BackgroundHIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania.MethodsA mobile community-based sexual and reproductive health service for women working as informal food vendors or in (...) traditional and modern bars, restaurants, hotels and guesthouses has been established in 10 city wards. Wards were divided into geographical clusters and community representatives elected at cluster and ward level. A city-level Community Advisory Committee (CAC) with representatives from each ward has been established. Workshops and community meetings at ward and city-level have explored project-related concerns using tools adapted from participatory learning and action techniques e.g. chapati diagrams, pair-wise ranking. Secondary stakeholders representing local public-sector and non-governmental health and social care providers have formed a trial Stakeholders' Advisory Group (SAG), which includes two CAC representatives.ResultsKey recommendations from participatory community workshops, CAC and SAG meetings conducted in the first year of the trial relate to the quality and range of clinic services provided at study clinics as well as broader standard of care issues. Recommendations have included streamlining clinic services to reduce waiting times, expanding services to include the children and spouses of participants and providing care for common local conditions such as malaria. Participants, community representatives and stakeholders felt there was an ethical obligation to ensure effective access to antiretroviral drugs and to provide supportive community-based care for women identified as HIV positive during the trial. This obligation includes ensuring sustainable, post-trial access to these services. Post-trial access to an effective vaginal microbicide was also felt to be a moral imperative.ConclusionParticipatory methodologies enabled effective partnerships between researchers, participant representatives and community stakeholders to be developed and facilitated local dialogue and consensus on what constitutes a locally-appropriate standard of care in the context of a vaginal microbicide trial in this setting.Trial registrationCurrent Controlled Trials ISRCTN64716212. (shrink)

In this essay, I examine the relationship between lawsuits for medical malpractice and the legal standard of care. I suggest that there is an insidious, dynamic relationship between physicians' reactions to the recent increase in malpractice litigation and an artificial elevation of the legal standard of care. Since, that is, the legal standard for proper medical care is based upon the community standard of care rather than the reasonable person standard, to the extent that overtreatment (...) or “defensive” medicine becomes widespread as a reaction to malpractice litigation, the legal standard becomes elevated as well. Thus, it will increasingly be the case that unless a physician practices defensive medicine, and hence practices unreasonably, she risks being found liable for medical malpractice. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of molnupiravir through the large-scale Platform Adaptive trial of Novel antiviRals for eArly treatMent of COVID-19 In the Community randomised control trial. By analysing the ways in which the authorisation and clinical use of molnupiravir complicate standard approaches to clinical equipoise, standard of care and participant consent in the PANORAMIC randomised control trial, we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

In a pluralistic society, the “best interests” standard is an inadequate criterion for determining what level of medical care to provide incompetent patients. Instead, the standard of care should be derived from the deliberations of particular communities. A “community‐federated” plan would enhance individual choice and diminish family and physician uncertainty.

In this essay, we suggest practical ways to shift the framing of crisis standards of care toward disability justice. We elaborate on the vision statement provided in the 2010 Institute of Medicine (National Academy of Medicine) “Summary of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations,” which emphasizes fairness; equitable processes; community and provider engagement, education, and communication; and the rule of law. We argue that interpreting these elements through disability justice (...) entails a commitment to both distributive and recognitive justice. The disability rights movement's demand “Nothing about us, without us” requires substantive inclusion of disabled people in decision‐making related to their interests, including in crisis planning before, during, and after a pandemic like Covid‐19. (shrink)

Public health emergencies invariably entail difficult decisions among medical and emergency first responders about how to allocate essential, scarce resources. To the extent that these critical choices can profoundly impact community and individual health outcomes, achieving consistency in how these decisions are executed is valuable. Since the terrorist attacks on September 11, 2001, however, public and private sector allocation plans and decisions have followed uncertain paths. Lacking empirical evidence and national input, various entities and actors have proffered multifarious approaches (...) on how best to allocate scarce resources to protect the public's health. Though beneficial in some jurisdictions, these approaches fail to clarify how the type and amount of care delivered in major emergencies might be curtailed. This is due, in part, to a lack of meaningful guidance on shifting standards of care in major emergencies. (shrink)

Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of (...) class='Hi'>care upwards for research participants and their communities is an ethical obligation of those in resource-rich countries who sponsor and implement research in poorer ones. (shrink)

In this article we will be arguing in favour of legislating to protect doctors who bring about the deaths of PVS patients, regardless of whether the death is through passive means or active means. We will first discuss the ethical dilemmas doctors and lawmakers faced in the more famous PVS cases arising in the US and UK, before exploring what the law should be regarding such patients, particularly in Australia. We will continue by arguing in favour of allowing euthanasia in (...) the interests of PVS patients, their families, and finally the wider community, before concluding with some suggestions for how these ethical arguments could be transformed into a set of guidelines for medical practice in this area. (shrink)

ABSTRACT:It may be too late to avoid the climate crisis, likely to be humanity's most expensive, widespread, and enduring catastrophe. This is a qualitatively different kind of catastrophe, in which increased costs, decreased revenue, and no possibility of bailout force communities to harshly cut budgets, especially in health care. Little is known about making such brutal cuts fair or efficient, nor how to help the public accept them. The crisis presents an opportunity for bioethicists to play a crucial role, (...) but one for which traditional approaches are inherently inadequate. Although often dismissed as heartless, Garrett Hardin's "lifeboat ethics" started a conversation about making ethical choices in global disasters—where all options are painful and unacceptable—and may provide guidance. Bioethics during the climate crisis must focus on communities rather than individuals and help survivors grieve the terrible consequences. Because today's choices will affect many generations, with the burdens falling most heavily on poor communities, we have to construct a radical bioethics to help tomorrow's health care become green, efficient, and fair. (shrink)

Person‐centred care, with its central focus on the patient in partnership with healthcare practitioners, is considered to be the contemporary gold standard of care. This type of care implies effective communication from and by both the patient and the healthcare practitioner. This is often problematic in the case of the paediatric population, because of the many communicative challenges that may arise due to the child's developmental level, illness and distress, linguistic competency and disabilities. The principle of universal (...) design put forth in conventions and legislation means that the design of products and services should be usable by all people, to the greatest extent possible. Augmentative and alternative communication encompasses strategies, for example pictures and apps, that are typically used with people with communication disability. In this position paper, we argue for the universal use of augmentative and alternative communication to support person‐centred communication and care for children, regardless of age or potential disability. Clinical examples are shared from three different paediatric care settings where pictorial supports were applied universally. Interviews were conducted with children and adolescents (with and without disabilities), parents and healthcare practitioners, and the principles of universal design were used as a framework to demonstrate how person‐centred communication is supported in paediatric care. (shrink)

Background The COVID-19 pandemic has forced rapid and widespread change to standards of patient care and nursing practice, inevitably leading to unprecedented shifts in the moral conditions of nursing work. Less is known about how these challenges have affected nurses’ capacity to meet their ethical responsibilities and what has helped to sustain their efforts to continue to care. Research objectives 1) To explore nurses’ experiences of striving to fulfill their ethical responsibilities of care during the COVID-19 (...) pandemic and 2) to explore what has fostered nurses’ capacity to fulfill these responsibilities. Research Design A generic qualitative approach was used incorporating concepts coming from fundamental features of care. Participants Twenty-four Canadian Registered Nurses from a variety of practice settings were interviewed. Ethical Considerations After receiving ethics approval, signed informed consent was obtained before participants were interviewed. Findings Four themes were identified. 1) Challenges providing good care in response to sudden changes in practice. 2) Tensions in juggling the responsibility to prevent COVID-19 infections with other competing moral responsibilities. 3) Supports to foster nurses’ capacity to meet their caring responsibilities. 4) The preservation of nurses’ moral identity through expressions of gratitude and health improvement. Discussion Infection control measures and priorities set in response to the pandemic made at distant population and organizational levels impacted nurses who continued to try to meet the ideals of care in close proximity to patients and their families. Despite the challenges that nurses encountered, the care they received themselves enabled them to continue to care for others. Nurses benefited most from the moral communities they had with their colleagues and occasionally nurse leaders, especially when they were supported in a face-to-face manner. Conclusion: Moral community can only be sustained if nurses are afforded the working conditions that make it possible for them to support each other. (shrink)

