4D3B7B391183C231934F85202FEF7C32
Governance Framework for Biomedical Research in Singapore
https://www.asiabiotech.com/15/1505/0013_0017.pdf
http://leaux.net/URLS/ConvertAPI Text Files/A83A2F8BDE441833DCDE325BF037F425.en.txt
Examining the file media/Synopses/A83A2F8BDE441833DCDE325BF037F425.html:
This file was generated: 2020-05-31 04:19:04
| 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
Political / political affiliation
Searching for indicator political:
(return to top)
p.000016: National Medical Ethics Committee, Singapore, Recommendations on Clinical Trials: Update Focusing on Phase I Trials,
p.000016: May 2007.
p.000016: Singapore Regulations: Medicines (Clinical Trials) Regulations, Regulation 3, Revised 2000.
p.000016: Singapore Regulations: Medicines (Clinical Trials) Regulations, Directives for Private Healthcare Institutions
p.000016: Providing Assisted Reproduction Services: Regulation 4 of the Private Hospitals and Medical Clinics Regulations (Cap.
p.000016: 248, Reg. 1), Revised March 2006.
p.000016: Singapore Statutes: Human Cloning and Other Prohibited Practices Act (Cap. 131B), Revised 2005. Singapore Statues:
p.000016: Biological Agents and Toxins Act (Cap. 24A), Revised 2006.
p.000016: Singapore Statues: National Registry of Diseases Act (Cap. 201B), Revised 2008.
p.000016: UK Department of Health, Governance arrangements for NHS Research Ethics Committees, July 2001. US Code of Federal
p.000016: Regulations at Title 45, Part 46, various provisions.
p.000016: Duff R Waring and Trudo Lemmens, “Integrating Values in Risk Analysis of Biomedical Research: The Case for Regulatory
p.000016: and Law Reform”. In Law Commission of Canada (ed), Law and Risk. Vancouver and Toronto: University of British Columbia
p.000016: Press, 2005, pp 156-200.
p.000016:
p.000016: About the Author
p.000016: W Calvin Ho read law at Cornell University (New York), National University of Singapore, and University of Cambridge
p.000016: (England). In addition, he read sociology and economics at the London School of Economics and Political Science, and at
p.000016: the School of Oriental and African Studies, University of London. He practiced law in London and Singapore, and is
p.000016: currently Senior Research Associate with the Bioethics Advisory Committee. He will assume the position of Assistant
p.000016: Professor at the Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, from
p.000016: July 2011.
p.000016: Calvin has published articles and book chapters on biomedical law and ethics, intellectual property law, conflict of
p.000016: laws and scientific integrity. He has served as the deputy editor of the Singapore Law Review, associate editor of the
p.000016: Cornell International Law Journal, and assistant guest editor of the Singapore Academy of Law Journal. In 2010,
p.000016: he was co-editor (with Associate Professor John M Elliott and Dr Sylvia SN Lim) of the monograph “Bioethics
p.000016: in Singapore: The Ethical Microcosm”, which was published by World Scientific. This book analyses the ways in which an
p.000016: ethical framework for biomedical research has been established in Singapore over the past decade. Ethical discussions
p.000016: in the book include stem cell research and cloning, genetics, research with human participants, as well as likely
p.000016: future developments. He is currently editing a book (with Associate Professor Terry Kaan) on genetic privacy (to be
p.000016: published by World Scientific), and is involved in a study on compulsory licensing for public health
p.000016: under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
p.000016:
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000013: Health (MOH) a year later by way of a written directive, with the effect that all government and restructured
p.000013: hospitals are required to set up ethics committees to review research proposals involving human subjects (BAC
p.000013: 2004: 13). Even then, ethics review was not widely perceived as necessary (Ho and Lim 2010: 3). With the adoption
p.000013: and implementation of the Biomedical Sciences Initiative from 2000, the guidelines of the NMEC were elaborated
p.000013: on and expanded
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: by the Bioethics Advisory Committee (BAC) into a more comprehensive system of ethics review centred around
p.000013: institutional review boards (IRBs). The BAC defines IRBs as “full- time permanent supervisory bodies organised at and
p.000013: integral to the function of the highest administrative level in all institutions in which research is carried
p.000013: out” (BAC 2004: 28). The fundamental responsibility of an IRB is to act as an ethics review gateway to minimise
p.000013: the likelihood of harm to research subjects on the one hand, and to ensure that research proceeds on sound
p.000013: ethical basis, on the other hand. Hence, both the NMEC and the BAC gave considerable emphasis to the
p.000013: requirement of informed consent and appropriate safeguards for vulnerable subjects, such as children and
p.000013: people with reduced mental capacities in decision-making. However, IRBs are not concerned with risks to
p.000013: scientific objectivity and integrity as they do not review research proposals for scientific merits (BAC 2004: 31). The
p.000013: importance of the BAC’s 2004 guidelines lies not only in the articulation of the basic operational
p.000013: requirements of IRBs (such as composition and operational procedures), but also in the BAC’s recognition of the
p.000013: need for IRBs to be provided with adequate resources and administrative support, as well as for their
p.000013: members who have acted in good faith to be fully indemnified from liability (BAC 2004: 51, 54). The substantive
p.000013: effect of the BAC’s guidelines has been to entrench ethics review through IRBs within the governance framework.
