represented by the potential participant, (b) the research cannot be
p.000027: conducted with participants who can give informed consent, and
p.000027: (c) the research participation entails only minimal risk or burden.15 It may thus be ethical for a
p.000027: court deputy or donee of a lasting power of attorney to enrol an incapacitated adult in minimal risk
p.000027: research where this is consistent with the incapacitated person’s beliefs and values, and not contrary
p.000027: to the person’s present wishes and feelings.
p.000027:
p.000027: Consent for Research Involving Vulnerable Persons Not Lacking Mental Capacity
p.000027:
p.000027: 3.17 Vulnerable research participants not only include those who are lacking mental capacity, but also
p.000027: those whose autonomy might be prejudiced by being under the influence or control of, or by being obligated to,
p.000027: third parties. Potentially vulnerable participants might include, but are not limited to:
p.000027:
p.000027: (a) Prisoners;
p.000027:
p.000027: (b) Uniformed personnel, especially junior ranks;
p.000027:
p.000027: (c) Patients, especially if the intending researcher is their attending physician; and
p.000027:
p.000027: (d) Employees, junior collaborators, or students.
p.000027:
p.000027:
p.000027:
p.000027: 14 For example, the courts have permitted a simple paternity blood test for a child where this was not clearly
p.000027: against the interests of the child, notwithstanding there was no direct benefit to the child: S v S [1972] AC 24 (House
...
p.000029: taken as the age at which a person is considered an adult and thus able to make all decisions for oneself. The category
p.000029: of minors thus spans a wide range, from children of tender years who lack any capacity to give consent, to young
p.000029: persons who have acquired the capacity to understand and make decisions on research participation.
p.000029: Parents generally have the authority to make decisions on behalf of minors, and this would include research
p.000029: participation. However, the welfare and best interests of the child or young person is the paramount consideration and
p.000029: parents must discharge their responsibilities to promote these.16 Unless research participation offers direct benefit
p.000029: to the minor, the authority of parents or guardians to consent to research without direct benefit is constrained
p.000029: in a similar fashion to proxy decisions for incapacitated adults as discussed in para. 3.16 above. Participation
p.000029: in research without direct benefit should involve no more than minimal risk and not be contrary to the best
p.000029: interests of the minor.
p.000029:
p.000029: 3.24 It is nevertheless ethically important to give due respect to the developing capacity of minors to be involved
p.000029: in, and make their own decisions about research participation. This consideration is reinforced in the case of research
p.000029: without direct benefit, where the minor should appreciate its altruistic nature. Respect for a minor’s
p.000029: developing autonomy is thus recognised by the Medicines (Clinical Trials) Regulations, which require both the
p.000029: minor who has sufficient understanding and a parent or guardian to consent to participation in a clinical
p.000029: trial.17 Similarly, the common law will not subject a child with sufficient understanding to a
p.000029: non-therapeutic procedure against his/her will.18
p.000029:
p.000029: Determining decision making capacity
p.000029:
...
p.000072: far as is reasonably ascertainable –
p.000072: (a) the person’s past and present wishes and feelings (and, in particular, any relevant written statement made by him
p.000072: when he had capacity);
p.000072: (b) the beliefs and values that would be likely to influence his decision if he had capacity; and
p.000072: (c) the other factors that he would be likely to consider if he were able to do so.”
p.000072:
p.000072:
p.000072:
p.000072: A21
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: behalf of a non-competent person cannot be defended as in the person’s best interest if no clinical trial is involved.
p.000072:
p.000072: Consent Involving Vulnerable Persons
p.000072:
p.000072: 3.15 While it is usual to treat the individual as an autonomous agent for purposes of taking consent, provision has
p.000072: to be made when considering research participants who might be considered vulnerable. Such participants include:
p.000072:
p.000072: (a) Adults with diminished mental powers (such as the intellectually disabled or patients with dementia
p.000072: or others who lack mental capacity as defined in the Mental Capacity Act) or because they are incapacitated
p.000072: through accident, injury or illness;
p.000072:
p.000072: (b) Those whose autonomy might be prejudiced by being under the influence of, or the control of, or obligated to,
p.000072: third parties; and
p.000072:
p.000072: (c) Infants or children. In the case of under-aged research participants issues of consent primarily
p.000072: involve parent or guardians.
p.000072:
p.000072: Consent from Vulnerable Persons not Lacking Capacity
p.000072:
p.000072: 3.16 Vulnerable adult research participants not only include those who are of diminished capacity, but also
p.000072: those whose autonomy might be prejudiced by being under the influence of, or the control of, or
p.000072: obligated to, third parties. Potentially vulnerable participants might include, but are not limited to:
p.000072:
p.000072: (a) Prisoners;
p.000072:
p.000072: (b) Serving uniformed personnel, especially junior ranks;
p.000072:
...
General/Other / Manipulable
Searching for indicator manipulate:
(return to top)
p.000009: that is clinical, and it could include research that does not use human participants at all. Much fundamental research
p.000009: in physiology and other disciplines has the goals of medicine as its ultimate aim. In a similar way, the goal of much
p.000009: bioengineering research is ultimately medical, though this is not true of the foundational disciplines in engineering.
p.000009: For these reasons, it is difficult to provide a single definition that covers all obvious examples of research
p.000009: that have a clearly medical goal, while not becoming over-inclusive with respect to basic research that might
p.000009: ultimately be important for medicine but is not done with the primary aim of furthering its goals.
p.000009:
p.000009: 1.8 The BAC therefore adopts the following definition of human biomedical research:
p.000009:
p.000009: Human Biomedical Research refers to any research done for the ultimate purpose of studying, diagnosing, treating
p.000009: or preventing, any disease, injury, disorder, or condition of the human mind or body, and which entails the
p.000009: involvement of humans, human biological materials or information derived from humans or human biological materials.
p.000009: Also included is research on human physiological processes.
p.000009:
p.000009: 1.9 The BAC takes the view that human biomedical research usually needs to be regulated because one
p.000009: or more of the following conditions will inevitably apply to any proposed human biomedical research:
p.000009:
p.000009: (a) The research involves intervention with respect to, interaction with, or observation of one
p.000009: or more human participants;
p.000009:
p.000009: (b) The research will use or manipulate human biological materials (e.g. human cells, tissues, organs and
p.000009: body fluids);
p.000009:
p.000009: (c) The research entails the systematic review, analysis, use or publication of previously compiled
p.000009: identifiable (identified or reversibly de-identified) medical or personal information or biodata;
p.000009:
p.000009:
p.000009: 1 Office for Human Research Protections, 45 Code of Federal Regulations 46.102(d).
p.000009: 2 Levine, RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al.
p.000009: (Eds.) The Oxford Textbook of Clinical Research Ethics. Oxford: OUP (2011), page 211.
p.000009:
p.000010: 10
p.000010:
p.000010: INTRODUCTION
p.000010:
p.000010: (d) The research topic is sufficiently sensitive to likely raise questions of public acceptability or
p.000010: public policy (e.g. research on human embryos or human-animal combinations); or
p.000010:
p.000010: (e) The research could be considered sensitive by virtue of the nature of the personal information it
p.000010: proposes to gather.
p.000010:
p.000010: 1.10 The BAC is concerned with human biomedical research, and not with the wider issues of research with human
p.000010: participants generally. It does not seek to determine the extent to which ethics governance for the protection
p.000010: of human participants should be extended to research that is not biomedical, though this is clearly a
p.000010: matter of importance and public interest. It does, however, cover economic, sociological and other research
...
p.000072: such reasons it is difficult to provide a single definition that covers all obvious examples of research that
p.000072: have a clearly medical goal, while not becoming over-inclusive with respect to basic research that might ultimately
p.000072: be important for medicine but is not done with the aim of furthering its goals.
p.000072:
p.000072: 1.9 The BAC therefore adopts the following definition of human biomedical research:
p.000072:
p.000072: Human Biomedical Research refers to any research done for the ultimate purpose of studying, diagnosing, treating or
p.000072: preventing, any disease, injury or disorder of the human mind or body, and which entails the involvement of
p.000072: humans, human tissues or information derived from humans or human tissues.
p.000072:
p.000072: 1.10 The BAC takes the view that human biomedical research normally needs to be regulated because one
p.000072: or more of the following conditions will inevitably apply to any proposed human biomedical research:
p.000072:
p.000072:
p.000072: 36 US Department of Health and Human Services, 45 CFR 46.102(d).
p.000072: 37 Levine, RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al. (Eds.) The Oxford
p.000072: textbook of clinical research ethics. Oxford: OUP (2008), page 211.
p.000072:
p.000072:
p.000072:
p.000072: A3
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) The research involves intervention with respect to, interaction with, or observation of one
p.000072: or more human participants; or
p.000072: (b) The research will use or manipulate human biological materials (e.g. human cells, tissues, organs
p.000072: and body fluids), including those which were previously acquired and stored; or
p.000072: (c) The research entails the systematic review, analysis, use or publication of previously compiled
p.000072: identifiable (identified or reversibly de-identified) medical or personal information or biodata; or
p.000072: (d) The research topic is sufficiently sensitive to likely raise questions of public acceptability or
p.000072: public policy (e.g. research on human embryos or human- animal combinations); or
p.000072: (e) The research could be considered sensitive by virtue of the nature of the personal information it
p.000072: proposes to gather.
p.000072: 1.11 The BAC is concerned with human biomedical research, not with the wider issues of research with human
p.000072: participants generally. It does not seek to determine the extent to which ethics governance for the protection of human
p.000072: subjects should be extended to research that is not biomedical, though this is clearly a matter of
p.000072: importance and public interest. It does, however, cover economic, sociological and other research in the humanities
p.000072: and social sciences whenever this research fits the above definition of human biomedical research.
p.000072: 1.12 The BAC also recognises that biomedical research could be more or less sensitive in character, where
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.000055:
p.000055: 7.20 The risk of hubris and ‘playing God’. The expression ‘playing God’ is often heard in connection with
p.000055: research or practice at the boundaries of medicine, and the exact meaning to be attributed to it may depend
p.000055: on the speaker. Religious critics may mean by it that interference with the process of creating and destroying life is
p.000055: interference with divine prerogative. In its secular form, this criticism can imply that we may suffer
p.000055: from scientific or ethical hubris, a pride in power that blinds us to limitations or unforeseen risks. Such concerns
p.000055: should not be lightly dismissed, but they are not without answers. Whatever we do will affect future
p.000055: generations. It is thus also ‘playing God’ if we prohibit research that might help patients.
p.000055:
p.000055: 7.21 The BAC’s view is that the problem of slippery slope, hubris, and other ethical concerns
p.000055: discussed above present a powerful case for ethical and legal regulation, rather than a case for outright
p.000055: prohibition. Regulation is an assurance that change will be introduced without abrupt and radical challenges to the
p.000055: fundamental values, beliefs and practices in society, and only when the key ethical issues arising from research
p.000055: involving human-animal combinations have been considered in each case.
p.000055:
p.000055: 7.22 The possibility of creating humanised animals. Most of the concerns just discussed are related to
p.000055: the possibility of allowing actual independent living entities to develop from human-animal combinations. It seems to
p.000055: the BAC that the main ethical hazard lies in the possibility of inadvertently creating an animal with human
p.000055: characteristics, especially, but not exclusively, mental attributes. The risks can be seen most clearly in the
p.000055: specific case of human neural stem cells grafted into the brains of non-human
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: HUMAN STEM CELL RESEARCH
p.000056:
p.000056: primate foetuses32, which offers an in-principle possibility of a degree of humanisation of the
p.000056: resulting brain. In this case, six relevant factors have been suggested for the guidance of ethics committees,
p.000056: namely:33
p.000056:
p.000056: (a) The proportion or ratio of human to animal cells in the animal’s brain: When the amount of human material
p.000056: is low, the likelihood of the animal acquiring something like human awareness as a result is correspondingly
p.000056: remote;
p.000056:
p.000056: (b) The age of the animal: The earlier in development, the greater the likely integration of
p.000056: transplanted cells, so human cells transplanted into animal embryos will probably result in greater
p.000056: likelihood of humanisation of the host animal’s brain than implantation into a fully developed animal;
p.000056:
p.000056: (c) The recipient species: Species with a closer approximation to human neural organisation are more
p.000056: problematic, because the likelihood of human attributes occurring in another species is increased when the other
p.000056: species is biologically close;
p.000056:
p.000056: (d) The brain size of the animal involved: It is reasonable to suppose that animals with larger brains are more
...
p.000072: research or practice at the boundaries of medicine, and the exact meaning to be read into it may depend on
p.000072: the speaker. Religious critics may mean by it that interference with the process of creating and destroying life is
p.000072: interference with divine prerogative. In its secular form, this criticism can imply that we may suffer from
p.000072: scientific or ethical hubris, a pride in power that blinds us to limitations or unforeseen risks. Such
p.000072: concerns are not to be lightly dismissed, but they are not without answers. Whatever we do will affect
p.000072: future generations. It is thus also ‘playing God’ if we prohibit research that might help patients.
p.000072: 7.20 The BAC’s view is that the problem of slippery slopes, hubris, and other ethical concerns
p.000072: discussed above present a powerful case for ethical and legal regulation, rather than a case for outright
p.000072: prohibition. Regulation is an assurance that change will be introduced without abrupt and radical challenge to the
p.000072: fundamental values, beliefs and practices that underlie society, and only when the key ethical issues arising from
p.000072: research involving human-animal combinations have been considered in each case.
p.000072:
p.000072:
p.000072: A49
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 7.21 The possibility of creating humanised animals. Most of the concerns just discussed are related to the
p.000072: possibility of allowing actual independent living entities to develop from human-animal combinations. It seems to the
p.000072: BAC that the main ethical hazard lies in the possibility of inadvertently creating an animal with human
p.000072: characteristics, especially, but not exclusively, mental attributes. The risks can be seen most clearly in the
p.000072: specific case of human neural stem cells grafted into the brains of non-human primate foetuses57, which
p.000072: offers an in-principle possibility of a degree of humanisation of the resulting brain. In this
p.000072: case, six relevant factors have been suggested58 for the guidance of ethics committees, namely:
p.000072: (a) The proportion or ratio of human to animal cells in the animal’s brain: When the amount of human material
p.000072: is low, the likelihood of the animal acquiring something like human awareness as a result is correspondingly
p.000072: remote;
p.000072: (b) The age of the animal: The earlier in development, the greater the likely integration of
p.000072: transplanted cells, so human cells transplanted into animal embryos will probably result in greater
p.000072: likelihood of humanisation of the host animal’s brain than implantation into a fully developed animal;
p.000072: (c) The recipient species: Species with a closer approximation to human neural organisation are more
p.000072: problematic, because the likelihood of human attributes occurring in another species is increased when the other
p.000072: species is biologically close;
p.000072:
p.000072: (d) he brain size of the animal involved: It is reasonable to suppose that animals with larger brains
p.000072: are more likely to be capable of an approximation to human consciousness in the event that they incorporate human
p.000072: neural cells;
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000010: of human participants should be extended to research that is not biomedical, though this is clearly a
p.000010: matter of importance and public interest. It does, however, cover economic, sociological and other research
p.000010: in the humanities and social sciences whenever this research fits the above definition of human biomedical
p.000010: research.
p.000010:
p.000010: 1.11 The BAC also recognises that human biomedical research could be more or less sensitive in
p.000010: character, where ‘sensitivity’ depends on societal considerations. For example, research that relies on
p.000010: sensitive information, such as participants’ sexual practices or psychiatric history, would ipso facto be
p.000010: regarded as sensitive research. Similarly, research on cloning technology would generally be considered
p.000010: sensitive simply because the idea of using the technology it generates to clone a human being is widely seen as
p.000010: unacceptable. Research deemed sensitive would attract more exacting regulatory control, or could be prohibited.3
p.000010:
p.000010: 1.12 Human biomedical research can be basic and far removed from the likelihood of immediate
p.000010: application, or it can be explicitly clinical and therapeutic in character. Clinical research includes
p.000010: clinical trials, which are regulated by the Health Sciences Authority (HSA) in Singapore.
p.000010:
p.000010: 1.13 There is a long tradition in medicine of medical practitioners publishing clinical case reports based on their
p.000010: own cases, and these reports have often been a valuable source of learning in the profession. The BAC is of
p.000010: the view that the publication of case reports not amounting to a systematic programme of research is under the
p.000010: purview of journal editors and the Singapore Medical Council, as the latter is the authority for upholding the
p.000010: requirements of professional medical ethics and conduct in Singapore. Such publication does not necessarily
p.000010: require independent ethics review, as both medical ethics and conduct, and the requirements of journal
p.000010: editors that informed consent be obtained, offer safeguards against the improper publication of case reports.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: 3 The sensitivity of research with human embryonic stem cells, or with cloning technology, is
p.000010: manifestly sensitive in the sense that the morality and acceptability of such research is disputed. For this reason,
p.000010: the BAC had in its Stem Cell Report, recommended a strict regulatory regime, especially for the creation
p.000010: of human embryos specifically for research, and additionally recommended a ‘conscience clause’ allowing
p.000010: conscientious objection to participation in any manner in human stem cell research. See Recommendations 3 to 5 and 11
p.000010: of that Report.
p.000010:
p.000011: 11
p.000011:
p.000011: INTRODUCTION
p.000011:
p.000011: The Legislative and Regulatory Framework of Human Biomedical Research in Singapore
p.000011:
p.000011: 1.14 All research in Singapore, like any other activity, is bound by the laws of Singapore, comprising a
p.000011: combination of statute and case law. A number of statutes and regulations made under them are relevant
p.000011: to the conduct of human biomedical research.
p.000011:
...
p.000012: (Cap. 7, R 10) (revised 2007): An Act for preventing the introduction into, and the spreading within, Singapore
p.000012: of diseases of animals, birds or fish; for the control of the movement of animals, birds or fish into, within and from
p.000012: Singapore; for the prevention of cruelty to animals, birds or fish; for measures pertaining to the general welfare and
p.000012: improvement of animals, birds or fish in Singapore and for purposes incidental thereto; Regulations
p.000012: under this Act govern the use of laboratory animals for research.
p.000012:
p.000012: (j) Personal Data Protection Act (Act 26 of 2012): This Act governs the collection, use and disclosure of personal
p.000012: data, including for the purposes of research.
p.000012:
p.000012: Guidelines / Directives
p.000012:
p.000012: 1.16 Relevant guidelines / directives are as follows:
p.000012:
p.000012: (a) Ministry of Health (MOH), Singapore Guideline for Good Clinical Practice, 1998, Revised 1999;
p.000012:
p.000012: (b) MOH, Governance Framework for Human Biomedical Research, 2007;
p.000012:
p.000012: (c) MOH, Operational Guidelines for Institutional Review Boards, 2007;
p.000012:
p.000012: (d) MOH, Code of Ethical Practice in Human Biomedical Research, 2009;
p.000012:
p.000012: (e) MOH, Licensing Terms and Conditions (LTC) on Assisted Reproduction (AR) Services (2011). Sections 9 and 10 of
p.000012: the Licensing Terms and Conditions relate to research;
p.000012:
p.000012: (f) National Advisory Committee for Laboratory Animal Research, Guidelines on the Care and Use of Animals for
p.000012: Scientific Purposes, 2004. Administered by the Agri-Food and Veterinary Authority of Singapore and the National
p.000012: Advisory Committee on Laboratory Animal Research;
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: INTRODUCTION
p.000013:
p.000013: (g) National Medical Ethics Committee (NMEC),4 Recommendations On Clinical Trials: Update Focusing On Phase 1
p.000013: Trials, 2007;
p.000013:
p.000013: (h) NMEC, Ethical Guidelines for Gene Technology, 2001;
p.000013:
p.000013: (i) NMEC, Ethical Guidelines on Research involving Human Subjects, 1997; and
p.000013:
p.000013: (j) Singapore Medical Council, Ethical Code and Ethical Guidelines.
p.000013:
p.000013: 1.17 The ultimate responsibility for ethical governance of research lies with research institutions.
p.000013: Since 1998, the MOH has required all government and restructured hospitals to set up hospital ethics
p.000013: committees for the ethics review of research involving human participants. After the publication of the 2004 BAC
p.000013: IRB Report, this system of ethics review was further strengthened, with appropriately constituted IRBs, and researchers
p.000013: bound by the procedures and rules laid down by the applicable IRB. The system of ethics governance is discussed further
p.000013: in Part II of these Guidelines.
p.000013:
p.000013: 1.18 The BAC reports have all been accepted by the MOH as providing guidance on matters not covered by
p.000013: statute, subsidiary legislation, or otherwise.
p.000013:
...
p.000018: requirements of research integrity are observed, and IRBs have a responsibility to check that
p.000018: research integrity, as well as research merit, has been considered.
p.000018:
p.000018: 2.17 The principles described above are general in nature and fundamental to ethics governance of
p.000018: biomedical research involving human participants, the use of the biological materials that they have
p.000018: contributed, and information about persons obtained or derived from the research process. In practice,
p.000018: these principles are engaged in a number of specific guidelines, considered below.
p.000018:
p.000018: Ethics Review of Human Biomedical Research in Singapore – The IRB System
p.000018:
p.000018: 2.18 Ethics governance of research in Singapore has been established by statute for clinical trials. The
p.000018: Medicines Act 1975 (Chapter 176, Sections 18 and 74) and Medicines (Clinical Trials) (Amendment)
p.000018: Regulations 1998, require that all clinical trials be conducted in accordance with the Singapore Guideline
p.000018: for Good Clinical Practice (SGGCP), which is adapted from the International Conference on Harmonisation
p.000018: Tripartite Guideline E6: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). The
p.000018: SGGCP requires that all proposals for pharmaceutical clinical trials be reviewed by independent ethics
p.000018: committees.
p.000018:
p.000018: 2.19 The HSA is the regulatory authority for clinical trials. Since January 2006, researchers can make parallel
p.000018: submissions to both HSA and to their respective IRBs. The regulatory approval from HSA, in the form of a
p.000018: Clinical Trial Certificate, is issued independently of ethics approval. Researchers are to initiate their studies only
p.000018: when both regulatory and ethics approvals have been obtained.
p.000018:
p.000018: 2.20 In 1998, based on the recommendations of the NMEC’s Ethical Guidelines on Research Involving Human
p.000018: Subjects (1997), the MOH required all government and restructured hospitals to establish hospital ethics
p.000018: committees to review all research protocols involving human experimentation, whether pharmaceutical trials,
p.000018: trials of
p.000018:
p.000018:
p.000018:
p.000018: 11 The Statement is available at http://www.singaporestatement.org/.
p.000018:
p.000019: 19
p.000019:
p.000019: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000019:
p.000019: new medical devices, new clinical procedures, or any other kinds of clinical studies requiring the participation of
p.000019: human subjects or the use of human biological materials.
p.000019:
p.000019: 2.21 The focus of the research covered by these legislative provisions and guidelines was primarily clinical,
p.000019: although the NMEC Guidelines clearly included epidemiological research. No explicit provision existed for
p.000019: biomedical research that involved human participants, or human biological materials, which was not clinical in
...
p.000026: has to be made when considering research participants who are vulnerable. Such participants include:
p.000026:
p.000026: (a) Persons lacking mental capacity (such as the intellectually disabled, people who are incapacitated through
p.000026: accident, injury or illness, and others as defined in the Mental Capacity Act);
p.000026:
p.000026: (b) Those whose autonomy might be prejudiced by being under the influence of, or the control of, or obligated to,
p.000026: third parties; and
p.000026:
p.000026: (c) Minors.
p.000026:
p.000026: Consent for Research Involving Persons Lacking Mental Capacity
p.000026:
p.000026: The Mental Capacity Act
p.000026:
p.000026: 3.13 The Mental Capacity Act lays down the general framework under which decisions can be made on behalf of a
p.000026: person lacking capacity. As the Act states in Section 13(7) that treatment includes the conduct of a clinical
p.000026: trial, a deputy appointed by the court under the Act, or a donee who has been expressly given
p.000026: authority under a Lasting Power of Attorney (LPA) to give or refuse consent to the carrying out or continuation of
p.000026: medical treatment by a health care provider, may also decide on the person’s participation in clinical
p.000026: trials. But this is subject to the restrictions in Sections 13(8) and 25(3)(c), on both a deputy and a donee,
p.000026: concerning life-sustaining treatment or treatment necessary to prevent a serious deterioration in the patient’s
p.000026: condition.
p.000026:
p.000026: 3.14 In making such decisions on personal welfare, the deputy or the donee must follow the statutory principles
p.000026: under the Act, viz., act in the incapacitated person’s (i.e. donor’s) best interests,13 have regard to the
p.000026: guidance in the Code of Practice of the Act, carry out the donor’s instructions and make decisions within the
p.000026: scope of authority specified in the LPA. To give consent for the person lacking capacity to participate
p.000026: in clinical trials, the deputy or the donee must be satisfied that:
p.000026:
p.000026: (a) The incapacitated individual has previously indicated a willingness to participate; or
p.000026:
p.000026: 13 With regard to best interests, Mental Capacity Act, section 6(7) states: “He [the deputy or
p.000026: donee] must consider, so far as is reasonably ascertainable –
p.000026: (a) the person’s past and present wishes and feelings (and, in particular, any relevant written statement made by him
p.000026: when he had capacity);
p.000026: (b) the beliefs and values that would be likely to influence his decision if he had capacity; and
p.000026: (c) the other factors that he would be likely to consider if he were able to do so.”
p.000026:
p.000027: 27
p.000027:
p.000027: CONSENT
p.000027:
p.000027: (b) Consent would, in the judgement of the deputy or donee, have been given had the incapacitated individual (not
p.000027: being a child), been able to make an informed choice.
p.000027:
...
p.000027: International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research
p.000027: Involving Human Subjects (2002), Articles 9 and 15.
p.000027:
p.000028: 28
p.000028:
p.000028: CONSENT
p.000028:
p.000028: 3.18 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000028: prospective participants reassured that they have nothing to fear in declining research participation or
p.000028: in contributing biological materials or personal information for research. Thus, consent from uniformed
p.000028: personnel, for example, should not be taken by a senior officer, and preferably not by uniformed personnel.
p.000028:
p.000028: 3.19 When it is not possible for consent to be taken by an independent third party, the IRB may give directions for
p.000028: the consent to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000028: sufficient safeguards to protect the welfare and interests of the participant.
p.000028:
p.000028: 3.20 A further issue of vulnerability arises in societies where social proxy arrangements are widespread, for
p.000028: example, where a village headman might be thought to have the authority to give consent on behalf of a
p.000028: village, or a husband on behalf of a wife. Not all societies treat their individual members as autonomous. This can
p.000028: become an issue if researchers based in Singapore seek to conduct research in places where social proxy
p.000028: arrangements are widespread. In such cases, while local customs are to be respected, they cannot supersede a
p.000028: requirement for individual consent.
p.000028:
p.000028: Consent for Research Involving Patients
p.000028:
p.000028: 3.21 It is important to note the differences between a patient’s consent for medical treatment and
p.000028: an individual’s consent for participating in research. The main difference is that in giving
p.000028: consent for treatment, a patient is accepting a proposed action that is intended for his or her benefit, and
p.000028: thus, needs to balance any risks or undesired consequences (such as side effects) against the benefit(s)
p.000028: sought. These risks may be substantial, but may be acceptable to the patient if no better treatment is available and
p.000028: some benefit is strongly indicated. Because research, by contrast, is not generally intended to confer benefit on
p.000028: the research participant (although it may sometimes do so), there are thus usually no personal benefits against
p.000028: which to balance risks. The benefits derived are generally for society as a public good, and the consent of the
...
p.000028: researcher-physician so long as there are provisions to manage the conflict of interest and sufficient safeguards to
p.000028: protect the welfare and interests of the patient.
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: CONSENT
p.000029:
p.000029: Consent for Research Involving Minors
p.000029:
p.000029: Respect for the developing autonomy of minors
p.000029:
p.000029: 3.23 In Singapore, under the common law, the age of majority is 21 years. This age is generally
p.000029: taken as the age at which a person is considered an adult and thus able to make all decisions for oneself. The category
p.000029: of minors thus spans a wide range, from children of tender years who lack any capacity to give consent, to young
p.000029: persons who have acquired the capacity to understand and make decisions on research participation.
p.000029: Parents generally have the authority to make decisions on behalf of minors, and this would include research
p.000029: participation. However, the welfare and best interests of the child or young person is the paramount consideration and
p.000029: parents must discharge their responsibilities to promote these.16 Unless research participation offers direct benefit
p.000029: to the minor, the authority of parents or guardians to consent to research without direct benefit is constrained
p.000029: in a similar fashion to proxy decisions for incapacitated adults as discussed in para. 3.16 above. Participation
p.000029: in research without direct benefit should involve no more than minimal risk and not be contrary to the best
p.000029: interests of the minor.
p.000029:
p.000029: 3.24 It is nevertheless ethically important to give due respect to the developing capacity of minors to be involved
p.000029: in, and make their own decisions about research participation. This consideration is reinforced in the case of research
p.000029: without direct benefit, where the minor should appreciate its altruistic nature. Respect for a minor’s
p.000029: developing autonomy is thus recognised by the Medicines (Clinical Trials) Regulations, which require both the
p.000029: minor who has sufficient understanding and a parent or guardian to consent to participation in a clinical
...
p.000046: institutions should inform patients that there is a possibility that their surplus biological materials may be used for
p.000046: research, and assure them that only research with the necessary safeguards in place will be allowed to proceed after
p.000046: approval from an IRB.
p.000046:
p.000046: Surplus Biological Materials from Research Projects
p.000046:
p.000046: 5.39 Biological materials that are collected for a specific research project may subsist after the project is
p.000046: completed. Such materials can be stored for future research if consent for storage and future research use had been
p.000046: obtained from the donors.
p.000046:
p.000046: 5.40 Consent need not be re-taken if IRBs are satisfied that subsequent use of the biological
p.000046: materials for research is covered by the initial consent, unless the research is deemed sensitive, in which case
p.000046: specific and personal consent is required. If the subsequent use is not covered by the initial consent, and
p.000046: re-contact is not possible or practicable, IRBs should have the discretion to determine whether or not the materials
p.000046: can be used without re-consent.
p.000046:
p.000046: Imported Biological Materials
p.000046:
p.000046: 5.41 When imported biological materials are to be used for research, the researcher should obtain written
p.000046: assurance from the source authority that the materials have been ethically and legally obtained. The test of
p.000046: ethical acceptability should be the criteria that would have applied had the biological materials been obtained in
p.000046: Singapore and not imported, and the researcher and IRB should be satisfied that this test has been met in substance.
p.000046:
p.000046: Biobanks
p.000046:
p.000046: 5.42 Institutions that maintain tissue banks or biobanks for research should have in place transparent and
p.000046: appropriate systems and standards for the proper ethical, legal and operational governance of research
p.000046: using biological materials from the bank. As custodians of the biological materials, they are responsible
p.000046: not only for the general maintenance of the biobank, but also for ensuring the following:
p.000046:
p.000046: (a) That appropriate consent has been obtained for the storage and use of the biological materials;
p.000046:
p.000047: 47
p.000047:
p.000047: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000047:
p.000047: (b) That all research involving the biological materials is approved by an IRB, and also by MOH where relevant,
p.000047: before the materials are handed over to the researcher(s);
p.000047:
p.000047: (c) Protection of the privacy of the donors and of any other individuals whose identity or personal
p.000047: particulars to which such information may relate, and the confidentiality of personal information associated
p.000047: with the biological materials;
p.000047:
p.000047: (d) Keeping proper records of all uses of the biological materials;
p.000047:
...
p.000048: relation an incidental finding made during the conduct of research; and
p.000048:
p.000048: (c) The potential commercial value of large-scale genomic studies makes issues of research integrity and data
p.000048: ownership especially important.
p.000048:
p.000048: 6.4 Genetic interventions also raise ethical and moral issues, with germline genetic modification being
p.000048: the most contentious. Any intervention that alters the germline of
p.000048:
p.000049: 49
p.000049:
p.000049: HUMAN GENETIC RESEARCH
p.000049:
p.000049: an individual will lead to a change in the genetic makeup of that individual’s descendants. At present,
p.000049: there is insufficient knowledge of the potential long-term consequences of such interventions, as they are still
p.000049: in the experimental stage. Many countries, such as Australia, Canada, and Finland therefore have laws that
p.000049: prohibit germline modification.
p.000049:
p.000049: 6.5 With the emergence of assisted reproductive techniques to prevent the transmission of mitochondrial disease,
p.000049: such as ooplasmic transfer, pronuclear transfer and maternal spindle transfer, the Nuffield Council on
p.000049: Bioethics (NCB) conducted a public consultation in early 2012, which explored the ethical issues concerning the
p.000049: possible use of such treatments in the future. It concluded that if these novel techniques are adequately
p.000049: proven to be acceptably safe and effective, it would be ethical for families to use them, if they choose to.
p.000049: However, a continuing debate on these issues is important.29 Following this report, the Human Fertilisation &
p.000049: Embryology Authority (HFEA) also launched a public consultation, and it advised the Government that there was general
p.000049: public support for permitting mitochondrial replacement in the UK, so long as it is safe enough to
p.000049: offer in a treatment setting and is done so within a regulatory framework.30. The Department of Health (DoH)
p.000049: held public consultations in early 2014 on its draft regulations that will allow the use of such
p.000049: techniques in patients for the prevention of serious mitochondrial disease. A scientific review by an expert panel
p.000049: convened by the HFEA published in June 2014 concluded that the evidence it has seen does not suggest
p.000049: the techniques unsafe. As a result, the UK Parliament passed the DoH’s draft Human
p.000049: Fertilisation and Embryology (Mitochondrial Donation) Regulations31 in early 2015 to allow
p.000049: mitochondrial donation for prevention of serious mitochondrial diseases, with UK being the first country to
p.000049: do so.
p.000049:
p.000049: 6.6 In 2005 BAC Genetics Report, the Committee had recommended that the clinical practice of
p.000049: germline modification be prohibited, pending scientific evidence that techniques to prevent or eliminate
p.000049: serious genetic disorders have been proven effective. In light of recent international deliberations on
p.000049: germline modification techniques for the treatment of serious diseases, the BAC appointed a Germline
p.000049: Modification Working Group in October 2014 to review these developments and its current recommendations on the matter.
p.000049:
p.000049: 6.7 Information obtained from genetic research could be financially valuable. For example,
...
p.000068:
p.000068: Uganda. Uganda National Council for Science and Technology. National Guidelines for Research Involving Humans
p.000068: as Research Participants. March 2007.
p.000068:
p.000068: United Kingdom. Access to Health Records Act. 1990.
p.000068:
p.000068: United Kingdom. Association of the British Pharmaceutical Industry. Guidelines for Phase 1 Clinical Trials. 2007.
p.000068:
p.000068: United Kingdom. Data Protection Act. 1998.
p.000068:
p.000068: United Kingdom. Department of Health, Royal College of General Practitioners, British Medical Association.
p.000068: The Good Practice Guidelines for GP electronic patient records. 2011.
p.000068:
p.000068: United Kingdom. Department of Health. Innovative Genetic Treatment to Prevent Mitochondrial Disease
p.000068: (Press Release). 28 June 2013.
p.000068:
p.000068: United Kingdom. England and Wales Court of Appeal (Civil Division): Jonathan Yearworth & Ors v North Bristol NHS Trust
p.000068: [2009] 3 Weekly Law Reports 118, 4 February 2009.
p.000068:
p.000068: United Kingdom. General Medical Council. Confidentiality. 12 October 2009.
p.000068:
p.000068: United Kingdom. General Medical Council. Good Practice in Research and Consent to Research. April 2010.
p.000068:
p.000068: United Kingdom. House of Lords: S (An Infant, by her Guardian ad Litem the Official Solicitor) v. S
p.000068: [1972] Appeal Cases 24, 23 July 1970.
p.000068:
p.000068: United Kingdom. Human Fertilisation and Embryology Act. 2008.
p.000068:
p.000068: United Kingdom. Human Fertilisation and Embryology Authority. Mitochondria Replacement
p.000068: Consultation: Advice to Government. March 2013.
p.000068:
p.000068: United Kingdom. Human Fertilisation and Embryology Authority. Third Scientific Review of the Safety and Efficacy of
p.000068: Methods to Avoid Mitochondrial Disease through Assisted Conception: 2014 Update. June 2014.
p.000068:
p.000068: United Kingdom. Human Fertilisation and Embryology (Mitochondrial Donation) Regulations. 2015.
p.000068: United Kingdom. Human Genetics Commission. Inside Information: Balancing Interests in the Use of Personal Genetic Data.
p.000068: 2002.
p.000068:
p.000068: United Kingdom. Human Tissue Act. 2004.
p.000068:
p.000068: United Kingdom. Human Tissue Authority. Code of Practice 9: Research. September 2009.
p.000068:
p.000068: United Kingdom. Medical Research Council. Ethics Guide: Medical Research Involving Adults who Cannot Consent.
p.000068: 2007.
p.000068:
p.000068: United Kingdom. Medical Research Council. Ethics Guide: Medical Research Involving Children. 2004.
p.000068:
p.000069: 69
p.000069:
p.000069: BIBLIOGRAPHY
p.000069:
p.000069: United Kingdom. Medical Research Council. Human Tissue and Biological Samples for Use in Research: Operational and
p.000069: Ethical Guidelines. 2005.
p.000069:
p.000069: United Kingdom. Medical Research Council. MRC Operational and Ethical Guidelines: Human Tissue and Biological
p.000069: Samples for Use in Research Clarification following passage of the Human Tissue Act 2004. 2005.
p.000069:
p.000069: United Kingdom. Medical Research Council. Personal Information in Medical Research.
p.000069: 2002.
p.000069:
p.000069: United Kingdom. Mental Capacity Act. 2005.
p.000069:
p.000069: United Kingdom. National Children’s Bureau Research Centre. Guidelines for Research with Children and Young People.
p.000069: March 2011.
p.000069:
p.000069: United Kingdom. National Health Service Act. 2006.
p.000069:
p.000069: United Kingdom. National Health Services, National Patient Safety Agency, National Research Ethics Service.
...
p.000072: subjects should be extended to research that is not biomedical, though this is clearly a matter of
p.000072: importance and public interest. It does, however, cover economic, sociological and other research in the humanities
p.000072: and social sciences whenever this research fits the above definition of human biomedical research.
p.000072: 1.12 The BAC also recognises that biomedical research could be more or less sensitive in character, where
p.000072: ‘sensitivity’ depends on societal considerations. For example, research that relied on sensitive
p.000072: information, such as about participants’ sexual practices or psychiatric history, would ipso facto be
p.000072: regarded as sensitive research. Similarly, research on cloning technology would generally be considered
p.000072: sensitive simply because the idea of using it to clone a human being is widely seen as unacceptable.
p.000072: Research deemed sensitive would attract more exacting regulatory control, or could be prohibited.38
p.000072: 1.13 Human biomedical research can be basic and far removed from the likelihood of immediate
p.000072: application, or it can be explicitly clinical and therapeutic in character. Clinical research includes
p.000072: clinical trials, for which the Health Sciences Authority (HSA) is the licensing authority.
p.000072:
p.000072:
p.000072:
p.000072: 38 The sensitivity of research with human embryonic stem cells, or with cloning technology, is manifestly
p.000072: sensitive in the sense that the morality and acceptability of such research is disputed. For this reason the BAC had
p.000072: in its Stem Cell Report, recommended a strict regulatory regime, especially for the creation of human
p.000072: embryos specifically for research, and additionally recommended a ‘conscience clause’ allowing conscientious
p.000072: objection to participation in any manner in human stem cell research. See Recommendations 3-5 and 11 of that Report.
p.000072:
p.000072:
p.000072:
p.000072: A4
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 1.14 There is a long tradition in medicine of medical practitioners publishing clinical case reports based on their
p.000072: own cases, and these reports have often been a valuable source of learning in the profession. The BAC is of
p.000072: the view that the publication of case reports not amounting to a systematic programme of research is a matter for
p.000072: journal editors, and the Singapore Medical Council as the authority for upholding the requirements of
p.000072: medical ethics in Singapore. Such publication does not necessarily require independent ethics review, as
p.000072: both medical ethics and the requirements of journal editors that informed consent be obtained offer
p.000072: safeguards against the improper publication of case reports.
p.000072: The Legislative and Regulatory Framework of Human Biomedical Research in Singapore
p.000072:
p.000072: 1.15 All research in Singapore, like any other activity, is bound by the laws of Singapore, comprising a
p.000072: combination of case and statute law. A number of statutes and regulations made under them are relevant to the
p.000072: conduct of biomedical research.
p.000072: Statutes and Subsidiary Legislation
p.000072:
p.000072: 1.16 Relevant statutes and subsidiary legislation are as follows. The list is not exhaustive, but covers all the
p.000072: principal sources of legislation impinging on biomedical research practice:
p.000072: (a) Medicines (Clinical Trials) Regulations (Cap. 176, Rg 3) made under Sections 18 and 74 of the Medicines Act
p.000072: (Cap. 176) (1985 Ed.), which is an Act to make provisions with respect to medicinal products and medical advertisements
p.000072: and matters connected therewith;
p.000072: (b) Health Products Act (Cap. 122D) (2008 Ed.): An Act to regulate the manufacture, import,
p.000072: supply, presentation and advertisement of health products and of active ingredients used in the manufacture of health
p.000072: products and provide for matters connected therewith;
...
p.000072: Singapore of diseases of animals, birds or fish; for the control of the movement of animals, birds or fish into, within
p.000072: and from Singapore; for the prevention of cruelty to animals, birds or fish; for measures pertaining to the general
p.000072: welfare and improvement of animals, birds or fish in Singapore and for purposes incidental thereto;
p.000072: Regulations under this Act govern the use of laboratory animals for research.
p.000072: 1.17 If and when passed, the Personal Data Protection Bill would govern the collection, use and
p.000072: disclosure of personal data, including for the purposes of research. The BAC recognises that revisions may be made to
p.000072: these Guidelines when the Bill is eventually passed, but it has taken into consideration the provisions
p.000072: provided in the draft Bill made public in March 2012.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A6
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Guidelines
p.000072:
p.000072: 1.18 Relevant guidelines are as follows:
p.000072:
p.000072: (a) MOH, Singapore Guideline for Good Clinical Practice, 1998, Revised 1999;
p.000072:
p.000072: (b) MOH, Governance Framework for Human Biomedical Research, 2007;
p.000072:
p.000072: (c) MOH, Operational Guidelines for IRBs, 2007;
p.000072:
p.000072: (d) MOH, Code of Ethical Practice in Human Biomedical Research, 2009;
p.000072:
p.000072: (e) National Advisory Committee for Laboratory Animal Research, Guidelines on the Care and Use of Animals for
p.000072: Scientific Purposes, 2004. Administered by the Agri-Food and Veterinary Authority of Singapore and the National
p.000072: Advisory Committee on Laboratory Animal Research;
p.000072: (f) National Medical Ethics Committee (NMEC),39 Recommendations On Clinical Trials: Update Focusing On Phase 1
p.000072: Trials, 2007;
p.000072: (g) NMEC, Ethical Guidelines for Gene Technology, 2001;
p.000072:
p.000072: (h) NMEC, Ethical Guidelines on Research involving Human Subjects, 1997; and
p.000072:
p.000072: (i) Singapore Medical Council, Ethical Code and Ethical Guidelines.
p.000072:
p.000072: 1.19 The ultimate responsibility for ethical governance of research lies with the individual researcher and the
p.000072: research institution. Since 1998, the MOH has therefore required all government and restructured hospitals to set
p.000072: up hospital ethics committees (or IRBs) for the ethics review of research involving human participants.
p.000072: From 2004, after the publication of the BAC IRB Report, this system of ethics review was further strengthened, with
p.000072: appropriately constituted IRBs, and researchers bound by the procedures and rules laid down by the
p.000072: applicable IRB. The system of ethics governance is discussed further in Part II of these Guidelines.
p.000072: 1.20 The BAC Reports have all been accepted by the MOH as providing guidance on matters not covered by
p.000072: statute, subsidiary legislation, or otherwise.
p.000072: 1.21 As research should be appropriately conducted regardless of where it is done, the BAC Guidelines
...
p.000072: requirements of research integrity are observed, and IRBs have a responsibility to check that
p.000072: research integrity, as well as research merit, has been considered.
p.000072: 2.20 The principles given above are general in nature and fundamental to ethics governance
p.000072: of biomedical research involving human participants or the use of the biospecimens that they have
p.000072: contributed, and of information about persons obtained or derived from the research process. In practice these
p.000072: principles emerge in a number of more specific guidelines, considered below.
p.000072:
p.000072: Ethics Review of Biomedical Research in Singapore – the IRB system
p.000072:
p.000072: 2.21 Ethics governance of research in Singapore has been established in statute for the specific case
p.000072: of clinical trials. The Medicines Act 1975 (Chapter 176, Sections 18 and
p.000072: 74) and Medicines (Clinical Trials) (Amendment) Regulations 1998, require that all clinical trials be conducted in
p.000072: accordance with the Singapore Guideline for Good Clinical Practice (SGGCP), which is adapted from the
p.000072: International Conference on Harmonisation Tripartite Guideline E6: Note for Guidance on Good Clinical Practice
p.000072: (CPMP/ICH/135/95). The SGGCP in turn requires that all proposals for pharmaceutical clinical
p.000072: trials be reviewed by independent ethics committees.
p.000072:
p.000072: 2.22 The HSA is the licensing authority for clinical trials. Since January 2006, researchers can make parallel
p.000072: submissions to both HSA and to their respective IRB. The regulatory approval from HSA, in the form of a
p.000072: Clinical Trial Certificate, is issued independently of ethics approval. Researchers are to initiate their studies only
p.000072: when both regulatory and ethics approvals have been obtained.
p.000072:
p.000072: 2.23 In 1997, the NMEC published a document entitled “Ethical Guidelines on Research Involving Human Subjects”.
p.000072: Accordingly, in 1998, the MOH required all government and restructured hospitals to establish ethics committees
p.000072: to review all research protocols involving human experimentation, whether pharmaceutical trials, trials of
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A13
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: new medical devices, new clinical procedures, or any other kinds of clinical studies requiring the participation of
p.000072: human subjects or the use of human tissues or organs.
p.000072:
p.000072: 2.24 The focus of the research covered by all these provisions was primarily clinical, although the
p.000072: NMEC Guidelines clearly included epidemiological research. No explicit provision existed for biomedical research that
p.000072: involved human participants, or human cells or tissues, which was not clinical in orientation. It appeared
p.000072: to the BAC (in 2003) timely to consider the ethical issues that might arise in basic research, since it could
p.000072: involve researchers, who not being medical practitioners, are not bound by obligations to patients, and could
...
p.000072: things as the affiliation of the researcher, the uses or value of the research, or their rights in respect of
p.000072: participation.
