Open Data in the Era of the GDPR: Lessons from the Human Cell Atlas.

The Human Cell Atlas (HCA) is striving to build an open community that is inclusive of all researchers adhering to its principles and as open as possible with respect to data access and use. However, open data sharing can pose certain challenges. For instance, being a global initiative, the HCA must contend with a patchwork of local and regional privacy rules. A notable example is the implementation of the European Union General Data Protection Regulation (GDPR), which caused some concern in the biomedical and genomic data-sharing community. We examine how the HCA's large, international group of researchers is investing tremendous efforts into ensuring appropriate sharing of data. We describe the HCA's objectives and governance, how it defines open data sharing, and ethico-legal challenges encountered early in its development; in particular, we describe the challenges prompted by the GDPR. Finally, we broaden the discussion to address tools and strategies that can be used to address ethical data governance.

Anchor bias, autonomy, and 20th-century bioethicists' blindness to racism.

The central thesis of this article is that by anchoring bioethics' core conceptual armamentarium in a four-principled theory emphasizing autonomy and treating justice as a principle of allocation, theorists inadvertently biased 20th-century bioethical scholarship against addressing such subjects as ableism, anti-Black racism, classism, and other forms of discrimination, placing them outside of the scope of bioethics research and scholarship. It is also claimed that these scope limitations can be traced to the displacement of the nascent concept of respect for persons-a concept designed to address classist and racist discrimination-with the morally solipsistic concept of autonomy.

A QALY is [still] a QALY is [still] a QALY? : Evaluating proportional shortfall as the answer to the problem of equity in healthcare allocations.

Despite clinical evidence of drug superiority, therapeutic modalities, like combination immunotherapy, are mostly considered cost-ineffective due to their high costs per life year(s) gained. This paper, taking an ethical stand, reevaluates the standard cost-effectiveness analysis with that of the more recent justice-enhanced methods and concludes by pointing out the shortcomings of the current methodologies.

The New Ethics of Neuromodulation with Transcranial Magnetic Stimulation: A Critical Appraisal.

With over 16 years of experience in clinical, research, and educational activities related to transcranial magnetic stimulation (TMS), I have written this article exploring the ethical dimensions of TMS. This article aims to provide valuable and informative content for those unfamiliar with TMS as well as those just starting in the field. Specifically, this article elaborates on four principles of medical ethics, including those applicable to TMS therapy, the disparity between public medical insurance coverage and medical indications in private practice for TMS therapy, and issues concerning research ethics in practice. I also provide recommendations regarding roles and strategies for adoption by academia and those in this field dedicated to making TMS therapy accessible to a larger patient population in a suitable manner. Lastly, it is my hope that this article will serve as a contemporary "Ethics of TMS Neuromodulation", resonating with the inherent human pursuit of "truth, goodness, and beauty" for a sound mind and spirit.

[The Basel model of principle-oriented clinical ethics consultation 2.0 : An introduction for psychiatry]. / Das Basler Modell der prinzipienorientierten klinischen Ethikkonsultation 2.0 : Eine Einführung für die Psychiatrie.

BACKGROUND: The effectiveness of clinical ethics counselling in medicine in terms of satisfaction of the participants, support of ethical decision-making, perceived impact on clinical care, moral competence and quality of communication is now empirically well validated. In psychiatry, more and more institutions have structures for clinical ethics consultation as well; however, there is still a lack of evaluative accompanying research on the benefits and differential indications of the various forms and models of clinical ethics counselling in psychiatry. AIM OF THE WORK: The article presents the principles and the step by step application of the principle-oriented clinical ethics consultation according to the Basel model 2.0. MATERIAL AND METHODS: The article is based on material and procedures developed at the Clinical Ethics Unit of the University Hospital Basel and the University Psychiatric Clinics Basel for the principle-oriented clinical ethics consultation according to the Basel model 2.0. RESULTS AND DISCUSSION: Principle-oriented clinical ethics consultation according to the Basel model 2.0 is suitable for dealing with moral issues and conflicts in psychiatric practice and for their ethical reflection; however, further evaluative accompanying research is needed on the benefits and differential indications of this and other models of clinical ethics support in psychiatry.

[Palliative neurology]. / Palliativneurologie.

Palliative medicine represents the holistic multiprofessional treatment of severely and incurably ill people and their relatives, addressing their complex physical, psychological, social and spiritual needs. The central therapeutic goals are the quality of life and alleviation of suffering. In the course of many neurological diseases, high symptom burden, long and variable trajectories and unfavorable prognosis at times create a need for palliative care even at an early stage, which is currently still inadequately met. This can be countered by qualified neuropalliative care. In addition to intensifying interdisciplinary collaboration, this requires neurologists to have core competencies in palliative care. These include a team-oriented attitude, communication skills, expertise in symptom control and knowledge of biomedical ethics including palliative options at the end of life.

When Should the Appropriateness of PEG be Questioned?

