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)

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)

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)

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)

Discussions about the role of practice guidelines and the strength of the evidence on which they are based should begin with a set of more basic questions: What is the function of such guidelines and what forces shape their use?At least two forces can be seen behind the press for guidelines. On the one hand, guidelines can be used to improve the quality of care by raising the general level of practice to meet at (...) least the standards set by experts. At the other, they become vehicles for cost containment.By international standards, the United States spends a disproportionate share of its gross domestic product on health care. The majority of spending increases are traceable to the growth in technology. Whether couched as a concern that resources could be better used to provide other parts of the population with more effective health care or as a general concern that money spent on health might be better used for other social goods, a notion exists that less is better. (shrink)

Discussions about the role of practice guidelines and the strength of the evidence on which they are based should begin with a set of more basic questions: What is the function of such guidelines and what forces shape their use?At least two forces can be seen behind the press for guidelines. On the one hand, guidelines can be used to improve the quality of care by raising the general level of practice to meet at (...) least the standards set by experts. At the other, they become vehicles for cost containment.By international standards, the United States spends a disproportionate share of its gross domestic product on health care. The majority of spending increases are traceable to the growth in technology. Whether couched as a concern that resources could be better used to provide other parts of the population with more effective health care or as a general concern that money spent on health might be better used for other social goods, a notion exists that less is better. (shrink)

Research that has been sponsored by pharmaceutical, medical device and biotechnology companies is often presented at scientific and medical conferences. However, practices vary between organizations and it can be difficult to follow both individual conference requirements and good publication practice guidelines. Until now, no specific guidelines or recommendations have been available to describe best practice for conference presentations.This document was developed by a working group of publication professionals and uploaded to PeerJ Preprints for consultation prior (...) to publication; an additional 67 medical societies, medical conference sites and conference companies were also asked to comment. The resulting recommendations aim to complement current good publication practice and authorship guidelines, outline the general principles of best practice for conference presentations and provide recommendations around authorship, contributorship, financial transparency, prior publication and copyright, to conference organizers, authors and industry professionals.While the authors of this document recognize that individual conference guidelines should be respected, they urge organizers to consider authorship criteria and data transparency when designing submission sites and setting parameters around word/character count and content for abstracts. It is also important to recognize that conference presentations have different limitations to full journal publications, for example, in the case of limited audiences that necessitate refocused abstracts, or where lead authors do not speak the local language, and these have been acknowledged accordingly. The authors also recognize the need for further clarity regarding copyright of previously published abstracts and have made recommendations to assist with best practice.By following Good Practice for Conference Abstracts and Presentations: GPCAP recommendations, industry professionals, authors and conference organizers will improve consistency, transparency and integrity of publications submitted to conferences worldwide. (shrink)

Publishing has become, in several respects, more challenging in recent years. Academics are faced with evolving ethics that appear to be more stringent in a bid to reduce scientific fraud, the emergence of science watchdogs that are now scrutinizing the published literature with critical eyes to hold academics, editors and publishers more accountable, and a barrage of checks and balances that are required between when a paper is submitted and eventually accepted, to ensure quality control. Scientists are often under increasing (...) pressure to produce papers in an increasingly stringent publishing environment. In such a climate, timing is everything, as is the efficiency of the process. Academics appreciate that rejections are part of the fabric of attempting to get a paper published, but they expect the reason to be clear, based on careful evaluation of their work, and not on superficial or unsubstantiated excuses. A desk rejection occurs when a paper gets rejected even before it has entered the peer review process. This paper examines the features of some desk rejections and offers some guidelines that would make desk rejections valid, fair and ethical. Academics who publish are under constant pressure to do so quickly, but effectively. They are dependent on the editors’ good judgment and the publisher’s procedures. Unfair, unsubstantiated, or tardy desk rejections disadvantage academics, and editors and publishers must be held accountable for wasting their time, resources, and patience. (shrink)

Publishing has become, in several respects, more challenging in recent years. Academics are faced with evolving ethics that appear to be more stringent in a bid to reduce scientific fraud, the emergence of science watchdogs that are now scrutinizing the published literature with critical eyes to hold academics, editors and publishers more accountable, and a barrage of checks and balances that are required between when a paper is submitted and eventually accepted, to ensure quality control. Scientists are often under increasing (...) pressure to produce papers in an increasingly stringent publishing environment. In such a climate, timing is everything, as is the efficiency of the process. Academics appreciate that rejections are part of the fabric of attempting to get a paper published, but they expect the reason to be clear, based on careful evaluation of their work, and not on superficial or unsubstantiated excuses. A desk rejection occurs when a paper gets rejected even before it has entered the peer review process. This paper examines the features of some desk rejections and offers some guidelines that would make desk rejections valid, fair and ethical. Academics who publish are under constant pressure to do so quickly, but effectively. They are dependent on the editors’ good judgment and the publisher’s procedures. Unfair, unsubstantiated, or tardy desk rejections disadvantage academics, and editors and publishers must be held accountable for wasting their time, resources, and patience. (shrink)