p.000013: They also created a normative expectation for any biomedical research in Singapore that involves a human
p.000013: subject, personal information or human tissue to commence only after ethical clearance by an IRB has been
p.000013: secured. In spite of this seemingly broad normative reach, it is important to recognise that the BAC was established as
p.000013: a high-level
p.000013: advisory body to the government, and is not
p.000013: a regulatory body. Hence, the BAC’s guidelines (or indeed, any of its recommendations) do not have any regulatory force
p.000013: or effect in and of themselves unless otherwise empowered by a regulator or through voluntary adoption by an
p.000013: organisation. In 2006, a Directive was issued by the MOH to require all registered medical practitioners to comply
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000014: investigators or any holder of the certificate to observe provisions set out in the Singapore Guideline for Good
p.000014: Clinical Practice (SGGCP) (Singapore Regulations 2000: Section 21). The SGGCP is in turn adapted from the Guideline for
p.000014: Good Clinical Practice of the International Conference on Harmonisation, which sets out the baseline standards
p.000014: for the conduct of clinical trials.
p.000014:
p.000014: Comparative Governance Structures
p.000014: The basic structure of the governance framework in Singapore, comprising a general requirement of IRB oversight
p.000014: and review of research protocols, complemented by more targeted regulatory regimes for specific risks,
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: FEATURE
p.000015:
p.000015:
p.000015:
p.000015: is similar to that in the United States (US). The Common Rule (45 CFR 46) requires US federal agencies and research
p.000015: institutions receiving funding from the Federal Government to establish an IRB to review research proposals
p.000015: following a set of prescribed requirements. Research institutions that do not receive funding from the US
p.000015: government will nevertheless have to observe requirements similar to those under the Common Rule if they should
p.000015: require approval from the US Food and Drug Administration. Risk assessment is intrinsic to the Common Rule requirements
p.000015: in at least three respects. First, an IRB must determine if appropriate measures have been adopted in the research
p.000015: protocols to minimise risk (45 CFR 46.111(a)). Second, the extent of IRB review is dependent on whether the risks
p.000015: entailed are expected to exceed “minimal risk” (45 CFR 46.102(i) and 45 CFR 46.110).
p.000015: Third, any risks entailed must be reasonable in relation to the non-monetary benefits. In Britain, a nationalised
p.000015: health system has enabled a more centralised approach to ethics review. The National Research Ethics Service has
p.000015: the responsibility of ensuring that research ethics committees (similar to IRBs in Singapore) safeguard the
p.000015: rights, safety, dignity and well-being of research participants in the National Health Service. Like IRBs in the
p.000015: US and Singapore, research ethics committees (RECs) review research protocols and provide an opinion on their
p.000015: ethical acceptability. Although centralised, RECs are sub-divided into two groups: those that review clinical
p.000015: trials of investigational medicinal products (‘recognised’ RECs) and those that do not (‘authorised’ RECs).
...