PURPOSE OF REVIEW: This review aims to analyze the evidence regarding the appropriateness of PEG placement in the following clinical situations: short bowel syndrome, head and neck cancer, dementia and palliative use in malignant bowel obstruction. RECENT FINDINGS: Percutaneous endoscopic gastrostomy (PEG) tubes are placed for a variety of clinical indications by numerous different specialties. First described in 1980, PEG tubes are now the dominant method of enteral access. Typically, PEG tubes are technically feasible procedures that can come with significant risk for both minor and major complications. Therefore, it is important to perform an in-depth, patient specific risk-benefit analysis when considering insertion. By analyzing the current evidence regarding benefits in these situations, superimposed by the lens of biomedical ethics, we make recommendations that are accessible to any provider who may be a consultant or proceduralist, helping to provide informed care that is in the patient's best interest.

Mapping ethical issues in the use of smart home health technologies to care for older persons: a systematic review.

BACKGROUND: The worldwide increase in older persons demands technological solutions to combat the shortage of caregiving and to enable aging in place. Smart home health technologies (SHHTs) are promoted and implemented as a possible solution from an economic and practical perspective. However, ethical considerations are equally important and need to be investigated. METHODS: We conducted a systematic review according to the PRISMA guidelines to investigate if and how ethical questions are discussed in the field of SHHTs in caregiving for older persons. RESULTS: 156 peer-reviewed articles published in English, German and French were retrieved and analyzed across 10 electronic databases. Using narrative analysis, 7 ethical categories were mapped: privacy, autonomy, responsibility, human vs. artificial interactions, trust, ageism and stigma, and other concerns. CONCLUSION: The findings of our systematic review show the (lack of) ethical consideration when it comes to the development and implementation of SHHTs for older persons. Our analysis is useful to promote careful ethical consideration when carrying out technology development, research and deployment to care for older persons. REGISTRATION: We registered our systematic review in the PROSPERO network under CRD42021248543.

A Critical Analysis of Dobbs v. Jackson Women's Health Organization and the Consequences of Fetal Personhood.

In this paper, I will examine the Supreme Court of the United States' (SCOTUS) arguments in the majority decision in Dobbs v. Jackson Women's Health Organization, and I will show how some of those arguments are flawed. Primarily, I will show that the right to bodily autonomy is a well-established right, both in the courts and in societal practices, and that the right to an abortion should be understood as an example of the right to bodily autonomy or bodily integrity. Second, I will examine the justices' arguments that viability is not a reasonable place to restrict abortion access, in contrast to both Roe v. Wade and Planned Parenthood v. Casey, and will offer arguments that defend viability as a valid point to limit abortion access. Third, I will highlight some politicians' goals to enact a federal ban on abortion, and show how the attempt to pass Personhood Amendments is a pathway for doing so. The upshot of this essay to is show how the SCOTUS decision is flawed, and how granting personhood to "potential life" has consequences that extend beyond abortion access.

Epigenetic Inheritance and Transgenerational Environmental Justice.

Many chemicals and toxicants are released into our ecosystem and environment every day, which can cause harmful effects on human populations. Agricultural compounds are used in most crop production and have been shown to cause negative health impacts, including effects on reproduction and other pathologies. Although these chemicals can be helpful for pest and weed control, the compounds indirectly impact humans. Several compounds have been banned in the European Union but continue to be used in the United States. Recent work has shown most toxicants affect transgenerational generations more than the directly exposed generations through epigenetic inheritance. While some toxicants do not impact the directly exposed generation, the later generations that are transgenerational or ancestrally exposed suffer health impacts. Due to impacts to future generations, exposure becomes an environmental justice concern. The term "environmental justice" denotes the application of fair strategies when resolving unjust environmental contamination. Fair treatment means that no group should bear a disproportionate share of negative environmental consequences resulting from industrial, municipal, and commercial operations. This article illustrates how research on directly exposed generations is often prioritized over studies on transgenerational generations. However, research on the latter generations suggests the need to take environmental justice concerns seriously moving forward, as future generations could be unduly shouldering harms, while not enjoying benefits of production.

The scientific productions in Iranian biomedical ethics: A combined study of bibliometrics and social network analysis.

This study aims at increasing our understanding of the research activities of Iranian researchers and institutions in the field of biomedical ethics from 1995 to 2015. A combination of bibliometrics and social network analysis was used to examine the bibliographic data of 580 documents published on Iranian biomedical ethics in Web of Science and Scopus databases to investigate the publication trend, scientific impact, subject keywords network, and social network analysis indicators for international and cross-institutional co-authorship networks. The results showed that the publication of documents has had a consistent and increasing growth and that the citation trend has grown along with it. The analysis of thematic clusters by keyword co-occurrence network shows that Iranian biomedical ethics research has dealt with various topics and that has introduced different research directions. Researchers from 28 countries were identified in the international collaboration network. The main partners of Iranian researchers were from the US (17.8%) and the UK (9.2%). However, there is a tendency to develop and complete cooperation with researchers from different countries. The cross-institutional collaboration network comprises of 63 institutes, of which Tehran University of Medical Sciences (38%), Shahid Beheshti University of Medical Sciences (11%) and Shiraz University of Medical Sciences (7%) have the largest share in publishing documents. The superiority of the first two universities based on centralization indicators in the cross-institutional collaboration network has caused the exchange of cross-network knowledge between and via these players. The network density indicator shows that almost half of the co-authorship links within the international collaboration network and 8% of the co-authorship links within the cross-institutional collaboration network have been implemented and that these networks are not very coherent.

