Trustworthy governance for sharing health-related data
Grant Period
October 2019 to September 2021
Funding Source
October 2019 to September 2021
Investigators
Principal Investigator:
Tamra Lysaght (National University of Singapore)
Co-Investigators:
Tai E Shyong (National University of Singapore and National University Hospital)
Owen Schaefer (National University of Singapore)
Collaborators:
Ainsley Newson (University of Sydney)
Helena Legido-Quigley (National University of Singapore)
Vicki Xafis (National University of Singapore)
Project Summary
This project focuses on the governance of sharing regimens for big data-based health research. It is situated in broader international interest in developing ethically and socially responsible oversight models for the sharing of health-related data from large repositories and answers the critical question of: How should the sharing of health-related data in Singapore be governed in a way that protects data providers and their communities while promoting the health sciences? In light of rapid developments in precision medicine, we focus especially on the sharing of genetic data.
Taking into account Singaporean values and priorities, we will combine empirical and normative approaches to develop an ethical and socially responsible model of trustworthy governance for sharing health-related research from large datasets.
Key Outcomes
From 2019 to 2021, we undertook mixed methods research to examine trustworthy governance models of sharing health-related data. This research was conducted over three studies consisting of (1) focus group discussions to examine public perceptions and concerns on health-related data sharing for precision medicine (PM) and explore possible policy options; (2) a nationally representative survey to measure priorities in Singaporeans’ decision-making about PM data sharing; and (3) a citizens’ jury to deliberate on conditions under which it would be ethically permissible to share PM data with private industry for research. We also convened a knowledge transfer workshop with religious representatives on data sharing for PM. In the following paragraphs, we describe the key outcomes of this project.
Taking into account Singaporean values and priorities, we will combine empirical and normative approaches to develop an ethical and socially responsible model of trustworthy governance for sharing health-related research from large datasets.
In 2019, we completed a series of focus group discussions with Singaporeans to explore the conditions in which they are comfortable with sharing health-related data for research purposes, and their related concerns with certain sharing arrangements. We focused the discussions on sharing de-identified data generated from a hypothetical precision medicine programme with researchers from both publicly funded institutions as well as private industry. We found broad support for sharing data with public universities and hospitals under certain conditions, but less so for pharmaceutical company and not for private insurers out of concerns for genetic discrimination. Further findings are available in these peer reviewed publications:
Lysaght, T., Ballantyne, A., Xafis, V., Ong, S., Schaefer, G. O., Ling, J., Tai, E. S. (2020). “Who is watching the watchdog?”: ethical perspectives of sharing health-related data for precision medicine in Singapore. BMC Medical Ethics. 21. 118. doi: 10.1186/s12910-020-00561-8 https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-020-00561-8#citeas
Ong, S. Lysaght, T., Ballantyne, A., Xafis, V., Ong, S., Ling, J. (2021). “Perceptions of ‘precision’ and ‘personalised’ medicine in Singapore and associated ethical issues”. Asian Bioethics Review. 13. 179–194. https://link.springer.com/article/10.1007/s41649-021-00165-3
In 2020, we convened a virtual workshop with religious authorities in Singapore to discuss precision medicine (PM) and PM data sharing with public and private sectors. While PM has the potential to promote common good and aligns with values of charity and community benefit, the religious authorities expressed ethical concerns about sharing PM data with the private sector, particularly on profiteering from PM data for commercial purposes and the potential for genetic discrimination. Robust governance and oversight to ensure transparency and accountability, and a clear public benefit are pre-requisites for PM data sharing. Further outcomes from this workshop are presented in the following publication:
Toh, H.J., Ballantyne, A., Ong, S.A.K., Sankaran, C., Tay, H.Y., Singh, M., Zaidi, R., Chia, R., Singh, S., Samachittananda, S., Shi, Y.G, Tan, Z., Lysaght, T. (2021). Religious Perspectives on Precision Medicine in Singapore. Asian Bioethics Review. 6. 13(4). 473-483. doi: 10.1007/s41649-021-00180-4 https://pubmed.ncbi.nlm.nih.gov/34611464/
In early 2021, we completed a nationally representative survey and a Citizens’ Jury. The design of both studies was informed by insights gained from our focus group discussions.