Over recent years, the research community has been increasingly using preprint servers to share manuscripts that are not yet peer-reviewed. Even if it enables quick dissemination of research findings, this practice raises several challenges in publication ethics and integrity. In particular, preprints have become an important source of information for stakeholders interested in COVID19 research developments, including traditional media, social media, and policy makers. Despite caveats about their nature, many users can still confuse pre-prints with peer-reviewed manuscripts. If unconfirmed (...) but already widely shared first-draft results later prove wrong or misinterpreted, it can be very difficult to “unlearn” what we thought was true. Complexity further increases if unconfirmed findings have been used to inform guidelines. To help achieve a balance between early access to research findings and its negative consequences, we formulated five recommendations: (a) consensus should be sought on a term clearer than ‘pre-print’, such as ‘Unrefereed manuscript’, “Manuscript awaiting peer review” or ‘’Non-reviewed manuscript”; (b) Caveats about unrefereed manuscripts should be prominent on their first page, and each page should include a red watermark stating ‘Caution—Not Peer Reviewed’; (c) pre-print authors should certify that their manuscript will be submitted to a peer-review journal, and should regularly update the manuscript status; (d) high level consultations should be convened, to formulate clear principles and policies for the publication and dissemination of non-peer reviewed research results; (e) in the longer term, an international initiative to certify servers that comply with good practices could be envisaged. (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)

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)

Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines recommend that parents or another proxy provide legal consent for children to participate, but that children should be involved in the decision through providing assent. However, there remain uncertainties about how to judge when children are ready to give assent and about appropriate assent processes. Malawi does not yet have (...) detailed guidelines on assent. Understanding perspectives among children and their parents can assist in developing contextually-appropriate assent guidance. Qualitative research was conducted with children and parents in three settings in Southern Malawi, to take account of any variations between socioeconomic and cultural contexts. In each setting, interviews were conducted with parents and their children who had participated in paediatric research to understand their experiences of assent and views on appropriate assent practice. Focus groups were also conducted with children and parents, to understand broader social perspectives. We found widespread support for involving children in decisions on research participation. Participants identified a range of factors that affect children’s capacity to give assent, including intellectual capacity, emotional development, life experience and cultural norms. Age was often mentioned as a consideration, but deemed an unreliable sole indicator of capacity to assent. In relation to appropriate assent processes, participants emphasised considerations such as supporting effective understanding and minimizing harms. Views on how to achieve these aims varied; for example, there were different ideas about the appropriate order in which to approach children and parents, and about whose decision to respect in the event of disagreement. Parents and children agreed about the value of involving children in decisions on research, and about the need to promote children’s decision-making capacity while respecting parents’ interests in children’s welfare. Developing practical guidance that meets these principles is challenging, particularly given the need for flexible approaches that suit different study types, children’s capacities and family environments. Further discussion within the Malawi research and ethics community will help develop contextually-appropriate guidelines. (shrink)

This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, and suggests (...) procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees. (shrink)

Numerous recommendations and guidelines aim to improve the quality, timeliness and transparency of medical publications. However, these guidelines use ambiguous language that can be challenging to interpret, particularly for speakers of English as a second language. Cultural expectations within the Asia-Pacific region raise additional challenges and several studies have suggested that awareness and application of ethical publication practices in the Asia-Pacific region is relatively low compared with other regions. However, guidance on applying ethical publication practice guidelines (...) in the Asia-Pacific region is lacking. This commentary aims to improve publication practices in the Asia-Pacific region by providing guidance on applying the 10 principles of the Good Publication Practice 3 (GPP3) guidelines and the International Committee of Medical Journal Editors (ICMJE) criteria for authorship. Recommendations are provided for encore presentations, applying the ICMJE authorship criteria in the context of regional cultural expectations, and the role of study sponsors and professional medical writers. Ongoing barriers to compliance with guidelines are also highlighted, and additional guidance is provided to support authors submitting manuscripts for publication. The roles of regional journals, regulatory authorities and professional bodies in improving practices are also discussed. (shrink)

