• Build bioethics capability in Singapore that supports and facilitates research excellence;
• Work with other enablers to support development and implementation of policy concerning the ethical conduct, governance and translation of clinical research, in ways that are responsive to local ethical challenges; and
• Develop scholarship and guidance related to the ethical dimensions of innovative technologies and therapies.

Our key areas of focus are (1) Clinical Trials and Clinical Research, (2) Ethics of Clinical Innovation and (3) Artificial Intelligence and Trust Technologies.

1) Clinical Trials and Clinical Research

Rapidly evolving changes to the conduct and design of clinical trials and clinical research have emerged in recent years, bringing new challenges to research ethics. This includes changes to how stakeholders (such as clinicians, researchers and IRBs) engage and interact with one another to shape the planning and conduct of ethical research. While there are well-established standards for conduct and oversight for research ethics, these new developments require updating and refining existing practices & policy.

We aim to provide clinician-scientists, IRBs and policymakers with the means to address ethical issues encountered in the process of bringing innovative therapies and technologies to the bedside. SHAPES also intends to facilitate research excellence through building research ethics capacity amongst key enablers.

2) Ethics of Clinical Innovation

At the forefront of latest clinical innovations, SHAPES has identified two burgeoning research areas that are key-priorities: regenerative medicine and neuro-ethics. SHAPES aims to guide policymaking of these sub-areas in Singapore, and translate ethical guidelines developed from international research into guidance that is applicable to regulatory and health law context of Singapore.

With continuing interest in stem cell and cell therapy-related research, as well as new pioneering work in neurology and machine-human interfaces, we anticipate that regenerative medicine and neuro-ethics will remain priorities within clinical innovations. SHAPES will continue to seek input from stakeholders, experts and our advisory committee to stay relevant and responsive to emerging needs.

3) Artificial Intelligence and Trust Technologies

Artificial Intelligence (AI) is rapidly being developed and adopted in healthcare settings. For example, AI is being developed to aid and support clinical decision-making for primary care doctors and to profile patients for the risk of developing chronic diseases. Addressing the ethical, legal and social issues that underlie such innovations is critical for their development and to engender trust in AI-driven technologies. Issues identified previously from SHAPES’ work include the potential harms (e.g. algorithmic bias in training sets), the public interest in building more efficient health systems, transparency, accountability and liability of medical professionals and developers in AI-assisted decision-making.

SHAPES will collaborate with key stakeholders, international and local expertise to produce ethical guidance for the adoption of AI-assisted decision-making tools in healthcare settings within Singapore. We anticipate this work will complement the practical guidance and policymaking of regulators and advisory groups.

Expert and stakeholder engagement workshops

SHAPES convenes workshops that engage experts and key stakeholders in Singapore on key bioethical issues and challenges faced.

Discussion and guidance papers

Through stakeholder engagement and research, we develop discussion and guidance papers to help guide the practice and oversight of emerging bioethical challenges as they arise locally.

Training

Informed by research and needs of stakeholders, we provide training and capacity-building both for clinician-scientists and other researchers in their research, graduate students, as well IRBs and regulators in their crucial oversight role.

• The Ethics of Big Data in Health & Research
  In 2018, SHAPES convened an international interdisciplinary Working Group to develop a framework that provides ethical guidance to decision-makers who work with big data in health and research. A general overview of the resulting Framework can be found here. The Framework and other recent publications on big data ethics by members of the Working Group are available here.

   

• The Ethics of Gene-Modifying Technologies
  In 2019, SHAPES convened an international interdisciplinary Working Group to explore ethical issues arising in gene modifying technologies.

   

• Research on Local Ethics Review Processes
  The SHAPES Initiative has recently completed a research project that contributes to a general understanding of perceptions around IRB functions and characteristics in Singapore. The project findings can be found here.