From the survey, we found that most people would likely be willing to share de-identified health data for research studies that are approved by an ethics review committee. The most important factors likely to shape people’s decision-making are the purposes the data would be used for and who would be using it. Less important were the level of sensitivity and the type of consent taken to share the data. More in-depth findings are available in the peer reviewed publication:
Lysaght, T., Ballantyne, A., Toh, H. J., Lau, A., Ong, S., Schaefer, O., … & Tai, E. S. (2021). Trust and Trade-Offs in Sharing Data for Precision Medicine: A National Survey of Singapore. Journal of Personalized Medicine. 11(9). 921. doi: 10.3390/jpm11090921 https://www.mdpi.com/2075-4426/11/9/921/htm
Participants of the citizens’ jury were particularly concerned about the potential for genetic discrimination and recommended that before any PM data sharing can occur with private insurers, anti-discrimination laws must be initiated first. PM data sharing is ethically acceptable when the public interests of Singapore are prioritized and the following measures are strengthened: (1) accountability for data breaches and misuse in the form of criminal charges for individuals, teams and organisations and (2) transparency to enable more informed decision-making for members of the public on PM data sharing. Further findings are reported in the following publication:
Ballantyne, A., Lysaght, T., Toh, H. J., Ong, S., Lau, A., Owen Schaefer, G., Xafis, V., Tai, E. S., Newson, A. J., Carter, S., Degeling, C., & Braunack-Mayer, A. (2022). Sharing precision medicine data with private industry: Outcomes of a citizens’ jury in Singapore. Big Data & Society. 9(1). doi: 10.1177/20539517221108988 https://journals.sagepub.com/doi/full/10.1177/20539517221108988
Documents and Resources
Precision Medicine
The genetic make-up of an individual can affect health, as genetic variations can influence one’s likelihood of getting certain diseases. Genetic variations also determine how well a person responds to different treatments. Understanding the genetic make-up of a person can therefore improve treatment effectiveness for many diseases.
Precision medicine (PM) is an approach that tailors disease prevention and treatment to an individual by combining information on a person’s genes, lifestyle and physical surroundings. Unlike the traditional medical practice of developing similar treatment plans for patients with common clinical presentations, PM uses genetic information to distinguish characteristics of one patient from another. In this way, PM is able to more accurately predict disease risk, diagnose disease, and develop targeted treatments for individuals. PM aims to improve clinical outcomes while reducing healthcare costs from ineffective or harmful treatments.
In recent years, many countries have invested heavily in developing nationwide PM initiatives. These initiatives integrate genomic data with electronic health records for research with the aim of informing clinical decision making. There is presently a lack of large-scale databases containing Asian-specific genome data. Researchers need large amounts of data from diverse groups to analyse the genomic profile of individuals with and without disease so that they can identify subtle patterns in disease progression and response to medicines and other treatments.
Article: Hudson M et al. 2020. Rights, interests and expectations – Indigenous perspectives on unrestricted access to genomic data
Background: Promoting equity in genetic resources for Indigenous communities (i.e., minority populations or socially disadvantaged groups) has become increasingly challenging. Throughout history, Indigenous communities have had past negative experiences with genomic research from its lack of accountability and equity. The negative experiences have resulted in the communities’ mistrust in genomic research and data sharing. However, to work towards equity in genetic resources, we need greater participation from these Indigenous communities.
What this is about: This perspectives article presents Indigenous communities’ definitions of responsible access to genetic data. It explores the communities’ rights and interests in genomic data and proposes principles and actions that genomic researchers can adopt in data sharing.
