The guidelines of _Scientia et Fides_ can be found on: https://www.chicagomanualofstyle.org/tools_citationguide/citation-guide-2.html or https://apcz.umk.pl/SetF/about/submissions.

Clinical guidelines are special types of plans realized by collective agents. We provide an ontological theory of such plans that is designed to support the construction of a framework in which guideline-based information systems can be employed in the management of workflow in health care organizations. The framework we propose allows us to represent in formal terms how clinical guidelines are realized through the actions of are realized through the actions of individuals organized into teams. We provide various (...) levels of implementation representing different levels of conformity on the part of health care organizations. Implementations built in conformity with our framework are marked by two dimensions of flexibility that are designed to make them more likely to be accepted by health care professionals than standard guideline-based management systems. They do justice to the fact 1) that responsibilities within a health care organization are widely shared, and 2) that health care professionals may on different occasions be non-compliant with guidelines for a variety of well justified reasons. The advantage of the framework lies in its built-in flexibility, its sensitivity to clinical context, and its ability to use inference tools based on a robust ontology. One disadvantage lies in its complicated implementation. (shrink)

Current guidelines treat palliative sedation to unconsciousness as an effective medical treatment for terminally ill patients who need relief from severe symptoms, yet also restrict its use in ways that are extraordinary for medical treatments. A closer look at the kinds of cases in which palliative sedation is used suggests a way of adjusting the guidelines to resolve this seeming contradiction.

Healthcare professionals often face ethical conflicts and challenges related to decision-making that have necessitated consideration of the use of conscientious objection (CO). No current guidelines exist within Spain’s healthcare system regarding acceptable rationales for CO, the appropriate application of CO, or practical means to support healthcare professionals who wish to become conscientious objectors. As such, a procedural framework is needed that not only assures the appropriate use of CO by healthcare professionals but also demonstrates its ethical validity, legislative compliance (...) through protection of moral freedoms and patients’ rights to receive health care. Our proposal consists of prerequisites of eligibility for CO (individual reference, specific clinical context, ethical justification, assurance of non-discrimination, professional consistency, attitude of mutual respect, assurance of patient rights and safety) and a procedural process (notification and preparation, documentation and confidentiality, evaluation of prerequisites, non-abandonment, transparency, allowance for unforeseen objection, compensatory responsibilities, access to guidance and/or consultative advice, and organizational guarantee of professional substitution). We illustrate the real-world utility of the proposed framework through a case discussion in which our guidelines are applied. (shrink)

Ontologies are being used increasingly to promote the reusability of scientific information by allowing heterogeneous data to be integrated under a common, normalized representation. Definitions play a central role in the use of ontologies both by humans and by computers. Textual definitions allow ontologists and data curators to understand the intended meaning of ontology terms and to use these terms in a consistent fashion across contexts. Logical definitions allow machines to check the integrity of ontologies and reason over data annotated (...) with ontology terms to make inferences that promote knowledge discovery. Therefore, it is important not only to include in ontologies multiple types of definitions in both formal and in natural languages, but also to ensure that these definitions meet good quality standards so they are useful. While tools such as Protégé can assist in creating well-formed logical definitions, producing good definitions in a natural language is still to a large extent a matter of human ingenuity supported at best by just a small number of general principles. For lack of more precise guidelines, definition authors are often left to their own personal devices. This paper aims to fill this gap by providing the ontology community with a set of principles and conventions to assist in definition writing, editing, and validation, by drawing on existing definition writing principles and guidelines in lexicography, terminology, and logic. (shrink)