Newsletter:

Oct-Nov 2021

Aug-Sep 2021

June-July 2021

Apr-May 2021

Feb-Mar 2021

Nov-Dec 2020

Sep-Oct 2020

July-Aug 2020

May-June 2020

Mar-Apr 2020

Jan-Feb 2020

2023

• Exploring the Acceptability of Patient and Public Involvement (PPI) in Singapore Context, 27 July 2023

• Seminar on Ethical AI in Healthcare, 17 Apr 2023
  
  

2023

• Webinar: New Research Practices in the wake of COVID-19: Ethical Aspects of Remote Consent and Remote Data Gathering, online, 6 Mar 2023

2022

• Webinar: Translational health research on AI: A roundtable to identify new ethical challenges on the front line

• Webinar: New Research Practices in the wake of  COVID-19: Remote Consent and Remote Data Gathering, online, 8 July 2022 (organised by SHAPES, CBmE, NUS)

Aim: In this workshop, participants will learn through lectures, facilitated discussion and case studies, how to tackle ethical aspects of remote consent and remote study visits conducted in Singapore.

Panellists (in alphabetical order, by last name): Dr Austin Ang, Mr Markus Labude, Ms Sumitra Sachidanandan, Dr Owen Schaefer, Dr Aaron Tan

Facilitators (in alphabetical order, by last name): Dr Chan Hui Yun, Dr Victor Cole, A/Prof Michael Dunn, A/Prof Roy Joseph, Mr Markus Labude, Dr Tamra Lysaght, Dr Anantharaman Muralidharan, Ms Serene Ong, Dr Owen Schaefer, Dr Voo Teck Chuan

2021

• Webinar: Singaporean perspectives on actual and ideal IRB review functions and characteristics, online, 5 February 2021

Aim: This webinar presented SHAPES’ research findings on Singaporean perspectives on IRB functions and characteristics. The discussion session gave participants the opportunity to contribute their views and pose questions about this novel research. 

Authors Present:  Markus K. Labude, Liang Shen, Owen Schaefer, Catherine Ong, Vicki Xafis

• Workshops: Ethics Framework for Big Data in Health and Research – Learning to Apply the Framework, online, 13 & 15 January 2021

Aim: These workshops aimed to facilitate a deeper understanding of the Framework and its application. The case-based activity enabled attendees to apply the Framework and discuss the issues and values relevant to the case.

Facilitators (in alphabetical order): A/Prof Angela Ballantyne, Mr Markus Labude, Prof Graeme Laurie, Dr Tamra Lysaght, Dr Owen Schaefer, Dr Vicki Xafis.

2020

• Webinar: Conceptual Issues Impeding Uses & Sharing of Big Data in Biomedicine, online, 25 November 2020
  (by invitation – organized by SHAPES, CBmE, NUS, in collaboration with FHT, ETH Zurich)

Aim: The aim of this webinar was to discuss and elucidate how different understandings of certain concepts across disciplines, different interpretations, and different prioritisation of issues impede the use and sharing of big data in biomedicine.

Panellists: A/Prof Mark J Taylor, Dr Reza Shokri, Clinical A/Prof Yeo Khung Keong, Ms Agata Ferretti, Dr Michael Chapman, Dr Natalie Banner, Dr Shona Kalkman and A/Prof Josip Car

2019

• Symposium on Gene-Modifying Technologies: current ethical issues, Hotel Fort Canning, Singapore, 29-30 April 2019
  (by invitation – organized by SHAPES, CBmE NUS)

• Gene-Modifying Technologies Working Group Meeting, CBmE, NUS 1-3 May 2019 (organized by SHAPES, CBmE NUS)

2018

• Big Data Ethics Symposium, Hotel Fort Canning, Singapore, 5-6 March 2018
  (by invitation – organized by SHAPES, CBmE NUS)

• Big Data Ethics Working Group Meeting, CBmE, NUS, 7-9 March 2018
  (organized by SHAPES, CBmE, NUS)

• Gene Editing: Ethics and Regulation Symposium, University of Manchester, 16-17 July 2018 (organized by the Centre for Social Ethics and Policy (CSEP), University of Manchester, in collaboration with SHAPES, CBmE, NUS)