Towards a Design Toolkit of Informed Consent Models Across Fields: A Systematic Review.

In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, abstracts, and if applicable, full publications were screened and coded. The resulting data on fields, models, and themes were then analyzed. We scanned 300 sources from three databases to find 207 uniquely named consent models, and created a network visualization displaying which models occur primarily in one field, and which models overlap between fields. This analysis identifies trends in the consent debate in different fields, as well as common goals of consent models. The most frequently occurring consent models are identified and defined. The analysis contributes toward a cross-disciplinary "consent design toolkit" and highlights that there are more interrelationships between models and fields than are acknowledged in the literature. Where some models are designed to solve distinctively field-specific issues and are specific to biomedical ethics, some may be adaptable and applicable for other fields including engineering and design.

The concept of social dignity as a yardstick to delimit ethical use of robotic assistance in the care of older persons.

With robots being introduced into caregiving, particularly for older persons, various ethical concerns are raised. Among them is the fear of replacing human caregiving. While ethical concepts like well-being, autonomy, and capabilities are often used to discuss these concerns, this paper brings forth the concept of social dignity to further develop guidelines concerning the use of robots in caregiving. By social dignity, we mean that a person's perceived dignity changes in response to certain interactions and experiences with other persons. In this paper, we will first present the concept of social dignity, and then identify a niche where robots can be used in caregiving in an ethical manner. Specifically, we will argue that, because some activities of daily living are performed in solitude to maintain dignity, a care recipient will usually prefer robotic assistance instead of human assistance for these activities. Secondly, we will describe how other philosophical concepts, which have been commonly used to judge robotic assistance in caregiving for the elderly so far, such as well-being, autonomy, and capabilities, are less useful in determining whether robotic assistance in caregiving is ethically problematic or not. To conclude, we will argue that social dignity offers an advantage to the other concepts, as it allows to ask the most pressing questions in caregiving.

Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project.

BACKGROUND: We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases. RESULT: The authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries. CONCLUSION: This work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/CAs. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort.

Ethics of Radiological Protection-recent developments.

The International Commission on Radiological Protection (ICRP) has recently reviewed the ethical foundations of its recommendations. The approach taken in its report is similar to principlism, i.e. the system of Beauchamp and Childress proposed in their 'Principles of Biomedical Ethics.' The commission identifies a number of 'core values' which have helped shape the evolution of the ICRP system of radiological protection, namely 'Beneficence and non-maleficence', 'Prudence', 'Justice' and 'Dignity'. In addition, 'procedural values' are cited that are important for the system's applications in practice, 'Accountability', 'Transparency' and 'Inclusiveness (Stakeholder Participation)'. It is emphasized that these values are common to or at least acceptable for people from different cultural backgrounds, which for an endeavour as global in nature as radiological protection seems to be quite important and appropriate. Thus, the ICRP document on 'Ethics of radiological protection' could set a standard for other areas.

Moral Status and the Architects of Principlism.

In this article, we discuss Beauchamp and Childress's treatment of the issue of moral status. In particular, we (1) introduce the five different perspectives on moral status that Beauchamp and Childress consider in Principles of Biomedical Ethics and explain their alternative to those perspectives, (2) raise some critical questions about their approach, and (3) offer a different way to think about one of the five theories of moral status (the theory based on human properties) that is more in line with what we believe some of its leading advocates affirm.

Principlism's Balancing Act: Why the Principles of Biomedical Ethics Need a Theory of the Good.

Principlism, the bioethical theory championed by Tom Beauchamp and James Childress, is centered on the four moral principles of beneficence, non-maleficence, respect for autonomy, and justice. Two key processes related to these principles are specification-adding specific content to general principles-and balancing-determining the relative weight of conflicting principles. I argue that both of these processes necessarily involve an appeal to human goods and evils, and therefore require a theory of the good. A significant problem with principlism is that it lacks a theory of the good and consequently does not have an adequate solution to the problems of specification and balancing. My conclusion is that principlism must adopt some account of human well-being in order to be a satisfactory bioethical framework.

Response to Commentaries.

After expressing our gratitude to the commentators for their valuable analyses and assessments of Principles of Biomedical Ethics, we respond to several particular critiques raised by the commentators under the following rubrics: the compatibility of different sets of principles and rules; challenges to the principle of respect for autonomy; connecting principles to cases and resolving their conflicts; the value of and compatibility of virtues and principles; common morality theory; and moral status. We point to areas where we see common agreement with our commentators and respond to their critical evaluations.

Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better.

BACKGROUND: The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change. MAIN TEXT: We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies. CONCLUSION: Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate.