79C3C34C52B45572883A05D425EB0F82

Ethical Guidelines for Human Biomedical Research

https://www.bioethics-singapore.org/files/publications/reports/ethics-guidelines-for-human-biomedical-research-full-report.pdf

http://leaux.net/URLS/ConvertAPI Text Files/4C65A090796CFF0AB4C9113DC33F021C.en.txt

Examining the file media/Synopses/4C65A090796CFF0AB4C9113DC33F021C.html:

This file was generated: 2020-12-01 07:46:36

Indicators in focus are typically shown highlighted in yellow; Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; "Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalCriminal Convictionsprisoners5
Politicalpolitical affiliationparty17
Politicalvulnerablevulnerable19
Politicalvulnerablevulnerability4
HealthCadaverscadavers2
HealthCognitive Impairmentcognitive4
HealthCognitive Impairmentimpaired3
HealthDrug Usagedrug6
HealthDrug Usageinfluence11
HealthDrug Usagesubstance2
HealthDrug Usageusage1
HealthHIV/AIDSHIV1
HealthHealthy Peoplehealthy volunteers2
HealthHealthy Peoplevolunteers2
HealthMentally Disableddisabled2
HealthMentally Disabledmentally4
HealthMotherhood/Familyfamily17
HealthPhysically Disabledillness2
Healthdegenerative conditionsdegenerative1
Healthinjuredinjured2
Healthstem cellsstem cells57
SocialAccess to Social Goodsaccess21
SocialAgeage28
SocialChildchild50
SocialChildchildren33
SocialElderlyelderly1
SocialEthnicityethnic2
SocialFetus/Neonatefoetus1
SocialFetus/Neonatefoetuses10
SocialIncarceratedrestricted2
SocialInfantinfant1
SocialLaboratory Staffresearch staff3
SocialLinguistic Proficiencylanguage3
SocialMarital Statussingle7
SocialOccupationjob1
SocialPolice Officerofficer3
SocialPresence of Coercioncoerced2
SocialProperty Ownershipproperty11
SocialRacial Minorityminority1
SocialRacial Minorityrace3
SocialReligionfaith2
SocialReligionreligious10
SocialSoldiermilitary2
SocialThreat of Stigmathreat2
SocialVictim of Abusetrauma2
SocialWomenwomen7
SocialYouth/Minorsminor35
Socialeducationeducation16
Socialeducationeducational9
Socialembryoembryo38
Socialemployeesemployees8
Socialgendergender2
Socialparentsparent24
Socialparentsparents18
Socialphilosophical differences/differences of opinionopinion7
Socialphilosophical differences/differences of opinionphilosophy1
EconomicEconomic/Povertypoor4
General/OtherDiminished Autonomydiminished2
General/OtherImpaired Autonomyautonomy24
General/OtherIncapacitatedincapacitated10
General/OtherManipulablemanipulate2
General/OtherNatural Hazardshazard2
General/OtherRelationship to Authorityauthority30
General/OtherUndue Influenceundue influence7
General/Otherbelmontbelmont8
General/Othercioms guidelinescioms1
General/Othercommon rule45XcfrX461
General/Othercultural differenceculturally1
General/Otherdeclaration of helsinkihelsinki5
General/Otherparticipants in a control groupcontrol group2
General/Otherparticipants in a control groupplacebo2
General/Othertri-council policy statementtri-council1

Political / Criminal Convictions

Searching for indicator prisoners:

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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.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.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.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: 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
...

Political / political affiliation

Searching for indicator party:

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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.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.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.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.000028: an individual’s consent for participating in research. The main difference is that in giving
...

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.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:
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.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.000037: disclosed to a third party, the requirements in the Fourth Schedule, paragraphs 1(q) and 4 apply.
p.000037:
p.000038: 38
p.000038:
p.000038: PERSONAL INFORMATION IN RESEARCH
p.000038:
p.000038: obtained for all research involving personal information. However, this may not be practicable in certain
p.000038: situations; for example, the use of information (including linkages from multiple databases) from any national
p.000038: or disease registry for research, where information may have been collected routinely by law. Such use is
p.000038: of tremendous value in epidemiological and public health research, which is ultimately a public good. As there is
p.000038: minimal risk of harm to individuals, it is ethically justifiable to waive the consent requirement for the
p.000038: use of personal information for epidemiological and public health research, provided there are adequate
p.000038: measures to protect individual privacy and the confidentiality of the information. In most cases, reversibly
p.000038: de-identified information could be used. Such research has to be approved by an IRB. The conditions for a waiver of
p.000038: consent are provided in paragraph 3.29.
p.000038:
p.000038: Guidelines on the Use of Personal Information in Research
p.000038:
p.000038: 4.15 All biomedical research involving personal information, whether identified or de- identified should
p.000038: be reviewed by an IRB, and approved, or granted an exemption from review, before it commences. IRBs should have
...