The ethics of care and Confucian care ethics are both characterised by relations-based moral reasoning and decision-making. Acknowledging this similarity, this article compares and contrasts these two ethics, highlighting Western and Eastern moral concerns. One of the main differences between the two ethical theories is their different focus on vulnerability and inequality as factors in achieving equality in the ethics of care; another is the reciprocity, rather than equality, dimension in Confucian ethics. Both theories enshrine the view (...) that the characteristics of care offer scope for developing the capacity for judgement. However, a fundamental difference is revealed when considering that Confucian ethics emphasises care as a virtue in the cultivation of one's moral agency, whereas the ethics of care sees care as both a disposition and practice, and the caring relationship to be a primary means of moral evaluation. For the care ethicists, the practice of care embraces communicative morality, within fluid, dynamic interpersonal relationships - in sharp contrast to Confucian care practices, which are constructed within formal standards and fixed, role-based relationships. (shrink)

In this essay the ethical issues related to the ‘standard of care’ are discussed together with the implications for the treatment of the control group in transnational clinical trials. It is argued that the human right to health and the duty of justice formulate the moral basis on which this case should be debated.

The high technology and the costs involved in critical care disclose the implausibility of applying the American standard version of bioethics in the developing world. The American standard version of bioethics was framed during the rapid secularization of the American culture, the emergence of a new image for the medical profession, the development of high technology medicine, an ever greater demand in resources, and a shift of focus from families and communities to individuals. This all brought with it a (...) particular ideology of health care which promised Americans (1) the best of care, (2) equal care, and (3) physician/patient choice, without (4) runaway costs. This essay argues that this moral project is impossible in practice. This impossibility is especially salient in developing countries. In addition to the fact that it is financially impossible to provide all in the developing world with the standard of care accepted by law, policy, and convention in developed countries, different moral perspectives with different orderings of values will seem more or less plausible in different cultures. Indeed, such an approach would be harmful. A concrete bioethics applicable across the world does not appear possible. (shrink)

Life-saving healthcare technology evolves over time, raising new ethical questions. What was once experimental becomes standard care, and what was once unthinkable becomes the next frontier. Ethici...

This article investigates the construction of laboratory animal science as a version of “good science.” In the 1950s, a transnational community of scientists initiated large-scale standardization of animals for biomedicine, which included the standardization of care of laboratory animals as well as the development of guidelines and regulations on laboratory animal use. The article traces these developments and investigates how the standardization work took part in enacting laboratory animals as compound objects of care—and laboratory animal science as (...) being an intrinsically ethical practice—as good science. Importantly, the analysis shows how technological development is inextricably accompanied by ethics, as it is the result of complex social organization involving multiple ethical commitments. By investigating the development of laboratory animal science historically, it is possible to tease out how values, norms, and standards have been made integral to specific practices in the first place and how they have developed and been sustained over time. The article contributes to current concerns in science and technology studies about how life is made, valued, and ordered at the intersection of science and society and in biomedicine, including how certain values and positions of valuation come to count as authoritative and others not. (shrink)

The pandemic creates unprecedented challenges to society and to health care systems around the world. Like all crises, these provide a unique opportunity to rethink the fundamental limiting assumptions and institutional inertia of our established systems. These inertial assumptions have obscured deeply rooted problems in health care and deflected attempts to address them. As hospitals begin to welcome all patients back, they should resist the temptation to go back to business as usual. Instead, they should retain the more (...) deliberative, explicit, and transparent ways of thinking that have informed the development of crisis standards of care. The key lesson to be learned from those exercises in rational deliberation is that justice must be the ethical foundation of all standards of care. Justice demands that hospitals take a safety‐net approach to providing services that prioritizes the most vulnerable segments of society, continue to expand telemedicine in ways that improve access without exacerbating disparities, invest in community‐based care, and fully staff hospitals and clinics on nights and weekends. (shrink)