Background Intensivists must provide enough analgesia and sedation to ensure dying patients receive good palliative care. However, if it is perceived that too much is given, they risk prosecution for committing euthanasia. The goal of this study is to develop consensus guidelines on analgesia and sedation in dying intensive care unit patients that help distinguish palliative care from euthanasia. Methods Using the Delphi technique, panelists rated levels of agreement with statements describing how analgesics and sedatives should be given to (...) dying ICU patients and how palliative care should be distinguished from euthanasia. Participants were drawn from 3 panels: 1) Canadian Academic Adult Intensive Care Fellowship program directors and Intensive Care division chiefs (N = 9); 2) Deputy chief provincial coroners (N = 5); 3) Validation panel of Intensivists attending the Canadian Critical Care Trials Group meeting (N = 12). Results After three Delphi rounds, consensus was achieved on 16 statements encompassing the role of palliative care in the intensive care unit, the management of pain and suffering, current areas of controversy, and ways of improving palliative care in the ICU. Conclusion Consensus guidelines were developed to guide the administration of analgesics and sedatives to dying ICU patients and to help distinguish palliative care from euthanasia. (shrink)

Covid‐19 confronts us with tragic choices, in which every option is unacceptable. On the New York State Task Force on Life and the Law, I worked on guidelines for such situations. We did not envision the scale or character of Covid‐19. To minimize fear that the decisions made in these situations might be unfair, we all must know what guidelines or mandates inform them. Only with transparency about how decisions will be made, by whom, and according to what (...) requirements can we have confidence that fairness prevails. We now face many related questions about process, goals, leadership, and trust. For example, how might ethical guidelines evolve as scientific understanding advances? Should guidelines vary with different venues? And if, as I have argued, judgment is necessary even with the best of guidelines, how can we prepare clinicians to make good judgments? Are there implications for better training of personnel in nonemergency times for what they might face in the worst of times? (shrink)

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on work (...) done since 1990 at the Institute of Medicine and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic? (shrink)

Although guidelines to regulate user involvement in research have been advocated and implemented for several years, literature still describes the process as challenging. In this qualitative study, we take a critical view on guidelines that are developed to regulate and govern the collaboration process of user involvement in research. We adapt a social constructivist view of guidelines and our aim is to explore how guidelines construct the perception of users and researchers and thus the process of (...) involvement. Twenty‐two guidelines published between 2006 and 2019 were analyzed iteratively. The analysis focuses on values which are emphasized in the guidelines on the distribution of entities, knowledge, and tasks between users and researchers. The analysis indicates that users and researchers are constructed differently; researchers are mainly constructed as responsible initiators and caretakers, while users are constructed as powerless and vulnerable. The guidelines portray the collaboration process as harmonious and assume a normative perspective. In doing so, challenges described in the literature related to power imbalances are not addressed. Based on these findings, we ask if these guidelines might function to maintain existing power imbalances between users and researchers. (shrink)

Historically, scientists in training have learned the rules of ethical conduct by the example of their advisors and other senior scientists and by practice. This paper is intended to serve as a guide for the beginning scientist to some fundamental principles of scientific research ethics. The paper focuses less on issues of outright dishonesty or fraud, and more on the positive aspects of ethical scientific behavior; in other words, what a scientist should do to maintain a high level of ethical (...) conduct in research.There are a number of fairly specific rules, guidelines, or commonly accepted operating principles that have evolved for the ethical conduct of science. In order to discuss this code of ethics, this paper is divided into sections dealing with specific areas of scientific ethics. These areas are: data collection and storage, ownership of data, confidentiality, communication, authorship, collaboration, the peer review system, and rules of dealing with ethical complaints. Illustrative case histories are presented to provide examples of the type of ethical dispute or problem being discussed. If scientific trainees learn the accepted rules of behavior that govern the conduct of science, ethical problems that arise out of ignorance, misunderstanding, or poor communication can be avoided. (shrink)

The paper develops value based management guidelines from the famous Indian treatise on management, Kautilya's Arthashastra. Guidelines are given for individual components of a total framework in detail, which include guidelines for organizational philosophy, value based leadership, internal corporate culture, accomplishment of corporate purpose and feedback from stakeholders.

