BackgroundBiobanks provide an important foundation for genomic and personalised medicine. In order to enhance their scientific power and scope, they are increasingly becoming part of national or international networks. Public trust is essential in fostering public engagement, encouraging donation to, and facilitating public funding for biobanks. Globalisation and networking of biobanking may challenge this trust.MethodsWe report the results of an Australian study examining public attitudes to the networking and globalisation of biobanks. The study used quantitative and qualitative methods in conjunction (...) with bioethical analysis in order to determine factors that may contribute to, and threaten, trust.ResultsOur results indicate a generally high level of trust in biobanks and in medical research more broadly. Key factors that can reduce perceived trustworthiness of biobanks are commercialisation and involvement in global networking.ConclusionsWe conclude that robust ethical oversight and governance standards can both promote trust in global biobanking and ensure that this trust is warranted. (shrink)

Singapore has been ruled by a single party, the People’s Action Party, since its political independence in 1965. The history of the party’s rise to monopolistic parliamentary power was strewn with political repressions of radical left, throughout the entire Cold War period. It was without doubt a history of authoritarianism. At the same time, it had achieved spectacular national economic success within global capitalism, spawned an expansive middle class and improved the material life of Singaporeans across the board. In defiance (...) of the current hegemonic liberal democratic capitalism, the ruling Singapore government has very explicitly rejected American liberalism as the necessary end point of Singapore’s political ideological development. Instead, drawing on its root as a social democratic party, it has reworked and reinscribed the idea of the ‘social’ and weaved it into a ‘communitarianism’, with supposedly Asian characters distilled from its multiracial citizenry. The concept of the social/collective/communitarian in practice is institutionalized in the universal provision of public housing through a national housing program, the redistribution of gains generated by state capitalism through the subvention of the annual national budget and the governing of race through the insistence on racial harmony as a public good. Arguably, it is the concrete benefits delivered by these institutions which have the collective well-being as the core value that explains the longevity of the People’s Action Party in parliamentary power rather than its diminishing authoritarianism in these post-Cold War days. (shrink)

When it comes to using patient data from the National Health Service for research, we are often told that it is a matter of trust: we need to trust, we need to build trust, we need to restore trust. Various policy papers and reports articulate and develop these ideas and make very important contributions to public dialogue on the trustworthiness of our research institutions. But these documents and policies are apparently constructed with little sustained reflection on the nature of trust (...) and trustworthiness, and therefore are missing important features that matter for how we manage concerns related to trust. We suggest that what we mean by ‘trust’ and ‘trustworthiness’ matters and should affect the policies and guidance that govern data sharing in the NHS. We offer a number of initial, general reflections on the way in which some of these features might affect our approach to principles, policies and strategies that are related to sharing patient data for research. This paper is the outcome of a ‘public ethics’ coproduction activity which involved members of the public and two academic ethicists. Our task was to consider collectively the accounts of trust developed by philosophers as they applied in the context of the NHS and to coproduce an argumentative position relevant to this context. (shrink)

Background Outbreaks of infectious disease cause serious and costly health and social problems. Two new technologies – pathogen whole genome sequencing and Big Data analytics – promise to improve our capacity to detect and control outbreaks earlier, saving lives and resources. However, routinely using these technologies to capture more detailed and specific personal information could be perceived as intrusive and a threat to privacy. Method Four community juries were convened in two demographically different Sydney municipalities and two regional cities in (...) New South Wales, Australia to elicit the views of well-informed community members on the acceptability and legitimacy of: making pathogen WGS and linked administrative data available for public health researchusing this information in concert with data linkage and machine learning to enhance communicable disease surveillance systems Fifty participants of diverse backgrounds, mixed genders and ages were recruited by random-digit-dialling and topic-blinded social-media advertising. Each jury was presented with balanced factual evidence supporting different expert perspectives on the potential benefits and costs of technologically enhanced public health research and communicable disease surveillance and given the opportunity to question experts. Results Almost all jurors supported data linkage and WGS on routinely collected patient isolates for the purposes of public health research, provided standard de-identification practices were applied. However, allowing this information to be operationalised as a syndromic surveillance system was highly contentious with three juries voting in favour, and one against by narrow margins. For those in favour, support depended on several conditions related to system oversight and security being met. Those against were concerned about loss of privacy and did not trust Australian governments to run secure and effective systems. Conclusions Participants across all four events strongly supported the introduction of data linkage and pathogenomics to public health research under current research governance structures. Combining pathogen WGS with event-based data surveillance systems, however, is likely to be controversial because of a lack of public trust, even when the potential public health benefits are clear. Any suggestion of private sector involvement or commercialisation of WGS or surveillance data was unanimously rejected. (shrink)

