Can we know if donor trust expires? About trust relationships and time in the context of open consent for future data use.

As donor trust legitimises research, trust is vital for research in the fields of biomedicine, genetics, translational medicine and personalised medicine. For parts of the donor community, the consent signature is a sign of trust in research. Many consent processes in biomedical research ask donors to provide their data for an unspecified future use, which introduces uncertainty of the unknown. This uncertainty can jeopardise donor trust or demand blind trust. But which donor wants to trust blindly? To reduce this uncertainty, we explore first, which future-proof actors donors could trust when signing a consent form. Second, we discuss the question Can we know if donor trust expires? and what prevents donor trust from expiring. Finally, we present possible measures that can help to nurture trust in the far future. In this article, we draw on our previous research on trust in biomedical research, on trust in the broader healthcare system and Niklas Luhmann's and Anthony Giddens' trust theories. Our findings suggest that, in the far future, researchers will need to consider donor autonomy, as well as societal norms and values of the time period in which the data were donated. They will need to find mechanisms where possible to publicly announce the use of old data sets. However, foremost researchers will need to treat the data respectfully. It remains vital that professionals and the society continue to elaborate on the norms and values that shape the common understanding of what is morally right and wrong when researching data.

Ethics, health policy-making and the economic crisis: a qualitative interview study with European policy-makers.

BACKGROUND: The economic crisis posed various challenges to policy-makers who had to decide on which health policy measures to focus on and on which to refrain from. The aim of this research was to assess the relevance of ethics and to highlight ethical dimensions in decision-taking by policy-makers with regard to policy and priority-setting in health systems posed by the economic crisis. METHODS: Semi-structured qualitative interviews were conducted with eight European policy-makers from six countries. RESULTS: All interviewees recalled difficult and strenuous situations where they had to prioritise between distinct areas to focus on and invest in, for example around choices between prioritising medications, health professional staffing, care specific equipment, or urgent infrastructure issues. Values could be identified which they deemed as important within the policy-making process, such as trust and responsibility. They explicitly expressed the need for ethical tools and assistance in terms of policy advice for reaching morally sustainable decisions in health policy matters. CONCLUSIONS: The study showed that ethical concepts and values frequently come into play in health policy-making, and that ethics is highly relevant in policy-makers' daily decision-taking, yet that they lack ethical guidance on what to base their decisions. The study is of relevance since it can provide future decisions on austerity-related issues with an ethical underpinning and could identify areas of moral concern.

Ethical aspects of digital health from a justice point of view.

Digital health is transforming healthcare systems worldwide. It promises benefits for population health but might also lead to health inequities. From an ethical perspective, it is hence much needed to adopt a fair approach. This article aims at outlining chances and challenges from an ethical perspective, focusing especially on the dimension of justice-a value, which has been described as the core value for public health. Analysed through the lenses of a standard approach for health justice-Norman Daniels' account of just health and accountability for reasonableness-most recent and relevant literature was reviewed and challenges from a justice point of view were identified. Among them are challenges with regard to digital illiteracy, resulting inequities in access to healthcare, truthful information sharing to end users demanding fully informed consent, dignity and fairness in storage, access, sharing and ownership of data. All stakeholders involved bear responsibilities to shape digital health in an ethical and fair way. When all stakeholders, especially digital health providers and regulators, ensure that digital health interventions are designed and set up in an ethical and fair way and foster health equity for all population groups, there is a chance for this transformation resulting in a fair approach to digital health.

The Economic Crisis and Its Ethical Relevance for Public Health in Europe - an Analysis in the Perspective of the Capability Approach.

Policy responses to the economic crisis have manifest consequences to European population health and health systems. The aim of this article is to assess, by using the capability approach advanced by Sen, the ethical dimension of trade-offs made in health policy due to austerity measures. From a capability approach point of view, austerity measures such as reducing resources for health care, further deregulating the health care market or moving towards privatisation are ethically challenging since they limit opportunities and capabilities for individuals of a population. Public policies should thus aim to guarantee sufficient capabilities (options to access health care and possibilities to make healthy choices) for its populations. Prioritising those in need is a notion the capability approach particularly focuses on in its goal of supporting those with the least capabilities.

Teaching seven principles for public health ethics: towards a curriculum for a short course on ethics in public health programmes.