Global fatalities related to COVID-19 are expected to be high in 2020–2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods—that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and (...) against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made. (shrink)

Practice guidelines are an increasingly relevant feature of health insurance. One hundred and seventy-eight million people in the United States have some form of private health insurance coverage; coverage for 150 million of them is employment-related. Traditionally, this coverage was provided by employers purchasing a group contract under which an insurance carrier provided indemnity coverage for employees—that is, the insurance company paid all usual, customary, and reasonable charges incurred by an employee for medical care, subject in some cases to (...) an annual deductible and to a percentage of covered expenses, co-paid by the employee, for each service. In recent years, however, employers in greater numbers have switched to so-called self-insurance plans in which employees’ health care claims are paid directly by the employer. (shrink)

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on work (...) done since 1990 at the Institute of Medicine and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic? (shrink)

Human embryo models formed from stem cells—known as embryoids—allow scientists to study the elusive first stages of human development without having to experiment on actual human embryos. But clear ethical guidelines for research involving embryoids are still lacking. Previously, a handful of researchers put forward new recommendations for embryoids, which they hope will be included in the next set of International Society for Stem Cell Research guidelines. Although these recommendations are an improvement over the default approach, they are (...) nonetheless unworkable, because they rely on a poorly conceived notion of an embryoid’s ‘potential’ to trigger stringent research regulations. (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 February 1975, a group of leading scientists, physicians, and policymakers convened at Asilomar, California, to consider the safety of proceeding with recombinant DNA research. The excitement generated by the promise of this new technology was counterbalanced by concerns regarding dangers that might arise from it, including the potential for accidental release of genetically modified organisms into the environment. Guidelines developed at the conference to direct future research endeavors had several consequences. They permitted research to resume, bringing to an (...) end the voluntary moratorium that the National Academy of Sciences had instituted several months earlier. They also served to illustrate that the scientific community was capable of self-governance, thereby securing public trust and persuading Congress not to institute legislative restrictions. Finally, they underscored the importance of weighing unforeseen risks inherent in some research against potential benefits that may arise from these same endeavors. (shrink)

Practice guidelines are an increasingly relevant feature of health insurance. One hundred and seventy-eight million people in the United States have some form of private health insurance coverage; coverage for 150 million of them is employment-related. Traditionally, this coverage was provided by employers purchasing a group contract under which an insurance carrier provided indemnity coverage for employees—that is, the insurance company paid all usual, customary, and reasonable charges incurred by an employee for medical care, subject in some cases to (...) an annual deductible and to a percentage of covered expenses, co-paid by the employee, for each service. In recent years, however, employers in greater numbers have switched to so-called self-insurance plans in which employees’ health care claims are paid directly by the employer. (shrink)

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair (...) inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (shrink)

The COVID-19 pandemic has been overwhelming public health-care systems around the world. With demand exceeding the availability of medical resources in several regions, hospitals have been forced to invoke triage. To ensure that this difficult task proceeds in a fair and organised manner, governments scrambled experts to draft triage guidelines under enormous time pressure. Although there are similarities between the documents, they vary considerably in how much weight their respective authors place on the different criteria that they propose. Since (...) most of the recommendations do not come with ethical justifications, analysing them requires that one traces back these criteria to their underlying theories of distributive justice. In the literature, COVID-19 triage has been portrayed as a value conflict solely between utilitarian and egalitarian elements. While these two accounts are indeed the main antipodes, I shall show that in fact all four classic theories of distributive justice are involved: utilitarianism, egalitarianism, libertarianism, and communitarianism. Detecting these in the documents and classifying the suggested criteria accordingly enables one to understand the balancing between the different approaches to distributive justice—which is crucial for both managing the current pandemic and in preparation for the next global health crisis. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not expressed in (...) local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not expressed in (...) local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

Technologies to rapidly alert people when they have been in contact with someone carrying the coronavirus SARS-CoV-2 are part of a strategy to bring the pandemic under control. Currently, at least 47 contact-tracing apps are available globally. They are already in use in Australia, South Korea and Singapore, for instance. And many other governments are testing or considering them. Here we set out 16 questions to assess whether — and to what extent — a contact-tracing app is ethically justifiable.

