Suchergebnisse

The aim of this dissertation is to reconstruct analytically and to assess normatively the emerging governance of stem cell clinical translation. I show that the therapeutic promise of stem cell medicine is potentially revolutionary, and that its fulfilment depends on variables that are at the same time scientific and political. The establishment of the governance of stem cell translational research is however taking intricate routes. It is being contested and challenged in many ways by different actors and, most importantly, its development is yet in the making and, hence, uncertain. In this dissertation I show that democracy is called into question by emerging disagreements about the appropriate framing of stem cell innovation. Such disagreements, that are indeed the hallmarks of our pluralistic societies, are relative to the very role of politics with respect to science, citizens' interests, and patients' rights. I therefore suggest that a democratic polity incurs in risks of democratic erosion due to the current political configuration of stem cell translation. I thus articulate some normative proposals as to the political stakes of innovative medicine and I propose technology assessment mechanisms for stakeholders inclusion and public participation to cope with them.

On May 6th 2014, the European Court of Human Rights added yet a new element to the judicial history of stem cells as it ruled in Durisotto v. Italy [appeal n. 62804/13]. The ruling rejected a patient claim to access an unproven cell therapy—an outcome that is certainly to be welcomed. However, this ruling is a missed occasion to clarify and reaffirm some important legal distinctions that could have greatly benefited the whole field of regenerative medicine. We claim that the ethical and political assumptions that sustain the regulation of expanded access programs to new therapies should be carefully scrutinized, with particular attention to the justifications for the risks connected to unconventional therapies. A clear legal definition of what counts as compassionate cure as distinct from unregulated and untested therapies cannot be provided unless those points are previously addressed.

Whilst basic science rapidly produces new insights into the biological determinants of human health and disease, clinical innovation is often said to lag behind, as it fails to rapidly turn such knowledge into new tools for innovative patient care. This view of biomedical innovation constitutes a 'translational lag narrative', which is widely present in current research policy. This paper presents a qualitative content analysis of a corpus of documents (n = 28) issued by key policy actors in the domain of clinical translation between 2000 and 2018 in the United States and the European Union. The aim is to reconstruct how policy discourse articulates the translational lag narrative, and to analyze how the latter relates to specific sociotechnical imaginaries of progress and of the role of policymaking in their realization. The article identifies key impediments to clinical translation and highlights salient differences in the sociotechnical imaginaries of translation in the US and the EU. In the US, policy discourse around translation is mostly driven by the perceived need to re-instate linearity in the transition from knowledge-production to clinical innovation. In the European context, instead, the driving imaginary of the policy discourse around clinical translation has to do with constructing a distinctly European model of economic growth centered around the idea of a knowledge-based economy, thereby connecting policy stimuli for translation with broader political imaginations. This analysis elucidates how publicly staged narratives about science and technology in the biomedical field simultaneously contain state-specific visions of progress and statecraft. ; ISSN:2662-9992

The SARS-CoV-2 pandemic is a public health challenge of unprecedented scale. In the midst of the first wave of the pandemic, governments worldwide introduced digital contact tracing systems as part of a strategy to contain the spread of the virus. In Europe, after intense discussion about privacy-related risks involving policymakers, technology experts, information technology companies, and—albeit to a limited extent—the public at large, technical protocols were created to support the development of privacy-compatible proximity tracing apps. However, as the second wave of SARS-CoV-2 sweeps the continent, digital contact tracing in Europe is evolving in terms of both technological and governance features. To enable policymakers to harness the full potential of digital health tools against SARS-CoV-2, this paper examines the evolution of digital contact tracing in eight European countries. Our study highlights that while privacy and data protection are at the core of contact tracing apps in Europe, countries differ in their technical protocols, and in their capacity to utilize collected data beyond proximity tracing alone. In particular, the most recently released apps tend to offer users more granular information about risk in specific locations, and to collect data about user whereabouts, in order to enhance retrospective contact tracing capacity. These developments signal a shift from a strict interpretation of data minimization and purpose limitation toward a more expansive approach to digital contact tracing in Europe, calling for careful scrutiny and appropriate oversight.