Research ethics is a very exciting field at the moment. Important public debate is continuing at national and international levels, concerning the proposed revisions to the Declaration of Helsinki and the Council for the International Organisation of Medical Sciences (CIOMS) guidelines, the proposed European clinical trials directive and the recent Good Clinical Practice guidelines. There is also debate about obtaining, using and storing genetic, and tissue, samples. This ferment has resulted in a wealth of guidelines (...) and learned articles, but as yet there are few useful and up-to-date book-length discussions of the field. This is partly due to the increasing diversity of types of research (including research design), and the variety of the contexts of research (the hospital-based clinical trial is arguably no longer typical of medical research). However, it is also to do with what such a book is supposed to do. Recent works like Baruch Brody's Ethics of Biomedical Research (OUP, 1998) give, in effect, an …. (shrink)

Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained.

German medical schools have not yet sufficiently introduced students to the field of good scientific practice. In order to prevent scientific misconduct and to foster scientific integrity, courses on GSP must be an integral part of the curriculum of medical students. Based on a review of the literature, teaching units and materials for two courses on GSP were developed and tested in a pilot course. The pilot course was accompanied by a pre-post evaluation that assessed students’ knowledge and (...) attitudes towards scientific integrity and scientific misconduct. A syllabus was designed that comprised the following six topics: theoretical foundations of GSP; scientific publishing; empirical data; scientific supervision and teamwork; clinical research; personal interests. The comparison pre versus post-intervention yielded statistically significant changes in regard to the participants’ knowledge and attitude toward all forms of scientific misconduct treated in the course. As the majority of participants was not familiar with the fundamental regulations or guidelines of GSP, it seems crucial to train students in actively applying such norms to real-world conflicts. Students’ unfamiliarity with the fundamentals of GSP can be linked to the fact that many students have already experienced forms of scientific misconduct. Thus, GSP syllabi should be closely adjusted to a student’s realm of experience. All in all, courses on GSP can be seen as a potential means to increase the number of young scholars. (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)

Gaski (1999) is critical of marketing ethics and suggests that its ethical guidelines amount to no more than "obey the law" and "act in your self-interest". This reply questions Gaski''s critique and clarifies possible misconceptions about the field that might otherwise result. It identifies the limitations and assumptions of Gaski''s argument and shows that there are exceptions to his central proposition even when narrowly circumscribed. It is not disputed that there is merit to reminding managers of their obligations to (...) obey the law and to act in their enlightened self-interest. However, although fulfilling these obligations is generally a necessary requirement for good conduct, it is not sufficient. There are situations where ethics demands more of marketing managers than "obey the law" and "act in your self-interest". In addition, managers may face situations where ethics, the law and self-interest are inconsistent. The article incorporates observations on the role of normative marketing ethics, including the requirement to develop ethical theory for marketing as well as ethical guidelines. (shrink)

BackgroundThere is growing interest in the collection, storage and reuse of biological samples for future research. Storage and future use of biological samples raise ethical concerns and questions about approaches that safeguard the interests of participants. The situation is further complicated in Africa where there is a general lack of governing ethical frameworks that could guide the research community on appropriate approaches for sample storage and use. Furthermore, there is limited empirical data to guide development of such frameworks. A qualitative (...) study to address this gap was conducted with key stakeholders in Malawi to understand their experiences and perspectives regarding storage and usage of samples for future research.MethodsThis study conducted 13 in-depth interviews with ethics committee members, regulators and researchers, and five focus group discussions with community representatives and clinical trial participants in Malawi. Interviews and focus group discussions were audio-recorded, transcribed verbatim, and thematically analysed.ResultsOn the current regulatory guidelines that governs the collection, storage and reuse of samples in Malawi, participants highlighted their different understanding of it, with some indicating that it prohibited the reuse and sharing of samples, while others believed it permitted.Views on the informed consent model used in Malawi, some stakeholders expressed that the current model limited options for sample contributors regarding future use. Researchers supported storing samples for future use in order to maximize their value and reduce research costs. However, they expressed concern over the exportation of samples highlighting that it could lead to misuse and would not support the development of research capacity within Malawi. They recommended use of broad consent or tiered consent and establishment of biobanks to address these concerns.ConclusionsStudy findings highlighted the need for a review of the current regulatory guideline and the development of infrastructure to support the use of stored biological samples for future use among the research community in Malawi. At the moment, there are ethical and practical concerns arising from the collection, storage and secondary use of biological samples make it hard to reconcile scientific progress and the protection of participants. (shrink)

