Ethical, legal and social implications (ELSIs) in forensic genetics investigations (FGIs) also involve conducting a careful assessment of the potential benefits and responsible use of genetic information. FGIs have become an invaluable tool in solving crimes and identifying individuals in various legal and investigative contexts. Moreover, forensic geneticists are called on to manage a series of controversial aspects during the daily practice of forensic investigation, including informed consent, cases of unintended genetic findings, the proband’s privacy, post-mortem sample (...) collection, misinterpretation of results, and the correct management of genetic databases. In this scenario, this article aims to discuss the main aspects of ELSIs regarding FGIs, providing an opportunity to delve into the complexities and nuances of ethical decision-making in the context of FGIs, considering that justice should be served while upholding the highest ethical standards. To date, ELSIs in FGIs involve respecting human dignity, safeguarding privacy, ensuring justice, promoting social solidarity, and carefully weighing up risks and benefits. By adhering to these principles, the forensic geneticist can advance criminal justice while upholding individual rights and privacy. In this way, the development of clear guidelines and protocols can help navigate this ethical dilemma and ensure that FGIs are conducted with integrity, transparency, and respect for individual autonomy. (shrink)

Bioethics, Volume 36, Issue 5, Page 576-586, June 2022.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the (...) research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four‐step checklist aiming to (...) facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU. (shrink)

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The (...) continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration. (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)

Informed consent is one of the foundational ethical and legal requirements of research with human subjects. The Nuremberg Code, the Helsinki Declaration, the Belmont Report, the Common Rule and many other laws and codes require that research subjects make a voluntary, informed choice to participate in research.12345 Informed consent is based on the moral principle of respect for autonomy, which holds that rational individuals have a right to make decisions and take actions that reflect their values and preferences. (...) 6 Whereas most guidelines and codes also require that informed consent be properly documented, informed consent is much more than signing a piece of paper: It is a continuous process of communication between the investigator and the research subject. 7 Because the body of knowledge impacting a study frequently changes, subjects should receive information from investigators after they have enrolled in a study, such as significant new findings that may affect their decision to participate in research or clinically useful tests results. 8910 In large studies, some investigators use newsletters to update subjects on the progress of research and other developments.11Most of the ongoing communications between investigators and subjects involve little more than information sharing, without revisiting the decision to participate in research or signing any additional documents. Sometimes, however, it may be necessary for subjects to reaffirm their decision to participate, to re-consent, or to sign or re-sign a document. 8 Re-consent can be defined as an action in which a subject makes the decision to participate in research once again. Re-consent is different from reaffirming a commitment to participate in a study, because in re-consent one actually reconsiders the information necessary to make decision, whereas in reaffirmation one simply expresses …. (shrink)

The coronavirus crisis is causing considerable disruption and anguish. However, the COVID-19 pandemic and consequent explosion of telehealth services also provide an unparalleled opportunity to consider ethical, legal, and social issues beyond immediate needs. Ethicists, informaticians, and others can learn from experience, and evaluate information technology practices and evidence on which to base policy and standards, identify significant values and issues, and revise ethical guidelines. This paper builds on professional organizations’ guidelines and ELSI scholarship to (...) develop emerging concerns illuminated by current experience. Four ethical themes characterized previous literature: quality of care and the doctor–patient relationship, access, consent, and privacy. More attention is needed to these and to expanding the scope of ethical analysis to include health information technologies. An applied ethics approach to ELSI would addresses context-specific issues and the relationships between people and technologies, and facilitate effective and ethical institutionalization of telehealth and other health information technologies. (shrink)

In 2001, leaders with palliative care convened to discuss the standardization of palliative care and formed the National Consensus Project for Quality Palliative Care. In 2004, the National Consensus Project for Quality Palliative Care produced the first edition of Clinical Guidelines for Quality Palliative Care. The Guidelines were developed by leaders in the field who examined other national and international standards with the intent to promote consistent, accessible, comprehensive, optimal palliative care through the health care spectrum. Within the (...) guidelines there are eight domains to the provision of palliative care. This article focuses on the last, but very significant Domain 8—Ethical and Legal Aspects of Care. (shrink)

When science takes man as its subject, tensions arise between two values basic to Western society: freedom of scientific inquiry and protection of individual inviolability.... At the heart of this conflict lies an age-old question: When may a society, actively or by acquiescence, expose some of its members to harm in order to seek benefits for them, for others, or for society as a whole?

