The progress of electronic health technologies and biobanks holds enormous promise for efficient research. Evidence shows that studies based on sharing and secondary use of data/samples have the potential to significantly advance medical knowledge. However, sharing of such resources for international collaboration is hampered by the lack of clarity about ethical and legal requirements for transfer of data and samples across international borders. Here, the International Clinical Trial Center Network reports the legal and ethical requirements governing (...) data and sample exchange across four continents. The most recurring requirement is ethical approval, whereas only in specific conditions approval of national health authorities is required. Informed consent is not required in all sharing situations. However, waiver of informed consent is only allowed in certain countries/regions and under certain circumstances. The current legal and ethical landscape appears to be very complex and under constant evolution. Regulations differ between countries/regions and are often incomplete, leading to uncertainty. With this work, ICN illuminates the unmet need for a single international collaborative framework to facilitate DSE. Harmonising requirements for global DSE will reduce inefficiency and waste in research. There are many challenges to realising this ambitious vision, including inconsistent terminology and definitions, and heterogeneous and dynamic legal constraints. Here, we identify areas of agreement and significant difference as a necessary first step towards facilitating international collaboration. We propose the establishment of a working group to continue the comparison across jurisdictions, create a standardised glossary and define a set of basic principles and fundamental requirements for DSE. (shrink)

Increasing genetic knowledge over the last decade has enabled hundreds of genetic variants associated with inherited cardiac conditions to be identified, many of which cause increased risk of sudden cardiac death. While individually these conditions are rare, taken together they impose a significant burden. The severity of these conditions—the possibility that they might cause sudden unheralded death of a teenager or young adult—juxtaposed with uncertainty about the pathology linked with many of the genetic variants is significant in terms of professional (...) practice because, increasingly, clinicians have been encouraged to cascade out genetic testing from the proband or consultand to other family members who may be at risk of developing the same condition. This process often involves sharing human tissue samples, DNA or personal information. This paper reviews the legal and regulatory frameworks which may apply when tissue and DNA samples are collected, used and retained, both for the purpose of diagnosis and for benefiting other family members, when a suspected or definitive diagnosis of an inherited cardiovascular condition is made. Sometimes the interests of family members may conflict, and it may be difficult for practitioners to reconcile the interests of one family member with another, particularly if the balance of benefits and harms from testing is unclear. The paper then examines some of the ethical tensions which may arise in practice and concludes that all involved should be conversant with the legal and ethical frameworks that apply. (shrink)

Artificial intelligence (AI) will drastically change the healthcare system. Radiology is one speciality that is most affected as AI algorithms are increasingly used in diagnostic imaging. AI‐enhanced health technologies will, inter alia, increase workflow efficiency, improve diagnostic accuracy, reduce healthcare‐related costs, and help alleviate medical personnel shortages in under‐resourced settings. However, the development of AI‐enhanced technologies in healthcare is fraught with legal, ethical, and human rights concerns. Currently, the use of AI in South African healthcare is not governed (...) by sui generis legislation or ethical guidance focused exclusively and specifically on AI, although various provisions and principles from law and ethics find application. This article outlines these normative principles and explains their relationship with the extant legal obligations and regulatory framework as applied to the use of AI in radiology services in South Africa. The article concludes with three key recommendations for radiology practitioners using AI in South Africa. These are the need for: vigilant monitoring of AI use in practice, reforms to the liability framework, and appropriate guidance from local regulators and the Health Professions Council of South Africa on the ethical use of AI. (shrink)

Animals in Brazil: Economic, Legal and Ethical Perspectives presents a broad overview of the complicated role of animals in Brazilian society. Its four substantive chapters survey the landscape of animal agriculture, animal protection laws, recent animal jurisprudence, and the underlying cultural factors that have shaped the Brazilian people's relationship with and treatment of animals. Despite the book's title, there is no chapter addressing economics. However, it represents the first book in English addressing the plight of animals in Brazil (...) and makes a marked contribution to animal ethics in Latin America. At its best, it is very good, and overall, the volume is a worthwhile addition to the bookshelf of anyone interested in Brazilian animal law.The introduction by the book's editor, Carlos Naconecy, does exactly what an introduction should do: it succinctly describes the content of the chapters to follow. My quibble is that while Naconecy has excellent English and expresses himself well, the essay badly needed the editorial scrutiny of a native English speaker. The succeeding chapters each begin with an abstract, a simple but useful aid to any scholar who might not be interested in all of the issues the book covers.Chapter 1, “Food Animals in Brazil: Five Decades of Transformation,” ably describes Brazil's progression from a primarily subsistence-based agrarian culture to its full-scale embrace of industrial agriculture with all of its incumbent horrors. In just 50 years, Brazil has gone from a net importer to the world's second-largest exporter.The story of the country's transition to confinement, meat-based agriculture is all too familiar. It wrought havoc on community and family ties and overwrote traditional dietary practices, leading to widespread obesity, disease, and nutrient deficiencies. It also made indifference toward agricultural animals a new national norm. The level of cruelty that is both legal and common in Brazilian industrial agriculture would strain credulity if it weren't so similar to those of so many other countries. Indeed, the authors’ discussion of the systemic animal mistreatment, devastating environmental consequences, and accompanying cultural erosion in Brazil could easily have been cut and pasted into a chapter surveying the last 50 years in the United States.The second chapter is the strongest in the collection. “The Legal Protection of Animals in Brazil: An Overview” summarizes the country's animal-legal framework and situates it within the context of Brazil's constitutional prohibition against animal cruelty. The authors explain why the constitution offers little practical protection. Under the prevailing view, only those acts undertaken for the purpose of causing needless suffering constitute cruelty. Since much animal cruelty is ostensibly done for other reasons (food, science, etc.), the cruelty prohibition does not reach the majority of offenses.The authors next construct a syllogistic argument that the current legal classification of animals as “things” rather than beings who are the subjects of rights is logically and ethically flawed. Since cruelty involves suffering, and objects cannot suffer, and since animals suffer (otherwise animal cruelty laws would be pointless), then animals must be subjects of the law. Phrased differently, animals must be rights-holders. This leads into a compelling argument that the constitution not only supports but requires such an interpretation.“Cases and Debates in the Brazilian Animal Rights Arena” does exactly what its title suggests. It looks at recent animal-related judicial developments and situates them within a broader cultural and legal context. For example, the Supreme Court recently held that the Vaquejada, a rodeo-like event involving chasing and tackling terrified cows, was unconstitutional.Immediately following the decision, the legislature amended the constitution to classify the Vaquejada as an important cultural activity and thus protected under a different constitutional provision. The courts are currently considering whether that constitutional amendment is itself unconstitutional. We are further told about movements against foie gras and vivisection and about recent developments regarding custody disputes over domestic animal companions.The final chapter, “Factors That Influence the Brazilian Ethos Regarding Animals” is a broad discussion of the ways Brazilian history and culture have impacted attitudes toward animals. It is argued that because Brazil was the last Western country to eliminate slavery, Brazilians are more prone to treat animals like property and that the Brazilian temperament makes them more likely to be passionate than pragmatic. We also learn that a cultural reluctance to protest against social wrongs enables Brazilians to remain silent in the face of animal injustice and that the country's Catholic tradition instilled the idea that only people were made in the image of God and that animals therefore matter less. These observations strike me as overbroad and problematic. For example, millions of Brazilians have spent much of the past decade protesting government corruption, and the country has an impassioned animal advocacy movement. Furthermore, it is not clear that Brazilians necessarily treat animals differently than people from other countries with very different histories.Overall, Animals in Brazil begins the work of new scholarship in English on animals in the Brazilian context. The fact that some chapters are more informative and useful than others is an inevitable by-product of an edited volume and should not deter those interested in Brazilian animal law from reading it. The excellence of the first two chapters alone makes the book worthwhile. (shrink)

