WorldWideScience

Sample records for clinical ethics revisited

  1. Revisiting Ethics in Correspondence Testing

    OpenAIRE

    Zschirnt, Eva

    2017-01-01

    Questions of research ethics always arise when planning a correspondence test to study discrimination in the market place. However, the issue is addressed relatively little in published correspondence tests with authors usually referring to the two seminal articles written in this field (i.e. Banton (1997) and Riach and Rich (2004)). Since then correspondence testing has become more widespread and the technique is increasingly relying on the internet to find and send applications. It is there...

  2. Clinical ethics and happiness.

    Science.gov (United States)

    Devettere, R J

    1993-02-01

    Most contemporary accounts of clinical ethics do not explain why clinicians should be ethical. Those few that do attempt an explanation usually claim that clinicians should be ethical because ethical behavior provides an important good for the patient--better care. Both these approaches ignore the customary traditional reason for being ethical, namely, the good of the moral agent. This good was commonly called 'happiness'. The following article shows how the personal happiness of the moral agent provided a major reason for being ethical in the ancient philosophical and biblical traditions and how it continues to play a role in the more modern rights-based, Kantian and utilitarian theories. This history suggests that the personal happiness of the clinician, rightly understood, is a legitimate and important goal of clinical ethics.

  3. Revisiting eco-ethics and econ-ethics

    Directory of Open Access Journals (Sweden)

    Otto Kinne

    2002-11-01

    Full Text Available Modern humanity can survive only if traditional ethics are extended to include eco-ethics and econ-ethics. Success or failure in developing and implementing these new ethical constructs will affect the fate of our species Homo sapiens and that of millions of other forms of life. In the long run failure to accept and apply eco-ethics and econ-ethics would reduce the capacities of Planet Earth to support life.

  4. [Continuing education in ethics: from clinical ethics to institutional ethics].

    Science.gov (United States)

    Brazeau-Lamontagne, Lucie

    2012-01-01

    The mandate of the Ethics Committee of the Conseil de médecins, dentistes et pharmaciens (CMDP) at the Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec is three-fold: to guide the clinical decision; to address the institutional ethical function; to create the program for continuing education in ethics (Formation éthique continue or FEC). Might FEC be the means of bridging from individual ethics to institutional ethics at a hospital? To take the FEC perspectives considered appropriate for doctors and consider them for validation or disproving in the context of those of other professionals. Situate the proposed FEC mandate in a reference framework to evaluate (or triangulate) the clinical decision and the institutional ethic. CONVICTION: Sustainable professional development for doctors (DPD) includes ethics; it cannot be ignored. Without constant attention to upgrading one's abilities in professional ethics, these suffer the same fate as other professional aptitudes and competences (for example, techniques and scientific knowledge): decay.

  5. The Ethics of Social Work Supervision Revisited.

    Science.gov (United States)

    Cohen, Ben-Zion

    1987-01-01

    Charles Levy's classic 1973 article outlined a set of basic value-orientations for supervisors. Attempts to operationalize Levy's principles in order to develop practical guidelines for ethical practice. Discusses problem of "careerism" in social worker supervisors. Recommends supervisors examine ethical implications of their behavior.…

  6. revisiting the ethics of genome generation

    Indian Academy of Sciences (India)

    This paper will explore some of the ethical imperatives that have shaped strategic and policy frameworks for the use of new genetic technologies and how these play a role in shaping the nature of research and changing attitudes; with an attempt to conceptualize some theories of genetic determinism. I analyse why there is ...

  7. Ethics of clinical trials.

    Science.gov (United States)

    Palter, S F

    1996-05-01

    The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in this context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond those of the patient's health, into the doctor-patient therapeutic alliance. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocratic oath dictate that the physician must respect the individual patient's rights and hold such interests paramount. These principles are the basis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship.

  8. Radiation protection in medicine: Ethical framework revisited

    International Nuclear Information System (INIS)

    Malone, J. F.

    2009-01-01

    The ethical framework within which medicine operates has changed radically over the last two decades. This has been stimulated by events leading to controversy, such as the infant organ retention scandals; concerns about blood products; self regulation of medical practice in the wake of the Harold Shipman Enquiry in the UK; and many other events. It has become obvious following investigations and/or public enquiries that a gap has opened up between what is acceptable to the public on the one hand, and what appears reasonable to, or is at least accepted by, the professionals involved on the other. This paper reviews these issues and some conclusions of a workshop held to consider them. It places the developments in the context of the idea that the approach to problems and communication in a group of people/professionals such as doctors, radiologists, radiation protection specialists, or even the general public may be regarded as a 'culture'. Current practice of radiation protection in medicine is examined in the light of these considerations. (authors)

  9. Four Roles of Ethical Theory in Clinical Ethics Consultation.

    Science.gov (United States)

    Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

    2016-09-01

    When clinical ethics committee members discuss a complex ethical dilemma, what use do they have for normative ethical theories? Members without training in ethical theory may still contribute to a pointed and nuanced analysis. Nonetheless, the knowledge and use of ethical theories can play four important roles: aiding in the initial awareness and identification of the moral challenges, assisting in the analysis and argumentation, contributing to a sound process and dialogue, and inspiring an attitude of reflexivity. These four roles of ethical theory in clinical ethics consultation are described and their significance highlighted, while an example case is used as an illustration throughout.

  10. Expertise, Ethics Expertise, and Clinical Ethics Consultation: Achieving Terminological Clarity

    Science.gov (United States)

    Iltis, Ana S.; Sheehan, Mark

    2016-01-01

    The language of ethics expertise has become particularly important in bioethics in light of efforts to establish the value of the clinical ethics consultation (CEC), to specify who is qualified to function as a clinical ethics consultant, and to characterize how one should evaluate whether or not a person is so qualified. Supporters and skeptics about the possibility of ethics expertise use the language of ethics expertise in ways that reflect competing views about what ethics expertise entails. We argue for clarity in understanding the nature of expertise and ethics expertise. To be an ethics expert, we argue, is to be an expert in knowing what ought to be done. Any attempt to articulate expertise with respect to knowing what ought to be done must include an account of ethics that specifies the nature of moral truth and the means by which we access this truth or a theoretical account of ethics such that expertise in another domain is linked to knowing or being better at judging what ought to be done and the standards by which this “knowing” or “being better at judging” is determined. We conclude with a discussion of the implications of our analysis for the literature on ethics expertise in CEC. We do think that there are clear domains in which a clinical ethics consultant might be expert but we are skeptical about the possibility that this includes ethics expertise. Clinical ethics consultants should not be referred to as ethics experts. PMID:27256848

  11. Ethical problems in clinical psychopharmacology.

    Science.gov (United States)

    Müller-Oerlinghausen, B

    1978-10-01

    The present article originates from some intriguing problems which the author, working as a clinical pharmacologist and psychiatrist, was faced with during clinical investigations. Practical difficulties appearing at first glance as of a rather methodological nature often reveal themselves as ethical questions. Investigation of psychotropic drugs in normal volunteers as well as in psychiatric patients is taken as a model to exemplify certain fundamental ethical aspects of medical research. It is emphasized that the "solution" of ethical problems cannot be achieved by referring to a given code of norms which themselves depend on certain historical circumstances, but rather by recognizing and reasoning the conflicts which result from various moral maxims. Clinical psychopharmacology should not only be conscious of its methodological shortcomings and future goals but also accept the justification of discussions about the ethical and legal questions involved in its dealings and take an active part in these debates. With regard to the relationship between patient and investigator, "solidarity" [23] instead of ongoing paternalism or legal formalism, appears to be a realistic goal. This is also true in the area of psychopharmacological research.

  12. Meta-analysis in clinical trials revisited.

    Science.gov (United States)

    DerSimonian, Rebecca; Laird, Nan

    2015-11-01

    In this paper, we revisit a 1986 article we published in this Journal, Meta-Analysis in Clinical Trials, where we introduced a random-effects model to summarize the evidence about treatment efficacy from a number of related clinical trials. Because of its simplicity and ease of implementation, our approach has been widely used (with more than 12,000 citations to date) and the "DerSimonian and Laird method" is now often referred to as the 'standard approach' or a 'popular' method for meta-analysis in medical and clinical research. The method is especially useful for providing an overall effect estimate and for characterizing the heterogeneity of effects across a series of studies. Here, we review the background that led to the original 1986 article, briefly describe the random-effects approach for meta-analysis, explore its use in various settings and trends over time and recommend a refinement to the method using a robust variance estimator for testing overall effect. We conclude with a discussion of repurposing the method for Big Data meta-analysis and Genome Wide Association Studies for studying the importance of genetic variants in complex diseases. Published by Elsevier Inc.

  13. Ethics in clinical research: The Indian perspective

    OpenAIRE

    J Sanmukhani; C B Tripathi

    2011-01-01

    Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organiza...

  14. Regulating clinical trials in India: the economics of ethics.

    Science.gov (United States)

    Porter, Gerard

    2017-07-09

    The relationship between the ethical standards for the governance of clinical trials and market forces can be complex and problematic. This article uses India as a case study to explore this nexus. From the mid-2000s, India became a popular destination for foreign-sponsored clinical trials. The Indian government had sought to both attract clinical trials and ensure these would be run in line with internationally accepted ethical norms. Reports of controversial medical research, however, triggered debate about the robustness and suitability of India's regulatory system. In response to civil society pressure and interventions by the Supreme Court, the Indian government proposed additional measures aimed at strengthening protections for clinical trial participants. Whilst the reforms can be seen as a victory for human rights activists, they have also been criticised as being overly burdensome for sponsors. Indeed, their announcement prompted an exodus of clinical trials from India. Fearful of losing business to 'rival' countries, the Indian government is revisiting some of its proposals. The Indian example suggests that research ethics frameworks and national policies for economic development are increasingly intertwined. Host countries are in theory free to improve the lot of research participants, but doing so may make them appear less attractive to foreign sponsors, who can simply shift their activities to more industry-friendly jurisdictions. Although these economic pressures are unlikely to lead to a regulatory 'race to the bottom', they may limit host countries' ability to enact socially desirable reforms. © 2017 John Wiley & Sons Ltd.

  15. Impact of ethical climate on moral distress revisited: multidimensional view.

    Science.gov (United States)

    Atabay, Gülem; Çangarli, Burcu Güneri; Penbek, Şebnem

    2015-02-01

    Moral distress is a major problem in nursing profession. Researchers identified that the stronger the ethical basis of the organization, the less moral distress is reported. However, different ethical climates may have different impacts on moral distress. Moreover, conceptualization of moral distress and ethical climate as well as their relationship may change according to the cultural context. The main aim of the study is to investigate the relationship between different types of ethical climate as described in Victor and Cullen's framework, and moral distress intensity among nurses in Turkish healthcare settings. An online survey was administrated to collect data. Questionnaires included moral distress and ethical climate scales in addition to demographic questions. Data were collected from registered nurses in Turkey. In all, 201 of 279 nurses completed questionnaires, resulting in a response rate of 72%. Ethical approval was obtained from the university to which the authors were affiliated, after a detailed investigation of the content and data collection method. Factor analyses showed that moral distress had three dimensions, namely, organizational constraints, misinformed and over-treated patients, and lack of time and resources, while ethical climate had four types, namely, rules, well-being of stakeholders, individualism, and organizational interests. Positive correlations were identified between certain types of ethical climate (rules, individualism, or organizational interests) and moral distress intensity. Factor distribution of the scales shows some commonalities with the findings of previous research. However, context-specific dimensions and types were also detected. No particular ethical climate type was found to have a negative correlation with moral distress. Recommendations were made for reducing the negative impact of ethical climate on moral distress. These include solving the nursing-shortage problem, increasing autonomy, and improving physical

  16. Ethics in the practice of clinical psychology.

    Science.gov (United States)

    Isaac, Rathna

    2009-01-01

    The paper presents an overview of ethical issues in clinical psychology. Specifically, it addresses the broad philosophical ideas and views on mental illness on which ethical principles are based, including Greek philosophy and Christianity. It goes on to describe the ethical code of the American Psychological Association as it pertains to general principles, psychological assessment or psychometry, education or training and psychological interventions. The principles of the code and research on the same are discussed with relevance to issues and challenges to ethical practice in India, and suggestions for ethical conduct are made. The paper emphasises the need to consider different viewpoints and take individual responsibility for difficult decisions.

  17. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  18. After the Financial Crisis: The Ethics and Economics Debate Revisited

    Directory of Open Access Journals (Sweden)

    Jacob Dahl Rendtorff

    2010-03-01

    Full Text Available The recent international events, with a major financial crisis all over the world, involve important questions about the relation between ethics and economics and the responsibilities of the economic market in relation to broader social and political concerns. This paper addresses this issue in five parts 1 Ethics in economic history 2 The neoliberal concept of economics 3 Welfare economics and the criticism of neo-classical concepts of rationality 4 Ethics within economics 5 Economic anthropology and the foundations of rationality.

  19. Ethical Competence Training for Members on Clinical Ethics Committees (CEC)

    DEFF Research Database (Denmark)

    Knox, Jeanette Bresson Ladegaard

    2017-01-01

    To address the moral questions in patient care and medical practice, Danish hospitals are starting to solicit clinical ethics committees (CEC). As in other places around the world, CECs in Denmark is an interdisciplinary group that includes physicians, nurses, social workers, psychologists, lawyers...... lingering moral quandaries. Thus, the creation of CECs in Denmark has raised the question of qualifications for those who serve on a committee. When the Danish Society of Clinical Ethics was formed in 2012, it was therefore at the forefront of its agenda to establish a training program that would offer...... valuable contributions to the ethical aspect of medical decision making and to serve as an important resource for health care providers, patients and their families. This article describes the history, development and preliminary results of the current training program as well as reflects on future ideas...

  20. Ethics in clinical research: the Indian perspective.

    Science.gov (United States)

    Sanmukhani, J; Tripathi, C B

    2011-03-01

    Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

  1. Research ethics for clinical researchers.

    Science.gov (United States)

    Harnett, John D; Neuman, Richard

    2015-01-01

    This chapter describes the history of the development of modern research ethics. The governance of research ethics is discussed and varies according to geographical location. However, the guidelines used for research ethics review are very similar across a wide variety of jurisdictions. The paramount importance of protecting the privacy and confidentiality of research participants is discussed at length. Particular emphasis is placed on the process of informed consent, and step-by-step practical guidelines are described. The issue of research in vulnerable populations is touched upon and guidelines are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards. Issues related to scientific misconduct and research fraud are not dealt with in this paper.

  2. Medical Ethics in Contemporary Clinical Practice

    Directory of Open Access Journals (Sweden)

    John R. Williams

    2005-11-01

    Full Text Available This review article describes and analyzes ethical issues in medical practice, particularly those issues encountered by physicians in their relationships with their patients. These relationships often involve ethical conflicts between 2 or more interests, which physicians need to recognize and resolve. The article deals with 4 topics in clinical practice in which ethical conflicts occur: physicians' duty of confidentiality in a digital environment, their responsibilities for dealing with abuses of the human rights of patients, their role in clinical research, and their relationships with commercial enterprises. The ethical policies of the World Medical Association provide the basis for determining appropriate physician conduct on these matters. The article concludes with reflections on the need for international standards of medical ethics.

  3. Considering virtue: public health and clinical ethics.

    Science.gov (United States)

    Meagher, Karen M

    2011-10-01

    As bioethicists increasingly turn their attention to the profession of public health, many candidate frameworks have been proposed, often with an eye toward articulating the values and foundational concepts that distinguish this practice from curative clinical medicine. First, I will argue that while these suggestions for a distinct ethics of public health are promising, they arise from problems within contemporary bioethics that must be taken into account. Without such cognizance of the impetus for public health ethics, we risk developing a set of ethical resources meant exclusively for public health professionals, thereby neglecting implications for curative medical ethics and the practice of bioethics more broadly. Second, I will present reasons for thinking some of the critiques of dominant contemporary bioethics can be met by a virtue ethics approach. I present a virtue ethics response to criticisms that concern (1) increased rigor in bioethics discourse; (2) the ability of normative theory to accommodate context; and (3) explicit attention to the nature of ethical conflict. I conclude that a virtue ethics approach is a viable avenue for further inquiry, one that leads us away from developing ethics of public health in a vacuum and has the potential for overcoming certain pitfalls of contemporary bioethics discourse. © 2011 Blackwell Publishing Ltd.

  4. [Organizational ethics: a study in ophthalmologic clinics].

    Science.gov (United States)

    Sanches, Maria Aparecida; Scarpi, Marinho Jorge

    2005-01-01

    Research on the field of organizational ethics to investigate to which extent ophthalmologic clinics, inserted in the competitive atmosphere, in the condition of organizations in search of survival, subordinate ethics to competitiveness in the managerial praxis, that is, in the administrative sphere. Kohlberg is taken as theoretical reference, approaching the theme of ethical subordination to competitiveness. The instrument to evaluate moral behaviors of organizations, elaborated by Licht, is applied. The quantitative method is used, adopting analytic instruments, such as Q of Yule and non parametric tests, when dealing with the data of 41 ophthalmologic clinics. The results of the research seem to indicate that administrators of ophthalmologic clinics of greater performance subordinate ethical principles to competitiveness, seeking to assure the survival of the company and, when confronted with the instrument to evaluate their moral behavior, proposed by Kohlberg, have a significantly smaller presence in the postconventional stage than administrators of ophthalmologic clinics with a smaller performance. One may affirm, according to non parametric tests, at the level of significance of 0.05, that the levels of moral development of the two groups differ significantly. The obtained results are according to the literature, especially concerning the "paradox of the ethical subordination and competitiveness". They also suggest that the warrant of the survival of the company tends to reduce the perception of the groups in power regarding the problems that happen in the community, and that a reduction of the ethical values subordinated to competition occurs, and such reduction provokes growing feelings of economical disputes in the social sphere.

  5. [Clinical trials: vulnerability and ethical relativism].

    Science.gov (United States)

    Lima, Cristina

    2005-01-01

    Research in human beings is an important chapter of medical ethics. In recent years, investigation has been taken over by profit driven corporations that must guarantee the medical and commercial application of results. This new model of investigation has generated conflicts of interest in doctor-patient, researcher-subject relationship. The inevitable debate and media reaction has led. These trials of controversial design to regions of the globe where the vulnerability of the populations continues to allow their undertaking. This article includes a historical perspective on experimentation in human beings and the conditions that led to its regulation: the Nuremberg CODE, followed by the Helsinky Declaration in its different versions, and the Belmont Report, that defend the subject according to the ethic of principles used in western medicine. There is then a review of the attempts to change international regulation to reintroduce clinical trials with placebo--which since 1996 is only permitted where there are no therapeutic or diagnostic methods--on populations that would otherwise have no access to treatment. This then leads on to the issue of double standards in medical investigation defended by many investigators and some official entities. The article concludes that it may be prudent to allow local ethical commissions to approve deviation from the established norm if such is necessary to resolve urgent questions of health in the country, but it is unacceptable that any such emergency is used as a reason to reduce the ethical prerequisites, in clinical trials. It also concludes that true urgency is in making available to all who need it the effective products already in existence. Furthermore, that the acceptance of ethical relativism can result in the exploitation of vulnerable third world populations for research programmes that cannot be undertaken in their sponsoring countries due to the ethical restrictions in place.

  6. Barriers and challenges in clinical ethics consultations: the experiences of nine clinical ethics committees.

    Science.gov (United States)

    Pedersen, Reidar; Akre, Victoria; Førde, Reidun

    2009-10-01

    Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, conflict, and 'outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper.

  7. The business of ethics. Hospitals need to focus on managerial ethics as much as clinical ethics.

    Science.gov (United States)

    Weber, L J

    1990-01-01

    Business ethics begins with the recognition of the various values and "goods" involved in judgements of what to do. Four key values are individual rights, individual self-interest, the company's best interest, and the public good. Often a company has to choose which of these goals or values should be subordinated to another. Business ethics, then, must clarify priorities among these values and establish priority principles to resolve conflicts. One approach to contemporary business ethics emphasizes personal integrity, focusing on conflicts of interest; another approach stresses social responsibility, focusing on the effect of company policy on groups and individuals in society. In business, most of the attention to conflicts of interest focuses on the conflict between employee self-interest and the firm's interest. Healthcare organizations may need to focus on potential conflicts between the patient's interest and the institution's or physician's interest. Physician referrals and pharmaceutical companies' marketing practices are two areas with potential conflicts. Not-for-profit organizations have been quicker than the business world to acknowledge social responsibility. In many ways, however, the social impact of healthcare policies and decisions has not been as carefully considered as it should be. Institutionalizing deliberation about clinical ethical issues has helped to raise awareness about the ethical dimensions of medical care. It would also be useful to institutionalize attention to business ethics in healthcare.

  8. Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review.

    Science.gov (United States)

    Rasoal, Dara; Skovdahl, Kirsti; Gifford, Mervyn; Kihlgren, Annica

    2017-12-01

    This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a "bottom-up" perspective might give healthcare personnel opportunities to think and reflect more than a "top-down" perspective. A "bottom-up" approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a "top-down" approach risks removing such moral responsibility.

  9. Clinical ethics consultation's dilemma, and a solution.

    Science.gov (United States)

    Rasmussen, Lisa M

    2011-01-01

    Clinical ethics consultation is on the horns of a dilemma. One horn skewers the field for its lack of standards, while the other horn skewers it for proposing arbitrary or deeply contested foundations. I articulate the dilemma by discussing several critiques of the field and the challenge of formulating standards and suggest that the solution lies, at least until a robust consensus emerges, with establishing a list of proscriptive standards to guide the field.

  10. \\How Can Clinical Ethics Committees Take on Organizational Ethics? Some Practical Suggestions.

    Science.gov (United States)

    Sabin, James E

    2016-01-01

    Although leaders in the field of ethics have for many years pointed to the crucial role that organizations play in shaping healthcare ethics, organizational ethics remains a relatively undeveloped area of ethics activity. Clinical ethics committees are an important source of potential expertise, but new skills will be required. Clinical ethics committees seeking to extend their purview to organizational issues will have to respond to three challenges-how to gain sanction and support for addressing controversial and sensitive issues, how to develop an acceptable process, and how to make a difference on the ground. The article presents practical suggestions for how clinical ethics committees meet these challenges. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  11. Clinical ethics and the role of clinical ethics committees: proposals for a revival. Commentary.

    Science.gov (United States)

    Petrini, Carlo; Ricciardi, Walter

    2017-01-01

    The issue addressed in the paper published by the Italian National Bioethics Committee (NBC) entitled "Clinical ethics committees", is highly significant for many reasons. One of these is the fact that the ethics committees charged with assessing clinical trials have so much responsibility and such a heavy work-load that they have little time available for other tasks such as engaging directly with patients "at the bedside", as a result of which the role of committees responsible for assessing clinical cases is especially important. According to the NBC, the opinions of clinical ethics committees should be formulated jointly and are non-binding. The NBC offers practical proposals not only for the Italian context. While the Italian National Institute of Health (Istituto Superiore di Sanità - ISS) is not involved directly in treating patients, its role in providing guidance is crucial to the national health service and it has always paid special attention to these issues.

  12. A model for ethical practices in clinical phonetics and linguistics.

    Science.gov (United States)

    Powell, Thomas W

    2007-01-01

    The emergence of clinical phonetics and linguistics as an area of scientific inquiry gives rise to the need for guidelines that define ethical and responsible conduct. The diverse membership of the International Clinical Phonetics and Linguistics Association (ICPLA) and the readership of this journal are uniquely suited to consider ethical issues from diverse perspectives. Accordingly, this paper introduces a multi-tiered six-factor model for ethical practices to stimulate discussion of ethical issues.

  13. [Clinical ethics consultation - an integrative model for practice and reflection].

    Science.gov (United States)

    Reiter-Theil, Stella

    2008-07-01

    Broad evidence exists that health care professionals are facing ethical difficulties in patient care demanding a spectrum of useful ethics support services. Clinical ethics consultation is one of these forms of ethics support being effective in the acute setting. An authentic case is presented as an illustration. We introduce an integrative model covering the activities being characteristic for ethics consultation and going beyond "school"-specific approaches. Finally, we formulate some do's and don'ts of ethics consultation that are considered to be key issues for successful practice.

  14. Development of Bioethics and Clinical Ethics in Bulgaria.

    Science.gov (United States)

    Aleksandrova-Yankulovska, Silviya S

    2017-03-01

    Bioethics and clinical ethics emerged from the classical medical ethics in the 1970s of the 20th century. Both fields are new for the Bulgarian academic tradition. The aims of this paper were to demarcate the subject fields of medical ethics, bioethics, and clinical ethics, to present the developments in the field of medical ethics in Bulgaria, to delineate the obstacles to effective ethics education of medical professionals, and to present the results of the application of an adapted bottom-up methodology for clinical ethics consultation in several clinical units in Bulgaria. Extended literature review and application of an adapted METAP methodology for clinical ethics consultation in six clinical units in the Northern Bulgaria between May 2013 and December 2014. Teaching of medical ethics in Bulgaria was introduced in the 1990s and still stands mainly as theoretical expertise without sufficient dilemma training in clinical settings. Earlier studies revealed need of clinical ethics consultation services in our country. METAP methodology was applied in 69 ethics meetings. In 31.9% of them non-medical considerations affected the choice of treatment and 34.8% resulted in reaching consensus between the team and the patient. Participants' opinion about the meetings was highly positive with 87.7% overall satisfaction. Development of bioethics in Bulgaria follows recent worldwide trends. Several ideas could be applied towards increasing the effectiveness of ethics education. Results of the ethics meetings lead to the conclusion that it is a successful and well accepted approach for clinical ethics consultation with a potential for wider introduction in our medical practice.

  15. [Ethical principles of clinical trials in minors].

    Science.gov (United States)

    Koch, H J; Raschka, C

    2002-12-05

    Clinical trials in volunteers and patients are essential to ensure rational treatment of patients. As a rule, drugs are routinely developed for adults, but children are excluded. A major reason for this restriction are ethical justifications, in particular the lack of autonomy on the part of children. The principle of fairness, however, requires that everyone should benefit from progress. Industry, science and society are therefore called upon to find ways of making available safe and adequate treatment for children as quickly as possible, by defining the required conditions for pediatric clinical trials. Important principles are minimal risk, minimal invasivity, rapid decision-making, and careful documentation of trial results. Dynamic ethical principles, such as autonomy and competence in adolescents must be considered on equal footing with existing international GCP guidelines. Aspects of child psychology indicate that the autonomy of adolescents should be respected. Where economic incentives for such trials are absent, for example, in the case of non-pharmacological problems, pediatric trials must be considered a task for society as a whole.

  16. The Ethics of Clinical Care and the Ethics of Clinical Research: Yin and Yang.

    Science.gov (United States)

    Kowalski, Charles J; Hutchinson, Raymond J; Mrdjenovich, Adam J

    2017-02-01

    The Belmont Report's distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  17. Ethical aspects in clinical trials in the CIS, in particular the setting up of ethical committees.

    Science.gov (United States)

    Kubar, Olga

    2005-01-01

    The ethical aspects of clinical trials in the CIS are based on the development of systematic ethical review and ethical insight and responsibility on the part of researchers, sponsors, and government agencies and society. This is the main purpose of the Forum for Ethics Committees in the Commonwealth of Independent States (FECCIS) whose establishment and activities are focused on the integration of the CIS into the world system of biomedical research with regard to safeguarding ethical standards of human rights protection and harmonization of regulative and methodological space to safeguard protection of human rights and the dignity of biomedical research participants in the CIS.

  18. Ethics outside of inpatient care: the need for alliances between clinical and organizational ethics.

    Science.gov (United States)

    Barina, Rachelle

    2014-12-01

    The norms and practices of clinical ethics took form relative to the environment and relationships of hospital care. These practices do not easily translate into the outpatient context because the environment and relational dynamics differ. Yet, as outpatient care becomes the center of health care delivery, the experiences of ethical tension for outpatient clinicians warrant greater responses. Although a substantial body of literature on the nature of the doctor-physician relationship has been developed and could provide theoretical groundwork for an outpatient ethics, this literature is not sufficient to support outpatient caregivers in practical dilemmas. For physicians who are employed by or affiliated with a larger organization, a stronger alliance between clinical ethics and organizational ethics, identity, and mission will promote expansion of ethics resources in outpatient settings and address structural constraints in outpatient clinical care.

  19. Revisited

    DEFF Research Database (Denmark)

    Tegtmeier, Silke; Meyer, Verena; Pakura, Stefanie

    2017-01-01

    were captured when they described entrepreneurs. Therefore, this paper aims to revisit gender role stereotypes among young adults. Design/methodology/approach: To measure stereotyping, participants were asked to describe entrepreneurs in general and either women or men in general. The Schein......Purpose: Entrepreneurship is shaped by a male norm, which has been widely demonstrated in qualitative studies. The authors strive to complement these methods by a quantitative approach. First, gender role stereotypes were measured in entrepreneurship. Second, the explicit notions of participants......: The images of men and entrepreneurs show a high and significant congruence (r = 0.803), mostly in those adjectives that are untypical for men and entrepreneurs. The congruence of women and entrepreneurs was low (r = 0.152) and insignificant. Contrary to the participants’ beliefs, their explicit notions did...

  20. Exploring accountability of clinical ethics consultants: practice and training implications.

    Science.gov (United States)

    Weise, Kathryn L; Daly, Barbara J

    2014-01-01

    Clinical ethics consultants represent a multidisciplinary group of scholars and practitioners with varied training backgrounds, who are integrated into a medical environment to assist in the provision of ethically supportable care. Little has been written about the degree to which such consultants are accountable for the patient care outcome of the advice given. We propose a model for examining degrees of internally motivated accountability that range from restricted to unbounded accountability, and support balanced accountability as a goal for practice. Finally, we explore implications of this model for training of clinical ethics consultants from diverse academic backgrounds, including those disciplines that do not have a formal code of ethics relating to clinical practice.

  1. Clinical Ethics Consultation After God: Implications for Advocacy and Neutrality.

    Science.gov (United States)

    Parker, J Clint

    2018-06-01

    In After God: Morality and Bioethics in a Secular Age, H. Tristram Engelhardt, Jr. explores the broad implications for moral reasoning once a culture has lost a God's-eye perspective. In this paper, I focus on the implications of Engelhardt's views for clinical ethics consultation. I begin by examining the question of whether clinical ethics consultants (CECs) should advocate a particular viewpoint and/or process during consultations or adopt a neutral stance. I then examine the implications of Engelhardt's views for this question. Finally, I discuss some of Engelhardt's foundational ontological, metaphysical, meta-ethical, and epistemological commitments and how these commitments connect to his views on clinical ethics consultation.

  2. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

    Science.gov (United States)

    Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

    2016-04-01

    A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  3. Treating infidelity: clinical and ethical directions.

    Science.gov (United States)

    Snyder, Douglas K; Doss, Brian D

    2005-11-01

    This article addresses clinical and ethical directions in treating clients coping with infidelity. Developing competence in this domain requires familiarity with empirical research regarding infidelity, individual and cultural differences involving non-monogamy, and assessment and intervention skills related to treating infidelity. Practical directions will entail distinguishing among responsibilities to individual partners versus their relationship and managing related potential conflicts of interest with other involved parties. Confidentiality assumes increased complexity when confronting undisclosed infidelity in couple therapy and when a client engaging in high-risk behaviors for contracting STDs or testing seropositive for HIV has not informed his or her partner(s). Finally, we discuss therapists' need to concretely articulate their values that influence treatment of infidelity.

  4. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  5. Ethical decision making in clinical practice.