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.,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.,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.,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.,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.,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.,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)

Considerable controversy has recently arisen regarding the patenting of medical and surgical processes in the United States. One such patent, viz. for a "chevron" incision used in ophthalmologic surgery, has especially occasioned heated response including a major, condemnatory ethics policy statement from the American Medical Association as well as federal legislation denying patent protection for most uses of a patented medical or surgical procedure. This article identifies and discusses the major legal, ethical and public policy considerations offered by (...) proponents and opponents of such patents. The existing literature divides up into those who favor such patents essentially without qualification, and those who condemn and wish to outlaw them. We advance a compromise position where administrative and legislative action is called for to provide more specific guidelines regarding the patentability of such processes by the Patent and Trademark Office. Our position, in sum, will be that too much is at stake in this complicated area for either the blanket prohibition, or wholesale, uncritical acceptance, of the patenting of medical and surgical processes or techniques. (shrink)

Children and adults with dementia are vulnerable populations. Both groups are also relatively seldom included in biomedical research. However, including them in clinical trials is necessary, since both groups are in need of scientific innovation and new therapies. Their dependence and limited decision‐making capacities increase their vulnerability, necessitating extra precautions when including them in clinical trials. Beside these similarities there are also many differences between the groups. The most obvious one is that children have an entire life ahead of them (...) and will become persons with certain ideals and preferences, while adults with dementia have lived a life in which they have expressed their ideals and preferences. Some of the available research guidelines recognize these differences, setting one list of specific requirements for groups of incapacitated adults and another list for children. Other documents, however, do not differentiate and only set requirements for subjects unable to consent as a single category of subjects.In this article we analyse to what extent the similarities and differences between the two groups are represented in legal documents and ethical guidelines. The article presents an overview and an analysis of the requirements for doing research with children and dementia patients. We conclude with suggestions about how to better incorporate the morally relevant aspects of these two groups in legislation and ethical guidelines. (shrink)

As guidelines for neonatal resuscitation evolve from a growing evidence base, clinicians must ensure that practice is closely aligned with the available evidence, based on methodologically sound and ethically conducted research. This paper reviews ethical, legal and risk-management issues arising during the design of a quality-assurance project to make video recordings of neonatal resuscitations after high-risk deliveries. The issues, which affect patients, researchers, staff and the hospital at large, include the following: 1) Informed consent for research involving (...) emergency procedures is often not possible, for lack of time to provide sufficient information. The mental capacity of the subject or parent may be compromised by the impending emergency, and freedom of choice is threatened by the time pressure to consent. 2) Video recording of the inevitable medical errors raises issues of whether participating staff may be identifiable and accountable, affecting their willingness to participate in such research. The approach to staff participation and identification is reviewed. 3) The use of video data for education threatens the privacy of research subjects. The ethics of maintaining privacy is balanced with the ethics of using the data to improve practice of resuscitation. 4) The research subjects (patients, or the staff whose performance is being monitored) must be defined. 5) There are legal and ethical aspects of management and ownership of data. 6) The role of the Human Research Ethics Committee in protecting the research subject and possibly the medicolegal interests of the hospital is discussed. This paper reviews the literature and discusses the issues. (shrink)

Mandatory reporting of various forms of abuse, from violence to corruption, is an attempt by the state to intervene in circumstances where there is a public or a private interest that ought to be protected. This intrusion of the state into what is often a very personal space, such as the home, is largely justified on the basis of the need to provide protection to prevent further harm, and in services to vulnerable populations such as children, the disabled or the (...) elderly. In some instances, researchers and other members of the study team may encounter reportable information requiring the consideration of mandatory reporting in the design, implementation and review of health research. This is not simple. There are complex and competing interests at play, particularly as there are differing approaches in law and ethical guidelines. This article aims to describe the mandatory reporting obligations in South African law, discussing the ways in which these provisions apply within the context of health research, and to propose some factors that could be used to determine whether it is ethical or not to report information. (shrink)