p.000072:
p.000072:
p.000072:
p.000072: A20
p.000072:
p.000072: ANNEX A
p.000072:
p.000072:
p.000072:
p.000072: 3.10 In any general consent for future research, donors may wish to impose some limits to the use of their tissue
p.000072: or information. If the donation is accepted, any such conditions must be observed. If the conditions are
p.000072: unacceptable or impractical, the donation should be declined. In general, the intention should be to seek a
p.000072: completely general consent without restriction, given that the tissue or information will be used only if the research
p.000072: is approved by an IRB.
p.000072:
p.000072: The Mental Capacity Act
p.000072:
p.000072: 3.11 Under the Mental Capacity Act, decisions in matters affecting day-to-day living of a person lacking capacity
p.000072: may be taken by a proxy, such as a parent, caregiver or legal guardian, or a “donee”, who is a proxy appointed
p.000072: with a lasting power of attorney (LPA). The Act is silent with regards to whether or not next-of-kin can assume
p.000072: the responsibility for seeking and giving consent for medical treatment, including clinical trials. However, a donee
p.000072: who has been specifically given authority under the LPA to give or refuse consent to the carrying out or continuation
p.000072: of medical treatment by a health care provider, may also decide on the conduct of clinical trials.
p.000072:
p.000072: 3.12 In making such decisions, the donee must follow the statutory principles under the Act, viz., act
p.000072: in the donor’s best interests,50 have regard to the guidance in the Codes of Practice, carry out the donor’s
p.000072: instructions and make decisions within the scope of authority specified in the LPA. To give consent for the
p.000072: person lacking capacity to participate in clinical trials, the donee must be satisfied that:
p.000072:
p.000072: (a) The individual has previously indicated a willingness to participate; or
p.000072:
p.000072: (b) Consent would, in the judgement of the donee, have been given had the individual (not being a
p.000072: child), been able to make an informed choice.
p.000072:
p.000072: 3.13 Legal protection is offered to any individual acting in connection with the care or treatment of
p.000072: a person lacking capacity, provided certain requirements, set out in Section 7(1) of the Act, are met.
p.000072: However, this statutory immunity does not apply to clinical trials, by virtue of an express exclusion in Section 7(3).
p.000072:
p.000072: 3.14 It should be stressed that biomedical research other than clinical trials research is not covered under the
p.000072: Act. A donee or other proxy is obligated under the Act to put the best interests of the participant first, yet
p.000072: participation in research is not usually a benefit to the participant. Consequently, consenting to
p.000072: participation in research on
p.000072:
p.000072: 50 With regard to best interests, Mental Capacity Act, section 6 (7) states: “He [the proxy] must consider, so
p.000072: far as is reasonably ascertainable –
...
p.000072:
p.000072: (c) Patients, especially if the intending researcher is their attending physician; and
p.000072:
p.000072: (d) Employees, junior collaborators, or students.
p.000072:
p.000072: 3.17 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000072: prospective participants reassured that they have nothing to fear in declining research participation or
p.000072: in contributing tissue for research. Thus consent among uniformed personnel, for example, should not be taken by
p.000072: a senior officer, and preferably not by uniformed personnel at all.
p.000072:
p.000072: 3.18 When it is not possible for consent to be taken by an independent third party, the IRB may give directions for
p.000072: the consent to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000072: sufficient safeguards to protect the welfare and interests of the participant.
p.000072:
p.000072:
p.000072:
p.000072: A22
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 3.19 A further issue of vulnerability arises in societies where social proxy arrangements are widespread, for
p.000072: example, where a village headman might be felt to have authority to give consent on behalf of a village, or a husband
p.000072: on behalf of a wife. Not all societies treat their individual members as autonomous. This can become
p.000072: an issue if researchers based in Singapore seek to conduct research in places where social proxy arrangements are
p.000072: widespread. In such cases, while local customs are to be respected, they cannot supersede a requirement for individual
p.000072: consent.
p.000072:
p.000072: Consent from Patients
p.000072:
p.000072: 3.20 It is important to note differences between a patient’s consent for treatment and an individual’s
p.000072: consent for participating in research. The main difference is that in giving consent for treatment, a patient is
p.000072: accepting a proposed action that is intended for his or her benefit, and thus, needs to balance any risks or undesired
p.000072: consequences (such as side effects) against the benefit(s) sought. These risks may be substantial, but may be
p.000072: acceptable to the patient if no better treatment is available and some treatment is strongly indicated. Because
p.000072: research, by contrast, is not designed to confer benefit for the research participant (although it may sometimes do
p.000072: so), there are thus usually no personal benefits against which to balance risks. The benefit is general and
...
p.000072: validating laboratory tests or for purposes of clinical audit without consent of the originators and without IRB
p.000072: approval, if the specimens are irreversibly de-identified. Although this practice is ethically acceptable, since it is
p.000072: not possible for individuals to be identified, it is good practice for healthcare institutions to inform
p.000072: patients that there is a possibility that their surplus biospecimens may be used for such purposes, for example, by
p.000072: displaying a notice to that effect.
p.000072: Surplus Tissues from Research Projects
p.000072:
p.000072: 5.39 Tissues that are collected for a specific research project may remain after the project is completed. Such
p.000072: tissues can be stored for future research if consent for storage and future research use has been obtained from the
p.000072: donors.
p.000072: 5.40 Consent need not be re-taken if IRBs are satisfied that subsequent use of the tissue for research is covered
p.000072: by the initial consent. If the subsequent research use of the tissue is not covered by the initial consent, and
p.000072: re-contact is not possible or practicable, IRBs should have the discretion to determine whether or not
p.000072: the research may progress without re-consent.
p.000072: Imported Tissues
p.000072:
p.000072: 5.41 When the tissues to be used for research are imported, the researcher should obtain written assurance from the
p.000072: source authority that the samples have been ethically and legally obtained. The test of ethical acceptability
p.000072: should be the criteria that would have applied had the tissue been obtained in Singapore and not
p.000072: imported, and the researcher and IRB should be satisfied that this test has been met in substance.
p.000072: Biobanks
p.000072:
p.000072: 5.42 Institutions that maintain tissue banks or biobanks for research should have in place transparent and
p.000072: appropriate systems and standards for the proper ethical, legal and operational governance of research using
p.000072: specimens from the bank. As custodians of the biospecimens, they are responsible not only for the general
p.000072: maintenance of the biobank, but also for ensuring the following:
p.000072: (a) That appropriate consent has been obtained for the storage and use of the biospecimens;
p.000072:
p.000072:
p.000072:
p.000072: A40
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (b) Protection of the privacy of the donors and of any other individuals whose identity or personal
p.000072: particulars to which such information may relate, and the confidentiality of personal information associated
p.000072: with the biospecimens;
p.000072: (c) That all research involving the biospecimens is approved by an IRB, and also by MOH in certain cases, such
p.000072: as when the biospecimens are human gametes or embryos;
p.000072: (d) Keeping proper records of all uses of the biospecimens;
p.000072:
p.000072: (e) Proper disposal of the biospecimens when no longer needed; and
p.000072:
...
p.000072: detecting findings that may be suggestive or prove clinically significant in future. Parties should be clear in
p.000072: advance as to when the obligation of the researcher ceases; and
p.000072: (c) The potential commercial value of large-scale genomic studies makes issues of research integrity and data
p.000072: ownership especially important.
p.000072:
p.000072:
p.000072:
p.000072: A42
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 6.4 Genetic interventions also raise ethical and moral issues, with germ-line genetic modification
p.000072: being the most contentious. Any intervention that alters the germ-line of an individual will lead to a change in
p.000072: the genetic makeup of that individual’s descendants. At present, there is insufficient knowledge of the
p.000072: potential long-term consequences of such interventions, as they are still in the experimental stage. Many countries,
p.000072: such as Australia, Canada, and Finland have laws that prohibit germline modification. With emerging
p.000072: assisted reproductive techniques such as ooplasmic transfer, pronuclear transfer and maternal spindle transfer, to
p.000072: prevent the transmission of mitochondrial disease, the Nuffield Council on Bioethics conducted a public
p.000072: consultation early this year. The Council recently published a report, which explores the ethical issues concerning
p.000072: the possible use of such treatments in future.56 It concluded that if these novel techniques are adequately
p.000072: proven to be acceptably safe and effective, it would be ethical for families to use them, if they choose
p.000072: to, but a continuing debate on these issues is important. The Human Fertilisation & Embryology
p.000072: Authority (HFEA), which licenses and monitors all fertility clinics and research involving human embryos in the
p.000072: UK, will take a lead in continuing the debate by launching a public consultation in September 2012, and report
p.000072: its findings in Spring 2013. The clinical use of such techniques is currently prohibited in the UK. In its 2005
p.000072: Genetics Report, the BAC had similarly recommended that the clinical practice of germ-line modification be
p.000072: prohibited and its position remains, pending evidence from research that clinical procedures to prevent or
p.000072: eliminate serious genetic disorders has been proven effective.
p.000072: 6.5 Genetic research can also be viewed to be financially valuable, for example research involving individuals
p.000072: who have genetic resistance to certain diseases, or whose genome might be found to contain genes
p.000072: relevant to understanding superior human athletic performance, could potentially be very valuable to researchers and
p.000072: institutions able to develop and commercially exploit the research. Thus pharmacogenomics depends on the
p.000072: presumption that optimal drug treatments may be tailored to the genetic makeup of the patient, or a subset of
p.000072: patients, for example classified by ethnic group. For this and other reasons, economic exploitation has been the
p.000072: subject of some controversy, and it is correspondingly important that all parties to research be well aware
p.000072: of the implications.
p.000072: 6.6 Genetic information refers to any information about the genetic makeup of an individual. It can
...
p.000072: U.S. Government Printing Office, Washington D.C. Law No. 10, Vol. 2: 181-182 (1949).
p.000072:
p.000072: Ourednik V and 10 others. Segregation of Human Neural Stem Cells in the Developing Primate
p.000072: Forebrain. Science. 293 (2001): 1820-1824.
p.000072:
p.000072: Personal Data Protection Bill. Singapore, 2012.
p.000072:
p.000072: Private Hospitals and Medical Clinics Act (Cap. 248). Singapore, 1999. Singapore Medical Council. Ethical Code and
p.000072: Ethical Guidelines (nd).
p.000072: United Nations Educational, Scientific and Cultural Organization (UNESCO)
p.000072: Universal Declaration on Bioethics and Human Rights, 2005.
p.000072:
p.000072: Wilfond BS and Diekema DS. Engaging children in genomics research: decoding the meaning of assent in research, Genetics
p.000072: in Medicine.14 (2012): 437-443.
p.000072:
p.000072: World Medical Association. Declaration of Helsinki:Ethical Principles for Medical Research Involving Human
p.000072: Subjects (revised 2008).
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A55
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: List of Abbreviations
p.000072:
p.000072:
p.000072: BAC Bioethics Advisory Committee
p.000072: HFEA Human Fertilisation and Embryology Authority
p.000072: HSA Health Sciences Authority
p.000072: IRB Institutional Review Board
p.000072: LPA Lasting power of attorney
p.000072: MOH Ministry of Health
p.000072: NMEC National Medical Ethics Committee
p.000072: SGGCP Singapore Guideline for Good Clinical Practice
p.000072: UNESCO United Nations Educational, Scientific and Cultural Organization
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A56
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: ANNEX B
p.000072:
p.000072: CONSULTATION PAPER DISTRIBUTION LIST
p.000072:
p.000072:
p.000072:
p.000072: ANNEX B
p.000072:
p.000072: Distribution List for Consultation Paper on
p.000072: “Ethics Guidelines for Human Biomedical Research – for comments” (Public Consultation Period: 20 June 2012 to 15 August
p.000072: 2012)
p.000072:
p.000072: 1. Academy of Medicine
p.000072: 2. Agency for Integrated Care
p.000072: 3. Alice Lee Centre for Nursing Studies
p.000072: 4. Alzheimer’s Disease Association
p.000072: 5. Association of Muslim Professionals
p.000072: 6. Autism Association (Singapore)
p.000072: 7. Bioinformatics Institute
p.000072: 8. Biomedical Research Council
p.000072: 9. Bioprocessing Technology Institute
p.000072: 10. Buddhist Fellowship
p.000072: 11. Cardiovascular Research Institute
p.000072: 12. The Catholic Medical Guild of Singapore
p.000072: 13. Changi General Hospital
p.000072: 14. College of Family Physicians Singapore
p.000072: 15. Defence Medical & Environmental Research Institute @ DSO National Laboratories
p.000072: 16. Department of Biological Sciences, National University of Singapore
p.000072: 17. Duke-NUS Graduate Medical School
p.000072: 18. ES Cell International
p.000072: 19. Experimental Therapeutics Centre
p.000072: 20. Genome Institute of Singapore
p.000072: 21. Graduates’ Christian Fellowship (Singapore)
p.000072: 22. Health Sciences Authority
p.000072: 23. Hindu Advisory Board
p.000072: 24. Institute of Bioengineering and Nanotechnology
p.000072: 25. Institute of Medical Biology
p.000072: 26. Institute of Mental Health
p.000072: 27. Institute of Molecular and Cell Biology
p.000072: 28. Inter-Religious Organisation Singapore
p.000072: 29. Jewish Welfare Board
p.000072: 30. John Hopkins Singapore International Medical Centre
p.000072: 31. Khoo Teck Puat Hospital
p.000072: 32. KK Women’s and Children’s Hospital
p.000072: 33. Khoo Teck Puat - National University Children's Medical Institute
p.000072: 34. Law Reform Committee, Singapore Academy of Law
p.000072: 35. The Law Society of Singapore
p.000072: 36. Majlis Ugama Islam Singapura (Islamic Religious Council of Singapore)
p.000072: 37. Muscular Dystrophy Association Singapore
p.000072: 38. Nanyang Polytechnic
p.000072:
p.000072: B1
p.000072:
p.000072: ANNEX B
p.000072:
p.000072: 39. Nanyang Technological University
p.000072: 40. National Arthritis Foundation
p.000072: 41. National Cancer Centre
p.000072: 42. National Council of Churches of Singapore
p.000072: 43. National Council of Social Service
p.000072: 44. National Dental Centre
p.000072: 45. National Healthcare Group
p.000072: 46. National Heart Centre
p.000072: 47. National Neuroscience Institute
p.000072: 48. National Skin Centre
p.000072: 49. National University Cancer Institute, Singapore
p.000072: 50. Ngee Ann Polytechnic
...
p.000072: child might be allowed to proceed even without the child’s
p.000072: C34
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: consent, if the parents give consent.
p.000072:
p.000072: We have two suggestions:
p.000072: (a) First, we suggest that the Guidelines make clear that such waivers by the IRB in paragraph 3.44 can only
p.000072: apply in the case where the research is not regulated under the Clinical Trials Regulations. Otherwise, an
p.000072: anomaly may arise in a case where there may be a clinical trial which may not involve more than minimal
p.000072: risks (i.e. a non-invasive clinical trial), and IRB may waive a requirement for parental consent, which is
p.000072: required under Clinical Trials Regulations.
p.000072:
p.000072: (b) Secondly, on the assumption that consent of the child is a requirement in all research
p.000072: involving children (we have advocated above that there should not be such a requirement), we suggest that it should be
p.000072: the consent of the child that is waivable, rather than parental consent. Otherwise, there may an inadvertent
p.000072: displacement of the authority of the parent over the child, where the child may agree to participate, but where the
p.000072: parent may not. For example, it is likely that a parent would still need to be involved in the child’s participation in
p.000072: the research (such as arranging for the parent to be present for the research or tests to be carried
p.000072: out, etc). The parent’s wishes should be respected in such a case. This position would also be consistent with the
p.000072: position articulated in paragraph 3.45 and therefore does not run the risk of creating many different layer of consents
p.000072: (for invasive research, for non-invasive research, and for clinical research).
p.000072:
p.000072: As important as it is to take into consideration the views of the minor who will be subject to the
p.000072: research, an approach requiring both consent from the minor and parent may pose a potential problem in situations
p.000072: where the parent consents to the research and the minor does not.
p.000072:
...
p.000072: 12. 5.8 Guidelines on Human Tissue Research
p.000072: We note that the Guidelines provide that all research involving human tissue, whether identified or de-identified,
p.000072: should be reviewed by an IRB and approved before it commences.
p.000072:
p.000072: At present, we understand that tissue banks are required to be licensed under the PHMC Act. We note that under the
p.000072: Guidelines for Healthcare Institutions promulgated pursuant to Regulation 4 of the Private Hospitals and
p.000072: Medical Clinics Regulations (“PHMC Regulations”), the term “Tissue Banking” is defined as “the activities
p.000072: of donor screening, procurement, processing, storage and distribution of human tissue intended for transplantation
p.000072: into a human”. The term “tissue bank” or “tissue banking” does not appear to be defined in the PHMC Act or the PHMC
p.000072: Regulations. Accordingly, it is not clear if it is only tissue banks that deal with organs for transplantation (and not
p.000072: tissue banks in general (or biobanks for that matter)) that would need to be regulated under the PHMC Act.
p.000072:
p.000072: The question thus arises as to whether a private tissue bank dealing with tissue banking only for purposes of research
p.000072: and not for transplantation would necessarily fall within the jurisdiction or purview of a hospital’s IRB. If it does
p.000072: not, then the requirement that all research involving human tissue be approved by an IRB may be hard to
p.000072: be implemented in practice.
p.000072:
p.000072: C36
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: 13. 5.41 Imported Tissue We also note that the Guidelines require
p.000072: researchers to obtain written assurance from the
p.000072: source authority when dealing with imported human samples that the samples have been ethically and legally obtained,
p.000072: and that the test of ethical acceptability would seemingly be the Singapore ethical standards. We suggest that
p.000072: this requirement be removed. We understand that typically, tissue imported from overseas laboratories and
p.000072: institutions are usually done by way of Material Transfer Agreements, and such samples are usually provided
p.000072: on an “AS IS, WHERE IS” basis. Accordingly, it would be an uphill task to require these overseas laboratories to
p.000072: provide written assurance of any form that the samples have been ethically obtained according to their ethical
p.000072: standards. Furthermore, it appears that the applicable ethical standards are that of Singapore. Given that these are
p.000072: foreign laboratories, it is hard to conceive that the foreign laboratories would be prepared to give any
p.000072: such assurances at all.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C37
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: Comments from member of the public (1)
p.000072:
p.000072: 27 July 2012
p.000072:
p.000072:
p.000072:
p.000072: From the press report and brief look at the provisions related to children, I am deeply concerned about
...
p.000072: In addition, the so-called 'disciplinary committee' usually consist of a more senior staff who will have the
p.000072: unfeterred sole decision to do what he/she prefers while the rest will usually be the silent majority.
p.000072:
p.000072: After several complaints from members of public, a new statutory board Council for Estate Agencies was set up to hear
p.000072: grievances and allow them to investigate complaints while at the same time, help be a bridge of communication
p.000072: and to increase public trust between consumers and property agents.
p.000072:
p.000072: They also help to standardise the system by having a demerit point systems for each property agent so that the process
p.000072: will be clear and transparent.
p.000072:
p.000072: IRBs in Singapore usually consist of members who have full time day jobs. Quite a lot of them may not have enough
p.000072: training or time to fully assess the merits of each projects.
p.000072:
p.000072: Research institutions are may not be truly capable of having a good IRB in place. Having a centralised IRB with full
p.000072: time staff with adequate training allows more transparency and accountability while at the same time, maps out
p.000072: the common similarities between researchers and research participants. Moreover, it disallows researchers and PIs from
p.000072: shopping around any research institution in Singapore.
p.000072:
p.000072: For example, HSA Singapore already regulates and enforces clinical trials in Singapore and metes out punitive action to
p.000072: manufacturers or importers of poorly made medical devices or harmful pharmaceuticals. In UK, HRA Health Research
p.000072: Authority was set up in 2011 Dec to look into this issue.
p.000072:
p.000072: HRA UK allows the blowing of whistle from research participants but at the same time, it helps gather patient advocacy
p.000072: groups as a one-stop service so that research institutions can forward to having a more cohesive adequately informed
p.000072: patient advocacy groups rather than having to hunt or source for research participants.
p.000072: May I know if there is a consideration along this line?
p.000072:
p.000072: C39
p.000072:
p.000072: ANNEX C
p.000072:
p.000072: In your ethical guidelines that "3.17 In such cases, consent should be taken by independent third parties, whenever
p.000072: possible, and prospective participants reassured that they have nothing to fear in declining research
p.000072: participation or in contributing tissue for research."
p.000072:
p.000072: My working place needs many research participants who serve as control groups. As a result, many researchers need to
p.000072: 'advertise' around and ask if their friends, families or spouses are willing to donate their time for research
p.000072: purposes. Many fear reprisals. Even when there was an assurance that it is not true, there were rumours that it could
p.000072: turn up in other ways such as a delay in promotion, or lower bonuses or getting marked down or denied opportunities
p.000072: later.
p.000072:
p.000072: In reality, it is quite difficult to even get independent third parties. Presently, many researchers
p.000072: already have difficulties to get people to be the controls for their research. To get independent third parties will be
p.000072: an additional obstacle. It is necessary but in reality, it will be hard to implement on the ground level.
p.000072:
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000004: (Therapy, Education and Research) Act.
p.000004:
p.000004: 33. Specific and personal consent from the donors must be obtained before any gametes or embryos are to be
p.000004: used for research. Potential donors should be provided with sufficient information to make an informed decision
p.000004: and be given at least a week to decide.
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: EXECUTIVE SUMMARY
p.000005:
p.000005:
p.000005: 34. For women undergoing fertility treatment, consent for the donation of surplus oocytes or embryos for
p.000005: research should be separate from the consent for treatment. The treating physician should not also be the
p.000005: researcher seeking consent for the donation of oocytes or embryos for research. Donors should confirm in writing that
p.000005: they do not require the oocytes or embryos for future use.
p.000005:
p.000005: 35. Women wishing to donate eggs specifically for research must be interviewed by an independent panel. The panel
p.000005: must be satisfied that they are of sound mind, clearly understand the nature and consequences of the donation,
p.000005: and have freely given explicit consent, without any inducement, coercion or undue influence.
p.000005:
p.000005: 36. If complications occur as a direct and proximate result of the egg donation, the donor should be provided
p.000005: with prompt and full medical care. This provision is the responsibility of the researchers and their
p.000005: institutions.
p.000005:
p.000005: 37. Trans-species fertilisation involving human gametes is not allowed for the purpose of reproduction unless
p.000005: done to assess or diagnose sub-fertility, in which case, the resultant hybrid must be terminated at the
p.000005: two-cell stage, and must have written approval from the Director of Medical Services.
p.000005:
p.000005: 38. Human embryos created for research through in vitro fertilisation of human eggs by human sperm, or created
p.000005: through any form of cloning technology, should not be allowed to develop beyond 14 days in vitro, or to be
p.000005: implanted into the body of any human or animal.
p.000005:
p.000005: 39. Human cytoplasmic hybrid embryos created for research should not be allowed to develop beyond 14
p.000005: days in vitro, or to be implanted into the body of any human or animal.
p.000005:
p.000005: 40. Every effort should be made to obtain consent for the use of surplus biological materials for
p.000005: research. As the primary objective for removing such materials is clinical, consent for the clinical procedure
p.000005: should be separate from the consent for the use of left over materials for research. Consent for research should only
...
p.000006: occur.
p.000006:
p.000007: 7
p.000007:
p.000007: EXECUTIVE SUMMARY
p.000007:
p.000007:
p.000007: 50. Animals into which human embryonic stem cells, induced pluripotent stem cells, or any other kind of
p.000007: pluripotent stem cells have been introduced should not be allowed to breed.
p.000007:
p.000007: 51. If the research involves introducing human embryonic stem cells or any pluripotent cells, or products derived
p.000007: from these cells, into humans, or any novel applications of any stem cells that are outside the scope of established
p.000007: standards of medical care, it should be conducted in accordance with the requirements and standards of a clinical trial
p.000007: for cell-based products, as specified by the HSA, and approval from HSA must be obtained. IRBs must ensure that:
p.000007:
p.000007: (a) The proposal is reviewed and approved by a scientific review committee with the relevant expertise;
p.000007:
p.000007: (b) There is strong evidence of the safety and efficacy of the cells from pre-clinical studies;
p.000007:
p.000007: (c) The research participants have been provided with sufficient information, in particular information on
p.000007: the nature and risks of the research, and the source of the cells, so that their values and beliefs are respected; and
p.000007:
p.000007: (d) Appropriate and informed consent has been obtained, without any inducement, coercion or undue influence.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: INTRODUCTION
p.000008:
p.000008: ETHICS GUIDELINES FOR HUMAN BIOMEDICAL RESEARCH
p.000008:
p.000008: I. INTRODUCTION
p.000008:
p.000008:
p.000008: 1.1 The main purpose of these Guidelines is to present an accessible and updated ethics resource for
p.000008: researchers and members of ethics committees or institutional review boards (IRBs), based on a review of the
p.000008: previous reports and recommendations of the Bioethics Advisory Committee (BAC).
p.000008:
p.000008: 1.2 The BAC was formed in 2000 to examine the ethical, legal and social issues arising from research on human
p.000008: biology and behaviour, and its applications. The Committee develops and recommends policies on such issues, with
p.000008: the aim of protecting the rights and welfare of individuals, while allowing the biomedical sciences to develop and
p.000008: realise their full potential for the benefit of humankind.
p.000008:
p.000008: 1.3 The work of the BAC since its inception has focussed on human biomedical research. This is captured in seven
p.000008: reports issued between 2002 and 2010. In 2011, the BAC reviewed its past reports, and prepared these for
...
p.000044:
p.000044: 5.26 Specific and personal consent from the donors must be obtained before any gametes or embryos are to be
p.000044: used for research. Potential donors should be provided with sufficient information to make an informed decision
p.000044: and be given at least a week to decide.
p.000044:
p.000044: 5.27 For women undergoing fertility treatment, consent for the donation of surplus oocytes or embryos for
p.000044: research should be separate from the consent for treatment. The treating physician should not also be the
p.000044: researcher seeking consent for the donation of oocytes or embryos for research. Donors should confirm in writing that
p.000044: they do not require the oocytes or embryos for future use.
p.000044:
p.000044: 5.28 As the process of donating eggs for research is time-consuming, invasive and associated with a
p.000044: certain degree of discomfort and risk, women wishing to donate eggs specifically for research i.e. those
p.000044: who are not undergoing fertility treatment, must be interviewed by an independent panel. The panel must be
p.000044: satisfied that they are of sound mind, clearly understand the nature and consequences of the donation, and have
p.000044: freely given explicit consent, without any inducement, coercion or undue influence.
p.000044:
p.000044: 5.29 All egg donors should be informed if their eggs will be used to create embryos, including
p.000044: human-animal combination embryos, which will be destroyed in the process of research, and if any derived cells
p.000044: from the embryos so created will be kept for future research or possible clinical use. They should be
p.000044: assured that any embryos
p.000044:
p.000044:
p.000044:
p.000044: 25 At paragraphs 9.1-9.11.
p.000044:
p.000045: 45
p.000045:
p.000045: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000045:
p.000045: created for research will not be implanted or allowed to develop in vitro beyond 14 days.
p.000045:
p.000045: 5.30 Donors of eggs obtained specifically for research, and not as a result of clinical treatment,
p.000045: may be reimbursed for legitimate expenses incurred, such as cost of transport and childcare services, and
p.000045: actual loss of earnings, as a result of the procedures required to obtain the eggs. Any other payment, whether
p.000045: monetary or in kind, should not amount to an inducement and should be approved by an IRB. If
p.000045: complications occur as a direct and proximate result of the donation, the donor should be provided with prompt and full
p.000045: medical care. This provision is the responsibility of the researchers and their institutions.
p.000045:
p.000045: 5.31 Trans-species fertilisation involving human gametes is not allowed for the purpose of reproduction unless
p.000045: done to assess or diagnose sub-fertility, in which case, the resultant hybrid must be terminated at the
p.000045: two-cell stage, and in any case must have written approval from the Director of Medical Services.
p.000045:
...
p.000057: pluripotent stem cells have been introduced should not be allowed to breed.
p.000057:
p.000057: 7.29 Human cytoplasmic hybrid embryos should not be allowed to develop beyond 14 days
p.000057: in vitro or to be implanted into the body of any human or animal.
p.000057:
p.000057: 7.30 If the research involves introducing human embryonic stem cells or any pluripotent cells, or products derived
p.000057: from these cells, into humans, or any novel applications of any stem cells that are outside the scope of established
p.000057: standards of medical care, it should be conducted in accordance with the requirements and standards of a clinical trial
p.000057: for cell-based products, as specified by the HSA, and approval from HSA must be obtained. IRBs must ensure that:
p.000057:
p.000057: (e) The proposal is reviewed and approved by a scientific review committee with the relevant expertise;
p.000057:
p.000057: (f) There is strong evidence of the safety and efficacy of the cells from pre-clinical studies;
p.000057:
p.000057: (c) The research participants have been provided with sufficient information, in particular information on
p.000057: the nature and risks of the research, and the source of the cells, so that their values and beliefs are respected; and
p.000057:
p.000057: (d) Appropriate and informed consent has been obtained, without any inducement, coercion or undue influence.
p.000057:
p.000057: These recommendations do not apply to innovative or experimental uses of stem cells in clinical practice, which fall
p.000057: outside the remit of the BAC’s terms of reference.35
p.000057:
p.000057: 34 MOH, Licensing Terms and Conditions for Assisted Reproduction Centres (2011) at paras. 9.1 and 10.3.
p.000057: 35 The International Society for Stem Cell Research has issued recommendations for the clinical translation of stem
p.000057: cells, including innovative medical use of stem cells: Guidelines for the Clinical Translation of Stem.
p.000057:
p.000058: 58
p.000058:
p.000058: HUMAN STEM CELL RESEARCH
p.000058:
p.000058: 7.31 No clinical or research personnel should be under a duty to conduct or assist in human embryonic stem cell or
p.000058: induced pluripotent stem cell research, or research involving human-animal combinations, to which they have a
p.000058: conscientious objection, nor should they be put at a disadvantage because of such objection.
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058:
p.000058: Cells (2008), online: .
p.000058:
p.000059: 59
p.000059:
p.000059:
p.000059:
...
p.000072:
p.000072: A25
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 3.31 Communication of clinically significant findings to research participants could be directly by the
p.000072: researcher, or through a healthcare provider or other party authorised to receive the information and in a
p.000072: better position to advise and discuss the implications of the findings.
p.000072:
p.000072: 3.32 Communication of clinically significant incidental findings to biological relatives should be
p.000072: encouraged. This, including the question of who will do it and taking into account the participant’s preference, should
p.000072: be discussed and agreed upon at the time of obtaining consent
p.000072:
p.000072: 3.33 Parents who have indicated a wish to know, should be informed of clinically significant research
p.000072: results affecting their children’s health, when they are discovered. Upon reaching the age of 21 and if the
p.000072: research is still on-going, the individuals concerned will then be in a position to make their own decisions
p.000072: regarding whether or not to be contacted in the event that clinically significant incidental findings are
p.000072: uncovered.
p.000072:
p.000072: Guidelines on Consent
p.000072:
p.000072: 3.34 Consent for participation in research must be voluntary. There should be no coercion or undue influence.
p.000072: Participants may be reimbursed for legitimate expenses, such as cost of transport and child care services, and actual
p.000072: loss of earnings. Any additional payment to be given, whether monetary or in kind, should not amount to an
p.000072: inducement.
p.000072:
p.000072: 3.35 Participants should be allowed to withdraw from the research at any time without any explanation, and without
p.000072: penalty or prejudice to any treatment they may be receiving.
p.000072:
p.000072: 3.36 Prospective research participants or authorised third parties should be provided with sufficient information
p.000072: in an understandable form and appropriate manner, to enable them to make an informed decision. Such information
p.000072: include:
p.000072:
p.000072: (a) The nature and purpose of the research;
p.000072:
p.000072: (b) Any entailed risks and benefits to them, and how any such risks are to be managed and minimised;
p.000072:
p.000072: (c) The safeguards for protecting their privacy and confidentiality of their personal information;
p.000072:
p.000072: (d) Any reimbursement or other payment for participation in the research;
p.000072:
p.000072: (e) The procedures and implications for withdrawal from the research; and
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A26
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (f) Any other information specific to the type of research, as given in the parts on human tissue research,
p.000072: genetic research, and stem cell research in these Guidelines.
p.000072:
p.000072: 3.37 Where there is a possibility that the research may yield clinically significant incidental findings,
...
p.000072: 5.25 Consent from the donors must be obtained before any gametes or embryos are to be used for research.
p.000072: Individuals from whom the gametes or embryos are derived, should be provided with sufficient information to make an
p.000072: informed decision and be given at least a week to decide.
p.000072: 5.26 For women undergoing fertility treatment, consent for the donation of oocytes or embryos for
p.000072: research should be separate from the consent for treatment. The treating physician should not also be the
p.000072: researcher seeking consent for the donation of oocytes and embryos for research. Donors should confirm in writing
p.000072: that they do not require the oocytes or embryos for future use.
p.000072: 5.27 As the process of donating eggs for research is time-consuming, invasive and associated with a
p.000072: certain degree of discomfort and risks, women wishing to donate eggs specifically for research i.e. who are
p.000072: not also undergoing any fertility treatment, must be interviewed by an independent panel. The panel must be satisfied
p.000072: that they are of sound mind, clearly understand the nature and consequences of the donation, and have freely given
p.000072: explicit consent, without any inducement, coercion or undue influence.
p.000072: 5.28 All egg donors should be informed if their eggs will be used to create embryos, including
p.000072: human-animal combination embryos, which will be destroyed in the process of research, and if any derived cells
p.000072: from the embryos so created will be kept for future research or possible clinical use. They should be
p.000072: assured that any embryos created for research will not be implanted or allowed to develop in vitro beyond 14 days.
p.000072:
p.000072: 5.29 Donors of eggs obtained specifically for research, and not as a result of clinical treatment,
p.000072: may be reimbursed for legitimate expenses incurred, such as cost of transport and childcare services, and
p.000072: actual loss of earnings, as a result of the procedures required to obtain the eggs. Any additional payment to
p.000072: be given, whether monetary or in kind, should not amount to an inducement. If complications occur as a direct and
p.000072: proximate result of the donation, the donor should be provided with prompt and full medical care. The cost of this
p.000072: provision is the responsibility of the researchers and their institutions.
p.000072:
p.000072:
p.000072:
p.000072: A38
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 5.30 Trans-species fertilisation involving human gametes is not allowed for the purpose of reproduction unless
p.000072: done to assess or diagnose sub-fertility, in which case, the resultant hybrid must be terminated at the
p.000072: two-cell stage, and in any case must have written approval from the Director of Medical Services.
p.000072: 5.31 No human embryos created for research, including human cytoplasmic hybrid embryos54 and other
p.000072: embryos created through any form of cloning technology, should be allowed to develop beyond 14 days in vitro.
...
p.000072: 7.29 Human cytoplasmic hybrid embryos should not be allowed to develop beyond 14 days
p.000072: in vitro.
p.000072:
p.000072: 7.30 No human cytoplasmic embryo should be implanted into the body of any human or animal.
p.000072: 7.31 If the research involves introducing human embryonic stem cells or any pluripotent cells, or products derived
p.000072: from these cells, into humans, or any novel applications of any stem cells that are outside the scope of established
p.000072: standards of medical care, it should be conducted in accordance with the requirements and standards of a clinical trial
p.000072: for cell-based product, as specified by the HSA, and approval from HSA must be obtained. IRBs must ensure that:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A51
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) The proposal is reviewed and approved by a scientific review committee with the relevant expertise;
p.000072:
p.000072: (b) There is strong evidence of the safety and efficacy of the cells from pre-clinical studies;
p.000072:
p.000072: (c) The research participants have been provided with sufficient information, in particular information on
p.000072: the nature and risks of the research, and the source of the cells, so that their values and beliefs are respected; and
p.000072:
p.000072: (d) Appropriate and informed consent has been obtained, without any inducement, coercion or undue influence.
p.000072:
p.000072: 7.32 No clinical or research personnel should be under a duty to conduct or assist in human embryonic stem cell or
p.000072: induced pluripotent stem cell research, or research involving human-animal combinations, to which they have a
p.000072: conscientious objection, nor should they be put at a disadvantage because of such objection.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A52
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Bibliography
p.000072:
p.000072: Animals and Birds Act (Cap. 7). Singapore, Revised 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Donation of Human Eggs for Research. Singapore, 2008.
p.000072:
p.000072: Bioethics Advisory Committee. Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and
p.000072: Therapeutic Cloning. Singapore, 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Genetic Testing and Genetic Research. Singapore, 2005.
p.000072:
p.000072: Bioethics Advisory Committee. Human-Animal Combinations in Stem Cell Research. Singapore, 2010.
p.000072:
p.000072: Bioethics Advisory Committee. Human Tissue Research. Singapore, 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Personal Information in Biomedical Research. Singapore, 2007.
p.000072:
p.000072: Bioethics Advisory Committee. Research Involving Human Subjects: Guidelines for IRBs. Singapore, 2004.
p.000072:
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p.000014: basic standards of respect for participating human subjects,5 and such cases continue to recur. In
p.000014: addition, there are many wider ethical issues consequent on the internationalisation of research, with accompanying
p.000014: questions of equity in the carrying of risks and the sharing of benefits. Furthermore, researchers and their
p.000014: institutions can be subject to conflicts of interest, for example, when doctors wish to conduct research on their own
p.000014: patients, when commercial value or scientific prestige may be attached to the outcomes of research, or
p.000014: when findings may not support the hopes of those who provide funding.
p.000014:
p.000014: 2.2 Ethics governance of research seeks to ensure the protection and assurance of the safety, health,
p.000014: dignity, welfare and privacy of research participants, and to safeguard against unethical practices. There have been a
p.000014: number of international documents and declarations that form the foundation of ethical biomedical research
p.000014: governance as practised in major research jurisdictions. They have also formed the basis for the ethical
p.000014: principles that have guided the BAC. The following foundational documents and declarations are key:
p.000014:
p.000014: (a) The Nuremberg Code (1949);
p.000014:
p.000014: (b) The World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.000014: Subjects (1964, revised 2013);
p.000014:
p.000014: (c) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
p.000014: Research (1979);
p.000014:
p.000014: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000014:
p.000014: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000014: Declaration on Bioethics and Human Rights (2005).
p.000014:
p.000014: General Ethical Principles that have Guided the BAC
p.000014:
p.000014: 2.3 A review of the five foundational documents above reveals that participants need to be protected and their
p.000014: autonomy in matters of research participation recognised. Although these documents do not agree on every
p.000014: particular matter, they appear to be in accord in their fundamentals. Based on these, the BAC has formulated
p.000014: the following five guiding principles reflecting their local application, first summarised in its Egg Donation Report.
p.000014:
p.000014: 5 The BAC used the term “subject” in its earlier reports, but more recently has used the term “participant”. The
p.000014: latter is preferred as it implicitly acknowledges that research participants choose to participate, and
p.000014: should not be merely the passive subjects of research.
p.000014:
p.000015: 15
p.000015:
p.000015: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000015:
p.000015: Respect for persons
p.000015:
p.000015: 2.4 Individuals are to be respected as human beings and treated accordingly. This includes respecting
...
p.000016: entail compromises between competing interests. What different parties in a disagreement see as fair may depend
p.000016: upon widely different assumptions.
p.000016:
p.000016: Proportionality
p.000016:
p.000016: 2.10 The regulation of research should be in proportion to the possible threats to autonomy, individual welfare,
p.000016: or the public good. Proportionality is fundamental to the administration of any system of
p.000016: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000016: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000016: necessary regulation.9 It appeals to moderation and good sense in the determination of prohibited
p.000016: actions and the avoidance of micro-management and over-determination. The risk in any acceptable programme of
p.000016: research, and the stringency of its regulation, should not be disproportionate to any anticipated benefits.
p.000016: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
p.000016: decisions, which is in any case often impracticable in multicultural contexts.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: 7 “For example, during the 19th and early 20th centuries the burdens of serving as research
p.000016: subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to
p.000016: private patients.” Belmont Report, Part B(3), given as an example of manifest injustice. It would also breach the
p.000016: principle of solidarity.
p.000016: 8 An example would be a research participant assigned to a placebo control group.
p.000016: 9 See for example the discussion of proportionality in Harris, B. Disciplinary and Regulatory Proceedings, 6th
p.000016: Ed. London: Wiley & Sons (2011). The essential legal burden on the court was stated in de Freitas v. The Permanent
p.000016: Secretary of Ministry of Agriculture, Fisheries, Lands and Housing [1998] by Lord Clyde, that in deciding if a
p.000016: limitation imposed by an act, rule or decision is arbitrary or excessive, i.e. disproportionate, the
p.000016: court should ask itself “whether: (i) the legislative objective is sufficiently important to justify
p.000016: limiting a fundamental right; (ii) the measures designed to meet the legislative objective are rationally connected to
p.000016: it; and (iii) the means used to impair the right or freedom are no more than is necessary to
p.000016: accomplish the objective." http://www.bailii.org/uk/cases/UKPC/1998/30.html at section 25.
p.000016:
p.000017: 17
p.000017:
p.000017: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000017:
p.000017: Sustainability
p.000017:
p.000017: 2.11 The research process should be sustainable, in the sense that it should not jeopardise or prejudice the
p.000017: welfare of later generations. For example, research leading to permanent change to the human genome might
p.000017: not be considered ethical, even if immediately beneficial, on the grounds that the unforeseeable,
...
p.000017: to treat the patient. In research, however, the participants may not be patients, and even if they are, there
p.000017: is often no direct benefit for the patient from participation in the research. Indeed, it is
p.000017: necessary to ensure patients participating in research are not victims of therapeutic misconception, or
p.000017: mis- estimation – the fallacy of overestimating the benefits they may gain from participating in
p.000017: the research. Research is a process designed to yield a contribution to generalisable knowledge, which is practically
p.000017: useful or theoretically important, and is therefore a public good. This is not the same as beneficence. Indeed, many
p.000017: researchers would argue that a spirit of intellectual curiosity often impels valid research that is
p.000017: difficult to evaluate in any practical way. The importance of respect for persons seems to us to better capture
p.000017: the essential aspects of beneficence and non-maleficence insofar as these concepts apply to research
p.000017: participants, and we have thus framed the principle of respect for persons as, in effect, incorporating them.
p.000017:
p.000017: Research Integrity
p.000017:
p.000017: 2.14 Research integrity is the term used to refer to the integrity or validity of the research process. Anything
p.000017: which undermines the objectivity of the research and the validity of
p.000017:
p.000017: 10 In the US, for example, the regulatory requirements of minimising risks to participants and ensuring that the
p.000017: risks are acceptable in light of the anticipated benefits have been grounded in beneficence as a basic ethical
p.000017: principle in the Belmont Report, which subsumes non-maleficence under beneficence.
p.000017:
p.000018: 18
p.000018:
p.000018: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000018:
p.000018: the results can be regarded as a threat to research integrity; for example, if there is plagiarism, selectivity in
p.000018: the publication of results, or if the independence of researchers is undermined by their obligations to their
p.000018: employers or to the funders of their research.
p.000018:
p.000018: 2.15 The BAC’s view is that research integrity is essential. It is not a simple concept, but to some extent, the
p.000018: presumptive integrity of research and of researchers is already implicit in adherence to the BAC’s general
p.000018: ethical principles outlined above, and its importance is made explicit wherever appropriate in these
p.000018: Guidelines. Further guidance is available in the Singapore Statement on Research Integrity, developed by the 2nd
p.000018: World Conference on Research Integrity, which was the first international effort to encourage the
p.000018: development of unified policies, guidelines and codes of conduct, with the long-term goal of fostering greater
p.000018: integrity in research globally.11
p.000018:
p.000018: 2.16 The BAC is also of the view that research institutions have a responsibility to ensure that the
p.000018: requirements of research integrity are observed, and IRBs have a responsibility to check that
p.000018: research integrity, as well as research merit, has been considered.
p.000018:
p.000018: 2.17 The principles described above are general in nature and fundamental to ethics governance of
...
p.000069: Guidelines for the Ethical Conduct of Medical Research Involving Children. 2000.
p.000069:
p.000069: United Kingdom. The Health Service (Control of Patient Information) Regulations. 2002. United Kingdom. The Medicines
p.000069: for Human Use (Clinical Trials) Regulations. 2004.
p.000069: United Kingdom. UK Biobank Ethics and Governance Framework. October 2007.
p.000069:
p.000069: United Nations Educational, Scientific and Cultural Organisation. Report of the IBC on Pre- implantation Genetic
p.000069: Diagnosis and Germ-line Intervention. 24 April 2003.
p.000069:
p.000069: United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human Rights.
p.000069: 2005.
