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)

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)

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.

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)

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)

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)

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)

A clinical scenario is described where an anaesthetist is concerned about the seemingly high risk/benefit ratio relating to laparoscopic versus standard inguinal hernia operations. Some options for further action by the anaesthetist are introduced. The remainder of the paper explores the question of who can legitimately assess the acceptability of risk/benefit ratios, and defends the use of practice guidelines at the expense of so called clinical freedom. It is argued that respect for persons is not breached by limiting the (...) treatment options offered to patients to those therapies which have a ‘reasonable’ risk/benefit ratio. This ‘reasonableness’ is context dependent, and should be properly decided by those with expertise in the field. (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)

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)

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)

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)

In response to a series of allegations of scientific misconduct in the 1980’s, a number of scientific societies, national agencies, and academic institutions, including Harvard Medical School, devised guidelines to increase awareness of optimal scientific practices and to attempt to prevent as many episodes of misconduct as possible. The chief argument for adopting guidelines is to promote good science. There is no evidence that well-crafted guidelines have had any detrimental effect on creativity since they focus on design (...) of research studies, documentation of research findings, assignment of credit through authorship, data management and supervision of trainees, not on the origin and evolution of ideas. This paper addresses a spectrum of causes of scientific misconduct or unacceptable scientific behavior and couples these with estimates of the potential for prevention if guidelines for scientific investigation are adopted. The conclusion is that clear and understandable guidelines should help to reduce the chance that flawed research will escape from our institutions. However, they cannot be relied upon alone to prevent all instances of scientific misconduct and should be regarded rather as one means of bolstering the integrity of the entire scientific enterprise. (shrink)

It is shown in this article that the Gospel of John describes a battle between darkness and light, life and death, chaos and God’s new order. Although the certainty is given right at the beginning of the Gospel that the darkness will not overcome the light, God does not take the possibility of darkness away. Darkness in John is darkness of the mind, not seeing the light, not comprehending, not accepting and not believing the Word. The battle between light and (...) darkness is described at two levels – the visible level that you can see with your eyes and the invisible level that only those who have been regenerated by the Spirit can see. Although it may seem that the contrary is true, God is in control of both levels. Jesus made the invisible visible with his words and deeds and, eventually, with his resurrection. The diakonoi of Jesus are called to follow him in his task to honour the father by speaking the words of the father and doing the work of the father. In doing this, they will make the invisible God visible by their diakonia. Real social change will take place in God’s time, and he will use the diakonia of his children to bring order in the chaos, like he did in the beginning when he created the heavens and the earth. The results of the research are used to suggest guidelines on social change in South Africa. (shrink)

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)

This Report examines the ethical implications of electronic communication, focusing on the use of electronic mail (e-mail), considers its impact on a previously established patient-physician relationship, and the limitations in using e-mail to create a new patient-physician relationship. In its recommendations, this report offers guidance to physicians who use electronic mail to communicate with patients and online users. These guidelines maintain that e-mail should not be used to establish a patient-physician relationship, but rather to supplement personal encounters. When using (...) e-mail, physicians hold the same ethical responsibilities to their patients as they do during other encounters and that information must be presented in a manner that meets professional standards. The report requires that physicians notify patients of e-mail's inherent limitations and that patients be given the opportunity to accept these limitations prior to the communication of privileged information. Finally, physicians should be aware of privacy and confidentiality concerns when using e-mail to communicate with patients. (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)

Research ethics guidelines grew out of several infamous episodes where research subjects were exploited. There is significant international synchronization of guidelines. However, indigenous groups in New Zealand, Canada and Australia have criticized these guidelines as being inadequate for research involving indigenous people and have developed guidelines from their own cultural perspectives. Whilst traditional research ethics guidelines place a lot of emphasis on informed consent, these indigenous guidelines put much greater emphasis on interdependence and trust. (...) This article argues that traditional guidelines are premised on relationships of equal power, and that often the researcher has more power that is not fully equalized by providing information. Where there is a relationship of unequal power, then focusing on interdependence and trust is more likely to achieve ethical safety. We illustrate this thesis by describing the detail of a research project looking at the use of interpreters, where we video-recorded live consultations and then interviewed the patient, interpreter and doctor. We conclude by suggesting that mainstream research ethics guidelines should pay more attention to the development of a trustworthy relationship between subject and researcher, and that, following the lead from clinical medicine, we should develop a culturally competent ethical framework for research on human subjects. (shrink)

This item contains information about the Author Guidelines.