Ontology engineering is mainly done by domain experts who are specialists in their domain but have, if at all, limited knowledge in logics, computer science, or analytic philosophy. The literature on formal ontologies and biomedical ontologies is neither suited nor intended to serve as an educational resource that would help domain experts to become good ontologists. Existing educational resources focus rather on ontology tools and languages than on good practice. The purpose of the GoodOD guideline is to (...) pave the road for domain experts who want (or need) to become ontology engineers. It pursues the openly pragmatic approach that ontology engineers only need to know ontology theory to the extent which supports the (measurable) outcome of their work. The GoodOD Guideline builds upon given philosophical and methodological principles as well as preexisting tools and resources. In particular (pragmatic) scientific realism, first order logics and its subset OWL-DL (description logics), set theory, an upper-level ontology with high-level categories and a canonic set of relations, constraints which limit the freedom of choice when building coordinate expressions, the ontology editor Protégé 4, a complete DL reasoner, such as HermIT, ontology design patterns, and naming conventions. -/- Given these precepts the guideline contains all the knowledge to be acquired by a user to be able to solve ontology engineering problems in a foreseeable and non-arbitrary way. The didactic concept is to convey the skills not only by theory but also by practical examples. (shrink)

It is well known that prisoners’ human rights are often violated. In this chapter we examine whether guidelines can be effective in preventing such violations and in helping physicians resolve the significant conflicts of interest that they often face in trying to protect prisoners’ rights. We begin by explaining the role of clinical and ethical guidelines outside prisons, in the context of healthcare for non-incarcerated prisoners, and then the specific role of such guidelines within prisons, where the (...) main concerns are ensuring respect for the principle of equivalence of care, and for a prisoner patient’s autonomy in health care decisions. After reviewing and analysing various national and international guidelines, we review the literature and assess whether the good practices set out in these guidelines actually translate into changes in professional behaviour and consequent benefits for prisoners. It emerges that physicians both outside and within prisons tend to be insufficiently familiar with the relevant guidelines, and that they too infrequently use the guidance to make decisions, preferring instead to use personal codes of conduct. Guidelines designed specifically for the prison context are important to ensure equivalence of care and should be better known by health care personnel and other professional groups working in prison. Further guidelines should be developed that describe challenging situations and provide concrete guidance as to how to deal with them. (shrink)

“Evidence based medicine” is often seen as a scientific tool for quality improvement, even though its application requires the combination of scientific facts with value judgments and the costing of different treatments. How this is done depends on whether we approach the problem from the perspective of individual patients, doctors, or public health administrators. Evidence based medicine exerts a fundamental influence on certain key aspects of medical professionalism. Since, when clinical practice guidelines are created, costs affect the content (...) of EBM, EBM inevitably becomes a form of rationing and adopts a public health point of view. This challenges traditional professionalism in much the same way as managed care has done in the US. Here we chart some of these major philosophical issues and show why simple solutions cannot be found. The profession needs to pay more attention to different uses of EBM in order to preserve the good aspects of professionalism. (shrink)

In Good Citizens: Creating Enlightened Society, Thich Nhat Hanh lays out the foundation for an international solidarity movement based on a shared sense of compassion, mindful consumption, and right action. Following these principles, he believes, is the path to world peace. The book is based on our increased global interconnectedness and subsequent need for harmonious communication and a shared ethic to make our increasingly globalized world a more peaceful place. The book will be appreciated by people of all faiths (...) and cultural backgrounds. While based on the basic Buddhist teachings of the Four Noble Truths and the Eight-Fold Path, Thich Nhat Hanh boldly leaves Buddhist terms behind as he offers his contribution to the creation of a truly global and nondenominational blueprint to overcoming deep-seated divisions and a vision of a world in harmony and the preservation of the planet. Key topics include the true root causes of discrimination; the exploration of the various forms of violence; economic, social, and sexual violence. He encourages the reader to practice nonviolence in all daily interactions, elaborates on the practice of generosity, and teaches the art of deep listening and loving speech to help reach a compromise and reestablish communication after misunderstandings have escalated into conflicts. Good Citizens also contains a new wording of the Five Mindfulness Trainings (traditionally called "precepts") for lay practitioners, bringing them in line with modern-day needs and realities. In their new form they are concrete and practical guidelines of ethical conduct that can be accepted by all traditions. Good Citizens also includes the complete text of the UN Manifesto 2000, a declaration of transforming violence and creating a culture of peace for the benefit of the children of the world. It was drafted by numerous Peace Nobel Prize recipients and signed by over 100 million people worldwide. Coinciding with a US presidential election year, Good Citizens reaches across all political backgrounds and faith traditions. It shows that dualistic thinking--Republican/Democrat, Christian/Muslim--creates tension and a false sense of separateness. When we realize that we share a common ethic and moral code, we can create a community that can change the world. (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)