Epigenetic research has brought several important technological achievements, including identifying epigenetic clocks and signatures, and developing epigenetic editing. The potential military applications of such technologies we discuss are stratifying soldiers’ health, exposure to trauma using epigenetic testing, information about biological clocks, confirming child soldiers’ minor status using epigenetic clocks, and inducing epigenetic modifications in soldiers. These uses could become a reality. This article presents a comprehensive literature review, and analysis by interdisciplinary experts of the scientific, legal, ethical, and (...) societal issues surrounding epigenetics and the military. Notwithstanding the potential benefit from these applications, our findings indicate that the current lack of scientific validation for epigenetic technologies suggests a careful scientific review and the establishment of a robust governance framework before consideration for use in the military. In this article, we highlight general concerns about the application of epigenetic technologies in the military context, especially discrimination and data privacy issues if soldiers are used as research subjects. We also highlight the potential of epigenetic clocks to support child soldiers’ rights and ethical questions about using epigenetic engineering for soldiers’ enhancement and conclude with considerations for an ethical framework for epigenetic applications in the military, defense, and security contexts. (shrink)

This article, prompted by an extended essay published in the Journal of Medical Ethics by Charles Foster, and the current controversy surrounding the case of Vincent Lambert, analyses the legal and ethical arguments in relation to the withdrawal of life-sustaining treatment from patients with prolonged disorders of consciousness. The article analyses the legal framework through the prism of domestic law, case-law of the European Court of Human Rights and the Convention on the Rights of Persons with (...) Disabilities, and examines the challenge to the ethical consensus made by Foster. It concludes that the right approach remains a version of the approach that has prevailed for the last 25 years since the decision in Airedale NHS Trust v Bland[1993] AC 789, refined to reflect that that there is now, and rightly, a much more limited place for judgments made about the ‘burden’ of treatment or the quality of life enjoyed by the person made on the basis of assumptions about that person as a category as opposed to investigation of that person as an individual human being. (shrink)

In this article we examine the role of Entscheider (decision-makers) in the German asylum procedure, both legally and ethical. As the responsibility for deciding on asylum applications lies exclusively with them, their significance for the German asylum procedure can hardly be underestimated. However, over the last few decades the situation of Entscheider changed significantly: While the number and complexity of the cases they have to decide on has increased due to the growing immigration, the requirements for their education have (...) been lowered, owed to critical amendments to the relevant law. We analyze how the law currently defines the role of Entscheider, whether the legal framework is constitutional, and what modifications morality requires. Although the law defining their role seems to be constitutional, Entscheider’s education must be improved and they must be entrusted with the hearing of the applicants to meet what morality requires, we conclude. DOI: 10.17879/95189429199. (shrink)

This book considers coercion within the healing and ethical framework of therapeutic relationships and partnerships at all levels, and addresses the universal ...

Robots are slowly, but certainly, entering people's professional and private lives. They require the attention of regulators due to the challenges they present to existing legal frameworks and the new legal and ethical questions they raise. This paper discusses four major regulatory dilemmas in the field of robotics: how to keep up with technological advances; how to strike a balance between stimulating innovation and the protection of fundamental rights and values; whether to affirm prevalent social norms or (...) nudge social norms in a different direction; and, how to balance effectiveness versus legitimacy in techno-regulation. The four dilemmas are each treated in the context of a particular modality of regulation: law, market, social norms, and technology as a regulatory tool; and for each, we focus on particular topics? such as liability, privacy, and autonomy? that often feature as the major issues requiring regulatory attention. The paper then highlights the role and potential of the European framework of rights and values, responsible research and innovation, smart regulation and soft law as means of dealing with the dilemmas. (shrink)