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000070: BIBLIOGRAPHY
p.000070:
p.000070: United States of America. Office for Human Research Protections, Department of Health and Human Services. Protection of
p.000070: Human Subjects, Title 45 Code of Federal Regulations, Part
p.000070: 46. Revised 2009.
p.000070:
p.000070: United States of America. National Bioethics Advisory Commission. Research Involving Human Biological
p.000070: Materials: Ethical Issues and Policy Guidance. August 1999.
p.000070:
p.000070: United States of America. National Commission for the Protection of Human Subjects of Biomedical and
p.000070: Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human
p.000070: Subjects of Research. 1979.
p.000070:
p.000070: United States of America. National Institutes of Health. Guidelines for the Conduct of Research Involving
p.000070: Human Subjects at the National Institutes of Health. August 2004.
p.000070:
p.000070: United States of America. National Institutes of Health. NIH Guidelines for Research Involving Recombinant
p.000070: DNA Molecules. October 2011.
p.000070:
p.000070: United States of America. Nuremberg Code. In: Trials of War Criminals before the Nuremberg Military
p.000070: Tribunals under Control Council. Law No. 10, Vol. 2: 181-182. 1949.
p.000070:
p.000070: United States of America. Office for Civil Rights HIPAA Privacy. Research. 3 April 2003. World Health Organization. A
p.000070: Practical Guide for Health Researchers. 2004.
p.000070: World Health Organization. Genetic Databases Assessing the Benefits and the Impact on Human and Patient
p.000070: Rights. 2003.
p.000070:
p.000070: World Health Organization. Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells
p.000070: and Fluids in Research. 2003.
p.000070:
p.000070: World Health Organization. Handbook for Good Clinical Research Practice. 2005. World Health Organization. Review of
p.000070: Ethical Issues in Medical Genetics. 2003.
p.000070: World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research
p.000070: with Human Participants. 2011.
p.000070:
...
p.000072:
p.000072: 2.2 Ethical governance of research seeks to ensure the protection and assurance of the safety,
p.000072: health, dignity, welfare and privacy of research participants, and to safeguard against unethical practices. Moreover,
p.000072: it acts as a check that there is scientific value in the research.
p.000072:
p.000072: 2.3 It is also concerned with the integrity of the research process itself. Scientific research is
p.000072: self-correcting in the long run, since scientific reputations and scientific advances depend on the reliability of
p.000072: findings and the support of theories in the face of sceptical testing. However, the integrity of the research
p.000072: process can be affected if there is plagiarism, selectivity in the publication of results, or if the independence
p.000072: of scientists is undermined by their obligations to their employers or to the funders of their research.
p.000072:
p.000072: 2.4 As a consequence of such considerations there have been a number of international documents and declarations
p.000072: that form the foundations of ethical biomedical research governance as practised in major jurisdictions. They have
p.000072: also formed the basis for the ethical principles that have guided the BAC. Of these foundation documents and
p.000072: declarations the following are key:
p.000072:
p.000072: (a) The Nuremberg Code (1947), reported in 1949;
p.000072:
p.000072: (b) The Declaration of Helsinki: Ethical Principles for Research Involving Human Subjects (1964, Revised 2008);
p.000072:
p.000072: (c) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
p.000072: Research (1979);
p.000072:
p.000072:
p.000072: 40 The BAC used the term “subject” in its earlier reports, but more recently has used the term
p.000072: “participant”. The latter is increasingly used in many jurisdictions as it implicitly acknowledge the fact that
p.000072: research participants choose to participate, and should not be merely the passive subjects of research.
p.000072: These terms are however treated as interchangeable in these Guidelines.
p.000072:
p.000072:
p.000072:
p.000072: A8
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000072: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000072: Declaration on Bioethics and Human Rights (2005).
p.000072:
p.000072: General Ethical Principles that have Guided the BAC
p.000072:
p.000072: 2.5 A review of the five foundation documents above reveals that participants need to be protected and their
p.000072: autonomy in matters of research participation recognised. Although these documents do not agree in
p.000072: every particular, they appear to be in accord in their fundamentals. Based on these, the BAC formulated
p.000072: five guiding principles reflecting their local application, first summarised in its Egg Donation Report. In
p.000072: particular, as enjoined by the UNESCO Declaration, the BAC expects researchers to be aware of and respect the
...
p.000072: otherwise suitable patients from participation in research by virtue of economic status.42 The concept of justice also
p.000072: implies that researchers and their institutions incur some responsibility for the welfare of participants and their
p.000072: possible compensation and treatment in the event of adverse outcomes arising directly from their participation.
p.000072: It mandates careful consideration of the arrangements in place for ancillary care or follow-up in the case of
p.000072: research participants located in regions that may be resource-poor relative to the initiating country. Moreover, in
p.000072: the event research yields an immediate benefit that could apply to one of the participants in the research,
p.000072: justice would dictate that the benefit be offered.43
p.000072: 2.12 Although it is easy to defend the generic idea of justice as fundamental to the proper functioning of any
p.000072: society, both justifying and implementing a specific conception of justice is difficult, since research may
p.000072: entail compromises between competing
p.000072:
p.000072:
p.000072: 42 “For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell
p.000072: largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private
p.000072: patients.” Belmont Report, Part B 3, given as an example of a manifest injustice. It would also breach the principle of
p.000072: solidarity.
p.000072: 43 An obvious example would be a participant in a placebo control group.
p.000072:
p.000072:
p.000072:
p.000072: A10
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: interests. What different parties in a disagreement see as fair may depend upon widely different assumptions.
p.000072: Proportionality
p.000072:
p.000072: 2.13 The regulation of research should be in proportion to the possible threats to autonomy, individual welfare,
p.000072: or public good. Proportionality is fundamental to the administration of any system of
p.000072: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000072: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000072: necessary regulation.44 It appeals to moderation and good sense in the determination of prohibited actions
p.000072: and the avoidance of micro-management and over-determination. The risk in any acceptable programme of research, and
p.000072: the strictness of its regulation, should not be disproportional to any anticipated benefits.
p.000072: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
p.000072: decisions, which is in any case often impracticable in multicultural contexts.
p.000072: Sustainability
p.000072:
...
p.000072: non-maleficence insofar as these concepts apply to research participants, and we have thus framed the principle of
p.000072: respect for persons as, in effect, incorporating them.
p.000072: Research Integrity
p.000072:
p.000072: 2.17 It may be noted that the BAC principles do not include an explicit mention of research integrity. This is
p.000072: because the integrity of process in all aspects has to be a given for ethical governance of research, including
p.000072: judicial process and IRB decisions on research proposals. Research integrity is the term used to refer
p.000072: to the integrity or validity of the research process. Anything which undermines the objectivity of the
p.000072: research and the validity of the results can be regarded as a threat to research integrity. As can be seen from, for
p.000072: example, the Singapore Statement on Research Integrity put up by the 2nd World Conference on Research
p.000072: Integrity,46 research integrity is not a simple concept. Essentially it is thought of in terms of the following
p.000072: components:
p.000072: (a) The trustworthiness of the research product, as manifest in attention to the details of the
p.000072: scientific process in ways that maximise objectivity and minimise bias or selectivity by researchers. Research
p.000072: should be reported in ways that allow others to replicate it and test the research conclusions;
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 45 In the US, for example, the regulatory requirements of minimising risks to participants and ensuring that
p.000072: the risks are acceptable in light of the anticipated benefits have been grounded in beneficence as a basic ethical
p.000072: principle in the Belmont Report, which subsumes non-maleficence under beneficence.
p.000072: 46 More information on the World Conference on Research Integrity can be found at:
p.000072: http://www.singaporestatement.org/
p.000072:
p.000072:
p.000072:
p.000072: A12
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (b) The ethics of the research environment, as manifest for instance in institutional practice, the regulation of
p.000072: research, the sensitivity of the research to the social context in which it occurs, and the measures taken to ensure
p.000072: that professional standards are respected; and
p.000072:
p.000072: (c) The avoidance by researchers of any plagiarism or fabrication of data.
p.000072:
p.000072: 2.18 The BAC’s view is that research integrity is essential. To some extent the presumptive integrity of research,
p.000072: and of researchers, is already implicit in adherence to the general ethical principles outlined above, but its
p.000072: importance is made explicit wherever appropriate in these Guidelines.
p.000072: 2.19 The BAC is also of the view that research institutions have a responsibility to ensure that the
p.000072: requirements of research integrity are observed, and IRBs have a responsibility to check that
p.000072: research integrity, as well as research merit, has been considered.
p.000072: 2.20 The principles given above are general in nature and fundamental to ethics governance
p.000072: of biomedical research involving human participants or the use of the biospecimens that they have
p.000072: contributed, and of information about persons obtained or derived from the research process. In practice these
...
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A52
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Bibliography
p.000072:
p.000072: Animals and Birds Act (Cap. 7). Singapore, Revised 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Donation of Human Eggs for Research. Singapore, 2008.
p.000072:
p.000072: Bioethics Advisory Committee. Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and
p.000072: Therapeutic Cloning. Singapore, 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Genetic Testing and Genetic Research. Singapore, 2005.
p.000072:
p.000072: Bioethics Advisory Committee. Human-Animal Combinations in Stem Cell Research. Singapore, 2010.
p.000072:
p.000072: Bioethics Advisory Committee. Human Tissue Research. Singapore, 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Personal Information in Biomedical Research. Singapore, 2007.
p.000072:
p.000072: Bioethics Advisory Committee. Research Involving Human Subjects: Guidelines for IRBs. Singapore, 2004.
p.000072:
p.000072: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social
p.000072: Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research
p.000072: Involving Humans, 2010.
p.000072:
p.000072: Council for International Organizations of Medical Sciences/World Health Organization.
p.000072: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS, 2002.
p.000072:
p.000072: Department of Health and Human Services. The Belmont Report: Ethical Principles and Guidelines for the Protection of
p.000072: Human Subjects of Research. United States of America, 1979.
p.000072:
p.000072: Department of Health and Human Services. Protection of Human Subjects, Title 45 Code of Federal Regulations, Part 46,
p.000072: 102(d). United States of America, 1980.
p.000072:
p.000072: Greene M and 21 others. Moral Issues of Human-Non-Human Primate Neural Grafting. Science. 309 (2005):
p.000072: 385-386.
p.000072:
p.000072: Harris B. Disciplinary and Regulatory Proceedings. 6th Ed. London: Wiley & Sons, 2011.
p.000072:
p.000072: Health Products Act (Cap. 122D). Singapore, 2008.
p.000072:
p.000072: Human Cloning and other Prohibited Practices Act (Cap. 131B). Singapore, 2005.
p.000072:
p.000072: Human Fertilisation and Embryology Act 2008. United Kingdom: HMSO.
p.000072:
p.000072:
p.000072: A53
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Human Tissue Act 2004. United Kingdom: HMSO.
p.000072:
p.000072: Infectious Diseases Act (Cap. 137). Singapore, Amended 2010.
p.000072:
p.000072: Levine RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al. (Eds.) The Oxford
p.000072: textbook of clinical research ethics. Oxford: OUP (2008) page 211.
p.000072:
p.000072: Medical (Therapy, Education and Research) Act (Cap. 175). Singapore, amended 2010.
p.000072:
p.000072: Medical Research Council. Human tissue and biological samples for use in research: Operational and Ethical Guidelines.
p.000072: United Kingdom, 2005.
p.000072:
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A52
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Bibliography
p.000072:
p.000072: Animals and Birds Act (Cap. 7). Singapore, Revised 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Donation of Human Eggs for Research. Singapore, 2008.
p.000072:
p.000072: Bioethics Advisory Committee. Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and
p.000072: Therapeutic Cloning. Singapore, 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Genetic Testing and Genetic Research. Singapore, 2005.
p.000072:
p.000072: Bioethics Advisory Committee. Human-Animal Combinations in Stem Cell Research. Singapore, 2010.
p.000072:
p.000072: Bioethics Advisory Committee. Human Tissue Research. Singapore, 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Personal Information in Biomedical Research. Singapore, 2007.
p.000072:
p.000072: Bioethics Advisory Committee. Research Involving Human Subjects: Guidelines for IRBs. Singapore, 2004.
p.000072:
p.000072: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social
p.000072: Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research
p.000072: Involving Humans, 2010.
p.000072:
p.000072: Council for International Organizations of Medical Sciences/World Health Organization.
p.000072: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS, 2002.
p.000072:
p.000072: Department of Health and Human Services. The Belmont Report: Ethical Principles and Guidelines for the Protection of
p.000072: Human Subjects of Research. United States of America, 1979.
p.000072:
p.000072: Department of Health and Human Services. Protection of Human Subjects, Title 45 Code of Federal Regulations, Part 46,
p.000072: 102(d). United States of America, 1980.
p.000072:
p.000072: Greene M and 21 others. Moral Issues of Human-Non-Human Primate Neural Grafting. Science. 309 (2005):
p.000072: 385-386.
p.000072:
p.000072: Harris B. Disciplinary and Regulatory Proceedings. 6th Ed. London: Wiley & Sons, 2011.
p.000072:
p.000072: Health Products Act (Cap. 122D). Singapore, 2008.
p.000072:
p.000072: Human Cloning and other Prohibited Practices Act (Cap. 131B). Singapore, 2005.
p.000072:
p.000072: Human Fertilisation and Embryology Act 2008. United Kingdom: HMSO.
p.000072:
p.000072:
p.000072: A53
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Human Tissue Act 2004. United Kingdom: HMSO.
p.000072:
p.000072: Infectious Diseases Act (Cap. 137). Singapore, Amended 2010.
p.000072:
p.000072: Levine RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al. (Eds.) The Oxford
p.000072: textbook of clinical research ethics. Oxford: OUP (2008) page 211.
p.000072:
p.000072: Medical (Therapy, Education and Research) Act (Cap. 175). Singapore, amended 2010.
p.000072:
p.000072: Medical Research Council. Human tissue and biological samples for use in research: Operational and Ethical Guidelines.
p.000072: United Kingdom, 2005.
...
General/Other / common rule
Searching for indicator 45XcfrX46:
(return to top)
p.000072: 1.8 Biomedical research has been defined as research having as its purpose the enhancement
p.000072: or improvement of medical practice.37 This extends the scope of biomedical research beyond research that is
p.000072: clinical, and it could include research that does not use human subjects at all. Much fundamental research in
p.000072: physiology and other disciplines has the eventual goals of medicine as its ultimate aim. In a similar way, the goal
p.000072: of much bioengineering is ultimately medical, though this is not true of the foundation disciplines in engineering. For
p.000072: such reasons it is difficult to provide a single definition that covers all obvious examples of research that
p.000072: have a clearly medical goal, while not becoming over-inclusive with respect to basic research that might ultimately
p.000072: be important for medicine but is not done with the aim of furthering its goals.
p.000072:
p.000072: 1.9 The BAC therefore adopts the following definition of human biomedical research:
p.000072:
p.000072: Human Biomedical Research refers to any research done for the ultimate purpose of studying, diagnosing, treating or
p.000072: preventing, any disease, injury or disorder of the human mind or body, and which entails the involvement of
p.000072: humans, human tissues or information derived from humans or human tissues.
p.000072:
p.000072: 1.10 The BAC takes the view that human biomedical research normally needs to be regulated because one
p.000072: or more of the following conditions will inevitably apply to any proposed human biomedical research:
p.000072:
p.000072:
p.000072: 36 US Department of Health and Human Services, 45 CFR 46.102(d).
p.000072: 37 Levine, RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al. (Eds.) The Oxford
p.000072: textbook of clinical research ethics. Oxford: OUP (2008), page 211.
p.000072:
p.000072:
p.000072:
p.000072: A3
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) The research involves intervention with respect to, interaction with, or observation of one
p.000072: or more human participants; or
p.000072: (b) The research will use or manipulate human biological materials (e.g. human cells, tissues, organs
p.000072: and body fluids), including those which were previously acquired and stored; or
p.000072: (c) The research entails the systematic review, analysis, use or publication of previously compiled
p.000072: identifiable (identified or reversibly de-identified) medical or personal information or biodata; or
p.000072: (d) The research topic is sufficiently sensitive to likely raise questions of public acceptability or
p.000072: public policy (e.g. research on human embryos or human- animal combinations); or
p.000072: (e) The research could be considered sensitive by virtue of the nature of the personal information it
p.000072: proposes to gather.
p.000072: 1.11 The BAC is concerned with human biomedical research, not with the wider issues of research with human
p.000072: participants generally. It does not seek to determine the extent to which ethics governance for the protection of human
...
General/Other / cultural difference
Searching for indicator culturally:
(return to top)
p.000024: compliance with the law as it stands.
p.000024:
p.000024: Voluntary and Informed Consent
p.000024:
p.000024: 3.3 Consent must be voluntary and informed. Informed consent is not merely providing information, but
p.000024: requires that the person consenting does so with adequate understanding. The language, occasion and
p.000024: manner of explanation, the level of detail offered, and the process by which the consent is taken, should all be aimed
p.000024: at helping the potential research participant understand what consent is being asked for.
p.000024:
p.000024: 3.4 Obtaining the consent of prospective participants entails providing sufficient relevant information and
p.000024: explaining it in ways that allow them to make an informed decision with an appropriate level of
p.000024: understanding. The requirements vary somewhat depending on the nature of the research, such as whether
p.000024: the research involves biological materials or genetic information, and the likelihood of
p.000024: discovering clinically significant findings either directly or incidentally to the research. The consent
p.000024: process will also depend on the vulnerability of the participant. Anything in the nature of the research which
p.000024: the participant may find morally or culturally sensitive should entail some corresponding sensitivity in
p.000024: obtaining consent.
p.000024:
p.000024: 3.5 Therefore, valid consent should require that:
p.000024:
p.000024: (a) Research participants understand what is proposed, the nature of any entailed risks and benefits
p.000024: to them, and how any such risks are to be managed and minimised. This is particularly important in
p.000024: clinical research where new therapies are involved;
p.000024:
p.000024: (b) There is no coercion, deception or inducement. Any reimbursement for expenses incurred in relation to the
p.000024: research, whether monetary or in kind, should not amount to an inducement; and
p.000024:
p.000024: (c) Participants understand that they may withdraw from the research at any time without needing to provide any
p.000024: explanation or justification, and without penalty or prejudice to any treatment they may be receiving.
p.000024:
p.000025: 25
p.000025:
p.000025: CONSENT
p.000025:
p.000025: 3.6 Keeping research participants in ignorance of a research hypothesis, or of which intervention
p.000025: group they have been assigned to, does not amount to deception in the sense mentioned in paragraph 3.5(b). It is
p.000025: well recognised that the requirements of research may be inconsistent with full disclosure of the
p.000025: research purpose or hypothesis to intended participants, and there are procedures for managing this.
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000014: unethical research does not take place. Historically, there were many examples of research that failed to meet
p.000014: basic standards of respect for participating human subjects,5 and such cases continue to recur. In
p.000014: addition, there are many wider ethical issues consequent on the internationalisation of research, with accompanying
p.000014: questions of equity in the carrying of risks and the sharing of benefits. Furthermore, researchers and their
p.000014: institutions can be subject to conflicts of interest, for example, when doctors wish to conduct research on their own
p.000014: patients, when commercial value or scientific prestige may be attached to the outcomes of research, or
p.000014: when findings may not support the hopes of those who provide funding.
p.000014:
p.000014: 2.2 Ethics governance of research seeks to ensure the protection and assurance of the safety, health,
p.000014: dignity, welfare and privacy of research participants, and to safeguard against unethical practices. There have been a
p.000014: number of international documents and declarations that form the foundation of ethical biomedical research
p.000014: governance as practised in major research jurisdictions. They have also formed the basis for the ethical
p.000014: principles that have guided the BAC. The following foundational documents and declarations are key:
p.000014:
p.000014: (a) The Nuremberg Code (1949);
p.000014:
p.000014: (b) The World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.000014: Subjects (1964, revised 2013);
p.000014:
p.000014: (c) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
p.000014: Research (1979);
p.000014:
p.000014: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000014:
p.000014: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000014: Declaration on Bioethics and Human Rights (2005).
p.000014:
p.000014: General Ethical Principles that have Guided the BAC
p.000014:
p.000014: 2.3 A review of the five foundational documents above reveals that participants need to be protected and their
p.000014: autonomy in matters of research participation recognised. Although these documents do not agree on every
p.000014: particular matter, they appear to be in accord in their fundamentals. Based on these, the BAC has formulated
p.000014: the following five guiding principles reflecting their local application, first summarised in its Egg Donation Report.
p.000014:
p.000014: 5 The BAC used the term “subject” in its earlier reports, but more recently has used the term “participant”. The
p.000014: latter is preferred as it implicitly acknowledges that research participants choose to participate, and
p.000014: should not be merely the passive subjects of research.
p.000014:
p.000015: 15
p.000015:
p.000015: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
...
p.000027:
p.000027: 3.17 Vulnerable research participants not only include those who are lacking mental capacity, but also
p.000027: those whose autonomy might be prejudiced by being under the influence or control of, or by being obligated to,
p.000027: third parties. Potentially vulnerable participants might include, but are not limited to:
p.000027:
p.000027: (a) Prisoners;
p.000027:
p.000027: (b) Uniformed personnel, especially junior ranks;
p.000027:
p.000027: (c) Patients, especially if the intending researcher is their attending physician; and
p.000027:
p.000027: (d) Employees, junior collaborators, or students.
p.000027:
p.000027:
p.000027:
p.000027: 14 For example, the courts have permitted a simple paternity blood test for a child where this was not clearly
p.000027: against the interests of the child, notwithstanding there was no direct benefit to the child: S v S [1972] AC 24 (House
p.000027: of Lords). Nothing in the Mental Capacity Act (Chap 177A) expressly overrules the common law, except by necessary
p.000027: implication.
p.000027: 15 World Medical Association, Declaration of Helsinki (rev. 2013), article 28; Council for
p.000027: International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research
p.000027: Involving Human Subjects (2002), Articles 9 and 15.
p.000027:
p.000028: 28
p.000028:
p.000028: CONSENT
p.000028:
p.000028: 3.18 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000028: prospective participants reassured that they have nothing to fear in declining research participation or
p.000028: in contributing biological materials or personal information for research. Thus, consent from uniformed
p.000028: personnel, for example, should not be taken by a senior officer, and preferably not by uniformed personnel.
p.000028:
p.000028: 3.19 When it is not possible for consent to be taken by an independent third party, the IRB may give directions for
p.000028: the consent to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000028: sufficient safeguards to protect the welfare and interests of the participant.
p.000028:
p.000028: 3.20 A further issue of vulnerability arises in societies where social proxy arrangements are widespread, for
...
p.000070: Subjects of Research. 1979.
p.000070:
p.000070: United States of America. National Institutes of Health. Guidelines for the Conduct of Research Involving
p.000070: Human Subjects at the National Institutes of Health. August 2004.
p.000070:
p.000070: United States of America. National Institutes of Health. NIH Guidelines for Research Involving Recombinant
p.000070: DNA Molecules. October 2011.
p.000070:
p.000070: United States of America. Nuremberg Code. In: Trials of War Criminals before the Nuremberg Military
p.000070: Tribunals under Control Council. Law No. 10, Vol. 2: 181-182. 1949.
p.000070:
p.000070: United States of America. Office for Civil Rights HIPAA Privacy. Research. 3 April 2003. World Health Organization. A
p.000070: Practical Guide for Health Researchers. 2004.
p.000070: World Health Organization. Genetic Databases Assessing the Benefits and the Impact on Human and Patient
p.000070: Rights. 2003.
p.000070:
p.000070: World Health Organization. Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells
p.000070: and Fluids in Research. 2003.
p.000070:
p.000070: World Health Organization. Handbook for Good Clinical Research Practice. 2005. World Health Organization. Review of
p.000070: Ethical Issues in Medical Genetics. 2003.
p.000070: World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research
p.000070: with Human Participants. 2011.
p.000070:
p.000070: World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving
p.000070: Human Subjects. Revised 2013.
p.000070:
p.000070: World Medical Association. WMA Declaration on Ethical Considerations Regarding Health Databases. October 2002.
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
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p.000071:
p.000071:
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p.000071:
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p.000071:
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p.000071:
p.000071:
p.000071:
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p.000071:
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p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: CONSULTATION PAPER:
p.000072: ETHICS GUIDELINES FOR HUMAN BIOMEDICAL RESEARCH
p.000072:
p.000072:
p.000072:
p.000072: ANNEX A
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: ETHICS GUIDELINES FOR HUMAN BIOMEDICAL RESEARCH
p.000072:
p.000072:
p.000072: FOR COMMENTS
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: BIOETHICS ADVISORY COMMITTEE SINGAPORE
...
p.000072: their own patients, when commercial value or scientific prestige may attach to the outcome of research,
p.000072: or when findings may not support the hopes of those who provide funding.
p.000072:
p.000072: 2.2 Ethical governance of research seeks to ensure the protection and assurance of the safety,
p.000072: health, dignity, welfare and privacy of research participants, and to safeguard against unethical practices. Moreover,
p.000072: it acts as a check that there is scientific value in the research.
p.000072:
p.000072: 2.3 It is also concerned with the integrity of the research process itself. Scientific research is
p.000072: self-correcting in the long run, since scientific reputations and scientific advances depend on the reliability of
p.000072: findings and the support of theories in the face of sceptical testing. However, the integrity of the research
p.000072: process can be affected if there is plagiarism, selectivity in the publication of results, or if the independence
p.000072: of scientists is undermined by their obligations to their employers or to the funders of their research.
p.000072:
p.000072: 2.4 As a consequence of such considerations there have been a number of international documents and declarations
p.000072: that form the foundations of ethical biomedical research governance as practised in major jurisdictions. They have
p.000072: also formed the basis for the ethical principles that have guided the BAC. Of these foundation documents and
p.000072: declarations the following are key:
p.000072:
p.000072: (a) The Nuremberg Code (1947), reported in 1949;
p.000072:
p.000072: (b) The Declaration of Helsinki: Ethical Principles for Research Involving Human Subjects (1964, Revised 2008);
p.000072:
p.000072: (c) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
p.000072: Research (1979);
p.000072:
p.000072:
p.000072: 40 The BAC used the term “subject” in its earlier reports, but more recently has used the term
p.000072: “participant”. The latter is increasingly used in many jurisdictions as it implicitly acknowledge the fact that
p.000072: research participants choose to participate, and should not be merely the passive subjects of research.
p.000072: These terms are however treated as interchangeable in these Guidelines.
p.000072:
p.000072:
p.000072:
p.000072: A8
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000072: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000072: Declaration on Bioethics and Human Rights (2005).
p.000072:
p.000072: General Ethical Principles that have Guided the BAC
p.000072:
p.000072: 2.5 A review of the five foundation documents above reveals that participants need to be protected and their
p.000072: autonomy in matters of research participation recognised. Although these documents do not agree in
p.000072: every particular, they appear to be in accord in their fundamentals. Based on these, the BAC formulated
...
p.000072:
p.000072: National Medical Ethics Committee. Recommendations on Clinical Trials: Update Focusing on Phase I Trials,
p.000072: Singapore, 2007.
p.000072:
p.000072: National Registry of Diseases Act (Cap. 201). Singapore, 2007.
p.000072:
p.000072: Nuremberg Code. In: Trials of War Criminals before the Nuremberg Military Tribunals under Control Council.
p.000072: U.S. Government Printing Office, Washington D.C. Law No. 10, Vol. 2: 181-182 (1949).
p.000072:
p.000072: Ourednik V and 10 others. Segregation of Human Neural Stem Cells in the Developing Primate
p.000072: Forebrain. Science. 293 (2001): 1820-1824.
p.000072:
p.000072: Personal Data Protection Bill. Singapore, 2012.
p.000072:
p.000072: Private Hospitals and Medical Clinics Act (Cap. 248). Singapore, 1999. Singapore Medical Council. Ethical Code and
p.000072: Ethical Guidelines (nd).
p.000072: United Nations Educational, Scientific and Cultural Organization (UNESCO)
p.000072: Universal Declaration on Bioethics and Human Rights, 2005.
p.000072:
p.000072: Wilfond BS and Diekema DS. Engaging children in genomics research: decoding the meaning of assent in research, Genetics
p.000072: in Medicine.14 (2012): 437-443.
p.000072:
p.000072: World Medical Association. Declaration of Helsinki:Ethical Principles for Medical Research Involving Human
p.000072: Subjects (revised 2008).
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A55
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: List of Abbreviations
p.000072:
p.000072:
p.000072: BAC Bioethics Advisory Committee
p.000072: HFEA Human Fertilisation and Embryology Authority
p.000072: HSA Health Sciences Authority
p.000072: IRB Institutional Review Board
p.000072: LPA Lasting power of attorney
p.000072: MOH Ministry of Health
p.000072: NMEC National Medical Ethics Committee
p.000072: SGGCP Singapore Guideline for Good Clinical Practice
p.000072: UNESCO United Nations Educational, Scientific and Cultural Organization
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A56
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
...
General/Other / participants in a control group
Searching for indicator control group:
(return to top)
p.000016: or the public good. Proportionality is fundamental to the administration of any system of
p.000016: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000016: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000016: necessary regulation.9 It appeals to moderation and good sense in the determination of prohibited
p.000016: actions and the avoidance of micro-management and over-determination. The risk in any acceptable programme of
p.000016: research, and the stringency of its regulation, should not be disproportionate to any anticipated benefits.
p.000016: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
p.000016: decisions, which is in any case often impracticable in multicultural contexts.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: 7 “For example, during the 19th and early 20th centuries the burdens of serving as research
p.000016: subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to
p.000016: private patients.” Belmont Report, Part B(3), given as an example of manifest injustice. It would also breach the
p.000016: principle of solidarity.
p.000016: 8 An example would be a research participant assigned to a placebo control group.
p.000016: 9 See for example the discussion of proportionality in Harris, B. Disciplinary and Regulatory Proceedings, 6th
p.000016: Ed. London: Wiley & Sons (2011). The essential legal burden on the court was stated in de Freitas v. The Permanent
p.000016: Secretary of Ministry of Agriculture, Fisheries, Lands and Housing [1998] by Lord Clyde, that in deciding if a
p.000016: limitation imposed by an act, rule or decision is arbitrary or excessive, i.e. disproportionate, the
p.000016: court should ask itself “whether: (i) the legislative objective is sufficiently important to justify
p.000016: limiting a fundamental right; (ii) the measures designed to meet the legislative objective are rationally connected to
p.000016: it; and (iii) the means used to impair the right or freedom are no more than is necessary to
p.000016: accomplish the objective." http://www.bailii.org/uk/cases/UKPC/1998/30.html at section 25.
p.000016:
p.000017: 17
p.000017:
p.000017: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000017:
p.000017: Sustainability
p.000017:
p.000017: 2.11 The research process should be sustainable, in the sense that it should not jeopardise or prejudice the
p.000017: welfare of later generations. For example, research leading to permanent change to the human genome might
p.000017: not be considered ethical, even if immediately beneficial, on the grounds that the unforeseeable,
p.000017: potentially harmful long term implications outweigh the immediate benefits of the research.
p.000017:
p.000017: 2.12 The wider idea of sustainability has become an important aspect of contemporary thinking with
...
p.000072: possible compensation and treatment in the event of adverse outcomes arising directly from their participation.
p.000072: It mandates careful consideration of the arrangements in place for ancillary care or follow-up in the case of
p.000072: research participants located in regions that may be resource-poor relative to the initiating country. Moreover, in
p.000072: the event research yields an immediate benefit that could apply to one of the participants in the research,
p.000072: justice would dictate that the benefit be offered.43
p.000072: 2.12 Although it is easy to defend the generic idea of justice as fundamental to the proper functioning of any
p.000072: society, both justifying and implementing a specific conception of justice is difficult, since research may
p.000072: entail compromises between competing
p.000072:
p.000072:
p.000072: 42 “For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell
p.000072: largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private
p.000072: patients.” Belmont Report, Part B 3, given as an example of a manifest injustice. It would also breach the principle of
p.000072: solidarity.
p.000072: 43 An obvious example would be a participant in a placebo control group.
p.000072:
p.000072:
p.000072:
p.000072: A10
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: interests. What different parties in a disagreement see as fair may depend upon widely different assumptions.
p.000072: Proportionality
p.000072:
p.000072: 2.13 The regulation of research should be in proportion to the possible threats to autonomy, individual welfare,
p.000072: or public good. Proportionality is fundamental to the administration of any system of
p.000072: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000072: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000072: necessary regulation.44 It appeals to moderation and good sense in the determination of prohibited actions
p.000072: and the avoidance of micro-management and over-determination. The risk in any acceptable programme of research, and
p.000072: the strictness of its regulation, should not be disproportional to any anticipated benefits.
p.000072: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
p.000072: decisions, which is in any case often impracticable in multicultural contexts.
p.000072: Sustainability
p.000072:
p.000072: 2.14 The research process should be sustainable, in the sense that it should not jeopardise or prejudice the
p.000072: welfare of later generations. For example, research leading to permanent change to the human genome might
...
Searching for indicator placebo:
(return to top)
p.000016: or the public good. Proportionality is fundamental to the administration of any system of
p.000016: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000016: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000016: necessary regulation.9 It appeals to moderation and good sense in the determination of prohibited
p.000016: actions and the avoidance of micro-management and over-determination. The risk in any acceptable programme of
p.000016: research, and the stringency of its regulation, should not be disproportionate to any anticipated benefits.
p.000016: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
p.000016: decisions, which is in any case often impracticable in multicultural contexts.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: 7 “For example, during the 19th and early 20th centuries the burdens of serving as research
p.000016: subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to
p.000016: private patients.” Belmont Report, Part B(3), given as an example of manifest injustice. It would also breach the
p.000016: principle of solidarity.
p.000016: 8 An example would be a research participant assigned to a placebo control group.
p.000016: 9 See for example the discussion of proportionality in Harris, B. Disciplinary and Regulatory Proceedings, 6th
p.000016: Ed. London: Wiley & Sons (2011). The essential legal burden on the court was stated in de Freitas v. The Permanent
p.000016: Secretary of Ministry of Agriculture, Fisheries, Lands and Housing [1998] by Lord Clyde, that in deciding if a
p.000016: limitation imposed by an act, rule or decision is arbitrary or excessive, i.e. disproportionate, the
p.000016: court should ask itself “whether: (i) the legislative objective is sufficiently important to justify
p.000016: limiting a fundamental right; (ii) the measures designed to meet the legislative objective are rationally connected to
p.000016: it; and (iii) the means used to impair the right or freedom are no more than is necessary to
p.000016: accomplish the objective." http://www.bailii.org/uk/cases/UKPC/1998/30.html at section 25.
p.000016:
p.000017: 17
p.000017:
p.000017: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000017:
p.000017: Sustainability
p.000017:
p.000017: 2.11 The research process should be sustainable, in the sense that it should not jeopardise or prejudice the
p.000017: welfare of later generations. For example, research leading to permanent change to the human genome might
p.000017: not be considered ethical, even if immediately beneficial, on the grounds that the unforeseeable,
p.000017: potentially harmful long term implications outweigh the immediate benefits of the research.
p.000017:
p.000017: 2.12 The wider idea of sustainability has become an important aspect of contemporary thinking with
...
p.000072: implies that researchers and their institutions incur some responsibility for the welfare of participants and their
p.000072: possible compensation and treatment in the event of adverse outcomes arising directly from their participation.
p.000072: It mandates careful consideration of the arrangements in place for ancillary care or follow-up in the case of
p.000072: research participants located in regions that may be resource-poor relative to the initiating country. Moreover, in
p.000072: the event research yields an immediate benefit that could apply to one of the participants in the research,
p.000072: justice would dictate that the benefit be offered.43
p.000072: 2.12 Although it is easy to defend the generic idea of justice as fundamental to the proper functioning of any
p.000072: society, both justifying and implementing a specific conception of justice is difficult, since research may
p.000072: entail compromises between competing
p.000072:
p.000072:
p.000072: 42 “For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell
p.000072: largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private
p.000072: patients.” Belmont Report, Part B 3, given as an example of a manifest injustice. It would also breach the principle of
p.000072: solidarity.
p.000072: 43 An obvious example would be a participant in a placebo control group.
p.000072:
p.000072:
p.000072:
p.000072: A10
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: interests. What different parties in a disagreement see as fair may depend upon widely different assumptions.
p.000072: Proportionality
p.000072:
p.000072: 2.13 The regulation of research should be in proportion to the possible threats to autonomy, individual welfare,
p.000072: or public good. Proportionality is fundamental to the administration of any system of
p.000072: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000072: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000072: necessary regulation.44 It appeals to moderation and good sense in the determination of prohibited actions
p.000072: and the avoidance of micro-management and over-determination. The risk in any acceptable programme of research, and
p.000072: the strictness of its regulation, should not be disproportional to any anticipated benefits.
p.000072: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
p.000072: decisions, which is in any case often impracticable in multicultural contexts.
p.000072: Sustainability
p.000072:
p.000072: 2.14 The research process should be sustainable, in the sense that it should not jeopardise or prejudice the
...
General/Other / tri-council policy statement
Searching for indicator tri-council:
(return to top)
p.000072: conscientious objection, nor should they be put at a disadvantage because of such objection.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A52
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Bibliography
p.000072:
p.000072: Animals and Birds Act (Cap. 7). Singapore, Revised 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Donation of Human Eggs for Research. Singapore, 2008.
p.000072:
p.000072: Bioethics Advisory Committee. Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and
p.000072: Therapeutic Cloning. Singapore, 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Genetic Testing and Genetic Research. Singapore, 2005.
p.000072:
p.000072: Bioethics Advisory Committee. Human-Animal Combinations in Stem Cell Research. Singapore, 2010.
p.000072:
p.000072: Bioethics Advisory Committee. Human Tissue Research. Singapore, 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Personal Information in Biomedical Research. Singapore, 2007.
p.000072:
p.000072: Bioethics Advisory Committee. Research Involving Human Subjects: Guidelines for IRBs. Singapore, 2004.
p.000072:
p.000072: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social
p.000072: Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research
p.000072: Involving Humans, 2010.
p.000072:
p.000072: Council for International Organizations of Medical Sciences/World Health Organization.
p.000072: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS, 2002.
p.000072:
p.000072: Department of Health and Human Services. The Belmont Report: Ethical Principles and Guidelines for the Protection of
p.000072: Human Subjects of Research. United States of America, 1979.
p.000072:
p.000072: Department of Health and Human Services. Protection of Human Subjects, Title 45 Code of Federal Regulations, Part 46,
p.000072: 102(d). United States of America, 1980.
p.000072:
p.000072: Greene M and 21 others. Moral Issues of Human-Non-Human Primate Neural Grafting. Science. 309 (2005):
p.000072: 385-386.
p.000072:
p.000072: Harris B. Disciplinary and Regulatory Proceedings. 6th Ed. London: Wiley & Sons, 2011.
p.000072:
p.000072: Health Products Act (Cap. 122D). Singapore, 2008.
p.000072:
p.000072: Human Cloning and other Prohibited Practices Act (Cap. 131B). Singapore, 2005.
p.000072:
p.000072: Human Fertilisation and Embryology Act 2008. United Kingdom: HMSO.
p.000072:
p.000072:
p.000072: A53
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Human Tissue Act 2004. United Kingdom: HMSO.
p.000072:
p.000072: Infectious Diseases Act (Cap. 137). Singapore, Amended 2010.
p.000072:
p.000072: Levine RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al. (Eds.) The Oxford
...
Orphaned Trigger Words
p.000025: ethical guidance document for all who are involved in human biomedical research in Singapore. They have
p.000025: thoroughly reviewed the BAC’s past recommendations, re-engaged the research community and public on pertinent
p.000025: issues arising from areas such as stem cell research and genetic research, and compiled the relevant
p.000025: recommendations into a single, concise volume. I am confident that the standards and recommendations
p.000025: advocated in the Guidelines will enhance the responsible and ethical conduct of human biomedical research in
p.000025: Singapore.
p.000025:
p.000025:
p.000025: Professor Lim Pin Emeritus Advisor
p.000025: Bioethics Advisory Committee June 2015
p.000025:
p.000025:
p.000025:
p.000025: PREFACE
p.000025:
p.000025:
p.000025: As the BAC celebrates its 15th anniversary this year, we have reviewed the recommendations that the committee has made
p.000025: in the seven reports issued since its inception in 2000. The BAC was set up with the aim of protecting the rights and
p.000025: welfare of individuals, while allowing the development of biomedical sciences for the benefit of mankind, and this
p.000025: continues to be the impetus guiding the BAC in its work.
p.000025:
p.000025: In accordance with our mandate, the BAC has examined a wide range of topics, including human stem cell research,
p.000025: reproductive and therapeutic cloning, human tissue research, human genetics research, personal
p.000025: information, egg donation, and human-animal combinations – with an overarching focus on the area of human
p.000025: biomedical research. Given the extensive subject matter that the BAC has covered over more than a decade, we decided to
p.000025: consolidate our past recommendations into a single volume. We hope that the Ethics Guidelines for Human
p.000025: Biomedical Research will be an accessible resource for researchers and members of ethics committees, or any
p.000025: interested individual who is seeking guidance on the best practices for the ethical conduct of human biomedical
p.000025: research in Singapore.
p.000025:
p.000025: During the course of preparing the Guidelines, we also took the opportunity to reflect on the BAC’s past
p.000025: recommendations, review our positions where appropriate after taking into account new scientific, regulatory
p.000025: and legal developments. This was done to ensure that we are up-to-date with both local practices and
p.000025: international best standards. We sought to reconcile any apparent discrepancies, and to clarify any uncertainties
p.000025: that have emerged since publication of our original reports. This resulting document therefore contains the
p.000025: most current views of the BAC, advocating the standards expected of researchers and research institutions
p.000025: in Singapore, and setting out a framework for the ethics review of human biomedical research. Furthermore,
p.000025: in the course of our review, we have also deliberated on recent emerging issues, such as incidental findings and whole
p.000025: genome sequencing, and have incorporated new ethical guidance on these issues into the Guidelines.
p.000025:
p.000025: The Guidelines was an ambitious project, and is the result of countless hours of deliberation and conversations. I
p.000025: would like to express my heartfelt gratitude to my dedicated committee members, and our distinguished panel of
p.000025: international experts, for their tireless commitment to the development of these Guidelines. I would also like to thank
p.000025: members of the research community and the general public, who participated in our public consultation sessions and
p.000025: provided us with valuable comments on the 2012 draft. Their thoughtful feedback spurred further debate, and
p.000025: helped us to refine our consideration of pertinent issues. While our views may not always be compatible, we are
p.000025: nevertheless grateful for all the inputs we have received.
p.000025:
p.000025:
p.000025: Judge (ret.) Richard Magnus Chairman
p.000025: Bioethics Advisory Committee June 2015
p.000025:
p.000025:
p.000025:
p.000025: BIOETHICS ADVISORY COMMITTEE (MARCH 2011 TO DECEMBER 2015)
p.000025:
p.000025: Emeritus Advisor
p.000025: Professor Lim Pin
p.000025: University Professor, National University of Singapore (NUS)
p.000025:
p.000025: Chairman
p.000025: Mr Richard Magnus
p.000025: Judge (ret.)
p.000025:
p.000025: Members
p.000025: Professor Alastair Campbell
p.000025: Director, Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, NUS
p.000025:
p.000025: Associate Professor Chin Jing Jih
p.000025: Senior Consultant Geriatrician, Department of Continuing and Community Care, Tan Tock Seng Hospital
p.000025:
p.000025: Professor Kon Oi Lian
p.000025: Head, Division of Medical Sciences, National Cancer Centre Singapore
p.000025:
p.000025: Mr Alfian Yasrif Bin Kuchit
p.000025: Deputy Director, Community Relations Muslim Matters, Ministry of Culture, Community and Youth
p.000025:
p.000025: Mr Charles Lim Aeng Cheng
p.000025: Parliamentary Counsel (Special Projects) and Chief Knowledge Officer, Attorney-General's Chambers
p.000025:
p.000025: Associate Professor Lim Tit Meng
p.000025: Chief Executive, Science Centre Singapore
p.000025:
p.000025: Professor Ng Soon Chye
p.000025: Director, O & G Partners Fertility Centre, Gleneagles Hospital; and Medical Director, Sincere IVF Center, Novena
p.000025: Specialist Center, Singapore
p.000025:
p.000025: Associate Professor Ngiam Tee Liang
p.000025: Associate Professorial Fellow, Department of Social Work, Faculty of Arts and Social Sciences, NUS
p.000025:
p.000025: Associate Professor Nuyen Anh Tuan (till March 2013)
p.000025: Associate Professor (ret.), Department of Philosophy, Faculty of Arts and Social Sciences, NUS
p.000025:
p.000025: Professor Kandiah Satkunanantham
p.000025: Senior Consultant, Division of Hip & Knee Surgery, University Orthopaedics, Hand and Reconstructive Microsurgery
p.000025: Cluster, National University Hospital
p.000025:
p.000025: Professor Patrick Tan Boon Ooi
p.000025: Duke-NUS Graduate Medical School; and Group Leader, Genome Institute of Singapore
p.000025:
p.000025: Dr Mary Anne Tsao (from March 2014)
p.000025: President & Director, Tsao Foundation
p.000025:
p.000025: Mr Gregory Vijayendran
p.000025: Equity Partner, Rajah & Tann LLP
p.000025:
p.000025:
p.000025: INTERNATIONAL PANEL OF EXPERTS
p.000025:
p.000025: Professor Martin Bobrow (till March 2014)
p.000025: Emeritus Fellow, University of Cambridge, United Kingdom
p.000025: Professor Peter Braude (from June 2014)
p.000025: Emeritus Professor of Obstetrics and Gynaecology, King’s College London
p.000025:
p.000025: Dr Christine Grady (from November 2014)
p.000025: Chief, Department of Bioethics, National Institutes of Health
p.000025:
...