p.000038: be regarded as abrogated by such identification, and steps should be taken to reinstate and secure them.
p.000038:
p.000038: 4.18 Healthcare institutions should ensure that clear formal procedures are laid down for the release of medical
p.000038: records and other personal information for research, and to formulate these procedures in consultation with
p.000038: their IRBs.
p.000038:
p.000038: 4.19 IRBs may waive the consent requirement for the use of personal information for epidemiological or
p.000038: public health research, or the use of medical records for research, if they are satisfied that the following conditions
p.000038: are met:
p.000038:
p.000038: (a) The research is justified and poses no more than minimal risk to individuals concerned;
p.000038:
p.000038: (b) The research could not practicably proceed without the waiver;
p.000038:
p.000038: (c) Obtaining consent is not possible or practicable; and
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:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
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.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:
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: 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:
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 undue influence.
p.000072: Participants may be reimbursed for legitimate expenses, such as cost of transport and child care services, and actual
...

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: public health research, or the use of medical records for research, if they are satisfied that the following conditions
p.000072: are met:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A32
p.000072:
p.000072: ANNEX A
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: 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:
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:
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: 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.
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: acts for and on behalf of the Institution). One important point of consideration in establishing an
p.000072: appeal process is the need to consider whether the decision of the IRB is akin to that of a public
p.000072: administrative body, and therefore subject to the principles of administrative law and public law.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 8. 3 & 4 Roles and responsibilities of the
p.000072: Institutional Review Board (“IRB”)
p.000072: In any event, we suggest that, given that the IRBs are constituted pursuant to the directions of the
p.000072: MOH under the PHMC, any appeal against the decision of the IRB should be escalated beyond the Institution,
p.000072: and to the Director of Medical Services, who may be empowered to constituted a panel of experts to consider
p.000072: the appeal. The introduction of an elevated appeal process would be helpful to provide assurance that
p.000072: there is impartiality in the appeal process as it is easy for allegations of conflicts of interest if
p.000072: the Institution were to review the decision of the IRB (since the IRB acts for and on behalf of the Institution).
p.000072: We also note that there appears to be increased roles and responsibilities placed on the IRB under these Guidelines.
p.000072:
p.000072: For example:
p.000072: (i) at paragraph 3.18, in the case of vulnerable persons not lacking capacity and when it is not
p.000072: possible for consent to be taken by an independent third party, the IRB may now give directions for consent to be taken
p.000072: by the researchers so long
p.000072:
p.000072: C32
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: as there are provisions to manage the conflict of interest and sufficient safeguards to protect the welfare and
p.000072: interests of the participant.
p.000072: (ii) at paragraph 3.21, if the researcher is also the physician, the IRB may give directions for
p.000072: consent to be taken by the researcher as long as there are provisions to manage conflict of interest situations.
p.000072: (iii) at paragraph 3.26, IRBs should be able to waive parental consent in research that does not involve more than
p.000072: minimal risk.
p.000072: (iv) at paragraph 3.27, IRBs may consider a waiver of the consent requirement for research done in the
p.000072: public interest.
p.000072: (v) at paragraph 3.28, giving the IRBs the power in some cases to authorise research with regards to patients who
p.000072: are subject to the provisions of the Mental Capacity Act.
p.000072: (vi) at paragraph 3.47, giving the IRBs the ability the power to authorise research for valuable research
p.000072: involving recruitment of highly compromised patients who are unable to give consent and for whom no proxy is available
p.000072: to give consent.
...