IntroductionThe idea of video recording in the operating room with panoramic cameras and microphones is a new concept that is changing the approach to medical activities in the OR. However, VR in the OR has brought up many concerns regarding patient privacy and has highlighted legal and ethical issues that were never previously exposed.AimTo review the literature concerning these aspects and provide a better ethical and legal understanding of the new challenges concerning VR in the OR.ConclusionsThere (...) is a disparity between the two main legal models concerning VR in the OR, namely the European legal system ) and the American legal framework ). This difference mainly deals with two distinct bioethical paradigms: GDPR places a strong emphasis on protecting patients’ privacy to improve the public health system, whereas HIPAA indicates the need to generate protocols to safeguard the risks connected to medical activity and patient privacy. Following from this point, we may argue that, at the ethical and bioethical level, GDPR and HIPAA depend mainly on two different ethical models: a perspective based on moral acquaintances and weak proceduralism, respectively. It is worth noting the importance of developing additional guidelines concerning different world regions to avoid the ethical problems that may emerge when simply applying a foreign paradigm to a very different culture. (shrink)

The recently published BRAIN 2.0 Neuroethics Report offers a very helpful overview of the possible ethical, social, philosophical, and legal issues raised by neuroscience in the context of BRAIN’s research priorities thus contributing to the attempt to develop ethically sound neuroscience. In this article, we turn to a running theme of the document: the need for an ethical framework for the BRAIN Initiative and for further integration of neuroethics and neuroscience. We assess some of the issues (...) raised and provide an explanation of how we have addressed them in the Human Brain Project. We offer our experience in the HBP as a potential contribution to the international debate about neuroethics in the big brain initiatives. Our hope is that among other things, the type of exchange proposed by this AJOB special issue will prove productive in further identifying and discussing the issues and in inspiring appropriate solutions. (shrink)

The practice of covertly administering medications to patients without their consent is often discussed in the framework of legal questions around the right of patients to consent and refuse medical treatment. However, this practice also raises significant questions surrounding the professional duties and obligations of health care professionals as it relates to the decision-making process of whether to engage in the covert administration of medications. In this paper, I present an overview of the origin of those duties and (...) obligations, and discuss how those duties and obligations when seen from different perspectives may either justify or prohibit the practice. Further, I discuss whether the duties and obligations of health care professionals as they are currently framed are suited to address the complexities of this issue both from the health care professional and patient perspectives. This analysis is conducted in the context of duties and obligations that arise from not only legal framework but also from the ethical requirements from professional codes of ethics. (shrink)

Nanotechnology is an important platform technology which will add new features like improved biocompatibility, smaller size, and more sophisticated electronics to neuro-implants improving their therapeutic potential. Especially in view of possible advantages for patients, research and development of nanotechnologically improved neuro implants is a moral obligation. However, the development of brain implants by itself touches many ethical, social and legal issues, which also apply in a specific way to devices enabled or improved by nanotechnology. For researchers developing nanotechnology (...) such issues are rather distant from their daily work in the lab, but as soon as they use their materials or devices in medical applications such as therapy of brain diseases they have to be aware of and deal with them. This paper is intended to raise sensitivity for the ethical, legal and social aspects (ELSA) involved in applying nanotechnology in brain implants or other devices by highlighting the short term problems of testing and clinical trials within the existing regulatory frameworks (A), the short and medium-term questions of risks in the application of the devices (B) and the long-term perspectives related to problems of enhancement (C). To identify and address such issues properly nanotechnologists should involve ethical, legal and social experts and regulatory bodies in their research as early as possible. This will help to remove pressure from regulatory bodies, to settle public concern and to prevent non-acceptable developments for the benefit of the patients. (shrink)

This paper is sadly opportune. The general public is angry and bewildered if not hurt by the variety of strikes which are brought more or less forcibly to their attention. People used to understand what lay behind a strike - a demand for more pay, better conditions - but today a political element often intrudes, and it is this that worries those who ask themselves whether this or that dispute is either lawful or morally acceptable. Professor Dworkin, a lawyer, first (...) sets out the legal issues surrounding strikes and then advances the ethical arguments, closely relating them to the legal framework. The most interesting part of the paper, however, may well be that devoted to the moral obligation of example, in particular the example to be set by members of the medical profession and by all those caring for the sick. As public attitudes to industrial disputes `become dulled and quiescent' it is absolutely necessary that there should be a reappraisal of the moral standards of the past which coincide with a respect for the law. In the last century the term `anomie' was used to describe a `society which has shaken off its former restraints such as religion, respect for law and order and a definite moral code as to what is right and wrong'. We are living in that sort of society today, and one need not be a professional `ethicist' to recognize the signs, and hopefully, to work for the return of `ethical' values. (shrink)

The current legal framework within the Lithuanian health system is described including a review of the physician’s autonomy, rights and duties, and patients’ rights including the right to reimbursement. The role of ethical codes and the law are discussed.

Background In this study, we examined the ethical implications of Egypt’s new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients. Methods We (...) conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws. Results On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones. Conclusion The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond. (shrink)

Verbal autopsy presents the opportunity to understand the disease burden in many low-income countries where vital registration systems are underdeveloped and most deaths occur in the community. Advances in technology have led to the development of software that can provide probable cause of death information in real time, and research considering the ethical implications of these advances is necessary to inform policy. Our research explores these ethical issues in rural Nepal using a public health ethics framework. We (...) considered the burdens and benefits of VA and giving cause of death information to families of the deceased through qualitative research with VA interviewers, community members, national policy stakeholders and international academics. Burdens can be experienced differently, and it is important to balance the emotional burden of VA with utilization of the data to inform planning and increased access to health services. The training, support and supervision of VA interviewers should be prioritized if VA is taken to scale. Initial and ongoing community engagement is recommended in addition to engaging ethical, legal, health and policy personnel in developing protocols and systems. Integrating rigorous research while cautiously moving forward is recommended to ensure systems and responses to concerns are relevant to contexts. (shrink)