...
p.000063: exemptions.
p.000063:
p.000063: 5. Minimal risk refers to an anticipated level of harm and discomfort that is no greater than that ordinarily
p.000063: encountered in daily life, or during the performance of routine educational, physical, or psychological
p.000063: tasks.
p.000063:
p.000063: 6. In multi-centre research, a lead IRB could be designated that plays the main role in conducting a full
p.000063: ethics review. Multi-national research should be subject to review by the IRB of the local partner institution(s).
p.000063:
p.000063: 7. Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000063: carried out in their premises or facilities; or by their employees or
p.000063:
p.000001: 1
p.000001:
p.000001: EXECUTIVE SUMMARY
p.000001:
p.000001:
p.000001: on their patients; or involving access to or use of human biological materials, medical records or other personal
p.000001: information in their custody. They are also responsible for ensuring research integrity.
p.000001:
p.000001: 8. Every institution that conducts human biomedical research, or allows such research to be carried out in
p.000001: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000001: researchXstaff have access to an IRB at another institution. Should a research proposal be rejected by an
p.000001: IRB, an appeal mechanism should be available in which a second committee must be able to exercise independent
p.000001: judgement.
p.000001:
p.000001: 9. The responsibilities of the researchers include ensuring that their research is
p.000001: conducted with integrity and complies with all relevant laws and other regulatory obligations and
p.000001: requirements; submitting annual (or more frequent) progress reports as required by the IRBs; reports of adverse events
p.000001: arising from the research should be submitted to the IRBs within 15 days of their occurrence, while serious adverse
p.000001: events should be reported immediately; not altering or modifying in any way any drug or other clinical
p.000001: regimen without the IRB’s and attending physician’s approval; and ensuring that participants are informed
p.000001: of clinically significant findings that are discovered in the process of research, if they have indicated
p.000001: their desire to know these.
p.000001:
p.000001: III. Consent
p.000001:
p.000001: 10. Consent for participation in research must be voluntary. There should be no coercion, deception or undue
p.000001: influence. Participants may be reimbursed for legitimate expenses. Any other payment, whether monetary or
p.000001: in kind, should not amount to an inducement, and should be approved by an IRB. Consent to participation in
p.000001: research should be documented in writing.
p.000001:
p.000001: 11. Keeping research participants in ignorance of a research hypothesis, or of which intervention
p.000001: group they have been assigned to, does not amount to deception. However, the need to keep participants
p.000001: ignorant of a research hypothesis should be disclosed and justified to the satisfaction of an IRB. It is also best
p.000001: ethical practice to highlight to the participant the fact that, for methodological reasons, not
p.000001: all information concerning the research hypothesis and protocol will be revealed.
p.000001:
p.000001: 12. Prospective research participants or their legally authorised representatives should be provided with
p.000001: sufficient information in an understandable form and appropriate manner, to enable them to make an informed
p.000001: decision.
p.000001:
p.000001: 13. Consent could be specific to a particular research project, or general for the storage and future use of
p.000001: biological materials or personal information in research. In any general consent, donors should be allowed to
p.000001: impose some limits to the use of their biological materials or personal information. IRBs should have the
p.000001: discretion to decide, when considering a research proposal, whether specific consent is required or general consent is
p.000001: sufficient, if previously given.
p.000001:
p.000001:
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: EXECUTIVE SUMMARY
p.000002:
p.000002:
p.000002: 14. For research involving vulnerable persons not lacking mental capacity (for example, prisoners, uniformed
p.000002: personnel, and employees), consent should be taken by independent third parties, whenever possible. When
p.000002: it is not possible for consent to be taken by an independent third party, the IRB may give directions for the consent
p.000002: to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000002: sufficient safeguards to protect the welfare and interests of the participants.
p.000002:
p.000002: 15. For research involving patients, consent for participating in research should be clearly separated from
p.000002: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000002: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000002: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000002: and sufficient safeguards to protect the welfare and interests of the patient.
p.000002:
p.000002: 16. For research involving minors with decision-making capacity, consent from both the minor and a parent should
p.000002: be obtained; such a minor’s refusal of consent should be respected. Apart from this, it is still important to
p.000002: engage the minor in ways that respect his or her current level of understanding. Parents or guardians
p.000002: of minors lacking decision-making capacity are authorised to consent to their participation in research
p.000002: that involves no more than minimal risk and is not contrary to their best interests. For research that
p.000002: does not involve more than minimal risk, such as surveys seeking information relating only to the minor, IRBs should be
p.000002: able to waive parental consent for minors who have decision-making capacity, where there is otherwise no prohibition
p.000002: by law and parental consent is not a reasonable requirement for the protection of the minor’s interests.
p.000002:
p.000002: 17. IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000002: typically in epidemiological or public health research carried out with medical records or with data from national
p.000002: registries.
p.000002:
p.000002: 18. For research involving recruitment of highly compromised patients who are unable to give consent and for whom
p.000002: no proxy is available to give consent, and subject to the treatment of the patient remaining the priority, IRBs may
p.000002: authorise the research if it involves no more than minimal risk. Consent must be sought, directly or from
p.000002: a proxy, as soon as is practicable. The patient or proxy shall have every right to withdraw or decline
p.000002: with retrospective effect (which will require removing earlier collected data or biological material from the
p.000002: study).
p.000002:
p.000002: 19. Where there is a possibility that the research may yield clinically significant incidental findings,
p.000002: participants should be allowed to decide whether or not to be informed of such findings, during the consent-taking
p.000002: process.
p.000002:
p.000002: 20. If a clinically significant finding is discovered, but the preference of the research participant
p.000002: for receiving such information is unknown, researchers should refer to their IRBs for advice on the
p.000002: appropriate handling of such information.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: EXECUTIVE SUMMARY
p.000003:
p.000003:
p.000003: IV. Personal Information in Research
p.000003:
p.000003: 21. All biomedical research involving personal information, whether identified or de- identified, should
p.000003: be reviewed by an IRB and approved, or granted an exemption from review, before it commences. IRBs should have
p.000003: the discretion to decide whether specific consent is required or general consent is sufficient for the particular
p.000003: project.
p.000003:
p.000003: 22. It is not practicable to give research participants a right to view, amend, delete or otherwise
p.000003: control data they have provided for research purposes. Information created through research should be managed in
p.000003: ways that respect the need to observe confidentiality and care in use. It should remain in the care of and for
p.000003: the use of the researcher, subject to ethics governance procedures, rather than being treated as the continued property
p.000003: of the research participant or ‘donor’.
p.000003:
p.000003: 23. Personal information used for research should be de-identified as early as possible, and stored
p.000003: and managed as de-identified information. The principle of proportionality applies, such that the level of care and
p.000003: urgency regarding de-identification and data protection should be consistent with the sensitivity of the data. IRBs
p.000003: should consider the suitability of the extent and means of the de-identification in proportion to the
p.000003: risk.
p.000003:
p.000003: 24. To maximise the value of data and biological materials collected in cohort or follow- up studies, where a
p.000003: large amount of data is collected for analysis, it should be managed as reversibly de-identified data.
p.000003: Under the Personal Data Protection Act 2012 (PDPA), an organisation that collects and de-identifies
p.000003: personal data for processing and storage is still considered to hold personal data if it retains the ability to
p.000003: re-identify the data. Thus, in the re-identification of reversibly de-identified data, the management of the key to
p.000003: any code or encryption can and generally should be separated from the management of the data.
p.000003:
p.000003: 25. Should an individual be identified inadvertently from de-identified information, the confidentiality
p.000003: and privacy rights of this individual should not be regarded as abrogated by such identification, and
p.000003: steps should be taken to reinstate and secure them.
p.000003:
p.000003: 26. Healthcare institutions should ensure that clear formal procedures are laid down for the release of
p.000003: medical records and other personal information for research, and to formulate these procedures in consultation
p.000003: with their IRBs.
p.000003:
p.000003: 27. IRBs may waive the consent requirement for the use of personal information for epidemiological or
p.000003: public health research, or the use of medical records for research, if they are satisfied that the following conditions
p.000003: are met:
p.000003:
p.000003: (a) The research is justified and poses no more than minimal risk to individuals concerned;
p.000003:
p.000003: (b) The research could not practicably proceed without the waiver;
p.000003:
p.000003: (c) Obtaining consent is not possible or practicable; and
p.000003:
p.000004: 4
p.000004:
p.000004: EXECUTIVE SUMMARY
p.000004:
p.000004:
p.000004: (d) Individual privacy and confidentiality of the personal information are assured.
p.000004:
p.000004: 28. Research information may not be definitive, and research participants are entitled to expect that their data
p.000004: will not be used for purposes other than those for which they have given consent. Thus, such information should not be
p.000004: disclosed to any third party, including employers or insurance companies.
p.000004:
p.000004: V. Biobanking and Research Involving Human Biological Materials
p.000004:
p.000004: 29. Informed consent must be obtained before any human biological materials are taken for use in research. If the
p.000004: materials are intended for storage and future use in research, consent should also be obtained for this purpose.
p.000004:
p.000004: 30. Re-consent is required in the following situations:
p.000004:
p.000004: (a) When the proposed research is not covered by the consent that was given when the biological materials were
p.000004: collected (unless the re-consent requirement is waived by an IRB);
p.000004:
p.000004: (b) If the biological material was collected from a minor below 21 years of age, who did not at the time of collection
p.000004: possess decision-making capacity and therefore did not personally, or jointly together with his/her parent, consent to
p.000004: the donation. In the event that re-consent is not practicable, the IRB should generally have the discretion to waive
p.000004: the requirement in accordance with the relevant criteria for waiver of consent, where appropriate; or
p.000004:
p.000004: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000004: combinations.
p.000004:
p.000004: 31. Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000004: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000004: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000004: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000004: immediately before death.
p.000004:
p.000004: 32. For research using foetal tissues, consent for the termination of pregnancy should be separate from the
p.000004: consent for obtaining foetal tissue or any tissue related to the pregnancy for research. Where possible, an
p.000004: attending physician should not also seek consent for research participation from a patient in this situation. Consent
p.000004: for the use of foetal tissue for research could be obtained from either parent, as provided for in the Medical
p.000004: (Therapy, Education and Research) Act.
p.000004:
p.000004: 33. Specific and personal consent from the donors must be obtained before any gametes or embryos are to be
p.000004: used for research. Potential donors should be provided with sufficient information to make an informed decision
p.000004: and be given at least a week to decide.
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: EXECUTIVE SUMMARY
p.000005:
p.000005:
p.000005: 34. For women undergoing fertility treatment, consent for the donation of surplus oocytes or embryos for
p.000005: research should be separate from the consent for treatment. The treating physician should not also be the
p.000005: researcher seeking consent for the donation of oocytes or embryos for research. Donors should confirm in writing that
p.000005: they do not require the oocytes or embryos for future use.
p.000005:
p.000005: 35. Women wishing to donate eggs specifically for research must be interviewed by an independent panel. The panel
p.000005: must be satisfied that they are of sound mind, clearly understand the nature and consequences of the donation,
p.000005: and have freely given explicit consent, without any inducement, coercion or undueXinfluence.
p.000005:
...
p.000006: research practice with laboratory animals, should be exempted from review. All other human stem cell
p.000006: research should undergo full or expedited review by an IRB. Approval from MOH must also be obtained if
p.000006: the research involves the use of human eggs, human embryos, or human-animal combinations.
p.000006:
p.000006: 48. In human-animal combinations research involving live animals or resulting in the creation of live
p.000006: animals, the IRB should also ensure that the proposal has been approved by the Institutional Animal Care and
p.000006: Use Committee, whose remit covers the welfare of laboratory animals.
p.000006:
p.000006: 49. Where human embryonic stemXcells, induced pluripotent stemXcells, or any other kind of pluripotent stem
p.000006: cells are introduced into animals at any stage of development, particular attention should be paid to
p.000006: the need to avoid the creation of entities in which human sentience or consciousness might be expected to
p.000006: occur.
p.000006:
p.000007: 7
p.000007:
p.000007: EXECUTIVE SUMMARY
p.000007:
p.000007:
p.000007: 50. Animals into which human embryonic stemXcells, induced pluripotent stemXcells, or any other kind of
p.000007: pluripotent stemXcells have been introduced should not be allowed to breed.
p.000007:
p.000007: 51. If the research involves introducing human embryonic stemXcells or any pluripotent cells, or products derived
p.000007: from these cells, into humans, or any novel applications of any stemXcells that are outside the scope of established
p.000007: standards of medical care, it should be conducted in accordance with the requirements and standards of a clinical trial
p.000007: for cell-based products, as specified by the HSA, and approval from HSA must be obtained. IRBs must ensure that:
p.000007:
p.000007: (a) The proposal is reviewed and approved by a scientific review committee with the relevant expertise;
p.000007:
p.000007: (b) There is strong evidence of the safety and efficacy of the cells from pre-clinical studies;
p.000007:
p.000007: (c) The research participants have been provided with sufficient information, in particular information on
p.000007: the nature and risks of the research, and the source of the cells, so that their values and beliefs are respected; and
p.000007:
...
p.000009: experiences of medical practitioners and others have been vital in the history of medicine, the systematic
p.000009: scientific foundations are also essential. While good medical practice entails far more than the mechanical
p.000009: application of science, good biomedical research is fundamental to its success, and is a safeguard against
p.000009: unsubstantiated or harmful claims. Biomedical research in general is thus regarded by the BAC as a public good.
p.000009:
p.000009: 1.7 Biomedical research has been defined as research having as its purpose the enhancement
p.000009: or improvement of medical practice.2 This extends the scope of biomedical research beyond research
p.000009: that is clinical, and it could include research that does not use human participants at all. Much fundamental research
p.000009: in physiology and other disciplines has the goals of medicine as its ultimate aim. In a similar way, the goal of much
p.000009: bioengineering research is ultimately medical, though this is not true of the foundational disciplines in engineering.
p.000009: For these reasons, it is difficult to provide a single definition that covers all obvious examples of research
p.000009: that have a clearly medical goal, while not becoming over-inclusive with respect to basic research that might
p.000009: ultimately be important for medicine but is not done with the primary aim of furthering its goals.
p.000009:
p.000009: 1.8 The BAC therefore adopts the following definition of human biomedical research:
p.000009:
p.000009: Human Biomedical Research refers to any research done for the ultimate purpose of studying, diagnosing, treating
p.000009: or preventing, any disease, injury, disorder, or condition of the human mind or body, and which entails the
p.000009: involvement of humans, human biological materials or information derived from humans or human biological materials.
p.000009: Also included is research on human physiological processes.
p.000009:
p.000009: 1.9 The BAC takes the view that human biomedical research usually needs to be regulated because one
p.000009: or more of the following conditions will inevitably apply to any proposed human biomedical research:
p.000009:
p.000009: (a) The research involves intervention with respect to, interaction with, or observation of one
p.000009: or more human participants;
p.000009:
p.000009: (b) The research will use or manipulate human biological materials (e.g. human cells, tissues, organs and
p.000009: body fluids);
p.000009:
p.000009: (c) The research entails the systematic review, analysis, use or publication of previously compiled
p.000009: identifiable (identified or reversibly de-identified) medical or personal information or biodata;
p.000009:
p.000009:
p.000009: 1 Office for Human Research Protections, 45 Code of Federal Regulations 46.102(d).
p.000009: 2 Levine, RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al.
p.000009: (Eds.) The Oxford Textbook of Clinical Research Ethics. Oxford: OUP (2011), page 211.
p.000009:
p.000010: 10
p.000010:
p.000010: INTRODUCTION
p.000010:
p.000010: (d) The research topic is sufficiently sensitive to likely raise questions of public acceptability or
p.000010: public policy (e.g. research on human embryos or human-animal combinations); or
p.000010:
p.000010: (e) The research could be considered sensitive by virtue of the nature of the personal information it
p.000010: proposes to gather.
p.000010:
p.000010: 1.10 The BAC is concerned with human biomedical research, and not with the wider issues of research with human
p.000010: participants generally. It does not seek to determine the extent to which ethics governance for the protection
p.000010: of human participants should be extended to research that is not biomedical, though this is clearly a
p.000010: matter of importance and public interest. It does, however, cover economic, sociological and other research
p.000010: in the humanities and social sciences whenever this research fits the above definition of human biomedical
p.000010: research.
p.000010:
p.000010: 1.11 The BAC also recognises that human biomedical research could be more or less sensitive in
p.000010: character, where ‘sensitivity’ depends on societal considerations. For example, research that relies on
p.000010: sensitive information, such as participants’ sexual practices or psychiatric history, would ipso facto be
p.000010: regarded as sensitive research. Similarly, research on cloning technology would generally be considered
p.000010: sensitive simply because the idea of using the technology it generates to clone a human being is widely seen as
p.000010: unacceptable. Research deemed sensitive would attract more exacting regulatory control, or could be prohibited.3
p.000010:
p.000010: 1.12 Human biomedical research can be basic and far removed from the likelihood of immediate
p.000010: application, or it can be explicitly clinical and therapeutic in character. Clinical research includes
p.000010: clinical trials, which are regulated by the Health Sciences Authority (HSA) in Singapore.
p.000010:
p.000010: 1.13 There is a long tradition in medicine of medical practitioners publishing clinical case reports based on their
p.000010: own cases, and these reports have often been a valuable source of learning in the profession. The BAC is of
p.000010: the view that the publication of case reports not amounting to a systematic programme of research is under the
p.000010: purview of journal editors and the Singapore Medical Council, as the latter is the authority for upholding the
p.000010: requirements of professional medical ethics and conduct in Singapore. Such publication does not necessarily
p.000010: require independent ethics review, as both medical ethics and conduct, and the requirements of journal
p.000010: editors that informed consent be obtained, offer safeguards against the improper publication of case reports.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: 3 The sensitivity of research with human embryonic stem cells, or with cloning technology, is
p.000010: manifestly sensitive in the sense that the morality and acceptability of such research is disputed. For this reason,
p.000010: the BAC had in its Stem Cell Report, recommended a strict regulatory regime, especially for the creation
p.000010: of human embryos specifically for research, and additionally recommended a ‘conscience clause’ allowing
p.000010: conscientious objection to participation in any manner in human stem cell research. See Recommendations 3 to 5 and 11
p.000010: of that Report.
p.000010:
p.000011: 11
p.000011:
p.000011: INTRODUCTION
p.000011:
p.000011: The Legislative and Regulatory Framework of Human Biomedical Research in Singapore
p.000011:
p.000011: 1.14 All research in Singapore, like any other activity, is bound by the laws of Singapore, comprising a
p.000011: combination of statute and case law. A number of statutes and regulations made under them are relevant
p.000011: to the conduct of human biomedical research.
p.000011:
p.000011: Statutes and Subsidiary Legislation
p.000011:
p.000011: 1.15 Relevant statutes and subsidiary legislation are as follows. The list is not exhaustive, but covers all the
p.000011: principal sources of legislation impinging on human biomedical research practice:
p.000011:
p.000011: (a) Medicines (Clinical Trials) Regulations (Cap. 176, Rg 3) made under Sections 18 and 74 of the Medicines Act
p.000011: (Cap. 176) (1985 Ed.), which is an Act to make provisions with respect to medicinal products and medical
p.000011: advertisements and matters connected therewith;
p.000011:
p.000011: (b) Health Products Act (Cap. 122D) (2008 Ed.): An Act to regulate the manufacture, import,
p.000011: supply, presentation and advertisement of health products and of active ingredients used in the manufacture of health
p.000011: products and provide for matters connected therewith;
p.000011:
p.000011: (c) Private Hospitals and Medical Clinics Act (Cap. 248) (1999 Ed.): An Act to provide for the
p.000011: control, licensing and inspection of private hospitals, medical clinics, clinical laboratories and
p.000011: healthcare establishments, and for purposes connected therewith;
p.000011:
p.000011: (d) Medical (Therapy, Education and Research) Act (Cap. 175) (1985 Ed.) (amended vide Act 4/2010):
p.000011: This is an Act to make provision for the use of the bodies of deceased persons or parts thereof for purposes
p.000011: of medical or dental education, research, advancement of medical or dental science, therapy and
p.000011: transplantation, and for other purposes connected therewith;
p.000011:
p.000011: (e) Human Cloning and other Prohibited Practices Act (Cap. 131B) (2005 Ed.): An Act to prohibit the placing of a
p.000011: human embryo clone in the body of a human or an animal and certain other practices associated with reproductive
p.000011: technology;
p.000011:
p.000011: (f) National Registry of Diseases Act (Cap. 201) (2007 Ed.) (amended vide Act 56/2007): An Act to
...
p.000012: Advisory Committee on Laboratory Animal Research;
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: INTRODUCTION
p.000013:
p.000013: (g) National Medical Ethics Committee (NMEC),4 Recommendations On Clinical Trials: Update Focusing On Phase 1
p.000013: Trials, 2007;
p.000013:
p.000013: (h) NMEC, Ethical Guidelines for Gene Technology, 2001;
p.000013:
p.000013: (i) NMEC, Ethical Guidelines on Research involving Human Subjects, 1997; and
p.000013:
p.000013: (j) Singapore Medical Council, Ethical Code and Ethical Guidelines.
p.000013:
...
p.000014: Subjects (1964, revised 2013);
p.000014:
p.000014: (c) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
p.000014: Research (1979);
p.000014:
p.000014: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000014:
p.000014: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000014: Declaration on Bioethics and Human Rights (2005).
p.000014:
p.000014: General Ethical Principles that have Guided the BAC
p.000014:
p.000014: 2.3 A review of the five foundational documents above reveals that participants need to be protected and their
p.000014: autonomy in matters of research participation recognised. Although these documents do not agree on every
p.000014: particular matter, they appear to be in accord in their fundamentals. Based on these, the BAC has formulated
p.000014: the following five guiding principles reflecting their local application, first summarised in its Egg Donation Report.
p.000014:
p.000014: 5 The BAC used the term “subject” in its earlier reports, but more recently has used the term “participant”. The
p.000014: latter is preferred as it implicitly acknowledges that research participants choose to participate, and
p.000014: should not be merely the passive subjects of research.
p.000014:
p.000015: 15
p.000015:
p.000015: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000015:
p.000015: Respect for persons
p.000015:
p.000015: 2.4 Individuals are to be respected as human beings and treated accordingly. This includes respecting
p.000015: their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC
p.000015: refers to as autonomy.6 Their welfare and interests are to be protected, especially when their autonomy is
p.000015: impaired or lacking. This principle mandates the need for informed consent to participation in research,
p.000015: respect for privacy, safeguarding confidentiality, and minimising harm to research participants. It also
p.000015: requires a proper regard for religious and cultural diversity.
p.000015:
p.000015: 2.5 This principle integrates with many other aspects of life in societies that could be described
p.000015: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000015: Ideals of this democratic society include all citizens being equal under the law, or having rights to
p.000015: privacy in the management of their affairs, to the enjoyment of security and public health and safety,
p.000015: with rights over their own bodies, and many others. All of these, in the final analysis, come down to the principle
p.000015: that individuals should be accorded certain basic rights or entitlements arising from their existence in society.
p.000015: These entitlements exist notwithstanding individual differences in endowment of race, character, gender or talent,
p.000015: and without requirement that individuals justify them. However, an individual’s autonomy can be curtailed under certain
p.000015: circumstances, for the public good, such as when quarantined during disease epidemics.
p.000015:
p.000015: Solidarity
p.000015:
p.000015: 2.6 The BAC earlier advocated a principle of reciprocity between the individual and wider society, as
p.000015: a way to capture the well-established idea that there is some measure of mutual obligation that regulates the
p.000015: relationship between the two. However, the underlying principle is perhaps better expressed as solidarity. The
p.000015: essential principle is not one of individual exchange, but of a wider vision in which common interest is invoked as a
p.000015: reason for the subordination of individual interest to that of a group in specified circumstances. Solidarity
p.000015: reflects the importance of general altruism as a basis for participation in biomedical research.
p.000015:
p.000015: 2.7 In biomedical research, agreed social benefits – considered as a public good – carry an implication that, if
p.000015: accepted, they inherently reflect an in-principle willingness to consider participation in research of the kind
p.000015: yielding the accepted benefits. This means that there is a balance to be struck between the interests of the public
p.000015: and the rights of individual participants; and that incompatible and irreconcilable ethical perspectives
p.000015: should be resolved with some regard to public interest. The BAC is therefore of the view that that certain
p.000015: rights such as informed consent, derived from the principle of respect for individuals, may be subordinate to the
p.000015: public interest based on the principle of solidarity. However, this should only be permitted in certain
p.000015: minimal risk research such as public health and epidemiological research, and subject to appropriate safeguards.
p.000015:
p.000015:
p.000015: 6 NMEC similarly referred to autonomy as “the right of individuals to decide for themselves what is good for
p.000015: them.” Paragraph 2.3.1, Ethical Guidelines on Research Involving Human Subjects (1997).
p.000015:
p.000016: 16
p.000016:
p.000016: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000016:
p.000016: Justice
p.000016:
p.000016: 2.8 The concept of justice as applied to research includes the general principle of fairness and equality under
p.000016: the law. This concept implies that access to the benefits of research, and the burden of supporting
p.000016: it, should be equitably shared in society. It should not, for example, be considered ethical to exempt a class
p.000016: of otherwise suitable patients from participation in research by virtue of economic status.7 The concept of justice
p.000016: also implies that researchers and their institutions incur some responsibility for the welfare of participants, and
p.000016: their compensation and treatment in the event an adverse outcome results directly from their
p.000016: participation. It mandates careful consideration of the arrangements in place for ancillary care or follow-up in
p.000016: the case of research participants located in regions that may be resource-poor relative to the initiating country.
p.000016: Moreover, in the event research yields an immediate benefit that could apply to one of the participants in
p.000016: the research, justice would dictate that the benefit be offered.8
p.000016:
p.000016: 2.9 Although it is easy to defend the generic idea of justice as fundamental to the proper functioning of any
p.000016: society, both justifying and implementing a specific conception of justice is difficult, since research may
p.000016: entail compromises between competing interests. What different parties in a disagreement see as fair may depend
p.000016: upon widely different assumptions.
p.000016:
p.000016: Proportionality
p.000016:
p.000016: 2.10 The regulation of research should be in proportion to the possible threats to autonomy, individual welfare,
p.000016: or the public good. Proportionality is fundamental to the administration of any system of
p.000016: regulation or governance, not just in bioethics or research, and has legal standing as such. A robust
p.000016: formulation of the principle is that interference with individuals should not exceed what is needed to achieve
p.000016: necessary regulation.9 It appeals to moderation and good sense in the determination of prohibited
p.000016: actions and the avoidance of micro-management and over-determination. The risk in any acceptable programme of
p.000016: research, and the stringency of its regulation, should not be disproportionate to any anticipated benefits.
p.000016: Proportionality is a counterweight to an excessive reliance on absolute principles in the determination of ethical
p.000016: decisions, which is in any case often impracticable in multicultural contexts.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016: 7 “For example, during the 19th and early 20th centuries the burdens of serving as research
p.000016: subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to
p.000016: private patients.” Belmont Report, Part B(3), given as an example of manifest injustice. It would also breach the
p.000016: principle of solidarity.
p.000016: 8 An example would be a research participant assigned to a placebo controlXgroup.
p.000016: 9 See for example the discussion of proportionality in Harris, B. Disciplinary and Regulatory Proceedings, 6th
p.000016: Ed. London: Wiley & Sons (2011). The essential legal burden on the court was stated in de Freitas v. The Permanent
...
p.000017:
p.000018: 18
p.000018:
p.000018: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000018:
p.000018: the results can be regarded as a threat to research integrity; for example, if there is plagiarism, selectivity in
p.000018: the publication of results, or if the independence of researchers is undermined by their obligations to their
p.000018: employers or to the funders of their research.
p.000018:
p.000018: 2.15 The BAC’s view is that research integrity is essential. It is not a simple concept, but to some extent, the
p.000018: presumptive integrity of research and of researchers is already implicit in adherence to the BAC’s general
p.000018: ethical principles outlined above, and its importance is made explicit wherever appropriate in these
p.000018: Guidelines. Further guidance is available in the Singapore Statement on Research Integrity, developed by the 2nd
p.000018: World Conference on Research Integrity, which was the first international effort to encourage the
p.000018: development of unified policies, guidelines and codes of conduct, with the long-term goal of fostering greater
p.000018: integrity in research globally.11
p.000018:
p.000018: 2.16 The BAC is also of the view that research institutions have a responsibility to ensure that the
p.000018: requirements of research integrity are observed, and IRBs have a responsibility to check that
p.000018: research integrity, as well as research merit, has been considered.
p.000018:
p.000018: 2.17 The principles described above are general in nature and fundamental to ethics governance of
p.000018: biomedical research involving human participants, the use of the biological materials that they have
p.000018: contributed, and information about persons obtained or derived from the research process. In practice,
p.000018: these principles are engaged in a number of specific guidelines, considered below.
p.000018:
p.000018: Ethics Review of Human Biomedical Research in Singapore – The IRB System
p.000018:
p.000018: 2.18 Ethics governance of research in Singapore has been established by statute for clinical trials. The
p.000018: Medicines Act 1975 (Chapter 176, Sections 18 and 74) and Medicines (Clinical Trials) (Amendment)
p.000018: Regulations 1998, require that all clinical trials be conducted in accordance with the Singapore Guideline
p.000018: for Good Clinical Practice (SGGCP), which is adapted from the International Conference on Harmonisation
p.000018: Tripartite Guideline E6: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). The
p.000018: SGGCP requires that all proposals for pharmaceutical clinical trials be reviewed by independent ethics
p.000018: committees.
p.000018:
p.000018: 2.19 The HSA is the regulatory authority for clinical trials. Since January 2006, researchers can make parallel
p.000018: submissions to both HSA and to their respective IRBs. The regulatory approval from HSA, in the form of a
p.000018: Clinical Trial Certificate, is issued independently of ethics approval. Researchers are to initiate their studies only
...
p.000020: encountered in daily life, or during the performance of routine educational, physical, or psychological tasks.
p.000020:
p.000020: 2.28 A less formal process of review than that of a standard full review is permissible for research that
p.000020: involves no more than minimal risk to research participants. The Chairperson or other IRB delegate(s) may be
p.000020: empowered to conduct such expedited reviews.
p.000020:
p.000020: 2.29 In the case of exemption from review, there must be no likelihood of harm to research participants, for
p.000020: example, when irreversibly de-identified data or commercialised human cell lines are used. Researchers
p.000020: seeking exemption from review would accordingly need to make a request with an abbreviated protocol,
p.000020: and obtain endorsement from the IRB before commencing the research. The Chairperson or other IRB delegate(s) may be
p.000020: empowered to grant such exemptions.
p.000020:
p.000020: Multi-Centre and Multi-National Research
p.000020:
p.000020: 2.30 For multi-centre research, a lead IRB could be designated. The choice of the lead IRB should be dictated by
p.000020: considerations such as the primary institution of affiliation of the principal investigator, the location where the
p.000020: greater part of the research is carried out, the expertise of the IRBs, or the place where the largest number of
p.000020: participants is located. The lead IRB will play the main role in conducting a full ethics review, in coordinating the
p.000020: research programme, and in keeping the other participating IRBs informed of any decisions or amendments,
p.000020: including those made during the entire research period.
p.000020:
p.000020: 2.31 For multi-national research, the local portion should be subject to review by the IRB of the local partner
p.000020: institution(s), and the local IRB(s) should have a final say on matters affecting local participants.
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000021:
p.000021: Conflicts of Interest
p.000021:
p.000021: 2.32 Institutions, IRBs, members of IRBs and researchers should take special care to avoid conflicts of interest,
p.000021: whether actual, potential, or only the appearance of conflict. Institutions should develop policies and
p.000021: procedures to identify, eliminate, minimise or manage conflicts of interest that may affect research.
p.000021:
p.000021: 2.33 Should an IRB member have a personal interest in the research under review, that member should
p.000021: disqualify him- or herself from any consideration of the case, and he or she should refrain from offering his or
p.000021: her opinion to the IRB on the particular research under review. The member should make full disclosure
p.000021: of such an actual, potential or apparent conflict of interest to the IRB.
p.000021:
p.000021: 2.34 Researchers should disclose any actual, potential or perceived individual conflicts of interest, when
p.000021: submitting their research proposals to the IRB, as well as any institutional conflicts that they are aware of
p.000021: and may have an impact on their research. The IRB shall then decide on the appropriate steps to manage the conflict.
p.000021:
p.000021: 2.35 Threats to research integrity could arise when there is a conflict of interest between those who commission
p.000021: and fund research (including commercial organisations) and those who carry it out (the researchers).
p.000021: Routine checks and balances ensuring the integrity of the research process have been developed in
p.000021: universities and other research institutions with a commitment to research. When research is recruited to the service
p.000021: of commercial or institutional interests, researchers may be in a difficult position if their results are
p.000021: inconsistent with the expectations or hopes of their funders. IRBs need to consider how best to avoid such threats to
p.000021: integrity when considering applications in which they might arise.
p.000021:
p.000021: Responsibilities of Institutions
p.000021:
p.000021: 2.36 Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000021: carried out in their premises or facilities; or by their employees or on their patients; or involving access to or use
p.000021: of human biological materials, medical records or other personal information in their custody. They are also
p.000021: responsible for ensuring research integrity.
p.000021:
p.000021: 2.37 Every institution that conducts human biomedical research, or allows such research to be carried out in
p.000021: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000021: researchXstaff have access to an IRB at another institution.
p.000021:
p.000021: 2.38 Institutions should set up clear policies for the operation of their IRBs. The
p.000021: composition of IRBs and specific operational details are provided for in the MOH Operational Guidelines for
p.000021: Institutional Review Boards.12
p.000021:
p.000021: 2.39 Institutions should ensure that there is an arrangement for receiving feedback from research
p.000021: participants.
p.000021:
p.000021:
p.000021: 12 MOH, Operational Guidelines for Institutional Review Boards. 2007.
p.000021:
p.000022: 22
p.000022:
p.000022: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000022:
p.000022: 2.40 It is the responsibility of institutions to provide adequate resources, including resources for the
p.000022: training and education of IRB members, and administrative support for the IRBs to discharge their responsibilities in
p.000022: an effective and timely manner.
p.000022:
p.000022: 2.41 Institutions should ensure that provisions are made to treat and compensate research participants for the
p.000022: adverse consequences resulting directly from their participation, where appropriate.
p.000022:
p.000022: 2.42 An institution must accept legal responsibility for the decisions of its IRB and must provide the IRB members
p.000022: with a full indemnity for actions resulting from decisions made by those members in good faith in the course of
p.000022: discharging their duties.
p.000022:
p.000022: 2.43 In view of the investment of time and effort in preparing for research, including the sourcing of funds, it
p.000022: would be proper to have some kind of re-evaluation or appeal procedure in the event that a research proposal
p.000022: is not approved by an IRB. The principal investigator should then have an opportunity to further justify the
p.000022: research, or if disagreement persists, to make available an appeal mechanism in which adjudication by a
p.000022: third party is possible. Institutions are responsible for ensuring that such a mechanism is put in place.
p.000022: Appeals should be considered by another committee, whose members should not include any member of the IRB that
p.000022: initially reviewed the proposal. This committee must be able to exercise independent judgement,
p.000022: free from bias or a conflict of interests.
p.000022:
p.000022: Responsibilities of IRBs
p.000022:
p.000022: 2.44 The functions of an IRB include the following:
p.000022:
p.000022: (a) The ethics review and approval of proposed human biomedical research projects;
p.000022:
p.000022: (b) Ensuring that research proposals have been scientifically evaluated and have scientific merit, as it
p.000022: would be unethical to subject human participants to any risk or research that is so poorly designed that it
p.000022: could not yield generalisable knowledge. The IRB is not expected to undertake such scientific review itself;
p.000022:
p.000022: (c) Evaluating the provisions for the consent process to ensure that valid consent that is appropriate
p.000022: to the proposed research is obtained;
p.000022:
p.000022: (d) The continuing ethics review of the research projects approved by them, through requiring submissions of
p.000022: annual or more regular progress reports from researchers;
p.000022:
p.000022: (e) Reporting to their respective institutions any unusual or unexpected events arising from the research;
p.000022: and
p.000022:
p.000022: (f) Providing feedback to and maintaining dialogue about applicable standards with their constituent researchers.
p.000022:
p.000022: 2.45 IRBs should provide a fair hearing to those involved. If there are any doubts or difficulties
p.000022: with particular aspects of the proposals, IRBs should clarify these in
p.000022:
p.000023: 23
p.000023:
p.000023: ETHICS GOVERNANCE OF HUMAN BIOMEDICAL RESEARCH
p.000023:
p.000023: writing with the researchers, or in minuted face-to-face meetings between the IRB and researchers.
p.000023:
p.000023: 2.46 All discussions of the IRB should be appropriately minuted and all opinions recorded. The decision of the
p.000023: IRB should be provided in written form to the researcher and, where appropriate, a fair and frank account of
p.000023: the reasons for those decisions should be provided.
p.000023:
p.000023: Responsibilities of Researchers
p.000023:
p.000023: 2.47 Researchers are responsible for ensuring that their research is conducted with integrity and complies with all
p.000023: relevant laws and other regulatory obligations and requirements, including the conditions laid down by the IRB
p.000023: that approved their project. They should not vary their approved research without prior IRB agreement,
p.000023: unless the deviations are necessary to eliminate immediate hazards to participants, or when the changes involve only
p.000023: logistical or administrative aspects of the research.
p.000023:
p.000023: 2.48 Researchers should submit annual (or more frequent) progress reports as required by the IRBs, as well as
p.000023: project completion reports to their respective IRBs.
p.000023:
p.000023: 2.49 Reports of adverse events arising from the research should be submitted to the respective IRBs
p.000023: within 15 days of their occurrence. However, serious adverse events, such as those resulting in death or
p.000023: a life-threatening situation, or requiring hospitalisation of any research participant, should be reported
p.000023: immediately.
p.000023:
p.000023: 2.50 Researchers should not alter or modify in any way (whether in formulation, dosage or timing) any drug or
p.000023: other clinical regimen of a patient-participant, without the approval of the attending physician and the IRB.
p.000023:
p.000023: 2.51 Researchers should conduct their research in a professional manner and with due regard to
p.000023: applicable conventions and expectations with respect to the obtaining and managing of research data, the disclosure of
p.000023: conflicts of interest, and the reporting of the research.
p.000023:
p.000023: 2.52 When any clinically significant findings are discovered in the process of research, researchers
p.000023: should ensure that research participants are informed, if they have indicated their desire to know.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: CONSENT
p.000024:
p.000024: III. Consent
p.000024:
p.000024:
p.000024: 3.1 Consent is a vital component of ethical biomedical research. Consent requirements exemplify the
p.000024: principle of respect for persons by acknowledging the right of individuals to decide for themselves what is
p.000024: good for them. An IRB should evaluate the provisions for obtaining consent whenever it considers a research
p.000024: proposal entailing work with human participants, the use of human biological materials or identifiable
p.000024: personal information.
p.000024:
p.000024: 3.2 There is a distinction between the legal and ethical obligations relating to consent. There are
p.000024: various situations where the law requires consent to be obtained, and where a research procedure done without consent
p.000024: could be subsequently challenged in court. Legal requirements thus constrain what can or cannot be enforced concerning
p.000024: ethical obligations in obtaining an individual’s consent. However, these Guidelines refer to consent issues as a
p.000024: matter of ethics – what ought to be done in obtaining informed consent – and are to be understood as presuming
p.000024: compliance with the law as it stands.
p.000024:
p.000024: Voluntary and Informed Consent
p.000024:
p.000024: 3.3 Consent must be voluntary and informed. Informed consent is not merely providing information, but
p.000024: requires that the person consenting does so with adequate understanding. The language, occasion and
p.000024: manner of explanation, the level of detail offered, and the process by which the consent is taken, should all be aimed
p.000024: at helping the potential research participant understand what consent is being asked for.
p.000024:
p.000024: 3.4 Obtaining the consent of prospective participants entails providing sufficient relevant information and
p.000024: explaining it in ways that allow them to make an informed decision with an appropriate level of
p.000024: understanding. The requirements vary somewhat depending on the nature of the research, such as whether
p.000024: the research involves biological materials or genetic information, and the likelihood of
p.000024: discovering clinically significant findings either directly or incidentally to the research. The consent
p.000024: process will also depend on the vulnerability of the participant. Anything in the nature of the research which
p.000024: the participant may find morally or culturally sensitive should entail some corresponding sensitivity in
p.000024: obtaining consent.
p.000024:
p.000024: 3.5 Therefore, valid consent should require that:
p.000024:
p.000024: (a) Research participants understand what is proposed, the nature of any entailed risks and benefits
p.000024: to them, and how any such risks are to be managed and minimised. This is particularly important in
p.000024: clinical research where new therapies are involved;
p.000024:
p.000024: (b) There is no coercion, deception or inducement. Any reimbursement for expenses incurred in relation to the
p.000024: research, whether monetary or in kind, should not amount to an inducement; and
p.000024:
...
p.000026:
p.000026: 3.12 While it is usual to treat the individual as an autonomous agent for purposes of taking consent, provision
p.000026: has to be made when considering research participants who are vulnerable. Such participants include:
p.000026:
p.000026: (a) Persons lacking mental capacity (such as the intellectually disabled, people who are incapacitated through
p.000026: accident, injury or illness, and others as defined in the Mental Capacity Act);
p.000026:
p.000026: (b) Those whose autonomy might be prejudiced by being under the influence of, or the control of, or obligated to,
p.000026: third parties; and
p.000026:
p.000026: (c) Minors.
p.000026:
p.000026: Consent for Research Involving Persons Lacking Mental Capacity
p.000026:
p.000026: The Mental Capacity Act
p.000026:
p.000026: 3.13 The Mental Capacity Act lays down the general framework under which decisions can be made on behalf of a
p.000026: person lacking capacity. As the Act states in Section 13(7) that treatment includes the conduct of a clinical
p.000026: trial, a deputy appointed by the court under the Act, or a donee who has been expressly given
p.000026: authority under a Lasting Power of Attorney (LPA) to give or refuse consent to the carrying out or continuation of
p.000026: medical treatment by a health care provider, may also decide on the person’s participation in clinical
p.000026: trials. But this is subject to the restrictions in Sections 13(8) and 25(3)(c), on both a deputy and a donee,
p.000026: concerning life-sustaining treatment or treatment necessary to prevent a serious deterioration in the patient’s
p.000026: condition.
p.000026:
p.000026: 3.14 In making such decisions on personal welfare, the deputy or the donee must follow the statutory principles
p.000026: under the Act, viz., act in the incapacitated person’s (i.e. donor’s) best interests,13 have regard to the
p.000026: guidance in the Code of Practice of the Act, carry out the donor’s instructions and make decisions within the
p.000026: scope of authority specified in the LPA. To give consent for the person lacking capacity to participate
p.000026: in clinical trials, the deputy or the donee must be satisfied that:
p.000026:
p.000026: (a) The incapacitated individual has previously indicated a willingness to participate; or
p.000026:
p.000026: 13 With regard to best interests, Mental Capacity Act, section 6(7) states: “He [the deputy or
p.000026: donee] must consider, so far as is reasonably ascertainable –
p.000026: (a) the person’s past and present wishes and feelings (and, in particular, any relevant written statement made by him
p.000026: when he had capacity);
p.000026: (b) the beliefs and values that would be likely to influence his decision if he had capacity; and
p.000026: (c) the other factors that he would be likely to consider if he were able to do so.”
p.000026:
p.000027: 27
p.000027:
p.000027: CONSENT
p.000027:
p.000027: (b) Consent would, in the judgement of the deputy or donee, have been given had the incapacitated individual (not
p.000027: being a child), been able to make an informed choice.
p.000027:
p.000027: 3.15 Legal protection is offered to any individual acting in connection with the care or treatment of
p.000027: a person lacking capacity, provided certain requirements, as set out in Section 7(1) of the Act, are met.
p.000027: However, this statutory immunity does not apply to clinical trials, by virtue of an express exclusion in Section 7(3).
p.000027:
p.000027: 3.16 It should be stressed that biomedical research other than clinical trials is not expressly provided for or
p.000027: mentioned under the Act, unlike the specific provision made for research in the UK Mental Capacity Act 2005. A
p.000027: deputy or donee is obligated under the Act to make decisions on behalf of a potential participant in his best
p.000027: interests, yet participation in research, particularly non-clinical studies, does not usually benefit the participant
p.000027: directly. While an incapacitated person’s best interests would generally require that there be some direct
p.000027: benefit from the participation in research, the common law has not always interpreted the best
p.000027: interests test so narrowly.14 International guidelines on biomedical research also envisage the
p.000027: permissibility of research participation for incapacitated adults where (a) the research is intended to
p.000027: promote the health of the group represented by the potential participant, (b) the research cannot be
p.000027: conducted with participants who can give informed consent, and
p.000027: (c) the research participation entails only minimal risk or burden.15 It may thus be ethical for a
p.000027: court deputy or donee of a lasting power of attorney to enrol an incapacitated adult in minimal risk
p.000027: research where this is consistent with the incapacitated person’s beliefs and values, and not contrary
p.000027: to the person’s present wishes and feelings.
p.000027:
p.000027: Consent for Research Involving Vulnerable Persons Not Lacking Mental Capacity
p.000027:
p.000027: 3.17 Vulnerable research participants not only include those who are lacking mental capacity, but also
p.000027: those whose autonomy might be prejudiced by being under the influence or control of, or by being obligated to,
p.000027: third parties. Potentially vulnerable participants might include, but are not limited to:
p.000027:
p.000027: (a) Prisoners;
p.000027:
p.000027: (b) Uniformed personnel, especially junior ranks;
p.000027:
p.000027: (c) Patients, especially if the intending researcher is their attending physician; and
p.000027:
p.000027: (d) Employees, junior collaborators, or students.
p.000027:
p.000027:
p.000027:
p.000027: 14 For example, the courts have permitted a simple paternity blood test for a child where this was not clearly
p.000027: against the interests of the child, notwithstanding there was no direct benefit to the child: S v S [1972] AC 24 (House
p.000027: of Lords). Nothing in the Mental Capacity Act (Chap 177A) expressly overrules the common law, except by necessary
p.000027: implication.
p.000027: 15 World Medical Association, Declaration of Helsinki (rev. 2013), article 28; Council for
p.000027: International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research
p.000027: Involving Human Subjects (2002), Articles 9 and 15.
p.000027:
p.000028: 28
p.000028:
p.000028: CONSENT
p.000028:
p.000028: 3.18 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000028: prospective participants reassured that they have nothing to fear in declining research participation or
p.000028: in contributing biological materials or personal information for research. Thus, consent from uniformed
p.000028: personnel, for example, should not be taken by a senior officer, and preferably not by uniformed personnel.
p.000028:
p.000028: 3.19 When it is not possible for consent to be taken by an independent third party, the IRB may give directions for
p.000028: the consent to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000028: sufficient safeguards to protect the welfare and interests of the participant.
p.000028:
p.000028: 3.20 A further issue of vulnerability arises in societies where social proxy arrangements are widespread, for
...
p.000029:
p.000029: 3.23 In Singapore, under the common law, the age of majority is 21 years. This age is generally
p.000029: taken as the age at which a person is considered an adult and thus able to make all decisions for oneself. The category
p.000029: of minors thus spans a wide range, from children of tender years who lack any capacity to give consent, to young
p.000029: persons who have acquired the capacity to understand and make decisions on research participation.
p.000029: Parents generally have the authority to make decisions on behalf of minors, and this would include research
p.000029: participation. However, the welfare and best interests of the child or young person is the paramount consideration and
p.000029: parents must discharge their responsibilities to promote these.16 Unless research participation offers direct benefit
p.000029: to the minor, the authority of parents or guardians to consent to research without direct benefit is constrained
p.000029: in a similar fashion to proxy decisions for incapacitated adults as discussed in para. 3.16 above. Participation
p.000029: in research without direct benefit should involve no more than minimal risk and not be contrary to the best
p.000029: interests of the minor.
p.000029:
p.000029: 3.24 It is nevertheless ethically important to give due respect to the developing capacity of minors to be involved
p.000029: in, and make their own decisions about research participation. This consideration is reinforced in the case of research
p.000029: without direct benefit, where the minor should appreciate its altruistic nature. Respect for a minor’s
p.000029: developing autonomy is thus recognised by the Medicines (Clinical Trials) Regulations, which require both the
p.000029: minor who has sufficient understanding and a parent or guardian to consent to participation in a clinical
p.000029: trial.17 Similarly, the common law will not subject a child with sufficient understanding to a
p.000029: non-therapeutic procedure against his/her will.18
p.000029:
p.000029: Determining decision making capacity
p.000029:
p.000029: 3.25 In order to give a valid consent, the minor must have sufficient maturity and intelligence to
p.000029: understand the relevant information relating to the proposed research, and use that information to arrive at a reasoned
p.000029: decision. This capacity is, however, not easily linked to fixed ages, as it varies from minor to minor, and depends on
p.000029: the nature and complexity of the research. None of the current legal age thresholds bear immediate relevance to
p.000029: determining when a minor develops sufficient decision- making capacity to consent to research participation,
p.000029: although children between the ages of 12-14 may acquire near adult decision-making capacity.19 We therefore
p.000029: recommend that IRBs set suitable age thresholds for obtaining minors’ consent based on the relevant minors’
p.000029: developmental abilities, the context of the particular research protocol and the complexity of its procedures and
p.000029: risks. However, if researchers hold a reasonable doubt whether a particular minor possesses capacity to give consent,
p.000029: or if
p.000029:
p.000029: 16 Children and Young Persons Act (Cap. 38), s.3A; Guardianship of Infants Act (Cap 122), s.3
p.000029: 17 Medicines (Clinical Trials) Regulations, r.11(2).
p.000029: 18 S v S [1972] AC 24 at 45 (House of Lords).
p.000029: 19 Working Party of the Royal College of Paediatrics and Child Health, “Guidance on clinical research involving
p.000029: infants, children and young people: an update for researchers and research ethics committees” Arch Dis
p.000029: Child 2014 Oct; 99(10): 887-91.
p.000029:
p.000030: 30
p.000030:
p.000030: CONSENT
p.000030:
p.000030: the research risks involved are significantly greater than minimal, it would be prudent to assess capacity on an
p.000030: individual basis before enrolment.