Lawyers’ practice in mediation is evolving with the widespread use of processes other than litigation which have been commonly referred to as the alternative dispute resolution (‘ADR’) options in Australia. Legal representation in mediation is part of the changing nature of legal work and is informed by the Australian Solicitors’ Conduct Rules (‘ASCR’) and practice guidelines. This article explores selected areas in the Law Council of Australia Guidelines for Lawyers in Mediation (‘LCA Guidelines’) and the (...) ways that these guidelines provide a normative framework for practice including the incorporation of ethical rules. The article argues that the guidelines should be revised to promote legal practice that includes emotion, which may encourage settlement by assisting in identifying core concerns. It draws on a variety of Australian empirical studies on emotion including lawyers’ practice and judges’ engagement with emotion in their role. It recommends revising the LCA Guidelines to better engage with emotions, and additionally, the opportunity for law school dispute resolution curriculum to incorporate engagement with emotion using the LCA Guidelines is raised. (shrink)

This article describes how ethical guidelines have been applied while interviewing psychiatric patients who were recovering from mental illness, especially from psychosis, to allow nurses to understand these patients’ experiences. Because psychiatric patients are vulnerable, their participation in research involves ethical dilemmas, such as voluntary consent, legal capacity to consent, freedom of choice, and sufficient knowledge and comprehension. The first part of this article describes the most important ethical guidelines concerning human research. These have (...) been published by different organizations, departments, committees and commissions for the purpose of protecting human rights and dignity whenever research participants are vulnerable persons or their capacity to consent is limited. At present, however, no special regulations govern research involving adults who have been diagnosed with a condition characterized by mental impairment. Furthermore, a relatively small body of research has documented the effects of various disorders (e.g. psychiatric conditions) on decision-making capacity per se. One basic moral and policy question is whether these individuals should ever be involved in research. The second part of this article concentrates on how the investigator made sure that participating patients had understood their role in this particular piece of nursing research. During the interviews the investigator noticed that some ethical dilemmas required further study and debate because of the lack of consensus on the proposed regulatory provisions on research involving institutionalized persons and their ability to make an informed and voluntary decision. (shrink)

Children and adults with dementia are vulnerable populations. Both groups are also relatively seldom included in biomedical research. However, including them in clinical trials is necessary, since both groups are in need of scientific innovation and new therapies. Their dependence and limited decision-making capacities increase their vulnerability, necessitating extra precautions when including them in clinical trials. Beside these similarities there are also many differences between the groups. The most obvious one is that children have an entire life ahead of them (...) and will become persons with certain ideals and preferences, while adults with dementia have lived a life in which they have expressed their ideals and preferences. Some of the available research guidelines recognize these differences, setting one list of specific requirements for groups of incapacitated adults and another list for children. Other documents, however, do not differentiate and only set requirements for subjects unable to consent as a single category of subjects. In this article we analyse to what extent the similarities and differences between the two groups are represented in legal documents and ethical guidelines. The article presents an overview and an analysis of the requirements for doing research with children and dementia patients. We conclude with suggestions about how to better incorporate the morally relevant aspects of these two groups in legislation and ethical guidelines. (shrink)

Stay up-to-date on the ethical and legal issues that affect your clinical and professional decisions! Ethical and Legal Issues for Mental Health Professionals: A Comprehensive Handbook of Principles and Standards details the ethical and legal issues that involve mental health professionals. Respected authorities with diverse backgrounds, expertise, and professional experience discuss contemporary theories emphasizing professional ethics, the ramifications of professional actions and decisions, and ethical standards on teaching, training, research, and publication. This informative (...) handbook provides invaluable up-to-date information and guidelines vital for every mental health professional. This book is a thorough examination of ethical behavior which can be used as a reference source for the professional or a textbook for graduate students. The handbook itself is divided into five sections. The first section is a detailed introduction of ethics, law, and licensing. The second section presents general ethical principles like competence, integrity, and respect for individual rights and dignity. The third section examines confidentiality, privilege, consent, and protection. The fourth section focuses on general ethical standards in practice, including sexual contact, multiple relationships, and bartering. The fifth section presents the ethical principles and standards in teaching, training, and research. Appendices include the Ethical Principles of Psychologists and Code of Conduct (American Psychological Association, 2002) and the Code of Ethics of the National Association of Social Workers (National Association of Social Workers, 1999). Ethical and Legal Issues for Mental Health Professionals: A Comprehensive Handbook of Principles and Standards discusses: the history of basic approaches and issues in ethical philosophy five fundamental areas in the process of developing competence the necessary ingredients for the mental health professional's practice of integrity aspirational versus enforceable standards of ethics concern for the welfare of others as a core ethical principle the notion of social responsibility in the ethics codes of psychologists and social workers ethical principles, statutes, and case law protecting privacy and confidentiality issues involving the therapist-patient privilege the "duty to protect" doctrine and relevant legal issues the dynamics of multiple relationships and boundary violations sexualized dual relationships between psychologists and patients possible conflict of interest in bartering for services the requirements and implementation of maintaining patient records to avoid ethical and legal problems possible ethical dilemmas involving referrals and fees much, much more This Handbook is an essential resource for all mental health professionals, including psychologists, psychiatrists, social workers, counselors, therapists, and graduate students in mental health and the related fields. Ethical and Legal Issues for Mental Health Professionals: A Comprehensive Handbook of Principles and Standards is the first of three volumes under this title. The following volumes will focus on forensic settings and special populations/special treatment modalities. (shrink)