BackgroundThe prevention of HIV remains an ongoing global concern. The safety and welfare of participants in these trials are imperative. Research Ethics Committees (RECs) review all reports of serious adverse events, adverse events and social harms arising in the course of such trials. There is little guidance for RECs on how to respond appropriately to social harm reports.MethodologyThis paper reviews the literature on social harms in HIV prevention trials and offers suggestions for RECs on how to respond appropriately to such (...) reports.ResultsThis review confirms that social harms are reported in clinical trials in South Africa and that specific guidance on managing these is minimal.ConclusionSocial harms in South African HIV prevention trials need to be more systematically researched so that ethical evidence‐based prevention, care and treatment strategies can be developed. This review makes specific suggestions for further research on social harms that can inform further consultations to develop more specific guidance for stakeholders on appropriate responses to such social harms. Such future work may also inform future versions of relevant local and international ethics guidance on HIV prevention trials. (shrink)

It is argued by Lie et al in the current issue of the Journal of Medical Ethics that an international consensus opinion has formed on the issue of standards of care in clinical trials undertaken in developing countries. This opinion, so they argue, rejects the Declaration of Helsinki’s traditional view on this matter. They propose furthermore that the Declaration of Helsinki has lost its moral authority in the controversy in research ethics. Although the latter conclusion is supported by (...) this author, it will be demonstrated in this paper that there is not such a thing as an international consensus opinion, and that the authorities used by Lie et al as evidence in support of their claim should not be relied upon as authorities or final arbiters in this debate. Furthermore, it will be shown that arguments advanced substantively to show that lower standards of care are ethically acceptable in the developing world, conflate scientific with economic reasons, and ultimately fail to bolster the case they are designed to support. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind (...) the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)

Background: Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and (...) benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods: An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results: Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Conclusion: Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This has implications for the informed consent and consequent safety of Canadian medical tourists. (shrink)

Law wrangles with setting and applying standards for the practice of medicine in many different arenas. One of the most prominent is medical malpractice litigation in which the trial process examines a physician's performance and measures it against the standard of care. The profession's prevailing custom, with some substantial tolerance for “respectable minority” views, has been the gold standard for scrutinizing physician practice and treatment decisions in the malpractice context. Using the profession's custom as the measure against which (...) a physician's performance is judged defers to the expertise of medicine. Deference to the medical profession is attractive as a tool for reining in law. Reliance on customary practice is criticized, however, for driving physicians to the relative safety of the middle of the herd. Creating such a strong incentive for compliance with customary practice can dampen medical innovation and the diffusion of new clinical knowledge. The safety of the herd can also deprive individual patients of the best care in their particular circumstances.Several current trends are strengthening claims that professional practice patterns are an inappropriate tool for distinguishing between high‐quality and substandard care. In particular, advocacy for evidence‐based medicine aggressively asserts that the traditional way of making medical treatment decisions is largely untethered from scientific method or data, rendering professional judgment, even in the aggregate, suspect. (shrink)

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. (...) I examine two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private‐for‐profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private‐for‐profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice‐based account of standard of care. (shrink)

The law has therefore had two conflicting impacts on medical ethics: the positive effect of eroding paternalism and replacing it with a patient-centered ethic; and the negative effect of encouraging physicians to be more concerned with avoiding litigation than doing the "right" thing.