The aim of the present study was to describe and explore the perception of ethical guidelines and their role in ethical competence-building among Swedish physicians and research nurses. Twelve informants were interviewed in depth. The results demonstrated that the informants had a critical attitude towards ethical guidelines and claimed to make little use of them in practical moral judgements. Ethical competence was seen primarily as character-building, related to virtues such as being empathic, honest and loyal to patients. Ethical (...) competence was assumed to be learned through good examples, role models and practical experience, while ethical guidelines were not perceived as valuable in this process. In order to improve the staff's familiarity with and the usability of ethical guidelines, the workplace needs to provide opportunities for ethical dialogues. In such discussions, argumentation can improve, virtues can be developed and guidelines can be usefully invoked. (shrink)

Two practical measures that have been introduced in an effort to stop sports parents from behaving badly will be critically discussed. The first measure is known under the slogan quiet weekends'. These prohibit parents from attending games in which their child is participating. Although this strategy calls attention to an important issue, it is unfair. The second, and far more elaborate, measure is to have a set of ethical guidelines informing parents how they should behave towards their child and (...) others in the context of sport. Two central values tend to run through these guidelines: namely parental concern for the child's autonomy and parental concern for the child's well-being. These values are discussed as I apply them to cases in what can be called a grey area, where it is not obvious what is morally right or wrong. In the concluding discussion a tentative checklist will be presented which good sports parents can use when they are confronted with ethical issues. (shrink)

The idea of artificial intelligence for social good is gaining traction within information societies in general and the AI community in particular. It has the potential to tackle social problems through the development of AI-based solutions. Yet, to date, there is only limited understanding of what makes AI socially good in theory, what counts as AI4SG in practice, and how to reproduce its initial successes in terms of policies. This article addresses this gap by identifying seven ethical (...) factors that are essential for future AI4SG initiatives. The analysis is supported by 27 case examples of AI4SG projects. Some of these factors are almost entirely novel to AI, while the significance of other factors is heightened by the use of AI. From each of these factors, corresponding best practices are formulated which, subject to context and balance, may serve as preliminary guidelines to ensure that well-designed AI is more likely to serve the social good. (shrink)

Background: In order to improve ontology quality, tool- and language-related tutorials are not sufficient. Care must be taken to provide optimized curricula for teaching the representational language in the context of a semantically rich upper level ontology. The constraints provided by rigid top and upper level models assure that the ontologies built are not only logically consistent but also adequately represent the domain of discourse and align to explicitly outlined ontological principles. Finally such a curriculum must take into account the (...) pre-existing skills and knowledge of the target audience. -/- Objective: To develop a well-structured curriculum aligned to the particular requirements of life science professionals, in order to enable them to create logically sound, domain adequate and predicable ontologies using the Web Ontology Language (OWL) in Protégè. -/- Methods: Content selection for the curriculum was based on the literature, pre-existing tutorials, and a guideline for good ontology development (i.e ontology design enhancing domain adequacy, sustainability and interoperability) that drew on the authors previous experiences with large ontology development projects. Learning objectives were formulated according to a needs assessment of the targeted learners, who were students trained in life sciences with basic knowledge and practical skills in computer science. As instructional format we choose an approach with a high amount of practical exercises. The curriculum was first implemented with 24 Students and 7 lecturers/ tutors over 5 full days. The curriculum was evaluated by gathering the participants feedback via a questionnaire. -/- Results: Curricular development produced 16 modules of approximately 2 hours each, which covered basic principles of Applied Ontology, description logic syntax and semantics, as well as best design practices outlined in ontology design patterns and variants of the BioTop upper ontology. An opinion survey based on questionnaires indicated that the participants took advantage from the teaching strategies applied, as they indicated good knowledge gain and acknowledged the relevance of the modules. The difficulty was rated slightly lower. -/- Conclusion: The development of teaching material for principled ontology design and best practices is of crucial importance in order to enhance the quality of biomedical ontologies. Here, we present a curriculum for a week long workshop, leveraging on current educational principles, focusing on interactive hands-on exercises, group interactions, and problem-oriented learning. Whereas evaluation clearly showed the success of this approach, in particular regarding student’s satisfaction, the objective measurement of traceable effects on the quality of the generated ontology, although of much higher interest, has just started. (shrink)