Social / Child
Searching for indicator children:
(return to top)
p.000013: Health (MOH) a year later by way of a written directive, with the effect that all government and restructured
p.000013: hospitals are required to set up ethics committees to review research proposals involving human subjects (BAC
p.000013: 2004: 13). Even then, ethics review was not widely perceived as necessary (Ho and Lim 2010: 3). With the adoption
p.000013: and implementation of the Biomedical Sciences Initiative from 2000, the guidelines of the NMEC were elaborated
p.000013: on and expanded
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: by the Bioethics Advisory Committee (BAC) into a more comprehensive system of ethics review centred around
p.000013: institutional review boards (IRBs). The BAC defines IRBs as “full- time permanent supervisory bodies organised at and
p.000013: integral to the function of the highest administrative level in all institutions in which research is carried
p.000013: out” (BAC 2004: 28). The fundamental responsibility of an IRB is to act as an ethics review gateway to minimise
p.000013: the likelihood of harm to research subjects on the one hand, and to ensure that research proceeds on sound
p.000013: ethical basis, on the other hand. Hence, both the NMEC and the BAC gave considerable emphasis to the
p.000013: requirement of informed consent and appropriate safeguards for vulnerable subjects, such as children and
p.000013: people with reduced mental capacities in decision-making. However, IRBs are not concerned with risks to
p.000013: scientific objectivity and integrity as they do not review research proposals for scientific merits (BAC 2004: 31). The
p.000013: importance of the BAC’s 2004 guidelines lies not only in the articulation of the basic operational
p.000013: requirements of IRBs (such as composition and operational procedures), but also in the BAC’s recognition of the
p.000013: need for IRBs to be provided with adequate resources and administrative support, as well as for their
p.000013: members who have acted in good faith to be fully indemnified from liability (BAC 2004: 51, 54). The substantive
p.000013: effect of the BAC’s guidelines has been to entrench ethics review through IRBs within the governance framework.
p.000013: They also created a normative expectation for any biomedical research in Singapore that involves a human
p.000013: subject, personal information or human tissue to commence only after ethical clearance by an IRB has been
p.000013: secured. In spite of this seemingly broad normative reach, it is important to recognise that the BAC was established as
p.000013: a high-level
p.000013: advisory body to the government, and is not
p.000013: a regulatory body. Hence, the BAC’s guidelines (or indeed, any of its recommendations) do not have any regulatory force
p.000013: or effect in and of themselves unless otherwise empowered by a regulator or through voluntary adoption by an
p.000013: organisation. In 2006, a Directive was issued by the MOH to require all registered medical practitioners to comply
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000016: Biological Agents and Toxins Act (Cap. 24A), Revised 2006.
p.000016: Singapore Statues: National Registry of Diseases Act (Cap. 201B), Revised 2008.
p.000016: UK Department of Health, Governance arrangements for NHS Research Ethics Committees, July 2001. US Code of Federal
p.000016: Regulations at Title 45, Part 46, various provisions.
p.000016: Duff R Waring and Trudo Lemmens, “Integrating Values in Risk Analysis of Biomedical Research: The Case for Regulatory
p.000016: and Law Reform”. In Law Commission of Canada (ed), Law and Risk. Vancouver and Toronto: University of British Columbia
p.000016: Press, 2005, pp 156-200.
p.000016:
p.000016: About the Author
p.000016: W Calvin Ho read law at Cornell University (New York), National University of Singapore, and University of Cambridge
p.000016: (England). In addition, he read sociology and economics at the London School of Economics and Political Science, and at
p.000016: the School of Oriental and African Studies, University of London. He practiced law in London and Singapore, and is
p.000016: currently Senior Research Associate with the Bioethics Advisory Committee. He will assume the position of Assistant
p.000016: Professor at the Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, from
p.000016: July 2011.
p.000016: Calvin has published articles and book chapters on biomedical law and ethics, intellectual property law, conflict of
p.000016: laws and scientific integrity. He has served as the deputy editor of the Singapore Law Review, associate editor of the
p.000016: Cornell International Law Journal, and assistant guest editor of the Singapore Academy of Law Journal. In 2010,
p.000016: he was co-editor (with Associate Professor John M Elliott and Dr Sylvia SN Lim) of the monograph “Bioethics
p.000016: in Singapore: The Ethical Microcosm”, which was published by World Scientific. This book analyses the ways in which an
p.000016: ethical framework for biomedical research has been established in Singapore over the past decade. Ethical discussions
p.000016: in the book include stem cell research and cloning, genetics, research with human participants, as well as likely
p.000016: future developments. He is currently editing a book (with Associate Professor Terry Kaan) on genetic privacy (to be
p.000016: published by World Scientific), and is involved in a study on compulsory licensing for public health
p.000016: under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
p.000016:
...