The legal environment -- Regulation of nursing practice -- Nurses in legal actions -- Standards of care -- Defenses to negligence or malpractice -- Prevention of malpractice -- Nurses as witnesses -- Professional liability insurance -- Accepting or refusing an assignment/patient abandonment -- Delegation to unlicensed assistive personnel -- Patients' rights and responsibilities -- Confidential communication -- Competency and guardianship -- Informed consent -- Refusal of treatment -- Pain control -- Patient teaching and health counseling -- Medication administration (...) -- Clients with AIDS and HIV testing -- Abusive situations -- Reproductive services -- Restraints -- Emergency psychiatric admissions -- Organ and tissue donation and transplantation -- Discharge against medical advice -- The medical record and documentation standards -- Electronic health information and communications -- Interdependent nursing functions: verbal orders and telenursing -- Event reporting and compliance -- Quality and safety in nursing practice -- Forensic issues -- Employer and employee rights -- Contracts -- Corporate liability -- Employment contracts and unionization -- Employment status liability -- Staffing issues and floating -- Americans with Disabilities Act -- Employees with AIDS/HIV infection and exposure to bloodborne pathogens -- Impaired nurses -- Sexual harassment in the workplace -- Violence in the workplace -- Intentional torts -- Environmental health and safety -- Ethical decision making -- Professional boundaries and patient relationships -- Moral courage and patient advocacy -- Social media and online professionalism -- Reporting illegal, unethical, or unsafe conduct -- Maternal versus fetal rights -- Futility of care -- Advance directives and end-of-life decisions -- Assisted suicide. (shrink)

Professor Hall is to be congratulated on his thoughtful analysis of an issue that, as he rightly suggests, “is one of the most important issues that will confront health care tort law throughout the remainder of the century.”’ He argues that malpractice law currently can accommodate considerable latitude both for a conservative streamlining of medical practices in general and for a cost-sensitivity in individual treatment decisions. And he further argues that existing tort principles, such as the locality rule, can (...) comfortably be stretched to embrace still greater room for economics in the medical standard of care. I quite agree.Unfortunately, Hall's arguments do not go nearly far enough, for they are framed around a seriously oversimplified picture of the economic changes that are revolutionizing medicine in the United States. He envisions a fairly uniform, global set of resource constraints that generally pressure physicians to conserve on care—pressures that tort law can then encompass equally globally as it accepts more cost-efficient standards of care. However, neither the changing economics of medicine nor the resulting jurisprudential challenges are anywhere near this generalized. (shrink)

Although telepsychiatry consultations have been tried and tested for several years, at least in relatively limited numbers and settings, the current COVID-19 pandemic has caused an exponential increase in their application. Even as lockdown restrictions were lifted and a return to face-to-face consultations was possible, many practitioners and patients decided to uphold teleconsultations for some or a large part of their interactions. This was mostly driven by the exceptional circumstances of the pandemic, as ongoing safety concerns, the need for PPE (...) use and uncertainty around whether face-to-face meetings could go ahead continued to form barriers to usual care practices. Frittgen and Haltaufderheide aptly hypothesise that extensive changes in online communication behaviour will also impact ethical aspects of the therapeutic relationship.1 After considering how the use of technology may affect the therapeutic relationship in video-based consultations, they provide an ethical analysis of this impact along four dimensions: respect for autonomy, lucidity, fidelity and humanity.1 In this commentary I will have a look at the difference between crisis standards of care and usual care, the need to consider specific patient needs in teleconsultation use, the importance of justice understood as equity and access to technology, and a major challenge ahead. Throughout history, crisis situations have often been major catalysts of technological and other progress. Under challenging …. (shrink)