The Dutch experience has influenced the debate on euthanasia and death with dignity around the globe, especially with regard to whether physician-assisted suicide and euthanasia should be legitimized or legalized. Review of the literature reveals complex and often contradictory views about this experience. Some claim the Netherlands offers a model for the world to follow; others believe the Netherlands represents danger rather than promise, that the Dutch experience is the definitive answer to why we should not make active euthanasia and (...) physician-assisted suicide part of our lives.Given these contradictory views, fieldwork is essential to develop a fully informed opinion. Having investigated the Dutch experience for a number of years, in the summer of 1999 I went to the Netherlands to visit the major centres of medical ethics as well as some research hospitals, and to speak with leading figures in euthanasia policy and practice. This essay reports some of the main findings of my interviews and provides detailed accounts of the way in which some of the Netherlands’ leading experts perceive the policy and practice of euthanasia in their country. These accounts are quite fascinating.The discussion begins with background information on the guidelines for euthanasia. Next, explanation about the research methodology is outlined and then I discuss the interviewees’ views about the guidelines for euthanasia. I conclude by indicating that the Dutch guidelines on the policy and practice of euthanasia do not provide ample mechanisms against abuse. Virtually every guideline has been breached or violated. This finding reiterates Hendin’s finding. I recommend that the Netherlands amend its policy and remedy its troubling practice. (shrink)

The Royal Dutch Medical Association recently completed a researchproject aimed at investigating how guidelines for `appropriatemedical care' should be construed. The project took as a startingpoint that explicit attention should be given to ethical andpolitical considerations in addition to data about costs andeffectiveness. In the project, two research groups set out todesign guidelines and cost-effectiveness analyses (CEAs) for twocircumscribed medical areas (angina pectoris and majordepression). Our third group was responsible for the normativeanalysis. We undertook an explorative, qualitative pilot (...) study ofthe normative considerations that played a role in constructingthe guidelines and CEAs, and simultaneously interviewedspecialists about the normative considerations that guided theirdiagnostic and treatment decisions. Explicating normativeconsiderations, we argue, is important democratically: the issuesat stake should not be left to decision analysts and guidelinedevelopers to decide. Moreover, it is a necessary condition for asuccessful implementation of such tools: those who draw uponthese tools will only accept them when they can recognizethemselves in the considerations implied. Empirical normativeanalysis, we argue, is a crucial tool in developing guidelinesfor appropriate medical care. (shrink)

Over the last decade, standards for when and how to undertake a wide range of medical interventions have poured forth from medical specialty groups, commercial and nonprofit organizations, and state and federal panels. Known by a variety of names—from practice parameters to clinical guidelines—and intended for a range of purposes—from diminishing the incidence of maloccurences in hospitals to cutting the costs of health care—these guidelines share one important feature: the intention of decreasing the range of variation in medical (...) practice. Such standardization immediately appeals to anyone interested in improving the quality of health care and, in particular, reducing inappropriate medical interventions, in light of the difficulties for a conscientious physician today in adhering to the best standard of practice when faced with ever increasing medical knowledge and the growing number and complexity of diagnostic, preventive, and therapeutic interventions. (shrink)

Open peer review (OPR) is moving into the mainstream, but it is often poorly understood and surveys of researcher attitudes show important barriers to implementation. As more journals move to implement and experiment with the myriad of innovations covered by this term, there is a clear need for best practice guidelines to guide implementation. This brief article aims to address this knowledge gap, reporting work based on an interactive stakeholder workshop to create best-practice guidelines for editors and journals (...) who wish to transition to OPR. Although the advice is aimed mainly at editors and publishers of scientific journals, since this is the area in which OPR is at its most mature, many of the principles may also be applicable for the implementation of OPR in other areas (e.g., books, conference submissions). (shrink)