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p.000025:
p.000025:
p.000025: Bioethics Advisory Committee
p.000025: 16 College Road
p.000025: Singapore 169854
p.000025: Web: http://www.bioethics-singapore.org Email: bioethics_singapore@moh.gov.sg
p.000025:
p.000025:
p.000025:
p.000025: CONTENTS
p.000025: EXECUTIVE SUMMARY 1
p.000025: PART I INTRODUCTION 9
p.000025: What is Human Biomedical Research? 10
p.000025: The Legislative and Regulatory Framework of Human Biomedical 12 Research in Singapore
p.000025: PART II ETHICS GOVERNANCE OF HUMAN BIOMEDICAL 15
p.000025: RESEARCH
p.000025: General Ethical Principles That Have Guided The BAC 15
p.000025: Ethics Review of Human Biomedical Research in Singapore – The 19 IRB System
p.000025: Guidelines on Ethics Governance of Human Biomedical Research 21
p.000025: PART III CONSENT
p.000025: 25
p.000025: Voluntary and Informed Consent 25
p.000025: Specific and General Consent 26
p.000025: Consent Involving Vulnerable Persons 27
p.000025: Waiver of Consent 31
p.000025: Clinically Significant Incidental Findings 32
p.000025: Guidelines on Consent 33
p.000025: PART IV PERSONAL INFORMATION IN RESEARCH 36
p.000025: Protection of Personal Information 36
p.000025: Use of Medical Records for Research 38
p.000025: Epidemiological and Public Health Research 38
p.000025:
p.000025: Guidelines on the Use of Personal Information in Research 39
p.000025: PART V BIOBANKING AND RESEARCH INVOLVING HUMAN 41
p.000025: BIOLOGICAL MATERIALS
p.000025: Guidelines on Biobanking and Research Involving Human 42 Biological Materials
p.000025: PART VI HUMAN GENETIC RESEARCH 49
p.000025: Guidelines on Human Genetic Research 52
p.000025: PART VII HUMAN STEM CELL RESEARCH 53
p.000025: Legislation 54
p.000025: Ethical and Social Issues 55
...

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.000025: general consent.
p.000025:
p.000025: 3.10 A general consent may be taken for the storage and future use of biological materials or personal information
p.000025: for research. This consent would allow such use without the need for re-consent. IRBs should have the discretion to
p.000025: decide, when considering a research proposal, whether specific consent is required, or if a previously
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.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.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.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: 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: 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:
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: 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 stem cells 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 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: 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.
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: 7. 2.45 Appeal Mechanism We agree with the setting up of an appeal
p.000072: mechanism. However, we suggest that the
p.000072: implementation of such appeal mechanisms not be the responsibility of the Institution (given that the IRB
p.000072: acts for and on behalf of the Institution). One important point of consideration in establishing an
p.000072: appeal process is the need to consider whether the decision of the IRB is akin to that of a public
p.000072: administrative body, and therefore subject to the principles of administrative law and public law.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 8. 3 & 4 Roles and responsibilities of the
p.000072: Institutional Review Board (“IRB”)
p.000072: In any event, we suggest that, given that the IRBs are constituted pursuant to the directions of the
p.000072: MOH under the PHMC, any appeal against the decision of the IRB should be escalated beyond the Institution,
p.000072: and to the Director of Medical Services, who may be empowered to constituted a panel of experts to consider
p.000072: the appeal. The introduction of an elevated appeal process would be helpful to provide assurance that
p.000072: there is impartiality in the appeal process as it is easy for allegations of conflicts of interest if
p.000072: the Institution were to review the decision of the IRB (since the IRB acts for and on behalf of the Institution).
p.000072: We also note that there appears to be increased roles and responsibilities placed on the IRB under these Guidelines.
p.000072:
p.000072: For example:
p.000072: (i) at paragraph 3.18, in the case of vulnerable persons not lacking capacity and when it is not
p.000072: possible for consent to be taken by an independent third party, the IRB may now give directions for consent to be taken
p.000072: by the researchers so long
p.000072:
p.000072: C32
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072: as there are provisions to manage the conflict of interest and sufficient safeguards to protect the welfare and
p.000072: interests of the participant.
p.000072: (ii) at paragraph 3.21, if the researcher is also the physician, the IRB may give directions for
p.000072: consent to be taken by the researcher as long as there are provisions to manage conflict of interest situations.
p.000072: (iii) at paragraph 3.26, IRBs should be able to waive parental consent in research that does not involve more than
p.000072: minimal risk.
p.000072: (iv) at paragraph 3.27, IRBs may consider a waiver of the consent requirement for research done in the
p.000072: public interest.
p.000072: (v) at paragraph 3.28, giving the IRBs the power in some cases to authorise research with regards to patients who
p.000072: are subject to the provisions of the Mental Capacity Act.
...