Social / Religion
Searching for indicator faith:
(return to top)
p.000013: by the Bioethics Advisory Committee (BAC) into a more comprehensive system of ethics review centred around
p.000013: institutional review boards (IRBs). The BAC defines IRBs as “full- time permanent supervisory bodies organised at and
p.000013: integral to the function of the highest administrative level in all institutions in which research is carried
p.000013: out” (BAC 2004: 28). The fundamental responsibility of an IRB is to act as an ethics review gateway to minimise
p.000013: the likelihood of harm to research subjects on the one hand, and to ensure that research proceeds on sound
p.000013: ethical basis, on the other hand. Hence, both the NMEC and the BAC gave considerable emphasis to the
p.000013: requirement of informed consent and appropriate safeguards for vulnerable subjects, such as children and
p.000013: people with reduced mental capacities in decision-making. However, IRBs are not concerned with risks to
p.000013: scientific objectivity and integrity as they do not review research proposals for scientific merits (BAC 2004: 31). The
p.000013: importance of the BAC’s 2004 guidelines lies not only in the articulation of the basic operational
p.000013: requirements of IRBs (such as composition and operational procedures), but also in the BAC’s recognition of the
p.000013: need for IRBs to be provided with adequate resources and administrative support, as well as for their
p.000013: members who have acted in good faith to be fully indemnified from liability (BAC 2004: 51, 54). The substantive
p.000013: effect of the BAC’s guidelines has been to entrench ethics review through IRBs within the governance framework.
p.000013: They also created a normative expectation for any biomedical research in Singapore that involves a human
p.000013: subject, personal information or human tissue to commence only after ethical clearance by an IRB has been
p.000013: secured. In spite of this seemingly broad normative reach, it is important to recognise that the BAC was established as
p.000013: a high-level
p.000013: advisory body to the government, and is not
p.000013: a regulatory body. Hence, the BAC’s guidelines (or indeed, any of its recommendations) do not have any regulatory force
p.000013: or effect in and of themselves unless otherwise empowered by a regulator or through voluntary adoption by an
p.000013: organisation. In 2006, a Directive was issued by the MOH to require all registered medical practitioners to comply
p.000013: with the recommendations of the BAC, including its 2004 guidelines. The Agency for Science Technology and
p.000013: Research (A*STAR), the
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: principal biomedical research funding arm of the government, has adopted the BAC’s recommendations and
p.000013: guidelines on a voluntary basis, as have leading local academic institutions (primarily the National University
p.000013: of Singapore and the Nanyang Technological University). Hence, although the BAC’s guidelines are not binding per
p.000013: se, they do have regulatory effect on biomedical research that (a) involve registered medical practitioners,
p.000013: government and restructured hospitals, and key local academic institutions, or (b) receive funding from A*STAR.
p.000013:
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000015: following a set of prescribed requirements. Research institutions that do not receive funding from the US
p.000015: government will nevertheless have to observe requirements similar to those under the Common Rule if they should
p.000015: require approval from the US Food and Drug Administration. Risk assessment is intrinsic to the Common Rule requirements
p.000015: in at least three respects. First, an IRB must determine if appropriate measures have been adopted in the research
p.000015: protocols to minimise risk (45 CFR 46.111(a)). Second, the extent of IRB review is dependent on whether the risks
p.000015: entailed are expected to exceed “minimal risk” (45 CFR 46.102(i) and 45 CFR 46.110).