p.000030:
p.000030: Engagement
p.000030:
p.000030: 3.26 For minors who lack sufficient decision-making capacity, it is still important to engage them as
p.000030: far as their intellectual abilities permit. This may involve, for example, explaining the nature of the
p.000030: research procedures and dealing with the minor’s concerns. Engagement serves to minimise the potential risks
p.000030: associated with participation, such as any distress experienced while undergoing research
p.000030: procedures.20 In every instance, including the obtaining of consent, IRBs and researchers should
p.000030: ensure that such engagement or explanation should be communicated effectively with age
p.000030: appropriate language and methods, and appropriately documented.
p.000030:
p.000030: Summary
p.000030:
p.000030: 3.27 The BAC is thus of the view that for research involving minors with decision-making capacity, consent from
p.000030: both the minor and a parent should be obtained; such a minor’s refusal of consent should be respected. Apart from this,
p.000030: it is still important to engage the minor in ways that respect his or her current level of understanding.
p.000030: Parents or guardians of minors lacking decision-making capacity are authorised to consent to their
p.000030: participation in research that involves no more than minimal risk and is not contrary to their best
p.000030: interests.
p.000030:
p.000030: Waiver of Parental Consent
p.000030:
p.000030: 3.28 For research that does not involve more than minimal risk, such as surveys seeking information relating only
p.000030: to the minor, the BAC is of the view that IRBs should be able to waive parental consent for minors who have
p.000030: decision-making capacity, where there is otherwise no prohibition by law and parental consent is not a
p.000030: reasonable requirement for the protection of the minor’s interests.
p.000030:
p.000030: Waiver of Consent
p.000030:
p.000030: 3.29 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000030: typically in epidemiological or public health research carried out with medical records or with data from national
p.000030: registries, when the following conditions are met:
p.000030:
p.000030: (a) The research is justified and poses no more than minimal risk to research participants;
p.000030:
p.000030: (b) The waiver will not adversely affect the welfare and interests of research participants;
p.000030: (c) The research could not practicably proceed without the waiver;
p.000030:
p.000030: 20 This is addressed by the concept of assent in some jurisdictions like the US. However, as assent is a procedure that
p.000030: lacks clear legal recognition in Singapore, and may be confused with consent to research, it is best to focus on
p.000030: engagement with the minor participant.
p.000030:
p.000031: 31
p.000031:
p.000031: CONSENT
p.000031:
p.000031: (d) Obtaining consent is not possible or practicable; and
p.000031:
p.000031: (e) Individual privacy and confidentiality of the personal information are assured.
p.000031:
p.000031: 3.30 Exceptionally, valuable research might require the recruitment of highly compromised patients, such as
p.000031: accident trauma victims, who are unable to give consent and for whom no proxy is practically available to
p.000031: give consent within the timeframe required for the research procedures to be administered. In such cases, always
p.000031: subject to the treatment of the patient remaining the priority, and subject to the provisions of the
p.000031: Mental Capacity Act, it may be appropriate for an IRB to authorise the research, if it involves no more than
p.000031: minimal risk. Consent must be sought, directly or from a proxy, as soon as is practicable, and with the clear
p.000031: understanding that a patient shall have every right to withdraw or decline with retrospective effect (which will
p.000031: require removing earlier collected data from the study).
p.000031:
p.000031: Clinically Significant Incidental Findings
p.000031:
p.000031: 3.31 A clinically significant incidental finding occurs when, in the course of research done for some other
p.000031: purposes, a finding is made that has a clear implication for the health of the participant to whom it relates. Research
p.000031: findings are by their nature provisional and not definitive. Where research data suggests the presence of a clinical
p.000031: condition that would require a confirmation and possible treatment, there is some duty on the part of the researcher to
p.000031: ensure that the research participant is informed of the possible condition with advice to follow up on the matter with
p.000031: a medical practitioner.
p.000031:
p.000031: 3.32 If there is reasonable possibility that incidental findings may occur in a research, research
p.000031: participants should be given the choice of whether to be informed about such findings, during the consent-taking
p.000031: process, prior to the commencement of the research. Researchers should ensure that research participants,
p.000031: who so choose, are informed and advised to seek medical attention and confirmation of the research result in a
p.000031: clinical laboratory.
p.000031:
p.000031: 3.33 Communication of clinically significant findings to research participants could be done directly by
p.000031: the researcher, or through a healthcare provider or other party authorised to receive the information,
p.000031: and who is appropriately qualified and in a better position to advise and discuss the implications of the
p.000031: findings.
p.000031:
p.000031: 3.34 Parents who have indicated a wish to know, should be informed of clinically significant
p.000031: incidental findings affecting their children’s health, when they are discovered. Upon reaching the
p.000031: age of 21 and if the research is still on-going, the individuals concerned will then be in a position to make
p.000031: their own decisions regarding whether or not to be contacted in the event that such findings are uncovered.
p.000031:
p.000031: 3.35 If a clinically significant finding is discovered, but the preference of the research participant
p.000031: for receiving such information is unknown, researchers should refer to their IRBs for advice on the
p.000031: appropriate handling of such information.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: CONSENT
p.000032:
p.000032: Guidelines on Consent
p.000032:
p.000032: 3.36 Consent for participation in research must be voluntary. There should be no coercion or undue influence.
p.000032: Participants may be reimbursed for legitimate expenses. Any other payment, whether monetary or in kind,
p.000032: should not amount to an inducement, and should be approved by an IRB.
p.000032:
p.000032: 3.37 Participants should be allowed to withdraw from the research at any time without any explanation, and without
p.000032: penalty or prejudice to any treatment they may be receiving.
p.000032:
p.000032: 3.38 Prospective research participants or legally authorised representatives should be provided with
p.000032: sufficient information in an understandable form and appropriate manner, to enable them to make an informed
p.000032: decision. Such information include:
p.000032:
p.000032: (a) The nature and purpose of the research;
p.000032:
p.000032: (b) Any entailed risks and benefits to them, and how such risks are to be managed and minimised;
p.000032:
p.000032: (c) The safeguards for protecting their privacy and confidentiality of their personal information;
p.000032:
p.000032: (d) Any payment for participation in the research;
p.000032:
p.000032: (e) The procedures and implications for withdrawal from the research; and
p.000032:
p.000032: (f) Any other information specific to the type of research, as given in the parts on research involving human
p.000032: biological materials, genetic research and stem cell research in these Guidelines.
p.000032:
p.000032: 3.39 Prospective participants should be given adequate time to decide whether or not to participate in
p.000032: the research and the opportunity to clarify any doubts that they may have.
p.000032:
p.000032: 3.40 Consent to participation in research should be documented in writing.
p.000032:
p.000032: 3.41 Consent could be specific to a particular research project, or general for the storage and future use of
p.000032: biological materials or personal information. In any general consent, donors should be allowed to impose some
p.000032: limits to the use of their biological materials or personal information. IRBs should have the discretion
p.000032: to decide, when considering a research proposal, whether specific consent is required or general consent is
p.000032: sufficient, if previously given.
p.000032:
p.000032: 3.42 For research involving vulnerable persons not lacking mental capacity (for example, prisoners, uniformed
p.000032: personnel, and employees), consent should be taken by independent third parties, whenever possible.
p.000032: Prospective participants should be reassured that they have nothing to fear in declining research
p.000032: participation or in contributing biological materials for research. When it is not possible for consent to be taken
p.000032: by an independent third party, the IRB may give directions for the consent to
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: CONSENT
p.000033:
p.000033: be taken by the researcher so long as there are provisions to manage the conflict of interest and sufficient safeguards
p.000033: to protect the welfare and interests of the participant.
p.000033:
p.000033: 3.43 For research involving patients, consent for participating in research should be clearly separated from
p.000033: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000033: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000033: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000033: and sufficient safeguards to protect the welfare and interests of the patient.
p.000033:
p.000033: 3.44 While local customs should be respected when conducting research in places where social proxy arrangements
p.000033: are widespread, individual consent from the prospective participant is nevertheless essential.
p.000033:
p.000033: 3.45 For research involving minors with decision-making capacity, consent from both the minor and a parent should
p.000033: be obtained; such a minor’s refusal of consent should be respected. Apart from this, it is still important to
p.000033: engage the minor in ways that respect his or her current level of understanding. Parents or guardians
p.000033: of minors lacking decision-making capacity are authorised to consent to their participation in research
p.000033: that involves no more than minimal risk and is not contrary to their best interests.
p.000033:
p.000033: 3.46 For research that does not involve more than minimal risk, such as surveys seeking information relating only
p.000033: to the minor, IRBs should be able to waive parental consent for minors who have decision-making capacity,
p.000033: where there is otherwise no prohibition by law and parental consent is not a reasonable requirement
...
p.000035: individual where the identity of that individual is not known. If it is de-identified through reversible means, such
p.000035: as the use of a coding system or encryption, it is described as reversibly de-identified information. If it
p.000035: is permanently stripped of all identifying details, it is referred to as irreversibly de-identified information.
p.000035: Thus identifiable information includes identified information and reversibly de-identified information.
p.000035:
p.000035: 4.3 Personal information used in research may be obtained through various sources, such as through interviewing
p.000035: or testing individuals, from the course of medical diagnosis or treatment, analysis of biological materials contributed
p.000035: for research, and registries or databases. Such data may be stored electronically or as physical records, and managed
p.000035: by healthcare or research institutions, or government or non-government registries. Data that are routinely
p.000035: collected or submitted to national registries may be immensely valuable for human biomedical research. To enhance its
p.000035: value, it may be necessary to link the records of individuals from multiple databases.
p.000035:
p.000035: 4.4 In research, information can be used in many unforeseen ways, and it is not practicable to give
p.000035: research participants a right to view, amend, delete or otherwise control data they have provided for research
p.000035: purposes. Moreover, the information may have been, in a sense, created by the researcher through his or her
p.000035: observation and interventions – for instance a measure of memory, or an assessment of genetic potential,
p.000035: which might otherwise have been unknown. Information created through research should be managed in ways that
p.000035: respect the need to observe confidentiality and care in use. It should remain in the care of and for the
p.000035: use of the researcher, subject to ethics governance procedures; rather than being treated as the
...
p.000037: proportionate duty to maintain privacy and confidentiality. Under the principle of autonomy and respect for
p.000037: persons, healthcare practitioners and researchers alike have certain duties regarding the protection of confidential
p.000037: personal information that they collect or generate in the course of their work, whether or not such information forms
p.000037: or originally formed part of a medical record. This implies that storage and security of data should be
p.000037: secured in proportion to its sensitivity.
p.000037:
p.000037: Use of Medical Records for Research
p.000037:
p.000037: 4.12 Medical information and data collected or generated in the process of diagnosing and managing a person’s
p.000037: health condition form the individual’s medical records. These records may be stored electronically or as
p.000037: physical records. Most people regard their medical details as private and a matter for them and their physicians alone.
p.000037: Doctors are expected to respect the principle of medical confidentiality, as set out in the Ethical Code
p.000037: and Ethical Guidelines of the Singapore Medical Council. In a healthcare institution, all personnel
p.000037: who handle medical records are under legal and ethical obligation to observe the confidentiality of the information on
p.000037: the records and to safeguard the privacy of patients concerned.
p.000037:
p.000037: 4.13 Much valuable medical knowledge has resulted from the study of patients’ medical records. Further to the
p.000037: BAC’s recommendations in its 2005 Personal Information Report, the PDPA now affords an exemption under the Third
p.000037: Schedule allowing an organisation to use personal information for research without consent, provided that certain
p.000037: stringent conditions are satisfied.22 In addition, the BAC is of the view that although the primary
p.000037: responsibility for access to medical records should remain with medical practitioners, appropriate access could
p.000037: be given to suitably qualified professionals for the purpose of research. Healthcare institutions
p.000037: should ensure that clear formal procedures are laid down for the release of medical records and other
p.000037: personal information for research, and to formulate these procedures in consultation with their IRBs.
p.000037:
p.000037: Epidemiological and Public Health Research
p.000037:
p.000037: 4.14 The use of personal information in public health and epidemiological research can lead to a
p.000037: clash between public and private interests. Ideally, consent should be
p.000037:
p.000037:
p.000037: 22 See Personal Data Protection Act, Third Schedule, paragraphs 1(i) and 2. Where such personal information is
...
p.000039: be used for purposes other than those for which they have given consent. Thus, such information should not be disclosed
p.000039: to any third party, including employers or insurance companies.
p.000039:
p.000039:
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p.000039:
p.000040: 40
p.000040:
p.000040: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000040:
p.000040: V. BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000040:
p.000040:
p.000040: 5.1 Human biological materials are a valuable resource in biomedical research. These materials could be
p.000040: obtained from living or dead persons, or foetuses. It includes blood and other body fluids, solid body tissues and
p.000040: organs, gametes and embryos, as well as their derivatives. Even biological materials that have been stored for many
p.000040: years may be useful. The ethical issues concerning the use of human biological materials for research
p.000040: relate to the collection, storage, access, and use of these materials; and to the use of personal information
p.000040: generated from research using these materials. Such information may be of central importance to the research or
p.000040: merely incidental, may also have health implications for the donors of biological materials or their
p.000040: genetic relatives, and be of relevance to their employers or insurers.
p.000040:
p.000040: 5.2 Biological materials for research may be newly obtained specifically for the purpose of research or they
p.000040: may come from pre-existing stored specimens. They may be specifically requested for research or they may be
p.000040: surplus from a clinical procedure. They may also be identified or de-identified.
p.000040:
p.000040: 5.3 Human biological materials taken for clinical or research use may be stored in repositories
p.000040: called tissue banks. Tissue banks may be set up specifically for research, but many exist primarily for
p.000040: clinical use in transplantation. Clinical tissue repositories, which consist of samples that have been
p.000040: collected and used for clinical diagnosis, such as blood or tumours that have been surgically removed, are
p.000040: also potentially useful for research. Some repositories consist of accumulated and archived biological materials that
p.000040: have been acquired over a period of many years without specific or adequate donor consent for research use.
p.000040: These collections are referred to as legacy tissues.
p.000040:
p.000040: 5.4 Biobanks are collections of human biological materials that are linked to personal information,
p.000040: which may include medical information of individuals from whom the biological material originate. The individuals may
p.000040: or may not be identifiable by the biobank. Biobanks may be created for research purposes or be part of a
p.000040: clinical service, such as a health screening programme. As they consist of biological materials and data
p.000040: systematically collected from a large number of individuals, they are very valuable for research that may lead to a
p.000040: better understanding of diseases.
p.000040:
p.000040: 5.5 Many countries have created tissue banks and biobanks, some of which are national while others are
p.000040: institution-based. Several initiatives have also involved international collaborations. For such initiatives, all
p.000040: parties involved should agree to a common set of ethical guidelines and standards for the collection, storage, use and
p.000040: disposal of the biological materials collected.
p.000040:
p.000040: 5.6 It is still uncertain in Singapore whether a person, or a body corporate, can legally own human
p.000040: biological materials or whether the donor can have any property rights over his or her biological materials
p.000040: after it is contributed for research. However, there is gradual international legal recognition that individuals have
p.000040: at least some property
p.000040:
p.000040:
p.000040:
p.000040:
p.000040:
p.000041: 41
p.000041:
p.000041: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000041:
p.000041: type rights of control in respect of their excised tissues.23 The question of ownership applies not only to the
p.000041: physical forms of human biological materials but also to their derivatives - whether in the form of data, discoveries
p.000041: or biological products. However, it is generally accepted that the human body or any of its parts, should not be used
p.000041: as a means for financial gain. The donation of biological materials for use in research should thus be
p.000041: considered as an altruistic gift. An altruistic donor does not have intellectual property rights in any
p.000041: commercially valuable development arising from the research, and donations should be made and accepted on that
p.000041: understanding. Also, tissue banks and biobanks have been referred to as custodians of the biological
p.000041: materials that they are responsible for.24 The ‘gift’ model for the altruistic donation of biological materials for
p.000041: research is also appropriate for the provision and management of research data, as this would allow it to be shared or
p.000041: re-analysed in other contexts or for other research purposes, subject to appropriate safeguards.
p.000041:
p.000041: 5.7 As the use of human biological material is critical for biomedical research, both the public and research
p.000041: participants should have confidence that the biological materials that they contribute are handled and used
p.000041: sensitively and responsibly. Researchers should always ensure that the collection and use of human biological
p.000041: materials will not compromise the safety, welfare and interests of donors, which should be of paramount
p.000041: consideration.
p.000041:
p.000041: Guidelines on Biobanking and Research Involving Human Biological Materials
p.000041:
p.000041: General
p.000041:
p.000041: 5.8 All research involving human biological materials, whether identified or de-identified, should be reviewed
p.000041: and approved by an IRB, or granted an exemption from review, before it commences.
p.000041:
p.000041: 5.9 It is essential to protect the privacy and confidentiality of donors of biological materials and
p.000041: their personal information, as well as personal information given by donors about others. All the
p.000041: requirements for the use of personal information in research in Part IV of these Guidelines should be observed.
p.000041:
p.000041: 5.10 Donors of biological materials should not be offered any financial incentives for their donation, although
p.000041: reasonable reimbursement of expenses incurred may be given.
p.000041:
p.000041: 5.11 Researchers and those managing tissue banks and biobanks need to be sensitive to religious and
p.000041: cultural perspectives and traditions relating to human tissue. These vary considerably amongst various religions and
p.000041: cultures, especially when whole cadavers or gross organ parts are involved.
p.000041:
p.000041:
p.000041:
...
p.000043: (a) When the proposed research is not covered by the consent that was given when the biological materials were
p.000043: collected (unless the re-consent requirement is waived by an IRB);
p.000043:
p.000043: (b) If the biological material was collected from a minor below 21 years of age, who did not at the time of
p.000043: collection possess decision-making capacity and therefore did not personally, or jointly together with his/her
p.000043: parent, consent to the donation. Once the minor attains the age of 21, his or her consent should be
p.000043: obtained if research is to be conducted on the previously collected material or personal information related to the
p.000043: sample, or at the least notified of his or her right to withdraw the biological material from research or storage for
p.000043: research. In the event that re-consent is not practicable, the IRB should generally have the discretion to waive the
p.000043: requirement in accordance with the relevant criteria for waiver of consent, where appropriate; or
p.000043:
p.000043: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000043: combinations.
p.000043:
p.000043: 5.17 When any clinically significant findings are discovered in the process of research using human
p.000043: biological materials, researchers should ensure that donors of these materials are informed, if they have
p.000043: indicated their desire to know of such findings.
p.000043:
p.000043: 5.18 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000043: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000043: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000043: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000043: immediately before death, if there is no actual notice of contrary indications by the deceased person, or actual notice
p.000043: of opposition of another legally authorised person of the same or prior class.
p.000043:
p.000043: Foetal Tissues
p.000043:
p.000043: 5.19 Foetal tissues include membranes, amniotic fluid, placenta and umbilical cord. Foetal tissues for research
p.000043: should only be taken from dead or non-viable foetuses. Abortion should not be induced for the purpose of obtaining
p.000043: materials for research.
p.000043:
p.000043: 5.20 Consent for the termination of pregnancy should be separate from the consent for obtaining foetal
p.000043: tissue or any tissue related to the pregnancy for research. Where possible, an attending physician
p.000043: should not also seek consent for research participation from a patient in this situation.
p.000043:
p.000043: 5.21 Consent for the use of foetal tissue for research could be obtained from either parent, as provided in the
p.000043: Medical (Therapy, Education and Research) Act.
p.000043:
p.000043: 5.22 Any research intention to propagate foetal cells in vitro and/or to transplant these cells into a human
p.000043: recipient should be disclosed when consent is sought.
p.000043:
p.000043:
p.000044: 44
p.000044:
p.000044: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000044:
p.000044: Human Gametes and Embryos
p.000044:
p.000044: 5.23 The creation of human embryos specifically for research can only be justified when there is strong
p.000044: scientific merit in and potential medical benefit from such research. The Human Cloning and Other Prohibited
p.000044: Practices Act prohibits the development of a human embryo created other than by fertilisation of human egg by human
p.000044: sperm, for a period of more than 14 days, excluding any period when the development of the embryo is
p.000044: suspended. Commercial trading in human eggs, human sperm and human embryos is also prohibited.
p.000044:
p.000044: 5.24 The supply and use of human gametes and embryos is governed by the Human Cloning and Other
p.000044: Prohibited Practices Act (Cap. 131B). Researchers should also comply with the requirements stipulated in
p.000044: MOH’s 2011 Licensing Terms and Conditions (LTC) on Assisted Reproduction (AR) Services imposed under
p.000044: Section 6(5) of the Private Hospitals and Medical Clinics Act.
p.000044:
p.000044: 5.25 Under the LTC,25 written approval from the Director of Medical Services must be obtained for all
p.000044: research involving human embryos and human oocytes (including those obtained from excised ovarian tissue).
p.000044: This requirement extends to human- animal combination gametes or embryos, which are those containing both human
p.000044: and animal genetic or non-genetic material and includes an embryo created by the fertilisation of human and
p.000044: animal gametes.
p.000044:
p.000044: 5.26 Specific and personal consent from the donors must be obtained before any gametes or embryos are to be
p.000044: used for research. Potential donors should be provided with sufficient information to make an informed decision
p.000044: and be given at least a week to decide.
p.000044:
p.000044: 5.27 For women undergoing fertility treatment, consent for the donation of surplus oocytes or embryos for
p.000044: research should be separate from the consent for treatment. The treating physician should not also be the
p.000044: researcher seeking consent for the donation of oocytes or embryos for research. Donors should confirm in writing that
p.000044: they do not require the oocytes or embryos for future use.
p.000044:
p.000044: 5.28 As the process of donating eggs for research is time-consuming, invasive and associated with a
p.000044: certain degree of discomfort and risk, women wishing to donate eggs specifically for research i.e. those
p.000044: who are not undergoing fertility treatment, must be interviewed by an independent panel. The panel must be
p.000044: satisfied that they are of sound mind, clearly understand the nature and consequences of the donation, and have
p.000044: freely given explicit consent, without any inducement, coercion or undueXinfluence.
p.000044:
p.000044: 5.29 All egg donors should be informed if their eggs will be used to create embryos, including
p.000044: human-animal combination embryos, which will be destroyed in the process of research, and if any derived cells
p.000044: from the embryos so created will be kept for future research or possible clinical use. They should be
p.000044: assured that any embryos
p.000044:
p.000044:
p.000044:
p.000044: 25 At paragraphs 9.1-9.11.
p.000044:
p.000045: 45
p.000045:
p.000045: BIOBANKING AND RESEARCH INVOLVING HUMAN BIOLOGICAL MATERIALS
p.000045:
p.000045: created for research will not be implanted or allowed to develop in vitro beyond 14 days.
p.000045:
p.000045: 5.30 Donors of eggs obtained specifically for research, and not as a result of clinical treatment,
p.000045: may be reimbursed for legitimate expenses incurred, such as cost of transport and childcare services, and
p.000045: actual loss of earnings, as a result of the procedures required to obtain the eggs. Any other payment, whether
p.000045: monetary or in kind, should not amount to an inducement and should be approved by an IRB. If
p.000045: complications occur as a direct and proximate result of the donation, the donor should be provided with prompt and full
p.000045: medical care. This provision is the responsibility of the researchers and their institutions.
p.000045:
p.000045: 5.31 Trans-species fertilisation involving human gametes is not allowed for the purpose of reproduction unless
p.000045: done to assess or diagnose sub-fertility, in which case, the resultant hybrid must be terminated at the
p.000045: two-cell stage, and in any case must have written approval from the Director of Medical Services.
p.000045:
p.000045: 5.32 Human embryos created for research through in vitro fertilisation of human eggs by human sperm, or created
p.000045: through any form of cloning technology, should not be allowed to develop beyond 14 days in vitro.
p.000045:
p.000045: 5.33 Human embryos created for research through in vitro fertilisation of human eggs by human sperm, or created
p.000045: through any form of cloning technology, should not be implanted into the body of any human or animal.
p.000045:
p.000045: 5.34 Human cytoplasmic hybrid embryos26 created for research should not be allowed to develop beyond 14 days in
p.000045: vitro, or to be implanted into the body of any human or animal.
p.000045:
p.000045: 5.35 No one should be under a duty to participate in any manner of research involving human gametes
p.000045: or embryos, including human-animal combination embryos, to which he or she has a conscientious objection.
p.000045:
p.000045: Surplus Biological Materials from Clinical Procedures
p.000045:
p.000045: 5.36 Biological materials, such as blood, biopsy samples or even whole organs, may be left over after clinical
p.000045: procedures that may be therapeutic or diagnostic in nature. Such materials can be very useful for research.
p.000045: However, when these materials are being taken primarily for a therapeutic or diagnostic purpose, this purpose must be
p.000045: fulfilled before any surplus materials may be used for research.
p.000045:
p.000045: 5.37 Every effort should be made to obtain consent for the use of surplus biological materials for
p.000045: research. As the primary objective for removing such materials is clinical, consent for the clinical procedure
p.000045: should be separate from the consent for the use of left over materials for research. To avoid any conflict
p.000045: of interest and to
p.000045:
...
p.000046: assurance from the source authority that the materials have been ethically and legally obtained. The test of
p.000046: ethical acceptability should be the criteria that would have applied had the biological materials been obtained in
p.000046: Singapore and not imported, and the researcher and IRB should be satisfied that this test has been met in substance.
p.000046:
p.000046: Biobanks
p.000046:
...
p.000048: indirectly through the use of their biological materials or personal information from medical records or other
p.000048: databases. It may involve the study of a specific gene, multiple genes, gene-environment interactions, or
p.000048: the entire genome in seeking to establish associations between genomic variants and diseases or specific
p.000048: traits.
p.000048:
p.000048: 6.2 With the completion of the human genome project in 2003, genetic research has progressed more
p.000048: rapidly than ever before. There is an increasing interest in population-based research to study
p.000048: the genetic susceptibility of diseases, with numerous biobanks set up all over the world to store
p.000048: biological materials and associated biodata. These allow detailed long-term genetic studies to take place.
p.000048: Technological advances have also led to an increase in pre-clinical and clinical trials of gene-based therapies in
p.000048: recent years. Gene transfer in combination with stem cell therapy is also being studied in more detail. In
p.000048: addition, whole human genome sequencing can now be done in a relatively short period and at a lower cost. All these
p.000048: advances, together with advances in information technology, have resulted in new ethical challenges in the
p.000048: conduct and governance of genetic research.
p.000048:
p.000048: 6.3 Whole-genome research is likely to continue to advance and intensify. It involves the collection of
p.000048: biological materials, genome sequencing, data analysis, and, possibly, the use of the biological materials and
p.000048: data for future research projects that may not be contemplated when the materials are taken. In addition, the
p.000048: data may also be submitted to easily accessible scientific databases in order to facilitate research. Thus, the
p.000048: implications of whole genome studies and the use of very large data sets of potentially or actually
p.000048: identifiable genetic information raise ethical concerns. Research using these data sets is often
p.000048: international and is facilitated by increasing acceptance of the concept of open access. Moreover, very extensive
p.000048: analysis can be performed by cross-referencing genomic data with demographic or other information. The possibility of
p.000048: inadvertent identification is thus higher than it would be with more restricted data and more limited analysis.
p.000048: Specifically, therefore:
p.000048:
p.000048: (a) Research participants may also need to be informed if and why whole-genome studies make it harder to guarantee
p.000048: their anonymity with complete certainty;
p.000048:
p.000048: (b) Researchers may discover new patterns or relationships, and may feel there is considerable potential for
p.000048: detecting findings that may be suggestive or prove clinically significant in future. It should be made clear in
p.000048: advance as to when the obligation of the researcher to a research participant or tissue donor ceases in
p.000048: relation an incidental finding made during the conduct of research; and
p.000048:
p.000048: (c) The potential commercial value of large-scale genomic studies makes issues of research integrity and data
p.000048: ownership especially important.
p.000048:
p.000048: 6.4 Genetic interventions also raise ethical and moral issues, with germline genetic modification being
p.000048: the most contentious. Any intervention that alters the germline of
p.000048:
p.000049: 49
p.000049:
p.000049: HUMAN GENETIC RESEARCH
p.000049:
p.000049: an individual will lead to a change in the genetic makeup of that individual’s descendants. At present,
p.000049: there is insufficient knowledge of the potential long-term consequences of such interventions, as they are still
p.000049: in the experimental stage. Many countries, such as Australia, Canada, and Finland therefore have laws that
p.000049: prohibit germline modification.
p.000049:
p.000049: 6.5 With the emergence of assisted reproductive techniques to prevent the transmission of mitochondrial disease,
p.000049: such as ooplasmic transfer, pronuclear transfer and maternal spindle transfer, the Nuffield Council on
p.000049: Bioethics (NCB) conducted a public consultation in early 2012, which explored the ethical issues concerning the
p.000049: possible use of such treatments in the future. It concluded that if these novel techniques are adequately
p.000049: proven to be acceptably safe and effective, it would be ethical for families to use them, if they choose to.
p.000049: However, a continuing debate on these issues is important.29 Following this report, the Human Fertilisation &
p.000049: Embryology Authority (HFEA) also launched a public consultation, and it advised the Government that there was general
p.000049: public support for permitting mitochondrial replacement in the UK, so long as it is safe enough to
p.000049: offer in a treatment setting and is done so within a regulatory framework.30. The Department of Health (DoH)
p.000049: held public consultations in early 2014 on its draft regulations that will allow the use of such
p.000049: techniques in patients for the prevention of serious mitochondrial disease. A scientific review by an expert panel
p.000049: convened by the HFEA published in June 2014 concluded that the evidence it has seen does not suggest
p.000049: the techniques unsafe. As a result, the UK Parliament passed the DoH’s draft Human
p.000049: Fertilisation and Embryology (Mitochondrial Donation) Regulations31 in early 2015 to allow
p.000049: mitochondrial donation for prevention of serious mitochondrial diseases, with UK being the first country to
p.000049: do so.
p.000049:
p.000049: 6.6 In 2005 BAC Genetics Report, the Committee had recommended that the clinical practice of
p.000049: germline modification be prohibited, pending scientific evidence that techniques to prevent or eliminate
p.000049: serious genetic disorders have been proven effective. In light of recent international deliberations on
p.000049: germline modification techniques for the treatment of serious diseases, the BAC appointed a Germline
p.000049: Modification Working Group in October 2014 to review these developments and its current recommendations on the matter.
p.000049:
p.000049: 6.7 Information obtained from genetic research could be financially valuable. For example,
p.000049: research involving individuals who have genetic resistance to certain diseases, or whose genome might be found
p.000049: to contain genes relevant to understanding superior human athletic performance, could potentially be very valuable to
p.000049: researchers and institutions able to develop and commercially exploit such research findings. There is also
p.000049: much interest in pharmacogenomics, the aim of which is to create optimal drug treatments that are
p.000049: tailored to the genetic makeup of the patient, or a subset of patients, classified by (for example)
p.000049: ethnic group, in order to maximise
p.000049:
p.000049: 29 Nuffield Council on Bioethics, Novel Techniques for the Prevention of Mitochondrial DNA Disorders: an Ethical
p.000049: Review, June 2012.
p.000049: 30 The HFEA licenses and monitors all fertility clinics and research involving human embryos in the UK. Its
p.000049: report, Mitochondria Replacement Consultation: Advice to Government, was published in March 2013.
p.000049: 31 The National Archives, Human Fertilisation and Embryology (Mitochondrial Donation) Regulations, Available at:
p.000049: http://www.legislation.gov.uk/ukdsi/2015/9780111125816/contents.
p.000049:
p.000050: 50
p.000050:
p.000050: HUMAN GENETIC RESEARCH
p.000050:
p.000050: efficacy and minimise adverse effects. For this and other reasons, economic exploitation has been
p.000050: the subject of some controversy, and it is correspondingly important that all research participants be well
p.000050: aware of the implications.
p.000050:
p.000050: 6.8 Genetic information refers to any information about the genetic makeup of an individual. It can
p.000050: be derived from genetic testing in either a clinical or research setting, or from any other sources,
p.000050: including details of an individual’s family history of genetic diseases.
p.000050:
p.000050: 6.9 Genetic information is often seen as an exceptional kind of personal information. There are
p.000050: several reasons for this:
p.000050:
p.000050: (a) Genetic information is seen as a determining aspect of a person, yet many people are reluctant to
p.000050: countenance the role of genetic influences in considering human potential and conduct, lest it undermine the autonomy
p.000050: that we attribute to individuals;
p.000050:
p.000050: (b) Genetic information can be socially sensitive because it can convey information about others. Even though an
p.000050: individual genome is unique, it may also provide information about family members. This can be highly sensitive, since
p.000050: genetic relatedness may not correspond to expected social relatedness. In particular, paternity information
p.000050: may be obtained through genetic testing;
p.000050:
p.000050: (c) The increasing ease with which the individual human genome can now be completely sequenced has
p.000050: created a situation in which incidental findings of genetic conditions or susceptibility might become easy
p.000050: to obtain. The sheer volume of genetic detail available from large-scale genomic studies also raises issues of
p.000050: data protection and privacy, since much of the value of genetic information in research, as in medicine,
p.000050: depends upon linking findings to individuals and their characteristics;
p.000050:
p.000050: (d) Genetic information may have predictive power for heritable disorders that develop later in life. Even
p.000050: when untreatable, knowledge of such disorders may still allow the individual to make decisions affecting their
p.000050: future, such as whether to refrain from having children. But it is not always the case that individuals
p.000050: wish to know the details of their own genetic makeup, and consequent prognosis in certain cases.
p.000050: Especially if there is no current prospect of treatment, information about potentially disabling genetic conditions,
...
p.000052:
p.000052:
p.000052: 7.1 StemXcells are undifferentiated cells that have the potential to develop into specialised cell types. They
p.000052: may be derived from early embryos (embryonic stemXcells), the germ cells of foetuses (embryonic germ cells)
p.000052: or from the human body at a later developmental stage (somatic or adult stemXcells).
p.000052:
p.000052: 7.2 Since the discovery in 2007 that human skin cells can be reprogrammed into an embryonic state,
p.000052: research in this area has progressed rapidly. Researchers have been studying the characteristics of these
p.000052: reprogrammed cells, called induced pluripotent stem cells, creating disease models to further understand the
p.000052: pathophysiology of specific diseases, as well as creating patient-specific stemXcells and finding ways to transform
p.000052: these stemXcells into desired cells, which could then be used for treatment. Researchers are also trying to find
p.000052: more efficient ways to convert somatic cells directly into lineage-specific stem/progenitor cells,
p.000052: bypassing the intermediate pluripotent stage.
p.000052:
p.000052: 7.3 Stem cell research can be classified into two major categories:
p.000052:
p.000052: (a) Basic research to understand physiological cellular processes and disease mechanisms; and
p.000052:
p.000052: (b) Research into new therapies, including pre-clinical and clinical trials involving stemXcells or their
p.000052: derivatives.
p.000052: 7.4 The unique capacity of stemXcells to develop into various specialised cell types makes them of potential
p.000052: use for the regeneration or reconstruction of diseased or injured tissue. Stem cell research may thus lead to
p.000052: new and better ways of treating serious and debilitating diseases such as Alzheimer’s, diabetes and spinal cord injury.
p.000052: However, the derivation of pluripotent stemXcells from human embryos, and the use of human- animal combinations in stem
p.000052: cell research are controversial and raise ethical, legal and social concerns that must be addressed.
p.000052:
p.000052: 7.5 In 2002, the BAC published its Stem Cell Report. Subsequently it published the Egg Donation Report (2008) and
p.000052: the Human-Animal Combinations Report (2010). Taken together these reports have addressed what are for some the most
p.000052: contentious areas of biomedical research, namely, research involving the use of human embryonic stemXcells;
p.000052: research with human eggs and embryos; and research in which tissues or cellular components of humans and
p.000052: animals are combined. These are contentious because they involve techniques such as cloning technology
p.000052: that arouse unease or opposition among those who consider that science risks hubristically exceeding its
p.000052: proper function, or think that human embryos and gametes are not proper material for research.
p.000052:
p.000052: 7.6 Stem cell research may involve human-animal combinations, which is a term used to refer to any kind of
p.000052: living organism in which there is some mixing of human and animal material (genes, cells or tissues). It
p.000052: includes:
p.000052:
p.000052:
p.000052:
p.000052:
p.000053: 53
p.000053:
p.000053: HUMAN STEM CELL RESEARCH
p.000053:
p.000053: (a) Cytoplasmic hybrid embryos, which are created by fusing human somatic cell nuclei with enucleated
p.000053: animal eggs. These embryos can be used to derive stemXcells with human nuclear genetic material without the
p.000053: need to create human embryos or the use of human eggs; and
p.000053:
p.000053: (b) Animal chimeras, which are created by injecting human stemXcells, into animals at various stages of
p.000053: development to study stem cell integration and differentiation, to test the developmental
p.000053: potential of stem cells or their derivatives, to evaluate the potential usefulness and safety of
p.000053: transplanting human stem cells for clinical treatment or to study the possibility of growing human tissues
p.000053: and organs in animals for the transplantation into humans.
p.000053:
p.000053: 7.7 Transgenic animals are animals in which the genome has been modified to include human genes.
p.000053: They have been widely used in laboratory research into the understanding and treatment of
p.000053: diseases for many years. In its Human-Animal Combinations Report and in preparing these Guidelines, the BAC has
p.000053: not explicitly considered transgenic animals but insofar as these Guidelines are relevant they should apply. However,
p.000053: to the extent that research involves the use of transgenic mice or other small mammals in laboratory
p.000053: conditions, and subject to observance of provisions for laboratory animal welfare, the BAC does not
p.000053: foresee any ethical difficulty in the continued use of such animals.
p.000053:
p.000053: 7.8 The objectives of using human-animal combinations in stem cell research include:
p.000053:
p.000053: (a) To study stem cell integration and differentiation;
p.000053:
p.000053: (b) To test the developmental potential of human stemXcells or their derivatives;
p.000053:
p.000053: (c) To evaluate the potential usefulness and safety of transplanting human stemXcells for clinical
p.000053: treatment; and
p.000053:
p.000053: (d) To study the possibility of growing human tissues and organs in animals for transplantation into
p.000053: humans.
p.000053:
p.000053: 7.9 The unique nature of stem cells also sometimes risks uncontrolled growth and differentiation
p.000053: whether used clinically, or in experiments involving animals. Thus research involving the use of human
p.000053: pluripotent stem cells requires particularly careful attention if it is to be ethically conducted and monitored.
p.000053:
p.000053: Legislation
p.000053:
p.000053: 7.10 There is no specific legislation that governs stem cell research in Singapore. The Human Cloning
p.000053: and Other Prohibited Practices Act (Cap. 131B) was enacted in 2004 primarily to prohibit human reproductive
p.000053: cloning. This Act does not prohibit therapeutic cloning (research cloning), but it limits the
p.000053: development of a human embryo that is created by any process other than the fertilisation of a human egg by a human
p.000053: sperm, to not more than 14 days (excluding any period when the development of the embryo is suspended). It also
p.000053: prohibits the commercial trading of human gametes and embryos.
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054: HUMAN STEM CELL RESEARCH
p.000054:
p.000054: 7.11 The MOH’s LTC for AR Centres (2011) imposed under regulation 6(5) of the Private Hospitals and Medical
p.000054: Clinics Regulations (Cap 248, Rg 2), provides the requirements for the use of human gametes and embryos
p.000054: for research, including the use of human-animal combination gametes and embryos for research.
p.000054:
p.000054: 7.12 The Medicines (Clinical Trials) Regulations (Cap. 176, Rg 3) made under sections 18 and 74 of the Medicines
p.000054: Act (Cap. 176), govern all clinical trials, including first-in- human trials and trials of cell- and tissue-based
p.000054: therapeutic products.
p.000054:
p.000054: Ethical and Social Issues
p.000054:
p.000054: Moral status of the human embryo
p.000054:
p.000054: 7.13 The main controversy in embryonic stem cell research concerns the moral status of the human embryo, and
p.000054: arises from the fact that the human embryo is destroyed in the process of stem cell derivation. There is a wide
p.000054: spectrum of views concerning the human embryo. At one end, it is considered to be a human being from
p.000054: the time of fertilisation, while at the other, the view is that it is a mass of cells, no different from any other
p.000054: biological material used for research.
p.000054:
p.000054: 7.14 After public consultation, the BAC adopted an intermediate position, whereby a human embryo is
p.000054: considered to have the status of a potential human being, but not the same status as a living child or adult. As a
p.000054: measure of respect and protection for the human embryo, the BAC recommended that human embryonic stem cell
p.000054: research, including the creation of human embryos specifically for research, should be allowed only when there is
p.000054: strong scientific merit in and potential medical benefit from such research. In addition, only embryos less than
p.000054: 14 days old should be used for the derivation of stem cells. At around this threshold, the primitive
p.000054: streak appears, signalling the onset of cell differentiation and development of organ systems, including
p.000054: the nervous system. As for the use of surplus embryos donated from fertility treatment by consenting parents, the BAC
p.000054: was of the view that rather than allow them to perish, their use in research would serve a greater good. The BAC’s
p.000054: position on this issue remains unchanged.
p.000054:
p.000054: 7.15 With the increasing possibility of alternative means of generating pluripotent stemXcells, such as
p.000054: induced pluripotent stemXcells, it is more likely that cloning technology would be less frequently used for the
p.000054: creation of embryos. The BAC welcomes such diversity in research methodologies, but continues to regard
p.000054: research cloning (or therapeutic cloning) as defensible under strict regulation, if the scientific question
p.000054: addressed cannot reasonably be investigated using other methods.
p.000054:
p.000054: Cloning and Respect for Individuals
p.000054:
p.000054: 7.16 Respect for human dignity forms the basis for the prohibition of human reproductive cloning in many
p.000054: countries, including Singapore. In particular, there are serious concerns about the safety of the technology
p.000054: used for this purpose, and any unforeseen problems for those born as a result of the technology.
p.000054:
p.000054:
p.000054:
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: HUMAN STEM CELL RESEARCH
p.000055:
p.000055: Human-Animal Combinations
p.000055:
p.000055: 7.17 Repugnance. Many people express repugnance or disgust at the idea of human-animal combinations, as human and
p.000055: animal tissues are not normally thought of as something that can or should be mixed. It is seen as unnatural. The BAC’s
p.000055: position is that while feelings of repugnance cannot be ignored, the process of paying heed to them should involve an
p.000055: evaluation of actual or likely harms and benefits.
p.000055:
p.000055: 7.18 Slippery slope arguments. A concern is sometimes expressed that research with human-animal
p.000055: combinations risks a ‘slippery slope’ that will open the way to unacceptable research or applications.
p.000055: This was one reason for public concern over research cloning – it raised in the public mind the possibility of
p.000055: human reproductive cloning occurring if cloning techniques became widespread. The BAC takes the view that cases should
p.000055: be considered on their merits, and any danger of this kind should be considered when a case is reviewed.
p.000055:
p.000055: 7.19 Human dignity – maintaining a distinction between human and animals. There is and should be no intention,
p.000055: in research, to try and produce animals that have been rendered human in some important and essential
p.000055: mental, physical or existential characteristic. Human consciousness is the most fundamental of such characteristics.
p.000055: The BAC is of the view that acceptable research must preclude procedures that risk this consequence, and should
p.000055: certainly never have it as an explicit aim.
p.000055:
p.000055: 7.20 The risk of hubris and ‘playing God’. The expression ‘playing God’ is often heard in connection with
p.000055: research or practice at the boundaries of medicine, and the exact meaning to be attributed to it may depend
p.000055: on the speaker. Religious critics may mean by it that interference with the process of creating and destroying life is
p.000055: interference with divine prerogative. In its secular form, this criticism can imply that we may suffer
p.000055: from scientific or ethical hubris, a pride in power that blinds us to limitations or unforeseen risks. Such concerns
p.000055: should not be lightly dismissed, but they are not without answers. Whatever we do will affect future
p.000055: generations. It is thus also ‘playing God’ if we prohibit research that might help patients.
p.000055:
p.000055: 7.21 The BAC’s view is that the problem of slippery slope, hubris, and other ethical concerns
p.000055: discussed above present a powerful case for ethical and legal regulation, rather than a case for outright
p.000055: prohibition. Regulation is an assurance that change will be introduced without abrupt and radical challenges to the
p.000055: fundamental values, beliefs and practices in society, and only when the key ethical issues arising from research
p.000055: involving human-animal combinations have been considered in each case.
p.000055:
p.000055: 7.22 The possibility of creating humanised animals. Most of the concerns just discussed are related to
p.000055: the possibility of allowing actual independent living entities to develop from human-animal combinations. It seems to
p.000055: the BAC that the main ethical hazard lies in the possibility of inadvertently creating an animal with human
p.000055: characteristics, especially, but not exclusively, mental attributes. The risks can be seen most clearly in the
p.000055: specific case of human neural stem cells grafted into the brains of non-human
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: HUMAN STEM CELL RESEARCH
p.000056:
p.000056: primate foetuses32, which offers an in-principle possibility of a degree of humanisation of the
p.000056: resulting brain. In this case, six relevant factors have been suggested for the guidance of ethics committees,
p.000056: namely:33
p.000056:
p.000056: (a) The proportion or ratio of human to animal cells in the animal’s brain: When the amount of human material
p.000056: is low, the likelihood of the animal acquiring something like human awareness as a result is correspondingly
p.000056: remote;
p.000056:
p.000056: (b) The age of the animal: The earlier in development, the greater the likely integration of
p.000056: transplanted cells, so human cells transplanted into animal embryos will probably result in greater
p.000056: likelihood of humanisation of the host animal’s brain than implantation into a fully developed animal;
p.000056:
p.000056: (c) The recipient species: Species with a closer approximation to human neural organisation are more
p.000056: problematic, because the likelihood of human attributes occurring in another species is increased when the other
p.000056: species is biologically close;
p.000056:
p.000056: (d) The brain size of the animal involved: It is reasonable to suppose that animals with larger brains are more
p.000056: likely to be capable of an approximation to human consciousness in the event that they incorporate human neural cells;
p.000056:
p.000056: (e) The site of integration of the human neural cells: Integration into the parts of the brain which control
p.000056: cognitive functions is more likely to affect cognitive abilities than integration into other parts of the brain;
p.000056: and
p.000056:
p.000056: (f) The presence of pathologies in the host animal: It is possible that the humanising
p.000056: effect of transplanted human stem cells in an animal with a pathological condition might be greater than
p.000056: would be the case in a robust healthy organism. This is relevant if animal models of disease processes
p.000056: are used as a basis for trial approaches to treatment.
p.000056:
p.000056: 7.23 These factors and others need to be considered together and not in isolation, as they may combine or interact.
p.000056: The BAC is of the view that these or similar considerations should guide the deliberations of bodies in a position to
p.000056: permit or regulate research with human-animal combinations.
p.000056:
p.000056: Guidelines on Human Stem Cell Research
p.000056:
p.000056: 7.24 Human stem cell research that is not ethically contentious, such as research using established
p.000056: pluripotent stem cell lines and confined to cell culture or research that involves routine and standard
p.000056: research practice with laboratory animals, should be exempted from review. All other human stem cell
p.000056: research should undergo full or expedited review by an IRB. Approval from MOH must also be obtained if
p.000056: the
p.000056:
p.000056:
p.000056: 32 Ourednik V et al. Segregation of Human Neural StemXCells in the Developing Primate Forebrain. Science.
p.000056: 293 (2001): 1820-1824.
p.000056: 33 Greene M et al. Moral Issues of Human-Non-Human Primate Neural Grafting. Science. 309 (2005): 385- 386.
p.000056:
p.000057: 57
p.000057:
p.000057: HUMAN STEM CELL RESEARCH
p.000057:
p.000057: research involves the use of human eggs, human embryos, or human-animal combinations.34
p.000057:
p.000057: 7.25 The procurement of biological materials (gametes, embryos, foetal tissue or somatic cells), including
p.000057: imported materials for stem cell research, should be in accordance with the guidelines provided in Part V.
p.000057:
p.000057: 7.26 In human-animal combinations research involving live animals or resulting in the creation of live
p.000057: animals, the IRB should also ensure that the proposal has been approved by the Institutional Animal Care and
p.000057: Use Committee, whose remit covers the welfare of laboratory animals.
p.000057:
p.000057: 7.27 Where human embryonic stemXcells, induced pluripotent stemXcells, or any other kind of pluripotent stem
p.000057: cells are introduced into animals at any stage of development, particular attention should be paid to
p.000057: the need to avoid the creation of entities in which human sentience or consciousness might be expected to
p.000057: occur.
p.000057:
p.000057: 7.28 Animals into which human embryonic stemXcells, induced pluripotent stemXcells, or any other kind of
p.000057: pluripotent stemXcells have been introduced should not be allowed to breed.
p.000057:
p.000057: 7.29 Human cytoplasmic hybrid embryos should not be allowed to develop beyond 14 days
p.000057: in vitro or to be implanted into the body of any human or animal.
p.000057:
p.000057: 7.30 If the research involves introducing human embryonic stemXcells or any pluripotent cells, or products derived
p.000057: from these cells, into humans, or any novel applications of any stemXcells that are outside the scope of established
p.000057: standards of medical care, it should be conducted in accordance with the requirements and standards of a clinical trial
p.000057: for cell-based products, as specified by the HSA, and approval from HSA must be obtained. IRBs must ensure that:
p.000057:
p.000057: (e) The proposal is reviewed and approved by a scientific review committee with the relevant expertise;
p.000057:
p.000057: (f) There is strong evidence of the safety and efficacy of the cells from pre-clinical studies;
p.000057:
p.000057: (c) The research participants have been provided with sufficient information, in particular information on
p.000057: the nature and risks of the research, and the source of the cells, so that their values and beliefs are respected; and
p.000057:
p.000057: (d) Appropriate and informed consent has been obtained, without any inducement, coercion or undueXinfluence.
p.000057:
p.000057: These recommendations do not apply to innovative or experimental uses of stemXcells in clinical practice, which fall
p.000057: outside the remit of the BAC’s terms of reference.35
p.000057:
p.000057: 34 MOH, Licensing Terms and Conditions for Assisted Reproduction Centres (2011) at paras. 9.1 and 10.3.
p.000057: 35 The International Society for Stem Cell Research has issued recommendations for the clinical translation of stem
p.000057: cells, including innovative medical use of stemXcells: Guidelines for the Clinical Translation of Stem.
p.000057:
p.000058: 58
p.000058:
p.000058: HUMAN STEM CELL RESEARCH
p.000058:
p.000058: 7.31 No clinical or research personnel should be under a duty to conduct or assist in human embryonic stem cell or
p.000058: induced pluripotent stem cell research, or research involving human-animal combinations, to which they have a
p.000058: conscientious objection, nor should they be put at a disadvantage because of such objection.
