Guidelines orient best practices in medicine, yet, in health care, many real world constraints limit their optimal realization. Since guideline implementation problems are not systematically anticipated, they will be discovered only post facto, in a learning curve period, while the already implemented guideline is tweaked, debugged and adapted. This learning process comes with costs to human health and quality of life. Despite such predictable hazard, the study and modeling of medical guideline implementation is still seldom pursued. In this (...) article we argue that to systematically identify, predict and prevent medical guideline implementation errors is both an epistemic responsibility and an ethical imperative in health care, in order to properly provide beneficence, minimize or avoid harm, show respect for persons, and administer justice. Furthermore, we suggest that implementation knowledge is best achieved technically by providing simulation modeling studies to anticipate the realization of medical guidelines, in multiple contexts, with system and scenario analysis, in its alignment with the emerging field of implementation science and in recognition of learning health systems. It follows from both claims that it is an ethical imperative and an epistemic responsibility to simulate medical guidelines in context to minimize harm in health care, before guideline implementation. (shrink)

Volume 19, Issue 6, June 2019, Page W5-W9.

Modern Western medical individualism has had a significant impact on health care in China. This essay demonstrates the ways in which such Western-style individualism has been explicitly endorsed in China’s 2010 directive: The Basic Norms of the Documentation of the Medical Record. The Norms require that the patient himself, rather than a member of his family, sign each informed consent form. This change in clinical practice indicates a shift toward medical individualism in Chinese healthcare legislation. Such individualism, (...) however, is incompatible with the character of Chinese familism that is deeply rooted in the Chinese ethical tradition. It also contradicts family-based patterns of health care in China. Moreover, the requirement for individual informed consent is incompatible with numerous medical regulations promulgated in the past two decades. This essay argues that while Chinese medical legislation should learn from relevant Western ideas, it should not simply copy such practices by importing medical individualism into Chinese health care. Chinese healthcare policy is properly based on Chinese medical familist resources. (shrink)

PurposeThe aim of this paper is to assess the complex issue of responsibility in clinical practice. The paper focuses mainly on the relationship between personal- and medical-professional responsibility of practitioners and clinical guidelines.MethodsAfter a theoretical review of the different definitions of responsibility in selected bioethical and biojuridical literature, two recent juridical proceedings concerning medical responsibility from Italian Courts are discussed. Subsequently, a theoretical analysis of the definition of clinical practice guidelines is proposed in order to show (...) their feasibility to assess personal- and medical-professional responsibility.ResultsThe definitions of responsibility and the two Italian cases show the theoretical and practical difficulties of shared assessments of both personal-professional and medical-professional responsibility in clinical practice. Clinical practice guidelines cannot be assumed as an objective code of action stating exactly a rule of conduct in all situations, but as a tool suggesting how to decide what to do in different conditions.ConclusionsResponsibility in clinical practice is such a complex issue to deserve a special ethical assessment. The clinician’s personal-professional responsibility cannot be replaced or reduced by clinical practice guidelines, because medicine is as such a relationship focused on the expertize of practitioners. Nonetheless, a shared approach to different clinical conditions is needed in order to avoid a relativist outcome and protect patients’ and even clinicians’ rights. Formal guidelines (that describe not exactly what to do but how to decide what to do) are proposed as potential useful tool to achieve this aim. (shrink)

German medical students are not sufficiently introduced to the ethical principles and pitfalls of scientific work. Therefore, a compulsory course on good scientific practice has been developed and implemented into the curriculum of medical students, with the goal to foster scientific integrity and prevent scientific misconduct. Students’ knowledge and attitudes towards GSP were evaluated by a pre-post-teaching questionnaire survey. Most participants initially had startling knowledge gaps in the field. Moreover, they were not acquainted with core institutions on GSP, (...) the office of ombudsperson and the nationally binding guidelines on GSP. The pre-post-teaching comparison showed statistically significant improvement in all areas tested; moreover, after the course participants confided more trust in GSP institutions. Applying ethical rules into practice can be challenging; therefore, students need to learn to work independently with guidelines on GSP and should be introduced to institutions providing further guidance. As our study has shown, students are very willing to pursue a scientific career based on integrity and honesty, however, they lack the knowledge how to do so. In light of our results, we therefore recommend to integrate courses on GSP already at an early time into the mandatory curriculum of medical students. (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)

American medicine has long sought to control the standard of care that physicians are expected to provide to their patients. One effort to insulate the standard of care from external interference, called a “safe harbors” approach, would enable physicians to avoid liability for malpractice if they adhered to medical practice guidelines. The idea is to eliminate the “battle of experts” and reduce defensive medicine by requiring judges and juries to accept guidelines as conclusive evidence of the standard (...) of care. Yet current efforts to improve the guideline development process, including the use of evidence-based guidelines, are unlikely to be able to overcome the shortcomings that led a similar safe harbors initiative to fail in the early 1990s. Moreover, there is no adequate justification for conferring this degree of self-regulatory power on the medical profession. (shrink)