BACKGROUND: Teaching ethics in public health programmes is not routine everywhere - at least not in most schools of public health in the European region. Yet empirical evidence shows that schools of public health are more and more interested in the integration of ethics in their curricula, since public health professionals often have to face difficult ethical decisions. DISCUSSION: The authors have developed and practiced an approach to how ethics can be taught even in crowded curricula, requiring five to eight hours of teaching and learning contact time. In this way, if programme curricula do not allow more time for ethics, students of public health can at least be sensitised to ethics and ethical argumentation. This approach - focusing on the application of seven mid-level principles to cases (non-maleficence, beneficence, health maximisation, efficiency, respect for autonomy, justice, proportionality) - is presented in this paper. Easy to use 'tools' applying ethics to public health are presented. SUMMARY: The crowded nature of the public health curriculum, and the nature of students participating in it, required us to devise and develop a short course, and to use techniques that were likely to provide a relatively efficient introduction to the processes, content and methods involved in the field of ethics.

Talking Ethics Early in Health Data Public Private Partnerships.

Data access and data sharing are vital to advance medicine. A growing number of public private partnerships are set up to facilitate data access and sharing, as private and public actors possess highly complementary health data sets and treatment development resources. However, the priorities and incentives of public and private organizations are frequently in conflict. This has complicated partnerships and sparked public concerns around ethical issues such as trust, justice or privacy-in turn raising an important problem in business and data ethics: how can ethical theory inform the practice of public and private partners to mitigate misaligned incentives, and ensure that they can deliver societally beneficial innovation? In this paper, we report on the development of the Swiss Personalized Health Network's ethical guidelines for health data sharing in public private partnerships. We describe the process of identifying ethical issues and engaging core stakeholders to incorporate their practical reality on these issues. Our report highlights core ethical issues in health data public private partnerships and provides strategies for how to overcome these in the Swiss health data context. By agreeing on and formalizing ethical principles and practices at the beginning of a partnership, partners and society can benefit from a relationship built around a mutual commitment to ethical principles. We present this summary in the hope that it will contribute to the global data sharing dialogue.

Public preferences towards data management and governance in Swiss biobanks: results from a nationwide survey.

OBJECTIVES: This article aims to measure the willingness of the Swiss public to participate in personalised health research, and their preferences regarding data management and governance. SETTING: Results are presented from a nationwide survey of members of the Swiss public. PARTICIPANTS: 15 106 randomly selected Swiss residents received the survey in September 2019. The response rate was 34.1% (n=5156). Respondent age ranged from 18 to 79 years, with fairly uniform spread across sex and age categories between 25 and 64 years. PRIMARY AND SECONDARY OUTCOME MEASURES: Willingness to participate in personalised health research and opinions regarding data management and governance. RESULTS: Most respondents preferred to be contacted and reconsented for each new project using their data (39%, 95% CI: 37.4% to 40.7%), or stated that their preference depends on the project type (29.4%, 95% CI: 27.9% to 31%). Additionally, a majority (52%, 95% CI: 50.3% to 53.8%) preferred their data or samples be stored anonymously or in coded form (43.4%, 95% CI: 41.7% to 45.1%). Of those who preferred that their data be anonymised, most also indicated a wish to be recontacted for each new project (36.8%, 95% CI: 34.5% to 39.2%); however, these preferences are in conflict. Most respondents desired to personally own their data. Finally, most Swiss respondents trust their doctors, along with researchers at universities, to protect their data. CONCLUSION: Insight into public preference can enable Swiss biobanks and research institutions to create management and governance strategies that match the expectations and preferences of potential participants. Models allowing participants to choose how to interact with the process, while more complex, may increase individual willingness to provide data to biobanks.

Limits of data anonymity: lack of public awareness risks trust in health system activities.

Public trust is paramount for the well functioning of data driven healthcare activities such as digital health interventions, contact tracing or the build-up of electronic health records. As the use of personal data is the common denominator for these healthcare activities, healthcare actors have an interest to ensure privacy and anonymity of the personal data they depend on. Maintaining privacy and anonymity of personal data contribute to the trustworthiness of these healthcare activities and are associated with the public willingness to trust these activities with their personal data. An analysis of online news readership comments about the failed care.data programme in England revealed that parts of the public have a false understanding of anonymity in the context of privacy protection of personal data as used for healthcare management and medical research. Some of those commenting demanded complete anonymity of their data to be willing to trust the process of data collection and analysis. As this demand is impossible to fulfil and trust is built on a false understanding of anonymity, the inability to meet this demand risks undermining public trust. Since public concerns about anonymity and privacy of personal data appear to be increasing, a large-scale information campaign about the limits and possibilities of anonymity with respect to the various uses of personal health data is urgently needed to help the public to make better informed choices about providing personal data.

