Ethical, legal and social aspects of human cerebral organoids and their governance in Germany, the United Kingdom and the United States.

Human cerebral organoids (HCOs) are model systems that enable researchers to investigate the human brain in ways that had previously been impossible. The emergence of HCOs was accompanied by both expert and layperson discussions concerning the possibility of these novel entities developing sentience or consciousness. Such concerns are reflected in deliberations about how to handle and regulate their use. This perspective article resulted from an international and interdisciplinary research retreat "Ethical, Legal and Social Aspects of Human Cerebral Organoids and their Governance in Germany, the United Kingdom and the United States", which took place in Tübingen, Germany, in August 2022. The retreat focused on whether HCO research requires new ethical and regulatory approaches. It addressed epistemic issues around the detection and theorisation of consciousness, ethical concerns around moral status and research conduct, difficulties for legislation and guidelines managing these entities, and public engagement.

On the ethical permissibility of in situ reperfusion in cardiac transplantation after the declaration of circulatory death.

Transplant surgeons in the USA have begun performing a novel organ procurement protocol in the setting of circulatory death. Unlike traditional donation after circulatory death (DCD) protocols, in situ normothermic perfusion DCD involves reperfusing organs, including the heart, while still contained in the donor body. Some commentators, including the American College of Physicians, have claimed that in situ reperfusion after circulatory death violates the widely accepted Dead Donor Rule (DDR) and conclude that in situ reperfusion is ethically impermissible. In this paper I argue that, in terms of respecting the DDR, in situ reperfusion cardiac transplantation does not differ from traditional DCD cardiac transplantation. I do this by introducing and defending a refined conception of circulatory death, namely vegetative state function permanentism I also argue against the controversial brain occlusion feature of the in situ reperfusion DCD protocol, on the basis that it is ethically unnecessary and generates the problematic appearance of ethical dubiousness.

Mobile health technology and empowerment.

Mobile Health (m-health) technologies, such as wearables, apps, and smartwatches, are increasingly viewed as tools for improving health and well-being. In particular, such technologies are conceptualized as means for laypersons to master their own health, by becoming "engaged" and "empowered" "managers" of their bodies and minds. One notion that is especially prevalent in the discussions around m-health technology is that of empowerment. In this paper, I analyze the notion of empowerment at play in the m-health arena, identifying five elements that are required for empowerment. These are (1) knowledge, (2) control, (3) responsibility, (4) the availability of good choices, and (5) healthy desires. I argue that at least sometimes, these features are not present in the use of these technologies. I then argue that instead of empowerment, it is plausible that m-health technology merely facilitates a feeling of empowerment. I suggest this may be problematic, as it risks placing the burden of health and behavior change solely on the shoulders of individuals who may not be in a position to affect such change.

Consciousness and the Ethics of Human Brain Organoid Research.

The possibility of consciousness in human brain organoids is sometimes viewed as determinative in terms of the moral status such entities possess, and, in turn, in terms of the research protections such entities are due. This commonsense view aligns with a prominent stance in neurology and neuroscience that consciousness admits of degrees. My paper outlines these views and provides an argument for why this picture of correlating degrees of consciousness with moral status and research protections is mistaken. I then provide an alternative account of the correlation between moral status and consciousness, and consider the epistemic ramifications for research protections of this account.

Medical Ethics, Moral Courage, and the Embrace of Fallibility.

Experts have an obligation to make difficult decisions rather than offloading these decisions onto others who may be less well equipped to make them. This commentary considers this obligation through the lens of drafting critical care rationing protocols to address COVID-19-induced scarcity. The author recalls her own experience as a member of multiple groups charged with the generation of protocols for how hospitals and states should ration critical care resources like ventilators and intensive care unit beds, in the event that there would not be enough to go around as the COVID-19 pandemic intensified. She identifies several obvious lessons learned through this process, including the need to combat the pervasive effects of racism, ableism, and other forms of discrimination; to enhance the diversity, equity, and inclusion built into the process of drafting rationing protocols; and to embrace transparency, including acknowledging failings and fallibility. She also comes to a more complicated conclusion: Individuals in a position of authority, such as medical ethicists, have a moral obligation to embrace assertion, even when such assertions may well turn out to be wrong. She notes that when the decision-making process is grounded in legitimacy, medical ethics must have the moral courage to embrace fallibility.