    Science.gov (United States)

    Fowler, M D

    1989-12-01

    Contemporary nursing ethics education focuses on the use of an analytical model of ethical decision making for both its process and its content. Perhaps this is the case because it bears some resemblance to the nursing process, which is taught in a similar fashion. Thus, a deductivist method of ethical decision making fits within the same general schema of the hypotheticodeductive method of decision making that is taught for nursing diagnosis. Ethics requires that nurses respect persons, inform patients and secure their consent, not inflict harm, preserve the patient's quality of life, prevent harm and remove harmful conditions, do good for patients, and minimize risk to themselves. These are among the norms of obligation that guide ethical analysis and judgment in nursing practice and are the substance of the analytical model of ethical decision making. Nursing's ethics has established high ideals and strong demands for nurses. These are demands which nurses have met and ideals which have often been realized. Whatever the strength of our science, nursing is an inherently moral endeavor and is only as strong as its commitment to its ethical obligations and values. Between the grinding edges of the forces that affect it, nursing must establish its priorities among the aspects of its environment that it attempts to control. Ethics must be chief among those priorities.

  6. Ethical considerations in clinical training, care and research in psychopharmacology.

    Science.gov (United States)

    Strous, Rael D

    2011-04-01

    Psychopharmacology is a powerful tool in psychiatry; however, it is one that demands responsibility in order to deal with the ethical complexities that accompany advances in the field. It is important that questions are asked and that ethical mindfulness and sensitivity are developed along with clinical skills. In order to cultivate and deepen ethical awareness and subsequently solve issues in optimal fashion, investment should be made in the development of an ethical decision-making process as well as in education in the ethics of psychopharmacology to trainees in the field at all stages of their educational development. A clear approach to identifying ethical problems, engaging various ethical concepts in considering solutions and then applying these principles in problem resolution is demanded. An openness in identifying and exploring issues has become crucial to the future development and maturation of psychopharmacologists, both research and clinical. Consideration must be given to the social implications of psychopharmacological practice, with the best interests of patients always paramount. From both a research and clinical perspective, psychopharmacology has to be practised with fairness, sensitivity and ethical relevance to all. While ethical issues related to psychopharmacological practice are varied and plentiful, this review focuses on advances in technology and biological sciences, personal integrity, special populations, and education and training.

  7. Contentious Conversations: Using Mediation Techniques in Difficult Clinical Ethics Consultations.

    Science.gov (United States)

    Fiester, Autumn

    2015-01-01

    Mediators utilize a wide range of skills in the process of facilitating dialogue and resolving conflicts. Among the most useful techniques for clinical ethics consultants (CECs)-and surely the least discussed-are those employed in acrimonious, hostile conversations between stakeholders. In the context of clinical ethics disputes or other bedside conflicts, good mediation skills can reverse the negative interactions that have prevented the creation of workable treatment plans or ethical consensus. This essay lays out the central framework mediators use in distinguishing positions from interests and describes a set of strategies for managing contentious ethics consultations or working with "difficult" patients, families, or patient-careprovider interactions. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

  8. Goals of clinical ethics support: perceptions of dutch healthcare institutions

    NARCIS (Netherlands)

    Dauwerse, L.; Abma, T.A.; Molewijk, A.C.; Widdershoven, G.

    2013-01-01

    In previous literature, ethicists mention several goals of Clinical Ethics Support (CES). It is unknown what key persons in healthcare institutions see as main- - and sub-goals of CES. This article presents the goals of CES as perceived by board members and members of ethics support staff. This is

  9. A Second Opinion: A Case Narrative on Clinical Ethics Mediation.

    Science.gov (United States)

    Weinstein, Michael S

    2015-01-01

    Contrasting traditional and common forms of ethics consultation with bioethics mediation, I describe the case of a "second opinion" consultation in the care of a patient with advanced cancer for whom treatment was futile. While the initial ethics consultation, performed by a colleague, led to a recommendation that some may deem ethical, the process failed to involve key stakeholders and failed to explore the underlying values and reasons for the opinions voiced by various stakeholders. The process of mediation ultimately led to creative solutions in which all stakeholders could reach consensus on a plan of care. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

  10. [Ethic rounds in intensive care. Possible instrument for a clinical-ethical assessment in intensive care units].

    Science.gov (United States)

    Scheffold, N; Paoli, A; Gross, J; Riemann, U; Hennersdorf, M

    2012-10-01

    Ethical problems, such as medical end-of-life decisions or withdrawing life-sustaining treatment are viewed as an essential task in intensive care units. This article presents the ethics rounds as an instrument for evaluation of ethical problems in intensive care medicine units. The benchmarks of ethical reflection during the ethics rounds are considerations of ethical theory of principle-oriented medical ethics. Besides organizational aspects and the institutional framework, the role of the ethicist is described. The essential evaluation steps, as a basis of the ethics rounds are presented. In contrast to the clinical ethics consultation, the ethicist in the ethics rounds model is integrated as a member of the ward round team. Therefore ethical problems may be identified and analyzed very early before the conflict escalates. This preventive strategy makes the ethics rounds a helpful instrument in intensive care units.

  11. Physicians’ Professionally Responsible Power: A Core Concept of Clinical Ethics

    Science.gov (United States)

    McCullough, Laurence B.

    2016-01-01

    The gathering of power unto themselves by physicians, a process supported by evidence-based practice, clinical guidelines, licensure, organizational culture, and other social factors, makes the ethics of power—the legitimation of physicians’ power—a core concept of clinical ethics. In the absence of legitimation, the physician’s power over patients becomes problematic, even predatory. As has occurred in previous issues of the Journal, the papers in the 2016 clinical ethics issue bear on the professionally responsible deployment of power by physicians. This introduction explores themes of physicians’ power in papers from an international group of authors who address autonomy and trust, the virtues of perinatal hospice, conjoined twins in ethics and law, addiction and autonomy in clinical research on addicting substances, euthanasia of patients with dementia in Belgium, and a pragmatic approach to clinical futility. PMID:26671961

  12. Opportunity to discuss ethical issues during clinical learning experience.

    Science.gov (United States)

    Palese, Alvisa; Gonella, Silvia; Destrebecq, Anne; Mansutti, Irene; Terzoni, Stefano; Morsanutto, Michela; Altini, Pietro; Bevilacqua, Anita; Brugnolli, Anna; Canzan, Federica; Ponte, Adriana Dal; De Biasio, Laura; Fascì, Adriana; Grosso, Silvia; Mantovan, Franco; Marognolli, Oliva; Nicotera, Raffaela; Randon, Giulia; Tollini, Morena; Saiani, Luisa; Grassetti, Luca; Dimonte, Valerio

    2018-01-01

    Undergraduate nursing students have been documented to experience ethical distress during their clinical training and felt poorly supported in discussing the ethical issues they encountered. Research aims: This study was aimed at exploring nursing students' perceived opportunity to discuss ethical issues that emerged during their clinical learning experience and associated factors. An Italian national cross-sectional study design was performed in 2015-2016. Participants were invited to answer a questionnaire composed of four sections regarding: (1) socio-demographic data, (2) previous clinical learning experiences, (3) current clinical learning experience quality and outcomes, and (4) the opportunity to discuss ethical issues with nurses in the last clinical learning experience (from 0 - 'never' to 3 - 'very much'). Participants and research context: Participants were 9607 undergraduate nursing students who were attending 95 different three-year Italian baccalaureate nursing programmes, located at 27 universities in 15 Italian regions. Ethical considerations: This study was conducted in accordance with the Human Subject Research Ethics Committee guidelines after the research protocol was approved by an ethics committee. Overall, 4707 (49%) perceived to have discussed ethical issues 'much' or 'very much'; among the remaining, 3683 (38.3%) and 1217 (12.7%) students reported the perception of having discussed, respectively, 'enough' or 'never' ethical issues emerged in the clinical practice. At the multivariate logistic regression analysis explaining 38.1% of the overall variance, the factors promoting ethical discussion were mainly set at the clinical learning environment levels (i.e. increased learning opportunities, self-directed learning, safety and nursing care quality, quality of the tutorial strategies, competences learned and supervision by a clinical nurse). In contrast, being male was associated with a perception of less opportunity to discuss ethical issues

  13. A systematic format for resolving ethical issues in clinical periodontics.

    Science.gov (United States)

    Schloss, Alexander J

    2012-01-01

    Ethical dilemmas are becoming increasingly common in dentistry and periodontics. Clinicians, challenged with such dilemmas, may not know how to apply the appropriate moral reasoning needed to resolve these situations especially when any of the five fundamental principles of ethics that form the foundation of the American Dental Association Principles of Ethics and Code of Professional Conduct--patient autonomy, nonmaleficence, beneficence, justice, and veracity--come into conflict with each other. The author describes one clinical case that presented with an ethical dilemma. An analytic framework, used in medicine, is introduced and used to solve the clinical case on whether to proceed with periodontal surgery on a patient who is not aware of his terminal prognosis from metastatic prostate cancer. Upon using the analytic framework, recommendations are made on the ethically appropriate path for the periodontist to follow in providing care for the patient's periodontal problem consistent with the principles of patient autonomy, respect for persons, and veracity.

  14. Novel Paths to Relevance: How Clinical Ethics Committees Promote Ethical Reflection.

    Science.gov (United States)

    Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

    2016-09-01

    How may clinical ethics committees (CECs) inspire ethical reflection among healthcare professionals? How may they deal with organizational ethics issues? In recent years, Norwegian CECs have attempted different activites that stretch or go beyond the standard trio of education, consultation, and policy work. We studied the novel activities of Norwegian CECs by examining annual reports and interviewing CEC members. Through qualitative analysis we identified nine categories of novel CEC activities, which we describe by way of examples. In light of the findings, we argue that some novel working methods may be well suited to promote ethical reflection among clinicians, and that the CEC may be a suitable venue for discussing issues of organizational ethics.

  15. The Rise of Hospitalists: An Opportunity for Clinical Ethics.

    Science.gov (United States)

    McCarthy, Matthew W; Real de Asua, Diego; Fins, Joseph J

    2017-01-01

    Translating ethical theories into clinical practice presents a perennial challenge to educators. While many suggestions have been put forth to bridge the theory-practice gap, none have sufficiently remedied the problem. We believe the ascendance of hospital medicine, as a dominant new force in medical education and patient care, presents a unique opportunity that could redefine the way clinical ethics is taught. The field of hospital medicine in the United States is comprised of more than 50,000 hospitalists-specialists in inpatient medicine-representing the fastest growing subspecialty in the history of medicine, and its members have emerged as a dominant new force around which medical education and patient care pivot. This evolution in medical education presents a unique opportunity for the clinical ethics community. Through their proximity to patients and trainees, hospitalists have the potential to teach medical ethics in real time on the wards, but most hospitalists have not received formal training in clinical ethics. We believe it is time to strengthen the ties between hospital medicine and medical ethics, and in this article we outline how clinical ethicists might collaborate with hospitalists to identify routine issues that do not rise to the level of an "ethics consult," but nonetheless require an intellectual grounding in normative reasoning. We use a clinical vignette to explore how this approach might enhance and broaden the scope of medical education that occurs in the inpatient setting: A patient with an intra-abdominal abscess is admitted to the academic hospitalist teaching service for drainage of the fluid, hemodynamic support, and antimicrobial therapy. During the initial encounter with the hospitalist and his team of medical students and residents, the patient reports night sweats and asks if this symptom could be due to the abscess. How should the hospitalist approach this question? Copyright 2017 The Journal of Clinical Ethics. All rights

  16. Public titles of clinical trials should have ethics review.

    Science.gov (United States)

    Saenz, Carla; Reveiz, Ludovic; Tisdale, John F

    2015-09-01

    A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the "therapeutic misconception" might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled "novel therapy" when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects. Copyright © 2015 Pan American Health Organization. Published by Elsevier Inc. All rights reserved.

  17. Ethical considerations in industry-sponsored multiregional clinical trials.

    Science.gov (United States)

    Ibia, Ekopimo; Binkowitz, Bruce; Saillot, Jean-Louis; Talerico, Steven; Koerner, Chin; Ferreira, Irene; Agarwal, Anupam; Metz, Craig; Maman, Marianne

    2010-01-01

    During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes. Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations. This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider. Copyright © 2010 John Wiley & Sons, Ltd.

  18. Ethical dilemmas experienced by clinical psychology trainee therapists.

    Science.gov (United States)

    Bhola, Poornima; Sinha, Ananya; Sonkar, Suruchi; Raguram, Ahalya

    2015-01-01

    Ethical dilemmas are inevitable during psychotherapeutic interactions, and these complexities and challenges may be magnified during the training phase. The experience of ethical dilemmas in the arena of therapy and the methods of resolving these dilemmas were examined among 35 clinical psychologists in training, through an anonymous and confidential online survey. The trainees' responses to four open-ended questions on any one ethical dilemma encountered during therapy were analysed, using thematic content analysis. The results highlighted that the salient ethical dilemmas related to confidentiality and boundary issues. The trainees also raised ethical questions regarding therapist competence, the beneficence and non-maleficence of therapeutic actions, and client autonomy. Fifty-seven per cent of the trainees reported that the dilemmas were resolved adequately, the prominent methods of resolution being supervision or consultation and guidance from professional ethical guidelines. The trainees felt that the professional codes had certain limitations as far as the effective resolution of ethical dilemmas was concerned. The findings indicate the need to strengthen training and supervision methodologies and professional ethics codes for psychotherapists and counsellors in India.

  19. The Medical Ethics of Clinical Therapeutic Trials*

    African Journals Online (AJOL)

    carried out to advance knowledge, but from which the subject cannot be expected to receive any direct personal benefit. The Judicial Code of the American Medical Association' laid down only three requirements for human experimen- tation, to conform to its medical ethics. They are (i) the voluntary consent of the person on ...

  20. The Role of Communication and Interpersonal Skills in Clinical Ethics Consultation: The Need for a Competency in Advanced Ethics Facilitation.

    Science.gov (United States)

    Shelton, Wayne; Geppert, Cynthia; Jankowski, Jane

    2016-01-01

    Clinical ethics consultants (CECs) often face some of the most difficult communication and interpersonal challenges that occur in hospitals, involving stressed stakeholders who express, with strong emotions, their preferences and concerns in situations of personal crisis and loss. In this article we will give examples of how much of the important work that ethics consultants perform in addressing clinical ethics conflicts is incompletely conceived and explained in the American Society of Bioethics and Humanities Core Competencies for Healthcare Ethics Consultation and the clinical ethics literature. The work to which we refer is best conceptualized as a specialized type of interviewing, in which the emotional barriers of patients and their families or surrogates can be identified and addressed in light of relevant ethical obligations and values within the context of ethics facilitation. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  1. ETHICAL MODELS OF PHYSICIAN--PATIENT RELATIONSHIP REVISITED WITH REGARD TO PATIENT AUTONOMY, VALUES AND PATIENT EDUCATION.

    Science.gov (United States)

    Borza, Liana Rada; Gavrilovici, Cristina; Stockman, René

    2015-01-01

    The present paper revisits the ethical models of patient--physician relationship from the perspective of patient autonomy and values. It seems that the four traditional models of physician--patient relationship proposed by Emanuel & Emanuel in 1992 closely link patient values and patient autonomy. On the other hand, their reinterpretation provided by Agarwal & Murinson twenty years later emphasizes the independent expression of values and autonomy in individual patients. Additionally, patient education has been assumed to join patient values and patient autonomy. Moreover, several authors have noted that, over the past few decades, patient autonomy has gradually replaced the paternalistic approach based on the premise that the physician knows what is best for the patient. Neither the paternalistic model of physician-patient relationship, nor the informative model is considered to be satisfactory, as the paternalistic model excludes patient values from decision making, while the informative model excludes physician values from decision making. However, the deliberative model of patient-physician interaction represents an adequate alternative to the two unsatisfactory approaches by promoting shared decision making between the physician and the patient. It has also been suggested that the deliberative model would be ideal for exercising patient autonomy in chronic care and that the ethical role of patient education would be to make the deliberative model applicable to chronic care. In this regard, studies have indicated that the use of decision support interventions might increase the deliberative capacity of chronic patients.

  2. Managing ethical issues in patient care and the need for clinical ethics support.

    Science.gov (United States)

    Doran, Evan; Fleming, Jennifer; Jordens, Christopher; Stewart, Cameron L; Letts, Julie; Kerridge, Ian H

    2015-02-01

    To investigate the range, frequency and management of ethical issues encountered by clinicians working in hospitals in New South Wales (NSW), Australia. A cross-sectional survey was conducted of a convenience sample of 104 medical, nursing and allied health professionals in two NSW hospitals. Some respondents did not provide data for some questions, therefore the denominator is less than 105 for some items. Sixty-two (62/104; 60%) respondents reported occasionally to often having ethical concerns. Forty-six (46/105; 44%) reported often to occasionally having legal concerns. The three most common responses to concerns were: talking to colleagues (96/105; 91%); raising the issue in a group forum (68/105; 65%); and consulting a relevant guideline (64/105; 61%). Most respondents were highly (65/99; 66%) or moderately (33/99; 33%) satisfied with the ethical environment of the hospital. Twenty-two (22/98; 22%) were highly satisfied with the ethical environment of their department and 74 (74/98; 76%) were moderately satisfied. Most (72/105; 69%) respondents indicated that additional support in dealing with ethical issues would be helpful. Clinicians reported frequently experiencing ethical and legal uncertainty and concern. They usually managed this by talking with colleagues. Although this approach was considered adequate, and the ethics of their hospital was reported to be satisfactory, most respondents indicated that additional assistance with ethical and legal concerns would be helpful. Clinical ethics support should be a priority of public hospitals in NSW and elsewhere in Australia.

  3. Clinical research ethics in Irish healthcare: diversity, dynamism and medicalization.

    LENUS (Irish Health Repository)

    Condell, Sarah L

    2012-11-01

    Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as an early \\'rite of passage\\' in the category of \\'labouring the doctorate\\'. This article penetrates the complexities in Irish clinical research ethics by describing the practices these nurse and midwife researchers encountered and the experiences they had. The key issue of representation that occurred in the context of \\'medicalized\\' research ethics is further explored including its meaning for nursing or midwifery research.

  4. Ethics and epistemology of accurate prediction in clinical research.

    Science.gov (United States)

    Hey, Spencer Phillips

    2015-07-01

    All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  5. Sources of bias in clinical ethics case deliberation.

    Science.gov (United States)

    Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

    2014-10-01

    A central task for clinical ethics consultants and committees (CEC) is providing analysis of, and advice on, prospective or retrospective clinical cases. However, several kinds of biases may threaten the integrity, relevance or quality of the CEC's deliberation. Bias should be identified and, if possible, reduced or counteracted. This paper provides a systematic classification of kinds of bias that may be present in a CEC's case deliberation. Six kinds of bias are discussed, with examples, as to their significance and risk factors. Possible remedies are suggested. The potential for bias is greater when the case deliberation is performed by an individual ethics consultant than when an entire clinical ethics committee is involved. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  6. Arboriculture in clinical ethics: using philosophical critical appraisal to clear away underbrush in ethical analysis and argument.

    Science.gov (United States)

    McCullough, Laurence B

    2011-02-01

    This paper introduces the 2011 number of the Journal on Clinical Ethics. Philosophical critical appraisal is essential for the success of philosophical analysis and argument in clinical ethics. To clear away conceptual underbrush, papers in this Clinical Ethics number of the Journal address genetic engineering, conscience-based objections to forms of health care, placebos, and preventing exploitation of patients to be recruited to become research subjects.

  7. Huntington Revisited: Is Conservative Realism Still Essential for the Military Ethic

    National Research Council Canada - National Science Library

    Mahoney-Norris, Kathleen A

    2001-01-01

    ...). Furthermore, Huntington has developed what appears to be a powerful argument as to why conservative realism should be considered a fundamental component of the professional ethic of the military officer...

  8. [Ethics in clinical practice and in health care].

    Science.gov (United States)

    Pintor, S; Mennuni, G; Fontana, M; Nocchi, S; Giarrusso, P; Serio, A; Fraioli, A

    2015-01-01

    The clinical ethics is the identification, analysis and solution of moral problems that can arise during the care of a patient. Given that when dealing with ethical issues in health care some risks will be encountered (talking about ethics in general, or as a problem overlapped with others in this area, or by delegation to legislative determinations) in the text certain important aspects of the topic are examined. First of all ethics as human quality of the relationship between people for the common good, especially in health services where there are serious problems like the life and the health. It is also necessary a "humanizing relationship" between those who work in these services in order to achieve quality and efficiency in this business. It is important a proper training of health professionals, especially doctors, so that they can identify the real needs and means of intervention. It is also important that scientific research must respect fundamental ethical assumptions. In conclusion, ethics in health care is not a simple matter of "cookbook" rules, but involves the responsibility and consciousness of individual operators.

  9. Goals of clinical ethics support: perceptions of Dutch healthcare institutions.

    Science.gov (United States)

    Dauwerse, L; Abma, T A; Molewijk, B; Widdershoven, G

    2013-12-01

    In previous literature, ethicists mention several goals of Clinical Ethics Support (CES). It is unknown what key persons in healthcare institutions see as main--and sub-goals of CES. This article presents the goals of CES as perceived by board members and members of ethics support staff. This is part of a Dutch national research using a mixed methods design with questionnaires, focus groups and interviews. Quantitative and qualitative data were analyzed and combined in an iterative process. Four main clusters of goals were found: 1) encouraging an ethical climate, 2) fostering an accountable and transparent organization, 3) developing professionalism and a final goal, overarching the previous three, 4) good care. Most important sub-goals of CES were: attention for ethical issues, raising awareness of ethical issues, fostering ethical reflection and supporting employees. The article ends with a discussion on the desirability to further operationalize the general goal of good care, the context-boundedness of our findings and the need to relate goals of CES to the features of organizational cultures to further improve the integration of CES in healthcare institutions.

  10. Physicians' Professionally Responsible Power: A Core Concept of Clinical Ethics.

    Science.gov (United States)

    McCullough, Laurence B

    2016-02-01

    The gathering of power unto themselves by physicians, a process supported by evidence-based practice, clinical guidelines, licensure, organizational culture, and other social factors, makes the ethics of power--the legitimation of physicians' power--a core concept of clinical ethics. In the absence of legitimation, the physician's power over patients becomes problematic, even predatory. As has occurred in previous issues of the Journal, the papers in the 2016 clinical ethics issue bear on the professionally responsible deployment of power by physicians. This introduction explores themes of physicians' power in papers from an international group of authors who address autonomy and trust, the virtues of perinatal hospice, conjoined twins in ethics and law, addiction and autonomy in clinical research on addicting substances, euthanasia of patients with dementia in Belgium, and a pragmatic approach to clinical futility. © The Author 2015. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  11. Ethical Diversity and the Role of Conscience in Clinical Medicine

    Science.gov (United States)

    Genuis, Stephen J.; Lipp, Chris

    2013-01-01

    In a climate of plurality about the concept of what is “good,” one of the most daunting challenges facing contemporary medicine is the provision of medical care within the mosaic of ethical diversity. Juxtaposed with escalating scientific knowledge and clinical prowess has been the concomitant erosion of unity of thought in medical ethics. With innumerable technologies now available in the armamentarium of healthcare, combined with escalating realities of financial constraints, cultural differences, moral divergence, and ideological divides among stakeholders, medical professionals and their patients are increasingly faced with ethical quandaries when making medical decisions. Amidst the plurality of values, ethical collision arises when the values of individual health professionals are dissonant with the expressed requests of patients, the common practice amongst colleagues, or the directives from regulatory and political authorities. In addition, concern is increasing among some medical practitioners due to mounting attempts by certain groups to curtail freedom of independent conscience—by preventing medical professionals from doing what to them is apparently good, or by compelling practitioners to do what they, in conscience, deem to be evil. This paper and the case study presented will explore issues related to freedom of conscience and consider practical approaches to ethical collision in clinical medicine. PMID:24455248

  12. Imperfect twinning: a clinical and ethical dilemma.

    Science.gov (United States)

    Denardin, Daniela; Telles, Jorge Alberto B; Betat, Rosilene da Silveira; Fell, Paulo Renato K; Cunha, André Campos da; Targa, Luciano Vieira; Zen, Paulo Ricardo G; Rosa, Rafael Fabiano M

    2013-09-01

    OBJECTIVE To review the history, epidemiology, etiology, gestational aspects, diagnosis and prognosis of imperfect twinning. DATA SOURCES Scientific articles were searched in PubMed, SciELO and Lilacs databases, using the descriptors "conjoined twins", "multiple pregnancy", "ultrasound", "magnetic resonance imaging" and "prognosis". The research was not delimited to a specific period of time and was supplemented with bibliographic data from books. The description of conjoined twins is legendary. The estimated frequency is 1/45,000-200,000 births. These twins are monozygotic, monochorionic and usually monoamniotic. They can be classified by the most prominent fusion site, by the symmetry between the conjoined twins or by the sharing structure. The diagnosis can be performed in the prenatal period or after birth by different techniques, such as ultrasound, magnetic resonance imaging and echocardiography. These tests are of paramount importance for understanding the anatomy of both fetuses/children, as well as for prognosis and surgical plan determination. CONCLUSIONS Although imperfect twinning is a rare condition, the prenatal diagnosis is very important in order to evaluate the fusion site and its complexity. Hence, the evaluation of these children should be multidisciplinary, involving mainly obstetricians, pediatricians and pediatric surgeons. However, some decisions may constitute real ethical dilemmas, in which different points should be discussed and analyzed with the health team and the family.

  13. Ethical, legal, and social implications (ELSI) of microdose clinical trials.

    Science.gov (United States)

    Kurihara, Chieko

    2011-06-19

    A "microdose clinical trial" (microdosing) is one kind of early phase exploratory clinical trial, administering the compound at doses estimated to have no pharmacological or toxicological effects, aimed at screening candidates for further clinical development. This article's objective is to clarify the ethical, legal, and social implications (ELSI) of such an exploratory minimum-risk human trial. The definition and non-clinical study requirements for microdosing have been harmonized among the European Union (EU), United States (US), and Japan. Being conducted according to these regulations, microdosing seems to be ethically well justified in terms of respect for persons, beneficence, justice, human dignity, and animal welfare. Three big projects have been demonstrating the predictability of therapeutic dose pharmacokinetics from microdosing. The article offers suggestions as how microdosing can become a more useful and socially accepted strategy. Copyright © 2011 Elsevier B.V. All rights reserved.

  14. Ethical Inclinations of Tomorrow's Managers Revisited: How and Why Students Cheat.

    Science.gov (United States)

    Stevens, George E.; Stevens, Faith W.

    1987-01-01

    The study determined 210 business students' perceptions of their own and their peers' attitudes and behavior related to cheating. Students view themselves as more ethical than their peers; they believe that obtaining exam answers from peers is highly unethical, and they cheat to succeed or because the work is difficult. (CH)

  15. Reflections on Ethics and Humanity in Pediatric Neurology: the Value of Recognizing Ethical Issues in Common Clinical Practice.

    Science.gov (United States)

    Ronen, Gabriel M; Rosenbaum, Peter L

    2017-05-01

    Our goals in this reflection are to (i) identify the ethical dimensions inherent in any clinical encounter and (ii) bring to the forefront of our pediatric neurology practice the myriad of opportunities to explore and learn from these ethical questions. We highlight specifically Beauchamp and Childress's principles of biomedical ethics. We use the terms ethics in common clinical practice and an ethical lens to remind people of the ubiquity of ethical situations and the usefulness of using existing ethical principles to analyze and resolve difficult situations in clinical practice. We start with a few common situations with which many of us tend to struggle. We describe what we understand as ethics and how and why developments in technology, novel potential interventions, policies, and societal perspectives challenge us to think about and debate ethical issues. Individual patients are not a singular population; each patient has their own unique life situations, culture, goals, and expectations that need to be considered with a good dose of humanity and humility. We believe that using an ethical lens-by which we mean making an explicit effort to identify and consider these issues openly-will help us to achieve this goal in practice, education, and research.

  16. Evaluating clinical ethics support in mental healthcare: a systematic literature review.

    NARCIS (Netherlands)

    Hem, M.H.; Pedersen, R.; Norvoll, R.; Molewijk, A.C.

    2015-01-01

    A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five

  17. Ethics of safety reporting of a clinical trial

    Directory of Open Access Journals (Sweden)

    Amrita Sil

    2017-01-01

    Full Text Available Clinical trial related injury and serious adverse events (SAE are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases. Any unwanted and noxious effect of a drug when used in recommended doses is an adverse drug reaction (ADR whereas if causal association is not yet established it is termed adverse event (AE. An AE or ADR that is associated with death, in-patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly, or is otherwise life threatening is termed as an SAE. The principal investigator reports the event to the licensing authority (DCGI, sponsor and Chairperson of the Ethics Committee (EC within 24 hours of occurrence of the SAE. This report is furthered by a detailed report by both the investigator and the EC and given to the DCGI who then gives a final decision on the amount of compensation to be given by the sponsor or the sponsor's representative to the grieving party.

  18. Managing Ethical Difficulties in Healthcare: Communicating in Inter-professional Clinical Ethics Support Sessions.

    Science.gov (United States)

    Grönlund, Catarina Fischer; Dahlqvist, Vera; Zingmark, Karin; Sandlund, Mikael; Söderberg, Anna

    2016-12-01

    Several studies show that healthcare professionals need to communicate inter-professionally in order to manage ethical difficulties. A model of clinical ethics support (CES) inspired by Habermas' theory of discourse ethics has been developed by our research group. In this version of CES sessions healthcare professionals meet inter-professionally to communicate and reflect on ethical difficulties in a cooperative manner with the aim of reaching communicative agreement or reflective consensus. In order to understand the course of action during CES, the aim of this study was to describe the communication of value conflicts during a series of inter-professional CES sessions. Ten audio- and video-recorded CES sessions were conducted over eight months and were analyzed by using the video analysis tool Transana and qualitative content analysis. The results showed that during the CES sessions the professionals as a group moved through the following five phases: a value conflict expressed as feelings of frustration, sharing disempowerment and helplessness, the revelation of the value conflict, enhancing realistic expectations, seeing opportunities to change the situation instead of obstacles. In the course of CES, the professionals moved from an individual interpretation of the situation to a common, new understanding and then to a change in approach. An open and permissive communication climate meant that the professionals dared to expose themselves, share their feelings, face their own emotions, and eventually arrive at a mutual shared reality. The value conflict was not only revealed but also resolved.

  19. Internet research: an opportunity to revisit classic ethical problems in behavioral research.

    Science.gov (United States)

    Pittenger, David J

    2003-01-01

    The Internet offers many new opportunities for behavioral researchers to conduct quantitative and qualitative research. Although the ethical guidelines of the American Psychological Association generalize, in part, to research conducted through the Internet, several matters related to Internet research require further analysis. This article reviews several fundamental ethical issues related to Internet research, namely the preservation of privacy, the issuance of informed consent, the use of deception and false feedback, and research methods. In essence, the Internet offers unique challenges to behavioral researchers. Among these are the need to better define the distinction between private and public behavior performed through the Internet, ensure mechanisms for obtaining valid informed consent from participants and performing debriefing exercises, and verify the validity of data collected through the Internet.

  20. The philosophical moment of the medical decision: revisiting emotions felt, to improve ethics of future decisions.

    Science.gov (United States)

    Le Coz, Pierr; Tassy, Sebastien

    2007-08-01

    The present investigation looks for a solution to the problem of the influence of feelings and emotions on our ethical decisions. This problem can be formulated in the following way. On the one hand, emotions (fear, pity and so on) can alter our sense of discrimination and lead us to make our wrong decisions. On the other hand, it is known that lack of sensitivity can alter our judgment and lead us to sacrifice basic ethical principles such as autonomy, beneficence, non-maleficence and justice. Only emotions can turn a decision into an ethical one, but they can also turn it into an unreasonable one. To avoid this contradiction, suggest integrating emotions with the decisional factors of the process of "retrospective thinking". During this thinking, doctors usually try to identify the nature and impact of feelings on the decision they have just made. In this retrospective moment of analysis of the decision, doctors also question themselves on the feelings they did not experience. They do this to estimate the consequences of this lack of feeling on the way they behaved with the patient.