The idea that physicians should accept recommendations from learned colleagues on how to practice medicine is probably as old as medicine itself, but beginning around 1990, it took on new urgency in the face of rising health care costs, widespread, unjustifiable variation in practice patterns, concerns about medical errors and quality of care, and what some perceived to be perverse effects of the malpractice system. One solution put forward was practice guidelines, which the Institute of Medicine defined as (...) systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. (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)

International travel for medical care, or medical tourism, creates ethical and safety concerns for patients. Guidelines could be developed and distributed to help address these concerns, but they may at the same time appear to endorse this practice.

This manual is a compendium of various health care policies, guidelines, protocols, and programs that concern clinical issues with ethical implications. The collection of policies, guidelines, and procedures are helpful in drafting and reviewing institutional procedures and helping policymakers develop useful mechanisms for assuring ethical treatment of patients and staff.

Medically unnecessary penile circumcision (MUPC) performed on a non-consenting child has been the subject of increasing critical attention in recent years. This paper provides a behind-the-scenes narrative of the politics of ethical policymaking in the United Kingdom in this area including a discussion about some potential barriers to reform. After a brief overview of ethical guidance for medically unnecessary surgical procedures on children in general and on their genitalia in particular, the paper takes a closer look at three contemporary documents (...) released by UK medical bodies and highlights the unique ethical and safeguarding contradictions in this area. The outcomes of initiatives aimed at engaging constructively with the medical bodies and encouraging wider debate are then described, along with some of the main obstacles to engagement and counter-arguments employed. MUPC is subsequently discussed in a wider societal context, highlighting why serious safeguarding concerns have been raised about what many people believe to be a harmful, preventable practice hiding ‘in plain sight’. The paper ends by calling for UK MUPC guidance to be made consistent with the body of guidance that UK doctors are expected to follow. (shrink)

BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus. In this manuscript, we attempted to do just (...) that.MethodsWe extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative.ResultsWe found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus. Of the 12 clusters, Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences. (shrink)

Current guidelines and regulatory frameworks create a dilemma that threatens the effectiveness of much needed communication between patients and medical providers: How can patients be presented with detailed facts without creating cognitive “overload”? We explain how this is a false dichotomy and illustrate, using three examples, how fuzzy-trace theory offers a third way of informing patients.

This document is designed to give guidance on assessing researchers in bioethics/medical ethics. It is intended to assist members of selection, confirmation and promotion committees, who are required to assess those conducting bioethics research when they are not from a similar disciplinary background. It does not attempt to give guidance on the quality of bioethics research, as this is a matter for peer assessment. Rather it aims to give an indication of the type, scope and amount of research that (...) is the expected in this field. It does not cover the assessment of other activities such as teaching, policy work, clinical ethics consultation and so on, but these will be mentioned for additional context. Although it mentions the UK’s Research Excellence Framework, it is not intended to be a detailed analysis of the place of bioethics in the REF. (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)

Outcomes research in healthcare has been a topic much addressed in recent years. Efforts in this direction have been supplemented by work in the areas of guidelines for clinical practice and computer-interpretable workflow and careflow models.In what follows we present the outlines of a framework for understanding the relations between organizations, guidelines, individual patients and patient-related functions. The derived framework provides a means to extract the knowledge contained in the guideline text at different granularities, in ways that can (...) help us to assign tasks within the healthcare organization and to assess clinical performance in realizing the guideline. It does this in a way that preserves the flexibility of the organization in the adoption of the guidelines. (shrink)

Thirty-three physicians, bioethicists, and medical economists from ten different countries met at Lawrence University, Appleton, Wisconsin, to create The Appleton Consensus: International Guidelines for Decisions to Forego Medical Treatment. The guidelines deal with four specific decision-making circumstances: 1. Five guidelines were created for decisions involving competent patients or patients who have executed an advance directive before becoming incompetent, and those guidelines fell into three categories. 2. Thirteen guidelines were created for decisions involving patients (...) who were once competent, but are not now competent, who have not executed an advance directive. 3. Seven guidelines were created for decisions involving patients who are not now and never have been competent, for whom 'no substituted judgement' can be rendered. 4. Eleven guidelines were created for decisions involving the scarcity of medical resources, which exists in all communities. Five concepts were identified as being critical in the establishment of priorities, given the reality of scarce health resources (1). The term 'physician' is used in the American sense, synonymous with 'medical practitioner'. (shrink)