In this Second Edition of her best-selling ethics paperback text, renowned paralegal educator Therese Cannon clearly addresses pertinent case law, rules changes, and other developments involving this important area of the law. Organized in 10 concise chapters, Ethics and Professional Responsibility for Legal Assistants, Second Edition, covers key concepts, including unauthorized practice of law; confidentiality; conflicts of interest; fees; trends in legal malpractice; discovery abuse and other advocacy issues; pro bono work; and more. to help your students grasp (...) the material, the pedagogy features: chapter reviews discussion questions cases for further analysis helpful appendices, including the Model Guidelines, standards, and codes for ABA, NALA, and NFPA. Ideal for use in your next ethics class, this flexible paperback can also easily be used to add an ethics component to your Introduction to Law course, student internship program, or other courses in your curriculum. This superb book is also accompanied by a valuable Instructor's Guide, which provides answers to every discussion question in the text and the specific page numbers to find answers to all review questions. It also contains sample syllabi and references to additional source materials to help you adapt this book to your course. (shrink)

Mental health professionals frequently work with family caregivers in the provision of psychotherapy services to individuals with serious mental illness. To address the need for ethical guidelines for working with family caregivers, an analysis of relevant ethical and legal issues is provided within the context of dynamic mental health care and legal systems. When working with family caregivers, practitioners utilize the American Psychological Association’s Ethics Code (2010), legal codes, and a complex decision-making plan; identify (...) and communicate ethical obligations to family caregivers; consider the unmet needs of this population; avoid harm resulting from multiple relationships; and balance ethical duties of beneficence and respect for autonomy. (shrink)

The number of legal and nonlegal ethical regulations in the biomedical field has increased tremendously, leaving present-day practitioners and researchers in a virtual crossfire of legislations and guidelines. Judging by the production and by the way these regulations are motivated and presented, they are held to be of great importance to ethical practice. This view is shared by many commentators. For instance, Commons and Baldwin write that, within the nursing profession, patient care can be performed unethically (...) or ethically depending on the professional standards the nurses have set for themselves. They also hold that such standards are set when nurses become aware of the ethical codes available. As nurses are often not familiar with the codes, they do not all conform to them. Commons and Baldwin argue that nurses' ability to deal with ethical dilemmas is effectively secured with education on guidelines, creating a “barrier” between personal and professional values. (shrink)

Not only in Lithuania, but also in the other countries, there is a growing tendency among young people to choose a legal education. Law is a professional sphere of immense depth and breadth and it is evident that during several years in a school of higher education, designed to grant legal knowledge and skills, it is impossible to convey all aspects and nuances of the law. Legal education in a higher school is only the beginning of a (...) lawyer’s education, while on the other hand it provides a unifying experience among practising lawyers. Consequently, university law schools preparing lawyers certainly provide an important contribution to the creation of a legal state, while providing skills, modelling values and shaping attitudes for future judges, state officials, prosecutors, attorneys and other persons responsible for the implementation of legal mechanisms necessary for the proper functioning of the state. (shrink)