  1. The ethics of clinical innovation in psychopharmacology: Challenging traditional bioethics

    Directory of Open Access Journals (Sweden)

    Goodwin Frederick K

    2007-11-01

    Full Text Available Abstract Objective To assess the scientific and ethical basis for clinical innovation in psychopharmacology. Methods We conducted a literature review, utilizing MEDLINE search and bibliographic cross-referencing, and historical evidence regarding the discovery and development of new medications in psychiatry. Clinical innovation was defined as use of treatments in a clinical setting which have not been well-proven in a research setting. Results Empirical data regarding the impact of clinical innovation in psychopharmacology are lacking. A conceptual and historical assessment of this topic highlights the ethical and scientific importance of clinical innovation. Ethically, it touches a borderline that, in our judgment, is not adequately framed in contemporary mainstream bioethics. Currently, research is viewed as not at all benefiting the patients who participate in it, while clinical care is viewed as being solely for the benefit of patients. Clinical innovation straddles these two worlds, uncomfortably at times. While many argue that clinical innovation should either be avoided or folded into research projects, we argue that clinical innovation is necessary for progress in psychopharmacology research, and that it can prosper best when guided by the following ethical principles: 1. The treatment should be based on a viable hypothesis. 2. Whenever possible, one's clinical observations should be reported so they can be evaluated by the scientific community. 3. One should be willing to report unexpected observations of drug effects. 4. A high standard of informed consent should be maintained. Again, this proposal goes against the standard view among bioethicists that research and clinical care are categorically opposed activities, as made clear by the either-or dichotomy of the Belmont Report on bioethics. This approach has so polarized our profession into clinicians versus researchers, that many clinicians will not apply new knowledge produced by

  2. Novel ethical dilemmas arising in geriatric clinical practice.

    Science.gov (United States)

    Calleja-Sordo, Elisa Constanza; de Hoyos, Adalberto; Méndez-Jiménez, Jorge; Altamirano-Bustamante, Nelly F; Islas-Andrade, Sergio; Valderrama, Alejandro; García-Peña, Carmen; Altamirano-Bustamante, Myriam M

    2015-05-01

    The purpose of this study is to determine empirically the state of the art of the medical care, when healthcare personal is confronted with ethical dilemmas related with the care they give to the geriatric population. An observational, longitudinal, prospective and qualitative study was conducted by analyzing the correlation between healthcare personnel-patient relationship, and ethical judgments regarding dilemmas that arise in daily clinical practice with geriatric patients. Mexican healthcare personnel with current active practices were asked to write up an ethical dilemma that arose frequently or that had impacted their medical practice. From the narrative input, we were able to draw up a database with 421 dilemmas, and those corresponding to patients 60 years and older were selected (n = 54, 12.8 %). The axiological analysis of the narrative dilemmas of geriatric patients was made using dialectical empiricism. The axiological analysis values found most frequently were classified into three groups: the impact of healthcare, the roles of the physician, and refusal of therapy; the healthcare role of educator, caring for the patients' life and the risk of imminent death where the values found more often. The persistence and universality of certain dilemmas in geriatrics calls for awareness and requires a good training in the ethical discernment of these dilemmas. This would help to improve substantially the care and the life quality of this population.

  3. The Ethics of Clinical Trials Research in Severe Mood Disorders.

    Science.gov (United States)

    Nugent, Allison C; Miller, Franklin G; Henter, Ioline D; Zarate, Carlos A

    2017-07-01

    Mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD), are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including patients' motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  4. Clinical ethics in rehabilitation medicine: core objectives and algorithm for resident education.

    Science.gov (United States)

    Sliwa, J A; McPeak, L; Gittler, M; Bodenheimer, C; King, J; Bowen, J

    2002-09-01

    Described as the balance of values on either side of a moral dilemma, ethics and ethical issues are of increasing importance in the changing practice of rehabilitation medicine. Because the substance of ethics and true ethical issues can be difficult to identify, the education of rehabilitation residents in ethics can similarly be challenging. This article discusses topics pertinent to an understanding of clinical ethics in rehabilitation medicine and provides a method of teaching residents through an algorithm of ethical issues, learning objectives, and illustrative cases.

  5. Outcomes of moral case deliberation - the development of an evaluation instrument for clinical ethics support (the Euro-MCD)

    NARCIS (Netherlands)

    Svantesson, M.; Karlsson, J.; Boitte, P.; Schildman, J.; Dauwerse, L.; Widdershoven, G.; Pedersen, R.; Huisman, M.; Molewijk, A.C.

    2014-01-01

    Background: Clinical ethics support, in particular Moral Case Deliberation, aims to support health care providers to manage ethically difficult situations. However, there is a lack of evaluation instruments regarding outcomes of clinical ethics support in general and regarding Moral Case

  6. Evaluating clinical ethics support in mental healthcare: a systematic literature review.

    Science.gov (United States)

    Hem, Marit Helene; Pedersen, Reidar; Norvoll, Reidun; Molewijk, Bert

    2015-06-01

    A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded 'grey zone articles', in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients' and caregivers' views on ethical challenges, is presented. © The Author(s) 2014.

  7. Construction of ethics in clinical research: clinical trials registration

    OpenAIRE

    C. A. Caramori

    2007-01-01

    Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong c...

  8. Neglected ends: clinical ethics consultation and the prospects for closure.

    Science.gov (United States)

    Fiester, Autumn

    2015-01-01

    Clinical ethics consultations (CECs) are sometimes deemed complete at the moment when the consultants make a recommendation. In CECs that involve actual ethical conflict, this view of a consult's endpoint runs the risk of overemphasizing the conflict's resolution at the expense of the consult's process, which can have deleterious effects on the various parties in the conflict. This overly narrow focus on reaching a decision or recommendation in consults that involve profound moral disagreement can result in two types of adverse, lingering sequelae: moral distress or negative moral emotions. The problem, succinctly named, is that such consults have insufficient "closure" for patients, families, and providers. To promote closure, and avoid the ills of moral distress and the moral emotions, I argue that CECs need to prioritize assisted conversation between the different stakeholders in these conflicts, what is often referred to as "bioethics mediation."

  9. Qualitative analysis of healthcare professionals' viewpoints on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas.

    Science.gov (United States)

    Marcus, Brian S; Shank, Gary; Carlson, Jestin N; Venkat, Arvind

    2015-03-01

    Ethics consultation is a commonly applied mechanism to address clinical ethical dilemmas. However, there is little information on the viewpoints of health care providers towards the relevance of ethics committees and appropriate application of ethics consultation in clinical practice. We sought to use qualitative methodology to evaluate free-text responses to a case-based survey to identify thematically the views of health care professionals towards the role of ethics committees in resolving clinical ethical dilemmas. Using an iterative and reflexive model we identified themes that health care providers support a role for ethics committees and hospitals in resolving clinical ethical dilemmas, that the role should be one of mediation, rather than prescription, but that ultimately legal exposure was dispositive compared to ethical theory. The identified theme of legal fears suggests that the mediation role of ethics committees is viewed by health care professionals primarily as a practical means to avoid more worrisome medico-legal conflict.

  10. The first clinical liver transplantation of Brazil revisited.

    Science.gov (United States)

    Bacchella, T; Machado, M C C

    2004-05-01

    The first clinical orthotopic liver transplantation in Brazil was performed on August 5, 1968. The patient was awake after surgery and died on the seventh postoperative day due to subdural hematoma, bronchopneumonia, renal failure, and graft rejection. The report of this case is important to understand the evolution of clinical liver transplantation in Brazil, where this procedure is now routinely carried out in many medical centers.

  11. Clinical Ethics Consultants are not “Ethics” Experts—But They do Have Expertise 1

    Science.gov (United States)

    Rasmussen, Lisa M.

    2016-01-01

    The attempt to critique the profession of clinical ethics consultation by establishing the impossibility of ethics expertise has been a red herring. Decisions made in clinical ethics cases are almost never based purely on moral judgments. Instead, they are all-things-considered judgments that involve determining how to balance other values as well. A standard of justified decision-making in this context would enable us to identify experts who could achieve these standards more often than others, and thus provide a basis for expertise in clinical ethics consultation. This expertise relies in part on what Richard Zaner calls the “expert knowledge of ethical phenomena” (1988, 8). PMID:27302970

  12. [Ethic review on clinical experiments of medical devices in medical institutions].

    Science.gov (United States)

    Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

    2011-07-01

    Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

  13. Clinical ethics and values: how do norms evolve from practice?

    Science.gov (United States)

    Spranzi, Marta

    2013-02-01

    Bioethics laws in France have just undergone a revision process. The bioethics debate is often cast in terms of ethical principles and norms resisting emerging social and technological practices. This leads to the expression of confrontational attitudes based on widely differing interpretations of the same principles and values, and ultimately results in a deadlock. In this paper I would like to argue that focusing on values, as opposed to norms and principles, provides an interesting perspective on the evolution of norms. As Joseph Raz has convincingly argued, "life-building" values and practices are closely intertwined. Precisely because values have a more indeterminate meaning than norms, they can be cited as reasons for action by concerned stakeholders, and thus can help us understand how controversial practices, e.g. surrogate motherhood, can be justified. Finally, norms evolve when the interpretations of the relevant values shift and cause a change in the presumptions implicit in the norms. Thus, norms are not a prerequisite of the ethical solution of practical dilemmas, but rather the outcome of the decision-making process itself. Struggling to reach the right decision in controversial clinical ethics situations indirectly causes social and moral values to change and principles to be understood differently.

  14. Hydroxyurea revisited: a decade of clinical effects studies

    International Nuclear Information System (INIS)

    Sinclair, W.K.

    1981-01-01

    Over a decade ago hydroxyurea was shown to selectively kill cells in the S phase in a proliferating cell population and to block cells at the G 1 -S border. Consequently, blocked cells became sensitized to irradiation and were further sensitized when the drug was present after exposure. In the ensuing decade, many in vivo studies on hydroxyurea have confirmed that the main properties of hydroxyurea identified in the dish are also evident in vivo. During a period of about ten years, a considerable number of clinical studies have been performed, the results of which have been mixed, ranging from indeterminate to encouraging, depending to some extent on the site treated and whether careful randomized studies were done. The question arises whether the clinical studies have represented adequate tests, by laboratory standards, of the likely effectiveness of the drug in clinical circumstances. The clinical studies with hydroxyurea have been examined in this light, since the results might also bear on the use of many other such agents in combination therapy. This examination revealed that no attempts have been made to determine the concentration of hydroxyurea in the tumor and other relevant tissues as a function of time or to assess the cell kinetic features of the tumor and thus estimate the appropriate dose regimen. It would seem that a wide gap still exists between laboratory research and clinical application

  15. Variation in clinical practice: forests and trees revisited.

    Science.gov (United States)

    Wallis, Christopher J D; Naylor, C David; Detsky, Allan S

    2017-09-01

    Variations in clinical practice are commonly viewed as a sign of uneven quality of care and attributed to provider self-interest. However, patient preferences, physician practice patterns, and diagnostic and therapeutic uncertainty also cause variations. Greater attention to both doctor-patient interactions and limits to the available evidence might enable more effective assessment and improvement of health-care quality.

  16. Neurogenetics in Peru: clinical, scientific and ethical perspectives.

    Science.gov (United States)

    Cornejo-Olivas, Mario; Espinoza-Huertas, Keren; Velit-Salazar, Mario R; Veliz-Otani, Diego; Tirado-Hurtado, Indira; Inca-Martinez, Miguel; Silva-Paredes, Gustavo; Milla-Neyra, Karina; Marca, Victoria; Ortega, Olimpio; Mazzetti, Pilar

    2015-07-01

    Neurogenetics, the science that studies the genetic basis of the development and function of the nervous system, is a discipline of recent development in Peru, an emerging Latin American country. Herein, we review the clinical, scientific and ethical aspects regarding the development of this discipline, starting with the first molecular diagnosis of neurogenetic diseases, to family and population-based genetic association studies. Neurogenetics in Peru aims to better explain the epidemiology of monogenic and complex neurodegenerative disorders that will help in implementing public health policies for these disorders. The characterization of Peru and its health system, legal issues regarding rare diseases and the historical milestones in neurogenetics are also discussed.

  17. [Innovative Prenatal Testing: Clinical Applications and Ethical Considerations].

    Science.gov (United States)

    Huang, Mei-Chih; Lin, Shio-Jean; Chen, Chih-Ling; Huang, Tzu-Jung

    2017-10-01

    The biomedical technology related to prenatal screen/diagnosis has developed rapidly in recent decades. Many prenatal genetic examinations are now available to assist pregnant women to better understand the status and development of their fetus. Moreover, many commercial advertisements for innovative prenatal examinations are now shown in the media. Cell-free DNA Screening (cfDNA screening), a non-invasive prenatal testing (NIPT) procedure, is a safe and high accuracy test that may be done at an earlier gestational age to screen for fetal aneuploidy. The following questions should be considered when applying cfDNA screening in clinical practice: 1. what is cfDNA screening, 2. who are its potential users, and 3. what ethical and policy considerations are associated with this examination? This article provides relevant information, clinical practice guidelines, and ethical / policy considerations related to cfDNA screening. Discussing cases involving different clinical situations helps promote understanding of cfDNA screening and maternal-care quality.

  18. Ethical clinical translation of stem cell interventions for neurologic disease

    DEFF Research Database (Denmark)

    Cote, David J; Bredenoord, Annelien L; Smith, Timothy R

    2017-01-01

    The application of stem cell transplants in clinical practice has increased in frequency in recent years. Many of the stem cell transplants in neurologic diseases, including stroke, Parkinson disease, spinal cord injury, and demyelinating diseases, are unproven-they have not been tested...... in prospective, controlled clinical trials and have not become accepted therapies. Stem cell transplant procedures currently being carried out have therapeutic aims, but are frequently experimental and unregulated, and could potentially put patients at risk. In some cases, patients undergoing such operations...... are not included in a clinical trial, and do not provide genuinely informed consent. For these reasons and others, some current stem cell interventions for neurologic diseases are ethically dubious and could jeopardize progress in the field. We provide discussion points for the evaluation of new stem cell...

  19. Implicit and explicit clinical ethics support in The Netherlands: a mixed methods overview study

    NARCIS (Netherlands)

    Dauwerse, L.; Weidema, F.C.; Abma, T.; Molewijk, A.C.; Widdershoven, G.

    2014-01-01

    Internationally, the prevalence of clinical ethics support (CES) in health care has increased over the years. Previous research on CES focused primarily on ethics committees and ethics consultation, mostly within the context of hospital care. The purpose of this article is to investigate the

  20. [How to Understand "Clinical Ethics" and "Research Ethics" in Clinical Settings--Incorporation of IRB, REC, and CEC in Hospital Organizations].

    Science.gov (United States)

    Ita, Koichiro

    2016-02-01

    As the traditional definition of "medical ethics" has recently changed markedly with advances in medical knowledge and technology, medical doctors and researchers in Japan are required to understand and apply both research and clinical ethics. Quite frequently, ethical problems in clinical settings cannot be addressed by the simple application of good will, hard work, and perseverance by medical personnel. The Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science and Technology (MEXT) have jointly published "Ethical Guidelines for Clinical Studies;" however, clear guidelines (legal, ministerial, or governmental) outlining the expectations regarding clinical ethics do not exist. All medical personnel face deep ethical dilemmas. In these instances, if the fulfillment of 'ethics' relies solely on the capacity of personnel to apply their own individual moral efforts, the result will be burn-out among these workers who have a strong sense of responsibility. In order to avoid this, a system which comprises multiple physicians, nurses, and other personnel must be established, allowing collaboration when an appropriate response is required. A major factor supporting this approach is the offering of Clinical Ethics Consultations.

  1. Goltz-Gorlin Syndrome: Revisiting the Clinical Spectrum.

    Science.gov (United States)

    Yesodharan, Dhanya; Büschenfelde, Uta Meyer Zum; Kutsche, Kerstin; Mohandas Nair, K; Nampoothiri, Sheela

    2018-01-31

    To describe the varying phenotypic spectrum of Focal Dermal Hypoplasia (FDH) and to emphasize the need for identifying the condition in mildly affected females which is crucial for offering a prenatal diagnosis in subsequent pregnancy owing to the risk of having a severely affected baby. The phenotype-genotype correlation of 4 patients with FDH, over a period of 11 y from the genetic clinic in a tertiary care centre from Kerala, India was done. All four mutation proven patients were females (2 adults and 2 children). One of the adult female subjects were mildly affected, though she had a history of having a severely affected female child who expired on day six. Among the 2 affected children, one of them had an unaffected mother and the other had an affected mother. FDH has a wide clinical spectrum from very subtle findings to severe manifestations. The lethality of the condition in males and the disfigurement and multisystem involvement in females highlights the importance of confirmation of diagnosis by molecular analysis so that the family can be offered prenatal diagnosis in subsequent pregnancy.

  2. [Ethics in clinical research: contextualizing and reductionist problem definitions, forms of ethical reflection and some particular implications].

    Science.gov (United States)

    Roelcke, Volker

    2003-12-01

    The present paper starts off with a short outline of issues, conflicts, and goals of ethical reflection about clinical research. It is then argued that non-reductionist, patient-centred ethics should critically reflect on medically preformed problem definitions, ways of problem solution, and evaluations. The shortcomings of such preformed perceptions and interpretations are illustrated using the examples of dementia research, and the complexities of the notion of risk. A more comprehensive approach including the perceptions, interpretations, and evaluations of the patients' perspective necessitates a form of ethical reflection which takes into account the social and cultural contexts of clinical research, and which therefore relies on concepts and methods of the cultural sciences (in particular history, sociology, and cultural anthropology). The decision for a reductionist, or for a contextualising mode of ethical reflection represents in itself a value decision and needs to be explicitly justified.

  3. Revisiting ovarian hyper stimulation syndrome: Towards OHSS free clinic

    Directory of Open Access Journals (Sweden)

    Manish Banker

    2015-01-01

    Full Text Available A rapid development and application of assisted reproductive technologies (ARTs and ovulation-induction drugs may lead to ovarian hyper stimulation syndrome (OHSS. Young age, low body mass index (BMI, polycystic ovarian syndrome (PCOS, previous OHSS, high follicle count, and elevated serum estradiol (E2 are the certain factors that predispose women to OHSS. Many strategies have been used to reduce or avoid OHSS. Use of human chorionic gonadotropin (hCG increases ovarian vascular permeability and is responsible for activating the vascular endothelial growth factors (VEGF pathway and thus the entire cascade, leading to symptomatic OHSS. Gonadotropin-releasing hormone (GnRH agonists are used as a replacement for hCG for final oocyte maturation in antagonist cycles. Reducing or eliminating the use of hCG and use of GnRH agonist triggered GnRH antagonist cycles and cryopreservation of oocytes or embryos is the most promising approach in making OHSS free clinic a reality.

  4. PNH revisited: Clinical profile, laboratory diagnosis and follow-up

    Directory of Open Access Journals (Sweden)

    Gupta P

    2009-01-01

    Full Text Available Background: Paroxysmal nocturnal hemoglobinuria (PNH is characterized by intravascular hemolysis, marrow failure, nocturnal hemoglobinuria and thrombophila. This acquired disease caused by a deficiency of glycosylphosphatidylinositol (GPI anchored proteins on the hematopoietic cells is uncommon in the Indian population. Materials and Methods: Data of patients diagnosed with PNH in the past 1 year were collected. Clinical data (age, gender, various presenting symptoms, treatment information and follow-up data were collected from medical records. Results of relevant diagnostic tests were documented i.e., urine analysis, Ham′s test, sucrose lysis test and sephacryl gel card test (GCT for CD55 and CD59. Results: A total of 5 patients were diagnosed with PNH in the past 1 year. Presenting symptoms were hemolytic anemia (n=4 and bone marrow failure (n=1. A GCT detected CD59 deficiency in all erythrocytes in 4 patients and CD55 deficiency in 2 patients. A weak positive PNH test for CD59 was seen in 1 patient and a weak positive PNH test for CD55 was seen in 3 patients. All patients were negative by sucrose lysis test. Ham′s test was positive in two cases. Patients were treated with prednisolone and/or androgen and 1 patient with aplastic anemia was also given antithymocyte globulin. A total of 4 patients responded with a partial recovery of hematopoiesis and 1 patient showed no recovery. None of the patients received a bone marrow transplant. Conclusion: The study highlights the diagnostic methods and treatment protocols undertaken to evaluate the PNH clone in a developing country where advanced methods like flowcytometry immunophenotyping (FCMI and bone marrow transplants are not routinely available.

  5. [The challenges of the ethics of personalism to clinical toxicology].

    Science.gov (United States)

    Brusiło, Jerzy

    2011-01-01

    The fields of philosophical anthropology and the ethics of personalism overlap in the area of many difficult personal situations involving clinical toxicology. These therapeutic situations need an integral, multidimensional, and personal approach for both the patient and the toxicologist. This means that man is treated not only as a physical (biological) being but also there is an appreciation for the mental sphere, which includes rational, emotional, and spiritual elements while not forgetting that the human person is also part of the human community. Studying such an individual's personal decision as suicide, we must realize that it's not just physiological or biochemical poisons but also includes the poisoning of the psyche, as well as poisoning relationships with loved ones (family), poisoning social relations (in school or the workplace) and poisoning the spirit, in other words, there is no meaning in life itself, nor the meaning of God's existence, nor the meaning of faith, hope and love. Not only is there a greater "variety of poisons" than before, they are much more extensive and deep. For example, we can name environmental pollution, industrial poisons, chemical waste, genetic modification, powerful medications, or even the toxic social environment of evil ideas, malicious manipulation of the human mind (destructive religious sects). In approaching the challenges of clinical toxicology, the doctor must not only be a specialist in chemistry, biochemistry and pharmacology. What then is of future of toxicology because of this human dimension (anthropological, ethical and spiritual) of this teaching? As today marks the occasion of the 45th anniversary of the Clinic of Toxicology CM UJ, should we shape the ethos of young doctors who want to deal with toxicology seriously?

  6. Continuing Education in Research Ethics for the Clinical Nurse.

    Science.gov (United States)

    Jeffers, Brenda Recchia

    2002-01-01

    Review of professional nursing statements, federal policy, and recommendations for protection of human research subjects resulted in a topic and content outline for research ethics training for nurses. Suggestions for continuing education programs on research ethics were formulated. (SK)

  7. Clinical Ethics Consultation: Attention to Cultural and Historic Context

    Directory of Open Access Journals (Sweden)

    Youngner, Stuart J.

    2008-04-01

    Full Text Available The clinical ethics consultation is a relatively new activity in US; a sort of service set aside for helping individual patients and groups. The historical evolution of CEC is described from the very beginning to 1976. Among other duties CEC gives moral support and psychological comfort to professionals related to health in decision-making moments. The operative methods and the access systems to CEC are fully described.La Consulta Ética Clínica es una actividad relativamente nueva en USA, como un servicio destinado a ayudar a pacientes individuales o grupos. Se describe la evolución histórica de la CEC desde su inicio en 1976. Entre otras funciones, la CEC presta un soporte moral y un “confort” psicológico a los profesionales de la salud en la toma de decisiones. Se describen los métodos operativos y de acceso a la CEC.

  8. The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review.

    Science.gov (United States)

    Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

    2016-01-01

    When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure.

  9. Modeling the relations of ethical leadership and clinical governance with psychological empowerment in nurses

    Directory of Open Access Journals (Sweden)

    Goona Fathi

    2014-07-01

    Full Text Available Background: Ethical leadership appeared as a new approach in the leadership perspective and provided the ground for promoting individual and organizational efficiency by giving priorities to ethics in organizations. In this regard, the present study was conducted with the aim of modeling the relations of ethical leadership and clinical governance with psychological empowerment among nurses of public hospitals in Kermanshah in 2014. Methods: the research method was descriptive survey. The study sample consisted of all nurses (n=550 working in public hospitals of Kermanshah University of Medical Science for whom 163 nurses were selected using simple random sampling. The tools for data collection were ethical leadership, clinical governance and psychology empowerment questionnaires whose validity and reliability were confirmed. The structural equation modeling was used to analyze the data. Results: The results showed a significant relationship between ethical leadership and clinical governance (P<0.01 and psychological empowerment (P<0.01. Moreover, there was a significant correlation between clinical governance and psychological empowerment (P<0.05. Based on the results of the research, ethical leadership directly and through clinical governance affected the nurses’ psychological empowerment (P<0.05. Conclusion: reliance on ethics and ethical leadership in hospitals, in addition to providing the space and ground for improving the effectiveness of clinical governance approach, can promote the feeling of psychological empowerment in nurses. Accordingly, the ethical issues are required to be taken into consideration in hospitals.

  10. Ethics consultation in paediatric and adult emergency departments: an assessment of clinical, ethical, learning and resource needs.

    Science.gov (United States)

    Colaco, Keith A; Courtright, Alanna; Andreychuk, Sandra; Frolic, Andrea; Cheng, Ji; Kam, April Jacqueline

    2018-01-01

    We sought to understand ethics and education needs of emergency nurses and physicians in paediatric and adult emergency departments (EDs) in order to build ethics capacity and provide a foundation for the development of an ethics education programme. This was a prospective cross-sectional survey of all staff nurses and physicians in three tertiary care EDs. The survey tool, called Clinical Ethics Needs Assessment Survey, was pilot tested on a similar target audience for question content and clarity. Of the 123 participants surveyed, 72% and 84% of nurses and physicians fully/somewhat agreed with an overall positive ethical climate, respectively. 69% of participants reported encountering daily or weekly ethical challenges. Participants expressed the greatest need for additional support to address moral distress (16%), conflict management with patients or families (16%) and resource issues (15%). Of the 23 reported occurrences of moral distress, 61% were associated with paediatric mental health cases. When asked how the ethics consultation service could be used in the ED, providing education to teams (42%) was the most desired method. Nurses report a greater need for ethics education and resources compared with their physician colleagues. Ethical challenges in paediatric EDs are more prevalent than adult EDs and nurses voice specific moral distress that are different than adult EDs. These results highlight the need for a suitable educational strategy, which can be developed in collaboration with the leadership of each ED and team of hospital ethicists. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. A Comparison of General Medical and Clinical Ethics Consultations: What Can We Learn From Each Other?

    Science.gov (United States)

    Geppert, Cynthia M.A.; Shelton, Wayne N.

    2012-01-01

    Despite the emergence of clinical ethics consultation as a clinical service in recent years, little is known about how clinical ethics consultation differs from, or is the same as, other medical consultations. A critical assessment of the similarities and differences between these 2 types of consultations is important to help the medical community appreciate ethics consultation as a vital service in today's health care setting. Therefore, this Special Article presents a comparison of medical and clinical ethics consultations in terms of fundamental goals of consultation, roles of consultants, and methodologic approaches to consultation, concluding with reflections on important lessons about the physician-patient relationship and medical education that may benefit practicing internists. Our aim is to examine ethics consultation as a clinical service integral to the medical care of patients. Studies for this analysis were obtained through the PubMed database using the keywords ethics consultation, medical consultation, ethics consults, medical consults, ethics consultants, and medical consultants. All English-language articles published from 1970 through August 2011 that pertained to the structure and process of medical and ethics consultation were reviewed. PMID:22469350

  12. Ethically-based clinical decision-making in physical therapy: process and issues.

    Science.gov (United States)

    Finch, Elspeth; Geddes, E Lynne; Larin, Hélène

    2005-01-01

    The identification and consideration of relevant ethical issues in clinical decision-making, and the education of health care professionals (HCPs) in these skills are key factors in providing quality health care. This qualitative study explores the way in which physical therapists (PTs) integrate ethical issues into clinical practice decisions and identifies ethical themes used by PTs. A purposive sample of eight PTs was asked to describe a recent ethically-based clinical decision. Transcribed interviews were coded and themes identified related to the following categories: 1) the integration of ethical issues in the clinical decision-making process, 2) patient welfare, 3) professional ethos of the PT, and 4) health care economics and business practices. Participants readily described clinical situations involving ethical issues but rarely identified specific conflicting ethical issues in their description. Ethical dilemmas were more frequently resolved when there were fewer emotional sequelae associated with the dilemma, and the PT had a clear understanding of professional ethos, valued patient autonomy, and explored a variety of alternative actions before implementing one. HCP students need to develop a clear professional ethos and an increased understanding of the economic factors that will present ethical issues in practice.

  13. Clinical Ethics in Gabon: The Spectrum of Clinical Ethical Issues Based on Findings from In-Depth Interviews at Three Public Hospitals.

    Science.gov (United States)

    Sippel, Daniel; Marckmann, Georg; Ndzie Atangana, Etienne; Strech, Daniel

    2015-01-01

    Unlike issues in biomedical research ethics, ethical challenges arising in daily clinical care in Sub-Saharan African countries have not yet been studied in a systematic manner. However this has to be seen as a distinct entity as we argue in this paper. Our aim was to give an overview of the spectrum of clinical ethical issues and to understand what influences clinical ethics in the Sub-Saharan country of Gabon. In-depth interviews with 18 health care professionals were conducted at three hospital sites in Gabon. Interview transcripts were analyzed using a grounded theory approach (open and axial coding), giving a qualitative spectrum of categories for clinical ethical issues. Validity was checked at a meeting with study participants and other health care experts in Gabon after analysis of the data. Twelve main categories (with 28 further-specified subcategories) for clinical ethical issues were identified and grouped under three core categories: A) micro level: "confidentiality and information", "interpersonal, relational and behavioral issues", "psychological strain of individuals", and "scarce resources"; B) meso level: "structural issues of medical institutions", "issues with private clinics", "challenges connected to the family", and "issues of education, training and competence"; and C) macro level: "influence of society, culture, religion and superstition", "applicability of western medicine", "structural issues on the political level", and "legal issues". Interviewees reported a broad spectrum of clinical ethical issues that go beyond challenges related to scarce financial and human resources. Specific socio-cultural, historical and educational backgrounds also played an important role. In fact these influences are central to an understanding of clinical ethics in the studied local context. Further research in the region is necessary to put our study into perspective. As many participants reported a lack of awareness of ethical issues amongst other health

  14. “My whole life is ethics!” Ordinary ethics and gene therapy clinical trials

    DEFF Research Database (Denmark)

    Addison, Courtney; Lassen, Jesper

    2017-01-01

    acquire some control in difficult medical situations, and practitioners can attune their care to their patients’ needs. The human provenance of gene therapy practice, and the irreducible sociality of ethics, means that understanding the ethics of this medical field also requires understanding the everyday...

  15. Clinical Ethics in Gabon: The Spectrum of Clinical Ethical Issues Based on Findings from In-Depth Interviews at Three Public Hospitals

    Science.gov (United States)

    Sippel, Daniel; Marckmann, Georg; Ndzie Atangana, Etienne; Strech, Daniel

    2015-01-01

    Introduction Unlike issues in biomedical research ethics, ethical challenges arising in daily clinical care in Sub-Saharan African countries have not yet been studied in a systematic manner. However this has to be seen as a distinct entity as we argue in this paper. Our aim was to give an overview of the spectrum of clinical ethical issues and to understand what influences clinical ethics in the Sub-Saharan country of Gabon. Materials and Methods In-depth interviews with 18 health care professionals were conducted at three hospital sites in Gabon. Interview transcripts were analyzed using a grounded theory approach (open and axial coding), giving a qualitative spectrum of categories for clinical ethical issues. Validity was checked at a meeting with study participants and other health care experts in Gabon after analysis of the data. Results Twelve main categories (with 28 further-specified subcategories) for clinical ethical issues were identified and grouped under three core categories: A) micro level: “confidentiality and information”, “interpersonal, relational and behavioral issues”, “psychological strain of individuals”, and “scarce resources”; B) meso level: “structural issues of medical institutions”, “issues with private clinics”, “challenges connected to the family”, and “issues of education, training and competence”; and C) macro level: “influence of society, culture, religion and superstition”, “applicability of western medicine”, “structural issues on the political level”, and “legal issues”. Discussion Interviewees reported a broad spectrum of clinical ethical issues that go beyond challenges related to scarce financial and human resources. Specific socio-cultural, historical and educational backgrounds also played an important role. In fact these influences are central to an understanding of clinical ethics in the studied local context. Further research in the region is necessary to put our study into

  16. [Ethical dilemma for nurses who manage marital violence in clinical setting].