Xenotransplantation - the transfer of living tissue between species - has long been heralded as a potential solution to the severe organ shortage crisis experienced by the United Kingdom and other 'developed' nations. However, the significant risks which accompany this biotechnology led the United Kingdom to adopt a cautious approach to its regulation, with the establishment of a non-departmental public body - UKXIRA - to oversee the development of this technology on a national basis. In December 2006 UKXIRA was quietly (...) disbanded and replaced with revised guidance, which entrusts the regulation of xenotransplantation largely to research ethics committees. In this article we seek to problematize this new regulatory framework, arguing that specialist expertise and national oversight are necessary components of an adequate regulatory framework for a biotechnology which poses new orders of risk, challenges the adequacy of traditional understandings of autonomy and consent, and raises significant animal welfare concerns. We argue for a more considered and holistic approach, based on adequate consultation, to regulating biotechnological developments in the United Kingdom. (shrink)

For Lack of a Better Plan: A Framework for Ethical, Legal, and Clinical Challenges in Complex Inpatient Discharge Planning Content Type Journal Article Pages 311-326 DOI 10.1007/s10730-009-9117-6 Authors Jane Jankowski, Albany Medical Center Albany NY 12208 USA Terese Seastrum, Northeast Health 2212 Burdett Ave. Troy NY 12180 USA Robert N. Swidler, Northeast Health 2212 Burdett Ave. Troy NY 12180 USA Wayne Shelton, Alden March Bioethics Institute, Albany Medical College 47 New Scotland Avenue, MC 153 Albany NY 12208-3478 (...) USA Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737 Journal Volume Volume 21 Journal Issue Volume 21, Number 4. (shrink)

Although rapid genomic sequencing (RGS) is improving care for critically ill children with rare disease, it also raises important ethical questions that need to be explored as its use becomes more widespread. Two such questions relate to the degree of consent that should be required for RGS to proceed and whether it might ever be appropriate to override parents’ decisions not to allow RGS to be performed in their critically ill child. To explore these questions, we first examine the (...) legal frameworks on securing consent for genomic sequencing and how they apply to the specific context of RGS for critically ill children. We then use a tool from clinical ethics, the Zone of Parental Discretion, to explore two case studies and identify under which circumstances it might be appropriate for parental refusal of RGS to be overridden. We argue that RGS may be a context where, in addition to assessing the complexity of the test offered, it is ethically appropriate to consider an effect on patient outcomes when deciding the degree of consent required. We also suggest that there are some contexts where it may be ethically justified to perform RGS, even when it is actively against the wishes of the parents. More work is needed to examine exactly how ‘time-sensitive’ exceptions to current guidance on consent for genomic sequencing could be formulated and operationalised for RGS for critically ill-children. (shrink)

Much of recent medical, legal, and ethical focus has been directed toward the unborn or newly born. Guidelines and frameworks for decision making are in the early stages of evolution and are likely to shift as the politics, ethics, and economics of caregiving move beyond technologic accomplishments and debates into a more compassionate construct that may include input from an institutional bioethics committee. Beyond that, the courts may continue to be the place where unresolved issues are settled, and (...) with each passing year new and often divergent legal decisions are being generated that further complicate the physician's role as care giver and healer. (shrink)

When patients are admitted to the hospital, they are generally expected to remain in or within close proximity to their assigned rooms in order to promote their safety and appropriate medical care. Although there are circumstances when patients may safely leave their hospital room or floor, guidance within the medical literature for the management of patient movement within the hospital are lacking. Excessive restrictions on patient movement may be seen as overly paternalistic, while lax requirements may interfere with high quality (...) care, patient safety and efficient hospital practice. As a result, guidance in the form of institutional policy is warranted. Such policy development should take into consideration the potential clinical, legal, and ethical concerns in balancing the competing values of patients’ preferences and respect for autonomy, while ensuring high quality, safe, and efficacious medical care. This paper will provide a framework for hospitals to create institution-specific patient movement policies that are fair, systematic, and transparent. (shrink)

The Faculty of Medicine and Health Sciences of the University of Sherbrooke has observed year after year, that certain students have not started and or completed their immunizations for common infectious diseases, which in effect makes them inadmissible for their clinical internships in healthcare establishments. The program administrators have posed a series of questions on the best way to proceed with these students as, a certain number remain reluctant to vaccination. They are often confronted with ethical dilemmas, are not (...) necessarily comfortable with their rights and responsibilities and wish to be guided throughout the process. This article aims to put forth a procedure that would be put in place to support the administrators in a way for them to obtain a more favorable vaccination level for all of their students in the most reasonable amount of time possible. The interest of the procedure is to move forward in a few simple and well defined steps that are supported by a rigorous legal framework, while respecting the rights and freedoms of the students. It is also designed so that it could be replicated in other faculties of medicine. (shrink)

Genome Editing Techniques are seen to be at the frontier of current research in the field of emerging biotechnologies. The latest revolutionary development, the so-called CRISPR technology, represents a paradigmatic example of the ambiguity of such techniques and has resulted in an international interdisciplinary debate on whether or not it is necessary to ban the application of this technique by means of a moratorium on its use for human germline modifications, particularly in human embryos in the reproduction process. However, given (...) that other germline engineering techniques like mitochondrial DNA transfer techniques are already permitted and applied, the question arises what lies at the root of the apparent social unease about the modification of the human germline by Genome Editing Techniques like CRISPR. Against this background, the book seeks to make a substantial contribution to the current debate about a responsible and participatory framework for research on emerging biotechnologies by analysing underlying perceptions, attitudes, arguments and the reasoning on Genome Editing Techniques. (shrink)

