Felix Gille

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Gille

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Felix

ORCID

0000-0002-2847-4633

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Publications 1 - 10 of 14

Future-proofing biobanks’ governance
Gille, Felix; Vayena, Effy; Blasimme, Alessandro (2020)
European Journal of Human Genetics
Good biobank governance implies—at a minimum—transparency and accountability and the implementation of oversight mechanisms. While the biobanking community is in general committed to such principles, little is known about precisely which governance strategies biobanks adopt to meet those objectives. We conducted an exploratory analysis of governance mechanisms adopted by research biobanks, including genetic biobanks, located in Europe and Canada. We reviewed information available on the websites of 69 biobanks, and directly contacted them for additional information. Our study identified six types of commonly adopted governance strategies: communication, compliance, expert advice, external review, internal procedures, and partnerships. Each strategy is implemented through different mechanisms including, independent ethics assessment, informed consent processes, quality management, data access control, legal compliance, standard operating procedures and external certification. Such mechanisms rely on a wide range of bodies, committees and actors from both within and outside the biobanks themselves. We found that most biobanks aim to be transparent about their governance mechanisms, but could do more to provide more complete and detailed information about them. In particular, the retrievable information, while showing efforts to ensure biobanks operate in a legitimate way, does not specify in sufficient detail how governance mechanisms support accountability, nor how they ensure oversight of research operations. This state of affairs can potentially undermine biobanks’ trustworthiness to stakeholders and the public in a long-term perspective. Given the ever-increasing reliance of biomedical research on large biological repositories and their associated databases, we recommend that biobanks increase their efforts to future-proof their governance.
Vaccination, Autonomy, Complexity, Solidarity - Ethical analyses of a German policy discourse
Schröder-Bäck, Peter; Gille, Felix; Brall, Caroline; et al. (2019)
European Journal of Public Health
Background: Currently, measles immunization is high on the agenda of academic and public discourses - on both sides of the Atlantic. In Germany, the discussion of mandatory (measles) immunization was intensively publicly discussed in Spring 2019. Many stakeholders, including federal politicians, plea for mandatory measles immunization. In our paper we analyse the discourse from an ethical point of view. Methods: Statements and arguments from German stakeholders in the public debate in 2019 are analysed (among them statements of the federal minister of health, the German Medical Association, NGOs and the National Ethics Council). A vaccination ethics framework and a public trust framework are applied in the analysis. Results: Politicians and other public stakeholders debate (measles) immunization and increasingly demand mandatory (measles) vaccination. However, frequently it is unclear which vaccinations or immunization programmes they refer to. They often do ignore the epidemiological situation of immunization rates in Germany, regional differences, relevant target groups and implementation mechanisms, including potential sanctions. This way they simplify the complex problem and offer (populist) simplistic solutions. Normative arguments of stakeholders repeatedly use conceptions of ’autonomy’ and ’harm’; but sometimes also ’solidarity’ is mentioned. Conclusions: The call for mandatory measles immunization of school and kindergarten children is offering no adequate and sufficient solution to the problem of elimination of measles. Nevertheless, it contributes to reducing infection risks for the children in care and schooling facilities. Rather, the problem has to be understood in its complexity before discussing the ethical challenges and making effective policy recommendations. When discussing ways to increase immunization rates, ethical values like public trust and solidarity have to be in the foreground - not (only) the debate of autonomy and its restriction.
Beyond high hopes: A scoping review of the 2019–2021 scientific discourse on machine learning in medical imaging
Blasimme, Alessandro; Nittas, Vasileios; Daniore, Paola; et al. (2023)
PLOS Digital Health
Machine learning has become a key driver of the digital health revolution. That comes with a fair share of high hopes and hype. We conducted a scoping review on machine learning in medical imaging, providing a comprehensive outlook of the field’s potential, limitations, and future directions. Most reported strengths and promises included: improved (a) analytic power, (b) efficiency (c) decision making, and (d) equity. Most reported challenges included: (a) structural barriers and imaging heterogeneity, (b) scarcity of well-annotated, representative and interconnected imaging datasets (c) validity and performance limitations, including bias and equity issues, and (d) the still missing clinical integration. The boundaries between strengths and challenges, with cross-cutting ethical and regulatory implications, remain blurred. The literature emphasizes explainability and trustworthiness, with a largely missing discussion about the specific technical and regulatory challenges surrounding these concepts. Future trends are expected to shift towards multi-source models, combining imaging with an array of other data, in a more open access, and explainable manner.
Can we know if donor trust expires? About trust relationships and time in the context of open consent for future data use
Gille, Felix; Brall, Caroline (2022)
Journal of Medical Ethics
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.
Development of the mHealth App Trustworthiness checklist
van Haasteren, Afua; Gille, Felix; Fadda, Marta; et al. (2019)
Digital Health
Transparency About Governance Contributes to Biobanks' Trustworthiness: Call for Action
Gille, Felix; Axler, Renata; Blasimme, Alessandro (2021)
Biopreservation and Biobanking
This article examines biobank transparency mechanisms vis-à-vis their public information, as found on the public biobank webpages. Two independent studies about biobank governance in Europe and Canada identified a lack of governance-related information provided by biobanks on their public webpages. This lack of transparency stands in contrast to governance best practice guidelines highlighting the importance of transparency as a principle of good governance. Transparency is especially important as many biobanks are publicly funded, and it contributes to accountability and supports the development of donor trust in biobanks. Empirical evidence shows that the public supports greater transparency about biobank governance. It will be important that information provided online is relevant and accessible for a variety of different stakeholders (e.g. public and private sector scientists and institutions, donors and potential donors, members of the public). Transparency standards, however, need to be proportionate to avoid the situation that only large-scale biobanks can allocate appropriate resources to fulfil them. Implementing adequate standards of transparency about biobanks' governance will increase accountability but also allow current and future participants to make more informed decisions about their participation in biobank activities.
How the General Data Protection Regulation changes the rules for scientific research
Ienca, Marcello; Scheibner, James; Ferretti, Agata; et al. (2019)
The implementation of the General Data Protection Regulation (GDPR) raises a series of challenges for scientific research, in particular for research that is dependent on data. This study comprehensively investigates the promises and challenges associated with the implementation of the GDPR in the scientific domain, with a special focus on the impact of the new rights and obligations enshrined in the GDPR on the design and conduct of scientific research. Furthermore, the study examines the adequacy of the GDPR's derogations for scientific research in terms of safeguarding scientific freedom and technological progress. The study also provides policy options that delineate a pathway towards enhancing rather than stifling research, and facilitating privacy-preserving data-driven research under the provisions of the GDPR.
How Private Individuals Maintain Privacy and Govern Their Own Health Data Cooperative
Gille, Felix; Vayena, Effy (2021)
Governing Privacy in Knowledge Commons
Diverse and increasingly comprehensive data about our personal lives is collected. When these personal data are linked to health records or linked to other data collected in our environment, such as that collected by state administrations or financial systems, the data have huge potential for public health research and society in general. Precision medicine, including pharmacogenomics, particularly depends on the potential of data linkage. With new capacities to analyze linked data, researchers today can retrieve and assess valuable and clinically relevant information. One way to develop such linked data sets and to make them available for research is through health data cooperatives. An example of such a health data cooperation is MIDATA – a health data cooperative recently established in Switzerland and the main focus of this chapter. In response to concerns about the present health data economy, MIDATA was founded to provide a governance structure for data storage that supports individual’s digital self-determination by allowing MIDATA members to control their own personal data flow and to store such data in a secure environment.
What is public trust in the healthcare system? A new conceptual framework developed from qualitative data in England
Gille, Felix; Smith, Sarah; Mays, Nicholas (2021)
Social Theory & Health
The conceptual ambiguity of public trust in the healthcare system poses problems for governance and public trust measurement. Therefore, we aimed to answer: what is public trust in the healthcare system? We conducted in the context of the English NHS an analysis of online news with readership comments concerning the care.data initiative; a secondary analysis of interviews about participants’ experiences and perceptions of biobanks; and an analysis of public focus groups about perceptions of the 100,000 Genomes Project. Further, we engaged with existing conceptual work and trust theory. This resulted in a full conceptual framework of public trust in the healthcare system. Public trust is established in anticipation of net benefits. Public trust legitimises the actions of the healthcare system as well as encourages the public to participate in healthcare-related activities. Further, levels of public trust are affected by spill-over effects from high or low levels of public trust in other parts of the government system. Last, many actors inside and outside the healthcare system influence public trust. Future research needs to translate this conceptual framework into policy guidelines and a measurement scale, as well as to validate the conceptual framework for healthcare systems other than the British NHS.
A Case for Transformative Learning in Medical Ethics Education
Gille, Felix; Nardo, Aline (2020)
Journal of Medical Education and Curricular Development
In this article, we discuss the current state of medical ethics education. In Higher Education, ethics is taught predominantly through discussion and case study–based teaching formats. At present, however, only little can be said about the adequacy of these teaching methods in attaining complex educational objectives as ethics education poses challenges regarding meaningful student assessment and evaluation of educational methods. Output-oriented evaluation and assessment paradigms that centre quantified student performance fail to meaningfully capture the learning of ethics. Currently, we argue that comparatively small efforts are being devoted to the advancement of innovative and adequate approaches to teaching and assessment in ethics education. In response to these shortcomings, drawing from educational traditions that focus on preparatory activities, we work towards a new approach to evaluate teaching methods and assessing the learning in ethics.

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Felix Gille

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