    Science.gov (United States)

    Hou, Wen-Li; Kuo, Ya-Wen; Huang, Mei-Chih

    2008-06-01

    Marital violence or intimate partner violence is a serious and recurring public health issue. In the clinical setting, battered women often seek medical advice, because of the health problems that result from marital violence. Thus, nursing staff are the first persons to come into contact with the battered women. Can nurses execute their notify responsibility to prevent continued injury before obtained the woman's agreement? Will this action violate the principle of autonomy or not? Nurses would face an ethical dilemma when they care for battered women. The purpose of this article is to use Aroskar's ethical decision making model to analyze and clarify the ethical dilemmas involved in managing marital violence, including: under the value systems of the person, the profession, and time to illustrate the basic information, decision theory dimensions, and ethical theories or positions. It is hoped that this article provides an ethical decision making model for the ethical dilemmas facing nurses who manage marital violence in the clinical setting.

  17. Interprofessional Clinical Ethics Education: The Promise of Cross-Disciplinary Problem-Based Learning.

    Science.gov (United States)

    Kurtz, Melissa J; Starbird, Laura E

    2016-09-01

    A review of Lin et al.'s pilot study exploring the effects of an interprofessional, problem-based learning clinical ethics curriculum on Taiwanese medical and nursing students' attitudes towards interprofessional collaboration highlights the benefits of interprofessional collaboration and offers insight into how problem-based learning might be universally applied in ethics education. Interprofessional collaboration is an ideal approach for exploring ethical dilemmas because it involves all relevant professionals in discussions about ethical values that arise in patient care. Interprofessional ethics collaboration is challenging to implement, however, given time constraints and organizational and practice demands. Nevertheless, we suggest that when professionals collaborate, they can collectively express greater commitment to the patient. We also suggest future research avenues that can explore additional benefits of interprofessional collaboration in clinical ethics. © 2016 American Medical Association. All Rights Reserved.

  18. A new paradigm for HIV care: ethical and clinical considerations.

    Science.gov (United States)

    Noring, S; Dubler, N N; Birkhead, G; Agins, B

    2001-05-01

    Although dramatic advances in clinical treatment have greatly improved the lives of many people with HIV/AIDS, many other patients do not have information about or access to these treatments because of health care providers' presumptive judgments about patients' ability to adhere to medical regimens. The authors contend that with sufficient support and education most patients, even those with difficult social and medical problems, can be helped to initiate and maintain HIV treatment in accordance with current clinical standards. This commentary delineates a new paradigm for HIV care in which patients and providers collaborate on individualized plans to establish patients' readiness for treatment, ensure maintenance of treatment, and make use of the social services necessary to accomplish these goals. Providers have an ethical responsibility to do everything possible to see that patients who might benefit from new HIV treatments have a fair opportunity to do so, and health systems have a responsibility to facilitate this process. Substantial progress toward meeting these responsibilities can be made within the current health care environment.

  19. Early indicators and risk factors for ethical issues in clinical practice.

    Science.gov (United States)

    Pavlish, Carol; Brown-Saltzman, Katherine; Hersh, Mary; Shirk, Marilyn; Nudelman, Olga

    2011-03-01

    Nurses in all clinical settings encounter ethical issues that frequently lead to moral distress. This critical incident study explored nurses' descriptions of ethically difficult situations to identify risk factors and early indicators of ethical conflicts. Employing the critical incident technique, researchers developed a questionnaire that collected information on ethically difficult situations, their risk factors and early indicators, nurse actions, and situational outcomes. Two nurse researchers independently analyzed and categorized data using a constant comparison technique. Most of the ethically difficult situations pertained to end-of-life care for children and adults. Conflicts in interpersonal relationships were prevalent. Nurses were especially moved by patient and family suffering and concerned about patient vulnerability, harm-benefit ratio, and patient autonomy. Researchers discovered risk factor categories for patients, families, healthcare providers, and health systems. Additionally, researchers found subcategories in six major categories of early indicators: signs of conflict, patient suffering, nurse distress, ethics violation, unrealistic expectations, and poor communication. Nurses are keenly aware of pertinent risk factors and early indicators of unfolding ethical conflicts. Many nurses reported feeling powerless in the face of ethical conflict. Research that develops interventions to strengthen nurses' voices in ethically difficult situation is warranted. Nurses are in a key position to identify patient situations with a high risk for ethical conflict. Initiating early ethics consultation and interventions can alter the course of pending conflicts and diminish the potential for patient and family suffering and nurses' moral distress. © 2011 Sigma Theta Tau International.

  20. Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study

    OpenAIRE

    Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

    2018-01-01

    Background Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of...

  1. The informal curriculum - general practitioner perceptions of ethics in clinical practice.

    Science.gov (United States)

    Sturman, Nancy J; Parker, Malcolm; van Driel, Mieke L

    2012-12-01

    Australian medical students should graduate with an understanding of the principles of medical law and ethics, and their application to clinical settings. Although student perspectives have been studied previously, the teacher experience of ethical issues also needs to be understood, particularly in the general practice setting. Interviews were conducted with a convenience sample of 13 general practitioner teachers. They were asked to reflect on common and/or important ethical issues in their day-to-day practice. An inductive thematic analysis of the data was performed by two investigators, who reached a consensus on major themes using an iterative, dialogic process. Participants reported negotiating ethical issues frequently. Major themes included patient-doctor relationships, professional differences, truth-telling, ethically 'grey' areas and the personal demands of ethical decision making. General practitioners in this study describe sometimes needing to apply judgement and compromise in situations involving legal or ethical issues, in order to act in the best interests of patients and to successfully negotiate the patient-doctor relationship. Students learning in this clinical context may perceive mixed messages and ethical lapses in these challenging 'grey' areas. The ethical acumen and emotional resilience of both students and clinical teachers may be enhanced by ongoing reflective discussion with colleagues.

  2. Ethical dilemmas and financial burdens faced by clinical dental ...

    African Journals Online (AJOL)

    Ethics courses are part of most dental curricula, but have no standard, universally accepted outline or structure. Bribery was investigated by a student who had experienced it as a problem himself, highlighting the point that students will be more engaged in ethics education when it addresses issues directly relevant to them.

  3. Distance Supervision in Rehabilitation Counseling: Ethical and Clinical Considerations

    Science.gov (United States)

    Lund, Emily M.; Schultz, Jared C.

    2015-01-01

    Background: The use of technology-mediated distance supervision is a rapidly growing area in rehabilitation counseling and other fields. Distance supervision has both tremendous potential and notable challenges to address, including questions of ethics and evidence. Purpose: This article examines both the ethical and nonethical principles that…

  4. Constructing Baccalaureate Nursing Students' Ethical Experiences of Classroom Lessons and Clinical Practice

    Science.gov (United States)

    Knowles, Amy J. B.

    2014-01-01

    Ethics is an integral component of the nursing profession. This phenomenological study aimed to describe how baccalaureate nursing students experience learning ethics both in the classroom and clinical setting. The interviews in this study were conducted with eight second semester senior nursing students. Four themes emerged from analyses of the…

  5. Henry Beecher's Contributions to the Ethics of Clinical Research.

    Science.gov (United States)

    Veatch, Robert M

    2016-01-01

    In the 1950s and '60s, Henry Beecher pioneered the discussion of the ethics of clinical research, leading eventually to the publication of the famous New England Journal of Medicine article summarizing 22 research studies that Beecher suggests were unethical. Those studies generally showed a pattern of posing serious risks to subjects without anticipated proportional benefit. Beecher famously claimed that the problem was not that researchers were malicious or evil; rather, he claimed the problem was they manifested thoughtlessness or carelessness. He called for more rigorous self-scrutiny rather than public review.This article argues that Beecher's reliance on conscientious investigators is problematic. In particular, it focuses on benefits and harms to the exclusion of other moral criteria. However, both research subjects and public regulators are also concerned about autonomy and the consent requirement, confidentiality, and fairness in subject selection and research design. The movement in the 1970s toward more public scrutiny was critical, even though Beecher was right in holding that it was not "vicious disregard for subject welfare" that explained unethical protocols.

  6. Certification ISO 9001 in clinical ethics consultation for improving quality and safety in healthcare.

    Science.gov (United States)

    Tozzo, Pamela; Mazzi, Anna; Aprile, Anna; Rodriguez, Daniele; Caenazzo, Luciana

    2018-03-24

    This paper refers to the quality management process of the Laboratory of Clinical Bioethics (LCB) of the University of Padua (Italy), which has obtained the quality certification to ISO 9001:2008, as a Clinical Ethics Support Service. Its activities consist mainly in clinical ethics consultations and training services, addressed to those who are called to decisions with ethical implications in the clinical setting, proposing a structured approach to identify and analyze the ethical issues that may loom in the relationships between health professionals and patients, and participating in their solution. The expected benefits of the application of ISO 9001 were mainly the following: to formalize the procedure adopted for clinical ethics consultation and training, to obtain a controlled management of documents, information and data, to ensure and demonstrate the quality of the provided activities and to make methods and organization publicly available. The main results which have been achieved with the 'quality management project' are summarized as follows: the enunciation of LCB Mission and Quality Policy; the drafting of the procedure by which clinical ethics consultation is provided; the formalization of members' skills and the adoption of relevant process and outcome indicators. Our experience may be useful in promoting accountability for the quality of ethics consultation services. We consider the certification process as a tool for transparent and reliable management of one of the most critical tasks in the current context of healthcare, motivating similar facilities to undertake similar pathways, with the aim to provide quality control on their activities.

  7. The "difficult" patient reconceived: an expanded moral mandate for clinical ethics.

    Science.gov (United States)

    Fiester, Autumn

    2012-01-01

    Between 15 and 60% of patients are considered "difficult" by their treating physicians. Patient psychiatric pathology is the conventional explanation for why patients are deemed "difficult." But the prevalence of the problem suggests the possibility of a less pathological cause. I argue that the phenomenon can be better explained as a response to problematic interactions related to health care delivery. If there are grounds to reconceive the "difficult" patient as reacting to the perception of ill treatment, then there is an ethical obligation to address this perception of harm. Resolution of such conflicts currently lies with the provider and patient. But the ethical stakes place these conflicts into the province of the ethics consult service. As the resource for addressing ethical dilemmas, there is a moral mandate to offer assistance in the resolution of these ethically charged conflicts that is no less pressing than the more familiar terrain of clinical ethics consultation.

  8. A Second Opinion: A Case Narrative on Clinical Ethics Mediation.

    Science.gov (United States)

    Weinstein, Michael S

    2015-01-01

    Contrasting traditional and common forms if ethics consultation with bioethics mediation. I describe the case of a "second opinion" consultation in the care of a patient with advanced cancer for whom treatment was futile. While the initial ethics consultation, performed by a colleague, let to a recommendation that some may deem ethical, the process failed to involve key stakeholders and failed to explore the underlying values and reasons for the opinions voiced by various stakeholders. The process of mediation ultimately led to creative solutions in which all stakeholders could reach consensus on a plan of care.

  9. Ethics of orthodontic clinical research based on Helsinki declaration

    Directory of Open Access Journals (Sweden)

    Eka Erwansyah

    2016-06-01

    Full Text Available Declaration of Helsinki code of ethics on human experimentation, states that the desin and peformance of experimental procedures involving human should be clearly formulated in an experimental protocol, Todeterminewhetheraninvestigationin accordancewiththe code of conductin a researchthen letusconsider the contentofthe declarationhelsinkiasour referencein conductingaclinicalstudyusinghuman subjects. In journals, authors are expected to report if the study was carried out in accordance with international and national ethical guidelines and inform readers if approval from ethics committee was obtained and if written informed consent was taken from the participant or legal guardian.

  10. Teaching practical wisdom in medicine through clinical judgement, goals of care, and ethical reasoning.

    Science.gov (United States)

    Kaldjian, Lauris Christopher

    2010-09-01

    Clinical decision making is a challenging task that requires practical wisdom-the practised ability to help patients choose wisely among available diagnostic and treatment options. But practical wisdom is not a concept one typically hears mentioned in medical training and practice. Instead, emphasis is placed on clinical judgement. The author draws from Aristotle and Aquinas to describe the virtue of practical wisdom and compare it with clinical judgement. From this comparison, the author suggests that a more complete understanding of clinical judgement requires its explicit integration with goals of care and ethical values. Although clinicians may be justified in assuming that goals of care and ethical values are implicit in routine decision making, it remains important for training purposes to encourage habits of clinical judgement that are consciously goal-directed and ethically informed. By connecting clinical judgement to patients' goals and values, clinical decisions are more likely to stay focused on the particular interests of individual patients. To cultivate wise clinical judgement among trainees, educational efforts should aim at the integration of clinical judgement, communication with patients about goals of care, and ethical reasoning. But ultimately, training in wise clinical judgement will take years of practice in the company of experienced clinicians who are able to demonstrate practical wisdom by example. By helping trainees develop clinical judgement that incorporates patients' goals of care and ethical reasoning, we may help lessen the risk that 'clinical judgement' will merely express 'the clinician's judgement.'

  11. Theory and practice of clinical ethics support services: narrative and hermeneutical perspectives.

    Science.gov (United States)

    Porz, Rouven; Landeweer, Elleke; Widdershoven, Guy

    2011-09-01

    In this paper we introduce narrative and hermeneutical perspectives to clinical ethics support services (CESS). We propose a threefold consideration of 'theory' and show how it is interwoven with 'practice' as we go along. First, we look at theory in its foundational role: in our case 'narrative ethics' and 'philosophical hermeneutics' provide a theoretical base for clinical ethics by focusing on human identities entangled in stories and on moral understanding as a dialogical process. Second, we consider the role of theoretical notions in helping practitioners to understand their situation in clinical ethics practice, by using notions like 'story', 'responsibility', or 'vulnerability' to make explicit and explain their practical experience. Such theoretical notions help us to interpret clinical situations from an ethical perspective and to foster moral awareness of practitioners. And, thirdly, we examine how new theoretical concepts are developed by interpreting practice, using practice to form and improve our ethical theory. In this paper, we discuss this threefold use of theory in clinical ethics support services by reflecting on our own theoretical assumptions, methodological steps and practical experiences as ethicists, and by providing examples from our daily work. In doing so, we illustrate that theory and practice are interwoven, as theoretical understanding is dependent upon practical experience, and vice-versa. © 2011 Blackwell Publishing Ltd.

  12. Ethics and the electronic health record in dental school clinics.

    Science.gov (United States)

    Cederberg, Robert A; Valenza, John A

    2012-05-01

    Electronic health records (EHRs) are a major development in the practice of dentistry, and dental schools and dental curricula have benefitted from this technology. Patient data entry, storage, retrieval, transmission, and archiving have been streamlined, and the potential for teledentistry and improvement in epidemiological research is beginning to be realized. However, maintaining patient health information in an electronic form has also changed the environment in dental education, setting up potential ethical dilemmas for students and faculty members. The purpose of this article is to explore some of the ethical issues related to EHRs, the advantages and concerns related to the use of computers in the dental operatory, the impact of the EHR on the doctor-patient relationship, the introduction of web-based EHRs, the link between technology and ethics, and potential solutions for the management of ethical concerns related to EHRs in dental schools.

  13. Investigation Clinical Competence and Its Relationship with Professional Ethics and Spiritual Health in Nurses

    Directory of Open Access Journals (Sweden)

    Elahe Ramezanzade Tabriz

    2017-03-01

    Full Text Available Abstract Background and Objectives: Study of clinical competence in nursing helps determine the quality of health care delivered to patients. Given the priority of observance of principles over caretaking and necessity of spirituality existence at the core of health care provision, this study was conducted to investigate clinical competence and its relationship with professional ethics and spiritual health in nurses. Methods: In this cross-sectional, descriptive, and correlational study, 281 nurses were enrolled by consensus sampling. Sampling was conducted from February, 2016 till June, 2016. The data were gathered by a demographics questionnaire, a self-assessment scale of clinical competence, a nursing ethics questionnaire, and a spiritual health questionnaire, and analyzed by descriptive statistics and t-test, Pearson's correlation coefficient, ANOVA, and linear regression analysis in SPSS 21. Results: The total scores for self-assessment scale of nurses' clinical competence, professional ethics, and spiritual health were moderate. In the light of the results of Spearman's correlation coefficient, there was a significant and positive correlation between clinical competence and spiritual health. Moreover, a significant positive correlation was observed between professional ethics and spiritual health but there was no correlation between professional ethics and clinical competence. Conclusion: Managers' and personnel's Knowledge about the level of nurses clinical competence, professional ethics, and spiritual health in teaching health care centers provides valuable information to develop in-service and efficacious education programs and ultimately to improve the quality of nursing services.

  14. Ethical violations in the clinical setting: the hidden curriculum learning experience of Pakistani nurses.

    Science.gov (United States)

    Jafree, Sara Rizvi; Zakar, Rubeena; Fischer, Florian; Zakar, Muhammad Zakria

    2015-03-19

    The importance of the hidden curriculum is recognised as a practical training ground for the absorption of medical ethics by healthcare professionals. Pakistan's healthcare sector is hampered by the exclusion of ethics from medical and nursing education curricula and the absence of monitoring of ethical violations in the clinical setting. Nurses have significant knowledge of the hidden curriculum taught during clinical practice, due to long working hours in the clinic and front-line interaction with patients and other practitioners. The means of inquiry for this study was qualitative, with 20 interviews and four focus group discussions used to identify nurses' clinical experiences of ethical violations. Content analysis was used to discover sub-categories of ethical violations, as perceived by nurses, within four pre-defined categories of nursing codes of ethics: 1) professional guidelines and integrity, 2) patient informed consent, 3) patient rights, and 4) co-worker coordination for competency, learning and patient safety. Ten sub-categories of ethical violations were found: nursing students being used as adjunct staff, nurses having to face frequent violence in the hospital setting, patient reluctance to receive treatment from nurses, the near-absence of consent taken from patients for most non-surgical medical procedures, the absence of patient consent taking for receiving treatment from student nurses, the practice of patient discrimination on the basis of a patient's socio-demographic status, nurses withdrawing treatment out of fear for their safety, a non-learning culture and, finally, blame-shifting and non-reportage of errors. Immediate and urgent attention is required to reduce ethical violations in the healthcare sector in Pakistan through collaborative efforts by the government, the healthcare sector, and ethics regulatory bodies. Also, changes in socio-cultural values in hospital organisation, public awareness of how to conveniently report ethical

  15. Trust, moral responsibility, the self, and well-ordered societies: the importance of basic philosophical concepts for clinical ethics.

    Science.gov (United States)

    Mccullough, Laurence B

    2002-02-01

    Although the work of clinical ethics is intensely practical, it employs and presumes philosophical concepts from the central branches of philosophy, including metaphysics, epistemology, ethics, and political philosophy. This essay introduces this issue in the Journal on clinical ethics by considering how the papers and book reviews included in it illuminate four such concepts: trust, moral responsibility, the self and well-ordered societies.

  16. Psychotropics without borders: ethics and legal implications of internet-based access to psychiatric medications.

    Science.gov (United States)

    Klein, Carolina A

    2011-01-01

    Medical practitioners are revisiting many of the ethics and the legal implications surrounding the clinical frameworks within which we operate. In today's world, distinguishing between virtual and physical reality continues to be increasingly difficult. The physician may be found grappling with the decision of whether to continue to treat a patient who may be obtaining psychotropic medications through the Internet. This article approaches some of the clinical and legal implications and the ethics regarding the availability of prescription psychotropics over the Internet.

  17. Characterisation of organisational issues in paediatric clinical ethics consultation: a qualitative study.

    Science.gov (United States)

    Opel, D J; Wilfond, B S; Brownstein, D; Diekema, D S; Pearlman, R A

    2009-08-01

    The traditional approach to resolving ethics concerns may not address underlying organisational issues involved in the evolution of these concerns. This represents a missed opportunity to improve quality of care "upstream". The purpose of this study was to understand better which organisational issues may contribute to ethics concerns. Directed content analysis was used to review ethics consultation notes from an academic children's hospital from 1996 to 2006 (N = 71). The analysis utilised 18 categories of organisational issues derived and modified from published quality improvement protocols. Organisational issues were identified in 68 of the 71 (96%) ethics consult notes across a range of patient settings and reasons for consultation. Thirteen of the 18 categories of organisational issues were identified and there was a median of two organisational issues per consult note. The most frequently identified organisational issues were informal organisational culture (eg, collective practices and approaches to situations with ethical dimensions that are not guided by policy), policies and procedures (eg, staff knows policy and/or procedural guidelines for an ethical concern but do not follow it) and communication (eg, communication about critical information, orders, or hand-offs repeatedly does not occur among services). Organisational issues contribute to ethical concerns that result in clinical ethics consults. Identifying and addressing organisational issues such as informal culture and communication may help decrease the recurrence of future similar ethics concerns.

  18. Do organizational and clinical ethics in a hospital setting need different venues?

    Science.gov (United States)

    Førde, Reidun; Hansen, Thor Willy Ruud

    2014-06-01

    The structure of ethics work in a hospital is complex. Professional ethics, research ethics and clinical ethics committees (CECs) are important parts of this structure, in addition to laws and national and institutional codes of ethics. In Norway all hospital trusts have a CEC, most of these discuss cases by means of a method which seeks to include relevant guidelines and laws into the discussion. In recent years many committees have received more cases which have concerned questions of principle. According to Ellen Fox and co-authors the traditional CEC model suffers from a number of weaknesses. Therefore, in their organization a separate body deals with organizational matters. In this paper, we discuss what is gained and what is lost by creating two separate bodies doing ethics consultation. We do this through an analysis of detailed minutes of CEC discussions in one CEC during a 6-year period. 30 % of all referrals concerned matters of principle. Some of these discussions originated in a dilemma related to a particular patient. Most of the discussions had some consequences within the hospital organization, for clinical practice, for adjustment of guidelines, or may have influenced national policy. We conclude that a multiprofessional CEC with law and ethics competency and patient representation may be well suited also for discussion of general ethical principles. A CEC is a forum which can help bridge the gap between clinicians and management by increasing understanding for each others' perspectives.

  19. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations.

    Science.gov (United States)

    Pierre, Christine

    2008-01-01

    Physicians who participate in clinical research studies gain benefits for themselves, their practice, and their patients. Historically, private practice physicians have chosen to defer to their counterparts in academic medicine when it comes to contributing to scientific advancement through clinical studies. A growing number of private practice physicians are now taking a serious second look and deciding that there are unique benefits for both the practice and the patient. Physicians who decide to participate in clinical research should give serious consideration to the time and resources that are required to meet both federal regulations and industry standards. In addition, ethical and scientific principles for assuring the protection of human research subjects must be a paramount commitment.

  20. Effectiveness of faculty training to enhance clinical evaluation of student competence in ethical reasoning and professionalism.

    Science.gov (United States)

    Christie, Carole; Bowen, Denise; Paarmann, Carlene

    2007-08-01

    This study evaluated the short- and long-term effectiveness of faculty training to enhance clinical evaluation of ethical reasoning and professionalism in a baccalaureate dental hygiene program. Ethics, values, and professionalism are best measured in contexts comparable to practice; therefore, authentic evaluation is desirable for assessing these areas of competence. Methods were the following: 1) a faculty development workshop implementing a core values-based clinical evaluation system for assessing students' professional judgment; 2) subsequent evaluation of the clinical faculty's use of core values for grading and providing written comments related to students' professional judgment during patient care for three academic years; and 3) evaluation of program outcomes assessments regarding clinical learning experiences related to ethics and professionalism domains. Results revealed the clinical faculty's evaluation of professional judgment during patient care was enhanced by training; written comments more frequently related to core values defined in the American Dental Hygienists' Association (ADHA) Code of Ethics; and faculty members reported more confidence and comfort evaluating professional judgment after implementation of this evaluation system and receiving training in its application. Students were more positive in outcomes assessments about their competency and learning experiences related to professionalism and ethics. This article shares one approach for enhancing clinical faculty's authentic evaluation of student competence in ethical reasoning and professionalism.

  1. Developing an Evaluation Tool for Assessing Clinical Ethics Consultation Skills in Simulation Based Education: The ACES Project.

    Science.gov (United States)

    Wasson, Katherine; Parsi, Kayhan; McCarthy, Michael; Siddall, Viva Jo; Kuczewski, Mark

    2016-06-01

    The American Society for Bioethics and Humanities has created a quality attestation (QA) process for clinical ethics consultants; the pilot phase of reviewing portfolios has begun. One aspect of the QA process which is particularly challenging is assessing the interpersonal skills of individual clinical ethics consultants. We propose that using case simulation to evaluate clinical ethics consultants is an approach that can meet this need provided clear standards for assessment are identified. To this end, we developed the Assessing Clinical Ethics Skills (ACES) tool, which identifies and specifies specific behaviors that a clinical ethics consultant should demonstrate in an ethics case simulation. The aim is for the clinical ethics consultant or student to use a videotaped case simulation, along with the ACES tool scored by a trained rater, to demonstrate their competence as part of their QA portfolio. The development and piloting of the tool is described.

  2. Therapy in virtual environments--clinical and ethical issues.

    Science.gov (United States)

    Yellowlees, Peter M; Holloway, Kevin M; Parish, Michelle Burke

    2012-09-01

    As virtual reality and computer-assisted therapy strategies are increasingly implemented for the treatment of psychological disorders, ethical standards and guidelines must be considered. This study determined a set of ethical and legal guidelines for treatment of post-traumatic stress disorder (PTSD)/traumatic brain injury (TBI) in a virtual environment incorporating the rights of an individual who is represented by an avatar. A comprehensive literature review was undertaken. An example of a case study of therapy in Second Life (a popular online virtual world developed by Linden Labs) was described. Ethical and legal considerations regarding psychiatric treatment of PTSD/TBI in a virtual environment were examined. The following issues were described and discussed: authentication of providers and patients, informed consent, patient confidentiality, patient well-being, clinician competence (licensing and credentialing), training of providers, insurance for providers, the therapeutic environment, and emergencies. Ethical and legal guidelines relevant to these issues in a virtual environment were proposed. Ethical and legal issues in virtual environments are similar to those that occur in the in-person world. Individuals represented by an avatar have the rights equivalent to the individual and should be treated as such.

  3. Ethics.

    Science.gov (United States)

    Pellegrino, Edmund D

    In this brief annual review of ethical issues in medicine, Pellegrino focuses on two issues, AIDS and surrogate mothers. The AIDS epidemic has generated debate over public health needs vs. individual rights, modification of sexual practices, screening programs to detect infected persons, confidentiality of test results, experimental therapies, and the duty of physicians to care for AIDS patients. Surrogate motherhood arrangements have become one of the more controversial of the new reproductive technologies. The publicity that accompanied the custody battle over New Jersey's "Baby M" intensified debate over the commercialization of childbearing and the regulation of reproduction. Pellegrino concludes that physicians, along with ethicists and policymakers, have an obligation to "lead society in careful and judicious deliberation" of the ethical issues raised by AIDS and by reproductive technologies.

  4. Economics and industry do not mean ethical conduct in clinical trials.

    Science.gov (United States)

    Lexchin, Joel

    2013-01-01

    Clinical trials present an ethical dilemma for pharmaceutical companies. While companies may want to undertake and report these trials in an ethical manner, negative results can significantly affect product sales. There is accumulating evidence that company-financed trials are biased in favor of the product that the company makes. Ethical conduct in this article is defined as whether the trials are conducted in the best interests of the participants and/or reported in the best interests of patients. Nine examples of how clinical trials are violating multiple articles in the Declaration of Helsinki are discussed using concrete case reports from the literature. The recognition of ethical problems in company run trials is not something new, but to date no meaningful action has been taken to resolve this issue. What is necessary is to separate the financing of clinical trials from their conduct.

  5. Everyday ethics issues in the outpatient clinical practice of pediatric residents.

    Science.gov (United States)

    Moon, Margaret; Taylor, Holly A; McDonald, Erin L; Hughes, Mark T; Carrese, Joseph A

    2009-09-01

    To describe the ethics issues that pediatric residents encounter during routine care in an outpatient teaching clinic. Qualitative study including in-depth interviews with pediatric residents and direct observation of interactions between preceptors and residents in a pediatric teaching clinic. The Johns Hopkins Harriet Lane Pediatric Primary Care Clinic, March 20 through April 11, 2006. A convenience sample including all pediatric faculty preceptors supervising at the clinic during the 19 half-day sessions that occurred during the observation period (N = 15) and the pediatric residents seeing patients during these clinic sessions (N = 50). Main Outcome Measure Field notes of preceptor-resident discussions about patient care were made and transcribed for qualitative analysis. Qualitative analysis of the ethics content of cases presented by residents in this pediatric teaching clinic identified 5 themes for categorizing ethics challenges: (1) promoting the child's best interests in complex and resource-poor home and social settings; (2) managing the therapeutic alliance with parents and caregivers; (3) protecting patient privacy and confidentiality; (4) balancing the dual roles of learner and health care provider; and (5) using professional authority appropriately. Qualitative analysis of the ethics content of directly observed preceptor-resident case discussions yielded a set of themes describing the ethics challenges facing pediatric residents. The themes are somewhat different from the lists of residents' ethics experiences developed using recall or survey methods and may be very different from the ideas usually included in hospital-based ethics discussions. This may have implications for improving ethics education during residency training.

  6. The ethical justification for the use of non-human primates in research: the Weatherall report revisited.

    Science.gov (United States)

    Arnason, Gardar

    2017-10-14

    The Weatherall report on the use of non-human primates in research was published in 2006. Its main conclusion was that there is a strong scientific case for the use of non-human primates in some cases, but the report stressed the importance of evaluating each case in the light of the availability of alternatives. In addition to arguing for the scientific necessity of using non-human primates in research, the report also provided an ethical justification. As could be expected, the report was harshly criticised by animal rights groups, but in the academic literature, only two critical replies appeared. In what follows, I will describe the ethical justification for non-human primate research as it is laid out in the Weatherall report and then consider the criticism in the academic literature. I conclude that the report's ethical justification for the use of non-human primates in research, in particular in basic neuroscientific research, has not been convincingly challenged by its critics. Since the criticism of the report is limited and represents only a small part of the academic discussion about the use of non-human primates in research, and a still smaller part of the ethical discussion about animal research, it is important that the discussion continue both at the academic and social level. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  7. The Racialized Body of the Educator and the Ethic of Hospitality: The Potential for Social Justice Education Re-Visited

    Science.gov (United States)

    Sinha, Shilpi

    2018-01-01

    Derridean hospitality is seen to undergird ethical teacher-student interactions. However, hospitality is marked by three aporias that signal incommensurable and irreducible ways of being and responding that need to be held together in tension without eventual synthesis. Due to the sociopolitical materiality of race and the phenomenological…

  8. [Ethics in clinical routine care: example of prognosis information].