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p.000058: Cells (2008), online: .
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p.000060:
p.000060: GLOSSARY
p.000060:
p.000060: GLOSSARY
p.000060:
p.000060:
p.000060: Alzheimer’s disease – A degenerative brain disorder common in the elderly, characterised by progressive deterioration
p.000060: of mental functions leading to impaired cognition and increased reliance on others for daily activities.
p.000060:
p.000060: Assisted reproductive (AR) technologies – The use of clinical and laboratory techniques to increase the chances of
p.000060: conceiving a baby. An example is in vitro fertilization, or IVF.
p.000060:
p.000060: Chimera – An organism whose body contains cells from another organism of the same or a different species.
p.000060:
p.000060: Cytoplasmic hybrid embryo – An embryo created by the transfer of the nucleus of a somatic cell from one species
p.000060: into an egg of another species from which the nucleus has been removed.
p.000060:
p.000060: Embryo – The earliest stage of development of an organism.
p.000060:
p.000060: Embryonic germ cell – An unspecified cell derived from primordial reproductive cells of developing foetuses
p.000060: that is able to replicate itself indefinitely and develop into all types of cells.
p.000060:
p.000060: Embryonic stem cell – An unspecialised cell derived from an embryo that is able to replicate itself indefinitely and
p.000060: develop into all types of cells.
p.000060:
p.000060: Foetus – The stage of development of an organism beyond the embryo and before birth, when tissues and organs have
p.000060: started to differentiate.
p.000060:
p.000060: Gamete – Sperm or egg.
p.000060:
p.000060: Genome – The complete set of genetic information in an organism.
p.000060:
p.000060: Huntington’s disease – A neurodegenerative genetic disorder that causes the progressive breakdown of nerve
p.000060: cells in the brain and impacts the individual’s movement, cognition and behaviour. The disease is caused by an
p.000060: autosomal dominant mutation.
p.000060:
p.000060: Hybrid – An organism whose cells contain genetic material from organisms of different species.
p.000060:
p.000060: In vitro fertilisation (IVF) – A clinical and laboratory procedure whereby the eggs and sperm from a couple are
p.000060: extracted and fertilised outside their bodies. Such a procedure is a form of assisted reproduction aimed at increasing
p.000060: the chances of a couple conceiving a baby.
p.000060:
p.000060: Induced pluripotent stem cell – An adult somatic cell, such as a human skin cell, that has been
p.000060: reprogrammed (or induced) into an embryonic pluripotent state.
p.000060:
p.000060: Institutional review board (IRB) – A committee appointed by an institution to review the ethical standards
p.000060: of biomedical research proposals.
p.000060:
p.000060:
p.000061: 61
p.000061:
p.000061: GLOSSARY
p.000061:
p.000061: Oocyte – An egg cell.
p.000061:
p.000061: Pluripotent – The ability to differentiate into cells of the three germ layers in the body, namely the
p.000061: ectoderm, mesoderm and endoderm.
p.000061:
p.000061: Reproductive cloning – Process of creating a genetically identical copy of a human being or animal.
p.000061:
p.000061: Research cloning (also known as therapeutic cloning) – The use of cloning technology for research purposes that
p.000061: are directed towards a therapeutic goal, where genetically identical cells, tissues and organs may be used to
p.000061: treat the patient’s disease(s).
p.000061:
p.000061: Somatic or adult stemXcells – An unspecialised cell, present in a tissue or organ, that is able to replicate itself
p.000061: and develop into specialised cell types of that tissue or organ, or into some other cell types.
p.000061:
p.000061: Stem cell – An unspecialised cell that is able to replicate itself and develop into specialised cell types (such as a
p.000061: red blood cell, nerve, or heart cell).
p.000061:
p.000061: Tissue – An aggregation of similar cells that perform a particular function.
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p.000062: 62
p.000062:
p.000062: BIBLIOGRAPHY
p.000062:
p.000062: BIBLIOGRAPHY
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p.000062:
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p.000062:
p.000062: Australia. Privacy Act 1988. Amended 2012.
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p.000062: Australia. Prohibition of Human Cloning for Reproduction Act 2002. Amended 22 December 2008.
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p.000062: Brazil. Law Number 8974. 5 January 1995. Canada. Assisted Human Reproduction Act. 2004.
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p.000069: March 2011.
p.000069:
p.000069: United Kingdom. National Health Service Act. 2006.
p.000069:
p.000069: United Kingdom. National Health Services, National Patient Safety Agency, National Research Ethics Service.
p.000069: Information Sheets & Consent Forms: Guidance for Researchers & Reviewers. March 2011.
p.000069:
p.000069: United Kingdom. National Health Services, National Patient Safety Agency, National Research Ethics Service.
p.000069: Standard Operating Procedures for Research Ethics Committees. May 2010.
p.000069:
p.000069: United Kingdom, Nuffield Council on Bioethics. Novel Techniques for the Prevention of Mitochondrial DNA
p.000069: Disorders: An Ethical Review. June 2012.
p.000069:
p.000069: United Kingdom. Nuffield Council on Bioethics. Report on Human Tissue: Ethical and Legal Issues. April 1995.
p.000069:
p.000069: United Kingdom. Nuffield Council on Bioethics. The Ethics of Research Related to Healthcare in
p.000069: Developing Countries. 2002.
p.000069:
p.000069: United Kingdom. Royal College of Paediatrics and Child Health: Ethics Advisory Committee.
p.000069: Guidelines for the Ethical Conduct of Medical Research Involving Children. 2000.
p.000069:
p.000069: United Kingdom. The Health Service (Control of Patient Information) Regulations. 2002. United Kingdom. The Medicines
p.000069: for Human Use (Clinical Trials) Regulations. 2004.
p.000069: United Kingdom. UK Biobank Ethics and Governance Framework. October 2007.
p.000069:
p.000069: United Nations Educational, Scientific and Cultural Organisation. Report of the IBC on Pre- implantation Genetic
p.000069: Diagnosis and Germ-line Intervention. 24 April 2003.
p.000069:
p.000069: United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human Rights.
p.000069: 2005.
p.000069:
p.000069:
p.000070: 70
p.000070:
p.000070: BIBLIOGRAPHY
p.000070:
p.000070: United States of America. Office for Human Research Protections, Department of Health and Human Services. Protection of
p.000070: Human Subjects, Title 45 Code of Federal Regulations, Part
p.000070: 46. Revised 2009.
p.000070:
p.000070: United States of America. National Bioethics Advisory Commission. Research Involving Human Biological
p.000070: Materials: Ethical Issues and Policy Guidance. August 1999.
p.000070:
p.000070: United States of America. National Commission for the Protection of Human Subjects of Biomedical and
p.000070: Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human
p.000070: Subjects of Research. 1979.
p.000070:
p.000070: United States of America. National Institutes of Health. Guidelines for the Conduct of Research Involving
p.000070: Human Subjects at the National Institutes of Health. August 2004.
p.000070:
p.000070: United States of America. National Institutes of Health. NIH Guidelines for Research Involving Recombinant
p.000070: DNA Molecules. October 2011.
p.000070:
p.000070: United States of America. Nuremberg Code. In: Trials of War Criminals before the Nuremberg Military
p.000070: Tribunals under Control Council. Law No. 10, Vol. 2: 181-182. 1949.
p.000070:
p.000070: United States of America. Office for Civil Rights HIPAA Privacy. Research. 3 April 2003. World Health Organization. A
p.000070: Practical Guide for Health Researchers. 2004.
p.000070: World Health Organization. Genetic Databases Assessing the Benefits and the Impact on Human and Patient
p.000070: Rights. 2003.
p.000070:
p.000070: World Health Organization. Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells
p.000070: and Fluids in Research. 2003.
p.000070:
p.000070: World Health Organization. Handbook for Good Clinical Research Practice. 2005. World Health Organization. Review of
p.000070: Ethical Issues in Medical Genetics. 2003.
p.000070: World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research
p.000070: with Human Participants. 2011.
p.000070:
p.000070: World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving
p.000070: Human Subjects. Revised 2013.
p.000070:
p.000070: World Medical Association. WMA Declaration on Ethical Considerations Regarding Health Databases. October 2002.
p.000070:
p.000070:
...
p.000072: the BAC frequently receives enquiries about such matters, together with occasional requests for it to intervene or
p.000072: comment on issues.
p.000072: What is Human Biomedical Research?
p.000072:
p.000072: 1.7 Biomedical research is important because it is a basic prerequisite for evidence-based medicine. Research,
p.000072: in this context, means “a systematic investigation, including research development, testing and evaluation,
p.000072: designed to develop or contribute to generalisable knowledge.”36 Although the observations and clinical
p.000072: experiences of medical practitioners and others have been vital in the history of medicine, the systematic
p.000072: scientific foundations are also essential. While good medical practice entails far more than the mechanical
p.000072: application of science, good biomedical research is fundamental to its success, and is a safeguard against
p.000072: unsubstantiated or harmful claims. Biomedical research in general is thus regarded by the BAC as a public good.
p.000072: 1.8 Biomedical research has been defined as research having as its purpose the enhancement
p.000072: or improvement of medical practice.37 This extends the scope of biomedical research beyond research that is
p.000072: clinical, and it could include research that does not use human subjects at all. Much fundamental research in
p.000072: physiology and other disciplines has the eventual goals of medicine as its ultimate aim. In a similar way, the goal
p.000072: of much bioengineering is ultimately medical, though this is not true of the foundation disciplines in engineering. For
p.000072: such reasons it is difficult to provide a single definition that covers all obvious examples of research that
p.000072: have a clearly medical goal, while not becoming over-inclusive with respect to basic research that might ultimately
p.000072: be important for medicine but is not done with the aim of furthering its goals.
p.000072:
p.000072: 1.9 The BAC therefore adopts the following definition of human biomedical research:
p.000072:
p.000072: Human Biomedical Research refers to any research done for the ultimate purpose of studying, diagnosing, treating or
p.000072: preventing, any disease, injury or disorder of the human mind or body, and which entails the involvement of
p.000072: humans, human tissues or information derived from humans or human tissues.
p.000072:
p.000072: 1.10 The BAC takes the view that human biomedical research normally needs to be regulated because one
p.000072: or more of the following conditions will inevitably apply to any proposed human biomedical research:
p.000072:
p.000072:
p.000072: 36 US Department of Health and Human Services, 45XCFRX46.102(d).
p.000072: 37 Levine, RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al. (Eds.) The Oxford
p.000072: textbook of clinical research ethics. Oxford: OUP (2008), page 211.
p.000072:
p.000072:
p.000072:
p.000072: A3
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) The research involves intervention with respect to, interaction with, or observation of one
p.000072: or more human participants; or
p.000072: (b) The research will use or manipulate human biological materials (e.g. human cells, tissues, organs
p.000072: and body fluids), including those which were previously acquired and stored; or
p.000072: (c) The research entails the systematic review, analysis, use or publication of previously compiled
p.000072: identifiable (identified or reversibly de-identified) medical or personal information or biodata; or
p.000072: (d) The research topic is sufficiently sensitive to likely raise questions of public acceptability or
p.000072: public policy (e.g. research on human embryos or human- animal combinations); or
p.000072: (e) The research could be considered sensitive by virtue of the nature of the personal information it
p.000072: proposes to gather.
p.000072: 1.11 The BAC is concerned with human biomedical research, not with the wider issues of research with human
p.000072: participants generally. It does not seek to determine the extent to which ethics governance for the protection of human
p.000072: subjects should be extended to research that is not biomedical, though this is clearly a matter of
p.000072: importance and public interest. It does, however, cover economic, sociological and other research in the humanities
p.000072: and social sciences whenever this research fits the above definition of human biomedical research.
p.000072: 1.12 The BAC also recognises that biomedical research could be more or less sensitive in character, where
p.000072: ‘sensitivity’ depends on societal considerations. For example, research that relied on sensitive
p.000072: information, such as about participants’ sexual practices or psychiatric history, would ipso facto be
p.000072: regarded as sensitive research. Similarly, research on cloning technology would generally be considered
p.000072: sensitive simply because the idea of using it to clone a human being is widely seen as unacceptable.
p.000072: Research deemed sensitive would attract more exacting regulatory control, or could be prohibited.38
p.000072: 1.13 Human biomedical research can be basic and far removed from the likelihood of immediate
p.000072: application, or it can be explicitly clinical and therapeutic in character. Clinical research includes
p.000072: clinical trials, for which the Health Sciences Authority (HSA) is the licensing authority.
p.000072:
p.000072:
p.000072:
p.000072: 38 The sensitivity of research with human embryonic stemXcells, or with cloning technology, is manifestly
p.000072: sensitive in the sense that the morality and acceptability of such research is disputed. For this reason the BAC had
p.000072: in its Stem Cell Report, recommended a strict regulatory regime, especially for the creation of human
p.000072: embryos specifically for research, and additionally recommended a ‘conscience clause’ allowing conscientious
p.000072: objection to participation in any manner in human stem cell research. See Recommendations 3-5 and 11 of that Report.
p.000072:
p.000072:
p.000072:
p.000072: A4
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 1.14 There is a long tradition in medicine of medical practitioners publishing clinical case reports based on their
p.000072: own cases, and these reports have often been a valuable source of learning in the profession. The BAC is of
p.000072: the view that the publication of case reports not amounting to a systematic programme of research is a matter for
p.000072: journal editors, and the Singapore Medical Council as the authority for upholding the requirements of
p.000072: medical ethics in Singapore. Such publication does not necessarily require independent ethics review, as
p.000072: both medical ethics and the requirements of journal editors that informed consent be obtained offer
p.000072: safeguards against the improper publication of case reports.
p.000072: The Legislative and Regulatory Framework of Human Biomedical Research in Singapore
p.000072:
p.000072: 1.15 All research in Singapore, like any other activity, is bound by the laws of Singapore, comprising a
p.000072: combination of case and statute law. A number of statutes and regulations made under them are relevant to the
p.000072: conduct of biomedical research.
p.000072: Statutes and Subsidiary Legislation
p.000072:
p.000072: 1.16 Relevant statutes and subsidiary legislation are as follows. The list is not exhaustive, but covers all the
p.000072: principal sources of legislation impinging on biomedical research practice:
p.000072: (a) Medicines (Clinical Trials) Regulations (Cap. 176, Rg 3) made under Sections 18 and 74 of the Medicines Act
p.000072: (Cap. 176) (1985 Ed.), which is an Act to make provisions with respect to medicinal products and medical advertisements
p.000072: and matters connected therewith;
p.000072: (b) Health Products Act (Cap. 122D) (2008 Ed.): An Act to regulate the manufacture, import,
p.000072: supply, presentation and advertisement of health products and of active ingredients used in the manufacture of health
p.000072: products and provide for matters connected therewith;
p.000072: (c) Ministry of Health (MOH), Licensing Terms and Conditions on Assisted Reproduction Services (2011)
p.000072: imposed under Section 6(5) of the Private Hospitals and Medical Clinics Act (Cap. 248) (1999 Ed.),
p.000072: which is an Act to provide for the control, licensing and inspection of private hospitals, medical
p.000072: clinics, clinical laboratories and healthcare establishments, and for purposes connected therewith. Sections 9
p.000072: and 10 of the Licensing Terms and Conditions relate to research;
p.000072: (d) Medical (Therapy, Education and Research) Act (Cap. 175) (1985 Ed.) (amended vide Act 4/2010):
p.000072: This is an Act to make provision for the use of the bodies of deceased persons or parts thereof for purposes
p.000072: of medical or dental education, research, advancement of medical or dental science, therapy and
p.000072: transplantation, and for other purposes connected therewith;
p.000072:
p.000072:
p.000072:
p.000072: A5
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (e) Human Cloning and other Prohibited Practices Act (Cap. 131B) (2005Ed.): An Act to prohibit the placing of a
...
p.000072: Scientific Purposes, 2004. Administered by the Agri-Food and Veterinary Authority of Singapore and the National
p.000072: Advisory Committee on Laboratory Animal Research;
p.000072: (f) National Medical Ethics Committee (NMEC),39 Recommendations On Clinical Trials: Update Focusing On Phase 1
p.000072: Trials, 2007;
p.000072: (g) NMEC, Ethical Guidelines for Gene Technology, 2001;
p.000072:
p.000072: (h) NMEC, Ethical Guidelines on Research involving Human Subjects, 1997; and
...
p.000072:
p.000072: 2.4 As a consequence of such considerations there have been a number of international documents and declarations
p.000072: that form the foundations of ethical biomedical research governance as practised in major jurisdictions. They have
p.000072: also formed the basis for the ethical principles that have guided the BAC. Of these foundation documents and
p.000072: declarations the following are key:
p.000072:
p.000072: (a) The Nuremberg Code (1947), reported in 1949;
p.000072:
p.000072: (b) The Declaration of Helsinki: Ethical Principles for Research Involving Human Subjects (1964, Revised 2008);
p.000072:
p.000072: (c) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
p.000072: Research (1979);
p.000072:
p.000072:
p.000072: 40 The BAC used the term “subject” in its earlier reports, but more recently has used the term
p.000072: “participant”. The latter is increasingly used in many jurisdictions as it implicitly acknowledge the fact that
p.000072: research participants choose to participate, and should not be merely the passive subjects of research.
p.000072: These terms are however treated as interchangeable in these Guidelines.
p.000072:
p.000072:
p.000072:
p.000072: A8
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (d) The International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002); and
p.000072: (e) The United Nations Educational Scientific and Cultural Organisation (UNESCO) Universal
p.000072: Declaration on Bioethics and Human Rights (2005).
p.000072:
p.000072: General Ethical Principles that have Guided the BAC
p.000072:
p.000072: 2.5 A review of the five foundation documents above reveals that participants need to be protected and their
p.000072: autonomy in matters of research participation recognised. Although these documents do not agree in
p.000072: every particular, they appear to be in accord in their fundamentals. Based on these, the BAC formulated
p.000072: five guiding principles reflecting their local application, first summarised in its Egg Donation Report. In
p.000072: particular, as enjoined by the UNESCO Declaration, the BAC expects researchers to be aware of and respect the
p.000072: cultural and religious diversity of Singapore society. The BAC also indicated that respect for individuals can be
p.000072: subordinate to the public interest in certain cases, as in some kinds of public health research.
p.000072: 2.6 The five principles the BAC endorses are as follows:
p.000072:
p.000072: Respect for persons
p.000072:
p.000072: 2.7 Individuals are to be respected as human beings and treated accordingly. This includes respecting
p.000072: their right to make their own decisions without being coerced, misled, or kept in ignorance, which the BAC
p.000072: refers to as autonomy.41 Their welfare and interests are to be protected, especially when their autonomy is
p.000072: impaired or lacking. This principle mandates the need for informed consent to participation in research;
p.000072: respect for privacy; for safeguarding confidentiality; for protecting vulnerable participants; and it
p.000072: also requires a proper regard for religious and cultural diversity.
p.000072: 2.8 This principle integrates with many other aspects of life in societies that could be described
p.000072: as free or self-regulating (democratic) rather than totalitarian or highly communitarian (hierarchical).
p.000072: Ideals such as all citizens being equal under the law, or having rights to privacy and the management of their
p.000072: affairs, to the enjoyment of security and public health and safety, with rights over their own bodies,
p.000072: and many others, all, in the last analysis, come down to the principle that individuals should be accorded certain
p.000072: basic rights or entitlements arising from their existence in society. These entitlements exist notwithstanding
p.000072: individual differences in endowment of race, character, gender or talent, and without requirement that individuals
p.000072: justify them. An individual’s autonomy can be curtailed under certain circumstances, such as when quarantined
p.000072: in disease epidemics.
p.000072:
p.000072:
p.000072:
p.000072: 41 NMEC similarly referred to autonomy as “the right of individuals to decide for themselves what
p.000072: is good for them.” Paragraph 2.3.1, Ethical Guidelines on Research Involving Human Subjects (1997).
p.000072:
p.000072:
p.000072:
p.000072: A9
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Solidarity
p.000072:
p.000072: 2.9 The BAC earlier advocated a principle of reciprocity between the individual and the wider society, as a way
p.000072: to capture the well-established idea that there is some measure of mutual obligation that regulates the relationship
p.000072: between the individual and society. In biomedical research where there is minimal risk of harm to
p.000072: participants, agreed social benefits – considered as a public good – carry an implication that, if accepted, they
p.000072: inherently reflect an in-principle willingness to consider participation in research of the kind yielding the
p.000072: accepted benefits. This means that there is a balance to be struck between the interests of the public and
p.000072: the rights of individual participants; and that incompatible and irreconcilable ethical perspectives should be
p.000072: resolved with some regard to the public interest.
p.000072: 2.10 However, the underlying principle is perhaps better expressed as one of solidarity. The essential
p.000072: principle is not one of individual exchange, but of a wider vision in which a common interest is invoked as
p.000072: a reason for the subordination of individual interest to that of a group in specified circumstances. Expressing the
p.000072: idea as solidarity reflects the importance of general altruism as a basis for participation in biomedical research.
p.000072:
p.000072: Justice
p.000072:
p.000072: 2.11 The concept of justice as applied to research includes the general principle of fairness and equality under
p.000072: the law. This implies that access to the benefits of publicly funded research, and the burden of supporting it,
p.000072: should be equitably shared in society. It should not, for example, be considered ethical to exempt a class of
p.000072: otherwise suitable patients from participation in research by virtue of economic status.42 The concept of justice also
p.000072: implies that researchers and their institutions incur some responsibility for the welfare of participants and their
p.000072: possible compensation and treatment in the event of adverse outcomes arising directly from their participation.
p.000072: It mandates careful consideration of the arrangements in place for ancillary care or follow-up in the case of
p.000072: research participants located in regions that may be resource-poor relative to the initiating country. Moreover, in
p.000072: the event research yields an immediate benefit that could apply to one of the participants in the research,
p.000072: justice would dictate that the benefit be offered.43
p.000072: 2.12 Although it is easy to defend the generic idea of justice as fundamental to the proper functioning of any
p.000072: society, both justifying and implementing a specific conception of justice is difficult, since research may
p.000072: entail compromises between competing
p.000072:
p.000072:
p.000072: 42 “For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell
p.000072: largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private
p.000072: patients.” Belmont Report, Part B 3, given as an example of a manifest injustice. It would also breach the principle of
p.000072: solidarity.
p.000072: 43 An obvious example would be a participant in a placebo controlXgroup.
p.000072:
p.000072:
p.000072:
p.000072: A10
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: interests. What different parties in a disagreement see as fair may depend upon widely different assumptions.
p.000072: Proportionality
p.000072:
p.000072: 2.13 The regulation of research should be in proportion to the possible threats to autonomy, individual welfare,
p.000072: or public good. Proportionality is fundamental to the administration of any system of
...
p.000072: example, the Singapore Statement on Research Integrity put up by the 2nd World Conference on Research
p.000072: Integrity,46 research integrity is not a simple concept. Essentially it is thought of in terms of the following
p.000072: components:
p.000072: (a) The trustworthiness of the research product, as manifest in attention to the details of the
p.000072: scientific process in ways that maximise objectivity and minimise bias or selectivity by researchers. Research
p.000072: should be reported in ways that allow others to replicate it and test the research conclusions;
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 45 In the US, for example, the regulatory requirements of minimising risks to participants and ensuring that
p.000072: the risks are acceptable in light of the anticipated benefits have been grounded in beneficence as a basic ethical
p.000072: principle in the Belmont Report, which subsumes non-maleficence under beneficence.
p.000072: 46 More information on the World Conference on Research Integrity can be found at:
p.000072: http://www.singaporestatement.org/
p.000072:
p.000072:
p.000072:
p.000072: A12
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (b) The ethics of the research environment, as manifest for instance in institutional practice, the regulation of
p.000072: research, the sensitivity of the research to the social context in which it occurs, and the measures taken to ensure
p.000072: that professional standards are respected; and
p.000072:
p.000072: (c) The avoidance by researchers of any plagiarism or fabrication of data.
p.000072:
p.000072: 2.18 The BAC’s view is that research integrity is essential. To some extent the presumptive integrity of research,
p.000072: and of researchers, is already implicit in adherence to the general ethical principles outlined above, but its
p.000072: importance is made explicit wherever appropriate in these Guidelines.
p.000072: 2.19 The BAC is also of the view that research institutions have a responsibility to ensure that the
p.000072: requirements of research integrity are observed, and IRBs have a responsibility to check that
p.000072: research integrity, as well as research merit, has been considered.
p.000072: 2.20 The principles given above are general in nature and fundamental to ethics governance
p.000072: of biomedical research involving human participants or the use of the biospecimens that they have
p.000072: contributed, and of information about persons obtained or derived from the research process. In practice these
p.000072: principles emerge in a number of more specific guidelines, considered below.
p.000072:
p.000072: Ethics Review of Biomedical Research in Singapore – the IRB system
p.000072:
p.000072: 2.21 Ethics governance of research in Singapore has been established in statute for the specific case
p.000072: of clinical trials. The Medicines Act 1975 (Chapter 176, Sections 18 and
p.000072: 74) and Medicines (Clinical Trials) (Amendment) Regulations 1998, require that all clinical trials be conducted in
p.000072: accordance with the Singapore Guideline for Good Clinical Practice (SGGCP), which is adapted from the
p.000072: International Conference on Harmonisation Tripartite Guideline E6: Note for Guidance on Good Clinical Practice
p.000072: (CPMP/ICH/135/95). The SGGCP in turn requires that all proposals for pharmaceutical clinical
p.000072: trials be reviewed by independent ethics committees.
p.000072:
p.000072: 2.22 The HSA is the licensing authority for clinical trials. Since January 2006, researchers can make parallel
p.000072: submissions to both HSA and to their respective IRB. The regulatory approval from HSA, in the form of a
...
p.000072: review. Such research must present no more than minimal risks to the research participants, where minimal
p.000072: risk refers to an anticipated level of harm and discomfort that is no greater than that ordinarily encountered
p.000072: in daily life, or during the performance of routine educational, physical, or psychological tasks.
p.000072:
p.000072: 2.31 A less formal process of review than that of a standard full review is permissible for research that involves
p.000072: minimal risk. The Chairperson, or other IRB delegate(s) may be empowered to conduct such expedited reviews.
p.000072:
p.000072: 2.32 In the case of exemption from review, there should be no likelihood of harm, for example, when
p.000072: irreversibly de-identified data is used.. Researchers seeking exemption from review would need to make a request with
p.000072: an abbreviated protocol accordingly, and obtain endorsement from the IRB, before commencing the research.
p.000072:
p.000072: Multi-Centre and Multi-National Research
p.000072:
p.000072: 2.33 For multi-centre research, a lead IRB could be designated. The choice of the lead IRB should be dictated by
p.000072: considerations such as the principal institution of affiliation of the Principal Investigator, the location where the
p.000072: greater part of the research is carried out, the expertise of the constituted IRB, or the location where the largest
p.000072: number of subjects is located. The lead IRB will play the main role in conducting a full ethics
p.000072:
p.000072:
p.000072:
p.000072: A15
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: review, in coordinating the research programme, and in keeping other participating IRBs informed of any
p.000072: decisions or amendments, including those made during the whole research period.
p.000072:
p.000072: 2.34 For multi-national research, the local portion should be subject to review by the IRB of the local partner
p.000072: institution(s), and the local IRB(s) should have a final say on matters affecting local participants.
p.000072:
p.000072: Conflicts of Interest
p.000072:
p.000072: 2.35 Institutions, IRBs and members of IRBs, and researchers should take special care to avoid conflicts of
p.000072: interest, whether actual conflict, potential conflict, or only the appearance of conflict. Institutions should
p.000072: develop policies and procedures to identify, eliminate, minimise or manage conflicts of interest that may affect
p.000072: research.
p.000072:
p.000072: 2.36 Should an IRB member have a personal interest in the research under review, that member should
p.000072: disqualify himself or herself from any consideration of the case by the IRB, and he or she should refrain from offering
p.000072: his or her opinion to the IRB on the particular research under review. The member should make full disclosure of such
p.000072: an actual, potential or apparent conflict of interest to the IRB.
p.000072:
p.000072: 2.37 Researchers should disclose any real, potential or perceived individual conflicts of interest, when
p.000072: submitting their research proposals to the IRB, as well as any institutional conflicts which they are
p.000072: aware of, that may have an impact on their research. The IRB shall then decide on the appropriate steps to
p.000072: manage the conflict.
p.000072:
p.000072: 2.38 Threats to research integrity could arise when there is a conflict of interest between those who commission
p.000072: and fund research (including commercial organisations) and those who carry it out (the researchers).
p.000072: Routine checks and balances ensuring the integrity of the research process have developed in universities
p.000072: and other research institutions with a commitment to research. When research is recruited to the service of
p.000072: commercial or institutional interests, researchers may be in a difficult position if their results are inconsistent
p.000072: with the expectations or hopes of their source of funds. IRBs need to consider how best to avoid such threats to
p.000072: integrity when considering applications in which they might arise.
p.000072:
p.000072: Responsibilities of Institutions
p.000072:
p.000072: 2.39 Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research
p.000072: carried out on their premises or facilities; or by their employees or on their patients; or involving access to or use
p.000072: of human tissue collections, medical records or other personal information in their custody. They are also responsible
p.000072: for ensuring research integrity.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A16
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 2.40 Every institution that conducts human biomedical research, or allows such research to be carried out on
p.000072: its premises, should establish and maintain an appropriately constituted and effective IRB, or ensure that its
p.000072: researchXstaff have access to an IRB at another institution.
p.000072:
p.000072: 2.41 The institution should set up clear policies for the operation of IRBs. The composition of IRBs and
p.000072: specific operational details are provided in the MOH Operational Guidelines for Institutional Review Boards.47
p.000072:
p.000072: 2.42 It is the responsibility of institutions to provide adequate resources, including resources for the
p.000072: training and education of IRB members, and administrative support for the IRBs to discharge their responsibilities in
p.000072: an effective and timely manner.
p.000072:
p.000072: 2.43 Institutions should ensure that provisions are made to compensate or treat research participants
p.000072: for adverse consequences of their participation, where appropriate.
p.000072:
p.000072: 2.44 An institution must accept legal responsibility for the decisions of its IRB and must provide the IRB members
p.000072: with full indemnity against actions resulting from decisions made by those members in good faith in the course of their
p.000072: duties.
p.000072:
p.000072: 2.45 In view of the investment of time and effort in preparing for research, including the sourcing of funds, it
p.000072: would be proper for there to be in place some kind of mediation or appeals procedure, so that in the event that a
p.000072: research proposal is not approved by an IRB, the Principal Investigator has an opportunity to further justify the
p.000072: research, or if disagreement persists, to have available an appeal mechanism in which adjudication by some third party
p.000072: is possible. Institutions are responsible for ensuring that such a mechanism is in place.
p.000072:
p.000072: Responsibilities of IRBs
p.000072:
p.000072: 2.46 The functions of an IRB include the following:
p.000072:
p.000072: (a) The ethics review and approval of proposed human biomedical research projects;
p.000072:
p.000072: (b) Ensuring that research proposals have been scientifically evaluated and have scientific merit. The IRB
p.000072: is not expected to undertake the review itself, but has to be satisfied that it has been competently done;
p.000072:
p.000072: (c) Evaluating the provisions for the consent process to ensure that valid consent that is appropriate
p.000072: for the study to be undertaken is obtained;
p.000072:
p.000072: (d) The continuing review and oversight of the research projects approved by them;
p.000072:
p.000072: 47 Ministry of Health, Singapore, Operational Guidelines for Institutional Review Boards. 2007.
p.000072:
p.000072:
p.000072:
p.000072: A17
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (e) Reporting to their respective institutions any unusual or unexpected events arising from the research;
p.000072:
p.000072: (f) Providing feedback to and maintaining dialogue about applicable standards with their constituent researchers;
p.000072: and
p.000072:
p.000072: (g) Ensuring that there is an arrangement for receiving feedback from research participants.
p.000072:
p.000072: 2.47 IRBs should provide a fair hearing to those involved. If there are any doubts or difficulties
p.000072: with particular aspects of proposals, IRBs should clarify these in writing with the researchers, or in minuted
p.000072: face-to-face meetings between the IRB and researchers.
p.000072:
p.000072: 2.48 All discussions of the IRB should be appropriately minuted and all opinions recorded. The decision of the
p.000072: IRB should be provided in written form to the researcher and, where appropriate, a fair and frank account of
p.000072: the reasons for those decisions should be provided.
p.000072:
p.000072: Responsibilities of Researchers
p.000072:
p.000072: 2.49 Researchers are responsible for ensuring that their research is conducted with integrity and complies with all
p.000072: relevant laws and other regulatory obligations and requirements, including the conditions laid down by the IRB
p.000072: that approved their project. They should not vary their approved research without prior IRB agreement,
p.000072: unless the deviations are necessary to eliminate immediate hazards to participants, or when the changes involve only
p.000072: logistical or administrative aspects of the research.
p.000072:
p.000072: 2.50 Researchers should submit annual (or more frequent) progress reports as required by the IRBs, as well as
p.000072: project completion reports to their respective IRBs.
p.000072:
p.000072: 2.51 Reports of adverse events arising from the research should be submitted to the respective IRBs
p.000072: within 15 days of their occurrence. However, serious adverse events, such as those resulting in death or
p.000072: a life-threatening situation, or requiring hospitalisation of any research participant, should be reported
p.000072: immediately.
p.000072:
p.000072: 2.52 Researchers should not alter or modify in any way (whether in formulation, dosage or timing) any drug or
p.000072: other clinical regimen without the approval of the attending physician and the IRB.
p.000072:
p.000072: 2.53 Researchers should conduct their research in a professional manner and with due regards to
p.000072: applicable conventions and expectations with respect to the obtaining and managing of research data, the disclosure of
p.000072: conflicts of interest, and the reporting of the research.
p.000072:
p.000072:
p.000072:
p.000072: A18
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 2.54 When any clinically significant findings are discovered in the process of research, researchers
p.000072: should ensure that research participants are informed, if they have indicated their desire to know.
p.000072: III. Consent
p.000072:
p.000072: 3.1 Consent is a vital part of biomedical research. Consent requirements exemplify the principle of respect
p.000072: for persons by acknowledging individuals’ right to decide for themselves what is good for them. An IRB should
p.000072: evaluate the provision for consent whenever it considers a research proposal entailing work with human participants, or
p.000072: the use of biospecimens or identifiable personal information.
p.000072:
p.000072: 3.2 There is a distinction between the legal and ethical obligations arising on matters of consent. There are
p.000072: various situations where the law requires consent to be obtained, and where a procedure done without consent
p.000072: could be challenged in court. Legal requirements thus constrain what can or cannot be enforced concerning
p.000072: ethical obligations on consent. For instance, short of recommending a change in the law, it would not be possible to
p.000072: recommend waiving consent in any situation where the law sets some standard of consent. However, these
p.000072: Guidelines refer to ethical consent issues – what ought to be done in obtaining informed consent – and
p.000072: are to be understood as presuming observance of the law as it stands.
p.000072:
p.000072: Voluntary and Informed Consent
p.000072:
p.000072: 3.3 Consent must be voluntary and informed.48 Informed consent is not a matter of merely providing information,
p.000072: but requires that the person giving consent does so with adequate understanding. The language, occasion and
p.000072: manner of explanation, the level of detail offered, and the process by which the consent is taken, should all be aimed
p.000072: at helping the potential research participant to understand what consent is being asked for.
p.000072:
p.000072: 3.4 Consent taking entails providing sufficient relevant information and explaining it to prospective
p.000072: participants in ways that allow them to make an informed decision at an appropriate level of understanding. The
p.000072: requirements vary somewhat depending upon the nature of the research; whether involving tissue or genetic information;
p.000072: whether or not there may be clinically significant findings either directly or incidentally to the research;
...
p.000072: with a lasting power of attorney (LPA). The Act is silent with regards to whether or not next-of-kin can assume
p.000072: the responsibility for seeking and giving consent for medical treatment, including clinical trials. However, a donee
p.000072: who has been specifically given authority under the LPA to give or refuse consent to the carrying out or continuation
p.000072: of medical treatment by a health care provider, may also decide on the conduct of clinical trials.
p.000072:
p.000072: 3.12 In making such decisions, the donee must follow the statutory principles under the Act, viz., act
p.000072: in the donor’s best interests,50 have regard to the guidance in the Codes of Practice, carry out the donor’s
p.000072: instructions and make decisions within the scope of authority specified in the LPA. To give consent for the
p.000072: person lacking capacity to participate in clinical trials, the donee must be satisfied that:
p.000072:
p.000072: (a) The individual has previously indicated a willingness to participate; or
p.000072:
p.000072: (b) Consent would, in the judgement of the donee, have been given had the individual (not being a
p.000072: child), been able to make an informed choice.
p.000072:
p.000072: 3.13 Legal protection is offered to any individual acting in connection with the care or treatment of
p.000072: a person lacking capacity, provided certain requirements, set out in Section 7(1) of the Act, are met.
p.000072: However, this statutory immunity does not apply to clinical trials, by virtue of an express exclusion in Section 7(3).
p.000072:
p.000072: 3.14 It should be stressed that biomedical research other than clinical trials research is not covered under the
p.000072: Act. A donee or other proxy is obligated under the Act to put the best interests of the participant first, yet
p.000072: participation in research is not usually a benefit to the participant. Consequently, consenting to
p.000072: participation in research on
p.000072:
p.000072: 50 With regard to best interests, Mental Capacity Act, section 6 (7) states: “He [the proxy] must consider, so
p.000072: far as is reasonably ascertainable –
p.000072: (a) the person’s past and present wishes and feelings (and, in particular, any relevant written statement made by him
p.000072: when he had capacity);
p.000072: (b) the beliefs and values that would be likely to influence his decision if he had capacity; and
p.000072: (c) the other factors that he would be likely to consider if he were able to do so.”
p.000072:
p.000072:
p.000072:
p.000072: A21
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: behalf of a non-competent person cannot be defended as in the person’s best interest if no clinical trial is involved.
p.000072:
p.000072: Consent Involving Vulnerable Persons
p.000072:
p.000072: 3.15 While it is usual to treat the individual as an autonomous agent for purposes of taking consent, provision has
p.000072: to be made when considering research participants who might be considered vulnerable. Such participants include:
p.000072:
p.000072: (a) Adults with diminished mental powers (such as the intellectually disabled or patients with dementia
p.000072: or others who lack mental capacity as defined in the Mental Capacity Act) or because they are incapacitated
p.000072: through accident, injury or illness;
p.000072:
p.000072: (b) Those whose autonomy might be prejudiced by being under the influence of, or the control of, or obligated to,
p.000072: third parties; and
p.000072:
p.000072: (c) Infants or children. In the case of under-aged research participants issues of consent primarily
p.000072: involve parent or guardians.
p.000072:
p.000072: Consent from Vulnerable Persons not Lacking Capacity
p.000072:
p.000072: 3.16 Vulnerable adult research participants not only include those who are of diminished capacity, but also
p.000072: those whose autonomy might be prejudiced by being under the influence of, or the control of, or
p.000072: obligated to, third parties. Potentially vulnerable participants might include, but are not limited to:
p.000072:
p.000072: (a) Prisoners;
p.000072:
p.000072: (b) Serving uniformed personnel, especially junior ranks;
p.000072:
p.000072: (c) Patients, especially if the intending researcher is their attending physician; and
p.000072:
p.000072: (d) Employees, junior collaborators, or students.
p.000072:
p.000072: 3.17 In such cases, consent should be taken by independent third parties, whenever possible, and
p.000072: prospective participants reassured that they have nothing to fear in declining research participation or
p.000072: in contributing tissue for research. Thus consent among uniformed personnel, for example, should not be taken by
p.000072: a senior officer, and preferably not by uniformed personnel at all.
p.000072:
p.000072: 3.18 When it is not possible for consent to be taken by an independent third party, the IRB may give directions for
p.000072: the consent to be taken by the researcher so long as there are provisions to manage the conflict of interest and
p.000072: sufficient safeguards to protect the welfare and interests of the participant.
p.000072:
p.000072:
p.000072:
p.000072: A22
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 3.19 A further issue of vulnerability arises in societies where social proxy arrangements are widespread, for
p.000072: example, where a village headman might be felt to have authority to give consent on behalf of a village, or a husband
p.000072: on behalf of a wife. Not all societies treat their individual members as autonomous. This can become
p.000072: an issue if researchers based in Singapore seek to conduct research in places where social proxy arrangements are
p.000072: widespread. In such cases, while local customs are to be respected, they cannot supersede a requirement for individual
p.000072: consent.
p.000072:
p.000072: Consent from Patients
p.000072:
p.000072: 3.20 It is important to note differences between a patient’s consent for treatment and an individual’s
p.000072: consent for participating in research. The main difference is that in giving consent for treatment, a patient is
p.000072: accepting a proposed action that is intended for his or her benefit, and thus, needs to balance any risks or undesired
p.000072: consequences (such as side effects) against the benefit(s) sought. These risks may be substantial, but may be
p.000072: acceptable to the patient if no better treatment is available and some treatment is strongly indicated. Because
p.000072: research, by contrast, is not designed to confer benefit for the research participant (although it may sometimes do
p.000072: so), there are thus usually no personal benefits against which to balance risks. The benefit is general and
p.000072: the consent of the participant fundamentally altruistic in character. High levels of risk thus become very
p.000072: unacceptable, and even low levels are to be avoided as far as possible.
p.000072:
p.000072: 3.21 Consent for treatment should therefore be clearly separated from consent for participating
p.000072: in research. When a researcher is also the attending physician, the researcher-physician should be aware of
p.000072: a potential conflict of interest and of the fact that his or her patients may feel obliged to give consent.
p.000072: Ideally, the consent for research should be taken by an independent third person, though this is not
p.000072: always possible. In such situations, the IRB may give directions for the consent to be taken by the
p.000072: researcher-physician so long as there are provisions to manage the conflict of interest and sufficient safeguards to
p.000072: protect the welfare and interests of the patient.
p.000072:
p.000072: Consent for Research Involving Children
p.000072:
p.000072: 3.22 Children present certain consent issues if involved in research, and they are
p.000072: categorised as a vulnerable class of research participants. In some jurisdictions a distinction is made
p.000072: between consent and assent, such that if parents consent, research can proceed provided children assent, i.e.
p.000072: agree. The assent of a child is not comparable to the informed consent of an adult. It is perhaps
p.000072: better regarded as a mechanism for engaging the child in the research process, in such a way as to respect the
p.000072: child’s right to object, and to entitle them to as reasonable an explanation as may be reasonable, consistent with
p.000072: the child’s level of understanding, but without an
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A23
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: implication that the child is giving informed consent.51 In clinical research that has a reasonable expectation of
p.000072: benefitting a child, the research might be allowed to proceed even without the child’s assent, if the
p.000072: parents give consent, but in general, researchers should respect refusal by a child. Because, in Singapore, there
p.000072: is no clear legal standing for assent as a procedure – unlike the case of consent – the BAC retains the use of the term
p.000072: consent for children as well as adults, but on the understanding that a child’s consent can be informed only to the
p.000072: extent that is reasonable given the child’s age, and that a combination of parental and child consent is
p.000072: the normal requirement. The older the child and the more mature his or her understanding, the more important it is to
p.000072: engage them in ways that respect their level of understanding and their right to refuse.