The main premise of the Royal Dutch Medical Association's (RDMA) guideline on palliative sedation is that palliative sedation, contrary to euthanasia, is normal medical practice. Although we do not deny the ethical distinctions between euthanasia and palliative sedation, we will critically analyse the guideline's argumentation strategy with which euthanasia is demarcated from palliative sedation. First, we will analyse the guideline's main premise, which entails that palliative sedation is normal medical treatment. After this, we will critically discuss three (...) crucial propositions of the guideline that are used to support this premise: (1) the patient's life expectancy should not exceed 2 weeks; (2) the aim of the physician should be to relieve suffering and (3) expert consultation is optional. We will conclude that, if inherent problematic aspects of palliative sedation are taken seriously, palliative sedation is less normal than it is now depicted in the guideline. (shrink)

In 2006, the Indian Council of Medical Research (ICMR) published its ‘Ethical guidelines for Biomedical Research on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there (...) are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India. (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.

Objective: To identify factors that predict physicians’ intent to comply with the American Medical Association’s ethical guidelines on gifts from the pharmaceutical industry.Methods: A survey was designed and mailed in June 2004 to a random sample of 850 physicians in Florida, USA, excluding physicians with inactive licences, incomplete addresses, addresses in other states and pretest participants. Factor analysis extracted six factors: attitude towards following the guidelines, subjective norms , facilitating conditions , profession-specific precedents , individual-specific precedents and (...) intent. Multivariate regression modelling was conducted.Results: Surveys were received from 213 physicians representing all specialties, with a net response rate of 25.5%. 62% of respondents were aware of the guidelines; 50% had read them. 48% thought that following the guidelines would increase physicians’ credibility and professional image; 68% agreed that it was important to do so. Intent to comply was positively associated with attitude, subjective norms, facilitators and sponsorship of continuing medical education events, while individual-specific precedents had a negative relationship with intent to comply. Predictors of intent were attitude, subjective norms, the interaction term , sponsorship of CME events and individual-specific precedents.Conclusions: Physicians are more likely to follow the AMA guidelines if they have positive attitudes towards the guidelines, greater subjective norms, fewer expectations of CME sponsorship and fewer individual-specific precedents. Physicians believing that important individuals or organisations expect them to comply with the guidelines are more likely to express intent, despite having fewer beliefs that positive outcomes would result through compliance. (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)

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)

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

There is currently no international consensus around post-trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post-trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post-trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post-trial access (...) and participants and community members. Given that clinical trials conducted in low-income countries will likely continue, there is an urgent need for consideration of post-trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available. (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)

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)

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)

ZusammenfassungWährend die juristische und medizinethische Rechtfertigung des Verzichts auf Wiederbelebung in Deutschland akademisch hinreichend geklärt ist, zeigen sich doch erhebliche Unterschiede und zahlreiche Probleme bei der praktischen Umsetzung in der Klinik. Innerhalb des interdisziplinären Behandlungsteams gehören Kommunikationsdefizite und die Intransparenz der ethischen Entscheidungsprozesse zu den häufigsten Schwierigkeiten, die in der Medizinischen Klinik für Nephrologie und Hypertensiologie am Klinikum Nürnberg mit der Implementierung einer hausinternen Leitlinie, der Anordnung zum Verzicht auf Wiederbelebung, behoben werden sollten.Die Evaluationsstudie, die 118 VaW-Anordnungen bei 4718 Behandlungsfällen (...) im Zeitraum von November 2004 bis Juli 2005 einschloss, verfolgte einen dualen Forschungsansatz. Eine quantitative Dokumentationsanalyse aller VaW-Protokolle wurde mit der leitfadengestützten Befragung von 16 Ärzten und Pflegekräften kombiniert.Teambesprechungen waren in 62,4 %, Entscheidungsgründe in 74,6 % aller VaW-Protokolle dokumentiert. Die Interviews ergaben eine positive, aber berufsgruppendifferente Bewertung der Kommunikation, wobei die Pflegenden kritischer eingestellt waren als ihre medizinischen Kollegen. Die VaW-Dokumentation bewirkte nach Auffassung aller Befragten eine hohe Nachvollziehbarkeit und Transparenz. Die VaW-Anordnung wurde darüber hinaus als gut anwendbar und praxistauglich betrachtet. Nahezu alle Befragten sprachen sich für eine Beibehaltung des VaWVerfahrens in der Klinik aus.Die Implementierung der VaW-Anordnung als hausinterne Leitlinie und Dokumentationsstandard hat zu einer Förderung des interdisziplinären Dialogs und zu einer erheblichen Verbesserung der Transparenz der ethischen Entscheidungsprozesse im Rahmen des Verzichts auf Wiederbelebung geführt. Hilfreich und praxistauglich erfreut sich die VaW-Anordnung einer hohen Akzeptanz bei Pflegenden und Medizinern und wird seit drei Jahren in der Nephrologie am Klinikum Nürnberg konsequent angewendet. (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)