Background: Ethical reflections over care practices are important. In order to be able to perform such reflections, healthcare professionals must learn to think critically about their care practice. Aim: The aim of this study was to evaluate whether an introduction to and practice in ethical reflections in community healthcare have consequences for the healthcare personnel’s practice. Research design: A mixed-methods design was adopted with five focus group interviews and an electronic questionnaire based on results from the interviews. (...) Participants and research context: A total of 29 community healthcare personnel with experience in ethical reflections participated in the interviews. The electronic questionnaire was sent via email to 2382 employees in community healthcare services in 13 municipalities in southern part of Norway. Ethical considerations: The study was guided by the intentions of the Declaration of Helsinki and ethical standard principles and approved by the Norwegian Social Science Data Services. Results: An introduction to and practice in performing ethical reflections brought about an ethical awareness with understanding and respect for both colleagues and patients. The leader had a key role. Lack of time was a hindrance for ethical reflections. Three factors could predict meaningful ethical reflections: higher age of personnel, higher percentage of employment and longer experience with ethical reflections. Discussion: According to other studies, ethical reflections may enhance moral development of colleagues and their actions as advocates for the patients. A deepened ethical awareness, professional competency and sufficient time resources will guarantee proper caregiving. Conclusion: A supportive environment that prioritizes participation in reflection meetings is decisive. To practice ethical reflections will provide better care for patients. A challenge for the community healthcare system is to offer adequate positions that provide the personnel an opportunity to be involved as caregivers and to participate in ethical reflections. (shrink)

In this paper, we extend Michel Foucault’s final works on the ‘care of the self’ to an empirical examination of research practice in community-based research (CBR). We use Foucault’s ‘morality of behaviors’ to analyze interview data from a national sample of Canadian CBR practitioners working with communities affected by HIV. Despite claims in the literature that ethics review is overly burdensome for non-traditional forms of research, our findings suggest that many researchers using CBR have an ambivalent but ultimately (...) productive relationship with institutional research ethics review requirements. They understand and use prescribed codes, but adapt them in practice to account for the needs of participating community members, members of their research teams and the larger communities with whom they work. Complying with ethics protocols was seen as only the beginning, a minimum standard; our research suggests that the real ethical work happens in the field, where CBR practitioners encounter community members in diverse public roles and must forge ethical consensus across communities. CBR represents an ethical terrain in which practitioners challenge themselves to work differently, and as a result they care for themselves—and others—in ways that often resist the propensity for domination through public health research.‘…there are different ways to “conduct oneself” morally, different ways for the acting individual to operate, not just as an agent, but as an ethical subject of action.’ (Foucault, 1985: 26). (shrink)

Background: Recently, a singular survey titled “Measure of Moral Distress—Healthcare Professionals,” which addresses shortcomings of previous instruments, has been validated. Aim: To determine how moral distress affects nurses and physicians differently across the various wards of a community hospital. Participant and research context: We distributed a self-administered, validated survey titled “Measure of Moral Distress—Healthcare Professionals” to all nurses and physicians in the medical/surgical ward, telemetry ward, intensive care units, and emergency rooms of a community hospital. Findings: A (...) total of 101 surveys were included in the study. The mean Measure of Moral Distress—Healthcare Professionals score for all respondents was 143.0 (standard deviation = 79.8). The mean Measure of Moral Distress—Healthcare Professionals score was 1.75 greater for nurses than for physicians (92.5 vs 161.5, p <.001), and nurses were 2.52 times more likely to consider leaving their position due to moral distress (68% vs 27%). The mean Measure of Moral Distress—Healthcare Professionals score for moral distress was least prevalent in the medical/surgical ward (92.5, SD = 38.2) and highest in the telemetry ward (197.7, SD = 83.6). The intensive care unit ward had a mean Measure of Moral Distress—Healthcare Professionals score mildly greater than the emergency room. Ethical considerations: No participant identifying information or information connecting a survey response to an individual was collected. This study was approved by the Raritan Bay Medical Center’s Institutional Review Board. Discussion: This study provides insight into the level of moral distress in the community hospital setting. Telemetry nurses experience significantly more than nurses in other wards. Telemetry nurses typically manage patients sicker than medical/surgical wards, however do not have the resources of the critical care units. This scenario presents challenges for telemetry nurses and may explain their elevated moral distress. Conclusion: In community hospitals, telemetry nurses experience a considerably greater amount of moral distress compared to their colleagues in other wards. As measured by the Measure of Moral Distress—Healthcare Professionals questionnaire, moral distress continues to be higher among nurses compared to physicians. (shrink)