    Science.gov (United States)

    Elger, Bernice S

    2002-09-15

    The article discusses from an ethical point of view the question whether a physician should tell the patient the whole truth about a poor prognosis. From a legal viewpoint, the therapeutic privilege gives physicians in most countries the right to limit information, if they are concerned that this information will severely harm the patient. An overview about empirical studies, especially surveys of physicians and patients, shows that most patients always wish to know their prognosis, while physicians would less often tell the whole truth. Physicians explain their attitudes by referring to the ethical principles of nonmaleficience and beneficience. These principles are apparently in conflict with the principles of veracity and respect of patient autonomy. However, it can be shown that this conflict does not persist when empirical data about consequences of truthful information are considered: telling the truth seems not to have negative, but rather positive consequences on the overall well-being of the patient. After having summarized the empirical studies that have examined the consequences of truthful information about severe and incurable diseases, the article argues for always telling patients the truth if they want to know it. Many conflicts in medical ethics are between prima facie principles. In cases where the principles of beneficience and nonmaleficience are used in the argumentation, some of the conflicts can be eliminated when the ethical judgment is made on a thorough empirical basis, as shown by the example of truth-telling about prognosis.

  9. The evolution of integration: innovations in clinical skills and ethics in first year medicine.

    Science.gov (United States)

    Brunger, Fern; Duke, Pauline S

    2012-01-01

    Critical self-reflection, medical ethics and clinical skills are each important components of medical education but are seldom linked in curriculum development. We developed a curriculum that builds on the existing integration of ethics education into the clinical skills course to more explicitly link these three skills. The curriculum builds on the existing integration of clinical skills and ethics in first year medicine. It refines the integration through scheduling changes; adds case studies that emphasise the social, economic and political context of our province's patient population; and introduces reflection on the "culture of medicine" as a way to have students articulate and understand their own values and moral decision making frameworks. This structured Clinical Skills course is a model for successfully integrating critical self-reflection, reflection on the political, economic and cultural contexts shaping health and healthcare, and moral decision making into clinical skills training.

  10. Ethics of international clinical research collaboration - the experience of AlloStem.

    Science.gov (United States)

    Chaplin, C

    2006-02-01

    This paper examines the ethics of international clinical collaboration in stem cell research by focusing on the AlloStem project. AlloStem is an international research programme, financed by the European Union under the Sixth Framework Programme, with the aim of advancing the use of stem cells in treating leukaemia and other haematological diseases. Several areas of ethical importance are explored. Research justification and the need to consider both deontological and teleological aspects are examined. Ethical sensitivity in research and the requirement to respond to areas of ethical concern identified by the European Commission, such as the involvement of human beings, the use of human tissue, and the use of animals are also explored. Ethical issues around project structure and management, such as ethical standardization in international research, and achieving set targets are discussed. The ethical importance of dissemination of findings and teaching in clinical research is also considered. Finally, the distribution of benefits is addressed and the importance of distributive justice is emphasized.

  11. Monological versus dialogical consciousness: two epistemological views on the use of theory in clinical ethical practice.

    Science.gov (United States)

    Ohnsorge, Kathrin; Widdershoven, Guy

    2011-09-01

    In this article, we argue that a critical examination of epistemological and anthropological presuppositions might lead to a more fruitful use of theory in clinical-ethical practice. We differentiate between two views of conceptualizing ethics, referring to Charles Taylors' two epistemological models: 'monological' versus 'dialogical consciousness'. We show that the conception of ethics in the model of 'dialogical consciousness' is radically different from the classical understanding of ethics in the model of 'monological consciousness'. To reach accountable moral judgments, ethics cannot be conceptualized as an individual enterprise, but has to be seen as a practical endeavor embedded in social interactions within which moral understandings are being negotiated. This view has specific implications for the nature and the role of ethical theory. Theory is not created in the individual mind of the ethicist; the use of theory is part of a joint learning process and embedded in a cultural context and social history. Theory is based upon practice, and serves practical purposes. Thus, clinical ethics support is both practical and theoretical. © 2011 Blackwell Publishing Ltd.

  12. What Ethical Issues Really Arise in Practice at an Academic Medical Center? A Quantitative and Qualitative Analysis of Clinical Ethics Consultations from 2008 to 2013.

    Science.gov (United States)

    Wasson, Katherine; Anderson, Emily; Hagstrom, Erika; McCarthy, Michael; Parsi, Kayhan; Kuczewski, Mark

    2016-09-01

    As the field of clinical ethics consultation sets standards and moves forward with the Quality Attestation process, questions should be raised about what ethical issues really do arise in practice. There is limited data on the type and number of ethics consultations conducted across different settings. At Loyola University Medical Center, we conducted a retrospective review of our ethics consultations from 2008 through 2013. One hundred fifty-six cases met the eligibility criteria. We analyzed demographic data on these patients and conducted a content analysis of the ethics consultation write-ups coding both the frequency of ethical issues and most significant, or key, ethical issue per case. Patients for whom ethics consultation was requested were typically male (55.8 %), white (57.1 %), between 50 and 69 years old (38.5 %), of non-Hispanic origin (85.9 %), and of Roman Catholic faith (43.6 %). Nearly half (47.4 %) were in the intensive care unit and 44.2 % died in the hospital. The most frequent broad ethical categories were decision-making (93.6 %), goals of care/treatment (80.8 %), and end-of-life (73.1 %). More specifically, capacity (57.1 %), patient's wishes/autonomy (54.5 %), and surrogate decision maker (51.3 %) were the most frequent particular ethical issues. The most common key ethical issues were withdrawing/withholding treatment (12.8 %), patient wishes/autonomy (12.2 %), and capacity (11.5 %). Our findings provide additional data to inform the training of clinical ethics consultants regarding the ethical issues that arise in practice. A wider research agenda should be formed to collect and compare data across institutions to improve education and training in our field.

  13. A Qualitative Study of US Clinical Ethics Services: Objectives and Outcomes.

    Science.gov (United States)

    McClimans, Leah; Pressgrove, Geah; Rhea, James

    2016-01-01

    The quality of clinical ethics services in health care organizations is increasingly seen as an important aspect of the overall quality of care. But measuring this quality is difficult because there is a lack of clarity and consensus regarding the objectives of clinical ethics and the best outcome domains to measure. The aim of this qualitative study is to explore the views of experts about the objectives and outcomes of clinical ethics services in the US. We interviewed 19 experts in clinical ethics, focusing on the appropriate objectives and outcomes of a clinical ethics service (CES). Participants were selected using a purposive snowball sampling strategy. The development of the interview protocol was informed by the clinical ethics literature as well as by research and theories that inform clinical ethics practice. Interviews were conducted by phone, recorded, and transcribed for individual analysis. Analysis proceeded through the development of a codebook of categories using QDA Miner software. Our experts identified 12 objectives and nine outcomes. Some of these identifications were familiar (e.g., mediation and satisfaction) and some were novel (e.g., be of service and transformation). We found that experts are divided in their emphasis on the kinds of objectives that are most important. In terms of outcomes, our experts were concerned with the appropriateness of different proxy and direct measures. This study provides the perspectives of a select group of experts on the objectives and outcomes appropriate for a CES in the United States. The themes identified will be used in future research to inform a Delphi study to refine and obtain expert consensus.

  14. [Discussion on solutions to ethical issues of clinical researches in a real world].

    Science.gov (United States)

    Wang, Si-Cheng; Liu, Bao-Yan; Xiong, Ning-Ning; Xie, Qi; Zhang, Run-Shun; Zhou, Xue-Zhong; Qiao, Jie

    2013-04-01

    The paradigm of a real world study has become the frontiers of clinical researches, especially in the field of Chinese medicine, all over the world in recent years. In this paper, ethical issues which probably exist in real-world studies are raised and reviewed. Moreover, some preliminary solutions to these issues such as protecting subjects during the process of real-world studies and performing ethical review are raised based on recent years' practices to enhance the scientificity and ethical level of real-world studies.

  15. Contesting the science/ethics distinction in the review of clinical research

    Science.gov (United States)

    Dawson, Angus J; Yentis, Steve M

    2007-01-01

    Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee (REC) structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study's science, but that they have anobligation do so. PMID:17329389

  16. [Clinical research XXIV. From clinical judgment to ethics in research on humans].

    Science.gov (United States)

    Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Rivas-Ruiz, Rodolfo; Talavera, Juan O

    2014-01-01

    Bioethics in research is an essential part of the structured review process of an article and it is based on three fundamental principles: respect for persons, beneficence and justice. In addition to not providing valid knowledge, a research with inadequate design, execution and statistical analysis is not ethical either, since these methodological deficiencies will produce information that will not be useful and, therefore, the risks that the participants were exposed to will have been in vain. Beyond scientific validity, there are other aspects that outline if an investigation is ethical, such as the clinical and social value of a study, a fair selection of participants, favorable risk-benefit balance, an independent review, the informed consent and respect for participants and potential participants. Throughout the article here presented, the documents that profile the behavior of investigators to protect the participants, such as the Declaration of Helsinki, the national regulations that rule us and the differences between research without risk, with minimal risk and with greater than minimal risk are discussed. That like in daily life, behavior in research involving human participants must be self-regulated, ie, people with knowledge of the existence of the law discover that the man is outside the realm of nature where work is done under the necessity of natural causality, and falls within the scope of the will; only if the man is free to decide their actions may be a law regulating their action.

  17. Commercial Opportunities and Ethical Pitfalls in Personalized Medicine: A Myriad of Reasons to Revisit the Myriad Genetics Saga.

    Science.gov (United States)

    So, Derek; Joly, Yann

    2013-06-01

    In 1996, the US-based biotechnology company Myriad Genetics began offering genetic diagnostic tests for mutations in the genes BRCA1 and BRCA2 , which are linked to hereditary breast and ovarian cancer. Since that time, Myriad has been a forerunner in the field of personalized medicine through the use of effective commercialization strategies which have been emulated by other commercial biotechnology companies. Myriad's strategies include patent acquisition and active enforcement, direct-to-consumer advertising, diversification, and trade secrets. These business models have raised substantial ethical controversy and criticism, often related to the company's focus on market dominance and the potential conflict between private sector profitability and the promotion of public health. However, these strategies have enabled Myriad to survive the economic challenges that have affected the biotechnology sector and to become financially successful in the field of personalized medicine. Our critical assessment of the legal, economic and ethical aspects of Myriad's practices over this period allows the identification of the company's more effective business models. It also discusses of the consequences of implementing economically viable models without first carrying out broader reflection on the socio-cultural, ethical and political contexts in which they would apply.

  18. Public health ethics and a status for pets as person-things : revisiting the place of animals in urbanized societies.

    Science.gov (United States)

    Rock, Melanie; Degeling, Chris

    2013-12-01

    Within the field of medical ethics, discussions related to public health have mainly concentrated on issues that are closely tied to research and practice involving technologies and professional services, including vaccination, screening, and insurance coverage. Broader determinants of population health have received less attention, although this situation is rapidly changing. Against this backdrop, our specific contribution to the literature on ethics and law vis-à-vis promoting population health is to open up the ubiquitous presence of pets within cities and towns for further discussion. An expanding body of research suggests that pet animals are deeply relevant to people's health (negatively and positively). Pet bylaws adopted by town and city councils have largely escaped notice, yet they are meaningful to consider in relation to everyday practices, social norms, and cultural values, and thus in relation to population health. Nevertheless, not least because they pivot on defining pets as private property belonging to individual people, pet bylaws raise emotionally charged ethical issues that have yet to be tackled in any of the health research on pet ownership. The literature in moral philosophy on animals is vast, and we do not claim to advance this field here. Rather, we pragmatically seek to reconcile philosophical objections to pet ownership with both animal welfare and public health. In doing so, we foreground theorizations of personhood and property from sociocultural anthropology.

  19. In the Ethos of the Safety Net: An Expanded Role for Clinical Ethics Mediation.

    Science.gov (United States)

    McGreevy, Jolion

    2015-01-01

    Clinical ethics mediation is invaluable for resolving intractable disputes in the hospital. But it is also a critical day-to-day skill for clinicians, especially those who serve a disproportionate number of vulnerable patients. While mediation is typically reserved for intractable cases, there are two important opportunities to expand its use. First is preventative mediation, in which clinicians incorporate clinical ethics mediation into their daily routine in order to address value-laden conflicts before they reach the point at which outside consultation becomes necessary. Second is guided mediation, in which clinical teams resolve conflicts with patients or surrogates with guidance from an ethics consultant, who operates at some distance from the conflict and, rather than recommending a single action, counsels clinicians on the process they can use to resolve the conflict on their own. These approaches build the capacity of all clinicians to use clinical ethics mediation to improve the care of vulnerable patients. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

  20. Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report.

    Science.gov (United States)

    Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

    2016-09-27

    Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  1. Bioethics in practice: Addressing ethically sensitive requests in a Dutch fertility clinic

    NARCIS (Netherlands)

    Gerrits, T.; Reis, R.; Braat, D.D.M.; Kremer, J.A.M.; Hardon, A.P.

    2013-01-01

    This article provides insight into how ethically sensitive requests for the use of assisted reproductive technologies (ARTs) are dealt within the daily practice of a Dutch fertility clinic. The findings presented are part of an ethnographic study conducted in this clinic from September 2003 until

  2. Nurse leaders' perceptions of the ethical recruitment of study subjects in clinical research.

    Science.gov (United States)

    Nurmi, Sanna-Maria; Pietilä, Anna-Maija; Kangasniemi, Mari; Halkoaho, Arja

    2015-11-01

    The aim of this study was to describe nurse leaders' perceptions of ethical recruitment in clinical research. Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues. Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis. Nurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture. Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained. The duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff. © 2014 John Wiley & Sons Ltd.

  3. Teaching medical students to discern ethical problems in human clinical research studies.

    Science.gov (United States)

    Roberts, Laura Weiss; Warner, Teddy D; Green Hammond, Katherine A; Brody, Janet L; Kaminsky, Alexis; Roberts, Brian B

    2005-10-01

    Investigators and institutional review boards are entrusted with ensuring the conduct of ethically sound human studies. Assessing ethical aspects of research protocols is a key skill in fulfilling this duty, yet no empirically validated method exists for preparing professionals to attain this skill. The authors performed a randomized controlled educational intervention, comparing a criteria-based learning method, a clinical-research- and experience-based learning method, and a control group. All 300 medical students enrolled at the University of New Mexico School of Medicine in 2001 were invited to participate. After a single half-hour educational session, a written posttest of ability to detect ethical problems in hypothetical protocol vignettes was administered. The authors analyzed responses to ten protocol vignettes that had been evaluated independently by experts. For each vignette, a global assessment of the perceived significance of ethical problems and the identification of specific ethical problems were evaluated. Eighty-three medical students (27%) volunteered: 50 (60%) were women and 55 (66%) were first- and second-year students. On global assessments, the criteria-focused group perceived ethical problems as more significant than did the other two groups (p evaluation skills. This work supports the potential value of empirically derived methods for preparing professionals to discern ethical aspects of human studies.

  4. New perspectives on the theory of justice: implications for physical therapy ethics and clinical practice.

    Science.gov (United States)

    Edwards, Ian; Delany, Clare M; Townsend, Anne F; Swisher, Laura Lee

    2011-11-01

    Recent revisions of physical therapy codes of ethics have included a new emphasis concerning health inequities and social injustice. This emphasis reflects the growing evidence regarding the importance of social determinants of health, epidemiological trends for health service delivery, and the enhanced participation of physical therapists in shaping health care reform in a number of international contexts. This perspective article suggests that there is a "disconnect" between the societal obligations and aspirations expressed in the revised codes and the individualist ethical frameworks that predominantly underpin them. Primary health care is an approach to health care arising from an understanding of the nexus between health and social disadvantage that considers the health needs of patients as expressive of the health needs of the communities of which they are members. It is proposed that re-thinking ethical frameworks expressed in codes of ethics can both inform and underpin practical strategies for working in primary health care. This perspective article provides a new focus on the ethical principle of justice: the ethical principle that arguably remains the least consensually understood and developed in the ethics literature of physical therapy. A relatively recent theory of justice known as the "capability approach to justice" is discussed, along with its potential to assist physical therapy practitioners to further develop moral agency in order to address situations of health inequity and social injustice in clinical practice.

  5. Everyday ethics in internal medicine resident clinic: an opportunity to teach.

    Science.gov (United States)

    Carrese, Joseph A; McDonald, Erin L; Moon, Margaret; Taylor, Holly A; Khaira, Kiran; Catherine Beach, Mary; Hughes, Mark T

    2011-07-01

    Being a good doctor requires competency in ethics. Accordingly, ethics education during residency training is important. We studied the everyday ethics-related issues (i.e. ordinary ethics issues commonly faced) that internal medical residents encounter in their out-patient clinic and determined whether teaching about these issues occurred during faculty preceptor-resident interactions. This study involved a multi-method qualitative research design combining observation of preceptor-resident discussions with preceptor interviews. The study was conducted in two different internal medicine training programme clinics over a 2-week period in June 2007. Fifty-three residents and 19 preceptors were observed, and 10 preceptors were interviewed. Transcripts of observer field notes and faculty interviews were carefully analysed. The analysis identified several themes of everyday ethics issues and determined whether preceptors identified and taught about these issues. Everyday ethics content was considered present in 109 (81%) of the 135 observed case presentations. Three major thematic domains and associated sub-themes related to everyday ethics issues were identified, concerning: (i) the Doctor-Patient Interaction (relationships; communication; shared decision making); (ii) the Resident as Learner (developmental issues; challenges and conflicts associated with training; relationships with colleagues and mentors; interactions with the preceptor), and; (iii) the Doctor-System Interaction (financial issues; doctor-system issues; external influences; doctor frustration related to system issues). Everyday ethics issues were explicitly identified by preceptors (without teaching) in 18 of 109 cases (17%); explicit identification and teaching occurred in only 13 cases (12%). In this study a variety of everyday ethics issues were frequently encountered as residents cared for patients. Yet, faculty preceptors infrequently explicitly identified or taught these issues during their

  6. Nursing students' experiences of ethical issues in clinical practice: A New Zealand study.

    Science.gov (United States)

    Sinclair, J; Papps, E; Marshall, B

    2016-03-01

    Nursing students experience ethical problems in clinical practice in a different way from registered nurses. In order to develop ethical reasoning and competence in nursing students, nurse educators must recognise the unique issues students face. This research described the occurrence of ethical issues in clinical practice for 373 undergraduate nursing students who responded to a national questionnaire investigating the frequency of pre-determined ethical issues and the corresponding level of distress. Over two thirds of respondents experienced breaches of a patient's right to confidentiality, privacy, dignity or respect and 87% experienced unsafe working conditions. The most distressing issues were those that compromised patient safety, including unsafe healthcare practices, working conditions and suspected abuse or neglect. Themes that emerged from an open-ended question included lack of support and supervision, bullying and end of life issues. This research found the frequency at which ethical issues are experienced was highest in year three participants. However, the overall distress levels were lower for the majority of issues for those participants in the later part of their degree. Recommendations from this research include developing ethics education around the main concerns that students face in order to enhance students' understanding, resilience and ability to respond appropriately. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. From reactive to proactive: developing a valid clinical ethics needs assessment survey to support ethics program strategic planning (part 1 of 2).

    Science.gov (United States)

    Frolic, Andrea; Jennings, Barb; Seidlitz, Wendy; Andreychuk, Sandy; Djuric-Paulin, Angela; Flaherty, Barb; Peace, Donna

    2013-03-01

    As ethics committees and programs become integrated into the "usual business" of healthcare organizations, they are likely to face the predicament of responding to greater demands for service and higher expectations, without an influx of additional resources. This situation demands that ethics committees and programs allocate their scarce resources (including their time, skills and funds) strategically, rather than lurching from one ad hoc request to another; finding ways to maximize the effectiveness, efficiency, impact and quality of ethics services is essential in today's competitive environment. How can Hospital Ethics Committees (HECs) begin the process of strategic priority-setting to ensure they are delivering services where and how they are most needed? This paper describes the creation of the Clinical Ethics Needs Assessment Survey (CENAS) as a tool to understand interprofessional staff perceptions of the organization's ethical climate, challenging ethical issues and educational priorities. The CENAS was designed to support informed resource allocation and advocacy by HECs. By sharing our process of developing and validating this ethics needs assessment survey we hope to enable strategic priority-setting in other resource-strapped ethics programs, and to empower HECs to shift their focus to more proactive, quality-focused initiatives.

  8. Moving Clinical Deliberations on Administrative Discharge in Drug Addiction Treatment Beyond Moral Rhetoric to Empirical Ethics.

    Science.gov (United States)

    Williams, Izaak L

    2016-01-01

    Patients' admission to modern substance use disorder treatment comes with the attendant risk of being discharged from treatment-a widespread practice. This article describes the three mainstream theories of addiction that operate as a reference point for clinicians in reasoning about a decision to discharge a patient from treatment. The extant literature is reviewed to highlight the pathways that patients follow after administrative discharge. Little scientific research has been done to investigate claims and hypotheses about the therapeutic function of AD, which points to the need for empirical ethics to inform clinical addictions practice. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  9. Resolving ethical issues in stem cell clinical trials: the example of Parkinson disease.

    Science.gov (United States)

    Lo, Bernard; Parham, Lindsay

    2010-01-01

    Clinical trials of stem cell transplantation raise ethical issues that are intertwined with scientific and design issues, including choice of control group and intervention, background interventions, endpoints, and selection of subjects. We recommend that the review and IRB oversight of stem cell clinical trials should be strengthened. Scientific and ethics review should be integrated in order to better assess risks and potential benefits. Informed consent should be enhanced by assuring that participants comprehend key aspects of the trial. For the trial to yield generalizable knowledge, negative findings and serious adverse events must be reported.

  10. [Level of Development of Clinical Ethics Consultation in Psychiatry - Results of a Survey Among Psychiatric Acute Clinics and Forensic Psychiatric Hospitals].

    Science.gov (United States)

    Gather, Jakov; Kaufmann, Sarah; Otte, Ina; Juckel, Georg; Schildmann, Jan; Vollmann, Jochen

    2018-04-17

    The aim of this article is to assess the level of development of clinical ethics consultation in psychiatric institutions in North Rhine-Westphalia. Survey among medical directors, directors of nursing and administrative directors of all psychiatric acute clinics and forensic psychiatric hospitals in North Rhine-Westphalia. 113 persons working in psychiatric acute clinics responded (reponse rate: 48 %) and 13 persons working in forensic psychiatric hospitals (response rate 54 %). We received at least one response from 89 % of all psychiatric acute clinics and from 100 % of all forensic psychiatric hospitals. 90 % of the responding psychiatric acute clinics and 29 % of the responding forensic psychiatric hospitals have already implemented clinical ethics consultation. Clinical ethics consultation is more widespread in psychiatric institutions than was hitherto assumed. Future medical ethics research should therefore give greater attention to the methodology and the quality of clinical ethics consultation in psychiatric practice. © Georg Thieme Verlag KG Stuttgart · New York.

  11. The Numinous, the Ethical, and the Body. Rudolf Otto’s “The Idea of the Holy” Revisited

    Directory of Open Access Journals (Sweden)

    Nörenberg Henning

    2017-10-01

    Full Text Available In this paper, I investigate the non-rational, affective dimension of religious experience that Rudolf Otto attempted to address with his notion of the numinous. I argue that this notion is best understood in terms of an atmospheric quality impacting on the subject’s feeling body. Therefore, I draw on discussions in phenomenology and pragmatism, despite the fact that Otto’s own epistemological framework is rooted in a different tradition. Drawing on those discussions helps defend some of Otto’s claims about the relation between the non-rational, affective dimension and reason against the prevalent accusation of unscientific mysticism. I then illustrate the yet unexhausted potential of these very claims by arguing that the numinous in Otto’s sense plays an irreducible role in the ethical reflections of such distinct authors as Kant and Levinas.

  12. Mapping the Ethics of Translational Genomics: Situating Return of Results and Navigating the Research-Clinical Divide

    Science.gov (United States)

    Wolf, Susan M.; Burke, Wylie; Koenig, Barbara A.

    2015-01-01

    Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a “layered” approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation. PMID:26479558

  13. Evaluation of Viewpoints of Health Care Professionals on the Role of Ethics Committees and Hospitals in the Resolution of Clinical Ethical Dilemmas Based on Practice Environment.

    Science.gov (United States)

    Marcus, Brian S; Carlson, Jestin N; Hegde, Gajanan G; Shang, Jennifer; Venkat, Arvind

    2016-03-01

    We sought to evaluate whether health care professionals' viewpoints differed on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas based on practice location. We conducted a survey study from December 21, 2013 to March 15, 2014 of health care professionals at six hospitals (one tertiary care academic medical center, three large community hospitals and two small community hospitals). The survey consisted of eight clinical ethics cases followed by statements on whether there was a role for the ethics committee or hospital in their resolution, what that role might be and case specific queries. Respondents used a 5-point Likert scale to express their degree of agreement with the premises posed. We used the ANOVA test to evaluate whether respondent views significantly varied based on practice location. 240 health care professionals (108-tertiary care center, 92-large community hospitals, 40-small community hospitals) completed the survey (response rate: 63.6 %). Only three individual queries of 32 showed any significant response variations across practice locations. Overall, viewpoints did not vary across practice locations within question categories on whether the ethics committee or hospital had a role in case resolution, what that role might be and case specific queries. In this multicenter survey study, the viewpoints of health care professionals on the role of ethics committees or hospitals in the resolution of clinical ethics cases varied little based on practice location.

  14. [How does Hinduism analyze an ethical clinical dilemma].

    Science.gov (United States)

    Samtani B, Suraj; Jadue Z, Mariana; Beca I, Juan Pablo

    2009-11-01

    It is indispensable for physicians to understand and recognize the fusion of different cultures, to deliver the best possible service to patients with different cultural backgrounds, especially when ethical-medical problems are involved. The Hindu community in Chile differs in significant ways with the western culture. This is especially true for some issues such as the belief in reincarnation or gender inequality, among others. These discrepancies can be relevant for the analysis of several bioethical problems. Therefore, it is necessary to understand the different beliefs, traditions and Hindu visions. We hereby present a review of Hinduism, its relation with medical practice and, as an example, a case of abortion in a Hindu family. Reviewing the traditions, beliefs and methods will help to understand and respect the beliefs of different cultures in contemporary and globalized bioethics.

  15. Pediatric clinical drug trials in low-income countries: key ethical issues.

    Science.gov (United States)

    MacLeod, S M; Knoppert, D C; Stanton-Jean, M; Avard, D

    2015-02-01

    Potential child participants in clinical research trials in low-income countries are often vulnerable because of poverty, high morbidity and mortality, inadequate education, and varied local cultural norms. However, vulnerability by itself must not be accepted as an obstacle blocking children from the health benefits that may accrue as an outcome of sound clinical research. As greater emphasis is placed on evidence-based treatment of children, it should be anticipated that there will be a growing call for agreement on principles to guide clinical investigations in low-income countries. There is now general acceptance of the view that children must be protected from non-evidence-based interventions and from substandard treatments. The questions remaining relate to how best to stimulate clinical research activity that will serve the needs of infants, children, and youth in developing countries and how best to assign priority to ethically sound research that will meet their clinical requirements. In low-income countries, 39 % of citizens are 13 years of age or younger, and consequently it is certain that clinical investigations of some new therapeutic products will be conducted there more frequently. This review offers some suggestions for approaches that will help to achieve more effective ethical consideration, including (1) improving the quality of research ethics boards; (2) fostering collaborative partnerships among important stakeholders; (3) making concerted efforts to build capacity; (4) improving the quality of the consent and waiver process; and (5) developing improved governance for harmonized ethics platforms. Continuing support by international organizations is required to sustain the establishment and maintenance of stronger research ethics boards to protect children enrolled in clinical trials. This review underscores the importance of developing a culture of solidarity and true partnership between developed and low-income country organizations, which

  16. Evidence - competence - discourse: the theoretical framework of the multi-centre clinical ethics support project METAP.

    Science.gov (United States)

    Reiter-Theil, Stella; Mertz, Marcel; Schürmann, Jan; Stingelin Giles, Nicola; Meyer-Zehnder, Barbara

    2011-09-01

    In this paper we assume that 'theory' is important for Clinical Ethics Support Services (CESS). We will argue that the underlying implicit theory should be reflected. Moreover, we suggest that the theoretical components on which any clinical ethics support (CES) relies should be explicitly articulated in order to enhance the quality of CES. A theoretical framework appropriate for CES will be necessarily complex and should include ethical (both descriptive and normative), metaethical and organizational components. The various forms of CES that exist in North-America and in Europe show their underlying theory more or less explicitly, with most of them referring to some kind of theoretical components including 'how-to' questions (methodology), organizational issues (implementation), problem analysis (phenomenology or typology of problems), and related ethical issues such as end-of-life decisions (major ethical topics). In order to illustrate and explain the theoretical framework that we are suggesting for our own CES project METAP, we will outline this project which has been established in a multi-centre context in several healthcare institutions. We conceptualize three 'pillars' as the major components of our theoretical framework: (1) evidence, (2) competence, and (3) discourse. As a whole, the framework is aimed at developing a foundation of our CES project METAP. We conclude that this specific integration of theoretical components is a promising model for the fruitful further development of CES. © 2011 Blackwell Publishing Ltd.

  17. The ethics of clinical photography and social media.

    Science.gov (United States)

    Palacios-González, César

    2015-02-01

    Clinical photography is an important tool for medical practice, training and research. While in the past clinical pictures were confined to the stringent controls of surgeries and hospitals technological advances have made possible to take pictures and share them through the internet with only a few clicks. Confronted with this possibility I explore if a case could be made for using clinical photography in tandem with social media. In order to do this I explore: (1) if patient's informed consent is required for the publication of any clinical images that depicts her, irrespective of whether the patient can be identified from the image or not, (2) if social media is an adequate place for clinical images to be displayed, and finally (3) if there are special considerations that should be taken into account when publishing clinical images on social media.

  18. A New Ethical Challenge for Institutional Review Boards (IRBs/Ethics Committees (ECs in the Assessment of Pediatric Clinical Trials

    Directory of Open Access Journals (Sweden)

    Klaus Rose

    2015-05-01

    Full Text Available Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA’s Pediatric Committee (PDCO may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs/ethics committees (ECs and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

  19. Ethics and evidence-based medicine: fallibility and responsibility in clinical science

    National Research Council Canada - National Science Library

    Goodman, Kenneth W

    2003-01-01

    ... to their "clinical judgment." This tension- between efforts to make medical practice more scientific and the suspicions of many clinicians- has caused one of the greatest practical and ethical challenges in the history of the health professions. This incisive book reviews the history and conceptual origins of evidence-based practice and discusses ...

  20. Impact of Parental Severe Mental Illness: Ethical and Clinical Issues for Counselors

    Science.gov (United States)

    Spiegelhoff, Sarah F.; Ahia, C. Emmanuel

    2011-01-01

    This article draws attention to the issue of parental severe mental illness and the ethical and clinical implications for counselors who work with this population. Parents with mental illness face a multitude of life challenges including, but not limited to, parenting difficulties, medication and hospitalization, custody and placement of their…

  1. Methodological Reflections on the Contribution of Qualitative Research to the Evaluation of Clinical Ethics Support Services.

    Science.gov (United States)

    Wäscher, Sebastian; Salloch, Sabine; Ritter, Peter; Vollmann, Jochen; Schildmann, Jan

    2017-05-01

    This article describes a process of developing, implementing and evaluating a clinical ethics support service intervention with the goal of building up a context-sensitive structure of minimal clinical-ethics in an oncology department without prior clinical ethics structure. Scholars from different disciplines have called for an improvement in the evaluation of clinical ethics support services (CESS) for different reasons over several decades. However, while a lot has been said about the concepts and methodological challenges of evaluating CESS up to the present time, relatively few empirical studies have been carried out. The aim of this article is twofold. On the one hand, it describes a process of development, modifying and evaluating a CESS intervention as part of the ETHICO research project, using the approach of qualitative-formative evaluation. On the other hand, it provides a methodological analysis which specifies the contribution of qualitative empirical methods to the (formative) evaluation of CESS. We conclude with a consideration of the strengths and limitations of qualitative evaluation research with regards to the evaluation and development of context sensitive CESS. We further discuss our own approach in contrast to rather traditional consult or committee models. © 2017 John Wiley & Sons Ltd.