p.000072:
p.000072: 3.23 In Singapore, under the common law, the age of majority is 21 years. This age is generally
p.000072: taken as the age at which a person is considered an adult and thus able to make all decisions for oneself.
p.000072:
p.000072: 3.24 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000072: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy. The gift
p.000072: will take effect upon death.
p.000072:
p.000072: 3.25 Under the Medicines (Clinical Trials) Regulations, consent for participation in clinical trials must be
p.000072: obtained from the parent, guardian or legal representative of an individual below the age of 21.
p.000072:
p.000072: 3.26 The BAC is of the view that for research involving individuals less than 21 years of age and presenting more
p.000072: than minimal risk, such as those with invasive procedures, consent from parents should be obtained, in addition to
p.000072: consent from the child. For research that does not involve more than minimal risk, such as surveys, IRBs should be able
p.000072: to waive parental consent.
p.000072:
p.000072: Waiver of Consent
p.000072:
p.000072: 3.27 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000072: typically epidemiological or public health research carried out with medical records or with data from national
p.000072: registries, when the following conditions are met:
p.000072:
p.000072: (a) The research is justified and poses no more than minimal risk to research participants;
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 51 For a discussion on the meaning of assent in research see Wilfond, BS & Diekema, DS. Engaging
p.000072: children in genomics research: decoding the meaning of assent in research, Genetics in Medicine (2012), 14
p.000072: (4): 437-443.
p.000072:
p.000072:
p.000072:
p.000072: A24
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (b) The waiver will not adversely affect the welfare and interests of research participants;
p.000072:
p.000072: (c) The research could not practicably proceed without the waiver;
p.000072:
p.000072: (d) Obtaining consent is not possible or practicable;
p.000072:
p.000072: (e) Individual privacy and confidentiality of the personal information are assured; and
p.000072:
p.000072: (f) In the event that clinically significant findings are discovered, affected individuals who
p.000072: have indicated their wish to know will be informed in a timely manner, if reasonably possible.
p.000072:
p.000072: 3.28 Exceptionally, valuable research might require the recruitment of highly compromised patients, such as
p.000072: accident trauma victims, who are unable to give consent and for whom no proxy is available to give
p.000072: consent. In such cases, always subject to the treatment of the patient remaining the priority, and
p.000072: subject to the provisions of the Mental Capacity Act, it may be appropriate for an IRB to authorise the research,
p.000072: with patient consent being sought (directly or from a proxy) as soon as is practicable, and with the clear
p.000072: understanding that a patient shall have every right to withdraw or decline with retrospective effect (which
p.000072: will require removing earlier collected data from the study).52
p.000072:
p.000072: Clinically Significant Incidental Findings
p.000072:
p.000072: 3.29 A clinically significant incidental finding occurs when, in the course of research done for some other
p.000072: purposes, a finding is made that has a clear implication for the health of the participant to whom it relates. Research
p.000072: findings are by their nature provisional and not definitive. Where research data suggests the presence of a clinically
p.000072: important condition that would require a confirmation and possible treatment, there is some duty on the part of the
p.000072: researcher to ensure that the research participant is informed of the possible condition with advice to follow up the
p.000072: matter with a medical practitioner.
p.000072: 3.30 Research participants should be given the choice of whether to be informed about such findings,
p.000072: prior to the commencement of the research, if the research is such that there is some reasonable possibility that
p.000072: incidental findings may occur. Researchers should ensure that research participants, who so choose, are informed and
p.000072: advised to seek medical attention and confirmation of the research result in a clinical laboratory.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 52 This contingency has been considered by the UK MRC Ethics Guide: Medical research involving
p.000072: adults who cannot consent, 2007 (section 4.3).
p.000072:
p.000072:
p.000072:
p.000072: A25
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 3.31 Communication of clinically significant findings to research participants could be directly by the
p.000072: researcher, or through a healthcare provider or other party authorised to receive the information and in a
p.000072: better position to advise and discuss the implications of the findings.
p.000072:
p.000072: 3.32 Communication of clinically significant incidental findings to biological relatives should be
p.000072: encouraged. This, including the question of who will do it and taking into account the participant’s preference, should
p.000072: be discussed and agreed upon at the time of obtaining consent
p.000072:
p.000072: 3.33 Parents who have indicated a wish to know, should be informed of clinically significant research
p.000072: results affecting their children’s health, when they are discovered. Upon reaching the age of 21 and if the
p.000072: research is still on-going, the individuals concerned will then be in a position to make their own decisions
p.000072: regarding whether or not to be contacted in the event that clinically significant incidental findings are
p.000072: uncovered.
p.000072:
p.000072: Guidelines on Consent
p.000072:
p.000072: 3.34 Consent for participation in research must be voluntary. There should be no coercion or undueXinfluence.
p.000072: Participants may be reimbursed for legitimate expenses, such as cost of transport and child care services, and actual
p.000072: loss of earnings. Any additional payment to be given, whether monetary or in kind, should not amount to an
p.000072: inducement.
p.000072:
p.000072: 3.35 Participants should be allowed to withdraw from the research at any time without any explanation, and without
p.000072: penalty or prejudice to any treatment they may be receiving.
p.000072:
p.000072: 3.36 Prospective research participants or authorised third parties should be provided with sufficient information
p.000072: in an understandable form and appropriate manner, to enable them to make an informed decision. Such information
p.000072: include:
p.000072:
p.000072: (a) The nature and purpose of the research;
p.000072:
p.000072: (b) Any entailed risks and benefits to them, and how any such risks are to be managed and minimised;
p.000072:
p.000072: (c) The safeguards for protecting their privacy and confidentiality of their personal information;
p.000072:
p.000072: (d) Any reimbursement or other payment for participation in the research;
p.000072:
p.000072: (e) The procedures and implications for withdrawal from the research; and
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A26
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (f) Any other information specific to the type of research, as given in the parts on human tissue research,
p.000072: genetic research, and stem cell research in these Guidelines.
p.000072:
p.000072: 3.37 Where there is a possibility that the research may yield clinically significant incidental findings,
p.000072: participants should be allowed to decide whether or not to be informed of the result, prior to the commencement of the
p.000072: research. Participants should also have an opportunity to express their preferences about the sharing of such
p.000072: information with biological relatives, or others.
p.000072:
p.000072: 3.38 Prospective participants should be given adequate time to decide whether or not to participate in
p.000072: the research and the opportunity to clarify any doubts that they may have.
p.000072:
p.000072: 3.39 Consent to participation in research should be documented in writing.
p.000072:
p.000072: 3.40 Consent could be specific to a particular research project, or general for the storage and future use of
p.000072: tissue or personal information. In any general consent, donors should be allowed to impose some limits
p.000072: to the use of their tissue or information. IRBs should have the discretion to decide, when considering
p.000072: a research proposal, whether specific consent is required or general consent is sufficient, if previously
p.000072: given.
p.000072:
p.000072: 3.41 For research involving vulnerable adults not lacking capacity (for example, prisoners, serving uniformed
p.000072: personnel, and employees), consent should be taken by independent third parties, whenever possible.
p.000072: Prospective participants should be reassured that they have nothing to fear in declining research
p.000072: participation or in contributing tissue for research. When it is not possible for consent to be taken by an
p.000072: independent third party, the IRB may give directions for the consent to be taken by the researcher so long as there are
p.000072: provisions to manage the conflict of interest and sufficient safeguards to protect the welfare and interests of the
p.000072: participant.
p.000072:
p.000072: 3.42 For research involving patients, consent for participating in research should be clearly separated from
p.000072: consent for treatment. When a researcher is also the attending physician, the consent for research should
p.000072: ideally be taken by an independent third person. If it is not possible, IRBs may give directions for the consent
p.000072: to be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000072: and sufficient safeguards to protect the welfare and interests of the patient.
p.000072:
p.000072: 3.43 While local customs should be respected when conducting research in places where social proxy arrangements
p.000072: are widespread, individual consent from prospective participant is nevertheless essential.
p.000072:
p.000072: 3.44 For research involving individuals less than 21 years of age and presenting more than minimal risk, such as
p.000072: those involving invasive procedures, consent from parents
p.000072:
p.000072: A27
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: should be obtained, in addition to consent from the child. Researchers should respect a child’s right to refuse to
p.000072: participate in research, and their entitlement to such explanation as may be reasonable, consistent with the
p.000072: child’s level of understanding. For research that does not involve more than minimal risk, such as surveys,
p.000072: IRBs should be able to decide to waive parental consent.
p.000072:
p.000072: 3.45 Clinical research that has a reasonable expectation of benefitting a child might be allowed to
p.000072: proceed even without the child’s consent, if the parents give consent.
p.000072:
p.000072: 3.46 IRBs may consider a waiver of the consent requirement for research done in the public interest,
p.000072: typically epidemiological or public health research carried out with medical records or with data from national
p.000072: registries, when the following conditions are met:
p.000072:
p.000072: (a) The research is justified and poses no more than minimal risk to research participants;
p.000072:
p.000072: (b) The waiver will not adversely affect the welfare and interests of research participants;
p.000072:
p.000072: (c) The research could not practicably proceed without the waiver;
p.000072:
p.000072: (d) Obtaining consent is not possible or practicable;
p.000072:
p.000072: (e) Individual privacy and confidentiality of the personal information are assured; and
p.000072:
p.000072: (f) In the event that clinically significant findings are discovered, affected individuals who
p.000072: have indicated their wish to know will be informed in a timely manner, if reasonably possible.
p.000072:
p.000072: 3.47 For valuable research involving recruitment of highly compromised patients who are unable to give consent and
p.000072: for whom no proxy is available to give consent, subject to the treatment of the patient remaining the priority, IRBs
p.000072: may authorise the research, with patient consent being sought, directly or from a proxy, as soon as is practicable. The
p.000072: patient or proxy shall have every right to withdraw or decline with retrospective effect (which will require removing
p.000072: earlier collected data from the study).
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A28
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: IV. Personal Information in Research
p.000072:
p.000072: 4.1 Personal information is any identifiable information about an individual, living or dead. It not
p.000072: only includes personal particulars, but also details of medical conditions, as well as information disclosed or derived
p.000072: in the process of healthcare management. In the research context, it will include any information collected, used or
p.000072: generated as part of the research process. Personal information varies widely in its sensitivity, as a function of use
p.000072: and context.
p.000072: 4.2 In research, information can be used in many unforeseen ways, and it is not practicable to give
p.000072: research participants a right to view, amend, delete or otherwise control data they have provided for research
p.000072: purposes. Moreover, the information may be such that it was in a sense created by the researcher, who by his or her
p.000072: procedures and interventions may have created the information – for instance a measure of memory, or an
p.000072: assessment of genetic potential – that might otherwise have been unknown. The ‘gift’ model for the
p.000072: altruistic donation of tissue for research might therefore be appropriate for the provision and management of
p.000072: research data, as this would allow it to be shared or re-analysed in other contexts or for other research
p.000072: purposes, subject to safeguards. Information created through research should be managed in ways that respect
p.000072: the need to observe confidentiality and care in use. It should remain in the care of and for the use of the
p.000072: researcher, subject to ethics governance procedures; rather than being treated as the continued property
p.000072: of the research participant or ‘donor’.
p.000072: 4.3 In particular, it is often valuable, and customary, to retain research data, which may include personal
p.000072: information, for future use, re-analysis, or re-investigation in the light of fresh developments. Many
p.000072: journals also require that research data be made available to other researchers who wish to replicate and
...
p.000072: researchers have a proportionate duty to maintain proper confidentiality. Under the principle of autonomy and respect
p.000072: for persons, healthcare practitioners and researchers alike have certain duties regarding the protection of
p.000072: confidential personal information that accrues to them in the course of their work, whether or not such
p.000072: information forms or originally formed part of a medical record. This implies that storage and security of
p.000072: data should be secured in proportion to its sensitivity.
p.000072: Use of Medical Records for Research
p.000072:
p.000072: 4.11 Medical information and data collected or generated in the process of diagnosing and managing a person’s
p.000072: health condition form the individual’s medical records. These records may be stored as physical records or
p.000072: electronic records. Most people regard their medical details as private and a matter for them and their
p.000072: physicians alone. Doctors are expected to respect the principle of medical confidentiality, as set out in the Ethical
p.000072: Code and Ethical Guidelines of the Singapore Medical Council. In a healthcare institution, all personnel
p.000072: who handle medical records (both physical and electronic) are under a legal and ethical obligation to observe the
p.000072: confidentiality of the information on the records and to safeguard the privacy of patients concerned.
p.000072: 4.12 Much valuable medical knowledge has, however, resulted from the study of patients’ medical records. Thus,
p.000072: the BAC is of the view that although the primary responsibility for access to medical records should
...
p.000072: (f) In the event that clinically significant findings are discovered, affected individuals who
p.000072: have indicated their wish to know will be informed in a timely manner, if reasonably possible.
p.000072:
p.000072: 4.20 Personal health information obtained or used for research purposes should not be released for
p.000072: other purposes. Research information may not be definitive, and research participants are entitled to expect that their
p.000072: data will not be used for purposes other than those for which they have given consent. Thus such information should not
p.000072: be disclosed to any third party, including employers or insurance companies.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A33
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: V. HUMAN TISSUE RESEARCH AND BIOBANKING
p.000072:
p.000072: 5.1 The term “human tissue” refers to any kind of human biological material from living or dead individuals. It
p.000072: includes blood and other body fluids and their derivatives, as well as solid body tissues, organs, foetuses, gametes
p.000072: and embryos, and is a valuable resource for biomedical research. Even tissue that has been stored for many years may be
p.000072: useful. The ethical issues concerning the use of human tissue for research relate to the collection, storage,
p.000072: access, and actual usage of the tissue (the purpose of the research); and to the use of information generated
p.000072: from research. Such information, may be central to the research or incidental, and may also have health implications
p.000072: for tissue donors or for their genetic relatives, and relevance for their employers or insurers.
p.000072: 5.2 Tissues for research may be newly obtained specifically for the purpose of research or they may come from
p.000072: pre-existing stored specimens. They may be specifically requested for research or they may be surplus
p.000072: tissue, consequent to a clinical procedure. They may also be identified or de-identified.
p.000072: 5.3 Human tissue banks are repositories, where human biospecimens taken for clinical or research use are stored.
p.000072: Tissue banks can be set up specifically for research, but many tissue banks exist primarily for clinical
p.000072: use in transplantation. Clinical tissue repositories, which consist of samples, such as blood or a
p.000072: tumour that has been surgically removed, that have been collected and used for clinical diagnosis, are also
p.000072: potentially useful for research. Some such repositories consist of accumulated and archived biospecimens that
p.000072: may have been acquired over a period of many years and can be described as legacy tissues.
p.000072: 5.4 Biobanks are collections of human biospecimens that are linked to personal information,
p.000072: which may include medical information of individuals from whom the specimens originate. The individuals may or may not
p.000072: be identifiable by the biobank. They may be created for research purposes or be part of a clinical service, such as a
p.000072: health screening programme. As they consist of biospecimens and data systematically collected from a large number of
p.000072: individuals, they are very valuable for research that may lead to better understanding of diseases.
p.000072: 5.5 Many countries, including Singapore, have created tissue banks and biobanks, some of which are national,
p.000072: while others are institution-based. Several initiatives have also involved international collaborations. For such
p.000072: initiatives, all parties involved should agree to a common set of ethical guidelines and standards for the collection,
p.000072: storage, use and disposal of the biospecimens collected.
p.000072: 5.6 It is unclear whether a person, or a body corporate, can legally own human tissue samples or
p.000072: whether an individual can have any property rights over his or her tissue after it is contributed for research. The
p.000072: question of ownership applies not only to the physical forms of human biological materials but also to their
p.000072: derivatives - whether in the form of data, discoveries or biological products. For this reason, the term
p.000072: of
p.000072:
p.000072:
p.000072: A34
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: custodianship has been used to refer to the relationship of tissue banks to the tissues they contain.53 However, it is
p.000072: generally accepted that the human body or any of its parts, should not be used as a means for financial gain. The
p.000072: donation of tissue for use in research should thus be considered as an altruistic gift. An altruistic donor does not
p.000072: retain rights in the donated tissue, or an intellectual property right in any commercially
p.000072: valuable development arising from the research, and donations should be made and accepted on that understanding.
p.000072: 5.7 As the use of human tissue is critical for biomedical research, both the public and research
p.000072: participants should have confidence that the biospecimens that they contribute are handled and used
p.000072: sensitively and responsibly. Researchers should always ensure that their collection and use of human tissue will
p.000072: not compromise the safety, welfare and interests of donors, which should be of paramount consideration.
p.000072: Guidelines on Human Tissue Research and Biobanking
p.000072:
p.000072: General
p.000072:
p.000072: 5.8 All research involving human tissue, whether identified or de-identified, should be reviewed by an
p.000072: IRB, and approved before it commences.
p.000072: 5.9 It is essential to protect the privacy of tissue donors and the confidentiality of their personal
p.000072: information, including personal information given by donors about individuals who are not themselves
p.000072: donors. All the requirements for the use of personal information in research in Part IV of these Guidelines will
p.000072: apply.
p.000072: 5.10 Donors should not be offered any financial incentives for their donation, although reasonable
p.000072: reimbursement of expenses incurred may be given.
p.000072: 5.11 Researchers and those managing tissue banks and biobanks need to be sensitive to religious and
p.000072: cultural perspectives and traditions, as these vary considerably amongst various religions and cultures, especially
...
p.000072: guardian was required, and there is ongoing contact. Once the child attains the age of 21, his or her consent should be
p.000072: obtained if research is to
p.000072:
p.000072:
p.000072: A36
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: be conducted on the previously collected tissue or information related to this tissue specimen. In the event
p.000072: re-contact is not practicable, the IRB should have the discretion to determine whether or not the stored material or
p.000072: information can be used without re-consent; and
p.000072: (c) For research deemed to be sensitive, such as that involving human eggs and embryos, or human-animal
p.000072: combinations.
p.000072:
p.000072: 5.17 Under the Medical (Therapy, Education and Research) Act, any person who is not mentally disordered
p.000072: and who is 18 years of age or above may give all or any part of his or her body for research or for therapy.
p.000072: The gift will take effect upon death. Legally authorised relatives of deceased individuals (which include
p.000072: still-born infants and foetuses) may also give all or part of the deceased person for research after or
p.000072: immediately before death, if there are no actual notice of contrary indications by the deceased person, or actual
p.000072: notice of opposition of another legally authorised person of the same or prior class.
p.000072: Foetal Tissues
p.000072:
p.000072: 5.18 Foetal tissues include membranes, amniotic fluid, placenta and umbilical cord. Foetal tissues for research
p.000072: should only be taken from dead or non-viable foetuses. Abortion should not be induced for the purpose of obtaining
p.000072: material for research.
p.000072: 5.19 Consent for the termination of pregnancy should be separate from the consent for obtaining foetal
p.000072: tissue or any tissue related to the pregnancy for research. Provisions for ensuring that where possible an attending
p.000072: physician should not also seek consent for research participation from a patient apply mutatis mutandis in this
p.000072: situation.
p.000072: 5.20 Consent for the use of foetal tissue for research could be obtained from either parent, as indicated in the
p.000072: Medical (Therapy, Education and Research) Act.
p.000072: 5.21 Any intention to propagate foetal cells in vitro and/or to transplant these cells into a human recipient
p.000072: should be disclosed when consent is sought.
p.000072: Human Gametes and Embryos
p.000072:
p.000072: 5.22 The creation of human embryos specifically for research can only be justified when there is strong
p.000072: scientific merit and potential medical benefit from such research. Under the Human Cloning and Other Prohibited
p.000072: Practices Act, the development of a human embryo created other than by fertilisation of human egg by human sperm, for a
p.000072: period of more than 14 days, excluding any period when the development of the embryo is suspended, is
p.000072: prohibited. Commercial trading in human eggs, human sperm and human embryos is also not allowed.
p.000072: 5.23 The use of human gametes or embryos for research is governed by the requirements of the law, as given in the
p.000072: MOH’s 2011 Licensing Terms and Conditions on Assisted Reproduction Services imposed under Section 6(5) of the
p.000072: Private Hospitals and
p.000072:
p.000072:
p.000072: A37
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Medical Clinics Act and by the Human Cloning and Other Prohibited Practices Act (Cap. 131B).
p.000072: 5.24 Under the Licensing Terms and Conditions on Assisted Reproduction Services, written approval from
p.000072: the Director of Medical Services must be obtained for all research involving human embryos and human
p.000072: oocytes (including those obtained from excised ovarian tissue). This requirement extends to human-animal combination
p.000072: gametes or embryos, which are those containing both human and animal genetic or non-genetic material and includes an
p.000072: embryo created by the fertilisation of human and animal gametes.
p.000072: 5.25 Consent from the donors must be obtained before any gametes or embryos are to be used for research.
p.000072: Individuals from whom the gametes or embryos are derived, should be provided with sufficient information to make an
p.000072: informed decision and be given at least a week to decide.
p.000072: 5.26 For women undergoing fertility treatment, consent for the donation of oocytes or embryos for
p.000072: research should be separate from the consent for treatment. The treating physician should not also be the
p.000072: researcher seeking consent for the donation of oocytes and embryos for research. Donors should confirm in writing
p.000072: that they do not require the oocytes or embryos for future use.
p.000072: 5.27 As the process of donating eggs for research is time-consuming, invasive and associated with a
p.000072: certain degree of discomfort and risks, women wishing to donate eggs specifically for research i.e. who are
p.000072: not also undergoing any fertility treatment, must be interviewed by an independent panel. The panel must be satisfied
p.000072: that they are of sound mind, clearly understand the nature and consequences of the donation, and have freely given
p.000072: explicit consent, without any inducement, coercion or undueXinfluence.
p.000072: 5.28 All egg donors should be informed if their eggs will be used to create embryos, including
p.000072: human-animal combination embryos, which will be destroyed in the process of research, and if any derived cells
p.000072: from the embryos so created will be kept for future research or possible clinical use. They should be
p.000072: assured that any embryos created for research will not be implanted or allowed to develop in vitro beyond 14 days.
p.000072:
p.000072: 5.29 Donors of eggs obtained specifically for research, and not as a result of clinical treatment,
p.000072: may be reimbursed for legitimate expenses incurred, such as cost of transport and childcare services, and
p.000072: actual loss of earnings, as a result of the procedures required to obtain the eggs. Any additional payment to
p.000072: be given, whether monetary or in kind, should not amount to an inducement. If complications occur as a direct and
p.000072: proximate result of the donation, the donor should be provided with prompt and full medical care. The cost of this
p.000072: provision is the responsibility of the researchers and their institutions.
p.000072:
p.000072:
p.000072:
p.000072: A38
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 5.30 Trans-species fertilisation involving human gametes is not allowed for the purpose of reproduction unless
p.000072: done to assess or diagnose sub-fertility, in which case, the resultant hybrid must be terminated at the
p.000072: two-cell stage, and in any case must have written approval from the Director of Medical Services.
p.000072: 5.31 No human embryos created for research, including human cytoplasmic hybrid embryos54 and other
p.000072: embryos created through any form of cloning technology, should be allowed to develop beyond 14 days in vitro.
p.000072: 5.32 No human embryo created for research, including any human cytoplasmic embryo or other embryo created through
p.000072: any form of cloning technology, should be implanted into the body of any human or animal.
p.000072: 5.33 Research involving human germline modification for purposes other than the prevention or
p.000072: treatment of serious genetic conditions should not be allowed.
p.000072: 5.34 No one should be under a duty to participate in any manner of research involving human gametes
p.000072: or embryos, including human-animal combination embryos, to which he or she has a conscientious objection.
p.000072: Surplus Tissues from Clinical Procedures
p.000072:
p.000072: 5.35 Tissues, such as blood, biopsy samples or even whole organs, may be left over after clinical procedures, which
p.000072: may be therapeutic or diagnostic. Such tissues can be very useful for research. However, when tissue is being taken
p.000072: primarily for a therapeutic or diagnostic purpose, this purpose must be fulfilled before any surplus tissue
p.000072: may be used for research.
p.000072: 5.36 Every effort should be made to obtain consent for the use of surplus tissue for research. As the
p.000072: primary objective for removing such specimens is clinical, consent for the clinical procedure should be separate from
p.000072: the consent for the use of left over tissues for research. To avoid any conflict of interest and to safeguard the
p.000072: patient’s welfare, consent for research should only be taken after consent has been given for any clinical procedure
p.000072: and it should be taken by a different person. Ideally, the attending physician should obtain the consent
p.000072: for the diagnostic or therapeutic procedure, while the researcher should seek consent for the research. In the
p.000072: case that the researcher is also the attending physician, the IRB may give directions for the consent to
p.000072: be taken by the researcher-physician so long as there are provisions to manage the conflict of interest
p.000072: and sufficient safeguards to protect the welfare and interests of the patient. Patients should be assured
p.000072: that refusal to consent will not affect the quality of care that will be given to them.
p.000072:
p.000072: 54 A human cytoplasmic hybrid embryo is an embryo that is created by the fusion of the nucleus of a
p.000072: human somatic cell with that of an enucleated animal ovum. The nuclear DNA is human. The mitochondrial
p.000072: DNA and ooplasm are of predominantly animal origin. It is not known if human cytoplasmic hybrid embryos
p.000072: are viable, and it is not considered ethical to determine viability by allowing development to proceed.
p.000072:
p.000072:
p.000072:
p.000072: A39
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 5.37 If consent could not be obtained for the use of surplus tissue for research, IRBs should have the discretion
p.000072: to waive the consent requirement if the patient is not identifiable, since the research protocol would not have
p.000072: influenced the procedures used in obtaining the biospecimens. Healthcare institutions should inform patients that
p.000072: there is a possibility that their surplus biospecimens may be used for research, and assure them that only research
p.000072: with the necessary safeguards in place will be allowed to proceed after approval from an IRB.
p.000072: 5.38 It is current practice to use patients’ biospecimens that are surplus to clinical requirements for
p.000072: validating laboratory tests or for purposes of clinical audit without consent of the originators and without IRB
p.000072: approval, if the specimens are irreversibly de-identified. Although this practice is ethically acceptable, since it is
p.000072: not possible for individuals to be identified, it is good practice for healthcare institutions to inform
p.000072: patients that there is a possibility that their surplus biospecimens may be used for such purposes, for example, by
p.000072: displaying a notice to that effect.
p.000072: Surplus Tissues from Research Projects
p.000072:
p.000072: 5.39 Tissues that are collected for a specific research project may remain after the project is completed. Such
p.000072: tissues can be stored for future research if consent for storage and future research use has been obtained from the
p.000072: donors.
p.000072: 5.40 Consent need not be re-taken if IRBs are satisfied that subsequent use of the tissue for research is covered
p.000072: by the initial consent. If the subsequent research use of the tissue is not covered by the initial consent, and
p.000072: re-contact is not possible or practicable, IRBs should have the discretion to determine whether or not
p.000072: the research may progress without re-consent.
p.000072: Imported Tissues
p.000072:
p.000072: 5.41 When the tissues to be used for research are imported, the researcher should obtain written assurance from the
p.000072: source authority that the samples have been ethically and legally obtained. The test of ethical acceptability
p.000072: should be the criteria that would have applied had the tissue been obtained in Singapore and not
...
p.000072: directly and specifically, or it may involve stored tissue samples or personal information from medical records or
p.000072: other databases. It may involve the study of a specific gene, or multiple genes, or gene- environment
p.000072: interactions, or the entire genome, for example in seeking to establish associations between genomic variants
p.000072: and diseases or specific traits.
p.000072: 6.2 With the completion of the human genome project in 2003, genetic research has progressed more
p.000072: rapidly than before. There is an increasing interest in population- based research to study the genetic
p.000072: susceptibility of diseases, with numerous biobanks set up all over the world, to store biospecimens and associated
p.000072: biodata. These allow detailed long-term genetic studies to take place. Technological advances have led to an increase
p.000072: in pre-clinical and clinical trials of gene-based therapies in recent years. Gene transfer in combination with
p.000072: stem cell therapy is also being studied in more detail. In addition, whole human genome sequencing can now be
p.000072: done in a relatively short period and at a lower cost. All these advances, together with advances in
p.000072: information technology, have resulted in new ethical challenges in the conduct and governance of genetic
p.000072: research.
p.000072: 6.3 Whole-genome research is likely to continue to advance and intensify. It involves the collection of
p.000072: biospecimens, genome sequencing, data analysis, and, possibly, the use of the biospecimens and data for future research
p.000072: projects that may not be known when the biospecimens are taken. In addition, the data may also be submitted
p.000072: to easily accessible scientific databases, to facilitate research. Thus, the implications for whole genome studies
p.000072: and the use of very large data sets of potentially or actually identifiable genetic information raise
p.000072: ethical concerns. Research using these data sets is often international and is facilitated by a research culture of
p.000072: relatively open access. Moreover, very extensive analysis can be performed by cross-referencing genomic data
p.000072: with demographic or other information. The possibility of inadvertent identification is thus higher
p.000072: than it would be with more restricted data and more limited analysis. Specifically, therefore:
p.000072: (a) Participants may need to be informed if and why whole-genome studies make it harder to guarantee their
p.000072: anonymity with complete certainty;
p.000072: (b) Researchers may discover new patterns or relationships, and may feel there is considerable potential for
p.000072: detecting findings that may be suggestive or prove clinically significant in future. Parties should be clear in
p.000072: advance as to when the obligation of the researcher ceases; and
p.000072: (c) The potential commercial value of large-scale genomic studies makes issues of research integrity and data
p.000072: ownership especially important.
p.000072:
p.000072:
p.000072:
p.000072: A42
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 6.4 Genetic interventions also raise ethical and moral issues, with germ-line genetic modification
p.000072: being the most contentious. Any intervention that alters the germ-line of an individual will lead to a change in
p.000072: the genetic makeup of that individual’s descendants. At present, there is insufficient knowledge of the
p.000072: potential long-term consequences of such interventions, as they are still in the experimental stage. Many countries,
p.000072: such as Australia, Canada, and Finland have laws that prohibit germline modification. With emerging
p.000072: assisted reproductive techniques such as ooplasmic transfer, pronuclear transfer and maternal spindle transfer, to
p.000072: prevent the transmission of mitochondrial disease, the Nuffield Council on Bioethics conducted a public
p.000072: consultation early this year. The Council recently published a report, which explores the ethical issues concerning
p.000072: the possible use of such treatments in future.56 It concluded that if these novel techniques are adequately
p.000072: proven to be acceptably safe and effective, it would be ethical for families to use them, if they choose
p.000072: to, but a continuing debate on these issues is important. The Human Fertilisation & Embryology
p.000072: Authority (HFEA), which licenses and monitors all fertility clinics and research involving human embryos in the
p.000072: UK, will take a lead in continuing the debate by launching a public consultation in September 2012, and report
p.000072: its findings in Spring 2013. The clinical use of such techniques is currently prohibited in the UK. In its 2005
p.000072: Genetics Report, the BAC had similarly recommended that the clinical practice of germ-line modification be
p.000072: prohibited and its position remains, pending evidence from research that clinical procedures to prevent or
p.000072: eliminate serious genetic disorders has been proven effective.
p.000072: 6.5 Genetic research can also be viewed to be financially valuable, for example research involving individuals
p.000072: who have genetic resistance to certain diseases, or whose genome might be found to contain genes
p.000072: relevant to understanding superior human athletic performance, could potentially be very valuable to researchers and
p.000072: institutions able to develop and commercially exploit the research. Thus pharmacogenomics depends on the
p.000072: presumption that optimal drug treatments may be tailored to the genetic makeup of the patient, or a subset of
p.000072: patients, for example classified by ethnic group. For this and other reasons, economic exploitation has been the
p.000072: subject of some controversy, and it is correspondingly important that all parties to research be well aware
p.000072: of the implications.
p.000072: 6.6 Genetic information refers to any information about the genetic makeup of an individual. It can
p.000072: be derived from genetic testing in either a clinical or research setting, or from any other sources,
p.000072: including details of an individual’s family history of genetic diseases.
p.000072: 6.7 Genetic information is often seen as an exceptional kind of personal information. There are
p.000072: several reasons for this:
p.000072:
p.000072: 56 The report Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review was published
p.000072: in June 2012.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A43
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) Genetic information is seen as a determining aspect of a person, yet many people are reluctant to
p.000072: countenance the role of genetic influences in considering human potential and conduct, as well as when considering
p.000072: genetic diseases, lest it undermine the autonomy that we attribute to individuals;
p.000072: (b) Genetic information can be socially sensitive because it can convey information about others. Even though an
p.000072: individual genome is unique, it may also provide information about family members. This can be highly sensitive, since
p.000072: genetic relatedness may not correspond to expected social relatedness. In particular, paternity information
p.000072: may be obtained through genetic testing;
p.000072: (c) The relative ease with which the individual human genome can now be comprehensively analysed has
p.000072: created a situation in which incidental findings of genetic conditions or susceptibility might become easy to obtain,
p.000072: and in which the sheer volume of genetic detail available for large-scale genomic studies raises issues of
p.000072: data protection and privacy, since much of the value of genetic information in research, as in medicine, depends
p.000072: upon linking findings to individuals and their characteristics;
p.000072:
p.000072: (d) Genetic information has predictive power, predicting heritable disorders that develop later in life.
p.000072: Even when untreatable, knowledge of such disorders may still allow the individual to make decisions affecting
p.000072: their future, such as whether to refrain from having children. But it is not always the case that
p.000072: individuals wish to know the details of their own genetic makeup, and consequent prognosis in
p.000072: certain cases. Especially if there is no current prospect of treatment, information about potentially disabling genetic
p.000072: conditions, such as Huntington’s disease, may not be something a person wishes to know; and
p.000072:
p.000072: (e) Genetic information may be of interest to others, such as relatives, who may also be affected, and insurers and
p.000072: employers.
p.000072:
p.000072: 6.8 For all these reasons, there has been a tendency to regard genetic research as somehow
p.000072: sensitive in much the same way as medical records are regarded as sensitive, because the information yielded
p.000072: by the research ought to be considered as private to the individual since its implications might be
p.000072: considerable, and because respect for the body is an important aspect of autonomy. In some cases, of
p.000072: course, genetic information is actual medical information, but in other cases it is just raw data that can be
p.000072: interpreted to yield a particular kind of personal information. The BAC is not of the view that genetic
p.000072: information is always and inherently special or exceptional. The BAC considered issues arising from the use
p.000072: of personal information generally in its Personal Information Report and in Part IV of these Guidelines.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A44
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Guidelines on Human Genetic Research
p.000072:
p.000072: 6.9 All human genetic research should be reviewed by an IRB and approved before it commences.
p.000072: 6.10 Participation in genetic research should be voluntary, whether directly or by contribution
p.000072: of biospecimens or personal information, and all the requirements of voluntary informed consent in
p.000072: Part III will apply. The requirements for the procurement and use of human tissue and personal
p.000072: information for such research in Parts IV and V respectively, will also apply.
p.000072: 6.11 When clinically significant findings are discovered in any genetic research, researchers
p.000072: should ensure that affected participants are informed, if they have indicated their desire to know.
p.000072: 6.12 In whole-genome research, participants should be provided with as much detailed information as
p.000072: possible that is specific to such research, during the consent process. They should be provided with information on
p.000072: mechanisms for data security, and an explanation on the nature of whole-genome research, with its
p.000072: difficulty in guaranteeing their anonymity with complete certainty. As the dissemination of information in
p.000072: whole-genome research is likely to be rapid and wide, there will be practical limitations on withdrawal from
p.000072: research. Participants should be informed of these limitations and the implications of their withdrawal.
p.000072:
p.000072: 6.13 Approval from MOH is required for research involving germ-line modification. Such research is only allowed
p.000072: for purposes of preventing or treating serious genetic conditions.
p.000072:
p.000072: 6.14 For clinical trials involving gene-based therapies, approval from HSA is required.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A45
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: VII. HUMAN STEM CELL RESEARCH
p.000072:
p.000072: 7.1 StemXcells are unspecialised cells that have the potential to develop into specialised cell types. They may
p.000072: be derived from early embryos (embryonic stemXcells), or from the germ cells of foetuses (embryonic germ cells) or from
p.000072: the human body at a later developmental stage (somatic or adult stemXcells).
p.000072: 7.2 Since the discovery in 2007 that human skin cells can be reprogrammed into an embryonic state,
p.000072: research in this area has progressed rapidly. Researchers have been studying the characteristics of the
p.000072: reprogrammed cells, called induced pluripotent stem cells, creating disease models to further understand
p.000072: the pathophysiology of specific diseases, as well as creating patient-specific stemXcells and finding ways to
p.000072: transform these stem cells into desired cells, which could be used for treatment. Researchers are also
p.000072: trying to find more efficient ways to convert somatic cells directly into lineage-specific
p.000072: stem/progenitor cells, bypassing the intermediate pluripotent stage.
p.000072: 7.3 Stem cell research can be classified into two major categories:
p.000072:
p.000072: (a) Basic research into the understanding of physiological cellular processes and disease mechanisms; and
p.000072:
p.000072: (b) Research into new therapies, including pre-clinical and clinical trials involving stemXcells or their
p.000072: derivatives.
p.000072:
p.000072: 7.4 The unique capacity of stemXcells to develop into various specialised cell types makes them of potential
p.000072: use for the regeneration or reconstruction of diseased or injured tissue. Stem cell research may thus lead to
p.000072: new and better ways of treating serious and debilitating diseases such as Alzheimer’s disease, diabetes and
p.000072: spinal cord injury. However, the derivation of pluripotent stemXcells from human embryos, and the use of human-animal
p.000072: combinations in stem cell research are controversial and raise ethical, legal and social concerns that must be
p.000072: addressed.
p.000072: 7.5 In 2002, the BAC published its Stem Cell Report. Subsequently it published the Egg Donation Report (2008) and
p.000072: the Human-Animal Combinations Report (2010). Taken together these reports have covered what is for some the
p.000072: most contentious areas of biomedical research, namely, research involving the use of human embryonic stem
p.000072: cells; research with human eggs and embryos; and research in which tissues or cellular components of
p.000072: humans and animals are combined. These are contentious because they involve techniques such as cloning
p.000072: technology that arouse unease or opposition among those who consider that science risks hubristically
p.000072: exceeding its proper function, or feel that human embryos and gametes are not proper material for research.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A46
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 7.6 Stem cell research may involve human-animal combinations, which is a term used to refer to any kind of
p.000072: living organism in which there is some mixing of human and animal material (genes, cells or tissues). It
p.000072: includes:
p.000072: (a) Cytoplasmic hybrid embryos, which are created by fusing human somatic cell nuclei with enucleated animal eggs.
p.000072: These embryos can be used to derive stemXcells with human nuclear genetic material without the need to create
p.000072: human embryos or the use of human eggs;
p.000072: (b) Human-animal chimeras, which are created by injecting human stemXcells, into animals at various stages of
p.000072: development to study stem cell integration and differentiation, to test the developmental potential
p.000072: of stem cells or their derivatives, to evaluate the potential usefulness and safety of transplanting
p.000072: human stem cells for clinical treatment or to study the possibility of growing human tissues and organs in
p.000072: animals for the transplantation into humans; and
p.000072: (c) Transgenic animals, which are animals in which the genome has been modified to include human genes. They have
p.000072: been widely used in laboratory research into the understanding and treatment of diseases for many years. In
p.000072: its Human- Animal Combinations Report and in preparing these Guidelines, the BAC has not explicitly considered
p.000072: transgenic animals but insofar as these Guidelines are relevant they should apply. However, to the extent that research
p.000072: involves the use of transgenic mice or other small mammals in laboratory conditions, and subject to observance of
p.000072: provisions for laboratory animal welfare, the BAC does not foresee any ethical difficulty in the continued use
p.000072: of such animals.
p.000072:
p.000072: 7.7 The objectives of using human-animal combinations in stem cell research include:
p.000072:
p.000072: (a) To study stem cell integration and differentiation;
p.000072:
p.000072: (b) To test the developmental potential of human stemXcells or their derivatives;
p.000072:
p.000072: (c) To evaluate the potential usefulness and safety of transplanting human stemXcells for clinical
p.000072: treatment; and
p.000072:
p.000072: (d) To study the possibility of growing human tissues and organs in animals for transplantation into
p.000072: humans.
p.000072:
p.000072: 7.8 The unique nature of stem cells also sometimes risks uncontrolled growth and differentiation
p.000072: whether used clinically, or in experiments involving animals. Thus research involving the use of human
p.000072: pluripotent stem cells requires particularly careful attention if it is to be ethically conducted and monitored.
p.000072: Legislation
p.000072:
p.000072: 7.9 There is no specific legislation that governs stem cell research in Singapore. The Human Cloning
p.000072: and Other Prohibited Practices Act (Cap. 131B) was enacted in 2004 primarily to prohibit human reproductive
p.000072: cloning. This Act does not prohibit
p.000072:
p.000072:
p.000072: A47
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: therapeutic cloning (research cloning). It limits the development of a human embryo that is created by a process other
p.000072: than the fertilisation of a human egg by a human sperm, to not more than 14 days, excluding any period when the
p.000072: development of the embryo is suspended. It also prohibits the commercial trading of human gametes and embryos.
p.000072: 7.10 The MOH’s Licensing Terms and Conditions imposed under regulation 6(5) of the Private Hospitals
p.000072: and Medical Clinics Regulations (Cap 248, Rg 2), provides the requirements for the use of human gametes and
p.000072: embryos for research, including the use of human-animal combination gametes and embryos for research.
p.000072: 7.11 The Medicines (Clinical Trials) Regulations (Cap. 176, Rg 3) made under sections 18 and 74 of the Medicines
p.000072: Act (Cap. 176), govern all clinical trials, including first-in- man trials and trials of cell- and tissue-based
p.000072: therapeutic products.
p.000072: Ethical and Social Issues
p.000072:
p.000072: Moral status of the human embryo
p.000072:
p.000072: 7.12 The main controversial issue in embryonic stem cell research concerns the moral status of the
p.000072: human embryo, and arises from the fact that the human embryo is destroyed in the process of stem cell
p.000072: derivation. There is a wide spectrum of views concerning the human embryo. At one end, it is considered to be a human
p.000072: being from the time of fertilisation, while at the other end, the view is that it is a mass of cells, no different from
p.000072: any other biological material used for research.
p.000072: 7.13 After public consultation, the BAC adopted an intermediate position, whereby a human embryo is
p.000072: considered as having the status of a potential human being, but not the same status as a living child or adult. As a
p.000072: measure of respect and protection for the human embryo, the BAC recommended that human embryonic stem cell research,
p.000072: including the creation of human embryos specifically for research, should be allowed only when there is strong
p.000072: scientific merit in and potential medical benefit from such research. In addition, only embryos less than 14
p.000072: days old should be used for the derivation of stemXcells, as at around day 14, the primitive streak appears,
p.000072: signaling the onset of cell differentiation and development of organ systems, including the nervous system.
p.000072: As for the use of surplus embryos donated from fertility treatment by consenting parents, the BAC was of the view that
p.000072: rather than allow them to perish, their use in research would serve a greater good. This remains the BAC position on
p.000072: this issue.
p.000072: 7.14 With the increasing possibility of alternative means of generating pluripotent stemXcells, such as
p.000072: induced pluripotent stemXcells, it is increasingly less likely that cloning technology would be used for the
p.000072: creation of embryos. The BAC welcomes such diversity in research methodologies, but regards research
p.000072: cloning (or therapeutic cloning) as defensible under strict regulation, if the scientific question
p.000072: addressed cannot reasonably be investigated using other methods.
p.000072:
p.000072:
p.000072: A48
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Cloning and Respect for Individuals
p.000072:
p.000072: 7.15 Respect for human dignity forms the basis for the prohibition of human reproductive cloning in many
p.000072: countries, including Singapore. In particular, there are serious concerns about the safety of the
p.000072: technology used for this purpose, and about any unforeseen problems for those born as a result of the
p.000072: technology.
p.000072: Human-Animal Combinations
p.000072:
p.000072: 7.16 Repugnance. Many people express repugnance or disgust at the idea of human-animal combinations, as human and
p.000072: animal tissues are not normally thought of as something that can or should be mixed. It is seen as unnatural. The BAC’s
p.000072: position is that while feelings of repugnance cannot be ignored, the process of paying heed to them should involve an
p.000072: evaluation of actual likely harms and benefits.
p.000072: 7.17 Slippery slope arguments. A concern is sometimes expressed that research with human-animal
p.000072: combinations risks a ‘slippery slope’ that will open the way to unacceptable research or applications.
p.000072: This was one reason for public concern over research cloning – it raised in the public mind the possibility of
p.000072: human reproductive cloning occurring if cloning techniques became widespread. The BAC takes the view that cases should
p.000072: be considered on their merits, and any danger of this kind should be considered when a case is reviewed.
p.000072: 7.18 Human dignity – maintaining a distinction between human and animals. There is and should be no intention,
p.000072: in research, to try and produce animals that have been rendered human in some important and essential
p.000072: mental, physical or existential characteristic. Human consciousness is the most fundamental of such characteristics.
p.000072: The BAC is of the view that acceptable research must preclude procedures that risk this consequence, and should
p.000072: certainly never have it as an explicit aim.
p.000072: 7.19 The risk of hubris and ‘playing God’. The expression ‘playing God’ is often heard in connection with
p.000072: research or practice at the boundaries of medicine, and the exact meaning to be read into it may depend on
p.000072: the speaker. Religious critics may mean by it that interference with the process of creating and destroying life is
p.000072: interference with divine prerogative. In its secular form, this criticism can imply that we may suffer from
p.000072: scientific or ethical hubris, a pride in power that blinds us to limitations or unforeseen risks. Such
p.000072: concerns are not to be lightly dismissed, but they are not without answers. Whatever we do will affect
p.000072: future generations. It is thus also ‘playing God’ if we prohibit research that might help patients.
p.000072: 7.20 The BAC’s view is that the problem of slippery slopes, hubris, and other ethical concerns
p.000072: discussed above present a powerful case for ethical and legal regulation, rather than a case for outright
p.000072: prohibition. Regulation is an assurance that change will be introduced without abrupt and radical challenge to the
p.000072: fundamental values, beliefs and practices that underlie society, and only when the key ethical issues arising from
p.000072: research involving human-animal combinations have been considered in each case.