p.000015: Third, any risks entailed must be reasonable in relation to the non-monetary benefits. In Britain, a nationalised
p.000015: health system has enabled a more centralised approach to ethics review. The National Research Ethics Service has
p.000015: the responsibility of ensuring that research ethics committees (similar to IRBs in Singapore) safeguard the
p.000015: rights, safety, dignity and well-being of research participants in the National Health Service. Like IRBs in the
p.000015: US and Singapore, research ethics committees (RECs) review research protocols and provide an opinion on their
p.000015: ethical acceptability. Although centralised, RECs are sub-divided into two groups: those that review clinical
p.000015: trials of investigational medicinal products (‘recognised’ RECs) and those that do not (‘authorised’ RECs).
p.000015: This division could be explained on the basis of the different degrees of risk entailed; the level of
p.000015: uncertainty being greater in clinical trials. Even for research with presumably lower risks, authorised RECs will need
p.000015: to determine the extent of oversight and acceptability of the research design as a matter of risk-benefit
p.000015: assessment (UK DOH 2001: paragraph 7.27 and 9.13). In Singapore, the requirement of risk assessment is evident in
p.000015: the guidelines of the NMEC (1997: paragraph 2.4) and the BAC (2004: 18), although the risk to benefit calibrations will
p.000015: undoubtedly vary among the
p.000015: three jurisdictions given that notions of ‘risk’ and ‘benefit’ are intermediated by social and cultural values and
p.000015: conditions.
p.000015:
p.000015: Scientific Integrity and Professionalism
p.000015: Neither IRBs in Singapore (as we have seen) and in the US nor RECs in Britain are directly concerned with scientific
p.000015: merit of a research protocol and scientific integrity. These are often seen to be more directly the concerns of
p.000015: research funders. Generally regarded as falling within the ambit of “peer review”, the US was among the first
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000014:
p.000014: Comparative Governance Structures
p.000014: The basic structure of the governance framework in Singapore, comprising a general requirement of IRB oversight
p.000014: and review of research protocols, complemented by more targeted regulatory regimes for specific risks,
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: FEATURE
p.000015:
p.000015:
p.000015:
p.000015: is similar to that in the United States (US). The Common Rule (45 CFR 46) requires US federal agencies and research
p.000015: institutions receiving funding from the Federal Government to establish an IRB to review research proposals
p.000015: following a set of prescribed requirements. Research institutions that do not receive funding from the US
p.000015: government will nevertheless have to observe requirements similar to those under the Common Rule if they should
p.000015: require approval from the US Food and Drug Administration. Risk assessment is intrinsic to the Common Rule requirements
p.000015: in at least three respects. First, an IRB must determine if appropriate measures have been adopted in the research
p.000015: protocols to minimise risk (45 CFR 46.111(a)). Second, the extent of IRB review is dependent on whether the risks
p.000015: entailed are expected to exceed “minimal risk” (45 CFR 46.102(i) and 45 CFR 46.110).
p.000015: Third, any risks entailed must be reasonable in relation to the non-monetary benefits. In Britain, a nationalised
p.000015: health system has enabled a more centralised approach to ethics review. The National Research Ethics Service has
p.000015: the responsibility of ensuring that research ethics committees (similar to IRBs in Singapore) safeguard the
p.000015: rights, safety, dignity and well-being of research participants in the National Health Service. Like IRBs in the
p.000015: US and Singapore, research ethics committees (RECs) review research protocols and provide an opinion on their
p.000015: ethical acceptability. Although centralised, RECs are sub-divided into two groups: those that review clinical
p.000015: trials of investigational medicinal products (‘recognised’ RECs) and those that do not (‘authorised’ RECs).
p.000015: This division could be explained on the basis of the different degrees of risk entailed; the level of
p.000015: uncertainty being greater in clinical trials. Even for research with presumably lower risks, authorised RECs will need
p.000015: to determine the extent of oversight and acceptability of the research design as a matter of risk-benefit
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000014:
p.000014: FEATURE
p.000014:
p.000014:
p.000014:
p.000014: Animal Research (2004). The BAC’s guidelines and recommendations for genetic testing and genetic research were
p.000014: developed in consultation with the NMEC (BAC 2005: 14-15), which has earlier on published a set of guidelines
p.000014: on gene technology (NMEC 2001). Of relevance to biobanking are the BAC’s recommendations on the use of human
p.000014: tissue and personal information in biomedical research, published in two separate reports (BAC 2002b and 2007). Its
p.000014: report on personal information contributed to clarification of the legal basis of disease registries (Singapore
p.000014: Statutes 2008).