  2. Counselors' Role in Preventing Abuse of Older Adults: Clinical, Ethical, and Legal Considerations

    Science.gov (United States)

    Forman, Julia M.; McBride, Rebecca G.

    2010-01-01

    Mistreatment of older adults is commonplace. These individuals are subjected to abuse, financial exploitation, and neglect. The authors present an overview of the literature concerning mistreatment, with an emphasis on clinical, ethical, and legal considerations. Methods are proposed for prevention, including counselor education, advocacy, and…

  3. Theory and practice of clinical ethics support services: narrative and hermeneutical perspectives

    NARCIS (Netherlands)

    Porz, R.; Landeweer, E.G.M.; Widdershoven, G.A.M.

    2011-01-01

    In this paper we introduce narrative and hermeneutical perspectives to clinical ethics support services (CESS). We propose a threefold consideration of 'theory' and show how it is interwoven with 'practice' as we go along. First, we look at theory in its foundational role: in our case 'narrative

  4. Contextualism Revisited: Towards a More Relevant Conceptualization of Public Administration for Ethical and Sustainable Leadership in the Global Context

    Directory of Open Access Journals (Sweden)

    Asghar Zomorrodian

    2008-12-01

    Full Text Available The paper examines how the contextual approach to the conceptualization and the design of public administration systems can still be a viable alternative for today’s environment. By making reference to a proposed conceptual model, predominantly based on the cultural and social values in different contexts, the paper juxtaposes both the traditional Universalists and recent NPM approaches to the Contextual model by reviewing the literature on the impacts of globalization and other recent developments in the area public administration and public policy both at the national and international levels. Special attention is paid to the significance of two major elements of ethical leadership and governance for creating a viable and sustainable public administration system that incorporates and emphasizes the process of political development and enhancing the civil society based on indigenous cultural and social values. The conclusion of the paper reinforces the validity and utility of the contextual approach by including these two major elements into its original conceptual framework.

  5. CURRENT PERSPECTIVES OF POTTER'S GLOBAL BIOETHICS AS A BRIDGE BETWEEN CLINICAL (PERSONALIZED) AND PUBLIC HEALTH ETHICS.

    Science.gov (United States)

    Turina, Iva Sorta-Bilajac; Brkljacić, Morana; Grgas-Bile, Cecilija; Gajski, Domagoj; Racz, Aleksandar; Cengić, Tomislav

    2015-12-01

    In the context of modern scientific and technological developments in biomedicine and health care, and the potential consequences of their application on humans and the environment, Potter's global bioethics concept resurfaces. By actualizing Potter's original thoughts on individual bioethical issues, the universality of two of his books, which today represent the backbone of the world bioethical literature, "Bioethics--Bridge to the Future" and "Global Bioethics: Building on the Leopold Legacy", is emphasized. Potter's global bioethics today can legitimately be viewed as a bridge between clinical personalized ethics on the one hand and ethics of public health on the other.

  6. Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report

    OpenAIRE

    Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

    2016-01-01

    Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients i...

  7. HIV positive refugees/asylum seekers and clinical trials: some ethical issues

    OpenAIRE

    McDonald, Linda

    2014-01-01

    The aim of this thesis was to identify some of the ethical issues of HIV positive asylum seekers and refugees participating in clinical trials in Britain. While all individuals are to some degree vulnerable in clinical trials, I have shown in this thesis that this group is particularly vulnerable in a number of areas. Many will not have English as a first language and while they may be able to understand everyday language, the participant information sheet (PIS) may be difficult to comprehend...

  8. More ethical and more efficient clinical research: multiplex trial design.

    Science.gov (United States)

    Keus, Frederik; van der Horst, Iwan C C; Nijsten, Maarten W

    2014-08-14

    Today's clinical research faces challenges such as a lack of clinical equipoise between treatment arms, reluctance in randomizing for multiple treatments simultaneously, inability to address interactions and increasingly restricted resources. Furthermore, many trials are biased by extensive exclusion criteria, relatively small sample size and less appropriate outcome measures. We propose a 'Multiplex' trial design that preserves clinical equipoise with a continuous and factorial trial design that will also result in more efficient use of resources. This multiplex design accommodates subtrials with appropriate choice of treatment arms within each subtrial. Clinical equipoise should increase consent rates while the factorial design is the best way to identify interactions. The multiplex design may evolve naturally from today's research limitations and challenges, while principal objections seem absent. However this new design poses important infrastructural, organisational and psychological challenges that need in depth consideration.

  9. Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network.

    Science.gov (United States)

    Ali, Joseph; Califf, Robert; Sugarman, Jeremy

    2016-01-01

    PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.

  10. Can context justify an ethical double standard for clinical research in developing countries?

    Directory of Open Access Journals (Sweden)

    Landes Megan

    2005-07-01

    Full Text Available Abstract Background The design of clinical research deserves special caution so as to safeguard the rights of participating individuals. While the international community has agreed on ethical standards for the design of research, these frameworks still remain open to interpretation, revision and debate. Recently a breach in the consensus of how to apply these ethical standards to research in developing countries has occurred, notably beginning with the 1994 placebo-controlled trials to reduce maternal to child transmission of HIV-1 in Africa, Asia and the Caribbean. The design of these trials sparked intense debate with the inclusion of a placebo-control group despite the existence of a 'gold standard' and trial supporters grounded their justifications of the trial design on the context of scarcity in resource-poor settings. Discussion These 'contextual' apologetics are arguably an ethical loophole inherent in current bioethical methodology. However, this convenient appropriation of 'contextual' analysis simply fails to acknowledge the underpinnings of feminist ethical analysis upon which it must stand. A more rigorous analysis of the political, social, and economic structures pertaining to the global context of developing countries reveals that the bioethical principles of beneficence and justice fail to be met in this trial design. Conclusion Within this broader, and theoretically necessary, understanding of context, it becomes impossible to justify an ethical double standard for research in developing countries.

  11. Demonstrating Patterns in the Views Of Stakeholders Regarding Ethically-Salient Issues in Clinical Research: A Novel Use of Graphical Models in Empirical Ethics Inquiry.

    Science.gov (United States)

    Kim, Jane Paik; Roberts, Laura Weiss

    Empirical ethics inquiry works from the notion that stakeholder perspectives are necessary for gauging the ethical acceptability of human studies and assuring that research aligns with societal expectations. Although common, studies involving different populations often entail comparisons of trends that problematize the interpretation of results. Using graphical model selection - a technique aimed at transcending limitations of conventional methods - this report presents data on the ethics of clinical research with two objectives: (1) to display the patterns of views held by ill and healthy individuals in clinical research as a test of the study's original hypothesis and (2) to introduce graphical model selection as a key analytic tool for ethics research. In this IRB-approved, NIH-funded project, data were collected from 60 mentally ill and 43 physically ill clinical research protocol volunteers, 47 healthy protocol-consented participants, and 29 healthy individuals without research protocol experience. Respondents were queried on the ethical acceptability of research involving people with mental and physical illness (i.e., cancer, HIV, depression, schizophrenia, and post-traumatic stress disorder) and non-illness related sources of vulnerability (e.g., age, class, gender, ethnicity). Using a statistical algorithm, we selected graphical models to display interrelationships among responses to questions. Both mentally and physically ill protocol volunteers revealed a high degree of connectivity among ethically-salient perspectives. Healthy participants, irrespective of research protocol experience, revealed patterns of views that were not highly connected. Between ill and healthy protocol participants, the pattern of views is vastly different. Experience with illness was tied to dense connectivity, whereas healthy individuals expressed views with sparse connections. In offering a nuanced perspective on the interrelation of ethically relevant responses, graphical

  12. Non-invasive prenatal testing for fetal chromosome abnormalities: review of clinical and ethical issues.

    Science.gov (United States)

    Gekas, Jean; Langlois, Sylvie; Ravitsky, Vardit; Audibert, François; van den Berg, David Gradus; Haidar, Hazar; Rousseau, François

    2016-01-01

    Genomics-based non-invasive prenatal screening using cell-free DNA (cfDNA screening) was proposed to reduce the number of invasive procedures in current prenatal diagnosis for fetal aneuploidies. We review here the clinical and ethical issues of cfDNA screening. To date, it is not clear how cfDNA screening is going to impact the performances of clinical prenatal diagnosis and how it could be incorporated in real life. The direct marketing to users may have facilitated the early introduction of cfDNA screening into clinical practice despite limited evidence-based independent research data supporting this rapid shift. There is a need to address the most important ethical, legal, and social issues before its implementation in a mass setting. Its introduction might worsen current tendencies to neglect the reproductive autonomy of pregnant women.

  13. Informed Consent: Ethical Issues and Future Challenges in Clinical Education.

    Science.gov (United States)

    Angaran, David M.

    1989-01-01

    A look at pharmaceutical care needs in the future is the basis for discussion of the educational needs of clinical pharmacists. Issues discussed include the appropriate degree (bachelor's vs. doctoral), costs of instruction, faculty/student ratios, the pharmacy practice faculty as role models, and computer-assisted instruction. (MSE)

  14. Financial remuneration for clinical and behavioral research participation: ethical and practical considerations.

    Science.gov (United States)

    Permuth-Wey, Jennifer; Borenstein, Amy R

    2009-04-01

    Although the practice of providing payment to clinical research participants has been ongoing for more than a century, it remains an ethically controversial topic among members of the research community. The aims of this commentary are to summarize ethical and practical considerations regarding financial remuneration of research participants and to make recommendations for researchers contemplating this practice. A PubMed search was conducted to explore the ethical implications surrounding financial remuneration and review the body of empiric data on this topic. Financial remuneration is perceived to be ethically acceptable by many researchers and research participants and can be helpful in the recruitment process. It is recommended that when investigators are contemplating whether to offer payment to research participants, they should consider the nature of the study and the potential benefits and risks to the participants, institutional or organizational guidelines, and cultural and societal norms specific to the population being studied. Financial remuneration has the ability to serve as a sign of appreciation for the contributions of research participants and a way to facilitate clinical and behavioral research.

  15. Nurse supervisors' actions in relation to their decision-making style and ethical approach to clinical supervision.

    Science.gov (United States)

    Berggren, Ingela; Severinsson, Elisabeth

    2003-03-01

    The aim of the study was to explore the decision-making style and ethical approach of nurse supervisors by focusing on their priorities and interventions in the supervision process. Clinical supervision promotes ethical awareness and behaviour in the nursing profession. A focus group comprised of four clinical nurse supervisors with considerable experience was studied using qualitative hermeneutic content analysis. The essence of the nurse supervisors' decision-making style is deliberations and priorities. The nurse supervisors' willingness, preparedness, knowledge and awareness constitute and form their way of creating a relationship. The nurse supervisors' ethical approach focused on patient situations and ethical principles. The core components of nursing supervision interventions, as demonstrated in supervision sessions, are: guilt, reconciliation, integrity, responsibility, conscience and challenge. The nurse supervisors' interventions involved sharing knowledge and values with the supervisees and recognizing them as nurses and human beings. Nurse supervisors frequently reflected upon the ethical principle of autonomy and the concept and substance of integrity. The nurse supervisors used an ethical approach that focused on caring situations in order to enhance the provision of patient care. They acted as role models, shared nursing knowledge and ethical codes, and focused on patient related situations. This type of decision-making can strengthen the supervisees' professional identity. The clinical nurse supervisors in the study were experienced and used evaluation decisions as their form of clinical decision-making activity. The findings underline the need for further research and greater knowledge in order to improve the understanding of the ethical approach to supervision.

  16. Ongoing Evaluation of Clinical Ethics Consultations as a Form of Continuous Quality Improvement.

    Science.gov (United States)

    Volpe, Rebecca

    2017-01-01

    Ongoing evaluation of a clinical ethics consultation service (ECS) allows for continuous quality improvement, a process-based, data-driven approach for improving the quality of a service. Evaluations by stakeholders involved in a consultation can provide real-time feedback about what is working well and what might need to be improved. Although numerous authors have previously presented data from research studies on the effectiveness of clinical ethics consultation, few ECSs routinely send evaluations as an ongoing component of their everyday clinical activities. The primary purpose of this article is to equip and encourage others to engage in ongoing evaluation of their own ECS. Toward that end, the following resources are shared: (1) the survey tool used to gather the evaluation data, (2) the procedure used to elicit and collate responses, and (3) how the resulting data are used to support continuous quality improvement and justify the continued financial support of the ECS to hospital administration. Copyright 2017 The Journal of Clinical Ethics. All rights reserved.

  17. [Universal ethical principles and their application in clinical drug trials].

    Science.gov (United States)

    Gonorazky, Sergio Eduardo

    2015-03-01

    Since 1931, and especially since the Nuremberg Code of 1947, an increasing number of declarations, regulations, norms, guidelines, laws, resolutions, and rules intended to create conditions for better protection of subjects participating in research studies have been published, although some have meant setbacks in the human rights of vulnerable populations. As such, violations of the dignity of experimental subjects in clinical trials continue. What researchers investigate and how the research is done, the quality and transparency of the data, and the analysis and the publication of results (of both raw and processed data) respond to the financial interests of the pharmaceutical companies, coming into permanent tension with bioethical principles and the needs of society. The active participation of civil society is necessary to make it so that pharmaceutical research, results and applications subordinate economic benefits to the protection of human rights.

  18. Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees - results from a descriptive questionnaire-based study.

    Science.gov (United States)

    Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

    2018-01-11

    Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon?' This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score ± standard deviation. Ten RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6 ± 22.3/175 points reflecting thus an excellent adherence to international standards. Inadequate training of REC members and the lack of anti-bribery policies should be resolved to

  19. Intimacy and Sexuality in Institutionalized Dementia Care: Clinical-Ethical Considerations.

    Science.gov (United States)

    Mahieu, Lieslot; Anckaert, Luc; Gastmans, Chris

    2017-03-01

    Intimacy and sexuality expressed by nursing home residents with dementia remains an ethically sensitive issue for care facilities, nursing staff and family members. Dealing with residents' sexual longings and behaviour is extremely difficult, putting a burden on the caregivers as well as on the residents themselves and their relatives. The parties in question often do not know how to react when residents express themselves sexually. The overall aim of this article is to provide a number of clinical-ethical considerations addressing the following question: 'How can expressions of intimacy and sexuality by residents with dementia be dealt with in an ethically responsible way?' The considerations formulated are based on two cornerstones: (1) the current literature on older peoples' experiences regarding intimacy and sexuality after the onset of dementia, and (2) an anthropological-ethical framework addressing four fundamental pillars of human existence namely the decentred self, human embodiment, being-in-the-world and being-with-others. The resulting considerations are oriented toward the individual sphere, the partnership sphere, and the institutional sphere. The continuous interaction between these spheres leads to orientations that both empower the residents in question and respect the complex network of relationships that surrounds them.

  20. Responsibly managing students' learning experiences in student-run clinics: a virtues-based ethical framework.

    Science.gov (United States)

    Coverdale, John H; McCullough, Laurence B

    2014-01-01

    Many medical schools now offer students a distinctive clinical and learning opportunity, the student-run clinic (SRC), in which generalist physicians often play the major role. Although SRCs have become popular, they pose as-yet unexplored ethical challenges for the learning experiences of students. In SRCs students not only take on a significant administrative role especially in coordinating care, but also provide direct patient care for a clinically challenging, biopsychosocially vulnerable, medically indigent population of patients. SRCs provide an exemplar of the ethical challenges of care for such patients. The ethical framework proposed in this article emphasizes that these valued learning opportunities for students should occur in the context of professional formation, with explicit attention to developing the professional virtues, with faculty as role models for these virtues. The valued learning opportunities for students in SRCs should occur in the context of professional formation, with explicit attention to developing the professional virtues of integrity, compassion, self-effacement, self-sacrifice, and courage, which are required for the appropriate care of the vulnerable populations served by SRCs.

  1. Extubation versus tracheostomy in withdrawal of treatment-ethical, clinical, and legal perspectives.

    LENUS (Irish Health Repository)

    Chotirmall, Sanjay Haresh

    2010-06-01

    The provision of life-sustaining ventilation, such as tracheostomy to critically ill patients, is commonly performed. However, the utilization of tracheostomy or extubation after a withdrawal of treatment decision is debated. There is a dearth of practical information available to aid clinical decision making because withdrawal of treatment is a challenging scenario for all concerned. This is further complicated by medicolegal and ethical considerations. Care of the "hopelessly ill" patient should be based on daily evaluation and comfort making it impossible to fit into general algorithms. Although respect for autonomy is important in healthcare, it is limited for patients in an unconscious state. Beneficence remains the basis for withdrawing treatment in futile cases and underpins the "doctrine of double effect." This article presents a relevant clinical case of hypoxic brain injury where a question of withdrawal of treatment arose and examines the ethical, clinical, and medicolegal considerations inherent in such cases, including beneficence, nonmaleficence, and the "sanctity of life doctrine." In addition, the considerations of prognosis for recovery, patient autonomy, patient quality of life, and patient family involvement, which are central to decision making, are addressed. The varying legal frameworks that exist internationally regarding treatment withdrawal are also described. Good ethics needs sound facts, and despite the lack of legal foundation in several countries, withdrawal of treatment remains practiced, and the principles described within this article aim to aid clinician decision making during such complex and multifaceted end-of-life decisions.

  2. Ethical considerations in clinical research on herbal medicine for prevention of cardiovascular disease in the ageing.

    Science.gov (United States)

    Koonrungsesomboon, Nut; Karbwang, Juntra

    2016-10-15

    Cardiovascular disease (CVD) in the ageing is a major public health problem worldwide. The nature of most CVD is subclinical with pathological processes that can span over years. Use of preventive measures could be an appropriate approach to prevailing over CVD in the ageing, and herbal medicine is one of the promising preventive approaches and is currently of interest among medical societies. In the evidence-based era, herbal medicine is, however, often underestimated and approached with skepticism, mainly due to the paucity of scientific evidence. Properly designed clinical trials on herbal medicine for prevention of CVD in a geriatric population are thus of importance and of clinical value. To review ethical issues and discuss considerations when such research is proposed. Four ethical issues, including the scientific validity of research, risk-benefit assessments, subject selection and vulnerability, and informed consent, are structured and extensively discussed in this article. Ethical core considerations of prevention research of CVD on herbal medicine involve particular attention on the scientific validity of research, risk-benefit assessments, subject selection and vulnerability, and informed consent. These issues and considerations are keys, although they must be adapted to an individual research setting in which a clinical study is proposed. Copyright © 2015 Elsevier GmbH. All rights reserved.

  3. Inclusion and exclusion in nutrigenetics clinical research: ethical and scientific challenges.

    Science.gov (United States)

    Hurlimann, T; Stenne, R; Menuz, V; Godard, B

    2011-01-01

    There are compelling reasons to ensure the participation of ethnic minorities and populations of all ages worldwide in nutrigenetics clinical research. If findings in such research are valid for some individuals, groups, or communities, and not for others, then ethical questions of justice--and not only issues of methodology and external validity--arise. This paper aims to examine inclusion in nutrigenetics clinical research and its scientific and ethical challenges. In total, 173 publications were identified through a systematic review of clinical studies in nutrigenetics published between 1998 and 2007. Data such as participants' demographics as well as eligibility criteria were extracted. There is no consistency in the way participants' origins (ancestry, ethnicity, or race) and ages are described in publications. A vast majority of the studies identified was conducted in North America and Europe and focused on 'white' participants. Our results show that pregnant women (and fetuses), minors, and the elderly (≥ 75 years old) remain underrepresented. Representativeness in nutrigenetics research is a challenging ethical and scientific issue. Yet, if nutrigenetics is to benefit whole populations and be used in public and global health agendas, fair representation as well as clear descriptions of participants in publications are crucial. Copyright © 2012 S. Karger AG, Basel.

  4. Combining interdisciplinary and International Medical Graduate perspectives to teach clinical and ethical communication using multimedia.

    Science.gov (United States)

    Woodward-Kron, Robyn; Flynn, Eleanor; Delany, Clare

    2011-01-01

    In Australia, international medical graduates (IMGs) play a crucial role in addressing workforce shortages in healthcare. Their ability to deliver safe and effective healthcare in an unfamiliar cultural setting is intrinsically tied to effective communication. Hospital-based medical clinical educators, who play an important role in providing communication training to IMGs, would benefit from practical resources and an understanding of the relevant pedagogies to address these issues in their teaching. This paper examines the nature of an interdisciplinary collaboration to develop multimedia resources for teaching clinical and ethical communication to IMGs. We describe the processes and dynamics of the collaboration, and outline the methodologies from applied linguistics, medical education, and health ethics that we drew upon. The multimedia consist of three video clips of challenging communication scenarios as well as experienced IMGs talking about communication and ethics. The multimedia are supported by teaching guidelines that address relevant disciplinary concerns of the three areas of collaboration. In the paper's discussion we point out the pre-conditions that facilitated the interdisciplinary collaboration. We propose that such collaborative approaches between the disciplines and participants can provide new perspectives to address the multifaceted challenges of clinical teaching and practice.

  5. Ethical aspect of the clinical research. Informed consent in the clinical research for heavy ion radiotherapy of cancer

    International Nuclear Information System (INIS)

    Murata, Hajime

    2003-01-01

    The research center for heavy ion therapy of cancer was decided to be built in 1984 as a part of the national 10-year anticancer campaign, and construction of Heavy Ion Medical Accelerator in Chiba (HIMAC) was completed at the National Institute of Radiological Sciences in 1993. The HIMAC is the first heavy ion accelerator for only medical use in the world, and the clinical research of cancer radiotherapy was begun in 1994 using carbon ion generated by HIMAC. The purposes of the clinical research are to evaluate the safety and usefulness of carbon ion for cancer treatment, and to establish carbon ion therapy as a new and valuable tool for cancer therapy. Therefore, to obtain exact data in ethical aspect as well as scientific aspect of the clinical research, many special committees have been organized like as the committees of protocol planning for each organ, clinical study groups for each organ, evaluating committee of clinical data, and the ethical committee. Each clinical research is performed according to the research protocol of each organ, in which study purpose, rationale, patient condition, end-point of the study, adverse reaction are described. The document of informed consent (IC) contains study purpose, patient condition, method, predicted effect and demerit, protection of privacy, etc.. IC to each patient is done precisely by the doctor, and the freely-given IC of the patient is obtained. After the IC was completed, judgement of propriety for carbon ion therapy is done by the ethical committee for IC of each patient. Since 1994 carbon ion therapy has been performed over 1300 patients with cancer in various organs, and its safety and usefulness for cancer treatment has been clarified gradually. The carbon ion therapy is thought to be a new and promising tool for cancer treatment near future. (authors)

  6. Ethics committees and the changed clinical research environment in India in 2016: A perspective!

    Science.gov (United States)

    Davis, Sanish; Sule, Poonam; Bughediwala, Murtuza; Pandya, Vrunda; Sinha, Shilpi

    2017-01-01

    Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013-2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.

  7. Auditing of clinical research ethics in a children's and women's academic hospital.

    Science.gov (United States)

    Bortolussi, Robert; Nicholson, Diann

    2002-06-01

    Canadian and international guidelines for research ethics practices have advocated that research ethics boards (REBs) should implement mechanisms to review and monitor human research. Despite this, few Canadian REBs fulfil this expectation. The objective of this report is to summarize the results of 6 audits of clinical research ethics conducted between 1992 and 2000 in a children's and women's academic hospital in Canada in an effort to guide other academic centres planning a similar process. Research audits were conducted by members of a research audit review committee made up of REB volunteers. With use of random and selective processes, approximately 10% of research protocols were audited through interviews with research investigators and research coordinators and by sampling research records. Predetermined criteria were used to assess evidence of good record keeping, data monitoring, adherence to protocol, consents and the recording of adverse events during the research study. An estimate of time required to undertake an audit was made by recall of participants and records. Thirty-five research studies were reviewed including 16 multicentre clinical trials and 19 single-site clinical studies. Review of record keeping and research practice revealed some deficiencies: researchers failed to maintain original authorization (7%) or renewal documentation (9%); there was 1 instance of improper storage of medication; in 5% of 174 participants for whom consent was reviewed, an outdated consent form had been used, and in 4% the signature of the enrolee was not properly shown. Other deficiencies in consent documentation occurred in less than 2% of cases. Nineteen recommendations were made with respect to deficiencies and process issues. A total of 9 to 20 person-hours are required to review each protocol in a typical audit of this type. Information from research audits has been useful to develop educational programs to correct deficiencies identified through the audits

  8. Ethical issues in recruitment of "healthy volunteers": study of a clinical research organisation in Hyderabad.

    Science.gov (United States)

    Krishna, Shilpa; Prasad, N Purendra

    2014-01-01

    This paper raises some of the ethical issues involved in the recruitment of healthy volunteers (HVs) by clinical research organizations (CROs) for bioavailability and bioequivalent (BA/BE) studies. It also explores the underlying reasons for the participation of the HVs and their interaction with the CROs. The findings are based on the data collected from 50 HVs participating in a BA/BE study conducted by a CRO in Hyderabad and from the key officials involved in it. The findings indicate the existence of various complex networks, throw some light on the role of middlemen ("Anna") and the negotiation process, and give us an insight into the social norms and values that compelled the HVs to participate in the study. The paper offers a critical analysis of a few ethical concerns.

  9. Quagmires for clinical psychology and executive coaching? Ethical considerations and practice challenges.

    Science.gov (United States)

    Gebhardt, Judith Ann

    2016-04-01

    As the coaching field burgeons, both the mental health and coaching professionals, and their respective professions, face a myriad of potential quagmires, especially if the unique challenges encountered are ignored. After a short introduction and presentation on ethics and morals related to executive coaching and clinical therapy, a discussion follows on the lengthy and intimate relationship between executive coaching and psychology. Next are definitions and comparisons and 6 areas that are potential quagmires. This includes roles, skill sets/core competencies, education/training, licensing/credentialing-certification, governing bodies and confidentiality, and fees/reimbursement. Each section includes a discussion and several questions to highlight potentially problematic areas, practice challenges, and/or ethical issues, followed with brief responses. This paper concludes with the inquiry, "Where do we go from here?" (c) 2016 APA, all rights reserved).

  10. A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

    Science.gov (United States)

    Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

    2013-01-01

    Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960

  11. Reproductive Ethics in Commercial Surrogacy: Decision-Making in IVF Clinics in New Delhi, India.

    Science.gov (United States)

    Tanderup, Malene; Reddy, Sunita; Patel, Tulsi; Nielsen, Birgitte Bruun

    2015-09-01

    As a neo-liberal economy, India has become one of the new health tourism destinations, with commercial gestational surrogacy as an expanding market. Yet the Indian Assisted Reproductive Technology (ART) Bill has been pending for five years, and the guidelines issued by the Indian Council of Medical Research are somewhat vague and contradictory, resulting in self-regulated practices of fertility clinics. This paper broadly looks at clinical ethics in reproduction in the practice of surrogacy and decision-making in various procedures. Through empirical research in New Delhi, the capital of India, from December 2011 to November 2012, issues of decision-making on embryo transfer, fetal reduction, and mode of delivery were identified. Interviews were carried out with doctors in eighteen ART clinics, agents from four agencies, and fourteen surrogates. In aiming to fulfil the commissioning parents' demands, doctors were willing to go to the greatest extent possible in their medical practice. Autonomy and decision-making regarding choice of the number of embryos to transfer and the mode of delivery lay neither with commissioning parents nor surrogate mothers but mostly with doctors. In order to ensure higher success rates, surrogates faced the risk of multiple pregnancy and fetal reduction with little information regarding the risks involved. In the globalized market of commercial surrogacy in India, and with clinics compromising on ethics, there is an urgent need for formulation of regulative law for the clinical practice and maintenance of principles of reproductive ethics in order to ensure that the interests of surrogate mothers are safeguarded.

  12. Instruction in medical ethics during clinical training for medical students. Report on experience in radio-oncology

    International Nuclear Information System (INIS)

    Schaefer, C.; Lenk, C.; Koelbl, O.

    2006-01-01

    The article gives a review of the current state of education in medical ethics in Germany. The issue is considered from the viewpoint of radio-oncology. Both the pertinent literature and our own experience in teaching medical ethics are presented. In October 2003, medical ethics was integrated into the curriculum of medicine. The aim was to train competence in the field of personal attitudes and to intensify skills of moral reasoning. Our own experiences are positive, which is in accordance with the reports of other working groups. Most of the students were interested in education in medical ethics and looked upon ethical training as being an important part of their studies. Medical students are interested in ethical education during the clinical period of their studies, which has been taken into account since the actual change of the curriculum. Radio-oncologists as specialists in other clinical fields can offer important contributions when they discuss clinical cases from the viewpoint of medical ethics. The long-term effect of such an education will become the subject of future research. (orig.) [de

  13. Software engineering ethics

    Science.gov (United States)

    Bown, Rodney L.

    1991-01-01

    Software engineering ethics is reviewed. The following subject areas are covered: lack of a system viewpoint; arrogance of PC DOS software vendors; violation od upward compatibility; internet worm; internet worm revisited; student cheating and company hiring interviews; computing practitioners and the commodity market; new projects and old programming languages; schedule and budget; and recent public domain comments.

  14. NICE guidelines, clinical practice and antisocial personality disorder: the ethical implications of ontological uncertainty.

    Science.gov (United States)

    Pickersgill, M D

    2009-11-01

    The British National Institute for Health and Clinical Excellence (NICE) has recently (28 January 2009) released new guidelines for the diagnosis, treatment and prevention of the psychiatric category antisocial personality disorder (ASPD). Evident in these recommendations is a broader ambiguity regarding the ontology of ASPD. Although, perhaps, a mundane feature of much of medicine, in this case, ontological uncertainty has significant ethical implications as a product of the profound consequences for an individual categorised with this disorder. This paper argues that in refraining from emphasising uncertainty, NICE risks reifying a controversial category. This is particularly problematical given that the guidelines recommend the identification of individuals "at risk" of raising antisocial children. Although this paper does not argue that NICE is "wrong" in any of its recommendations, more emphasis should have been placed on discussions of the ethical implications of diagnosis and treatment, especially given the multiple uncertainties associated with ASPD. It is proposed that these important issues be examined in more detail in revisions of existing NICE recommendations, and be included in upcoming guidance. This paper thus raises key questions regarding the place and role of ethics within the current and future remit of NICE.

  15. [Perception and satisfaction of main researchers on the management of a Clinical Research Ethics Committee].

    Science.gov (United States)

    Vilardell Navarro, N; Redondo-Capafons, S; Giménez, N; Quintana, S

    2013-01-01

    To analyze the main researchers (MR) perception and satisfaction associated to face-to-face project presentation as well as Clinical Research Ethics Committee (CREC) functions related to administrative and advisement aspects. Descriptive study performed during nine months (January to September 2011) through voluntary participation questionnaire given to MR who assisted to CREC meetings. The questionnaire contained a numeric range (1-10) and open issues to evaluate the presentation process, the satisfaction of CREC functions considering bureaucratic aspects, ethics, scientific-methodological, legal recommendations and its global function. Descriptive statistics and Student test were performed. The questionnaire was answered by 36 (95%) of total MR. Average score obtained in the evaluation of face-to-face study presentation was 9.2 (SD 0.9). In reference to legal issues an average punctuation of 7.1 (DE 0.4) was obtained, whereas ethics and scientific-methodological aspects scored 8.2 (DE 0.2 and 0.4). Global average evaluation about CREC tasks was 8.6 (SD 1.0). A positive assessment related to attend to the project presentation was made for 22 (61%) of the MR. The study showed a high satisfaction of CREC operation and a high evaluation of face-to-face project presentation. There were detected further improvement aspects to optimize CREC meetings, taking into account the effort developed by MR and CREC members. Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.