• Ethics of Big Data in Health and Research Conference, Kent Ridge Guild House, NUSS, 30 Nov-1 Dec 2018 (organized by SHAPES & financially supported by CENTRES, CBmE, NUS)

1. Xafis V, Schaefer GO, Labude MK, Zhu Y, Holm S, Foo RS-Y, et al. (2021) Germline genome modification through novel political, ethical, and social lenses. PLoS Genet 17(9): e1009741. https://doi.org/10.1371/journal.pgen.1009741

2. Kaan T, Xafis V, Schaefer GO, Zhu Y, Labude MK, Chadwick R (2021) Germline genome editing: Moratorium, hard law, or an informed adaptive consensus? PLoS Genet 17(9): e1009742. https://doi.org/10.1371/journal.pgen.1009742

3. Zeps N, Lysaght T, Chadwick R, Erler A, Foo R, Giordano S, San Lai P, Schaefer GO, Xafis V, Chew WL, Sugarman J. Ethics and regulatory considerations for the clinical translation of somatic cell human epigenetic editing. Stem Cell Reports. 2021 Jun 29:S2213-6711(21)00310-6. doi: https://doi.org/10.1016/j.stemcr.2021.06.004. Epub ahead of print. PMID: 34214486.

4. Chen Q, Ma Y, Labude M, Schaefer GO, Xafis V, Mills P. Making sense of it all: Ethical reflections on the conditions surrounding the first genome-edited babies [version 2; peer review: 2 approved]. Wellcome Open Res 2021, 5:216 (https://doi.org/10.12688/wellcomeopenres.16295.2)

5. Markus K. Labude, Liang Shen, Yujia Zhu, G. Owen Schaefer, Catherine Ong, Vicki Xafis. Perspectives of Singaporean biomedical researchers and research support staff on actual and ideal IRB review functions and characteristics: A quantitative analysis. PLOS ONE. 31 Dec 2020.https://journals.plos.org/plosone/article id=10.1371/journal.pone.0241783
   
   

6. Schaefer, G.O., M.K. Labude, Y. Zhu, R.S.-Y. Foo, and V. Xafis, International Reporting Mechanism for Unethical Germline Gene Editing Experiments Is Needed. Trends in Biotechnology, 2020. http://www.sciencedirect.com/science/article/pii/S0167779920302614.
   
   

7. Lysaght, T., A. Ballantyne, V. Xafis, S. Ong, G.O. Schaefer, J.M.T. Ling, A.J. Newson, I.W. Khor, and E.S. Tai, “Who is watching the watchdog?”: ethical perspectives of sharing health-related data for precision medicine in Singapore. BMC Medical Ethics, 2020. Vol. 21(1). https://doi.org/10.1186/s12910-020-00561-8
   
   

8. Xafis, V., G.O. Schaefer, M.K. Labude, Y. Zhu, and L.Y. Hsu, The Perfect Moral Storm: Diverse Ethical Considerations in the COVID-19 Pandemic. Asian Bioethics Review, 2020. 12(2) pp. 65-83. https://doi.org/10.1007/s41649-020-00125-3.
   
   

9. Xafis, V. ‘What is Inconvenient for You is Life-saving for Me’: How Health Inequities are playing out during the COVID-19 Pandemic. Asian Bioethics Review, 2020. Vol 12(2), pp.223–234 (2020). https://doi.org/10.1007/s41649-020-00119-1.
   
   

10. Xafis V., Brombley K. (2020) Ethical Concepts in Neonatal Palliative Care. In: Mancini A., Price J., Kerr-Elliott T. (eds.) Neonatal Palliative Care for Nurses. Springer, Cham. https://doi.org/10.1007/978-3-030-31877-2_6.
    