Searching for indicator vulnerability:

(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.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.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.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
p.000072: technically redundant, but in lay parlance it serves to make clear that the need for consent should be a considered
p.000072: matter and not something to be taken for granted.
p.000072:
p.000072:
p.000072:
p.000072: A19
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: (a) Research participants understand what is proposed, the nature of any entailed risks and benefits to
p.000072: them, and how any such risks are to be managed and minimised. This is particularly important in
p.000072: clinical research where new therapies are involved;
p.000072:
p.000072: (b) There is no coercion, deception49 or inducement. Any payment in addition to expenses incurred, should
p.000072: not amount to an inducement; and
p.000072: (c) Participants understand that they may withdraw from the research at any time without any explanation, and
p.000072: without penalty or prejudice to any treatment they may be receiving.
p.000072:
...

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
...

Health / Cadavers

Searching for indicator cadavers:

(return to top)
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.000042: 5.13 Consent may be general or specific. General consent is consent that does not limit the use of the biological
p.000042: materials to any particular research project. It includes consent for storage and future use of the biological
...

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: from research with the tissue are put; any such limits must be respected, and it is for the researcher and IRB to
p.000072: decide if they disqualify the use of the tissue or the related information in any given project.
p.000072:
...

Health / Cognitive Impairment

Searching for indicator cognitive:

(return to top)
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 Stem Cells 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.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.
...

Searching for indicator impaired:

(return to top)
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:
...

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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.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:
...

Health / Drug Usage

Searching for indicator drug:

(return to top)
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.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.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:
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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.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.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: 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: 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:
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p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
...

Searching for indicator influence:

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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.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.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: 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.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.000047: individuals who have contributed the tissues; or
p.000047:
p.000047: (b) If the tissues are identifiable but it is impossible or impracticable to seek consent from the individuals who
p.000047: have contributed the tissues. In this case, IRBs should ensure that adequate measures are in place to protect the
p.000047: privacy of the donors and the confidentiality of any personal information associated with the tissues.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 27 BAC Tissue Report, paragraph 9.1, page 28: “A special difficulty …is posed by the existence of
p.000047: large collections of tissue samples accumulated over many years for which no specific or adequate consent for
p.000047: research investigations has been obtained. In the vast majority of the cases, the original donors can
p.000047: no longer be reliably traced for consent to research, or such tracing may no longer be practicable or socially
p.000047: acceptable…. We refer to these collections as legacy tissue collections.”
p.000047: 28 For what constitutes sensitive research, see paragraphs 1.9 and 1.11 above.
p.000047:
p.000048: 48
p.000048:
p.000048: HUMAN GENETIC RESEARCH
p.000048:
p.000048: VI. HUMAN GENETIC RESEARCH
p.000048:
p.000048:
p.000048: 6.1 Human genetic research is the study of genes, their functions, how they are associated with health and
p.000048: disease, and how genetic and environmental factors influence health. This research may involve participants directly or
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.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: (a) If the tissues are irreversibly de-identified and there is thus no possibility of re- identifying the
p.000072: individuals who have contributed the tissues; or
p.000072:
p.000072: (b) If the tissues are identifiable but it is impossible or impracticable to seek consent from the individuals who
p.000072: have contributed the tissues. In this case, IRBs should ensure that adequate measures are in place to protect the
p.000072: privacy of the donors and the confidentiality of any personal information associated with the tissues.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 55 “A special difficulty …is posed by the existence of large collections of tissue samples
p.000072: accumulated over many years for which no specific or adequate consent for research investigations has
p.000072: been obtained. In the vast majority of the cases, the original donors can no longer be reliably traced for
p.000072: consent to research, or such tracing may no longer be practicable or socially acceptable…. We refer to these
p.000072: collections as legacy tissue collections.” BAC Tissue Report, paragraph 9.1, page 28.
p.000072:
p.000072:
p.000072:
p.000072: A41
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: VI. HUMAN GENETIC RESEARCH
p.000072:
p.000072: 6.1 Human genetic research is the study of genes, their functions, how they are associated with health and
p.000072: disease and how genetic and environmental factors influence health. The study may involve research participants
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:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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
p.000072: first-in-man, biopharmaceutics and experimental medicine studies. These studies are conducted in healthy volunteers, 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 healthy volunteers, 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
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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.000047: (e) Proper disposal of the biological materials when no longer needed; and
p.000047:
p.000047: (f) Any training necessary to ensure the implementation of the above requirements.
p.000047:
p.000047: Legacy Tissues
p.000047:
p.000047: 5.43 Legacy tissues are tissues that were previously collected without specific or adequate consent for research,
...