Key findings: To promote benefit sharing, genomic researchers need to consistently recognise Indigenous rights and interests and see Indigenous communities as equal partners when developing genomic research initiatives. Fostering good relationships between genomic researchers as well as between Indigenous communities and Indigenous scientists is important to build trust and accountability.
Article: Kalkman S et al. 2019. Patients’ and public views and attitudes towards the sharing of health data for research: a narrative review of the empirical evidence
Background: Big Data health research has the potential to facilitate precision medicine’s goal of improving health, preventing and detecting disease early, and personalizing health interventions. However, lack of trust from the public has made data sharing challenging, as citizens are becoming more aware and critical of data privacy issues. Therefore, in order to keep trust in health research, public opinions need to be addressed.
What this is about: This study is a review of 27 articles on patients’ and public views and attitudes towards the use of health data for research.
Key findings: Concerns were related to potential breaches of confidentiality and abuses of data. Participants are willing to share data given conditions such as social value, privacy and confidentiality, data security, transparency, and accountability. It is important to develop a value-based governance framework that fulfils these conditions to build public trust.
Article: ML Wong et al. 2003. Willingness to donate blood samples for genetic research: a survey from a community in Singapore
Background: The success of genetic studies depends on the public’s willingness to donate blood for genetic research. However, studies on the public’s willingness to donate blood samples for genetic research were limited.
What this is about: A survey was conducted on the general Singaporean population to examine how willing they are in donating blood specimens for genetic research and the reasons for their willingness/unwillingness.
Key findings: Reasons for not donating blood included fear of pain, blood, injections, and needles; no self-benefits; fear of finding out about having a disease; fear of discrimination; and concerns about weakness and weight gain. In promoting participation in genetic research, public education programs should focus on communicating the benefits and addressing people’s fears and concerns.
Report: Ethical frameworks for obtaining informed consent in tumour profiling: an evidence-based case for Singapore
Background: Cancer is a genetic condition caused by heritable and tumour‐specific mutations. Testing tumours based on genetic make-up of a person (i.e., genomic tumour profiling) has helped doctors develop targeted treatments for many cancers. As tumour profiling is increasingly being used in this area, ethical frameworks are needed to govern large-scale data sharing.
What this is about: This study aimed to develop an ethical framework for obtaining informed consent to store and share tumour profiling test results and make recommendations on the return of individual results and incidental findings. Patients and clinicians were interviewed on their understandings, attitudes and preferences of participating in tumour profiling research, storage and sharing of tumour genetic data, and the return of tumour profiling results.
Key findings: Patients had limited knowledge on cancer genetics, tumour testing, and informed consent. The participants support a broad consent model, provided that an independent authority oversees the decision-making processes. The ethical framework should promote trust and benefit sharing with stakeholders and provide accountability and transparency in storing and sharing of biomolecular data.
Videos
Singapore Citizens’ Jury on Data Sharing with Private Industry in Precision Medicine – Dr Tamra Lysaght & Ms Serene Ong
A Singapore Citizens’ Jury on Data Sharing with Private Industry in Precision Medicine
Dr Tamra Lysaght & Serene Ong (NUS Centre for Biomedical Ethics)
5, 6 & 10 December 2020, and 10 April 2021
Short educational videos explaining precision medicine
Video A introduces the basics of precision medicine (PM). Two case examples (Clara and Wei Ming) describe the potential uses and benefits of PM for treating individual patients.
Video B describes what participants in a PM programme might expect. It also explains the basics and regulation of de-identifying participants’ data, potential security risks from a data breach, and explains how de-identified data is shared between researchers.
Sharing by Dr Tamra Lysaght – Trustworthy Governance of Data Sharing for Precision Medicine
Sharing by Dr Tamra Lysaght – Trustworthy Governance of Data Sharing for Precision Medicine
Virtual Conference on Trustworthy Health Data Governance – 31 Aug & 1 Sep 2021
1. Prof Graeme Laurie, Edinburgh Law School, The University of Edinburgh