The SARS-CoV-2 pandemic is a public health challenge of unprecedented scale. In the midst of the first wave of the pandemic, governments worldwide introduced digital contact tracing systems as part of a strategy to contain the spread of the virus. In Europe, after intense discussion about privacy-related risks involving policymakers, technology experts, information technology companies, and—albeit to a limited extent—the public at large, technical protocols were created to support the development of privacy-compatible proximity tracing apps. However, as the second wave of SARS-CoV-2 sweeps the continent, digital contact tracing in Europe is evolving in terms of both technological and governance features. To enable policymakers to harness the full potential of digital health tools against SARS-CoV-2, this paper examines the evolution of digital contact tracing in eight European countries. Our study highlights that while privacy and data protection are at the core of contact tracing apps in Europe, countries differ in their technical protocols, and in their capacity to utilize collected data beyond proximity tracing alone. In particular, the most recently released apps tend to offer users more granular information about risk in specific locations, and to collect data about user whereabouts, in order to enhance retrospective contact tracing capacity. These developments signal a shift from a strict interpretation of data minimization and purpose limitation toward a more expansive approach to digital contact tracing in Europe, calling for careful scrutiny and appropriate oversight. ; ISSN:2673-253X

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. ; ISSN:1476-5438 ; ISSN:1018-4813

Massive amounts of data are collected and stored on a routine basis in virtually all domains of human activities. Such data are potentially useful to biomedicine. Yet, access to data for research purposes is hindered by the fact that different kinds of individual-patient data reside in disparate, unlinked silos. We propose that data cooperatives can promote much needed data aggregation and consequently accelerate research and its clinical translation. Data cooperatives enable direct control over personal data, as well as more democratic governance of data pools. This model can realize a specific kind of data economy whereby citizens and communities are empowered to steer data use according to their motivations, preferences, and concerns. Policy makers can promote this model by recognizing citizens' rights to access and to obtain a copy of their own data, and by funding distributed data infrastructures piloting new data aggregation models. ; ISSN:2210-5433 ; ISSN:2210-5441

Background Explainability is one of the most heavily debated topics when it comes to the application of artificial intelligence (AI) in healthcare. Even though AI-driven systems have been shown to outperform humans in certain analytical tasks, the lack of explainability continues to spark criticism. Yet, explainability is not a purely technological issue, instead it invokes a host of medical, legal, ethical, and societal questions that require thorough exploration. This paper provides a comprehensive assessment of the role of explainability in medical AI and makes an ethical evaluation of what explainability means for the adoption of AI-driven tools into clinical practice. Methods Taking AI-based clinical decision support systems as a case in point, we adopted a multidisciplinary approach to analyze the relevance of explainability for medical AI from the technological, legal, medical, and patient perspectives. Drawing on the findings of this conceptual analysis, we then conducted an ethical assessment using the "Principles of Biomedical Ethics" by Beauchamp and Childress (autonomy, beneficence, nonmaleficence, and justice) as an analytical framework to determine the need for explainability in medical AI. Results Each of the domains highlights a different set of core considerations and values that are relevant for understanding the role of explainability in clinical practice. From the technological point of view, explainability has to be considered both in terms how it can be achieved and what is beneficial from a development perspective. When looking at the legal perspective we identified informed consent, certification and approval as medical devices, and liability as core touchpoints for explainability. Both the medical and patient perspectives emphasize the importance of considering the interplay between human actors and medical AI. We conclude that omitting explainability in clinical decision support systems poses a threat to core ethical values in medicine and may have detrimental consequences for individual and public health. Conclusions To ensure that medical AI lives up to its promises, there is a need to sensitize developers, healthcare professionals, and legislators to the challenges and limitations of opaque algorithms in medical AI and to foster multidisciplinary collaboration moving forward. ; ISSN:1472-6947

"Since the first successful application of the gene editing method based on the CRISPR/Cas-system, the technology has demonstrated great potential but also sparked a series of ethical concerns. Some of the issues are already known from earlier gene editing debates. However, the possibility of CRISPR to target genes with high accuracy and the easy application that allows a biohacker to experiment with a simple toolkit ordered online have introduced new ethical challenges. Further, thanks to preprint servers such as bioRxiv, biomedical research results are more and more accessible with little delay after an experiment was conducted. This enables researchers all over the world to participate and conduct their own experiments, making it a global endeavour. Not only does this make it difficult to monitor and regulate the technology but also speeds up the technological development significantly.CRISPR is only one of many examples of recent advancements with potentially high consequences for society at large. We think it is therefore paramount to identify new issues, understand their nature and assess their impact in a timely manner. In this paper, we propose the integration of digital methods into the toolbox of modern empirical bioethics and demonstrate their potential with two examples: We used 1) crawling and network analysis for hypothesis building, and 2) sentiment analysis to assess the public's attitudes towards CRISPR on Twitter over a six and a half years period. "