Ambient assisted living technologies are increasingly presented and sold as essential smart additions to daily life and home environments that will radically transform the healthcare and wellness markets of the future. An ethical approach and a thorough understanding of all ethics in surveillance/monitoring architectures are therefore pressing. AAL poses many ethical challenges raising questions that will affect immediate acceptance and long-term usage. Furthermore, ethical issues emerge from social inequalities and their potential exacerbation by AAL, accentuating the existing (...) access gap between high-income countries and low and middle-income countries. Legal aspects mainly refer to the adherence to existing legal frameworks and cover issues related to product safety, data protection, cybersecurity, intellectual property, and access to data by public, private, and government bodies. Successful privacy-friendly AAL applications are needed, as the pressure to bring Internet of Things devices and ones equipped with artificial intelligence quickly to market cannot overlook the fact that the environments in which AAL will operate are mostly private. The social issues focus on the impact of AAL technologies before and after their adoption. Future AAL technologies need to consider all aspects of equality such as gender, race, age and social disadvantages and avoid increasing loneliness and isolation among, e.g. older and frail people. Finally, the current power asymmetries between the target and general populations should not be underestimated nor should the discrepant needs and motivations of the target group and those developing and deploying AAL systems. Whilst AAL technologies provide promising solutions for the health and social care challenges, they are not exempt from ethical, legal and social issues. A set of ELSI guidelines is needed to integrate these factors at the research and development stage. (shrink)

This commentary proceeds as follows. First, it is argued from both ethical and legal perspectives through an analysis of Court precedents that Etzioni’s has improperly developed a too narrow First Amendment interpretation and conclusion that Apple should comply with the FBI’s demand to provide the FBI with a key to open iPhones. That is, broad First Amendment considerations and not solely narrow First Amendment “compelled speech” or only Fourth Amendment privacy issues are offered and analyzed from both (...) class='Hi'>ethical and legal perspectives. A key point here is that broad First Amendment considerations protect, with exceptions, political and ethical discretion space for “Press” organizations to exercise, or not, ethical responsibilities, including rights to publish or not publish information and opinions, rather than compliance with government orders to publish or not publish. Further, Court cases are discussed from both legal and ethical perspectives where the Courts have established that social media organizations such as Facebook and Twitter do and should have broad First Amendment protection of free expression and peaceful assembly as traditional media such as newspapers have. It is suggested that Apple can and should be considered a social media organization. In addition, special First Amendment protection and limitations concerning national security are analyzed. Second, it is suggested that Etzioni’s point that Apple protected its clients soley for “business profitability” reasons is also a too narrow interpretation since there are more complex, mixed, and combined ethical and political-economic reasons for protecting clients and First Amendment protections. Third, the philosopher Paul Ricoeur’s ethics process responsibility framework concerning relationships between ethics and law and the need for an ethics responsibility rather than a compliance approach, which is similar to Brandeis’ legal ethics approach, is compared with and offered as an alternative to Etzioni’s compliance based “Liberal communitarian” approach. It is suggested that the difference between the Rocoeur and Etzioni approaches is similar to the difference between compliance and ethics responsibility process programs in organizations. (shrink)

Purpose Artificial intelligence (AI) has sparked interest in various areas, including marketing. However, this exhilaration is being tempered by growing concerns about the moral and legal implications of using AI in marketing. Although previous research has revealed various ethical and legal issues, such as algorithmic discrimination and data privacy, there are no definitive answers. This paper aims to fill this gap by investigating AI’s ethical and legal concerns in marketing and suggesting feasible solutions. Design/methodology/approach The (...) paper synthesises information from academic articles, industry reports, case studies and legal documents through a thematic literature review. A qualitative analysis approach categorises and interprets ethical and legal challenges and proposes potential solutions. Findings The findings of this paper raise concerns about ethical and legal challenges related to AI in the marketing area. Ethical concerns related to discrimination, bias, manipulation, job displacement, absence of social interaction, cybersecurity, unintended consequences, environmental impact, privacy and legal issues such as consumer security, responsibility, liability, brand protection, competition law, agreements, data protection, consumer protection and intellectual property rights are discussed in the paper, and their potential solutions are discussed. Research limitations/implications Notwithstanding the interesting insights gathered from this investigation of the ethical and legal consequences of AI in marketing, it is important to recognise the limits of this research. Initially, the focus of this study is confined to a review of the most important ethical and legal issues pertaining to AI in marketing. Additional possible repercussions, such as those associated with intellectual property, contracts and licencing, should be investigated more deeply in future studies. Despite the fact that this study gives various answers and best practices for tackling the stated ethical and legal concerns, the viability and efficacy of these solutions may differ depending on the context and industry. Thus, more research and case studies are required to evaluate the applicability and efficacy of these solutions in other circumstances. This research is mostly based on a literature review and may not represent the experiences or opinions of all stakeholders engaged in AI-powered marketing. Further study might involve interviews or surveys with marketing professionals, customers and other key stakeholders to offer a full knowledge of the practical difficulties and solutions. Because of the rapid speed of technical progress, AI’s ethical and regulatory ramifications in marketing are continually increasing. Consequently, this work should be a springboard for more research and continuing conversations on this subject. Practical implications This study’s findings have several practical implications for marketing professionals. Emphasising openness and explainability: Marketing professionals should prioritise transparency in their use of AI, ensuring that customers are fully informed about data collection and utilisation for targeted advertising. By promoting openness and explainability, marketers can foster customer trust and avoid the negative consequences of a lack of transparency. Establishing ethical guidelines: Marketing professionals need to develop ethical rules for the creation and implementation of AI-powered marketing strategies. Adhering to ethical principles ensures compliance with legal norms and aligns with the organisation’s values and ideals. Investing in bias detection tools and privacy-enhancing technology: To mitigate risks associated with AI in marketing, marketers should allocate resources to develop and implement bias detection tools and privacy-enhancing technology. These tools can identify and address biases in AI algorithms, safeguard consumer privacy and extract valuable insights from consumer data. Social implications This study’s social implications emphasise the need for a comprehensive approach to address the ethical and legal challenges of AI in marketing. This includes adopting a responsible innovation framework, promoting ethical leadership, using ethical decision-making frameworks and conducting multidisciplinary research. By incorporating these approaches, marketers can navigate the complexities of AI in marketing responsibly, foster an ethical organisational culture, make informed ethical decisions and develop effective solutions. Such practices promote public trust, ensure equitable distribution of benefits and risk, and mitigate potential negative social consequences associated with AI in marketing. Originality/value To the best of the authors’ knowledge, this paper is among the first to explore potential solutions comprehensively. This paper provides a nuanced understanding of the challenges by using a multidisciplinary framework and synthesising various sources. It contributes valuable insights for academia and industry. (shrink)