Ethics of Digital Mental Health During COVID-19: Crisis and Opportunities.

Social distancing measures due to the COVID-19 pandemic have accelerated the adoption and implementation of digital mental health tools. Psychiatry and therapy sessions are being conducted via videoconferencing platforms, and the use of digital mental health tools for monitoring and treatment has grown. This rapid shift to telehealth during the pandemic has given added urgency to the ethical challenges presented by digital mental health tools. Regulatory standards have been relaxed to allow this shift to socially distanced mental health care. It is imperative to ensure that the implementation of digital mental health tools, especially in the context of this crisis, is guided by ethical principles and abides by professional codes of conduct. This paper examines key areas for an ethical path forward in this digital mental health revolution: privacy and data protection, safety and accountability, and access and fairness.

Dimensions of Ethical Direct-to-Consumer Neurotechnologies.

The direct-to-consumer (DTC) neurotechnology market, which includes some brain-computer interfaces, neurostimulation devices, virtual reality systems, wearables, and smartphone apps is rapidly growing. Given this technology's intimate relationship with the brain, a number of ethical dimensions must be addressed so that the technology can achieve the goal of contributing to human flourishing. This paper identifies safety, transparency, privacy, epistemic appropriateness, existential authenticity, just distribution, and oversight as such dimensions. After an initial exploration of the relevant ethical foundations for DTC neurotechnologies, this paper lays out each dimension and uses examples to justify its inclusion.

Citizen Science and Gamification.

According to the mainstream conception of research involving human participants, researchers have been trained scientists acting within institutions and have been the individuals doing the studying, while participants, who are nonscientist members of the public, have been the individuals being studied. The relationship between the public and scientists is evolving, however, giving rise to several new concepts, including crowdsourcing and citizen science. In addition, the practice of gamification has been applied to research protocols. The role of gamified, crowdsourced citizen scientist is new in the domain of scientific research and does not fit into the existing taxonomy of researchers and participants. We delineate and explicate this role and show that, while traditional roles are governed by well-established norms and regulations, individuals engaged in gamified, crowdsourced citizen science-gamers-fall through the cracks of research protections and regulations. We consider the issues this raises, including exploitation and the absence of responsibility and accountability. Finally, we offer suggestions for how the current lack of appropriate norms may be rectified.

Ethical Issues for Direct-to-Consumer Digital Psychotherapy Apps: Addressing Accountability, Data Protection, and Consent.

This paper focuses on the ethical challenges presented by direct-to-consumer (DTC) digital psychotherapy services that do not involve oversight by a professional mental health provider. DTC digital psychotherapy services can potentially assist in improving access to mental health care for the many people who would otherwise not have the resources or ability to connect with a therapist. However, the lack of adequate regulation in this area exacerbates concerns over how safety, privacy, accountability, and other ethical obligations to protect an individual in therapy are addressed within these services. In the traditional therapeutic relationship, there are ethical obligations that serve to protect the interests of the client and provide warnings. In contrast, in a DTC therapy app, there are no clear lines of accountability or associated ethical obligations to protect the user seeking mental health services. The types of DTC services that present ethical challenges include apps that use a digital platform to connect users to minimally trained nonprofessional counselors, as well as services that provide counseling steered by artificial intelligence and conversational agents. There is a need for adequate oversight of DTC nonprofessional psychotherapy services and additional empirical research to inform policy that will provide protection to the consumer.

Practical Implications of the Minimally Conscious State Diagnosis in Adults.

This article addresses questions surrounding the minimally conscious state (MCS) from the perspective of adult clinical ethics. It describes the background of the MCS diagnosis, analyzes phenomenological ambiguities inherent in the nature of MCS, and raises epistemological concerns surrounding its diagnosis. It argues that in many cases, the burdens of prolonging treatment for people who have sustained certain severe brain injuries (SBI) outweigh the benefits, even if they are in or have the prospect of entering into MCS. It also argues that often such long-term measures are problematic from the perspective of patient preferences and stewardship of resources. Consequently, it suggests that the delineation of MCS as a distinct neurological state, along with research that seeks to expand how MCS is diagnosed, poses ethical difficulties for families and providers making decisions for affected patients.