p.000014: In recent years, a statutory regime on biosafety was established and the existing regime on clinical
p.000014: trials was strengthened. In 2006, the Biological Agents and Toxins Act was enacted to regulate the possession, use
p.000014: and transportation of biological agents
p.000014: and toxins. Also in that year, the adverse outcome in the TGN1412 clinical trial in the UK provided the
p.000014: occasion for the NMEC to review its 1997 guidelines and to provide a set of recommendations on Phase I clinical
p.000014: trials. Observing an increase in the number of Phase I trials conducted in Singapore, the NMEC emphasised the
p.000014: importance of precautionary measures to prevent injuries from unexpected adverse events, the availability and adequacy
p.000014: of medical response should such events arise, and vigilance against undue inducement from the provision of
p.000014: excessive remuneration or benefits in recruiting research subjects (NMEC 2007). Clinical trials on medical
p.000014: products are regulated by the Health Products Regulation Group of the Health Sciences Authority under a licensing
p.000014: scheme. Clinical Trial Certificates issued under this scheme imposes a requirement for sponsors, principal
p.000014: investigators or any holder of the certificate to observe provisions set out in the Singapore Guideline for Good
p.000014: Clinical Practice (SGGCP) (Singapore Regulations 2000: Section 21). The SGGCP is in turn adapted from the Guideline for
p.000014: Good Clinical Practice of the International Conference on Harmonisation, which sets out the baseline standards
p.000014: for the conduct of clinical trials.
p.000014:
p.000014: Comparative Governance Structures
p.000014: The basic structure of the governance framework in Singapore, comprising a general requirement of IRB oversight
p.000014: and review of research protocols, complemented by more targeted regulatory regimes for specific risks,
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: FEATURE
p.000015:
p.000015:
p.000015:
p.000015: is similar to that in the United States (US). The Common Rule (45 CFR 46) requires US federal agencies and research
p.000015: institutions receiving funding from the Federal Government to establish an IRB to review research proposals
p.000015: following a set of prescribed requirements. Research institutions that do not receive funding from the US
p.000015: government will nevertheless have to observe requirements similar to those under the Common Rule if they should
...
Orphaned Trigger Words
p.000013: people with reduced mental capacities in decision-making. However, IRBs are not concerned with risks to
p.000013: scientific objectivity and integrity as they do not review research proposals for scientific merits (BAC 2004: 31). The
p.000013: importance of the BAC’s 2004 guidelines lies not only in the articulation of the basic operational
p.000013: requirements of IRBs (such as composition and operational procedures), but also in the BAC’s recognition of the
p.000013: need for IRBs to be provided with adequate resources and administrative support, as well as for their
p.000013: members who have acted in good faith to be fully indemnified from liability (BAC 2004: 51, 54). The substantive
...
p.000014: tissue and personal information in biomedical research, published in two separate reports (BAC 2002b and 2007). Its
p.000014: report on personal information contributed to clarification of the legal basis of disease registries (Singapore
p.000014: Statutes 2008).
p.000014: In recent years, a statutory regime on biosafety was established and the existing regime on clinical
p.000014: trials was strengthened. In 2006, the Biological Agents and Toxins Act was enacted to regulate the possession, use
p.000014: and transportation of biological agents
p.000014: and toxins. Also in that year, the adverse outcome in the TGN1412 clinical trial in the UK provided the
p.000014: occasion for the NMEC to review its 1997 guidelines and to provide a set of recommendations on Phase I clinical
p.000014: trials. Observing an increase in the number of Phase I trials conducted in Singapore, the NMEC emphasised the
p.000014: importance of precautionary measures to prevent injuries from unexpected adverse events, the availability and adequacy
p.000014: of medical response should such events arise, and vigilance against undue inducement from the provision of
p.000014: excessive remuneration or benefits in recruiting research subjects (NMEC 2007). Clinical trials on medical
p.000014: products are regulated by the Health Products Regulation Group of the Health Sciences Authority under a licensing
p.000014: scheme. Clinical Trial Certificates issued under this scheme imposes a requirement for sponsors, principal
p.000014: investigators or any holder of the certificate to observe provisions set out in the Singapore Guideline for Good
p.000014: Clinical Practice (SGGCP) (Singapore Regulations 2000: Section 21). The SGGCP is in turn adapted from the Guideline for
p.000014: Good Clinical Practice of the International Conference on Harmonisation, which sets out the baseline standards
p.000014: for the conduct of clinical trials.