This valuable resource provides academic and student affairs practitioners with the tools to make informed legal and ethical decisions in their college and university contexts. Law is constantly changing and is interpreted differently from campus to campus based on institutional culture and history. This text provides higher education practitioners with tools to anticipate practical and responsible action, engaging readers in anticipatory and reflective practice. In this text, Boettcher and Salinas introduce the Institutional Intelligence Model, a helpful framework (...) that guides practitioners in examining a wide variety of campus issues. Throughout the book, readers can explore perspectives from current practitioners and utilize case studies to examine specific topics including admissions, academics, student living, confidential resources, and graduate student experiences. By using the strategies in this book, practitioners will be equipped to successfully navigate legal and ethical issues on their campuses. This text is ideal for graduate students, student and academic affairs professionals, and those in leadership positions responsible for working with and supporting students and staff teams. (shrink)

A spate of legislations prohibiting cigarette smoking in enclosed public spaces, mainly on grounds of public health protection, recently swept across cities around the world. This is in tandem with a raft of increasingly restrictive national laws that emerged on the back of the ratification of the WHO Framework for Tobacco Control by more than one 168 countries in 2005. The central debate on the increasingly restrictive tobacco laws revolves on the extent to which public health interests justification should (...) ground political intervention in a private right as basic as tobacco smoking, which interestingly is often lumped in the food and beverage category. The pertinent legal and ethical questions therefore are the following: Is or should there be a general unrestricted right to tobacco smoking? If there were such a right, should public health or ethical considerations trump private right to smoke in enclosed public spaces? And if public health interests were so paramount, should they go farther and ground tobacco smoking proscription in all private and public spheres? Using ethical principles and rights-based arguments, the paper critically examines the legal and ethical ramifications of public health justification for tobacco smoking proscription in enclosed public spaces. (shrink)

An expanding policy framework aimed at monitoring alcohol consumption during pregnancy has emerged. The primary justification is prevention of harm from what is termed ‘prenatal alcohol exposure’ (PAE), by enabling more extensive diagnosis of the disability labelled fetal alcohol spectrum disorder (FASD). Here we focus on proposals to include biomarkers as a PAE ‘screening tool’, specifically those found in meconium (the first newborn excrement), which are discussed as an ‘objective’ measure of PAE.We ask the overarching question, ‘Can routine screening (...) of meconium to establish PAE be ethically or legally justified’, and we answer, ‘No’. To reach this conclusion, we discuss three areas. First, we consider the reasons why meconium screening should not be deemed ‘typical’ within the scope of accepted screening tools. We argue that given the aim and necessary timing of the screen, it cannot achieve what it promises. Second, we outline why patient autonomy and consent are not properly accounted for and cannot be reconciled with the ‘routinisation’ of the proposed ‘screening’. Last, we outline why the benefit of such a screen is not clear, focusing on the significance of trust in healthcare professionals (HCP) for the best interests of the future child and pregnant woman.While recognising the adverse effects of heavy alcohol consumption during pregnancy, we emphasise the case for robust ethical, legal and social considerations and the central need for trust between HCP and patients in maternity care. We conclude the permissibility of meconium screening has not been proven, and it is not justified. (shrink)

At the UN, important projects laying down transnational corporations' (TNCs) human rights responsibilities have been launched without ever clarifying the relevant theoretical foundations. One of the consequences is that the human rights principles in projects like the 2000 UN Global Compact and the 2003 Norms on the Responsibilities of Transnational Corporations and Other Business Enterprises with Regard to Human Rights can be understood in different ways, which should not cause surprise given that their authors come from diverse backgrounds, including economics (...) and public policy. An examination of these projects and the views of their authors reveals that, although they are superficially linked to international human rights law, they go well beyond it and attempt to deal with corporate social responsibility issues in ways that elude neat classification as fitting neatly in either legal or non-legal categories. Too little attention has been paid to how in the course of developing these projects the legal and ethical dimensions have become entwined and how lines have gotten blurred. Meanwhile, there has been recognition that these UN projects have emerged simply as ad hoc responses to practical concerns about the sustainability of globalization. The lack of any foundational theory or normative framework should be addressed; it is time to bring together specialists from different fields concerned with the human rights responsibilities of corporations to see if it is possible to define a coherent overarching theory for these UN projects. (shrink)

BackgroundExpanded access is the use of investigational drugs (IDs) outside of clinical trials. Generally it is performed in patients with serious and life-threatening diseases who cannot be treated satisfactorily with authorized drugs. Legal regulations of expanded access to IDs have been introduced among others in the USA, the European Union (EU), Canada and Australia. In addition, in the USA an alternative to expanded access is treatment under the Right-to-Try law. However, the treatment use of IDs is inherently associated with (...) a number of ethically relevant problems.Main textThe objective of this article is to present a coherent framework made up of eight requirements which have to be met for any treatment use of an ID to be ethical. These include a justified need for the use of an ID, no threat to clinical development of the ID, adequate scientific evidence to support the treatment, patient’s benefit as the primary goal of the use of an ID, informed decision of a patient, fair access of patients to IDs, independent review, as well as the dissemination of treatment results.ConclusionsWhile this framework is essentially consistent with the legal regulations of expanded access of the USA, the EU, Canada and Australia, it is substantially wider in scope because it addresses some important issues that are not covered by the regulations. Overall, the framework that we developed minimizes the risks and threats, and maximizes potential benefits to each of the four key stakeholders involved in the treatment use of IDs including patients, doctors, drug manufacturers, and society at large. (shrink)