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: (f) Any training necessary to ensure the implementation of the above requirements.
p.000072:
p.000072: Legacy Tissues
p.000072:
p.000072: 5.43 Legacy tissues are tissues that have been previously collected without specific or adequate consent
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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
...

Health / HIV/AIDS

Searching for indicator HIV:

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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:
...

Health / Healthy People

Searching for indicator healthy volunteers:

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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:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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
p.000072: first-in-man, biopharmaceutics and experimental medicine studies. These studies are conducted in healthy volunteers, 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 healthy volunteers, 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.
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
...

Searching for indicator volunteers:

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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.
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:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C14
p.000072:
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:
...

Health / Mentally Disabled

Searching for indicator disabled:

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p.000025: decide, when considering a research proposal, whether specific consent is required, or if a previously
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.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
...

Searching for indicator mentally:

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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.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.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:
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
...

Health / Motherhood/Family

Searching for indicator family:

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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.000050: such as Huntington’s disease, may be something a person would not wish to know; and
p.000050:
p.000050: (e) Genetic information may be of interest to others, such as biological relatives, who may also be
p.000050: affected, insurers and employers.
p.000050:
...

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:
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: 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:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C5
p.000072:
p.000072: ANNEX C
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:
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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:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: C6
p.000072:
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:
p.000072:
p.000072:
p.000072:
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
p.000072:
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: C8
p.000072:
p.000072: ANNEX C
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: C9
p.000072:
p.000072: ANNEX C
p.000072:
...

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)
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:
...

Health / Physically Disabled

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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.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:
...

Health / degenerative conditions

Searching for indicator degenerative:

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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: 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:
...

Health / injured

Searching for indicator injured:

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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
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 stem cells 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 stem cells;
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.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
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 stem cells 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.
...

Health / stem cells

Searching for indicator stem cells:

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p.000006: possible that is specific to such research, during the consent taking process. They should be informed of the
p.000006: mechanisms for data security, and given an explanation on the nature of whole-genome research, highlighting the
p.000006: difficulty in guaranteeing their anonymity with complete certainty. As the dissemination of information in
p.000006: whole-genome research is likely to be rapid and wide, there will also be practical limitations on withdrawal from
p.000006: such research. Participants should be informed of these limitations and the implications of their withdrawal.
p.000006:
p.000006: VII. Human Stem Cell Research
p.000006:
p.000006: 47. Human stem cell research that is not ethically contentious, such as research using established
p.000006: pluripotent stem cell lines and confined to cell culture or research that involves routine and standard
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 stem cells, induced pluripotent stem cells, 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 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:
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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.000051:
p.000051: 6.13 When clinically significant findings are discovered in the course of any genetic research,
p.000051: researchers should ensure that affected participants are informed, if they have indicated their desire to
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:
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p.000051:
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
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 stem cells 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 stem cells;
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 stem cells 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 stem cells, 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 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: 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.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.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 Stem Cells 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 stem cells, induced pluripotent stem cells, 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 stem cells, induced pluripotent stem cells, or any other kind of
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.
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p.000058: Cells (2008), online: .
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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 stem cells – 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
p.000062:
p.000062:
p.000062: Australia. National Health and Medical Research Council, Australian Research Council, Australian
p.000062: Vice-Chancellor’s Committee. National Statement on Ethical Conduct in Human Research. Updated 2009.
p.000062:
p.000062: Australia. Privacy Act 1988. Amended 2012.
p.000062:
p.000062: Australia. Prohibition of Human Cloning for Reproduction Act 2002. Amended 22 December 2008.
p.000062:
p.000062: Australia. The Royal Children’s Hospital Melbourne. Understanding Consent in Research Involving Children: The
p.000062: Ethical Issues. 2010.
p.000062:
p.000062: Austria. Reproductive Medicine Act. 4 June 1992.
p.000062:
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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.000064: Italy. Regulation of Medically Assisted Reproduction, Law n. 40. 19 February 2004.
p.000064:
p.000064: Levine RJ. The Nature, Scope, and Justification of Clinical Research. In Emanuel, EJ et al. (Eds.) The Oxford
p.000064: Textbook of Clinical Research Ethics. Oxford: Oxford University Press (2008) page 211.
p.000064:
p.000064: Lithuania. Law on Ethics of Biomedical Research. Amended 15 November 2007.
p.000064:
p.000064: Malaysia. Ministry of Health, National Committee for Clinical Research. Guideline on the Use of Human
p.000064: Biological Tissues for Research. 31 October 2006.
p.000064:
p.000064: Malaysia. Ministry of Health, National Committee for Clinical Research. Malaysian Guideline for Good
p.000064: Clinical Practice (Third Edition). 2011.
p.000064:
p.000064: National Heart, Lung, and Blood Institute Working Group. Ethical and Practical Guidelines for Reporting Genetic
p.000064: Research Results to Study Participants: Updated Guidelines from a National Heart, Lung, and Blood
p.000064: Institute Working Group. Circulation Cardiovascular Genetics. December 2010.
p.000064:
p.000064: Nepal. Nepal Health Research Council. Guidelines for Institutional Review Committees for Health Research in Nepal.
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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: 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:
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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
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 stem cells 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 stem cells 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 stem cells, 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 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: 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: 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: 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 stem cells 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 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:
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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.
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Social / Access to Social Goods