The aim of this article is to articulate and critically discuss different answers to the following question: How should decision-makers deal with conflicts that arise when the values usually entailed in ethical guidelines – such as accuracy, privacy, non-discrimination and transparency – for the use of Artificial Intelligence clash with one another? To begin with, I focus on clarifying some of the general advantages of using such guidelines in an ethical analysis of the use of AI. Some disadvantages (...) will also be presented and critically discussed. Second, I will show that we need to distinguish between three kinds of conflict that can exist for ethical guidelines used in the moral assessment of AI. This section will be followed by a critical discussion of different answers to the question of how to handle what we shall call internal and external values conflicts. Finally, I will wrap up with a critical discussion of three different strategies to resolve what is called a ‘genuine value conflict’. These strategies are: the ‘accepting the existence of irresolvable conflict’ view, the ranking view, and value monism. This article defends the ‘accepting the existence of irresolvable conflict’ view. It also argues that even though the ranking view and value monism, from a merely theoretical point of view, are better equipped to solve genuine value conflicts among values in ethical guidelines for artificial intelligence, this is not the case in real-life decision-making. Keywords: AI; ethical guidelines; algorithm-based sentencing; value conflicts. (shrink)

Current regulations and guidelines identify specific subject populations as vulnerable. Regulations and guidelines generally stipulate protections with regard to the process of informed consent. Recent clinical trials suggest that satisfying the legal requirements for additional safeguards may not protect subjects to the extent we may desire. We present proposed guidelines for the protection of decisionally impaired subjects throughout the course of the trial.

To describe the content of practice guidelines on euthanasia and assisted suicide (EAS) and to compare differences between settings and guidelines developed before or after enactment of the euthanasia law in 2002 by means of a content analysis. Most guidelines stated that the attending physician is responsible for the decision to grant or refuse an EAS request. Due care criteria were described in the majority of guidelines, but aspects relevant for assessing these criteria were not always (...) described. Half of the guidelines described the role of the nurse in the performance of euthanasia. Compared with hospital guidelines, nursing home guidelines were more often stricter than the law in excluding patients with dementia (30% vs 4%) and incompetent patients (25% vs 4%). As from 2002, the guidelines were less strict in categorically excluding patients groups (32% vs 64%) and in particular incompetent patients (10% vs 29%). Healthcare institutions should accurately state the boundaries of the law, also when they prefer to set stricter boundaries for their own institution. Only then can guidelines provide adequate support for physicians and nurses in the difficult EAS decision-making process. (shrink)

Health care has become increasingly patient-centred and medical guidelines are considered to be one of the instruments that contribute towards making it so. We reviewed the literature to identify studies on this subject. Both normative and empirical studies were analysed. Many studies recommend active patient participation in the process of guideline development as the instrument to make guidelines more patient-centred. This is done on the assumption that active patient participation will enhance the quality of the guidelines. We (...) found no empirical evidence, however, to support this assumption. Moreover, the studies show that patients experience several difficulties in the participation process, which cannot solely be traced back to flawed practices. Given this poor track record we conclude that the plea to actively involve patients in the guideline development process should be reconsidered. (shrink)

Humans participate in an immense variety of relationships with other persons and other entities: human and nonhuman, living and nonliving, tangible and intangible, real and imagined. Participation in relationships is considered a key benchmark of personhood. Some of these relationships, particularly friendships, involve close emotional attachments, and some friendships have been described since antiquity as spiritual in nature. Different types of friendship depend upon factors such as proximity, social formality, physical intimacy, information exchanged, and the costs and benefits of maintaining (...) the relationship. There are time‐extended processes and narrative practices involved in forming and dissolving relationships. A question is raised how androids (hypothetical humanoid robots that people would accept as equals in society) can participate in friendships with humans and other entities. This article explores the space of friendships with the aim of formulating guidelines for a computational model that can make explicit the information processing requirements and step‐by‐step processes involved with participating in the many different types of friendships, including those known as spiritual friendships. (shrink)