Public health emergencies have occurred throughout history, encompassing such events as plagues and famines arising from natural causes, disease pandemics interrelated with wars, and industrial accidents such as the 1986 Chernobyl disaster, among others. Law and legal tools have played an important role in addressing such emergencies. Three prime U.S. examples are Congressional authorization of quarantine as early as 1796, legally mandated smallpox vaccination upheld in a landmark 1905 U.S. Supreme Court ruling, and the President's 2003 executive order adding (...) SARS to the federal government's list of “quarantinable communicable diseases.”The public health emergencies of the present — both actual and potential — pose equally serious threats but do so in the context of greatly magnified expectations that stem directly from the attacks of September 11, 2001, and the immediately following anthrax attacks. (shrink)

Advances in neuroscience and other disciplines are producing large-scale brain data consisting of datasets from multiple organisms, disciplines, and jurisdictions in different formats. However, due to the lack of an international data governance framework brain data is currently being produced under various contextual ethical and legal principles which may influence key stakeholders involved in the generation, collection, processing and sharing of brain data thereby raising ethical and legal challenges. In addition, despite the demand for a (...) brain data governance framework that accounts for culture, there is a gap in empirical research and actions to understand how key stakeholders around the world view these issues using neuroscientists who are affected by these ethical and legal principles. Therefore, using the research question how do ethical and legal principles influence data governance in neuroscience? we attempt to understand the perceptions of key actors on the principles, issues and concerns that can arise from brain data research. We carried out interviews with 21 leading international neuroscientists. The analytical insights revealed key ethical and legal principles, areas of convergence, visibility, and the contextual issues and concerns that arise in brain data research around these principles. These issues and concerns circulate around intimately connected areas which include ethics, human rights, regulations, policies and guidelines, and participatory governance. Also, key contextual insights around animal research and ethics were identified. The research identifies key principles, issues, and concerns that need to be addressed in advancing the development of a framework for global brain data governance. By presenting contextual insights from neuroscientists across regions, the study contributes to informing discussions and shaping policies aimed at promoting responsible and ethical practices in brain data research. The research answers the call for a cross cultural study of global brain data governance and the results of the study will assist in understanding the issues and concerns that arise in brain data governance. (shrink)

The possibility of obtaining stem cells from human embryos has given rise to an intensive legal and ethical debate. In this paper, attention is paid to the normative disparity and ambiguity in Europe. An argument for the need for a minimal legal harmonization is made; and a prudent and flexible way to reach this successfully is suggested. Establishing a common legal framework seems to be the only way to guarantee true competitiveness for the European scientific (...) community. (shrink)

Over the last century, and especially since the publication of the Belmont Report in 1978, respect for persons, as exemplified by respect for autonomous decision-making, has become a central tenet in the practice of medicine. The authority of cognitively competent adults to make their own healthcare decisions is enshrined in both law and practice in most advanced industrialized nations. The right to consent to or to refuse medical interventions is virtually absolute, but is contingent on the provision of materially relevant (...) information about the benefits and burdens or risks of the proposed treatment as well as the freedom from coercion by others, especially healthcare personnel. This power also extends to the kinds, amounts and details of the proposed intervention, including the option to decline to hear anything, if one so chooses, assuming that this is a rational choice. This respect transfers to other competent individuals who are authorized as surrogates to decide for those who have temporarily or permanently lost the capacity to make their own healthcare decisions. (shrink)

The possibility of obtaining stem cells from human embryos has given rise to an intensive legal and ethical debate. In this paper, attention is paid to the normative disparity and ambiguity in Europe. An argument for the need for a minimal legal harmonization is made; and a prudent and flexible way to reach this successfully is suggested. Establishing a common legal framework seems to be the only way to guarantee true competitiveness for the European scientific (...) community. (shrink)

As euthanasia has become a widely debated issue in many Western countries, hospitals and nursing homes especially are increasingly being confronted with this ethically sensitive societal issue. The focus of this paper is how healthcare institutions can deal with euthanasia requests on an organizational level by means of a written institutional ethics policy. The general aim is to make a critical analysis whether these policies can be considered as organizational-ethical instruments that support healthcare institutions to take their institutional responsibility (...) for dealing with euthanasia requests. By means of an interpretative analysis, we conducted a process of reinterpretation of results of former Belgian empirical studies on written institutional ethics policies on euthanasia in dialogue with the existing international literature. The study findings revealed that legal regulations, ethical and care-oriented aspects strongly affected the development, the content, and the impact of written institutional ethics policies on euthanasia. Hence, these three cornerstones—law, care and ethics—constituted the basis for the empirical-based organizational-ethical framework for written institutional ethics policies on euthanasia that is presented in this paper. However, having a euthanasia policy does not automatically lead to more legal transparency, or to a more professional and ethical care practice. The study findings suggest that the development and implementation of an ethics policy on euthanasia as an organizational-ethical instrument should be considered as a dynamic process. Administrators and ethics committees must take responsibility to actively create an ethical climate supporting care providers who have to deal with ethical dilemmas in their practice. (shrink)

This project has been supported by the Australian Government through the Australian Research Council (project number CS170100008); the Department of Industry, Innovation and Science; and the Department of Prime Minister and Cabinet. ACOLA collaborates with the Australian Academy of Health and Medical Sciences and the New Zealand Royal Society Te Apārangi to deliver the interdisciplinary Horizon Scanning reports to government. The aims of the project which produced this report are: 1. Examine the transformative role that artificial intelligence may play in (...) different sectors of the economy, including the opportunities, risks and challenges that advancement presents. 2. Examine the ethical, legal and social considerations and frameworks required to enable and support broad development and uptake of artificial intelligence. 3. Assess the future education, skills and infrastructure requirements to manage workforce transition and support thriving and internationally competitive artificial intelligence industries. (shrink)