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.

Background The early phase of the COVID-19 pandemic affected nursing homes and their residents heavily. Guidelines on how to mitigate the virus’s spread and ensuring safe healthcare delivery were continually evolving. Concurrently, nursing homes faced intense media scrutiny. This challenging environment severely impacted registered nurses and physicians employed within these facilities. Aim To understand the ethical challenges experienced by registered nurses and physicians working in nursing homes during the COVID-19 pandemic. Research design Qualitative descriptive research using thematic analysis. Participants (...) and research context Individual online interviews with four registered nurses and eight physicians clinically active at nursing homes in Sweden. Ethical considerations The study was approved by the Swedish Ethical Review Authority. All participants provided written consent. Results Registered nurses and physicians working in nursing homes perceived ethical challenges stemming from early COVID-19 pandemic guidelines and media coverage. The main theme generated was ‘Struggling to maintain professional and ethical standards under pressure’ incorporating two subthemes: ‘Guidelines developed without the profession put pressure on staff’ and ‘Media’s biased reporting was perceived as unethical and undermined care’. Guidelines from the authorities were considered as developed without professional involvement. It made them difficult to adhere to without deviating from professional and ethical compasses. Media coverage adversely influenced relatives’ perceptions, resulting in mistrust towards physicians’ and registered nurses’ in delivering optimal care for the residents. Conclusions Resilient care in nursing homes necessitates the collaborative development of guidelines involving registered nurses and physicians, particularly amidst crises. Moreover, it is vital to provide support to registered nurses navigating ethical dilemmas, especially during pandemics. Guidelines and principles for care during a crisis should be development with professional involvement, be transparent, and be available to the public, to promote neutral media coverage. Future research is crucial to enhance ethical standards and tackle challenges in this context. (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)

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)

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)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.2 (2001) 165-168 [Access article in PDF] UPMC Presbyterian Policy and Procedure Manual Guidelines for Disclosure and Discussion of Conditions and Events with Patients, Families and Guardians* I. Introduction and Background In the course of hospital care, an extensive amount of clinical information is generated. It includes diagnostic findings, treatment options, responses to interventions, and professional opinions. The information can be positive or (...) negative. Clinical events may or may not be caused by clinicians and consequently may be iatrogenic (caused by medical treatment), nosocomial (occurring in the hospital) or natural events.In accordance with the informed consent policy (#4011), Patients' Bill of Rights (# 0154, Section II H), and the Guidelines on Forgoing Life Sustaining Treatment (#4007), patients have the right to information regarding their condition and care. Physicians and other caregivers are obligated to provide accurate information as expeditiously as possible. While it is usually easy to provide positive information, negative information is more difficult to disclose, especially when the cause is iatrogenic."Therapeutic privilege" has been invoked to explain why certain negative information might be withheld. By invoking therapeutic privilege, the physician refrains from full disclosure to protect the patient from the effects of receiving the information itself. The use of therapeutic privilege is increasingly being called into question because it decreases patient autonomy and reduces trust.The following recommendations are provided to clinicians to help guide delivery of sensitive information, positive and negative. Specific recommendations [End Page 165] are provided for situations where the information is about an unfavorable or adverse event, or where the information might best be characterized as "bad news." II. Definitions Unfavorable event or unfavorable condition. For the purposes of these guidelines, an unfavorable condition is an occurrence or diagnosis that results in or is likely to result in a significant negative outcome, and/or a significant alteration in the care plan.An unfavorable event in this context is not the same as a sentinel event, which in policy #4025 is defined as, "a serious, unexpected, adverse patient event which has resulted in, or if repeated would have a significant probability of resulting in, loss of life or serious physical or psychological injury, that is judged to be a warning of an underlying problem involving hospital facilities, policies, procedures, systems or personnel."Adverse Event. An unfavorable event for the purposes of these guidelines is also distinguished from the FDA definition of the term "adverse event", which is a reportable negative effect of a drug or device potentially resulting in death, hospitalization, or medical or surgical intervention. (See policy #4022 Safe Medical Device Act.)Examples of unfavorable events or conditions for the purpose of these guidelines include a new diagnosis of cancer, a perioperative myocardial infarction, or unintended delivery of an incorrect medication that results in clinical change.Examples of events not covered by these guidelines are intravenous saline infiltration and medication dosing errors that have no clinical impact on care.Iatrogenic. Event caused by the treatment of a healthcare provider. III. Guidelines and Principles It is appropriate that UPMC Presbyterian support basic principles for patient and family notification regarding all clinical events and conditions, including unfavorable ones. Physicians must be honest because that is a cornerstone of the patient-physician relationship, and because it fosters patient autonomy.UPMC Presbyterian supports the following AMA position regarding patient information: [End Page 166] It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and to be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician's mistake or judgement. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care. Ethical responsibility includes informing patients of changes in their diagnoses... (shrink)

Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed the use of animals in (...) research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries. (shrink)

This item contains information about the Author Guidelines.

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)

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)

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)

We have national guidelines for the responsible conduct of research (RCR) and procedures for handling allegations of misconduct in Finland. The guidelines have been formulated and updated by the Finnish Advisory Board on Research Integrity (TENK). In this article, we introduce and evaluate the national RCR guidelines. We also present statistics of alleged and proven RCR violation cases and frequency of appeals to TENK on the decisions or procedures of the primary institutions. In addition, we analyze the (...) available data on seven investigated cases in more detail. Positive aspects in the Finnish system are a fairly good infrastructure to investigate suspected RCR violations and a wide concept of RCR violations, which consists of fabrication, falsification, plagiarism, misappropriation, and other misbehaviors. However, the guidelines contain poorly elaborated definitions, do not treat the complainant and the suspect in an equal way, and need to be revised. Confusion about the concepts and criteria of the RCR violations seems to be common in primary institutions and among the complainants. Even if research institutions and universities have officially adhered to the national RCR guidelines, slipping from the guidelines occurs quite commonly. All these factors lead to frequent dissatisfaction with the decisions or procedures applied, high rate of appeals to TENK, and far from optimal functionality of the system. (shrink)

Purpose The purpose of this paper is clearly illustrate this convergence and the prescriptive recommendations that such documents entail. There is a significant amount of research into the ethical consequences of artificial intelligence. This is reflected by many outputs across academia, policy and the media. Many of these outputs aim to provide guidance to particular stakeholder groups. It has recently been shown that there is a large degree of convergence in terms of the principles upon which these guidance documents are (...) based. Despite this convergence, it is not always clear how these principles are to be translated into practice. Design/methodology/approach In this paper, the authors move beyond the high-level ethical principles that are common across the AI ethics guidance literature and provide a description of the normative content that is covered by these principles. The outcome is a comprehensive compilation of normative requirements arising from existing guidance documents. This is not only required for a deeper theoretical understanding of AI ethics discussions but also for the creation of practical and implementable guidance for developers and users of AI. Findings In this paper, the authors therefore provide a detailed explanation of the normative implications of existing AI ethics guidelines but directed towards developers and organisational users of AI. The authors believe that the paper provides the most comprehensive account of ethical requirements in AI currently available, which is of interest not only to the research and policy communities engaged in the topic but also to the user communities that require guidance when developing or deploying AI systems. Originality/value The authors believe that they have managed to compile the most comprehensive document collecting existing guidance which can guide practical action but will hopefully also support the consolidation of the guidelines landscape. The authors’ findings should also be of academic interest and inspire philosophical research on the consistency and justification of the various normative statements that can be found in the literature. (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)

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)

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)

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

This study aims to develop guidelines of key concepts and specific considerations to make the research more ethical when conducting neurological examinations and treatment interventions in mentally ill patients. We analyzed guideline development theory and literature, previous issues, and discussions with specialists of philosophy, medicine, sociology, and bioethics. The selection of research participants, drafting of intervention plans, and informed consent process were examined with reference to the dual burden; the minimal risk as a general rule of ethical allowance levels, (...) assent and dissent to assess the individual’s judgment capacity for consent, relational autonomy for personal consent with assistance by the proxy, and risk/benefit assessments. When conducting studies, this guideline requires that these three processes be set up appropriately on a case-by-case basis. (shrink)