Professional statements guide neonatal resuscitation thresholds at the border of viability. A 2015 systematic review of international guidelines by Guillen et al. found considerable variability between statements’ clinical recommendations for infants at 23–24 weeks gestational age (GA). The authors concluded that differences in the type of data included were one potential source for differing resuscitation thresholds within this “ethical gray zone.” How statements present ethical considerations that support their recommendations, and how this may account for variability, has not been (...) as rigorously explored. We performed a mixed-methods exploratory analysis of 25 current international guidelines for neonatal resuscitation at 22+0−25+0 weeks GA. Qualitative analysis using a modified grounded theory yielded 34 distinct codes, eight categories, and four overarching themes. Three themes, consequentialism, principlism, and rights-based, consisted of concepts central to these ethical frameworks. The fourth theme, clinical reasoning, described counseling practices, medical management, outcomes data, and prognostic uncertainty, without any ethical context. The theme of clinical reasoning appeared in 22 of 25 guidelines. Ten guidelines lacked any ethical theme. Guidelines with an identified ethical theme were more likely to recommend comfort care than guidelines without an identified ethical theme, and recommended it at a higher average GA (22.7 weeks vs. 22.0 weeks, p = 0.03). Thus, how ethical concepts are incorporated into guidelines potentially impacts resuscitation thresholds. We argue that inclusion of explicit discussion of ethical considerations surrounding resuscitation in the “gray zone” would clarify values that inform recommendations and facilitate discussions about how neonatology ought to approach periviability as outcomes continue to evolve. (shrink)

The context in which the British Medical Association first considered publishing specific guidelines on decisions about attempting cardiopulmonary resuscitation , in the early 1990s, needs to be remembered. At that time the subject was often seen as far too sensitive to be mentioned to patients. Many hospitals had no formal policy about how CPR decisions should be made, apart from an expectation that these were purely medical matters. Advance decision making about CPR, where it existed, appears to have been (...) generally on an ad hoc basis by doctors. Patients, their relatives and the rest of the health care team were often unaware of it. After several cases in which nurses had been disciplined–unfairly in the eyes of some–for complying with their patients' known wishes about non-resuscitation in cases where no advance medical decision had been recorded, there was a demand for guidance.The BMA was approached by nurses' representatives with a view to publishing some very basic advice. This advice, issued in 1993 jointly with the Royal College of Nursing, and in association with the Resuscitation Council, was under 1000 words. Whether this brevity reflects difficulties in achieving consensus or lower expectations about what was required is a matter for speculation. Throughout the 1990s the guidance was distributed widely and used as a basis for many hospitals' local policies. Recently, however, the demands on the BMA and other professional bodies for ethical advice have changed and grown. Discussion of sensitive decisions about potentially life-prolonging interventions is now …. (shrink)

This paper presents a pedagogical framework for teaching cross-cultural clinical ethics. The approach, offered at the intersection of anthropology and bioethics, is innovative in that it takes on the “social sciences versus bioethics” debate that has been ongoing in North America for three decades. The argument is made that this debate is flawed on both sides and, moreover, that the application of cross-cultural thinking to clinical ethics requires using the tools of the social sciences within a principles-based framework for clinical (...) ethics. This paper introduces the curriculum and provides guidelines for how to teach cross-cultural clinical ethics. The learning points that are introduced emphasize culture in its relation to power and underscore the importance of viewing both biomedicine and bioethics as culturally constructed. (shrink)

To achieve lower medical spending with as little reduction as possible in good outcomes, practitioners and policy makers alike have been experimenting with the use of practice guidelines. These guidelines both recommend certain types of therapies and proscribe others in the treatment of patients with particular conditions. This paper explores the question of whether guidelines which do reduce total resource costs of medical care to a population will be feasible and produce “acceptable” results. The definition of acceptable (...) is part of the policy problem, so it will be left open for a while, but the question of which outcomes match with which levels of resource cost will form the positive basis for the normative judgment of “acceptability.”. (shrink)

The informed consent process presents challenges for psychological trauma research (e.g. Institutional Review Board [IRB] apprehension). While previous research documents researcher and IRB-member perspectives on these challenges, participant views remain absent. Thus, using a mixed-methods approach, we investigated participant views on consent guidelines in two convenience samples: crowdsourced (N = 268) and undergraduate (N = 265) participants. We also examined whether trauma-exposure influenced participant views. Overall, participants were satisfied with current guidelines, providing minor feedback and ethical reminders for (...) researchers. Moreover, participant views for consent were similar irrespective of trauma-exposure. Our study has implications for IRBs and psychological researchers. (shrink)