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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: 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.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.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.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
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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.000037: disclosed to a third party, the requirements in the Fourth Schedule, paragraphs 1(q) and 4 apply.
p.000037:
p.000038: 38
p.000038:
p.000038: PERSONAL INFORMATION IN RESEARCH
p.000038:
p.000038: obtained for all research involving personal information. However, this may not be practicable in certain
p.000038: situations; for example, the use of information (including linkages from multiple databases) from any national
p.000038: or disease registry for research, where information may have been collected routinely by law. Such use is
p.000038: of tremendous value in epidemiological and public health research, which is ultimately a public good. As there 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:
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.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.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.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.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
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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: 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: 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: 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: purpose of research. Healthcare institutions should ensure that clear formal procedures are laid down for the release
p.000072: of medical records and other personal information for research, and to formulate these procedures in consultation with
p.000072: their IRBs.
p.000072: 4.13 Healthcare institutions should also inform patients that their medical records may sometimes be
p.000072: used for research and explain the reasons for such research. They should reassure patients that all
p.000072: research will require the approval of an IRB, that there are safeguards to protect their privacy and the
p.000072: confidentiality of their medical information and that the institution will answer any questions patients may have.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: A31
p.000072:
p.000072: ANNEX A
p.000072:
p.000072: Epidemiological and Public Health Research
p.000072:
p.000072: 4.14 The use of personal information in public health and epidemiological research can lead to clashes
p.000072: between public and private interests. Ideally, consent should be obtained for all research involving
p.000072: personal information. However, this may not be practicable in certain situations, for example, the use of
p.000072: information (including linkages from multiple databases) from any national or disease registry, where
p.000072: information may have been collected routinely by law. Such use is of tremendous value in epidemiological
...

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: 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: 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: 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: 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.
...

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
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:
...

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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.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: 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.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.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.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.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.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: 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: (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: 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: 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: 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: 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: 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: (vi) at paragraph 3.47, giving the IRBs the ability the power to authorise research for valuable research
p.000072: involving recruitment of highly compromised patients who are unable to give consent and for whom no proxy is available
p.000072: to give consent.
p.000072: (vii) at paragraphs 4.12 and 4.18, the IRB is tasked to formulate formal procedures in consultation with the
p.000072: institution with regards to the release of medical records and other personal information.
p.000072: (viii) at paragraph 4.16, the IRB is tasked with the responsibility of considering the suitability of
p.000072: the extent and means of the de-identification of personal information in proportion to the risk posed.
p.000072:
p.000072: With the increased roles and responsibilities on the IRB, the onus on the Institutions would also increase
p.000072: to ensure that there is proper training provided for members of the IRBs. It may well then be that there is a greater
p.000072: need to have a properly defined appeals mechanism.
p.000072: Consent Involving Children
p.000072: 9. 3.22 Consent v Assent We are generally not in favour of introducing
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
...