_This is a personal account based on many years experience as a medical writer. It considers aspects of medical writing with particular focus on the intellectual and ethical dilemmas it can raise. What makes medical writing both so interesting and so challenging is the fact that it often takes place at the border between different disciplines. For example, it straddles both science and art. Ethical issues also arise at the boundaries between academia and commerce. Until recently there have been few (...) guidelines to help navigate such potentially dangerous territory. I have been privileged to be involved in developing two such guidelines and I describe how I hope the Good Publication Practice guidelines for pharmaceutical companies and the European Medical Writers Association guidelines may improve the practice of this fascinating profession, Medical Writing._. (shrink)

Purpose The paper aims to analyze the content of the newly published National AI Ethics Guideline in Thailand. Thailand’s ongoing political struggles and transformation has made it a good case to see how a policy document such as a guideline in AI ethics becomes part of the transformations. Looking at how the two are interrelated will help illuminate the political and cultural dynamics of Thailand as well as how governance of ethics itself is conceptualized. Design/methodology/approach The author looks at (...) the history of how the National AI Ethics Guidelines came to be and interprets its content, situating the Guideline within the contemporary history of the country as well as comparing the Guideline with some of the leading existing guidelines. Findings It is found that the Guideline represents an ambivalent and paradoxical nature that characterizes Thailand’s attempt at modernization. On the one hand, there is a desire to join the ranks of the more advanced economies, but, on the other hand, there is also a strong desire to maintain its own traditional values. Thailand has not been successful in resolving this tension yet, and this lack of success is shown in the way that content of the AI Ethics Guideline is presented. Practical implications The findings of the paper could be useful for further attempts in drafting and revising AI ethics guidelines in the future. Originality/value The paper represents the first attempt, so far as the author is aware, to analyze the content of the Thai AI Ethics Guideline critically. (shrink)

In this article, we present a dialogical approach to empirical ethics, based upon hermeneutic ethics and responsive evaluation. Hermeneutic ethics regards experience as the concrete source of moral wisdom. In order to gain a good understanding of moral issues, concrete detailed experiences and perspectives need to be exchanged. Within hermeneutic ethics dialogue is seen as a vehicle for moral learning and developing normative conclusions. Dialogue stands for a specific view on moral epistemology and methodological criteria for moral inquiry. Responsive (...) evaluation involves a structured way of setting up dialogical learning processes, by eliciting stories of participants, exchanging experiences in (homogeneous and heterogeneous) groups and drawing normative conclusions for practice. By combining these traditions we develop both a theoretical and a practical approach to empirical ethics, in which ethical issues are addressed and shaped together with stakeholders in practice. Stakeholders' experiences are not only used as a source for reflection by the ethicist; stakeholders are involved in the process of reflection and analysis, which takes place in a dialogue between participants in practice, facilitated by the ethicist. This dialogical approach to empirical ethics may give rise to questions such as: What contribution does the ethicist make? What role does ethical theory play? What is the relationship between empirical research and ethical theory in the dialogical process? In this article, these questions will be addressed by reflecting upon a project in empirical ethics that was set up in a dialogical way. The aim of this project was to develop and implement normative guidelines with and within practice, in order to improve the practice concerning coercion and compulsion in psychiatry. (shrink)

Using a Rawlsian approach to analyze the ethical implications of data mining within three major codes of ethics used by American marketing firms, the author argues that marketers should re-conceptualize their business conduct, as defined in their individual codes of ethics, to incorporate a Rawlsian concern for society's least advantaged members. Rawls's concept of primary goods provides the framework for the argument that anonymity, a component of privacy, is vital for consumers whose autonomy is affected by data mining. A combination (...) of practical measures, ethical guidelines, and legislative protections are recommended for minimizing concerns about data mining, while still allowing for commercial advantages provided by the practice. (shrink)

Biobanks correspond to different situations: research and technological development, medical diagnosis or therapeutic activities. Their status is not clearly defined. We aimed to investigate human biobanking in Europe, particularly in relation to organisational, economic and ethical issues in various national contexts. Data from a survey in six EU countries were collected as part of a European Research Project examining human and non-human biobanking. A total of 147 institutions concerned with biobanking of human samples and data were investigated by questionnaires and (...) interviews. Most institutions surveyed belong to the public or private non-profit-making sectors, which have a key role in biobanking. This activity is increasing in all countries because few samples are discarded and genetic research is proliferating. Collections vary in size, many being small and only a few very large. Their purpose is often research, or research and healthcare, mostly in the context of disease studies. A specific budget is very rarely allocated to biobanking and costs are not often evaluated. Samples are usually provided free of charge and gifts and exchanges are the common rule. Good practice guidelines are generally followed and quality controls are performed but quality procedures are not always clearly explained. Associated data are usually computerised. Biobankers generally favour centralisation of data rather than of samples. Legal and ethical harmonisation within Europe is considered likely to facilitate international collaboration. We propose a series of recommendations and suggestions arising from the EUROGENBANK project. (shrink)