Developing and applying a framework for understanding the complexities of economic and legal considerations in two recent Supreme Court rulings was the focus of this research. Of especial concern was the protection of intellectual property in the pharmaceutical industry. Two cases from 2013 were selected: FTC v. Activis and Association for Molecular Pathology v. Myriad Genetics, Inc.. Part of the rationale for the selection was the importance of the Supreme Court rulings and the importance of the pharmaceutical sector. (...) A qualitative content analysis of the Court’s reported decision in each case was analyzed. Since ethical considerations may or may not be consistent with efficiency considerations of plaintiffs, defendants, or the courts, both efficiency and ethical arguments were included. Equally important to the understanding of the economic and ethical issues in the two above- mentioned cases was the development of a rationale for including and excluding a variety of ethical theories, ultimately influenced by Markkula Center For Applied Ethics Of Santa Clara University and Schumann :93–111, 2001). The refinement and use of a levels analysis approach portrays societal, organizational, and individual impacts, and allows for deeper understanding of litigated cases, irrespective of the country in which the litigation takes place :385–393, 2004; Foss et al., J Manag Stud 47:455–482, 2010). A rationale for this framework is the societal and organizational impacts on the myriad of stakeholders in the pharmaceutical sector. We suggest that this framework can be applied to other industries and other complex conflicts among stakeholders as well. (shrink)

This article argues that state government actors concerned about gun violence prevention should prioritize enactment of robust firearm purchaser regimes at the state level. First, the article outlines the empirical evidence base for purchaser licensing. Then, the article describes how state governments can design this policy. Next, the article assesses the likelihood that purchaser licensing legislation will continue to be upheld by federal courts. Finally, the article addresses the implications of this policy, aimed at curbing gun deaths, for equally important (...) racial justice priorities. Taken together, these various considerations indicate that purchaser licensing policies are among the most effective firearm-focused laws state governments can enact to reduce gun deaths within the existing federal legislative and legal frameworks. (shrink)

Background: As a non–European Union member state, Albania is increasingly orienting itself on Western models regarding human rights, patient rights, and legal regulations for healthcare. Due to its limited fiscal and legal power, enforcing legal and ethical regulations poses a major problem. Aim: The aim of this study is to investigate nurse’s knowledge and experiences regarding ethical and legal issues in Albanian elder care in state-funded and privately run institutions. Research design: The study was (...) conducted using an inductive and qualitative design, utilizing a focused ethnographic approach, based on Roper and Shapira’s framework. Method: Data were collected between June 2017 and September 2018 using participant observation, field notes, and semi-structured interviews with 15 nurses in seven different elder care institutions. In total, 100 h of observation and 15 interviews were performed. Data analysis was based on Mayring’s qualitative content analysis. Ethical consideration: The approval for the study was obtained from UMIT—The Health and Life Sciences University, Austria. Findings: The findings of the study fell into the following main categories: “Everyday care issues,” “End-of-life issues,” “Legal issues,” and “Ethical-legal education and conflicts.” Discussion: The participants reported many ethical and legal issues when describing their everyday challenges and displayed a strong lack of ethical and legal education. Despite a wide spectrum in the quality of care between private and state-funded nursing homes, older people mostly do not know their own diagnosis. Conclusion: This study indicates that further ethical and legal education is needed. Furthermore, nurses need to be better prepared for ethical conflicts with families, as strengthening patient rights could come into conflict with traditional rights of the Albanian family. (shrink)

The term “innovation” or “innovative care” has recently gained attention in the context of the use of novel and not yet fully validated medical interventions and technologies. Most notably, there have been various incidences of medical activities insufficiently validated for its regular use in healthcare that fall into this category, such as stem cell treatments, genome sequencing for diagnostic purposes, or novel reproductive technologies. Latin American countries are among the places where new and non-validated medical activities take place, notably due (...) to a lack of clear regulations and the poor support of authorities of existent legal and ethical guidelines, which is driven by “hidden battles” on the moral status of certain interventions. The increasing importance of innovative care underlines the importance of developing a general framework for these practices. Therefore, the present chapter scrutinizes this nascent field of inquiry in Latin America and offers a conceptual framework for innovation as well as its ethical justification. As we will argue, an important use of the term “innovation” or “innovative care” is best interpreted as “new non-validated practice” and not as a research activity. Then, we will defend that responsible innovation understood as responsible new non-validated practice is ethically permissible and poses an acceptable medical option if done in exceptional circumstances—where no reasonable alternatives can be provided to an individual patient—and following special ethical principles. Finally, we focus on the peculiarities and specific difficulties the concept of new non-validated practice poses to the Latin American context. We will conclude the chapter by some remarks and recommendations we draw from our analysis for individual patients, doctors, and societies in Latin America. (shrink)

Public health emergencies have occurred throughout history, encompassing such events as plagues and famines arising from natural causes, disease pandemics interrelated with wars, and industrial accidents such as the 1986 Chernobyl disaster, among others. Law and legal tools have played an important role in addressing such emergencies. Three prime U.S. examples are Congressional authorization of quarantine as early as 1796, legally mandated smallpox vaccination upheld in a landmark 1905 U.S. Supreme Court ruling, and the President's 2003 executive order adding (...) SARS to the federal government's list of “quarantinable communicable diseases.”The public health emergencies of the present — both actual and potential — pose equally serious threats but do so in the context of greatly magnified expectations that stem directly from the attacks of September 11, 2001, and the immediately following anthrax attacks. (shrink)

This book draws on both the historical context & contemporary research evidence to present the roles of mental health social work, AMHP & BIA, within an ethical framework. Codes of practice & statutory legal requirements, such as the Mental Health Act, Mental Capacity Act & the Human Rights Act, are all considered.