Public willingness to participate in personalized health research and biobanking: A large-scale Swiss survey.

This paper reports survey findings on the Swiss public's willingness, attitudes, and concerns regarding personalized health research participation by providing health information and biological material. The survey reached a sample of 15,106 Swiss residents, from which we received 5,156 responses (34.1% response rate). The majority of respondents were aware of research using human biological samples (71.0%) and held a positive opinion towards this type of research (62.4%). Of all respondents, 53.6% indicated that they would be willing to participate in a personalized health research project. Willingness to participate was higher in younger, higher educated, non-religious respondents with a background in the health sector. Respondents were more willing to provide 'traditional' types of health data, such as health questionnaires, blood or biological samples, as opposed to social media or app-related data. All respondents valued the return of individual research results, including risk for diseases for which no treatment is available. Our findings highlight that alongside general positive attitudes towards personalized health research using data and samples, respondents have concerns about data privacy and re-use. Concerns included potential discrimination, confidentiality breaches, and misuse of data for commercial or marketing purposes. The findings of this large-scale survey can inform Swiss research institutions and assist policymakers with adjusting practices and developing policies to better meet the needs and preferences of the public. Efforts in this direction could focus on research initiatives engaging in transparent communication, education, and engagement activities, to increase public understanding and insight into data sharing activities, and ultimately strengthen personalized health research efforts.

Reporting Genetic Findings to Individual Research Participants: Guidelines From the Swiss Personalized Health Network.

In 2017 the Swiss federal government established the Swiss Personalized Health Network (SPHN), a nationally coordinated data infrastructure for genetic research. The SPHN advisory group on Ethical, Legal, and Social Implications (ELSI) was tasked with the creation of a recommendation to ensure ethically responsible reporting of genetic research findings to research participants in SPHN-funded studies. Following consultations with expert stakeholders, including geneticists, pediatricians, sociologists, university hospitals directors, patient representatives, consumer protection associations, and insurers, the ELSI advisory group issued its recommendation on "Reporting actionable genetic findings to research participants" in May 2020. In this paper we outline the development of this recommendation and the provisions it contains. In particular, we discuss some of its key features, namely: (1) that participation in SPHN-funded studies as a research subject is conditional to accepting that medically relevant genetic research findings will be reported; (2) that a Multidisciplinary Expert Panel (MEP) should be created to support researchers' decision-making processes about reporting individual genetic research findings; (3) that such Multidisciplinary Expert Panel will make case-by-case decisions about whether to allow reporting of genetic findings, instead of relying on a pre-defined list of medically relevant variants; (4) that research participants shall be informed of the need to disclose genetic mutations when applying for private insurance, which may influence individual decisions about participation in research. By providing an account of the procedural background and considerations leading to the SPHN recommendation on "Reporting actionable genetic findings to research participants," we seek to promote a better understanding of the proposed guidance, as well as to contribute to the global dialog on the reporting of genetic research findings.

Research Ethics 2.0: New Perspectives on Norms, Values, and Integrity in Genomic Research in Times of Even Scarcer Resources.

Research ethics anew gained importance due to the changing scientific landscape and increasing demands and competition in the academic field. These changes are further exaggerated because of scarce(r) resources in some countries on the one hand and advances in genomics on the other. In this paper, we will highlight the current challenges thereof to scientific integrity. To mark key developments in research ethics, we will distinguish between what we call research ethics 1.0 and research ethics 2.0. Whereas research ethics 1.0 focuses on individual integrity and informed consent, research ethics 2.0 entails social scientific integrity within a broader perspective of a research network. This research network can be regarded as a network of responsibilities in which every stakeholder involved has to jointly meet the ethical challenges posed to research.

Personalised Medicine and Scarce Resources: A Discussion of Ethical Chances and Challenges from the Perspective of the Capability Approach.

In the aftermath of the economic crisis that started in 2008, resources have become scarcer than ever in some countries, also in health care. Priority setting and rationalisation of existing resources also affect pharmaceutical innovations, including those that would contribute to what is called personalised medicine. In this paper, we will highlight the ethical issues surrounding rationalisation and its impact on personalised medicine through the lens of the capability approach. Thereby, challenges to and opportunities for personalised medicine will be examined, assessing how they affect patients' 'real options' to access innovative therapies. In our focus on the 'first challenge: citizens and patients' of the so-called Strategic Research and Innovation Agenda, the strength of the capability approach becomes particularly apparent in identifying what different values are at stake in this context.