The rise of neurotechnologies, especially in combination with artificial intelligence (AI)-based methods for brain data analytics, has given rise to concerns around the protection of mental privacy, mental integrity and cognitive liberty – often framed as “neurorights” in ethical, legal, and policy discussions. Several states are now looking at including neurorights into their constitutional legal frameworks, and international institutions and organizations, such as UNESCO and the Council of Europe, are taking an active interest in developing international policy (...) and governance guidelines on this issue. However, in many discussions of neurorights the philosophical assumptions, ethical frames of reference and legal interpretation are either not made explicit or conflict with each other. The aim of this multidisciplinary work is to provide conceptual, ethical, and legal foundations that allow for facilitating a common minimalist conceptual understanding of mental privacy, mental integrity, and cognitive liberty to facilitate scholarly, legal, and policy discussions. (shrink)

This paper reviews common advertising claims by egg freezing companies and evaluates the medical evidence behind those claims. It then surveys legal standards for truth in advertising, including FTC and FDA regulations and the First Amendment right to free speech. Professional standards for medical advertising, such as guidelines published by the American Society for Reproductive Medicine, the American College of Obstetricians and Gynecologists, and the American Medical Association, are also summarized. A number of claims, many of which relate (...) to the targeting of younger women for eOC, are found to breach legal and ethical standards for truth in advertising. The ethical implications of misleading advertising claims are also discussed, and the central narrative woven by OC ads — that egg freezing is empowering to women — is examined. The paper concludes that a more balanced approach to the risks and benefits of OC is necessary to truly respect women's autonomy. Moreover, justice requires us to look beyond a medical procedure accessible only to a minority of women in order to address inequities in the workplace. (shrink)

mHealth refers to the rapidly evolving use of mobile devices for health care treatment purposes, particularly the use of apps and texting as adjuncts to psychotherapy. Although there is currently an extensive literature on issues related to telehealth, to date little guidance has been developed to help professionals function ethically in the rapidly emerging area of mHealth. This article identifies the major ethical considerations that need attention and proposes several recommendations to address mHealth use as an adjunct to psychotherapy, (...) including the pressing need for relevant American Psychological Association practice guidelines to assist mental health providers in the ethical implementation of mHealth. (shrink)

Advances in medical technology and information have facilitated clinical practices that favourably affect the success rates of treatment for diseases. Regenerative medicine has been the focus of the recent medical agenda, to the extent of fundamentally changing treatment paradigms. Stem cell practices, their efficacy, and associated ethical concerns have been debated intensively in many countries. Stem cell research is carried out along with the treatment of patients. Thus, various groups affected by the practices inevitably participate in the discussions. In (...) addition to discussions based on avoiding any harm, providing benefits and respecting personal autonomy and justice, problems arise owing to the lack of legal regulations for stem cell research and practice. The dimensions of the problems vary in the developing countries, with widespread use of advanced medical technology but with lack of sources allocated for healthcare, dominance of paternalistic physician–patient relationships and failure to achieve a sufficient level of awareness of patients’ rights. This article discusses the current situation of stem cell practices within the context of regenerative medicine in Turkey and ethical concerns about some of the legal regulations, such as the Regulation for Umblical Cord Blood Banking and Guidelines for Non-embryonic Stem Cell Study for Non-clinical Purposes directing the research on this issue. (shrink)

Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents (ethics guidelines), overseeing bodies (research ethics committees) and formal procedures (informed consent). The process of institutionalizing distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure the trustworthiness of the research system. This article examines some limitations of (...) this approach. First, past atrocities cannot provide the necessary justification unless institutionalized distrust is a necessary or efficient means to prevent future ones – and there are several reasons to doubt this. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers – the very qualities that institutionalized distrust calls into question. Third, ethics guidelines cannot, as is sometimes assumed, educate or guide researchers in moral behaviour unless they already possess considerable capacity for moral judgment. Fourth, institutionalized distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences if their moral competence is allowed to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and are not obstructed from so doing. (shrink)

The World Health Organisation declared COVID-19 a global pandemic on 11th March 2020, recognising that the underlying SARS-CoV-2 has caused the greatest global crisis since World War II. In this chapter, we present a framework to evaluate whether and to what extent the use of digital systems that track and/or trace potentially infected individuals is not only legal but also ethical.

