BackgroundA growing number of studies show the potential of loyalty card data for use in health research. However, research into public perceptions of using this data is limited. This study aimed to investigate public attitudes towards donating loyalty card data for academic health research, and the safeguards the public would want to see implemented. The way in which participant attitudes varied according to whether loyalty card data would be used for either cancer or COVID-19 research was also examined.MethodsParticipants were recruited (...) via Prolific Academic to take part in semi-structured telephone interviews, with questions focused on data sharing related to either COVID-19 or ovarian/bowel cancer as the proposed health condition to be researched. Content analysis was used to identify sub-themes corresponding to the two a priori themes, attitudes and safeguards.ResultsParticipant attitudes were found to fall into two categories, either rational or emotional. Under rational, most participants were in favour of sharing loyalty card data. Support of health research was seen as an important reason to donate such data, with loyalty card logs being considered as already within the public domain. With increased understanding of research purpose, participants expressed higher willingness to donate data. Within the emotional category, participants shared fears about revealing location information and of third parties obtaining their data. With regards to safeguards, participants described the importance of anonymisation and the level of data detail; the control, convenience and choice they desired in sharing data; and the need for transparency and data security. The change in hypothetical purpose of the data sharing, from Covid-19 to cancer research, had no impact on participants’ decision to donate, although did affect their understanding of how loyalty card data could be used.ConclusionsBased on interviews with the public, this study contributes recommendations for those researchers and the wider policy community seeking to obtain loyalty card data for health research. Whilst participants were largely in favour of donating loyalty card data for academic health research, information, choice and appropriate safeguards are all exposed as prerequisites upon which decisions are made. (shrink)

Population-based genomics studies have proven successful in identifying genetic variants associated with diseases. High-quality biospecimens linked with informative health data from diverse segments of the population have made such research possible. However, the success of biobank research depends on the willingness of the public to participate in this type of research. We aimed to explore the factors associated with the willingness of the public to participate in biobank research from four low- and middle-income countries in the Arab region (Egypt, Jordan, (...) Morocco, and Sudan). We used a previously validated questionnaire to assess several constructs that included the public’s perceptions, attitudes, and willingness to participate in biobank research. We recruited 967 participants. More than half did not have prior awareness of biobanks. Participants’ willingness to donate biospecimens and health data was less than 10%. Our results also showed that participants harbored concerns with trust, privacy, and with data-sharing involving international researchers. Predictors of willingness to participate in biobank research included no previous involvement in research and positive attitudes toward biobanks. Finally, our study showed several differences between the four countries regarding several of the investigated constructs. We conclude there should be additional efforts to raise public awareness and enhance perceptions of the public in biobanking research to enhance trust. We further recommend qualitative research to explore the underlying factors that contribute to the public’s concerns with international data sharing that would enhance global health. (shrink)

In their recent article, Porsdam Mann et al propose to share biomedical research data more widely, securely and efficiently using blockchain technologies. 1 They present compelling arguments for how the blockchain presents both a technological innovation, and a deontologically grounded policy innovation to traditional research consent. Their proposal can be read in conversation with a rich body of evidence to suggest current consent processes are problematic on at least one of tripartite bases in biomedical research: that it be fully informed. (...) This response attempts to further the author’s discussion of social justice discourse in, and of their proposed prosent model to enhance engagement among under-represented and vulnerable populations in research, specifically. Motivating this response is the view that advancing technological capabilities is no doubt necessary, but on its own insufficient to reinvigorate distributive, procedural and social justice as guiding principles for con/prosent processes. I offer three pros and cons to consider in effort to deepen the model’s commitments to social justice to historically marginalised groups in the biomedical research enterprise. (shrink)