Social / Child

Searching for indicator child:

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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: 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:
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.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.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.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.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.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: (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: 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: 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: 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:
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: (a) The purpose or intention of the research, and any risks or benefits to them;
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: 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:
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
p.000072: first-in-man, biopharmaceutics and experimental medicine studies. These studies are conducted in healthy volunteers, 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 healthy volunteers, 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.
p.000072:
p.000072:
...

p.000072: need to have a properly defined appeals mechanism.
p.000072: Consent Involving Children
p.000072: 9. 3.22 Consent v Assent We are generally not in favour of introducing
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: 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:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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: the waiver for consent for persons under 21 years if the risk equates with minimal risk. I think this is far too lax a
p.000072: standard.
p.000072:
p.000072: (1) The concept of “minimal risk” is poorly defined in current ethical guidelines in Singapore, and
p.000072: elsewhere. More importantly, empirical research has indicated that leaving the matter to IRB “judgment” is simply to
p.000072: invite significant variation of interpretation of what amounts to minimal risk. The indications in the proposed
p.000072: guidelines are simply insufficient considering the potential gravity of the issues involved.
p.000072:
p.000072: (2) Secondly, parental consent is not relevant simply because of various risks involved in the research, but also
p.000072: out of basic respect for parental responsibility and the implications participation might have on the child’s
p.000072: daily routines and so forth. None of this seems to be appreciated by para. 3.26 and I fear that it may open the door to
p.000072: unwise waivers. One possible additional caveat to the waiver should be that the research could not
p.000072: reasonably be undertaken if parental consent were insisted upon, and this would be detrimental to the public health
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
...

Searching for indicator children:

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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: 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.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.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.000050: such as Huntington’s disease, may be something a person would not wish to know; and
p.000050:
p.000050: (e) Genetic information may be of interest to others, such as biological relatives, who may also be
p.000050: affected, insurers and employers.
p.000050:
p.000050: 6.10 For all these reasons, there has been a tendency to regard genetic research in some way sensitive
p.000050: because the information it yields is exceptional. Certainly, genetic information ought to be considered as
p.000050: private to the individual since its implications might be considerable, and because respect for persons is a
p.000050: key principle, but this requires precautions no different from other sensitive personal information that is not
p.000050: genetic in nature. In some cases, genetic information is actual medical information, but in other cases it
p.000050: is just raw data that has to be analysed and interpreted to yield
p.000050:
p.000051: 51
p.000051:
p.000051: HUMAN GENETIC RESEARCH
p.000051:
p.000051: pertinent personal information. The BAC is therefore of the view that genetic information is not always
p.000051: and inherently special or exceptional, thereby requiring exceptional protection or precaution.
p.000051:
p.000051: Guidelines on Human Genetic Research
p.000051:
...

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 stem cells – 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.
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
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p.000061:
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p.000061:
p.000061:
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p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062: BIBLIOGRAPHY
p.000062:
p.000062: BIBLIOGRAPHY
p.000062:
p.000062:
p.000062: Australia. National Health and Medical Research Council, Australian Research Council, Australian
p.000062: Vice-Chancellor’s Committee. National Statement on Ethical Conduct in Human Research. Updated 2009.
p.000062:
p.000062: Australia. Privacy Act 1988. Amended 2012.
p.000062:
p.000062: Australia. Prohibition of Human Cloning for Reproduction Act 2002. Amended 22 December 2008.
p.000062:
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p.000062: Ethical Issues. 2010.
p.000062:
p.000062: Austria. Reproductive Medicine Act. 4 June 1992.
p.000062:
p.000062: Beskow LM et al. Informed Consent for Population-Based Research Involving Genetics.
p.000062: Journal of the American Medical Association. 286(18): 2315-2321, 14 November 2001.
p.000062:
p.000062: Brazil. Law Number 8974. 5 January 1995. Canada. Assisted Human Reproduction Act. 2004.
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p.000062: September 2005.
p.000062:
p.000062: Canada. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social
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p.000062: Involving Humans. 2010.
p.000062:
p.000062: Canada. Personal Health Information Protection Act 2004. Amended 2010.
p.000062:
p.000062: China. Ministry of Health. Guidelines on Human Assisted Reproductive Technologies. July 2003.
p.000062:
p.000062: Council for International Organizations of Medical Sciences in collaboration with the World Health Organization.
p.000062: International Ethical Guidelines for Biomedical Research Involving Human Subjects. 2002.
p.000062:
p.000062: Council for International Organizations of Medical Sciences in collaboration with the World Health Organization.
p.000062: International Ethical Guidelines for Epidemiological Studies. February 2008.
p.000062:
p.000062: Council for International Organizations of Medical Sciences. The Declaration of Inuyama on Human Genome Mapping,
p.000062: Genetic Screening and Gene Therapy. 1990.
p.000062:
...