    

11. Laurie, Graeme; Tai, E Shyong; Ballantyne, Angela; Brassington, Iain; Labude, Markus; Lim, Hannah; Lipworth, Wendy; Lysaght, Tamra; Stewart, Cameron; Sun, Shirley; Xafis, Vicki. (2019) Delivering a Practical Framework for Ethical Decision-Making Involving Big Data in Health and Research, Asian Bioethics Review, Vol.11(3), pp.223-225. https://doi.org/10.1007/s41649-019-00098-y.
    
    

12. Vicki Xafis, G. Owen Schaefer, Markus K. Labude, Iain Brassington, Angela Ballantyne, Hannah Yeefen Lim, Wendy Lipworth, Tamra Lysaght, Cameron Stewart, Shirley Sun, Graeme T. Laurie, E Shyong Tai. (2019) An Ethics Framework for Big Data in Health and Research, Asian Bioethics Review, Vol.11(3), pp.227-254. https://doi.org/10.1007/s41649-019-00099-x.
    
    

13. Vicki Xafis, Markus K. Labude. (2019) Openness in Big Data and Data Repositories: The Application of an Ethics Framework for Big Data in Health and Research, Asian Bioethics Review, Vol.11(3), pp.255-273. https://doi.org/10.1007/s41649-019-00097-z.
    
    

14. Owen Schaefer, Tai E Shyong, Shirley Sun. 2019. Precision Medicine and Big Data: The Application of an Ethics Framework for Big Data in Health and Research, Asian Bioethics Review, Vol.11(3), pp.275-288. https://doi.org/10.1007/s41649-019-00094-2.
    
    

15. Tamra Lysaght, Hannah Yeefen Lim, Vicki Xafis, Kee Yuan Ngiam. (2019) AI-assisted Decision Making in Healthcare: The Application of an Ethics Framework for Big Data in Health and Research, Asian Bioethics Review, Vol.11(3), pp.299-314. https://doi.org/10.1007/s41649-019-00096-0.
    
    

16. Markus K. Labude, Vicki Xafis. (2019) Ethically Justified Restrictions on Citizen Science: A Perspective from Singapore, The American Journal of Bioethics, Vol. 19(8), pp.38-40. https://doi.org/10.1080/15265161.2019.1619872.
    
    

17. Owen Schaefer (2019) Ethics in the Era of Big Data, Asian Bioethics Review, Vol.11(2), pp.169-171. https://doi.org/10.1007/s41649-019-00092-4.
    
    

18. Duszynski, Katherine; M. Pratt, Nicole L. Lynch, John W. Braunack‐Mayer, Annette; Taylor, Lee K.; Berry, Jesia G.; Xafis, Vicki; Buttery, Jim; Gold, Michael S. (2019) Process trumps potential public good: better vaccine safety through linked cross‐jurisdictional immunisation data in Australia. Australian and New Zealand Journal of Public Health, October 2019, Vol. 43(5), pp.496-503.
    
    

19. Vicki Xafis, Dominic Wilkinson. (2019) Treating ambiguity in the clinical context: Is what you hear the doctor say what the doctor means? Cambridge Quarterly of Healthcare Ethics, Vol 28(3), pp.422-432. https://doi.org/10.1017/S0963180119000343.
    
    

20. Merner  B, Hill  S, Colombo  C, Xafis  V, Gaulden  CM, Graham‐Wisener  L, Lowe  D, Walsh  L, Biggar  S, Bourke  N, Chmielewski  R, Gill  M, Martin  F, Martinek  N, McKinlay  L, Menzies  D, Mussared  A, Refahi  N, Smith  L, Sonawane  R, Wardrope  C. Consumers and health providers working in partnership for the promotion of person‐centred health services: a co‐produced qualitative evidence synthesis. Cochrane Database of Systematic Reviews 2019, Issue 2. Art. No.: CD013274. https://doi.org/10.1002/14651858.CD013274.
    
    

21. Owen Schaefer, Markus K Labude and Harisan Unais Nasir. 2018. Big Data: Ethical Considerations. In: David Boonin (ed.), Handbook of Philosophy and Public Policy (Palgrave McMillan).