Governments are investing in precision medicine with the aim of improving healthcare through the use of genomic analyses and data analytics to develop tailored treatment approaches for individual patients. The success of PM is contingent upon clear public communications that engender trust and secure the social licence to collect and share large population-wide data sets because specific consent for each data re-use is impractical. Variation in the terminology used by different programmes used to describe PM may hinder clear communication and (...) threaten trust. Language is used to create common understanding and expectations regarding precision medicine between researchers, clinicians and the volunteers. There is a need to better understand public interpretations of PM-related terminology. This paper reports on a qualitative study involving 24 focus group participants in the multi-lingual context of Singapore. The study explored how Singaporeans interpret and understand the terms ‘precision medicine’ and ‘personalised medicine’, and which term they felt more aptly communicates the concept and goals of PM. Results suggest that participants were unable to readily link the terms with this area of medicine and initially displayed preferences for the more familiar term of ‘personalised’. The use of visual aids to convey key concepts resonated with participants, some of whom then indicated preferences for the term ‘precision’ as being a more accurate description of PM research. These aids helped to facilitate dialogue around the ethical and social value, as well as the risks, of PM. Implications for programme developers and policy makers are discussed. (shrink)

New models of data governance for health data are a focus of growing interest in an era of challenge to the social licence. In this article, we reflect on what the data trust model, which is founded on principles of participatory governance, can learn from experiences of involving and engagement of members of the public and participants in the governance of large-scale biobanks. We distinguish between upstream and ongoing governance models, showing how they require careful design and operation if they (...) are to deliver on aspirations for deliberation and participation. Drawing on this learning, we identify a set of considerations important to future design for data trusts as they seek to ensure just, proportionate and fair governance. These considerations relate to the timing of involvement of participants, patterns of inclusion and exclusion, and responsiveness to stakeholder involvement and engagement. We emphasise that the evolution of governance models for data should be matched by a commitment to evaluation. (shrink)

BackgroundAs a consequence of precision medicine initiatives, genomic technologies have rapidly spread around the world, raising questions about genetic privacy and the ethics of data sharing. Previous scholarship in bioethics and science and technology studies has made clear that different nations have varying expectations about trust, transparency, and public reason in relation to emerging technologies and their governance. The key aims of this article are to assess genetic literacy, perceptions of genetic testing, privacy concerns, and governing norms amongst the Singapore (...) population by collecting surveys.MethodsThis study investigated genetic literacy and broad public attitudes toward genetic tests in Singapore with an online public survey (n = 560). To assess potential changes in attitudes following receipt of results from a genetic test, we also surveyed undergraduate students who underwent a genetic screen as part of a university class before and after they received their test results (n = 25).ResultsPublic participants showed broad support for the use of genetic tests; scored an average of 48.9% in genetic literacy; and expressed privacy concerns over data sharing and a desire for control over their genetic data. After taking a genetic test and receiving genetic test results, students reported less fear of genetic tests while other attitudes did not change significantly.ConclusionThese findings highlight the potential of genetic education and active engagement with genetic testing to increase support and participation in genomic projects, PM, and biobanking initiatives; and they suggest that data privacy protections could potentially reduce discrimination by giving participants control over who can access their data. More specifically, these findings and the dataset we provide may be helpful in formulating culturally sensitive education programs and regulations concerning genomic technologies and data privacy. (shrink)

A multitude of legislation impacts the use of samples and data for research in South Africa. With the coming into effect of the Protection of Personal Information Act No. 4 of 2013 in July 2021, recent attention has been given to safeguarding research participants’ personal information. The protection of participants’ privacy in research is essential, but it is not the only risk at stake in the use and sharing of personal information. Other rights and interests that must also be considered (...) and safeguarded include the right to non-discrimination, the right to dignity, and the right to enjoy the benefits of scientific progress. This can be achieved by ensuring that the ethical values and universal principles that underpin the research landscape, namely equity, reciprocity, justice and solidarity, are embedded in the regulatory framework for the management and use of personal information. This paper advocates an integrated bioethics approach to the use of personal information for research in SA. A key feature in embedding such an approach is a Data Transfer Agreement that appropriately integrates the safeguards and protections set out by our regulatory framework with bioethical rules and procedures when personal information is used and shared for research purposes. This paper thus calls for the development of a national DTA that is guided by key ethical principles when data are shared for research purposes. This paper will be followed by a webinar on 23 June 2022 hosted by the Department of Science and Innovation and the SA Medical Research Council, where the recommendations and suggestions set out herein will be unpacked, discussed and debated by relevant stakeholders. (shrink)