Protest is often theorized in terms of the relationship between the protest and its audience—lawmakers, the public, and the media. Refreshingly, José Medina’s The Epistemology of Protest balances this standard approach with consideration of the internal life of protest. Analyzing the complexity within what is often seen as a monolithic spectacle, Medina demonstrates that this internal perspective is important not only for understanding the experience, nature, and power of protest, but also for understanding how protests are—and ought to be—taken up (...) by society. After reviewing Medina’s analysis, I offer three comments. The first concerns the verbal-content-independence thesis, which is a crucial link in Medina’s analysis of the communicative complexity of protest. The second concerns uncivil protest and attention—while uncivil protest may be an efficient way to gather the “raw materials” for epistemic activism, the work of waking people from their epistemic and political slumber, as Medina puts it, requires far more careful engineering of attention. I conclude with considerations concerning the internal structure of protest. (shrink)

ABSTRACTThis module examines ethical debates about the level of care that should be provided to human research participants. Particular attention is placed on the question of what should be considered an ethically acceptable control arm. You will also learn what relevant international and domestic regulatory documents say about standards of care.

The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors (...) show that there is also consensus regarding the broad conditions under which this is acceptable. (shrink)

The purpose of this study is to compare and contrast the basic ethical values underpinning national health care policies in the United States and Canada. We use the framework of ethical theory to name and elaborate ethical values and to facilitate moral reflection about health care reform. Section one describes historical and contemporary social contract theories and clarifies the ethical values associated with them. Sections two and three show that health care debates and health care systems (...) in both countries reflect the values of this tradition; however, each nation interprets the tradition differently. In the U.S., standards of justice for health care are conceived as a voluntary agreement reached by self-interested parties. Canadians, by contrast, interpret the same justice tradition as placing greater emphasis on concern for others and for the community. The final section draws out the implications of these differences for future U.S. and Canadian health care reforms. (shrink)

The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination of the consent (...) forms reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements. (shrink)

Examining the ethics of long-term, career involvement by physicians in global health work is vital, given growing professional interest and potential health implications for communities abroad. However, current literature remains heavily focused on ethical considerations of short-term global health training experiences. A literature review informed our development of an ethics framework centered on two perspectives: the practitioner perspective, further subdivided into extrinsic and intrinsic factors, and community perspectives, specifically that of the host community and the physician’s home (...) class='Hi'>community. Some physician factors included cultural/linguistic differences, power imbalances, and sustainable skills/competencies. Receiving community factors included resource limitations, standard of care disparities, and community autonomy. Home community factors focused on the opportunity cost of an unavailable physician who was trained and supported by the local community. Descriptive review permitted comparison with existing short-term literature, noting similarities and differences. Our framework provides a basis for further research and critical analysis of ethical implications of career-long physician global health work. (shrink)

Historically, the standard of care in medical negligence provided considerable scope for external evaluation of clinical judgment. Under the Bolam test, however, determining the standard was seen by the courts as essentially a matter for the medical profession, to be resolved by expert testimony with minimal court scrutiny. In recent years, courts have become more willing to probe such testimony and challenge the credibility of medical experts, although they would very rarely override clinical judgment. The House of Lords' decision (...) in Bolitho may be construed as inviting courts to reach their own conclusions on the reasonableness of clinical conduct, along standard risk–benefit lines, after having made their own assessment of the expert opinion. Closer scrutiny of such opinion is the more welcome in the light of current concerns about partisanship in expert testimony. (shrink)

Hastings Center Report, Volume 51, Issue 5, Page 53-55, September‐October 2021.