p.000014:
p.000014: Comparative Governance Structures
p.000014: The basic structure of the governance framework in Singapore, comprising a general requirement of IRB oversight
p.000014: and review of research protocols, complemented by more targeted regulatory regimes for specific risks,
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: FEATURE
p.000015:
p.000015:
p.000015:
p.000015: is similar to that in the United States (US). The Common Rule (45 CFR 46) requires US federal agencies and research
p.000015: institutions receiving funding from the Federal Government to establish an IRB to review research proposals
p.000015: following a set of prescribed requirements. Research institutions that do not receive funding from the US
p.000015: government will nevertheless have to observe requirements similar to those under the Common Rule if they should
p.000015: require approval from the US Food and Drug Administration. Risk assessment is intrinsic to the Common Rule requirements
p.000015: in at least three respects. First, an IRB must determine if appropriate measures have been adopted in the research
p.000015: protocols to minimise risk (45 CFR 46.111(a)). Second, the extent of IRB review is dependent on whether the risks
p.000015: entailed are expected to exceed “minimal risk” (45 CFR 46.102(i) and 45 CFR 46.110).
p.000015: Third, any risks entailed must be reasonable in relation to the non-monetary benefits. In Britain, a nationalised
p.000015: health system has enabled a more centralised approach to ethics review. The National Research Ethics Service has
p.000015: the responsibility of ensuring that research ethics committees (similar to IRBs in Singapore) safeguard the
p.000015: rights, safety, dignity and well-being of research participants in the National Health Service. Like IRBs in the
p.000015: US and Singapore, research ethics committees (RECs) review research protocols and provide an opinion on their
p.000015: ethical acceptability. Although centralised, RECs are sub-divided into two groups: those that review clinical
p.000015: trials of investigational medicinal products (‘recognised’ RECs) and those that do not (‘authorised’ RECs).
p.000015: This division could be explained on the basis of the different degrees of risk entailed; the level of
p.000015: uncertainty being greater in clinical trials. Even for research with presumably lower risks, authorised RECs will need
p.000015: to determine the extent of oversight and acceptability of the research design as a matter of risk-benefit
p.000015: assessment (UK DOH 2001: paragraph 7.27 and 9.13). In Singapore, the requirement of risk assessment is evident in
p.000015: the guidelines of the NMEC (1997: paragraph 2.4) and the BAC (2004: 18), although the risk to benefit calibrations will
p.000015: undoubtedly vary among the
p.000015: three jurisdictions given that notions of ‘risk’ and ‘benefit’ are intermediated by social and cultural values and
p.000015: conditions.
p.000015:
p.000015: Scientific Integrity and Professionalism
p.000015: Neither IRBs in Singapore (as we have seen) and in the US nor RECs in Britain are directly concerned with scientific
p.000015: merit of a research protocol and scientific integrity. These are often seen to be more directly the concerns of
p.000015: research funders. Generally regarded as falling within the ambit of “peer review”, the US was among the first
p.000015: jurisdictions to establish a national framework for research integrity. Whereas the Office of Human
p.000015: Research Protections is concerned with administering the Common Rule, the Office of Research Integrity and the
p.000015: Office of the Inspector General oversee the national framework for research integrity governance. In Britain,
p.000015: research institutions and their funders retain responsibility for research integrity. Although there is no national
p.000015: framework as such, the UK Research Integrity Office (an independent advisory body) collaborates with other
p.000015: organisations such as Research Councils UK and the Department of Health to harmonise and coordinate guidance in this
p.000015: area.
p.000015: As in Britain, there is currently no national framework on scientific integrity governance in Singapore. The MOH
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| children | Child |
| dependent | Dependent |
| drug | Drug Usage |
| faith | Religion |
| opinion | philosophical differences/differences of opinion |
| political | political affiliation |
| property | Property Ownership |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
cultural
ethics
harm
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input