This article critically looks at the challenges that are incumbent in the deployment of married soldiers who work for the South African National Defence Force. The SANDF previously deployed soldiers outside the borders of South Africa for a period of 6 months or less. But currently, the SANDF has a deployment period of 12 months. This period is twice that of the earlier period, which means that soldiers and their families have to spend 12 months apart from one another. This (...) has an adverse effect on the marriages of soldiers and makes the SANDF appear as an uncaring institute because its military operations tend to impact family lives. Using a qualitative research approach, this article explores the emic experiences of married soldiers who were deployed, and concludes by suggesting some pastoral guidelines that may prove useful for a multi-professional team handling the issues of deployment. (shrink)

In the face of a perceived lack of widespread understanding of the theoretical issues underlying the development, dissemination and implementation of clinical guidelines, the Royal College of General Practitioners Guidelines Group developed a 2-day course aimed at teaching the theory in these areas. The course was targeted at potential opinion formers and ran on six occasions. Postal questionnaire assessment of the course revealed high levels of satisfaction with all aspects of the course and high levels of reported use (...) of the knowledge gained. Further developments of the course are discussed. (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.

Reuse of elements from existing ontologies in the construction of new ontologies is a foundational principle in ontological design. It offers the benefits, among others, of consistency and interoperability between such knowledge structures as well as sharing resources. Reuse is widely found within important collections of established ontologies, such as BioPortal and the OBO Foundry. However, reuse comes with its own potential problems involving ontological commitment, granularity, and ambiguity. Guidelines are proposed to aid ontology developers and curators in their (...) prospective reuse of content. These guidelines have been gleaned over years of practice in the ontology field. The guidelines are couched in experiential reports on designing and curating particular ontologies (e.g., EXACT and EXACT2) and using generally accepted approaches (e.g., MIREOT) in doing so. Various software tools to assist in ontology reuse are surveyed and discussed. (shrink)

Diese Abhandlung untersucht die Frage, ob internationale Richtlinien für die Gentechnologie, insbesondere im Hinblick auf "genetische Verbesserungen" , wünschenswert und machbar erscheinen. Es wird die Auffassung vertreten, daß die Forderung nach solchen internationalen Richtlinien sich unüberwindlichen praktischen Hindernissen gegenübersieht. Den Hintergrund für diese Auffassung bilden die Ambivalenz des Richtlinienkonzepts, das Fehlen einer Autorität, die solche Richtlinien in Kraft setzen könnte, mangelnder Konsens über zentrale Normen oder Werte, die in die Richtlinien einbezogen werden könnten, der Widerstand sowohl von Seiten der Wissenschaft (...) als auch der privaten Wirtschaft gegen solche Richtlinien und schließlich die öffentliche Forderung nach der Einführung von Methoden "genetischer Verbesserung". Die Forschung über Methoden "genetischer Verbesserung" hat schon begonnen und wird sich ohne Zweifel fortsetzen. Es wird daher in diesem Beitrag vorgeschlagen, daß öffentliche Mittel zur Unterstützung der Forschung über "genetische Verbesserung" zur Verfügung gestellt werden, um sicher zu stellen, daß Forschung dieser Art angemessene vorhergehende Begutachtung und andauernde Überwachung erfährt. Öffentlichkeit, Vorausschau und Kritik können uns helfen, vom Mißbrauch des Menschen als Forschungsobjekt und rücksichtslosem Forscherdrang weg und hin zu akzeptablen Formen der "genetischen Verbesserung" zu kommen. This essay explores whether international guidelines in genetics, specifically regarding genetic enhancement, are desirable and feasible. It is argued that the quest for international guidelines faces insuperable practical obstacles. These include the ambiguity of the concept of guidelines, no authoritative body to issue guidelines, lack of consensus about substantive norms or values to be incorporated into guidelines, resistance from the scientific as well as the private business sector to guidelines, and public demand for genetic enhancement. Genetic enhancement research has already begun and will no doubt continue. It is proposed that public funding for genetic enhancement research be provided to ensure that such research receives adequate prior review and continual monitoring. Publicity, oversight, and critique can help steer us away from abuses of human research subjects and reckless science toward acceptable forms of genetic enhancement. (shrink)