Reviews of research and development collaborations with indigenous communities have exhibited numerous challenges related to researcher–community interactions. Based on many accounts of indiscretions, indigenous communities have begun generating conduct guidelines for researchers. However, the effectiveness of their chosen communication methods, guaranteeing appropriate behavior of the researchers, has not been established. This research contributes to an ongoing debate around appropriate ethical conduct of researchers in situ. The aim of this study was to investigate the interpretation accuracy of interaction guidelines (...) produced in the form of sketches by a Malaysian indigenous community. We provided eight interaction sketches to 57 students, in three continents, for interpretation and expression of their intended behavior. We found that most were unable to accurately interpret the sketches and describe intended behavioral responses. A major concern remains with the tendency to fall back on prior practices of “good” behavior, with minimal guidance on contextual practices. In an attempt to provide greater direction, we explored a speech bubble exercise with further 15 students. Our findings directly contribute to current efforts in formulating researcher–community interaction practices that should form the basis of ethical research in situ. (shrink)

Companies that contribute to charitable organizations rightly hope that their philanthropic work will also be good for the bottom line. Marketers of good corporate conduct must be especially careful, however, to market such conduct in a morally acceptable fashion. Although marketers typically engage in mild deception or take artistic license when marketing goods and services, these sorts of practices are far more morally troublesome when used to market good corporate conduct. I argue that although mild deception is (...) not substantially worrisome with respect to the marketing of most goods and services, it is a far greater moral blunder to use such methods in the marketing of good corporate character. These erode trust and demonstrate alack of adequate respect for the moral good. In light of these concerns, I suggest that such practices must be re-examined when applied to the marketing of corporate character and good conduct. Finally, I develop a revised set of ethical guidelines that are needed in order to address the problems peculiar to the marketing of morally praiseworthy behavior. (shrink)

There is an increasing recognition of the need to provide ways for people to raise concerns about suspected wrongdoing by promoting internal policies and procedures which offer proper safeguards to actual and potential whistleblowers. Many organisations in both the public and private sectors now have such measures and these display a wide variety of operating modalities: in-house or outsourced, anonymous/confidential/identified, multi or single tiered, specified or open subject matter, etc. As a result of this development, a number of guidelines (...) and policy documents have been produced by authoritative bodies. This article reviews the following five documents from a management perspective, the first two deal with the principles upon which legislation might be based and the others describing good management practice: the Council of Europe Resolution 1729 (COER); Transparency International ‘Recommended Principles for Whistleblowing Legislation’ (TI); European Union Article 29 Data Protection Working Party Opinion (EUWP); International Chamber of Commerce ‘Guidelines on Whistleblowing’ (ICC); and the British Standards Institute ‘Whistleblowing arrangements Code of Practice 2008 (BSI). (shrink)

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for (...) International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. (shrink)

Ethics, communication skills, and the law ('practice skills') are important in all aspects of modern health care. Doctors and nurses must be sensitive to the ethical aspects of their work and understand the legal framework within which clinical decisions are made. Well developed skills of communication, with patients, their relatives and other members of the clinical team, are a key feature of good clinical practice Until recently, the important of practice skills has been relatively neglected in (...) health care education. This situation is changing. The UK General Medical Council, for example, has recently identified three aspects as part of the core of the medical course, and the move to degree courses in nursing has led to an increasing focus of practice skills in nurse education. The Oxford Practice Skills Project (OPSP) team have developed a course, within the University of Oxford Clinical School, which covers the teaching of practice skills in an integrated manner. This course is widely recognized as one of the most systematic developments of education in these areas. This manual describes the OPSP course in detail and provides teaching materials. Although developed initially for medical students, it should be helpful to all those involved in teaching ethics, communication skills, and law in health care. Each Seminar is described in detail Tutors' guides are provided Student handouts are included Contains guidelines for introducing 'practice skills' into a busy clinical curriculum Includes over forty case histories for teaching and examination Gives details of many useful sources and resources Details a variety of teaching methods together with their advantages and disadvantages Provides an ethics teaching toolkit for clinical teachers new to this area Readers are welcome to photocopy any part of this manual for their own teaching. (shrink)