IntroductionInternational sharing of health data opens the door to the study of the so-called ‘Big Data’, which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a ‘social license’ is identifying the views patients and the public may hold with regard to data sharing for health research.MethodsWe performed a narrative review of the empirical evidence addressing patients’ (...) and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed, Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients’ and public attitudes were extracted from selected references and thematically categorised.ResultsTwenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread—though conditional—support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability.ConclusionsOur results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests. (shrink)

As opposed to a ‘one size fits all’ approach, precision medicine uses relevant biological, medical, behavioural and environmental information about a person to further personalize their healthcare. This could mean better prediction of someone’s disease risk and more effective diagnosis and treatment if they have a condition. Big data allows for far more precision and tailoring than was ever before possible by linking together diverse datasets to reveal hitherto-unknown correlations and causal pathways. But it also raises ethical issues relating to (...) the balancing of interests, viability of anonymization, familial and group implications, as well as genetic discrimination. This article analyses these issues in light of the values of public benefit, justice, harm minimization, transparency, engagement and reflexivity and applies the deliberative balancing approach found in theEthical Framework for Big Data in Health and Research to a case study on clinical genomic data sharing. Please refer to that article for an explanation of how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. Our discussion is meant to be of use to those involved in the practice as well as governance and oversight of precision medicine to address ethical concerns that arise in a coherent and systematic manner. (shrink)

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.

A key ethical issue arising in data linkage research relates to consent requirements. Patients’ consent preferences in the context of health research have been explored but their consent preferences regarding data linkage specifically have been under-explored. In addition, the views on data linkage are often those of patient groups. As a result, little is known about lay people’s views and their preferences about consent requirements in the context of data linkage. This study explores lay people’s views and justifications regarding the (...) acceptability of conducting data linkage research without obtaining consent. (shrink)

We say we can no longer trust our public services, institutions or the people who run them. The professionals we have to rely on - politicians, doctors, scientists, businessmen and many others - are treated with suspicion. Their word is doubted, their motives questioned. Whether real or perceived, this crisis of trust has a debilitating impact on society and democracy. Can trust be restored by making people and institutions more accountable? Or do complex systems of accountability and control themselves damage (...) trust? Onora O'Neill challenges current approaches, investigates sources of deception in our society and re-examines questions of press freedom. 2002's Reith Lectures present a philosopher's view of trust and deception, and ask whether and how trust can be restored in a modern democracy. (shrink)

In the West, mainstream bioethicists tend to appreciate intimate relationships as a hindrance to individual autonomy. Scholars have even argued against approaching a mother to donate a kidney to save the life of her child; the request, they claim, is too manipulative and, thereby, violates her autonomy. For Chinese bioethicists, such a moral analysis is absurd. The intimate relationship between mother and child establishes strong mutual obligations. It creates mutual moral responsibilities that often require sacrifices for each other. This paper (...) argues that while aiding others is a moral duty, helping one’s family is a much stronger duty and poses no threat to one’s autonomy. For Confucianism, empathetic intimate feelings, the heart and mind of ren, rest at the root of morality. It requires that we, as moral beings, assume duties to relieve the suffering of others. The more intimate the relationship the stronger the obligation to assist. The family is a closely knitted moral community. Family members often share living resources, mutual experiences, and a sense of identity. Family members act as a social unit, and, ordinarily, mutual obligations among members have priority over duties to those outside of the family. For Confucian bioethics, family-based consent to medical treatment is regarded as natural and reasonable. Family-based decision making is a taken-for-granted norm of social life. While close family members have priority, Confucianism extends such obligations outward toward members of the extended family and the society at large. There is a general principle of gradation of love, which reflects different degrees of personal intimacy and, therefore, of moral obligation. In this fashion, Confucianism seeks to treat the whole of society as one extended family. Hence, in bioethics, mutual responsibility and family-based consent are regarded as basic principles. Through a series of case discussions, this paper illustrates that atomistic individual-based autonomy offers but a poor response to bioethical issues. (shrink)

BackgroundSharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group of (...) individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function.Main textWe propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics.ConclusionsIn this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them. (shrink)

Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current “web” of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, regulations, and procedures (...) is critical to ensuring not only that participants are protected, but also that their participation decisions are accurately informed. To address these gaps, we conducted in-depth interviews with a diverse group of 60 thought-leaders to explore their perspectives on the protections associated with precision medicine research. (shrink)

BackgroundThe Western-European concept of libertarian rights-based autonomy, which advocates respect for individual rights, may conflict with African cultural values and norms. African communitarian ethics focuses on the interests of the collective whole or community, rather than rugged individualism. Hence collective decision-making processes take precedence over individual autonomy or consent. This apparent conflict may impact informed consent practice during biomedical research in African communities and may hinder ethical principlism in African bioethics. This study explored African biomedical researchers' perspectives regarding informed consent (...) and potential limitations to the principle of respect for autonomy in African communities.MethodsWe conducted a qualitative study based on in-depth interviews with 12 biomedical researchers, five females and seven males aged 34 to 74 years, currently working at an African university. Interviews lasted 35–40 min each and involved semi-structured open-ended interviews, which allowed participants to offer information about their perceptions and feelings regarding respect for autonomy and informed consent as practised in Africa. Empirical data from the interviews were recorded, transcribed, and analysed using thematic content analysis, together with an interrogation of relevant scientific literature about African communitarian ethics, making evaluations and drawing inferences consistent with the empirical bioethics approach.ResultsBased on these interviews and analysis of relevant literature, we found that informed consent is difficult to apply in an African context because it derives from a Western conception of libertarian rights-based autonomy. Most respondents pointed out that it was challenging to implement informed consent in the African setting. Furthermore, communalism, customary beliefs, spirituality, and relational autonomy are predominant in most African communities, as exemplified by the African moral philosophies of Ubuntu/botho and Ukama, which emphasize communitarianism over individual rights. We also found that language, education, poverty, and cultural beliefs are barriers to obtaining proper informed consent in African communities.ConclusionsWe conclude that there are limitations to applying the principle of respect for autonomy and informed consent in African communities, especially in the context of human biomedical research. We recommend using a more relational approach, such as Ross’s prima facie duties, to implement informed consent in African communities. (shrink)

The collapse of confidence in anonymization as a robust approach for preserving the privacy of personal data has incited an outpouring of new approaches that aim to fill the resulting trifecta of technical, organizational, and regulatory privacy gaps left in its wake. In the latter category, and in large part due to the growth of Big Data–driven biomedical research, falls a growing chorus of calls for criminal and penal offences to sanction wrongful re-identification of “anonymized” data. This chorus cuts across (...) the fault lines of polarized privacy law scholarship that at times seems to advocate privacy protection at the expense of Big Data research or vice versa. Focusing on Big Data in the context of biomedicine, this article surveys the approaches that criminal or penal law might take toward wrongful re-identification of health data. It contextualizes the strategies within their respective legal regimes as well as in relation to emerging privacy debates focusing on personal data use and data linkage and assesses the relative merit of criminalization. We conclude that this approach suffers from several flaws and that alternative social and legal strategies to deter wrongful re-identification may be preferable. (shrink)