While the technologies that enable Artificial Intelligence (AI) continue to advance rapidly, there are increasing promises regarding AI’s beneficial outputs and concerns about the challenges of human–computer interaction in healthcare. To address these concerns, institutions have increasingly resorted to publishing AI guidelines for healthcare, aiming to align AI with ethical practices. However, guidelines as a form of written language can be analyzed to recognize the reciprocal links between its textual communication and underlying societal ideas. From this perspective, (...) we conducted a discourse analysis to understand how these guidelines construct, articulate, and frame ethics for AI in healthcare. We included eight guidelines and identified three prevalent and interwoven discourses: (1) AI is unavoidable and desirable; (2) AI needs to be guided with (some forms of) principles (3) trust in AI is instrumental and primary. These discourses signal an over-spillage of technical ideals to AI ethics, such as over-optimism and resulting hyper-criticism. This research provides insights into the underlying ideas present in AI guidelines and how guidelines influence the practice and alignment of AI with ethical, legal, and societal values expected to shape AI in healthcare. (shrink)

BackgroundClinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.FindingsIn Zimbabwe the parental informed consent document for children participating (...) in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.ConclusionThe challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers. (shrink)

American politicians often claim a moral imperative to ensure quality affordable health care to all Americans, but as Donald Munro points out, leaders rarely outline the content of this moral standard and whether it can be applied to all societies. Munro turns to recent research in cognitive science and evolutionary psychology to identify the ethical principles that help humans succeed as individuals and as cooperative groups. He then applies these principles to two practical problems affecting contemporary China: the moral (...) complexity of responding to global warming and the lack of consistency within the Chinese legal system. (shrink)

In early 2017, Nevada amended its Uniform Determination of Death Act, in order to clarify the neurologic criteria for the determination of death. The amendments stipulate that a determination of death is a clinical decision that does not require familial consent and that the appropriate standard for determining neurologic death is the American Academy of Neurology’s guidelines. Once a physician makes such a determination of death, the Nevada amendments require the withdrawal of life-sustaining treatment within twenty-four hours with limited (...) exceptions. Neurologists have generally supported Nevada’s amendments for clarifying the diagnostic standard and limiting the ability of family members to challenge it. However, it is more appropriate to view the Nevada amendments with concern. Even though the primary purpose of the UDDA is to ensure that all functions of a person’s entire brain have ceased, the AAN guidelines do not accurately assess this. In addition, by characterizing the determination of death as solely a clinical decision, the Nevada legislature has improperly ignored the doctrine of informed consent, as well as the beliefs of particular faiths and cultures that reject brain death. Rather than resolving controversies regarding brain death determinations, the Nevada amendments may instead instigate numerous constitutional challenges. (shrink)

The bioethical issues confronting the Jewish chaplain in a long-term care facility are critical, particularly as life-support systems become more sophisticated and advance directives become more commonplace. May an elderly competent patient refuse CPR in advance if it is perceived as a life-prolonging measure? May a physician withhold CPR or artificial nutrition and hydration (which some view as basic care and not as therapeutic intervention) from terminal patients with irreversible illnesses? In this study of Jewish ethics relating to these issues, (...) the author carefully examines the moral implications and legal precedents in the literature. Jewish ethics, affirming a 'sanctity of life' position, suggest that while an elderly person may direct in advance that CPR not be administered in most instances, in the absence of a DNR (Do Not Resuscitate) order, CPR must be performed. In reference to 'tube-feeding', while there is some debate about whether elderly patients may refuse the initiation of 'tube-feeding', there is a consensus that once initiated, it may not be withdrawn. (shrink)

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for (...) the database and its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics. (shrink)

Lawyers’ practice in mediation is evolving with the widespread use of processes other than litigation which have been commonly referred to as the alternative dispute resolution (‘ADR’) options in Australia. Legal representation in mediation is part of the changing nature of legal work and is informed by the Australian Solicitors’ Conduct Rules (‘ASCR’) and practice guidelines. This article explores selected areas in the Law Council of Australia Guidelines for Lawyers in Mediation (‘LCA Guidelines’) and the (...) ways that these guidelines provide a normative framework for practice including the incorporation of ethical rules. The article argues that the guidelines should be revised to promote legal practice that includes emotion, which may encourage settlement by assisting in identifying core concerns. It draws on a variety of Australian empirical studies on emotion including lawyers’ practice and judges’ engagement with emotion in their role. It recommends revising the LCA Guidelines to better engage with emotions, and additionally, the opportunity for law school dispute resolution curriculum to incorporate engagement with emotion using the LCA Guidelines is raised. (shrink)