Jennifer Saul is Waterloo Chair in Social and Political Philosophy of Language at the University of Waterloo. Originally American, she spent twenty-four years at the University of Sheffield in the United Kingdom. Her current focus is manipulative political language, which she explores in Dogwhistles and Figleaves: Linguistics Tricks for Racist and Conspiracist Discourse (forthcoming, Oxford, 2024). She has also written books and articles on feminism, lying and misleading, and implicit bias. She founded the blogs What is it Like to be (...) a Woman in Philosophy and Feminist Philosophers, and was Director of the Society for Women in Philosophy UK 2009–19. Along with Helen Beebee, she published two reports (in 2011 and 2021) on the state of women in philosophy in the UK and drew up good practice guidelines which have been adopted by dozens of departments. She’s also proud of having been a philosophical consultant on a zombie movie. (shrink)

The act of welcoming is often the first step in shaping the participatory contours of a collective’s social landscape. How and if individuals are invited into a space is often a product of the formal and informal social mechanisms used to facilitate newcomer or returner inclusion or exclusion. Notably, philosopher Iris Marion Young points out that greetings, as everyday communicative gestures, amount to acts of public acknowledgment. Moreover, during a successful greeting, Young argues that greeters announce themselves as “ready to (...) listen” and “takes responsibility for her relationship to her interlocutors,” in addition to meeting the greeted’s basic need for recognition. In light of these observations, this paper argues that we have good reasons to think that welcomings, as a subcategory of greetings, require us to adapt our classroom communication norms, policies, assignments, and curricula in important ways. Specifically, they should change to publicly acknowledge our students’ dignity as potential knowers; to see them as contributors to the classroom space. Additionally, this paper offers a non-exhaustive list of three guidelines that can be useful when navigating these efforts and the challenges associated with the practice of welcoming. (shrink)

In December, the National Data Guardian 1 for health and care in England, Dame Fiona Caldicott, published the outcomes of a public consultation about the Caldicott Principles and the role of Caldicott Guardians.1 The Caldicott Principles are good practice guidelines which have been used by health and social care organisations in the UK since 1997 to ensure that people’s data are kept safe and used in an ethical way.2 The role of the Caldicott Guardian is well-established in (...) the UK. Caldicott Guardians are senior people which support the upholding of the Caldicott Principles within organisations. In response to views expressed during the consultation the NDG has added an eighth Caldicott Principle to the existing seven and will use her statutory powers to issue guidance about the appointment of Caldicott Guardians for health and adult social care organisations. The new eighth Caldicott Principle is: ‘Inform patients and service users about how their confidential information is used’. It provides that: > A range of steps should be taken to ensure no surprises for patients and service users, so they can have clear expectations about how and why their confidential information is used, and what choices they have about this. These steps will vary depending on the use: as a minimum, this should include providing accessible, relevant and appropriate information - in some cases, greater engagement will be required. The NDG explains that the introduction of the new principle was prompted by consideration of the role that the legal concept of ‘reasonable expectations’ should play in shaping the circumstances under which health and care data may be legitimately shared. The NDG does not envisage that this principle will establish reasonable expectations as a legal basis in its own right …. (shrink)

This article proposes a retrospective analysis of a compassionate use, using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific ethical and clinical profiles that emerge from the compassionate use program issue. The secondary goals are: a) to promote (...) a moral reflection among physicians who require approval for the CUP and b) provide the basis for recommendations on how to request CUP. The instruments for carrying out the analysis of the case study and the discussion are as follows: Analysis of the audio-recording of the EC meeting regarding the selected Case study. In-depth discussion of topics that emerged during the meeting by means of administration of 5 semi-structured interviews with 2 doctors involved in the case and with 3 components of the EC who played a major role in the EC internal discussion. In an exploration of emerging clinical and ethical issues, four primary themes arise: 1. efficacy, safety of the treatment and patient’s quality of life; 2. clear, realistic, adequate communication; 3. right to hope; 4. simultaneous Palliative Care approach. The results of ethical analysis carried out concern two areas: 1) ethical profiles relating to the use of CUP; 2) the role of the EC concerning the compassionate use of drugs and the need to provide recommendations on how to request CUP. With the aim of implementing these conclusions, the provincial EC of Reggio Emilia chose to steer the request for drugs for compassionate use through recommendations for good clinical and ethical practice based on the following assumptions: 1) the “simultaneous care” approach must be preferred. Secondly, 2) the EC’s assessment must be part of the decision-making process that the care team conducts before proposing compassionate use to the patient. (shrink)