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p.000063: Finland. Medical Research Act. Revised 2010.
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p.000063: Finland. National Advisory Board on Health Care Ethics. Perspectives on Medical Research Conducted on Children. 2003.
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p.000063: France. Civil Code. 1994.
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p.000063: Germany. Act for Protection of Embryos - The Embryo Protection Act. 13 December 1990.
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p.000064: International Society for Stem Cell Research. Guidelines for the Conduct of Human Embryonic Stem Cell
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...

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p.000065: Pakistan. National Bioethics Committee Pakistan. Ethical Research Committee-Guidelines. (n.d.).
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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.
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p.000065: Singapore. Animals and Birds Act (Cap. 7). Revised 2002.
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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.
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p.000066: Singapore. Medical (Therapy, Education and Research) Act (Cap. 175). Amended 2010. Singapore. Medicines (Clinical
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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.
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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:
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.
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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:
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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
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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
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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
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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.
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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.000069: Information Sheets & Consent Forms: Guidance for Researchers & Reviewers. March 2011.
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p.000070: 70
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p.000070: BIBLIOGRAPHY
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...

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: 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: 3.26 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: 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: (b) Any entailed risks and benefits to them, and how any such risks are to be managed and minimised;
p.000072:
...

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: 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:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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: 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
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
...

p.000072: (iv) at paragraph 3.27, IRBs may consider a waiver of the consent requirement for research done in the
p.000072: public interest.
p.000072: (v) at paragraph 3.28, giving the IRBs the power in some cases to authorise research with regards to patients who
p.000072: are subject to the provisions of the Mental Capacity Act.
p.000072: (vi) at paragraph 3.47, giving the IRBs the ability the power to authorise research for valuable research
p.000072: involving recruitment of highly compromised patients who are unable to give consent and for whom no proxy is available
p.000072: to give consent.
p.000072: (vii) at paragraphs 4.12 and 4.18, the IRB is tasked to formulate formal procedures in consultation with the
p.000072: institution with regards to the release of medical records and other personal information.
p.000072: (viii) at paragraph 4.16, the IRB is tasked with the responsibility of considering the suitability of
p.000072: the extent and means of the de-identification of personal information in proportion to the risk posed.
p.000072:
p.000072: With the increased roles and responsibilities on the IRB, the onus on the Institutions would also increase
p.000072: to ensure that there is proper training provided for members of the IRBs. It may well then be that there is a greater
p.000072: need to have a properly defined appeals mechanism.
p.000072: Consent Involving Children
p.000072: 9. 3.22 Consent v Assent We are generally not in favour of introducing
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:
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:
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: the waiver for consent for persons under 21 years if the risk equates with minimal risk. I think this is far too lax a
p.000072: standard.
p.000072:
p.000072: (1) The concept of “minimal risk” is poorly defined in current ethical guidelines in Singapore, and
p.000072: elsewhere. More importantly, empirical research has indicated that leaving the matter to IRB “judgment” is simply to
p.000072: invite significant variation of interpretation of what amounts to minimal risk. The indications in the proposed
p.000072: guidelines are simply insufficient considering the potential gravity of the issues involved.
p.000072:
p.000072: (2) Secondly, parental consent is not relevant simply because of various risks involved in the research, but also
p.000072: out of basic respect for parental responsibility and the implications participation might have on the child’s
p.000072: daily routines and so forth. None of this seems to be appreciated by para. 3.26 and I fear that it may open the door to
p.000072: unwise waivers. One possible additional caveat to the waiver should be that the research could not
p.000072: reasonably be undertaken if parental consent were insisted upon, and this would be detrimental to the public health
p.000072: interest or the general public interest. I understand that this is already the view taken by some local IRBs.
p.000072:
...

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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:
...

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:
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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.
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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:
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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:
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:
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:

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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:

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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

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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:
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:
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p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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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: C10
p.000072:
p.000072: ANNEX C
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
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p.000072:
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:
p.000072:
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p.000072:
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
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...

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:
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
...

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