  16. Consanguineous marriages in the genetic counseling centers of Isfahan and the ethical issues of clinical consultations.

    Science.gov (United States)

    Nouri, Narges; Nouri, Nayereh; Tirgar, Samane; Soleimani, Elham; Yazdani, Vida; Zahedi, Farzaneh; Larijani, Bagher

    2017-01-01

    Consanguineous marriage, which is common in many regions in the world, has absorbed much attention as a causative factor in raising the incidence of genetic diseases. The adverse effects may be attributed to the expression of the genes received from common ancestors and mortality and morbidity of the offspring. Iran has a high rate of consanguineous marriages. In recent years genetic counseling has come to be considered in health care services. This cross-sectional study was conducted in order to determine the prevalence and types of consanguineous marriages in the genetic clinics in Isfahan. We aimed to define the different types of marriages, specific categories of genetic disorders associated with consanguineous marriages, and mode of inheritance in the family tree. We also narratively reviewed the ethical aspects of the issue. The data were collected using a simple questionnaire. A total number of 1535 couples from urban and rural areas formed the study population. The marriages were classified according to the degree of the relationship between couples, including: double cousin, first cousin, first cousin once removed, second cousin and beyond second cousin. The SPSS software version 16 was used for data analysis. Data obtained through genetic counseling offered during a 5-year period revealed that 74.3% had consanguineous relationships, 62.3% were first cousins, 1% were double cousins and 7.8% were second cousins. In addition, 76% of the couples had at least one genetic disease in their family tree. Related ethical issues were also considered in this study, including autonomy and informed decision making, benefit and harm assessment, confidentiality, ethics in research, justice in access to counseling services, financial problems ethics, and the intellectual property of scientific success.

  17. When ethics constrains clinical research: trial design of control arms in "greater than minimal risk" pediatric trials.

    Science.gov (United States)

    de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G

    2011-09-01

    For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

  18. [Ethical issues in a market dispute between clinical laboratories and a health plan: case report].

    Science.gov (United States)

    Pinheiro, Malone Santos; de Brito, Ana Maria Guedes; Jeraldo, Verônica de Lourdes Sierpe; Pinheiro, Kariny Souza

    2011-01-01

    In Brazil the private health plans appear as an alternative to the public health assistance. This segment suffered great intensification in the seventies and eighties, culminating in the entry of large insurance company in the scenario of supplementary medicine. Quickly, the service providers associated with these insurance companies, consolidating them in the market and triggering a relationship of dependency. This article analyzed, in the form of a case report, a marketing dispute between clinical laboratories and a health plan, emphasizing the moral and ethical aspects involved in this episode.

  19. Ethical implications for clinical practice and future research in "at risk" individuals.

    Science.gov (United States)

    Singh, Fiza; Mirzakhanian, Heline; Fusar-Poli, Paolo; de la Fuente-Sandoval, Camilo; Cadenhead, Kristin S

    2012-01-01

    The last 15 years have witnessed a shift in schizophrenia research with increasing interest in earlier stages of illness with the hope of early intervention and ultimately prevention of psychotic illness. Large-scale longitudinal studies have identified clinical and biological risk factors associated with increased risk of psychotic conversion, which together with symptomatic and demographic risk factors may improve the power of prediction algorithms for psychotic transition. Despite these advances, 45-70% of at risk subjects in most samples do not convert to frank psychosis, but continue to function well below their age matched counterparts. The issue is of utmost importance in light of the upcoming DSM-V and the possible inclusion of the attenuated psychotic symptoms syndrome (APSS) diagnosis, with clinical and ethical implications. Clinical considerations include feasibility of reliably diagnosing the at risk state in non-academic medical centers, variable psychotic conversion rates, a non-uniform definition of conversion and extensive debate about treatment for individuals with an ill-defined outcome. On the ethical side, diagnosing APSS could lead to unnecessary prescribing of antipsychotics with long-term deleterious consequences, slow research by providing a false sense of comfort in the diagnosis, and have psychosocial implications for those who receive a diagnosis. Thus it may be prudent to engage at risk populations early and to use broad-spectrum treatments with low risk benefit ratios to relieve functional impairments, while simultaneously studying all subsets of the at risk population.

  20. Faith-to-faith at the bedside: theological and ethical issues in ecumenical clinical chaplaincy.

    Science.gov (United States)

    Mellon, Brad F

    2003-04-01

    Chaplains who serve in a clinical context often minister to patients representing a wide variety of faiths. In order to offer the best pastoral care possible, the chaplain should first possess a set of personal theological convictions as a foundation for ministry. Second, he or she needs to be sensitive to the beliefs and practices of the patients. Third, it is vital to develop a relationship of acceptance and trust not only with patients under their care, but also with family members and caregivers as well. At times, situations will arise that are purely religious or theological. In a clinical setting, however, the questions and problems that arise more often are both theological and ethical. It is beneficial for the chaplain to be involved in an ethics committee, where the specifics of each case can be discussed, and staff can offer counsel to patients and their families. This study examines issues that chaplains face at the bedside, such as terminal care, life-prolonging treatments, dementia, persistent vegetative state, and euthanasia-assisted suicide. We will discover that those who are involved in clinical pastoral ministry will be called upon to be a comforter, mediator, educator, ethicist, and counselor.

  1. Some things ought never be done: moral absolutes in clinical ethics.

    Science.gov (United States)

    Pellegrino, Edmund D

    2005-01-01

    Moral absolutes have little or no moral standing in our morally diverse modern society. Moral relativism is far more palatable for most ethicists and to the public at large. Yet, when pressed, every moral relativist will finally admit that there are some things which ought never be done. It is the rarest of moral relativists that will take rape, murder, theft, child sacrifice as morally neutral choices. In general ethics, the list of those things that must never be done will vary from person to person. In clinical ethics, however, the nature of the physician-patient relationship is such that certain moral absolutes are essential to the attainment of the good of the patient - the end of the relationship itself. These are all derivatives of the first moral absolute of all morality: Do good and avoid evil. In the clinical encounter, this absolute entails several subsidiary absolutes - act for the good of the patient, do not kill, keep promises, protect the dignity of the patient, do not lie, avoid complicity with evil. Each absolute is intrinsic to the healing and helping ends of the clinical encounter.

  2. The Application of Standards and Recommendations to Clinical Ethics Consultation in Practice: An Evaluation at German Hospitals.

    Science.gov (United States)

    Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian

    2017-06-01

    The executive board of the Academy for Ethics in Medicine (AEM) and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation (including ethics consultation, ethics training and the establishment of policy guidelines) are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly.

  3. Global Ethics Applied: Global Ethics, Economic Ethics

    OpenAIRE

    Stückelberger, Christoph

    2016-01-01

    Global Ethics Applied’ in four volumes is a reader of 88 selected articles from the author on 13 domains: Vol. 1 Global Ethics, Economic Ethics; Vol. 2 Environmental Ethics; Vol. 3 Development Ethics, Political Ethics, Dialogue and Peace Ethics, Innovation and Research Ethics, Information and Communication Ethics; Vol. 4 Bioethics and Medical Ethics, Family Ethics and Sexual Ethics, Leadership Ethics, Theological Ethics and Ecclesiology, Methods of Ethics. It concludes with the extended Bibli...

  4. Doctors and Vampires in Sub-Saharan Africa: Ethical Challenges in Clinical Trial Research

    Science.gov (United States)

    Peeters Grietens, Koen; Ribera, Joan Muela; Erhart, Annette; Hoibak, Sarah; Ravinetto, Raffaella M.; Gryseels, Charlotte; Dierickx, Susan; O'Neill, Sarah; Muela, Susanna Hausmann; D'Alessandro, Umberto

    2014-01-01

    Collecting blood samples from individuals recruited into clinical research projects in sub-Saharan Africa can be challenging. Strikingly, one of the reasons for participant reticence is the occurrence of local rumors surrounding “blood stealing” or “blood selling.” Such fears can potentially have dire effects on the success of research projects—for example, high dropout rates that would invalidate the trial's results—and have ethical implications related to cultural sensitivity and informed consent. Though commonly considered as a manifestation of the local population's ignorance, these rumors represent a social diagnosis and a logical attempt to make sense of sickness and health. Born from historical antecedents, they reflect implicit contemporary structural inequalities and the social distance between communities and public health institutions. We aim at illustrating the underlying logic governing patients' fear and argue that the management of these beliefs should become an intrinsic component of clinical research. PMID:24821846

  5. Ethical, Legal, and Clinical Considerations when Disclosing a High-Risk Syndrome for Psychosis.

    Science.gov (United States)

    Mittal, Vijay A; Dean, Derek J; Mittal, Jyoti; Saks, Elyn R

    2015-10-01

    There are complex considerations when planning to disclose an attenuated psychosis syndrome (APS) diagnosis. In this review, we evaluate ethical, legal, and clinical perspectives as well as caveats related to full, non- and partial disclosure strategies, discuss societal implications, and provide clinical suggestions. Each of the disclosure strategies is associated with benefits as well as costs/considerations. Full disclosure promotes autonomy, allows for the clearest psychoeducation about additional risk factors, helps to clarify and/or correct previous diagnoses/treatments, facilitates early intervention and bolsters communication between providers but there are important considerations involving heritability, comorbidity, culture, and stigma. Non-disclosure advances nonmaleficence by limiting stigma and stress (which may inadvertently exacerbate the condition), and confusion (related to the rapidly evolving diagnosis) in a sensitive developmental period but is complicated by varying patient preferences and the possibility that, as new treatments without adverse effects become available, the risk with false positives no longer justifies the accompanying loss of autonomy. Partial disclosure balances ethical considerations by focusing on symptoms instead of labels, but evidence that laypersons may interpret this information as a pseudo-diagnosis and that symptoms alone also contribute to stigma limits the efficacy of this approach. In addition, there are notable societal considerations relating to disclosure involving conservatorship, the reach of insurance companies, and discrimination. We advocate a hybrid approach to disclosure and recommend future research aimed at understanding the effects of stigma on clinical course and a renewed focus on those help-seeking cases that do not transition but remain clinically relevant. © 2015 John Wiley & Sons Ltd.

  6. 'Good ethics and moral standing': a qualitative study of aesthetic leadership in clinical nursing practice.

    Science.gov (United States)

    Mannix, Judy; Wilkes, Lesley; Daly, John

    2015-06-01

    To explore how aesthetic leadership is embodied by clinical leaders in the nursing workplace. A number of different leadership styles have been developed, theorised and applied to the nursing workforce over the years. Many of these styles lack an explicit moral dimension in their identified leader attributes, due to a shift in theorising of leadership to focus on the impact of leader traits on followers. It is timely to look at aesthetic leadership, with its explicit moral dimension, as a way of improving outcomes for nurses, patients and health care organisations. Qualitative design, using conversation-style interviews with experienced registered nurses in designated clinical leadership roles. Twelve experienced registered nurses who worked in designated clinical leadership roles participated in an individual, digitally recorded, semi-structured conversation-style interview. Narrative data were transcribed and subject to thematic analysis. Three main themes emerged: 'True to their beliefs': embodying principled practice; 'Not all policies fit every patient': ethical leadership in ambiguous situations; and 'Being open to people's concerns': providing fair and just solutions. A strong moral compass shaped and guided participants' day-to-day clinical leadership activities. Participants provided a rich narrative on how aesthetic leadership is embodied in the clinical nursing setting. It was evident that their clinical leadership is shaped and guided by a strong moral compass. By incorporating into their practice an aesthetic world-view with its strong moral purpose, participants in this study have shown how aesthetic leadership can enhance the clinical nursing workplace. Nurses in the clinical setting value clinical leaders who embrace and operate with a strong moral compass. Aesthetic leadership, with its explicit strong moral purpose, offers a way of incorporating morality into clinical leadership in the nursing workplace. © 2015 John Wiley & Sons Ltd.

  7. Perspectives on Medical Students’ Reflections on Ethical Dilemmas during their Clinical Stay. Oral Presentation, COMET Conference in Aalborg, Denmark

    DEFF Research Database (Denmark)

    Gormsen, Lise Kirstine; Søndergaard, Sara; Hoffmann, Tine

    Work-in- progress Roundtable: Title: What ethical problems are out there? – a study of medical students’ reflexive writing about ethical dilemmas in the clinic. Authors: Lise Gormsen, MD, MHH, PhD., Institute of Clinical Medicine, Aarhus University, Denmark Jane Ege Møller, MA, PhD., Center...... Kristina Øgendahl Beeck, Medical student, Aarhus University, Denmark Corresponding and presenting author: Lise Gormsen, MD, MHH, Ph.D, Institute of Clinical Medicine, Aarhus University, Incuba/Skejby, building 2 Palle Juul-Jensens Boulevard 82, 8200 Aarhus N Denmark Phone: +45 23981599 Email: lise...... reflect themselves. Furthermore the material is ‘ negatively biased’ - the students write about the unsolved dilemmas. Conclusion: Reflective texts can be seen as data material that contains valuable knowledge, both concerning modes of reflection AND what types of ethical dilemmas that is a part...

  8. Non-invasive prenatal testing for fetal chromosome abnormalities: review of clinical and ethical issues

    Directory of Open Access Journals (Sweden)

    Gekas J

    2016-02-01

    Full Text Available Jean Gekas,1,2 Sylvie Langlois,3 Vardit Ravitsky,4 François Audibert,5 David Gradus van den Berg,6 Hazar Haidar,4 François Rousseau2,7 1Prenatal Diagnosis Unit, Department of Medical Genetics and Pediatrics, Faculty of Medicine, Université Laval, Québec City, QC, Canada; 2Department of Medical Biology, CHU de Québec, Québec City, QC, Canada; 3Department of Medical Genetics, University of British Columbia, Vancouver, BC, Canada; 4Bioethics Program, Department of Social and Preventive Medicine, School of Public Health, University of Montreal, Montreal, QC, Canada; 5Department of Obstetrics and Gynecology, Hospital Sainte-Justine, Montreal, QC, Canada; 6Department of Social and Preventive Medicine, Faculty of Medicine, Université Laval, Québec City, QC, Canada; 7Department of Molecular Biology, Medical Biochemistry and Pathology, Faculty of Medicine, Université Laval, Québec City, QC, Canada Abstract: Genomics-based non-invasive prenatal screening using cell-free DNA (cfDNA screening was proposed to reduce the number of invasive procedures in current prenatal diagnosis for fetal aneuploidies. We review here the clinical and ethical issues of cfDNA screening. To date, it is not clear how cfDNA screening is going to impact the performances of clinical prenatal diagnosis and how it could be incorporated in real life. The direct marketing to users may have facilitated the early introduction of cfDNA screening into clinical practice despite limited evidence-based independent research data supporting this rapid shift. There is a need to address the most important ethical, legal, and social issues before its implementation in a mass setting. Its introduction might worsen current tendencies to neglect the reproductive autonomy of pregnant women. Keywords: prenatal diagnosis, Down syndrome, non-invasive prenatal testing, cell-free fetal DNA, informed consent, reproductive autonomy

  9. Pedagogy, power and practice ethics: clinical teaching in psychiatric/mental health settings.

    Science.gov (United States)

    Ewashen, Carol; Lane, Annette

    2007-09-01

    Often, baccalaureate nursing students initially approach a psychiatric mental health practicum with uncertainty, and even fear. They may feel unprepared for the myriad complex practice situations encountered. In addition, memories of personal painful life events may be vicariously evoked through learning about and listening to the experiences of those diagnosed with mental disorders. When faced with such challenging situations, nursing students often seek counsel from the clinical and/or classroom faculty. Pedagogic boundaries may begin to blur in the face of student distress. For the nurse educator, several questions arise: Should a nurse educator provide counseling to students? How does one best negotiate the boundaries between 'counselor', and 'caring educator'? What are the limits of a caring and professional pedagogic relation? What different knowledges provide guidance and to what differential consequences for ethical pedagogic relationships? This paper offers a comparative analysis of three philosophical stances to examine differences in key assumptions, pedagogic positioning, relationships of power/knowledge, and consequences for professional ethical pedagogic practices. While definitive answers are difficult, the authors pose several questions for consideration in discerning how best to proceed and under what particular conditions.

  10. [Ethical dilemma in research: informed consent in clinical studies on persons with dementia].

    Science.gov (United States)

    Sinoff, Gary

    2012-09-01

    With the world's population aging, there is an increase in the number of demented elderly. It is vital to study this phenomenon in epidemiological and clinical studies, particularly the effects on the increasing numbers of demented elderly. Researchers need to understand the factors predicting the general decline in the demented elderly. However, before any research is undertaken, it is necessary to obtain approval from the Local Internal Review Board. This committee is responsible to maintain accepted national and international ethical standards. The basis for recruitment to a study is the signature on the informed consent form, where the patient is required to understand the study, internalize the study's aim, to consider all options and finally, to express an opinion. Potential elderly participants need to have their judgment evaluated before signing the form. In cases where the subject is incapable, some countries, including Israel, require that there be a legal guardianship. This is a long and complicated process that causes researchers not to recruit demented patients into a study which may actually be beneficial to all. Some countries allow a proxy to sign informed consent forms to permit the demented subject to participate in the study. Often the threshold may depend on the invasiveness of the intervention. The problem of proxies to sign informed consent form troubles researchers worldwide. This article addresses the history and development of ethics in research, and raises the issue to promote an official policy for proxy consent signing.

  11. Revisiting photodynamic therapy dosimetry: reductionist and surrogate approaches to facilitate clinical success

    International Nuclear Information System (INIS)

    Pogue, Brian W; Elliott, Jonathan T; Kanick, Stephen C; Davis, Scott C; Samkoe, Kimberley S; Maytin, Edward V; Pereira, Stephen P; Hasan, Tayyaba

    2016-01-01

    Photodynamic therapy (PDT) can be a highly complex treatment, with many parameters influencing treatment efficacy. The extent to which dosimetry is used to monitor and standardize treatment delivery varies widely, ranging from measurement of a single surrogate marker to comprehensive approaches that aim to measure or estimate as many relevant parameters as possible. Today, most clinical PDT treatments are still administered with little more than application of a prescribed drug dose and timed light delivery, and thus the role of patient-specific dosimetry has not reached widespread clinical adoption. This disconnect is at least partly due to the inherent conflict between the need to measure and understand multiple parameters in vivo in order to optimize treatment, and the need for expedience in the clinic and in the regulatory and commercialization process. Thus, a methodical approach to selecting primary dosimetry metrics is required at each stage of translation of a treatment procedure, moving from complex measurements to understand PDT mechanisms in pre-clinical and early phase I trials, towards the identification and application of essential dose-limiting and/or surrogate measurements in phase II/III trials. If successful, identifying the essential and/or reliable surrogate dosimetry measurements should help facilitate increased adoption of clinical PDT. In this paper, examples of essential dosimetry points and surrogate dosimetry tools that may be implemented in phase II/III trials are discussed. For example, the treatment efficacy as limited by light penetration in interstitial PDT may be predicted by the amount of contrast uptake in CT, and so this could be utilized as a surrogate dosimetry measurement to prescribe light doses based upon pre-treatment contrast. Success of clinical ALA-based skin lesion treatment is predicted almost uniquely by the explicit or implicit measurements of photosensitizer and photobleaching, yet the individualization of treatment

  12. Revisiting photodynamic therapy dosimetry: reductionist & surrogate approaches to facilitate clinical success

    Science.gov (United States)

    Pogue, Brian W.; Elliott, Jonathan T.; Kanick, Stephen C.; Davis, Scott C.; Samkoe, Kimberley S.; Maytin, Edward V.; Pereira, Stephen P.; Hasan, Tayyaba

    2016-04-01

    Photodynamic therapy (PDT) can be a highly complex treatment, with many parameters influencing treatment efficacy. The extent to which dosimetry is used to monitor and standardize treatment delivery varies widely, ranging from measurement of a single surrogate marker to comprehensive approaches that aim to measure or estimate as many relevant parameters as possible. Today, most clinical PDT treatments are still administered with little more than application of a prescribed drug dose and timed light delivery, and thus the role of patient-specific dosimetry has not reached widespread clinical adoption. This disconnect is at least partly due to the inherent conflict between the need to measure and understand multiple parameters in vivo in order to optimize treatment, and the need for expedience in the clinic and in the regulatory and commercialization process. Thus, a methodical approach to selecting primary dosimetry metrics is required at each stage of translation of a treatment procedure, moving from complex measurements to understand PDT mechanisms in pre-clinical and early phase I trials, towards the identification and application of essential dose-limiting and/or surrogate measurements in phase II/III trials. If successful, identifying the essential and/or reliable surrogate dosimetry measurements should help facilitate increased adoption of clinical PDT. In this paper, examples of essential dosimetry points and surrogate dosimetry tools that may be implemented in phase II/III trials are discussed. For example, the treatment efficacy as limited by light penetration in interstitial PDT may be predicted by the amount of contrast uptake in CT, and so this could be utilized as a surrogate dosimetry measurement to prescribe light doses based upon pre-treatment contrast. Success of clinical ALA-based skin lesion treatment is predicted almost uniquely by the explicit or implicit measurements of photosensitizer and photobleaching, yet the individualization of treatment

  13. The clinical phenotype of hereditary versus sporadic prostate cancer: HPC definition revisited

    NARCIS (Netherlands)

    Cremers, R.G.H.M.; Aben, K.K.H.; Oort, I.M. van; Sedelaar, J.P.M.; Vasen, H.F.A.; Vermeulen, S.H.; Kiemeney, L.A.L.M.

    2016-01-01

    BACKGROUND: The definition of hereditary prostate cancer (HPC) is based on family history and age at onset. Intuitively, HPC is a serious subtype of prostate cancer but there are only limited data on the clinical phenotype of HPC. Here, we aimed to compare the prognosis of HPC to the sporadic form

  14. Need for revisiting the role of sexually transmitted disease clinics in government hospitals in India

    Directory of Open Access Journals (Sweden)

    Madhulekha Bhattacharya

    2017-01-01

    Full Text Available Introduction: The Government of India provides treatment for sexually transmitted infections (STIs through government's sexually transmitted disease (STD clinics with the mandate of providing curative and preventive services for clients in the context of STIs. However, besides the patients suffering from STDs, other clients with problems related to reproductive and sexual health also attend these clinics. This study aimed to assess the profile and treatment-seeking behavior of clients attending STD clinics in government hospitals in India. Materials and Methods: This multicentric, cross-sectional study with 5098 participants was conducted over 2 months in identified 19 Indian states. Chi–square test was used for statistical analysis. Results: The percentage with STDs (62.98% was nearly double than those with non-STDs (37.1%. Around 8.2% of patients had an STD and were also HIV positive. Compared to the total STD cases, only 9% of the partners had turned up for screening. Of significance were the non-STD cases who presented with both physical and psychological symptoms including infertility. Among males, it was mainly sexual dysfunction and balanoposthitis, and in females, lower abdominal pain and bacterial vaginosis. Only 27.3% reported that they had come directly to the government facility/clinic. Nearly 38% of males and 30% of females had tried home remedies before coming to the government clinic. Majority (77.9% of the clients reported that they had never been counseled on any aspect of STD or HIV. Conclusion: The profile of clients in the various clinics across the country indicates that the name “STD Clinic” is a misnomer since the presenting complaints of clients are varied, and related not only to STDs but also to other reproductive tract problems. Furthermore, the average new patient load observed in our study is low and this was attributed to the name “STDs” given to these clinics. Renaming them as “Reproductive Health

  15. A perspective from clinical and business ethics on adverse events in hospitalized patients.

    Science.gov (United States)

    Wagner, J T; Meier, C; Higdon, T

    1997-11-01

    Adverse events occur in a significant, but undetermined, number of hospitalized patients. These types of patient injuries are more often the result of faulty systems than human maleficence. A culture exists among health care providers that discourages the reporting of such events and resists the implementation of formal efforts to eliminate them. This resistance serves to perpetuate the problem. Both business and clinical ethics argue that sound reasons exist for hospitals to reduce, if not eliminate, adverse events. To do so is cost effective, particularly in a managed care environment. It is also at the heart of responsible professional behavior. Physicians are afforded an opportunity to be at the forefront in this quality improvement effort.

  16. Combining value of information analysis and ethical argumentation in decisions on participation of vulnerable patients in clinical research.

    Science.gov (United States)

    van der Wilt, Gert J; Grutters, Janneke P C; Maas, Angela H E M; Rolden, Herbert J A

    2018-02-05

    The participation of vulnerable patients in clinical research poses apparent ethical dilemmas. Depending on the nature of the vulnerability, their participation may challenge the ethical principles of autonomy, non-maleficence, or justice. On the other hand, non-participation may preclude the building of a knowledge base that is a prerequisite for defining the optimal clinical management of vulnerable patients. Such clinical uncertainty may also incur substantial economic costs. We present the participation of pre-menopausal women with atrial fibrillation in trials of novel oral anticoagulant drugs as a case study. Due to their non-participation in pivotal trials, it is uncertain whether for them, the risks that are associated with these drugs are outweighed by the advantages compared with conventional treatment. We addressed the question whether research of this new class of drugs in this subgroup would be appropriate from both, an ethical as well an economic perspective. We used the method of specifying norms as a wider framework to resolve the apparent ethical dilemma, while incorporating the question whether research of oral anticoagulants in premenopausal women with atrial fibrillation can be justified on economic grounds. For the latter, the results of a value-of-information analysis were used. Further clinical research on NOACs in premenopausal women with atrial fibrillation can be justified on both, ethical and economic grounds. Addressing apparent ethical dilemmas by invoking a method such as specifying norms can improve the quality of public practical reasoning. As such, the method should also prove valuable to committees that have formally been granted the authority to review trial protocols and proposals for scientific research.

  17. Some aspects of cancer biomarkers and their clinical application in solid tumors – revisited

    Directory of Open Access Journals (Sweden)

    Isaac D

    2017-07-01

    Full Text Available Cancer biomarkers can be used for a variety of purposes related to screening, prediction, stratification, detection, diagnosis, prognosis, treatment design, and monitoring of a therapeutic response. One of the most important characteristics of a given biomarker includes ease of collection allowing for a non-invasive approach and frequent sampling. Such samples may be obtained from serum or plasma, sputum, bronchoalveolar lavage, saliva, nipple discharge, pleural, or peritoneal effusions. Validation of different biomarkers is considered a mandatory method for useful evaluation. In this review, we highlight the clinical applicability of some cancer biomarkers, as well as future approaches for their development and collection, which may help guide clinicians and researchers. The role of liquid biopsies will also be summarized. Further studies using liquid biopsies are needed to elucidate the significance of various sources of biomarkers suitable for clinical application.

  18. Reduction of Clinical Culture Contamination in an Inpatient Medical Unit by Revisiting Microbiology Education.

    Science.gov (United States)

    Yoon, Bona; Irmler, Monica; Faselis, Charles; Liappis, Angelike P

    2016-10-01

    Clinical culture contaminations delay the correct diagnosis, result in repeat testing, and may extend the length of a hospital stay. A simple educational session reminding providers of the ubiquitous presence of bacteria on the skin and in our environment, led to a significant decrease in contaminated cultures (16.9% versus 10.9%, p = 0.03). J Contin Educ Nurs. 2016;47(10):446-448. Copyright 2016, SLACK Incorporated.

  19. Revisiting Cotard’s Syndrome: Illustration of Two Psychiatric Clinical Cases

    Directory of Open Access Journals (Sweden)

    Lídia Sousa

    2016-07-01

    Full Text Available Background: Cotard’s Syndrome (CS is a rare and severe neuropsychiatric condition in which the central feature is the existence of nihilistic delusions. Controversy has ensued about the precise clinical picture Jules Cotard meant to describe and attempts have been made, more recently, not only to clarify the terminology, but also to define different types of this syndrome and explore its biological basis. Aims: We intend to briefly review the terminology, etiology, epidemiology and differential diagnosis of this syndrome, based on two clinical cases. Methods: Bibliographic search conducted through the electronic databases Medline and Gallica (French National Library, consultation of clinical records and direct interviews with the patients. Results and Conclusions: Typically the patients diagnosed with CS manifest the delusional idea that they are dying or already dead. However, it is also possible that they deny the existence of only some parts of their own body, or the functioning of some organs, and they may even sometimes deny the existence of the external world. We illustrate the case of a 66-year-old woman, diagnosed with bipolar affective disorder, admitted in the context of a severe depressive episode with psychotic symptoms, compatible with CS type II and the case of a young male aged 22, admitted due to a first  psychotic episode with schizophrenia like characteristics, presenting with nihilistic delusions compatible with CS type I.

  20. Informed Consent and Clinical Research Involving Children and Adolescents: Implications of the Revised APA Ethics Code and HIPAA

    Science.gov (United States)

    Fisher, Celia B.

    2004-01-01

    In 2003, 2 new sets of rules and regulations affecting the conduct of clinical research involving children and adolescents went into effect: the revised American Psychological Association's (APA) Ethical Principles of Psychologists and Code of Conduct (APA, 2002; effective June 1, 2003) and the Privacy Rule (45 CFR Part 160 and A and E of Part…

  1. Activity of Ethics Committees in Europe on issues related to clinical trials in paediatrics: Results of a survey

    Czech Academy of Sciences Publication Activity Database

    Altavilla, A.; Giaquinto, C.; Giocanti, D.; Manfredi, C.; Aboulker, J.-P.; Bartoloni, F.; Cattani, E.; Giudice, M. L.; Mellado Peňa, M.J.; Nagler, R.; Peterson, C.; Vajnerová, Olga; Bonifazi, F.; Ceci, A.

    2009-01-01

    Roč. 11, 1-2 (2009), s. 79-87 ISSN 1389-2827 Grant - others:EC(XE) LSHBCT-2005-005126 Institutional research plan: CEZ:AV0Z50110509 Keywords : ethic committees * clinical trials * pediatrics Subject RIV: FP - Other Medical Disciplines

  2. Ethical and social significance of microdose clinical trial. Background of guidance draw-up

    International Nuclear Information System (INIS)

    Kurihara, Chieko

    2008-01-01

    Microdose clinical trial (MCT) aims to elucidate only the mass balance (pharmacokinetics, PK) in human of a new drug candidate compound before the first Phase I trial and is going to be approved by the authority MHLW in Japan. In MCT, the compound is administered in human in an extremely small amount (microdose) that is unexpected to exert its pharmacological effect ( 14 C) labeled compound is administered, LC/MS/MS with non-isotopic compound and positron emission tomography (PET) with compound labeled by positron emitter like 11 C, 13 N, etc. Under promotions by support and demand of related scientific societies and corporations in Japan as well as by ICH agreement, MHLW has defined MCT as one of clinical trials linked with GMP standard of drug candidate for clinical trials, with concept for assessment of internal radiation exposure, and with consistency with handling of radioisotopes, because of ethical consideration for volunteers to be enrolled. MCT can expectedly improve the cost- and time-effectiveness of new drug development, which ultimately leads to earlier supply of superior medicines. (R.T.)

  3. Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials.

    Science.gov (United States)

    Ott, Mary A; Crawley, Francis P; Sáez-Llorens, Xavier; Owusu-Agyei, Seth; Neubauer, David; Dubin, Gary; Poplazarova, Tatjana; Begg, Norman; Rosenthal, Susan L

    2018-06-01

    Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12-14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.

  4. IS ETHICAL HACKING ETHICAL?

    OpenAIRE

    MUHAMMAD NUMAN ALI KHAN; DANISH JAMIL,

    2011-01-01

    This paper explores the ethics behind ethical hacking and whether there are problems that lie with this new field of work. Since ethical hacking has been a controversial subject over the past few years, the question remains of the true intentions of ethical hackers. The paper also looks at ways in which future research could be looked intoto help keep ethical hacking, ethical.