Background We aimed to examine the ethical concerns Singaporeans have about sharing health-data for precision medicine and identify suggestions for governance strategies. Just as Asian genomes are under-represented in PM, the views of Asian populations about the risks and benefits of data sharing are under-represented in prior attitudinal research. Methods We conducted seven focus groups with 62 participants in Singapore from May to July 2019. They were conducted in three languages and analysed with qualitative content and thematic analysis. Results Four (...) key themes emerged: nuanced understandings of data security and data sensitivity; trade-offs between data protection and research benefits; trust in the public and private sectors; and governance and control options. Participants were aware of the inherent risks associated with data sharing for research. Participants expressed conditional support for data sharing, including genomic sequence data and information contained within electronic medical records. This support included sharing data with researchers from universities and healthcare institutions, both in Singapore and overseas. Support was conditional on the perceived social value of the research and appropriate de-identification and data security processes. Participants suggested that a data sharing oversight body would help strengthen public trust and comfort in data research for PM in Singapore. Conclusion Maintenance of public trust in data security systems and governance regimes can enhance participation in PM and data sharing for research. Contrary to themes in much prior research, participants demonstrated a sophisticated understanding of the inherent risks of data sharing, analysed trade-offs between risks and potential benefits of PM, and often adopted an international perspective. (shrink)

Precision medicine (PM) aims to revolutionise healthcare, but little is known about the role religion and spirituality might play in the ethical discourse about PM. This Perspective reports the outcomes of a knowledge exchange fora with religious authorities in Singapore about data sharing for PM. While the exchange did not identify any foundational religious objections to PM, ethical concerns were raised about the possibility for private industry to profiteer from social resources and the potential for genetic discrimination by private health (...) insurers. According to religious authorities in Singapore, sharing PM data with private industry will require a clear public benefit and robust data governance that incorporates principles of transparency, accountability and oversight. (shrink)

BackgroundThe SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research.MethodsWe therefore (...) conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process.ResultsWe observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies.ConclusionsIn conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law. (shrink)

Background Big data and AI applications now play a major role in many health contexts. Much research has already been conducted on ethical and social challenges associated with these technologies. Likewise, there are already some studies that investigate empirically which values and attitudes play a role in connection with their design and implementation. What is still in its infancy, however, is the comparative investigation of the perspectives of different stakeholders. Methods To explore this issue in a multi-faceted manner, we conducted (...) semi-structured interviews as well as focus group discussions with patients and clinicians. These empirical methods were used to gather interviewee’s views on the opportunities and challenges of medical AI and other data-intensive applications. Results Different clinician and patient groups are exposed to medical AI to differing degrees. Interviewees expect and demand that the purposes of data processing accord with patient preferences, and that data are put to effective use to generate social value. One central result is the shared tendency of clinicians and patients to maintain individualistic ascriptions of responsibility for clinical outcomes. Conclusions Medical AI and the proliferation of data with import for health-related inferences shape and partially reconfigure stakeholder expectations of how these technologies relate to the decision-making of human agents. Intuitions about individual responsibility for clinical outcomes could eventually be disrupted by the increasing sophistication of data-intensive and AI-driven clinical tools. Besides individual responsibility, systemic governance will be key to promote alignment with stakeholder expectations in AI-driven and data-intensive health settings. (shrink)