Advances in medical technology and information have facilitated clinical practices that favourably affect the success rates of treatment for diseases. Regenerative medicine has been the focus of the recent medical agenda, to the extent of fundamentally changing treatment paradigms. Stem cell practices, their efficacy, and associated ethical concerns have been debated intensively in many countries. Stem cell research is carried out along with the treatment of patients. Thus, various groups affected by the practices inevitably participate in the discussions. In (...) addition to discussions based on avoiding any harm, providing benefits and respecting personal autonomy and justice, problems arise owing to the lack of legal regulations for stem cell research and practice. The dimensions of the problems vary in the developing countries, with widespread use of advanced medical technology but with lack of sources allocated for healthcare, dominance of paternalistic physician–patient relationships and failure to achieve a sufficient level of awareness of patients’ rights. This article discusses the current situation of stem cell practices within the context of regenerative medicine in Turkey and ethical concerns about some of the legal regulations, such as the Regulation for Umblical Cord Blood Banking and Guidelines for Non-embryonic Stem Cell Study for Non-clinical Purposes directing the research on this issue. (shrink)

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)

Respect for confidentiality is firmly established in codes of ethics and law. Medical care and the patients' trust depend on the ability of the doctors to maintain confidentiality. Without a guarantee of confidentiality, many patients would want to avoid seeking medical assistance The principle of confidentiality, however, is not absolute and may be overridden by public interests. On some occasions (birth, death, infectious disease) there is a legal obligation on the part of the doctor to disclose but only to (...) the appropriate authorities. Permissible disclosure can be granted by the patients' consent, for example, for the purpose of insurance they may wish to take out. Moreover, there are some ambivalent situations (such as criminal acts, or notification of sexual partner in case of a patient with AIDS) for which Greek law does not include relevant provisions, and the Codes of Medical Ethics do not offer clear guidelines. Therefore, the Greek doctor is called to estimate the situation and assume full responsibility for his decision. Finally, new considerations have arisen in the context of the recent advances in the field of telemedicine and electronic archiving. The paper discusses the current situation and legislation in Greece. (shrink)

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for (...) the database and its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics. (shrink)

International research collaborations engage multiple countries, researchers, and universities. This enhances the magnitude of contextual challenges, including legal and ethical dimensions across various jurisdictions, that must be bridged in qualitative research regardless of discipline, also in the construction of informed consents. From a Scandinavian perspective, this discussion paper explores challenges pertaining to the construction of informed consents related to EU data protection legislation, to which research institutions are subject when processing data related to EU residents. Next, it discusses (...) challenges related to different traditions in terms of handling informed consent and research participants’ integrity, including the possibilities to waive anonymity in research. In international, multidisciplinary studies where researchers also operate in relatively ‘unknown territory’, it is especially important to be aware of and reflect on (inter)national possibilities and limitations related to laws, ethics, and culture/traditions in societies and within the academic fields. The variations in laws, ethical guidelines, and traditions in different countries demand that researchers are up to date with laws and ethical guidelines in the studied countries. Their practical implementation in the countries at stake in international, collaborative research endeavours are important, especially since such regulations and guidelines are far from static and change over time. The implementation of good ethical research practice requires democratic, reflexive, and responsive processes in all phases of research. Especially the preparation phase functions as a period to increase and ensure the knowledge and legal/ethical competences of the entire research team to meet the demands in the countries at stake. (shrink)

Differences in guidance from various organisations is preventing uniform standards of practiceThe emphasis in medical law and ethics on protecting the patient’s right to choose is at an all time high. Apart from circumscribed situations, for instance where the Mental Health Act 19831 is applicable, the only justification for medically treating an adult patient against his or her wishes is on the basis of common law, using the principle of best interests, and only when he or she lacks capacity to (...) refuse treatment. As a result, it is important that clinicians should be able to assess capacity to refuse treatment. Given that judgements of incapacity involve deciding that a person does not have the ability to refuse treatment, a great deal of care needs to go into the assessment and characterisation of incapacity.There is divergence between the characterisation of capacity that is used by the courts and that which is recommended by the British Medical Association . The BMA usefully expands on the first element of capacity as set out in the standard legal definition of capacity in the Re C judgment2 but ignores the other two elements. By doing this, the BMA makes it unclear whether it is rejecting these as relevant to capacity; it also misses the opportunity to expand on these elements in a clinically useful way.We will begin with a description of the BMA’s advice3 and the standard English legal definition of capacity.2,4 Then we will show that there are important discrepancies between these two sources of advice. We think that the BMA ought to clarify its position on capacity in order to safeguard the interests of physicians, healthcare workers, and patients.THE RE C TESTMr C was a patient in a psychiatric secure hospital who had chronic paranoid schizophrenia with …. (shrink)

