Search

Pediatric health care providers caring for patients and families with genetic disease will encounter a range of ethical issues. These include traditional pediatric health care issues, such as surrogate decision making and end-of-life care. Genetic testing raises the importance of informed consent for potential risks that move beyond the oft discussed physical risks and into longer term concepts such as psychological impact, privacy and potential discrimination. Predictive testing in childhood also raises questions of whether the child has an autonomy interest in delaying testing until they have decision making capacity to do so on their own. And finally, treatments including gene therapies and gene editing, may raise issues of identity for families dealing with genetic disease.

Human pluripotent stem cells can be used to derive in vitromodels recapitulating post-implantation human embryos. While useful for research purposes, such integrated embryo models raise ethical issues that need to be addressed to facilitate ethically appropriate policies and regulations that permit scientific ingenuity and medical progress.

The online space has become a digital public square, where individuals interact and share ideas on the most trivial to the most serious of matters, including discussions of controversial ethical issues in science, technology and medicine. In the last decade, new disciplines like computational social science and social data science have created methods to collect and analyse such data that have considerably expanded the scope of social science research. Empirical bioethics can benefit from the integration of such digital methods to investigate novel digital phenomena and trace how bioethical issues take shape online.Here, using concrete examples, we demonstrate how novel methods based on digital approaches in the social sciences can be used effectively in the domain of bioethics. We show that a digital turn in bioethics research aligns with the established aims of empirical bioethics, integrating with normative analysis and expanding the scope of the discipline, thus offering ways to reinforce the capacity of bioethics to tackle the increasing complexity of present-day ethical issues in science and technology. We propose to call this domain of research in bioethics digital bioethics.

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.

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.

Physical frailty and loss of muscular mass (sarcopenia) are believed to be predictors of age-related conditions, such as disability and loss of autonomy. In this paper, I show that what in political and moral philosophy has come to be known as “the capability approach” may indeed provide much needed conceptual clarification in the area of frailty research. Other than being useful at the theoretical level, the capability approach can definitely help in the implementation of clinical guidelines and public health measures aimed at translating the results that are accumulating from frailty research. I will first briefly review the main philosophical tenets of the capability approach, and then analyze how they relate to current debates about frailty and sarcopenia by introducing the notion of “enablement”. Finally, I will show how my analysis bears on both clinical research in this domain and public policy aimed at tackling some of the age-related issues in an aging society.

Fuelled by adaptations to clinical trial implementation during the COVID-19 pandemic, decentralised clinical trials are burgeoning. Decentralised clinical trials involve many digital tools to facilitate research without physical contact between research teams and participants at various stages, such as recruitment, enrolment, informed consent, administering study interventions, obtaining patient-reported outcome measures, and safety monitoring. These tools can provide ways of ensuring participants' safety and research integrity, while sometimes reducing participant burden and trial cost. Research sponsors and investigators are interested in expanding the use of decentralised clinical trials. The US Food and Drug Administration and other regulators worldwide have issued guidance on how to implement such adaptations. However, there has been little focus on the distinct ethical challenges these trials pose. In this Health Policy report, which is informed by both traditional research ethics and digital ethics frameworks, we group the related ethical issues under three areas requiring increased ethical vigilance: participants' safety and rights, scientific validity, and ethics oversight. Our aim is to describe these issues, offer practical means of addressing them, and prompt the delineation of ethical standards for decentralised trials.

In this paper, I present an emerging explanatory framework about ageing and care. In particular, I focus on how, in contrast to most classical accounts of ageing, biomedicine today construes the ageing process as a modifiable trajectory. This framing turns ageing from a stage of inexorable decline into the focus of preventive strategies, harnessing the functional plasticity of the ageing organism. I illustrate this shift by focusing on studies of the demographic dynamics in human population, observations of ageing as an intraspecifically heterogenous phenotype, and the experimental manipulation of longevity, in both model organisms and humans. I suggest that such an explanatory framework about ageing creates the epistemological conditions for the rise of a peculiar form of prevention that does not aim to address a specific condition. Rather it seeks to stall the age-related accumulation of molecular damage and functional deficits, boosting individual resilience against age-related decline. I call this preventive paradigm “ground-state prevention.” While new, ground-state prevention bears conceptual resemblance to forms of medical wisdom prominent in classic Galenic medicine, as well as in the Renaissance period.