Background The opioid epidemic has enabled rapid and unsurpassed use of big data on people with opioid use disorder to design initiatives to battle the public health crisis, generally without adequate input from impacted communities. Efforts informed by big data are saving lives, yielding significant benefits. Uses of big data may also undermine public trust in government and cause other unintended harms. Objectives We aimed to identify concerns and recommendations regarding how to use big data on opioid use in ethical (...) ways. Methods We conducted focus groups and interviews in 2019 with 39 big data stakeholders who had interest in or knowledge of the Public Health Data Warehouse maintained by the Massachusetts Department of Public Health. Results Concerns regarding big data on opioid use are rooted in potential privacy infringements due to linkage of previously distinct data systems, increased profiling and surveillance capabilities, limitless lifespan, and lack of explicit informed consent. Also problematic is the inability of affected groups to control how big data are used, the potential of big data to increase stigmatization and discrimination of those affected despite data anonymization, and uses that ignore or perpetuate biases. Participants support big data processes that protect and respect patients and society, ensure justice, and foster patient and public trust in public institutions. Recommendations for ethical big data governance offer ways to narrow the big data divide, enact shared data governance, cultivate public trust and earn social license for big data uses, and refocus ethical approaches. Conclusions Using big data to address the opioid epidemic poses ethical concerns which, if unaddressed, may undermine its benefits. Findings can inform guidelines on how to conduct ethical big data governance and in ways that protect and respect patients and society, ensure justice, and foster patient and public trust in public institutions. (shrink)

Large data-intensive health research programmes benefit from collaboration amongst researchers who may be located in different institutions and international contexts. However, complexities in navigating privacy frameworks and data protection laws across various jurisdictions pose significant challenges to researchers seeking to share or transfer data outside of institutional boundaries. Research on the awareness of data protection and privacy laws amongst stakeholders is limited. Our qualitative study, drawn from a larger project in Singapore, revealed insights into stakeholders’ perceptions of the role of (...) law in cross-national health data research. Stakeholders in our study demonstrated a range of perceptions regarding the role of data protection law in governing the collection and transfer of health data for research. The main criticisms included inadequate legal protection to data and lack of uniformed data protection standards. Despite these criticisms, participants recognised the importance of data protection law in supporting cross-border data transfers and proposed measures to improve perceived limitations of existing laws. These measures include strengthening existing legal framework, establishing contractual agreements and imposing severe punishments for data misuse. (shrink)

In today’s online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in medicine and healthcare. In addition, when securely stored and de-identified, the privacy risks are minimal and manageable. In many jurisdictions, ethics committees routinely waive the requirement for researchers to obtain consent (...) from data subjects before using and linking these datasets in an effort to balance respect for individuals with research efficiency. In this paper, I explore the ethical justification for using routinely collected health data for research without consent. I conclude that, not only is this morally justified but also that data subjects have a moral obligation to contribute their data to such research, which would obviate the need for ethics committees to consider consent waivers. In justifying this argument, I look to the duty of easy rescue, distributive justice and draw analogies with vaccination ethics. (shrink)

Precision medicine is an emerging approach to treatment and disease prevention that relies on linkages between very large datasets of health information that is shared amongst researchers and health professionals. While studies suggest broad support for sharing precision medicine data with researchers at publicly funded institutions, there is reluctance to share health information with private industry for research and development. As the private sector is likely to play an important role in generating public benefits from precision medicine initiatives, it is (...) important to understand what the concerns are and how they might be mitigated. This study reports outcomes of a deliberative method of citizen engagement in Singapore that asked whether sharing precision medicine data with private industry would be permissible, and if so, under what circumstances. Findings from this citizens’ jury suggest sharing with industry would be permissible under certain conditions that are set out in nine recommendations. Implications of the recommendations and their underlying assumptions for policy decision makers are discussed. This study aligns with prior international studies which found conditional acceptance for data sharing with private industry, a public benefit requirement, specific reluctance to share with insurance companies and an emphasis on accountability and transparency to demonstrate trustworthiness. However, our results differ from prior studies in that opt-in consent did not dominate the deliberations as jurors were able to set it aside as an assumed prerequisite for participation in a precision medicine programme. (shrink)