After years of debate over the importance of ethical conduct in organizations, the federal government has decided to institutionalize ethics as a buffer to prevent legal violations in organizations. The key requirements of the Federal Sentencing Guidelines (FSG) are outlined, and suggested actions managers should adopt to improve ethical compliance are presented. An effective compliance program is more a process and commitment than a specific blueprint for conduct. The organization has the responsibility to create an organizational (...) climate to reduce misconduct. The adoption of a FSG compliance program has the potential to substantially lessen organizational penalties if there is due diligence to prevent misconduct. Federal courts determine the effectiveness of an FSG program after a violation occurs. (shrink)

This paper does not attempt to lay out the arguments relating to male circumcision for non-medical reasons. Rather, the aim is to focus more on the process and the problems of a professional body ) attempting to produce any consensus guidelines for its members on an issue which clearly polarises doctors as much as it divides society as a whole. The legal and ethical considerations of male circumcision are inevitably touched upon here but are not the central (...) issue. In 2003, the BMA published professional guidance on this subject. Some thought this a pointless exercise; others saw it as an initiative which simply failed to go far enough. Reservations centred on the fact that the BMA’s guidance—like that of the statutory body, the General Medical Council—explored the issues without either firmly rejecting or accepting non-therapeutic male circumcision. Was it then a fruitless project or a brave start to grasping the nettle? (shrink)

Guidelines advise that x-rays do not contribute to the clinical management of simple nasal fractures. However, in cases of simple nasal fracture secondary to assault, a facial x-ray may provide additional legal evidence should the victim wish to press charges, though there is no published guidance. We examine the ethical and medico-legal issues surrounding this controversial area.

The theme of the 10th Annual Research Ethics Conference organized by the Uganda National Council for Science and Technology (2018) was “Evolution of Research Ethics in Uganda and the Region: Past, Present and Future”. We were asked to address the topic: “The History of CIOMS and the recent changes in the international ethics guidelines: implications for local research”. The thrust of the conference was to track progress in ensuring ethical conduct of research, highlight challenges encountered, and to propose (...) strategies for effective and meaningful implementation of international ethical guidelines in local contexts. Consequently, the purpose of this paper is to comment on the implications of the history of CIOMS ethical guidelines and suggest strategies for their effective and meaningful implementation in the East African region, and perhaps the whole of Sub‐Saharan Africa. Inferring from the ‘evolutionary’, ‘flexible’, and ‘general’ nature of the CIOMS guidelines, we proposed a six‐point strategy for ensuring their effective and meaningful implementation in local contexts. This strategy is in the form of obligations for local research regulators and researchers, the fulfillment of which will go a long way towards their smooth and meaningful implementation in local contexts. These obligations are: ensuring evidence‐based adaptation of each individual guideline; ensuring sufficiently judicious and motivated RECs membership; acting proactively to ensure harmony between bioethics and local legal regimes; cultivating a ‘bioethics culture’ among the public; moving towards regional bioethics governance; and playing an active and meaningful role in future revisions of these guidelines. (shrink)

Background: Clinical trials involving children previously considered unethical are now considered a necessity because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.DiscussionThe Zimbabwean parental informed consent document for children (...) participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in interpreting and obtaining informed consent for orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation if the Zimbabwean courts had not legally appointed them. The situation contrasted with general clinical practice where legal papers where not required for providing consent for surgical procedures for example.SummaryExperiences gained from this clinical trial revealed that while there may be internationally established guidelines governing the process of obtaining informed consent for children participating in research, there may be need to be cognizant of the culture within which the research is taking place. This may call for the development of an ethico-legal framework that governs research-involving children in Zimbabwe that would facilitate their participation in clinical research, while ensuring that they are protected from exploitation. The Medical Research Council of Zimbabwe has since started developing that framework in a process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers. (shrink)