p.000072:
p.000072:
p.000072: A49
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: 7.21 The possibility of creating humanised animals. Most of the concerns just discussed are related to the
p.000072: possibility of allowing actual independent living entities to develop from human-animal combinations. It seems to the
p.000072: BAC that the main ethical hazard lies in the possibility of inadvertently creating an animal with human
p.000072: characteristics, especially, but not exclusively, mental attributes. The risks can be seen most clearly in the
p.000072: specific case of human neural stem cells grafted into the brains of non-human primate foetuses57, which
p.000072: offers an in-principle possibility of a degree of humanisation of the resulting brain. In this
p.000072: case, six relevant factors have been suggested58 for the guidance of ethics committees, namely:
p.000072: (a) The proportion or ratio of human to animal cells in the animal’s brain: When the amount of human material
p.000072: is low, the likelihood of the animal acquiring something like human awareness as a result is correspondingly
p.000072: remote;
p.000072: (b) The age of the animal: The earlier in development, the greater the likely integration of
p.000072: transplanted cells, so human cells transplanted into animal embryos will probably result in greater
p.000072: likelihood of humanisation of the host animal’s brain than implantation into a fully developed animal;
p.000072: (c) The recipient species: Species with a closer approximation to human neural organisation are more
p.000072: problematic, because the likelihood of human attributes occurring in another species is increased when the other
p.000072: species is biologically close;
p.000072:
p.000072: (d) he brain size of the animal involved: It is reasonable to suppose that animals with larger brains
p.000072: are more likely to be capable of an approximation to human consciousness in the event that they incorporate human
p.000072: neural cells;
p.000072: (e) The site of integration of the human neural cells: Integration into the parts of the brain which control
p.000072: cognitive functions, is more likely to affect cognitive abilities than integration into other parts of the
p.000072: brain; and
p.000072: (f) The presence of pathologies in the host animal: It is possible that the humanising
p.000072: effect of transplanted human stem cells in an animal with a pathological condition might be greater than
p.000072: would be the case in a robust healthy organism. This is relevant if animal models of disease processes
p.000072: are used as a basis for trial approaches to treatment.
p.000072: 7.22 These factors and others need to be considered together and not in isolation, as they may combine or interact.
p.000072: The BAC is of the view that these or similar considerations should guide the deliberations of bodies in a position to
p.000072: permit or regulate research with human-animal combinations.
p.000072:
p.000072: 57 Ourednik V et al. Segregation of Human Neural Stem Cells in the Developing Primate Forebrain.
p.000072: Science. 293 (2001): 1820-1824.
p.000072: 58 Greene M et al. Moral Issues of Human-Non-Human Primate Neural Grafting. Science. 309 (2005): 385-386.
p.000072:
p.000072:
p.000072:
p.000072: A50
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Guidelines on Human Stem Cell Research
p.000072:
p.000072: 7.23 Human stem cell research that is ethically uncontentious, such as research using established
p.000072: pluripotent stem cell lines and confined to cell culture or research that involves routine and standard
p.000072: research practice with laboratory animals, should be exempted from review. All other human stem cell research
p.000072: should be reviewed by an IRB. Approval from MOH must also be obtained if the research involves the use of human eggs,
p.000072: human embryos, or human-animal combinations.
p.000072: 7.24 The procurement of biological materials (gametes, embryos, foetal tissue or somatic cells), including
p.000072: imported materials for stem cell research, should be in accordance with the guidelines provided for the
p.000072: procurement of human tissues generally for research.
p.000072: 7.25 IRBs reviewing proposals involving human stemXcells should ensure that all proposals have been reviewed and
p.000072: approved by a scientific committee, and that the biological materials to be used have been obtained ethically,
p.000072: with appropriate consent, and without any inducement or coercion, especially when vulnerable people are involved.
p.000072: 7.26 In human-animal combinations research involving live animals or resulting in the creation of live
p.000072: animals, the IRB should also ensure that the proposal has been approved by the institutional animal care and
p.000072: use committee, whose remit covers the welfare of laboratory animals.
p.000072: 7.27 Where human embryonic stemXcells, induced pluripotent stemXcells, or any other kind of pluripotent stem
p.000072: cells are introduced into non-human animals at any stage of development, particular attention should be paid
p.000072: to the need to avoid the creation of entities in which human sentience or consciousness might be expected to occur.
p.000072: 7.28 Animals into which human embryonic stemXcells, induced pluripotent stemXcells, or any other kind of
p.000072: pluripotent stemXcells have been introduced should not be allowed to breed.
p.000072: 7.29 Human cytoplasmic hybrid embryos should not be allowed to develop beyond 14 days
p.000072: in vitro.
p.000072:
p.000072: 7.30 No human cytoplasmic embryo should be implanted into the body of any human or animal.
p.000072: 7.31 If the research involves introducing human embryonic stemXcells or any pluripotent cells, or products derived
p.000072: from these cells, into humans, or any novel applications of any stemXcells that are outside the scope of established
p.000072: standards of medical care, it should be conducted in accordance with the requirements and standards of a clinical trial
p.000072: for cell-based product, as specified by the HSA, and approval from HSA must be obtained. IRBs must ensure that:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A51
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) The proposal is reviewed and approved by a scientific review committee with the relevant expertise;
p.000072:
p.000072: (b) There is strong evidence of the safety and efficacy of the cells from pre-clinical studies;
p.000072:
p.000072: (c) The research participants have been provided with sufficient information, in particular information on
p.000072: the nature and risks of the research, and the source of the cells, so that their values and beliefs are respected; and
p.000072:
p.000072: (d) Appropriate and informed consent has been obtained, without any inducement, coercion or undueXinfluence.
p.000072:
p.000072: 7.32 No clinical or research personnel should be under a duty to conduct or assist in human embryonic stem cell or
p.000072: induced pluripotent stem cell research, or research involving human-animal combinations, to which they have a
p.000072: conscientious objection, nor should they be put at a disadvantage because of such objection.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A52
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Bibliography
p.000072:
p.000072: Animals and Birds Act (Cap. 7). Singapore, Revised 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Donation of Human Eggs for Research. Singapore, 2008.
p.000072:
p.000072: Bioethics Advisory Committee. Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and
p.000072: Therapeutic Cloning. Singapore, 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Genetic Testing and Genetic Research. Singapore, 2005.
p.000072:
p.000072: Bioethics Advisory Committee. Human-Animal Combinations in Stem Cell Research. Singapore, 2010.
p.000072:
p.000072: Bioethics Advisory Committee. Human Tissue Research. Singapore, 2002.
p.000072:
p.000072: Bioethics Advisory Committee. Personal Information in Biomedical Research. Singapore, 2007.
p.000072:
p.000072: Bioethics Advisory Committee. Research Involving Human Subjects: Guidelines for IRBs. Singapore, 2004.
p.000072:
p.000072: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social
p.000072: Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research
p.000072: Involving Humans, 2010.
p.000072:
p.000072: Council for International Organizations of Medical Sciences/World Health Organization.
p.000072: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS, 2002.
p.000072:
p.000072: Department of Health and Human Services. The Belmont Report: Ethical Principles and Guidelines for the Protection of
p.000072: Human Subjects of Research. United States of America, 1979.
p.000072:
p.000072: Department of Health and Human Services. Protection of Human Subjects, Title 45 Code of Federal Regulations, Part 46,
p.000072: 102(d). United States of America, 1980.
p.000072:
p.000072: Greene M and 21 others. Moral Issues of Human-Non-Human Primate Neural Grafting. Science. 309 (2005):
p.000072: 385-386.
p.000072:
p.000072: Harris B. Disciplinary and Regulatory Proceedings. 6th Ed. London: Wiley & Sons, 2011.
p.000072:
p.000072: Health Products Act (Cap. 122D). Singapore, 2008.
p.000072:
p.000072: Human Cloning and other Prohibited Practices Act (Cap. 131B). Singapore, 2005.
p.000072:
p.000072: Human Fertilisation and Embryology Act 2008. United Kingdom: HMSO.
p.000072:
p.000072:
p.000072: A53
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Human Tissue Act 2004. United Kingdom: HMSO.
p.000072:
p.000072: Infectious Diseases Act (Cap. 137). Singapore, Amended 2010.
p.000072:
p.000072: Levine RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al. (Eds.) The Oxford
p.000072: textbook of clinical research ethics. Oxford: OUP (2008) page 211.
p.000072:
p.000072: Medical (Therapy, Education and Research) Act (Cap. 175). Singapore, amended 2010.
p.000072:
p.000072: Medical Research Council. Human tissue and biological samples for use in research: Operational and Ethical Guidelines.
p.000072: United Kingdom, 2005.
p.000072:
p.000072: Medical Research Council. Ethics Guide: Medical research involving adults who cannot consent. United Kingdom,
p.000072: 2007.
p.000072:
p.000072: Medical Research Council. Ethics Guide: Medical research involving children. United Kingdom, 2004.
p.000072:
p.000072: Medicines Act (Cap. 176). Singapore, 1985.
p.000072:
p.000072: Mental Capacity Act 2005. United Kingdom: HMSO.
p.000072:
p.000072: Mental Capacity Act. Singapore, 2010.
p.000072:
p.000072: Ministry of Health. Code of Ethical Practice in Human Biomedical Research. Singapore, 2009.
p.000072:
p.000072: Ministry of Health. Governance Framework for Human Biomedical Research. Singapore, December 2007.
p.000072:
p.000072: Ministry of Health. Guideline for Good Clinical Practice. Singapore, Revised 1999.
p.000072:
p.000072: Ministry of Health. Licensing Terms and Conditions on Assisted Reproduction Services. Singapore, 2011.
p.000072:
p.000072: Ministry of Health. Operational Guidelines for Institutional Review Boards. Singapore, December 2007.
p.000072:
p.000072: Ministry of Information and the Arts. Public Consultation Paper on Proposed Data Protection Bill. Singapore,
p.000072: 2012.
p.000072:
p.000072: National Advisory Committee for Laboratory Animal Research. Guidelines on the Care and Use of Animals for
p.000072: Scientific Purposes. Singapore, 2004.
p.000072:
p.000072: National Health and Medical Research Council, National Statement on Ethical Conduct in Human Research.
p.000072: Australia, 2007.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A54
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: National Healthcare Group. Investigator Manual: All that an Investigator Needs to Know. Singapore, August
p.000072: 2009.
p.000072:
p.000072: National Medical Ethics Committee. Ethical Guidelines for Gene Technology. Singapore, 2001.
p.000072:
p.000072: National Medical Ethics Committee. Ethical Guidelines on Research Involving Human Subjects, Singapore, 1997.
p.000072:
p.000072: National Medical Ethics Committee. Recommendations on Clinical Trials: Update Focusing on Phase I Trials,
p.000072: Singapore, 2007.
p.000072:
p.000072: National Registry of Diseases Act (Cap. 201). Singapore, 2007.
p.000072:
p.000072: Nuremberg Code. In: Trials of War Criminals before the Nuremberg Military Tribunals under Control Council.
p.000072: U.S. Government Printing Office, Washington D.C. Law No. 10, Vol. 2: 181-182 (1949).
p.000072:
p.000072: Ourednik V and 10 others. Segregation of Human Neural Stem Cells in the Developing Primate
p.000072: Forebrain. Science. 293 (2001): 1820-1824.
p.000072:
p.000072: Personal Data Protection Bill. Singapore, 2012.
p.000072:
p.000072: Private Hospitals and Medical Clinics Act (Cap. 248). Singapore, 1999. Singapore Medical Council. Ethical Code and
p.000072: Ethical Guidelines (nd).
p.000072: United Nations Educational, Scientific and Cultural Organization (UNESCO)
p.000072: Universal Declaration on Bioethics and Human Rights, 2005.
p.000072:
p.000072: Wilfond BS and Diekema DS. Engaging children in genomics research: decoding the meaning of assent in research, Genetics
p.000072: in Medicine.14 (2012): 437-443.
p.000072:
p.000072: World Medical Association. Declaration of Helsinki:Ethical Principles for Medical Research Involving Human
p.000072: Subjects (revised 2008).
p.000072:
p.000072:
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p.000072: A55
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: List of Abbreviations
p.000072:
p.000072:
p.000072: BAC Bioethics Advisory Committee
p.000072: HFEA Human Fertilisation and Embryology Authority
p.000072: HSA Health Sciences Authority
p.000072: IRB Institutional Review Board
p.000072: LPA Lasting power of attorney
p.000072: MOH Ministry of Health
p.000072: NMEC National Medical Ethics Committee
p.000072: SGGCP Singapore Guideline for Good Clinical Practice
p.000072: UNESCO United Nations Educational, Scientific and Cultural Organization
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p.000072: A56
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p.000072:
p.000072: ANNEX B
p.000072:
p.000072: CONSULTATION PAPER DISTRIBUTION LIST
p.000072:
p.000072:
p.000072:
p.000072: ANNEX B
p.000072:
p.000072: Distribution List for Consultation Paper on
p.000072: “Ethics Guidelines for Human Biomedical Research – for comments” (Public Consultation Period: 20 June 2012 to 15 August
p.000072: 2012)
p.000072:
p.000072: 1. Academy of Medicine
p.000072: 2. Agency for Integrated Care
p.000072: 3. Alice Lee Centre for Nursing Studies
p.000072: 4. Alzheimer’s Disease Association
p.000072: 5. Association of Muslim Professionals
p.000072: 6. Autism Association (Singapore)
p.000072: 7. Bioinformatics Institute
p.000072: 8. Biomedical Research Council
p.000072: 9. Bioprocessing Technology Institute
p.000072: 10. Buddhist Fellowship
p.000072: 11. Cardiovascular Research Institute
p.000072: 12. The Catholic Medical Guild of Singapore
p.000072: 13. Changi General Hospital
p.000072: 14. College of Family Physicians Singapore
p.000072: 15. Defence Medical & Environmental Research Institute @ DSO National Laboratories
p.000072: 16. Department of Biological Sciences, National University of Singapore
p.000072: 17. Duke-NUS Graduate Medical School
p.000072: 18. ES Cell International
p.000072: 19. Experimental Therapeutics Centre
p.000072: 20. Genome Institute of Singapore
p.000072: 21. Graduates’ Christian Fellowship (Singapore)
p.000072: 22. Health Sciences Authority
p.000072: 23. Hindu Advisory Board
p.000072: 24. Institute of Bioengineering and Nanotechnology
p.000072: 25. Institute of Medical Biology
p.000072: 26. Institute of Mental Health
p.000072: 27. Institute of Molecular and Cell Biology
p.000072: 28. Inter-Religious Organisation Singapore
p.000072: 29. Jewish Welfare Board
p.000072: 30. John Hopkins Singapore International Medical Centre
p.000072: 31. Khoo Teck Puat Hospital
p.000072: 32. KK Women’s and Children’s Hospital
p.000072: 33. Khoo Teck Puat - National University Children's Medical Institute
p.000072: 34. Law Reform Committee, Singapore Academy of Law
p.000072: 35. The Law Society of Singapore
p.000072: 36. Majlis Ugama Islam Singapura (Islamic Religious Council of Singapore)
p.000072: 37. Muscular Dystrophy Association Singapore
p.000072: 38. Nanyang Polytechnic
p.000072:
p.000072: B1
p.000072:
p.000072: ANNEX B
p.000072:
p.000072: 39. Nanyang Technological University
p.000072: 40. National Arthritis Foundation
p.000072: 41. National Cancer Centre
p.000072: 42. National Council of Churches of Singapore
p.000072: 43. National Council of Social Service
p.000072: 44. National Dental Centre
p.000072: 45. National Healthcare Group
p.000072: 46. National Heart Centre
p.000072: 47. National Neuroscience Institute
p.000072: 48. National Skin Centre
p.000072: 49. National University Cancer Institute, Singapore
p.000072: 50. Ngee Ann Polytechnic
p.000072: 51. NUHS Research Office
p.000072: 52. Parkway Hospitals Singapore
p.000072: 53. The Parsi Zoroastrian Association of Singapore
p.000072: 54. Raffles Hospital
p.000072: 55. Republic Polytechnic
p.000072: 56. Saw Swee Hock School of Public Health, National University of Singapore
p.000072: 57. Sikh Advisory Board
p.000072: 58. SIM University
p.000072: 59. Singapore Association For Mental Health
p.000072: 60. Singapore Bioimaging Consortium
p.000072: 61. Singapore Buddhist Federation
p.000072: 62. Singapore Cancer Society
p.000072: 63. Singapore Children's Society
p.000072: 64. Singapore Chinese Buddhist Association
p.000072: 65. Singapore Clinical Research Institute
p.000072: 66. Singapore Epilepsy Foundation
p.000072: 67. Singapore Eye Research Institute
p.000072: 68. Singapore General Hospital
p.000072: 69. Singapore Health Services
p.000072: 70. Singapore Heart Foundation
p.000072: 71. Singapore Immunology Network
p.000072: 72. Singapore Institute for Clinical Sciences
p.000072: 73. Singapore Management University
p.000072: 74. Singapore Medical Association
p.000072: 75. Singapore Medical Council
p.000072: 76. Singapore National Stroke Association
p.000072: 77. Singapore Nurses Association
p.000072: 78. Singapore Nursing Board
p.000072: 79. Singapore Polytechnic
p.000072: 80. Singapore Sports Council
p.000072: 81. Singapore Taoist Federation
p.000072:
p.000072:
p.000072: B2
p.000072:
p.000072: ANNEX B
p.000072:
p.000072: 82. SingHealth Polyclinics
p.000072: 83. The Spiritual Assembly of the Bahá'ís of Singapore
p.000072: 84. Tan Tock Seng Hospital
p.000072: 85. Taoist Mission (Singapore)
p.000072: 86. Temasek Laboratories
p.000072: 87. Temasek Polytechnic
p.000072: 88. Yong Loo Lin School of Medicine, National University of Singapore
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p.000072: B3
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p.000072:
p.000072: ANNEX C
p.000072:
p.000072: WRITTEN RESPONSES RECEIVED DURING THE PUBLIC CONSULTATION
p.000072:
p.000072:
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Written Responses Received During the Public Consultation on Ethics Guidelines for Human Biomedical Research
p.000072:
p.000072:
p.000072: Organisations / Institutions
p.000072:
p.000072: C1 Alice Lee Centre for Nursing Studies C2 Buddhist Fellowship
p.000072: C7 Cancer Science Institute of Singapore C8 Catholic Medical Guild of Singapore C12 Humanist Society
p.000072: (Singapore)
p.000072: C13 Lily-NUS Centre for Clinical Pharmacology
p.000072: C15 School of Public Health, National University of Singapore C16 SingHealth Tissue Repository
p.000072: C20 The Law Society of Singapore
p.000072:
p.000072:
p.000072: Individuals
p.000072:
p.000072: C28 Mr Benjamin Gaw and Ms Keow Mei Yen C38 Member of the Public (1)
p.000072: C39 Member of the Public (2)
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Comments from Alice Lee Centre for Nursing Studies
p.000072:
p.000072: 14 August 2012
p.000072:
p.000072:
p.000072: Many thanks for the draft Ethics Guidelines for Human Biomedical Research.
p.000072:
p.000072: We welcome the Guidelines and are very supportive to its recommendations. We believe this document will be a valuable
p.000072: resource for researchers in our department. We are pleased to see that an appeal mechanisms has been implemented for
p.000072: those who have proposals rejected. The variability in review process and opinion makes this a valuable inclusion.
p.000072:
p.000072: We also noted the concerns raised regarding monetary coercion of participants. We support that every effort should be
p.000072: made to resists ‘tempting’ participation in research via monetary incentives (other than reasonable loss of time and
p.000072: costs).
p.000072:
p.000072: Warmest regards Professor Sally Chan
p.000072: Professor and Head, Alice Lee Centre for Nursing Studies
p.000072:
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p.000072: C1
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Comments from Buddhist Fellowship
p.000072:
p.000072: 26 July 2012
p.000072:
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p.000072: C2
p.000072:
p.000072: ANNEX C
p.000072:
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p.000072: C3
p.000072:
p.000072: ANNEX C
p.000072:
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p.000072: ANNEX C
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p.000072: ANNEX C
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p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Comments from Cancer Science Institute of Singapore
p.000072:
p.000072: 2 August 2012
p.000072:
p.000072:
p.000072: I have no major comments to this document except for the following:
p.000072:
p.000072: Section 3.32 states that 'communication of clinically significant incidental findings to biological
p.000072: relatives should be encouraged....'. This concept is further reinforced in section 3.37, which states that
p.000072: 'participants should also have the opportunity to express their preferences about the sharing of such
p.000072: information with biological relatives.'
p.000072:
p.000072: I am not sure why such a statement is required. Is it to facilitate disclosure of clinically
p.000072: significant incidental findings to family members in the event that the subject is deceased (particularly
p.000072: for genetic information)? For practical purpose, it should be noted that almost all informed consent documents do not
p.000072: have this provision for the patient to indicate whether to and who to share clinically significant incidental
p.000072: findings. How does the BAC expect the researchers to carry out this recommendation?
p.000072:
p.000072: With regards to genetic information, from the medical point of view, it will be ideal that all affected family
p.000072: members of an index patient who is found with a genetic mutation be informed as they are at risk. However,
p.000072: it should be noted that in reality, this does not always happen for various reasons. I run a cancer genetics
p.000072: clinic and test patients for hereditary cancer syndromes. When a patient is found with a deleterious
p.000072: mutation, we strongly encourage the patient to share the information with siblings, who have 50% chance
p.000072: of carrying the same mutation. Not all patients are willing to share the information.
p.000072:
p.000072: Similarly, not all cancer-free siblings are pleased to be told of the information (many would rather not know). If a
p.000072: cancer-free family member wants to know but the index patient refuses to share the information, the treating
p.000072: physician will be breaching patient confidentiality if he/she divulges the information, even if the information
p.000072: does benefit the family member. I am uncertain if the law will protect the physician if he chooses
p.000072: beneficence for the family member against respecting patient confidentiality. These are highly sensitive issues, and
p.000072: I am not sure that it is fair for a researcher to have to deal with communicating clinically significant
p.000072: incidental findings to family members, who did not directly participate in the research.
p.000072:
p.000072: A more practical approach would be for the researcher to communicate the information to the patient, refer the patient
p.000072: to an appropriate clinical facility for further management, and stress that the information should be shared with
p.000072: family members – but the patient must be the one initiating the sharing, not the physician/researcher.
p.000072:
p.000072: Regards,
p.000072:
p.000072: Dr Lee Soo Chin
p.000072: Cancer Science Institute of Singapore
p.000072:
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p.000072: C7
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Comments from Catholic Medical Guild of Singapore
p.000072:
p.000072: 15 August 2012
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p.000072: ANNEX C
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p.000072: ANNEX C
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p.000072: ANNEX C
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p.000072: ANNEX C
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p.000072: Comments from Humanist Society (Singapore)
p.000072:
p.000072: 13 August 2012
p.000072:
p.000072:
p.000072: To: Bioethics Advisory Committee, Singapore
p.000072: We, the Humanist Society (Singapore), a registered society representing the non-religious in Singapore, would like
p.000072: to express our support for the draft “Ethics Guidelines for Human Biomedical Research”.
p.000072:
p.000072: We believe that research is vital to understanding nature and holds great potential for extending human
p.000072: lifespans and improving quality of life. In particular, we agree with the committee’s stand that stem cell
p.000072: research should not be prohibited, but instead regulated with guidelines based on our current understanding of Science.
p.000072:
p.000072: Yours sincerely,
p.000072: Humanist Society (Singapore)
p.000072: Guided by reason, informed by evidence, driven by compassion
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p.000072: C12
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p.000072: ANNEX C
p.000072:
p.000072: Comments from Lily-NUS Centre for Clinical Pharmacology
p.000072:
p.000072: 16 and 21 August 2012
p.000072:
p.000072:
p.000072: Greetings,
p.000072:
p.000072: I am responding to the call for comments from the BAC on the proposed Draft Guidelines for Human Biomedical Research.
p.000072: Please allow me a short introduction. I am Dr Danny Soon, and currently the Managing Director of the Lilly-NUS Centre
p.000072: for Clinical Pharmacology, located at MD11 in NUS. We have been in operation for 14 years, and have
p.000072: conducted over 130 studies, in the field of clinical pharmacology research, including
p.000072: first-in-man, biopharmaceutics and experimental medicine studies. These studies are conducted in healthyXvolunteers, in
p.000072: the majority. According to HSA statistics, clinical pharmacology studies and Phase 1 studies, which overlap
p.000072: significantly, form 17% and 25% of all trials approved in 2011.
p.000072:
p.000072: There is one clause that I would like to seek clarification from the BAC.
p.000072:
p.000072: v. Compensation / payment to research participants. It has always been a fundamental principle that
p.000072: participation in research should be voluntary. There should be no coercion or undue influence on a prospective
p.000072: volunteer. In this connection, it is important to avoid financial inducement to participate in
p.000072: research. Participants may be reimbursed for legitimate expenses, such as the cost of transport and child
p.000072: care services, and actual loss of earnings. Reimbursement and any additional payment to be given, whether monetary or
p.000072: in kind, should not amount to an inducement. Donation of tissue for research, however, is considered an
p.000072: altruistic gift and there should be no payment of any kind, except in the case of donation of human eggs for research
p.000072: by healthyXvolunteers, as the process required to obtain the eggs is invasive and carries a health risk.
p.000072:
p.000072: Participation in our studies is always entirely voluntary. However, it is common and customary, in
p.000072: Singapore and in other geographies where healthy volunteer studies are conducted, that research subjects are
p.000072: paid for their time on the study. The principle applied in formulating an appropriate payment quantum is predicated on
p.000072: a ‘minimum wage’ approach, sometimes known as the ‘wage payment’ model (Dickert N, Grady C. N Engl J Med. 1999 Jul
p.000072: 15;341(3):198-203. What's the price of a research subject? Approaches to payment for research participation.) In this
p.000072: model, a research subject is paid a pre-determined stipend, in accordance with the duration of his participation in the
p.000072: study. This payment is submitted to the Ethical Review Board for approval, and provided to the subject at the time of
p.000072: informed consent for entry into a study. It should be noted that such payments are fixed, and not based on
p.000072: reimbursement of the subject’s expenses or loss of earnings. I seek clarification from the committee as to whether it
p.000072: is their intent to disallow such payments.
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p.000072: C13
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p.000072: ANNEX C
p.000072:
p.000072: I do feel the BAC’s position on this need to be clarified to researchers and IRBs. As to the question as to whether
p.000072: non‐patient volunteer research in general will suffer impact if ‘loss of time’ payments were discontinued, I think
p.000072: the answer is self-evident. One needs to be circumspect when using terms such as ‘vulnerable persons’ and
p.000072: ‘risky research’. It needs to be clear that the vast majority of healthy volunteer research subjects in our experience,
p.000072: are educated and with gainful employment. We have our own safeguards to prevent subjects from
p.000072: over‐volunteering in Lilly studies, and if the concern is around a small minority of the economically disadvantaged
p.000072: who may look upon these payments as a major source of income, then for further protection, I have
p.000072: proposed in the past that some form of central tracking of non‐patient research volunteers be administered by a
p.000072: coordinating body. Such a system already exists in the UK:
p.000072: .
p.000072:
p.000072: On the question of risk, it also needs to be clear to payment to volunteers are calculated mainly on
p.000072: the time spent on study, with degree of discomfort factored in if appropriate. There is no payment on the basis of
p.000072: ‘risk’ incurred. Further, any discussion of ‘risk’ is not complete without consideration of risk mitigation. In the
p.000072: phase 1 clinical protocols that are put forth to the IRB and HSA, a large measure of clinical monitoring is often in
p.000072: place. Also, not clinical pharmacology research is in novel therapeutics.
p.000072:
p.000072: Last, I am quite concerned that there was not more of an effort to engage with stakeholders on this discussion. I was
p.000072: only made aware of the proposed changes when I chanced upon it in a press report, and a couple of investigators in
p.000072: other institutions I spoke with who conduct healthy volunteer research, were not aware of these proposals at all. I
p.000072: would urge a nuanced approach to this matter from the BAC.
p.000072:
p.000072: Sincerely,
p.000072:
p.000072: Dr Danny Soon
p.000072: Managing Director & Principal Investigator
p.000072: Lily-NUS Centre for Clinical Pharmacology, Singapore
p.000072:
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p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Comments from School of Public Health, National University of Singapore
p.000072:
p.000072: 11 July 2012
p.000072:
p.000072:
p.000072: I would like to reiterate the following points for BAC's consideration:
p.000072:
p.000072: 1. Para 1.10
p.000072:
p.000072: The current definition of human biomedical research is very much disease focused and patient-centric.
p.000072: There is an increasing body of biomedical research that focuses on health seeking behaviour, knowledge,
p.000072: attitudes and practices of both patients and "normal" healthy individuals. In addition, clinical research requires
p.000072: "normal" subjects as a comparison group; etiological research using cohort studies starts with recruiting
p.000072: healthy subjects. A simple definition would encompass all research that involve human subjects/tissues/information
p.000072: with the aim of disease treatment, prevention and health promotion. I would like to propose that the following sentence
p.000072: be added the existing definition:
p.000072:
p.000072: "…..derived from humans or human tissues. Research on normal subjects and populations is also included in this
p.000072: definition."
p.000072:
p.000072: 2. Paras 4.7, 4.14
p.000072:
p.000072: The proposed Personal Data Protection Bill recognises the role of "data intermediaries" or "Trusted Third
p.000072: Parties" (TTPs). TTPs are fairly common in many non-biomedical sectors but need to be "popularized" in the biomedical
p.000072: sectors. With an efficient and trustworthy TTP, data owners and research subjects can have greater confidence
p.000072: that their reversibly de- identified data are well protected. Propose adding a short para after 4.7:
p.000072:
p.000072: "The use of 'data intermediaries' in the form of a 'Trusted Third Party' should be encouraged especially when data
p.000072: are kept in a reversibly de-identified form. Record linkages via TTP provide greater confidence to data
p.000072: owners and research participants that their data are adequately protected. Ideally for Singapore, either a
p.000072: single or a few large TTPs with the ability to conduct audits on the storage and use of reversibly
p.000072: de-identified data."
p.000072:
p.000072: Happy to provide further clarifications if required. Best regards
p.000072: Professor Chia Kee Seng Dean, School of Public Health
p.000072:
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p.000072: C15
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p.000072: ANNEX C
p.000072:
p.000072:
p.000072: Comments from SingHealth Tissue Repository
p.000072:
p.000072: 13 August 2012
p.000072:
p.000072:
p.000072: Background
p.000072:
p.000072: a. Incidental research findings (IF) are not limited to the disease area under study. A researcher
p.000072: looking into biomarkers for cancer may find that a sample of blood from a supposedly healthy volunteer
p.000072: actually shows hyperglycaemia whilst another researcher studying genetic predisposition for diabetes may instead
p.000072: discover that a patient sample shows BRCA1 mutation, which carries a high risk of breast and ovarian cancers.
p.000072:
p.000072: b. High-throughput interrogation of alterations at the genomic level is now widely performed, using
p.000072: donated patient samples removed during surgery. These samples are banked in research tissue biobanks or repositories,
p.000072: of which the two largest collections reside in the NUHS Tissue Repository and the SingHealth Tissue Repository (STR).
p.000072:
p.000072: c. Tissue repositories ensure that samples are collected ethically and legally. Processed and annotated samples
p.000072: with de-identified patient information are then distributed to Principal Investigators (PIs) after approval by an
p.000072: oversight or tissue access committee.
p.000072:
p.000072: d. Despite its noble intentions, the proposal currently under consideration by the Singapore
p.000072: Bioethics Advisory Committee (BAC) relating to the return of IF1 raises significant ethical and in
p.000072: particular, legal concerns.
p.000072:
p.000072: BAC's existing recommendations
p.000072:
p.000072: 2.1 The BAC has previously recommended that tissue donations for use in research should be treated as
p.000072: outright gifts. As such, there is no obligation for researchers or tissue bankers to return research data nor
p.000072: should donors expect such benefits arising from the donation:
p.000072:
p.000072: “Donations of tissue samples for use in research should be treated as outright gifts. Donors should not be paid any
p.000072: financial incentives for the donation….. As a corollary of this principle, donors should not expect any
p.000072: personal or direct benefit from the donation of tissue, including information of any medical condition or
p.000072: predisposition or likelihood of such discovered in the course of research on the sample. Likewise, researchers and
p.000072: tissue bankers should not be under any obligation to disclose such information to the donors, unless they
p.000072:
p.000072: 1 “Where there is a possibility that the research may yield clinically significant incidental findings, participants
p.000072: should be allowed to decide whether or not to be informed of the result, prior to the commencement of the research.
p.000072: Participants should also have an opportunity to express their
p.000072: preferences about the sharing of such information with biological relatives, or others.” (para 3.37, proposed “Ethics
p.000072: guidelines for Human Biomedical Research, Singapore Bioethics Advisory Committee, 20 June 2012, pg.27)
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p.000072: C16
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p.000072: ANNEX C
p.000072:
p.000072: have agreed to do so in advance of the donation.” (para 13.1.1.8, Consultation Paper: “Human Tissue
p.000072: Research”, Singapore Bioethics Advisory Committee, 27 Feb 2002)
p.000072:
p.000072: 2.2 The policies and SOPs of the STR have been formulated following these recommendations
p.000072: and we use a donation model for the acquisition of patient samples. It has been made clear to our donors that they will
p.000072: not receive any material benefits including any patient-specific data emerging from the research. The current
p.000072: proposal under consideration would be a complete deviation from the BAC's previous position and recommendations.
p.000072:
p.000072: 2.3 Nevertheless, I recognize that the position of the BAC might have shifted somewhat on this issue. In
p.000072: the subsequent publication on genetic testing, the BAC made a recommendation that appeared to run
p.000072: contrary to its previous guidelines as mentioned above:
p.000072:
p.000072: "Human genetic research is not conducted with the aim of providing research participants with specific information
p.000072: about their genetic status or health. However, if there is a possibility that the research may yield
p.000072: individual data of clinical significance, the research participant should be informed of this possibility and whether
p.000072: he or she would receive such information if so desired, prior to participation in the research." (para 46, Genetic
p.000072: testing and genetic research, Singapore Bioethics Advisory Committee, Nov 2005, pg 7)
p.000072:
p.000072: STR position: Return of research findings is not feasible
p.000072:
p.000072: 3.1 Return of research findings to donors is not feasible for the following reasons:
p.000072:
p.000072: 3.11 Unacceptable liabilities for biobanks. A large biobank like STR distributes up to thousands of
p.000072: samples a year to numerous researchers. A biobank has no means to monitor the research output of all these
p.000072: researchers and it is unlikely that PIs will allow the biobank access their research data. As tissue samples
p.000072: are donated to the biobank which subsequently distributes them, would the biobank be held jointly liable
p.000072: if a researcher fails to declare and return significant IF? The amount of data emanating from genomic
p.000072: research is colossal. Would the researcher/biobank be held liable if a significant IF has surfaced from
p.000072: the research but is not picked up by the PI who is studying a different question? The proposed policy will
p.000072: impose unacceptably high legal risks for the biobank and will threaten its very existence and the success of
p.000072: Singapore's biomedical initiative.
p.000072:
p.000072: 3.12 Danger of inaccurate data disclosure. A research laboratory is designed to uncover novel data and research
p.000072: assays are not conducted in a standardised manner as with an accredited service laboratory. The finding of a
p.000072: significant mutation may subsequently be found to be erroneou s, giving rise to unnecessary distress and patient
p.000072: concerns. In extreme circumstances, the patient might have taken steps to distribute his properties and manage his
p.000072: financial affairs differently had he known that the research data were inaccurate. It will be crucial to
p.000072: emphasize that the IF is preliminary and needs to be confirmed in an accredited laboratory but it does not take
p.000072: away the distress and damage it might have caused in the interim. There is also the question as to who is financially
p.000072: liable for performing the confirmatory assays in an accredited laboratory.
p.000072:
p.000072: 3.13 Absolute need for anonymization which precludes follow-up studies. To protect patient confidentiality, biobanks
p.000072: de-identify or anonymize tissue samples.
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p.000072: ANNEX C
p.000072:
p.000072: 3.14 Bioresources are only released to researchers after all identifiable patient information (ID) has been
p.000072: detached from the sample, which is then given a random code. In this process of de-identification, the biobank
p.000072: functions as the trusted third party who holds the link between the patient’s identity and the code. This allows for
p.000072: valuable follow-up clinical data to be collected, de-identified and provided to the researcher whilst
p.000072: protecting patient confidentiality.
p.000072:
p.000072: 3.15 Alternatively, the link between the patient’s ID and the sample code can be irreversibly destroyed in the process
p.000072: of anonymization. Obviously, this precludes the collection of crucial clinical information such as the response to
p.000072: chemotherapy and survival data.
p.000072:
p.000072: 3.16 Some biobanks will provide de-identified samples for researchers who require follow- up data but anonymize
p.000072: samples for studies that do not require such information.
p.000072:
p.000072: 3.17 If researchers and biobanks have an obligation to return IF, one possible consequence is that biobanks will
p.000072: completely anonymize all patient samples. This will render it impossible to return IF and thereby protect the
p.000072: researcher from legal liabilities, but will also impede important and valuable scientific research.
p.000072:
p.000072: 3.18 Patient autonomy and the need for genetic counselling. Some patients cannot handle the devastating news that
p.000072: they suffer from a mutation that will result in breast cancer or early dementia. For example, patients have
p.000072: jumped off buildings immediately after receiving news that they have HIV infection. Inheritance of a mutation like
p.000072: BRCA1 also has implications for family members and the donor will be burdened with the responsibility of
p.000072: disclosure to relatives who may be affected. A patient may well NOT wish to receive data relating to
p.000072: significant genetic alterations. For this reason, the BAC has emphasized the need for pre- and post-test counselling in
p.000072: the context of genetic testing2. If return of IF is necessary, one would assume that the same requirements for genetic
p.000072: counselling will apply as part of the consent procedures:
p.000072:
p.000072: “… When the tissue samples provided for clinical use are intended also for research, informed consent for
p.000072: the research is required in addition to the consent for taking the tissue for clinical use. Consent is also required if
p.000072: there is an intention to store the tissue for future use.” (para 4.4, Genetic testing and genetic
p.000072: research, Singapore Bioethics Advisory Committee, Nov 2005)
p.000072:
p.000072: “The individual should be given appropriate genetic counselling and informed about the nature of the test
p.000072: and risks of the procedure (if any) before giving consent. Pre-test counselling is thus intrinsic to the
p.000072: process of consent-taking. (para 4.6, Genetic testing and genetic research, Singapore Bioethics Advisory Committee, Nov
p.000072: 2005)
p.000072:
p.000072:
p.000072: 2 “An individual tested positive for a predisposition to developing a specific genetic condition has to decide whether
p.000072: this risk should be disclosed to other family members who may also be at risk of developing the same
p.000072: condition. The individual may be additionally burdened with considerations for the family members who may or may not be
p.000072: affected by the condition and their wish to know or not to know. Family members who are not affected by the
p.000072: genetic condition may nevertheless be affected psychologically (such as the condition of “survivor guilt”). In view
p.000072: of these considerations, we emphasise the importance of pre- and post-test genetic counselling.” (para 4.25, Genetic
p.000072: testing and genetic research, Singapore Bioethics Advisory Committee, Nov 2005, pg.30)
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p.000072: C18
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p.000072: ANNEX C
p.000072:
p.000072: One implication of the need to return IF is that there will be a need for pre- and post-test genetic
p.000072: counselling and there are simply insufficient resources and trained genetic counsellors for that
p.000072: matter.
p.000072:
p.000072: 3.19 No consensus on what constitutes significant incidental findings. The range of possible genetic and
p.000072: biochemical alterations that may emerge from tissue-based research are legion. Yet, it is near impossible to
p.000072: define which are sufficiently significant and should trigger a return of IF. A genetic predisposition
p.000072: towards low sperm count may not be significant to an 80-year-old single male but may well be very significant to
p.000072: the scion of a wealthy family. Placing on the researcher/biobank the duty to decide which of the numerous genetic
p.000072: alterations (which will include not only mutations but polymorphisms) to report will pose far too onerous a liability
p.000072: and may stop all human genomic research in its tracks. For that matter, it is impossible to conduct any
p.000072: meaningful genetic counselling when the implications of the IF can range from bilateral ovarian cancers
p.000072: at the age of 40 to a polymorphism that may render one less likely to win a marathon race.
p.000072:
p.000072: Concluding remarks
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p.000072: ANNEX C
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p.000072: ANNEX C
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p.000072: ANNEX C
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p.000072: ANNEX C
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p.000072: ANNEX C
p.000072:
p.000072: Comments from Mr Benjamin Gaw & Ms Keow Mei Yen
p.000072:
p.000072: 15 August 2012
p.000072:
p.000072:
p.000072:
p.000072: S/No. Para No. Subject Matter Comment
p.000072: Consolidation of Reports
p.000072:
p.000072: 1. 1.4 With the Guidelines, it is the
p.000072: intention of the BAC to render it unnecessary for readers to consult the various BAC reports.
p.000072: We agree that consolidation of BAC’s previous Reports would be of great assistance to researchers and organisations as
p.000072: it would facilitate reference and adherence to the BAC Guidelines. However, given the need for brevity, there
p.000072: is concern that there may be certain important concepts or principles expressed in the earlier Reports which may
p.000072: not have been incorporated in these Guidelines.
p.000072:
p.000072: A sampling of what does not seem to have been incorporated in the Guidelines:
p.000072: (i) The portion on Genetic Testing in the Guidelines is covered in paras 6.1 to 6.13. However, the BAC report
p.000072: on Genetic Testing and Genetic Research (“BAC Genetic Testing Guidelines”) spans 53 pages. Some content-specific
p.000072: items which appear very important in the BAC Genetic Testing Guidelines do not appear in the new Guidelines. These
p.000072: include: (i) a detailed explanation of what genetic testing is and what it can be used for (paragraphs 2.1 to 2.11);
p.000072: (ii) general and specific ethical considerations in genetic testing including the 20 recommendations given by
p.000072: the BAC with regards to how genetic testing should be conducted (paragraphs 4.1 to 4.80); and (iii) genetic
p.000072: counseling (paragraphs 4.81 to 4.89). The information set out in the Guidelines seem to provide a very broad summary of
p.000072: genetic testing and only appear to touch on the surface when it comes to content-specific information.
p.000072:
p.000072: (ii) The portion on Stem Cell research in the Guidelines is covered in paras 7.1 to 7.32. However the BAC Report on
p.000072: Human-Animal Combinations in Stem Cell Research (“BAC Stem Cell Research Guidelines”) spans 34 pages. Similar
p.000072: to the BAC Genetic Testing Guidelines, the Guidelines does not include large portions of the BAC Stem Cell
p.000072: Research Guidelines. These include: (i) the detailed explanation on
p.000072:
p.000072: C28
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p.000072: ANNEX C
p.000072:
p.000072:
p.000072: chimeras and hybrids as at out in paragraphs 2.1 to 2.15; (ii) the regulatory practices adopted by different countries
p.000072: set out at paragraphs 4.1 to 4.11; and (iii) the table of regulatory approaches adopted by different countries at pages
p.000072: 27 to 34 of the BAC Stem Cell Research Guidelines.
p.000072:
p.000072: (iii) Other omissions from the Guidelines include important principles such as the one stated in paragraph 8.7 of
p.000072: the Human Tissue Research Report “…the governing common law principle that informs the letter of the law of both
p.000072: the Human Organ Transplant Act, and of the Medical (Treatment, Education and Research) Act: no person may enter into
p.000072: a contract for the sale of his body or any part thereof, including organs, tissue or blood. No person is
p.000072: under any compulsion to give. Nor is any person under an obligation to accept a gift…”.
p.000072:
p.000072: Our view is that these background information can be very helpful in understanding the background and BAC’s
p.000072: thinking in relation to the relevant guidelines and recommendations. We therefore suggest that
p.000072: the Guidelines be expressed as being complementary to the previous Reports, and to also include references to the
p.000072: previous Reports, where helpful, within the Guidelines. This will also aid readers to navigate the BAC’s Reports.
p.000072:
p.000072: On another level, we also propose that there should be an effort in consolidating other relevant guidelines to human
p.000072: biomedical research. Particularly, we note that other than the BAC (which guidelines do not have the force of
p.000072: law), there are also a number of other guidelines issued by various bodies, including the Ministry of Health, the
p.000072: National Medical Ethics Committee, and the Singapore Medical Council. Whilst the guidelines issued by these
p.000072: bodies are presumably drafted with the specific target audience (such as the healthcare institutions licensed under the
p.000072: Private Hospitals and Medical Clinics Act (“PHMC Act”) in the case of the MOH guidelines), there may be a need to
p.000072: review and to consider whether there are any inconsistencies or ambiguities amongst these various guidelines, as a
p.000072: plethora of guidelines can lead to confusion as to the applicable ethical codes. In particular (see our comments to
p.000072: paragraph 1.10 below), there are some noted differences between the MOH guidelines and these Guidelines.
p.000072: C29
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p.000072: ANNEX C
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p.000072:
p.000072:
p.000072: 2. 1.10 Definition of “Human Biomedical
p.000072: Research”
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...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| 45XcfrX46 | common rule |
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belmont | belmont |
| cadavers | Cadavers |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| coerced | Presence of Coercion |
| cognitive | Cognitive Impairment |
| control group | participants in a control group |
| culturally | cultural difference |
| degenerative | degenerative conditions |
| diminished | Diminished Autonomy |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| elderly | Elderly |
| embryo | embryo |
| employees | employees |
| ethnic | Ethnicity |
| faith | Religion |
| family | Motherhood/Family |
| foetus | Fetus/Neonate |
| foetuses | Fetus/Neonate |
| gender | gender |
| hazard | Natural Hazards |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| incapacitated | Incapacitated |
| infant | Infant |
| influence | Drug Usage |
| injured | injured |
| job | Occupation |
| language | Linguistic Proficiency |
| manipulate | Manipulable |
| mentally | Mentally Disabled |
| military | Soldier |
| minor | Youth/Minors |
| minority | Racial Minority |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| parents | parents |
| party | political affiliation |
| philosophy | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| poor | Economic/Poverty |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| race | Racial Minority |
| religious | Religion |
| research staff | Laboratory Staff |
| restricted | Incarcerated |
| single | Marital Status |
| stem cells | stem cells |
| substance | Drug Usage |
| threat | Threat of Stigma |
| trauma | Victim of Abuse |
| tri-council | tri-council policy statement |
| undue influence | Undue Influence |
| usage | Drug Usage |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| cognitive | ['impaired'] |
| control group | ['placebo'] |
| disabled | ['mentally'] |
| drug | ['influence', 'substance', 'usage'] |
| education | ['educational'] |
| educational | ['education'] |
| faith | ['religious'] |
| foetus | ['foetuses'] |
| foetuses | ['foetus'] |
| healthy volunteers | ['volunteers'] |
| impaired | ['cognitive'] |
| influence | ['drug', 'substance', 'usage'] |
| mentally | ['disabled'] |
| minority | ['race'] |
| opinion | ['philosophy'] |
| parent | ['parents'] |
| parents | ['parent'] |
| philosophy | ['opinion'] |
| placebo | ['controlXgroup'] |
| race | ['minority'] |
| religious | ['faith'] |
| substance | ['drug', 'influence', 'usage'] |
| usage | ['drug', 'influence', 'substance'] |
| volunteers | ['healthyXvolunteers'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
exploit
harm
justice
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input