Shifting Burdens explores the process and features of mental patient deinstitutionalization as it occurred in America in the 1950s and 1960s. This paper examines the disillusionments American society had with mental institutions, such as faltering standards of care, staff failures, and inadequate treatment options. These issues resulted in the movement towards deinstitutionalization, resulting in the burden of care for displaced mental patients being shifted onto community homes and patients families. Shifting Burdens challenges the notion that deinstitutionalization (...) at the time was a successful endeavour, as the question of care for mental patients continues to exist today. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that (...) additional dimensions of the standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research (...) to improve emergency care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health. (shrink)

Background and PurposeMany critically ill patients in intensive care units (ICUs) are unable to communicate their wishes about goals of care, particularly about the use of life-sustaining treatments. Surrogates and clinicians struggle with medical decisions because of a lack of clarity regarding patients’ preferences, leading to prolonged hospitalizations and increased costs. This project focused on the development and implementation of a tool to facilitate a better communication process by (1) assuring the early identification of a surrogate if indicated (...) on admission and (2) clarifying the decision-making standards that the surrogate was to use when participating in decision making. Before introducing the tool into the admissions routine, the staff were educated about its use and value to the decision-making process.Project and MethodsThe study was to determine if early use of a simple method of identifying a patient’s surrogate and treatment preferences might impact length of stay (LOS) and total hospital charges. A pre- and post-intervention study design was used. Nurses completed the surrogacy information tool for all patients upon admission to the neuroscience ICU. Subjects (total N=203) were critically ill patients who had been on a mechanical ventilator for 96 hours or longer, or in the ICU for seven days or longer. The project included staff education on biomedical ethics, critical communication skills, early identification of families and staff in crisis, and use of a simple tool to document patients’ surrogates and previously expressed care wishes. Data on hospital LOS and hospital charges were collected through a retrospective review of medical records for similar four-month time frames pre- and post-implementation of the assessment tool.ResultsSignificant differences were found between pre- and post-groups in terms of hospital LOS (F=6.39, p=.01) and total hospital charges (F=7.03, p=.009).ConclusionsProject findings indicate that the use of a simple admission assessment tool, supported by staff education about its completion, use, and available resources, can decrease LOS and lower total hospital charges. The reasons for the difference between the pre- and post-intervention groups remain unclear. Further research is needed to evaluate if the quality of communications between patients, their legally authorized representatives, and clinicians—as suggested in the literature—may have played a role in decreasing LOS and total hospital charges. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

The primary purpose behind effectiveness research is to determine whether a treatment with demonstrated efficacy has utility when administered to the general population. The main questions these studies are meant to answer are these: Can the typical patient respond to treatment? Is the treatment acceptable to the typical patient? Can the treatment be administered safely and in its entirety in the typical treatment setting? Is the treatment under study significantly better than the community standard of care both from (...) a cost and outcome perspective? Answering these questions is meant to provide sufficient information to providers and policymakers so that effective interventions can be adopted and become the new community standard. For this research to make a meaningful impact on a provider and policymaker's decision to change the status quo, study interventions should be compared to the existing community standard of treatment, often referred to as treatment as usual (TAU). From an ethical perspective, this decision may not always be the safest choice. In some populations, TAU may mean no treatment at all, and in others TAU may be worse than withholding treatment. The effectiveness researcher is then caught between the pull to do no harm and the need for research to have an impact on change. The purpose of this article is to highlight certain conditions when TAU is ethically acceptable and to discuss alternatives when TAU may be an unethical treatment condition. For purposes of precision, we focus exclusively on psychotherapy effectiveness research rather than system-intervention research or medication-intervention research. (shrink)

Despite the recent increased emphasis on ethics in health care, the subject of community health care is rarely specifically addressed. Yet it is in the community that many ethical issues arise, both in the particular practice situation and in the wider social issues connected with changes in government policy. This edited text discusses these questions and looks at the whole range of community health nursing in the UK. The multidisciplinary group of contributors explore the issues (...) of theory and practice that arise in community health care. They encourage critical reflection on the differences between hospital-based care and community care. Everyday issues are addressed that confront health practitioners working in the community, such as discrimination, mental health, standard setting, rationing in health care, public health, health promotion and discharge decision making. This book will be essential reading for practitioners on post-registration courses in community health and students following courses in health care ethics and nursing studies. (shrink)