  5. Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

    Directory of Open Access Journals (Sweden)

    Ignacio Segarra

    2017-07-01

    Full Text Available The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug–drug interactions (DDI to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs and Research Ethics Committees (RECs. We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies.

  6. Use of antidepressants in the treatment of depression in Asia: guidelines, clinical evidence, and experience revisited.

    Science.gov (United States)

    Treuer, Tamás; Liu, Chia-Yih; Salazar, Gerardo; Kongsakon, Ronnachai; Jia, Fujun; Habil, Hussain; Lee, Min-Soo; Lowry, Amanda; Dueñas, Héctor

    2013-12-01

    Major depressive disorder is prevalent worldwide, and only about half of those affected will experience no further episodes or symptoms. Additionally, depressive symptoms can be challenging to identify, with many patients going undiagnosed despite a wide variety of available treatment options. Antidepressants are the cornerstone of depression treatment; however, a large number of factors must be considered in selecting the treatment best suited to the individual. To help support physicians in this process, international and national treatment guidelines have been developed. This review evaluates the current use of antidepressant treatment for major depressive disorder in six Asian countries (China, Korea, Malaysia, Philippines, Taiwan, and Thailand). No remarkable differences were noted between Asian and international treatment guidelines or among those from within Asia as these are adapted from western guidelines, although there were some local variations. Importantly, a shortage of evidence-based information at a country level is the primary problem in developing guidelines appropriate for Asia, so most of the guidelines are consensus opinions derived from western research data utilized in western guidelines. Treatment guidelines need to evolve from being consensus based to evidence based when evidence is available, taking into consideration cost/effectiveness or cost/benefit with an evidence-based approach that more accurately reflects clinical experience as well as the attributes of each antidepressant. In everyday practice, physicians must tailor their treatment to the patient's clinical needs while considering associated external factors; better tools are needed to help them reach the best possible prescribing decisions which are of maximum benefit to patients. Copyright © 2013 Wiley Publishing Asia Pty Ltd.

  7. Lakatos Revisited.

    Science.gov (United States)

    Court, Deborah

    1999-01-01

    Revisits and reviews Imre Lakatos' ideas on "Falsification and the Methodology of Scientific Research Programmes." Suggests that Lakatos' framework offers an insightful way of looking at the relationship between theory and research that is relevant not only for evaluating research programs in theoretical physics, but in the social…

  8. Using hormones to manage dairy cow fertility: the clinical and ethical beliefs of veterinary practitioners.

    Science.gov (United States)

    Higgins, Helen M; Ferguson, Eamonn; Smith, Robert F; Green, Martin J

    2013-01-01

    In the face of a steady decline in dairy cow fertility over several decades, using hormones to assist reproduction has become common. In the European Union, hormones are prescription-only medicines, giving veterinary practitioners a central role in their deployment. This study explored the clinical and ethical beliefs of practitioners, and provides data on their current prescribing practices. During 2011, 93 practitioners working in England completed a questionnaire (95% response rate). Of the 714 non-organic farms they attended, only 4 farms (0.6%) never used hormones to assist the insemination of lactating dairy cows. Practitioners agreed (>80%) that hormones improve fertility and farm businesses profitability. They also agreed (>80%) that if farmers are able to tackle management issues contributing to poor oestrus expression, then over a five year period these outcomes would both improve, relative to using hormones instead. If management issues are addressed instead of prescribing hormones, practitioners envisaged a less favourable outcome for veterinary practices profitability (p<0.01), but an improvement in genetic selection for fertility (p<0.01) and overall cow welfare (p<0.01). On farms making no efforts to address underlying management problems, long-term routine use at the start of breeding for timing artificial insemination or inducing oestrus was judged "unacceptable" by 69% and 48% of practitioners, respectively. In contrast, practitioners agreed (≥ 90%) that both these types of use are acceptable, provided a period of time has been allowed to elapse during which the cow is observed for natural oestrus. Issues discussed include: weighing quality versus length of cow life, fiscal factors, legal obligations, and balancing the interests of all stakeholders, including the increasing societal demand for food. This research fosters debate and critical appraisal, contributes to veterinary ethics, and encourages the pro-active development of professional

  9. Using hormones to manage dairy cow fertility: the clinical and ethical beliefs of veterinary practitioners.

    Directory of Open Access Journals (Sweden)

    Helen M Higgins

    Full Text Available In the face of a steady decline in dairy cow fertility over several decades, using hormones to assist reproduction has become common. In the European Union, hormones are prescription-only medicines, giving veterinary practitioners a central role in their deployment. This study explored the clinical and ethical beliefs of practitioners, and provides data on their current prescribing practices. During 2011, 93 practitioners working in England completed a questionnaire (95% response rate. Of the 714 non-organic farms they attended, only 4 farms (0.6% never used hormones to assist the insemination of lactating dairy cows. Practitioners agreed (>80% that hormones improve fertility and farm businesses profitability. They also agreed (>80% that if farmers are able to tackle management issues contributing to poor oestrus expression, then over a five year period these outcomes would both improve, relative to using hormones instead. If management issues are addressed instead of prescribing hormones, practitioners envisaged a less favourable outcome for veterinary practices profitability (p<0.01, but an improvement in genetic selection for fertility (p<0.01 and overall cow welfare (p<0.01. On farms making no efforts to address underlying management problems, long-term routine use at the start of breeding for timing artificial insemination or inducing oestrus was judged "unacceptable" by 69% and 48% of practitioners, respectively. In contrast, practitioners agreed (≥ 90% that both these types of use are acceptable, provided a period of time has been allowed to elapse during which the cow is observed for natural oestrus. Issues discussed include: weighing quality versus length of cow life, fiscal factors, legal obligations, and balancing the interests of all stakeholders, including the increasing societal demand for food. This research fosters debate and critical appraisal, contributes to veterinary ethics, and encourages the pro-active development of

  10. Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com.

    Directory of Open Access Journals (Sweden)

    Derek So

    Full Text Available Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process. The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR, which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval. However, the website does require that applicants without ethical approval state the reason it was not required. In order to examine the perspectives of researchers on this topic, we coded every response to that question received by CSDR between June 2014 and February 2017. Of 111 applicants who stated they were exempt from ethics approval, 63% mentioned de-identification, 57% mentioned the use of existing data, 33% referred to local or jurisdictional regulations, and 20% referred to the approvals obtained by the original study. We conclude by examining the experience of CSDR within the broader context of the access mechanisms and policies currently being used by other data sharing platforms, and discuss how our findings might be used to help clinical trial data providers design clear and informative access documents.

  11. Prostate alpha/beta revisited - an analysis of clinical results from 14 168 patients

    Energy Technology Data Exchange (ETDEWEB)

    Dasu, Alexandru [Dept. of Radiation Physics UHL, County Council of Oestergoetland, Linkoeping (Sweden); Radiation Physics, Dept. of Medical and Health Sciences, Faculty of Health Sciences, Linkoeping Univ., Linkoeping (Sweden); Toma-Dasu, Iuliana [Medical Radiation Physics, Stockholm Univ. and Karolinska Institutet, Stockholm (Sweden)

    2012-11-15

    Purpose. To determine the dose response parameters and the fractionation sensitivity of prostate tumours from clinical results of patients treated with external beam radiotherapy. Material and methods. The study was based on five-year biochemical results from 14 168 patients treated with external beam radiotherapy. Treatment data from 11 330 patients treated with conventional fractionation have been corrected for overall treatment time and fitted with a logit equation. The results have been used to determine the optimum {alpha}/{beta} values that minimise differences in predictions from 2838 patients treated with hypofractionated schedules. Results. Conventional fractionation data yielded logit dose response parameters for all risk groups and for all definitions of biochemical failures. The analysis of hypofractionation data led to very low {alpha}/{beta} values (1-1.7 Gy) in all mentioned cases. Neglecting the correction for overall treatment time has little impact on the derivation of {alpha}/{beta} values for prostate cancers. Conclusions. These results indicate that the high fractionation sensitivity is an intrinsic property of prostate carcinomas and they support the use of hypofractionation to increase the therapeutic gain for these tumours.

  12. Revisiting of etiology, clinical picture and diagnosis of the Kleine-Levin syndrome.

    Directory of Open Access Journals (Sweden)

    Ulyanova О.V.

    2017-03-01

    Full Text Available Objective: to draw the attention to the Kleine - Levin syndrome (SKL, a rare, poorly understood disease, not only in Russia but throughout the world. We analyzed the case of the 23-year old patient M, with the Kleine — Levin syndrome. SKL belongs to the group of recurrent hypersomnia and is characterized by long bouts of sleep lasting an average of 10-14 days, beginning with the imperative and difficulty awakening. During bouts of sleep observed unusual behavior of patients: hyperphagia; hypersexuality in males; irritability, restlessness, impaired mental activity; aggression; feeling of unreality of it all; confusion, hallucinatory episodes and depression in females. During wakefulness, marked dyspho-ria, emotional stupefaction, loss of memory. The syndrome develops in 4 times more often in men than in women, aged 12-25 years. Etiological factors: brain tumor, head trauma, metabolic disorders, acute infectious diseases with fever. Often the development of the syndrome is preceded by hyperemia and hypothalamic-pituitary dysfunction. The article discussed the etiology, diagnosis, and possible combinations of clinical manifestations in SKL.

  13. Van Wyk and Grumbach syndrome revisited: imaging and clinical findings in pre- and postpubertal girls

    Energy Technology Data Exchange (ETDEWEB)

    Browne, Lorna P.; Guillerman, R.P. [Texas Children' s Hospital, Department of Diagnostic Imaging, Houston, TX (United States); Boswell, Hillary B. [Texas Children' s Hospital, Department of Gynecology, Houston, TX (United States); Crotty, Eric J.; O' Hara, Sara M.; Birkemeier, Krista L. [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States)

    2008-05-15

    In 1960 Van Wyk and Grumbach described a syndrome of juvenile hypothyroidism, precocious puberty and ovarian enlargement. These findings undergo complete regression with thyroid hormone replacement therapy. This diagnosis can be made on the basis of imaging findings and thyroid function analysis, avoiding surgery. To relate the distinctive clinical and imaging features and putative pathophysiological mechanism of a series of patients with Van Wyk and Grumbach syndrome (VWGS). Patients with VWGS diagnosed at two large children's hospitals over a 6-year period beginning in 1999 were retrospectively reviewed. A literature review was also conducted. Five female patients were diagnosed with cystic ovarian enlargement and hypothyroidism at ages ranging from 9 to 17 years. Isosexual precocious puberty was found in prepubescent patients. Associated findings included delayed bone age, ascites, and pleural and pericardial effusions. Ovarian cyst involution occurred following treatment of the hypothyroidism. The association of primary hypothyroidism with cystic ovarian enlargement and precocious puberty is important to recognize. In the absence of suspected ovarian torsion, surgery is unnecessary, as cyst regression occurs after appropriate thyroid hormone replacement. Noncompliance with hormone replacement therapy should be considered when cystic ovarian enlargement is noted in patients with a history of hypothyroidism. (orig.)

  14. Van Wyk and Grumbach syndrome revisited: imaging and clinical findings in pre- and postpubertal girls

    International Nuclear Information System (INIS)

    Browne, Lorna P.; Guillerman, R.P.; Boswell, Hillary B.; Crotty, Eric J.; O'Hara, Sara M.; Birkemeier, Krista L.

    2008-01-01

    In 1960 Van Wyk and Grumbach described a syndrome of juvenile hypothyroidism, precocious puberty and ovarian enlargement. These findings undergo complete regression with thyroid hormone replacement therapy. This diagnosis can be made on the basis of imaging findings and thyroid function analysis, avoiding surgery. To relate the distinctive clinical and imaging features and putative pathophysiological mechanism of a series of patients with Van Wyk and Grumbach syndrome (VWGS). Patients with VWGS diagnosed at two large children's hospitals over a 6-year period beginning in 1999 were retrospectively reviewed. A literature review was also conducted. Five female patients were diagnosed with cystic ovarian enlargement and hypothyroidism at ages ranging from 9 to 17 years. Isosexual precocious puberty was found in prepubescent patients. Associated findings included delayed bone age, ascites, and pleural and pericardial effusions. Ovarian cyst involution occurred following treatment of the hypothyroidism. The association of primary hypothyroidism with cystic ovarian enlargement and precocious puberty is important to recognize. In the absence of suspected ovarian torsion, surgery is unnecessary, as cyst regression occurs after appropriate thyroid hormone replacement. Noncompliance with hormone replacement therapy should be considered when cystic ovarian enlargement is noted in patients with a history of hypothyroidism. (orig.)

  15. Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent.

    Science.gov (United States)

    Loh, Winnie Y; Butow, Phyllis N; Brown, Richard F; Boyle, Frances

    2002-12-01

    Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. Four focus groups in three large teaching hospitals were conducted. Twenty-one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes. Data managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start-up briefing. The issues raised by these data managers have important implications for the successful conduct of

  16. Emotions and clinical ethics support. A moral inquiry into emotions in moral case deliberation.

    Science.gov (United States)

    Molewijk, Bert; Kleinlugtenbelt, Dick; Pugh, Scott M; Widdershoven, Guy

    2011-12-01

    Emotions play an important part in moral life. Within clinical ethics support (CES), one should take into account the crucial role of emotions in moral cases in clinical practice. In this paper, we present an Aristotelian approach to emotions. We argue that CES can help participants deal with emotions by fostering a joint process of investigation of the role of emotions in a case. This investigation goes beyond empathy with and moral judgment of the emotions of the case presenter. In a moral case deliberation, the participants are invited to place themselves in the position of the case presenter and to investigate their own emotions in the situation. It is about critically assessing the facts in the case that cause the emotion and the related (moral) thoughts that accompany the emotion. It is also about finding the right emotion in a given situation and finding the right balance in dealing with that emotion. These steps in the moral inquiry give rise to group learning. It is a process of becoming open towards the perspectives of others, leading to new insights into what is an appropriate emotion in the specific situation. We show how this approach works in moral case deliberation. A physician presents a situation in which he is faced with a pregnant woman who is about to deliver multiple extremely premature infants at the threshold of viability. The moral deliberation of the case and the emotions therein leads to the participants' conclusion that "compassion" is a more adequate emotion than "sadness". The emotion "sadness" is pointed towards the tragedy that is happening to the woman. The emotion "compassion" is pointed towards the woman; it combines consideration and professional responsibility. Through the shift towards compassion, participants experienced more creativity and freedom to deal with the sad situation and to support the woman. The paper ends with an analysis and reflection on the deliberation process. In the conclusion we argue for more attention to

  17. Using newly deceased patients in teaching clinical skills: its ethical and educational challenges.

    Science.gov (United States)

    Saber, Mahboobeh; Enjoo, Seyed Ali; Mahboudi, Ali; Tabei, Seyed Ziaadin

    2018-04-01

    The newly deceased patients have long been used in medical schools to teach clinical skills without any challenges as it helps to train skilled doctors. Nowadays, the use of moulages and simulators are common in teaching clinical skills since these tools provide the opportunity for frequent practice without any pain and injury. There are specific procedures which still require the use of cadavers. However, the increased significance of patient rights has generally challenged the practicality of using the deceased bodies for this purpose. This study was designed with the aim of determining to what extent clinical skill training is dependent on the recently deceased patients. This was a cross-sectional mixed-method triangulation design conducted in two phases. In the first phase, a researcher-made questionnaire was used to collect quantitative data of the medical students and residents. The data were used to assess the frequency of experience. In the second stage, semi-structured interviews were conducted with faculty members and fellows in order to evaluate the educational impact of this type of procedure and the influential factors. The quantitative data were analyzed using statistical software, and the qualitative codes were extracted following a content analysis. Finally, a comparative analysis was performed. Twenty five residents (26%) and seven medical students (14%) had the experience of performing procedures on the recently deceased patients for training purposes. About half of the residents and 33% of the medical students had observed their colleagues practicing procedures on cadavers. In the qualitative phase, the main categories included professional ethics, law and educational requirements. A relatively low number of medical students and residents had experienced procedures on the newly deceased patients. In this regard, ethical, religious and legal concerns might have played a part despite the desire to learn. It would be effective to direct these

  18. Moral Reasoning among HEC Members: An Empirical Evaluation of the Relationship of Theory and Practice in Clinical Ethics Consultation.

    Science.gov (United States)

    Wasserman, Jason Adam; Stevenson, Shannon Lindsey; Claxton, Cassandra; Krug, Ernest F

    2015-01-01

    In light of the ongoing development and implementation of core competencies in bioethics, it is important to proceed with a clear sense of how bioethics knowledge is utilized in the functioning of hospital ethics committees (HECs). Without such an understanding, we risk building a costly edifice on a foundation that is ambiguous at best. This article examines the empirical relationship between traditional paradigms of bioethics theory and actual decision making by HEC members using survey data from HEC members. The assumption underlying the standardization of qualifications and corresponding call for increased education of HEC members is that they will base imminent case decisions on inculcated knowledge. Our data suggest, however, that HEC members first decide intuitively and then look for justification, thereby highlighting the need to re-examine the pedagogical processes of ethics education in the process of standardizing and improving competencies. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

  19. The clinical importance of axillary lymphadenopathy detected on screening mammography: revisited

    International Nuclear Information System (INIS)

    Patel, T.; Given-Wilson, R.M.; Thomas, V.

    2005-01-01

    AIM: The aim of this study was to re-evaluate our protocol for the management of isolated axillary lymphadenopathy (ALP) on mammographic screening. METHODS: In a retrospective review of 200,716 women screened at the South West London Breast Screening Service (SWLBSS) over 7 years, 72 women with ALP with an otherwise normal mammogram were identified. Thirteen patients were not recalled, nine of who had a known underlying diagnosis and the remainder had longstanding unchanged mammograms. Fifty-nine patients were recalled for further clinical assessment and investigations, including ultrasound, further mammographic views, fine-needle aspiration cytology (FNAC), blood tests and a chest radiograph. Those with a definite diagnosis were referred for appropriate management and those with benign reactive cytology on FNAC reviewed at 6 weeks with subsequent referral for excision of persisting abnormal nodes. RESULTS: The ultimate diagnosis was benign in 45 cases: 26 benign reactive changes, 11 arthritides, five with dermatological and viral conditions and three with tuberculosis. Malignancy was diagnosed in 13 cases: four with metastatic breast carcinoma and nine with lymphoma/leukaemia. The total number of newly diagnosed malignancies was 20% of women recalled. Another 5% of patients had active tuberculosis. Of the 22 patients with benign reactive cytology, one had significant pathology on excision biopsy: tuberculosis. Over 95% of the results from excision biopsy in these patients did not alter management. CONCLUSION: In the majority of patients, the FNAC results were representative of the final excision pathology. The present study suggests that excision biopsy could be omitted for those patients whose FNAC and culture are negative

  20. Association of Betel Nut with Carcinogenesis: Revisit with a Clinical Perspective

    Science.gov (United States)

    Sharan, Rajeshwar N.; Mehrotra, Ravi; Choudhury, Yashmin; Asotra, Kamlesh

    2012-01-01

    Abstract Betel nut (BN), betel quid (BQ) and products derived from them are widely used as a socially endorsed masticatory product. The addictive nature of BN/BQ has resulted in its widespread usage making it the fourth most abused substance by humans. Progressively, several additives, including chewing tobacco, got added to simple BN preparations. This addictive practice has been shown to have strong etiological correlation with human susceptibility to cancer, particularly oral and oropharyngeal cancers. The PUBMED database was searched to retrieve all relevant published studies in English on BN and BQ, and its association with oral and oropharyngeal cancers. Only complete studies directly dealing with BN/BQ induced carcinogenesis using statistically valid and acceptable sample size were analyzed. Additional relevant information available from other sources was also considered. This systematic review attempts to put in perspective the consequences of this widespread habit of BN/BQ mastication, practiced by approximately 10% of the world population, on oral cancer with a clinical perspective. BN/BQ mastication seems to be significantly associated with susceptibility to oral and oropharyngeal cancers. Addition of tobacco to BN has been found to only marginally increase the cancer risk. Despite the widespread usage of BN/BQ and its strong association with human susceptibility to cancer, no serious strategy seems to exist to control this habit. The review, therefore, also looks at various preventive efforts being made by governments and highlights the multifaceted intervention strategies required to mitigate and/or control the habit of BN/BQ mastication. PMID:22912735

  1. Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71% were completed according to protocol, 128 (16% discontinued and 42 (5% are still ongoing; for 61 (8% there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55. Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48% protocols and in 205 (49% of the publications. In most published studies (339; 81% this information corresponded between protocol and publication. Most studies were published in English (367; 88%; some in German (25; 6% or both languages (27; 6%. The local investigators were listed as (co-authors in the publications corresponding to 259 (62% studies.Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care

  2. Child Rights and Clinical Bioethics: Historical Reflections on Modern Medicine and Ethics.

    Science.gov (United States)

    Brosco, Jeffrey P

    2016-01-01

    Why might pediatric bioethicists in the United States reject the U.N. Convention on the Rights of the Child (CRC) as a framework for resolving ethical issues? The essays in this issue present arguments and counterarguments regarding the usefulness of the CRC in various clinical and research cases. But underlying this debate are two historical factors that help explain the seeming paradox of pediatric bioethicists' arguing against child's rights. First, the profession of clinical bioethics emerged in the 1970s as one component of modern medicine's focus on improving health through the application of technologically sophisticated treatments. The everyday work of U.S. bioethicists thus usually involves emerging technologies or practices in clinical or laboratory settings; the articles of the CRC, in contrast, seem better suited to addressing broad policy issues that affect the social determinants of health. Second, U.S. child health policy veered away from a more communitarian approach in the early 20th century for reasons of demography that were reinforced by ideology and concerns about immigration. The divide between clinical medicine and public health in the United States, as well as the relatively meager social safety net, are not based on a failure to recognize the rights of children. Indeed, there is some historical evidence to suggest that "rights language" has hindered progress on child health and well-being in the United States. In today's political climate, efforts to ensure that governments pledge to treat children in accordance with their status as human beings (a child right's perspective) are less likely to improve child health than robust advocacy on behalf of children's unique needs, especially as novel models of health-care financing emerge.

  3. A Framework for Professional Ethics Courses in Teacher Education

    Science.gov (United States)

    Warnick, Bryan R.; Silverman, Sarah K.

    2011-01-01

    Evidence suggests that professional ethics is currently a neglected topic in teacher education programs. In this article, the authors revisit the question of ethics education for teachers. The authors propose an approach to the professional ethics of teaching that employs a case-analysis framework specifically tailored to address the practice of…

  4. Systematic and transparent inclusion of ethical issues and recommendations in clinical practice guidelines: a six-step approach.

    Science.gov (United States)

    Mertz, Marcel; Strech, Daniel

    2014-12-04

    Clinical practice guidelines (CPGs), a core tool to foster medical professionalism, differ widely in whether and how they address disease-specific ethical issues (DSEIs), and current manuals for CPG development are silent on this issue. The implementation of an explicit method faces two core challenges: first, it adds further complexity to CPG development and requires human and financial resources. Second, in contrast to the in-depth treatment of ethical issues that is standard in bioethics, the inclusion of DSEIs in CPGs need to be more pragmatic, reductive, and simplistic, but without rendering the resulting recommendations useless or insufficiently justified. This paper outlines a six-step approach, EthicsGuide, for the systematic and transparent inclusion of ethical issues and recommendations in CPGs. The development of EthicsGuide is based on (a) methodological standards in evidence-based CPG development, (b) principles of bioethics, (c) research findings on how DSEIs are currently addressed in CPGs, and (d) findings from two proof-of-concept analyses of the EthicsGuide approach. The six steps are 1) determine the DSEI spectrum and the need for ethical recommendations; 2) develop statements on which to base ethical recommendations; 3) categorize, classify, condense, and paraphrase the statements; 4) write recommendations in a standard form; 5) validate and justify recommendations, making any necessary modifications; and 6) address consent. All six steps necessarily come into play when including DSEIs in CPGs. If DSEIs are not explicitly addressed, they are unavoidably dealt with implicitly. We believe that as ethicists gain greater involvement in decision-making about health, personal rights, or economic issues, they should make their methods transparent and replicable by other researchers; and as ethical issues become more widely reflected in CPGs, CPG developers have to learn how to address them in a methodologically adequate way. The approach proposed

  5. Scaling ethics up and down: moral craft in clinical genetics and in global health research.

    Science.gov (United States)

    Parker, Michael

    2015-01-01

    This paper engages with the question of what it is to 'do good medical ethics' in two ways. It begins with an exploration of what it might mean to say that health professionals practise good medical ethics as part of practising good ethical medicine. Using the example of the Genethics Club, a well-established national ethics forum for genetics professionals in the UK, the paper develops an account of moral craftsmanship grounded in the concepts of shared moral commitments and practices, moral work, ethics and living morality. In the light of this discussion, the paper goes on to consider what it might mean for a specialist in medical ethics, a bioethicist, to do good medical ethics. Finally, a research agenda focusing on the challenges of thinking about good medical ethics in a global context and a proposal for an innovative approach to bioethics methodology is outlined. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  6. Clinical and Ethical Implications for Teacher-Training in Behavior Modification.

    Science.gov (United States)

    Brion-Meisels, Linda

    The ethical issues concerning the use of behavioral procedures are founded on concerns relating to behavioral control. One major recurring ethical issue is that of coercion. The focus of this paper centers on the question: Ought behavioral programs to be employed even when they might be against the volition of the participant? A theoretical and…

  7. Clinical, social and ethical issues associated with non-invasive prenatal testing for aneuploidy.

    Science.gov (United States)

    Griffin, Blanche; Edwards, Samantha; Chitty, Lyn S; Lewis, Celine

    2018-03-01

    Non-invasive prenatal testing (NIPT), based on analysis of cell-free foetal DNA, is rapidly becoming a preferred method to screen for chromosomal aneuploidy with the technology now available in over 90 countries. This review provides an up-to-date discussion of the key clinical, social and ethical implications associated with this revolutionary technology. Stakeholders are positive about a test that is highly accurate, safe, can be perfomed early in pregnancy, identifies affected pregnancies that might otherwise have been missed and reduces the need for invasive testing. Nevertheless, professional societies currently recommend it as an advanced screening test due to the low false positive rate (FPR). Despite the practical and psychological benefits, a number of concerns have been raised which warrant attention. These include the potential for routinisation of testing and subsequent impact on informed decision-making, an "easy" blood test inadvertently contributing to women feeling pressured to take the test, fears NIPT will lead to less tolerance and support for those living with Down syndrome and the heightened expectation of having "perfect babies". These issues can be addressed to some extent through clinician education, patient information and establishing national and international consensus in the development of comprehensive and regularly updated guidelines. As the number of conditions we are able to test for non-invasively expands it will be increasingly important to ensure pre-test counselling can be delivered effectively supported by knowledgeable healthcare professionals.

  8. Donor Selection for Allogenic Hemopoietic Stem Cell Transplantation: Clinical and Ethical Considerations

    Directory of Open Access Journals (Sweden)

    Irene Riezzo

    2017-01-01

    Full Text Available Allogenic hematopoietic progenitor cell transplantation (allo-HSCT is an established treatment for many diseases. Stem cells may be obtained from different sources: mobilized peripheral blood stem cells, bone marrow, and umbilical cord blood. The progress in transplantation procedures, the establishment of experienced transplant centres, and the creation of unrelated adult donor registries and cord blood banks gave those without an human leucocyte antigen- (HLA- identical sibling donor the opportunity to find a donor and cord blood units worldwide. HSCT imposes operative cautions so that the entire donation/transplantation procedure is safe for both donors and recipients; it carries with it significant clinical, moral, and ethical concerns, mostly when donors are minors. The following points have been stressed: the donation should be excluded when excessive risks for the donor are reasonable, donors must receive an accurate information regarding eventual adverse events and health burden for the donors themselves, a valid consent is required, and the recipient’s risks must be outweighed by the expected benefits. The issue of conflict of interest, when the same physician has the responsibility for both donor selection and recipient care, is highlighted as well as the need of an adequate insurance protection for all the parties involved.

  9. From embryonic stem cells to functioning germ cells: science, clinical and ethical perspectives.

    Science.gov (United States)

    Kiatpongsan, Sorapop

    2007-10-01

    Embryonic stem cells have been well recognized as cells having a versatile potential to differentiate into all types of cells in the body including germ cells. There are many research studies focusing on the differentiation processes and protocols to derive various types of somatic cells from embryonic stem cells. However, germ cells have unique differentiation process and developmental pathway compared with somatic cells. Consequently, they will require different differentiation protocols and special culture techniques. More understanding and established in vitro systems for gametogenesis will greatly contribute to further progression of knowledge and technology in germ cell biology, reproductive biology and reproductive medicine. Moreover if oocytes can be efficiently produced in vitro, this will play an important role on progression in nuclear transfer and nuclear reprogramming technology. The present article will provide concise review on past important discoveries, current ongoing studies and future views of this challenging research area. An ethical perspective has also been proposed to give comprehensive summary and viewpoint for future clinical application.

  10. Impact of the economic crisis on the activity of a clinical research ethics committee

    Directory of Open Access Journals (Sweden)

    Paula Arcenillas

    2014-11-01

    Full Text Available Purpose: Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT and observational studies (ES from the activity of an Research Ethics Committee (REC. Method: REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1 promoted by pharmaceutical industry, 2 by scientific societies with industry support, 3 by scientific societies with government support and 4 unfunding.Two periods were compared: pre-crisis (2003-2007 and crisis (2008-2012. Results: During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. Conclusions: Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS.

  11. [Impact of the economic crisis on the activity of a clinical research ethics committee].

    Science.gov (United States)

    Redondo Capafons, S; Arcenillas, Paula; Giménez, Nuria; March López, Pablo; Soriano, Laura; Pla, Ramon; Quintana, Salvador

    2014-11-03

    Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT) and observational studies (ES) from the activity of an Research Ethics Committee (REC). REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1) promoted by pharmaceutical industry, 2) by scientific societies with industry support, 3) by scientific societies with government support and 4) unfunding.Two periods were compared: pre-crisis (2003-2007) and crisis (2008-2012). During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  12. Sensemaking Revisited

    DEFF Research Database (Denmark)

    Holt, Robin; Cornelissen, Joep

    2014-01-01

    We critique and extend theory on organizational sensemaking around three themes. First, we investigate sense arising non-productively and so beyond any instrumental relationship with things; second, we consider how sense is experienced through mood as well as our cognitive skills of manipulation ...... research by revisiting Weick’s seminal reading of Norman Maclean’s book surrounding the tragic events of a 1949 forest fire at Mann Gulch, USA....

  13. Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach.

    Science.gov (United States)

    van der Graaf, Rieke; van der Zande, Indira S E; den Ruijter, Hester M; Oudijk, Martijn A; van Delden, Johannes J M; Oude Rengerink, Katrien; Groenwold, Rolf H H

    2018-01-29

    Since pregnant women are severely underrepresented in clinical research, many take the position that the exclusion of pregnant women from research must be justified unless there are compelling "scientific reasons" for their exclusion. However, it is questionable whether this approach renders research with pregnant women fair. This paper analyzes and evaluates when research with pregnant women can be considered as fair and what constitutes scientific reasons for exclusion. Conceptual ethical and methodological analysis and evaluation of fair inclusion. Fair inclusion of pregnant women means (1) that pregnant women who are eligible are not excluded solely for being pregnant and (2) that the research interests of pregnant women are prioritized, meaning that they ought to receive substantially more attention. Fairness does not imply that pregnant women should be included in virtually every research project, as including only a few pregnant women in a population consisting only of women will not help to determine the effectiveness and safety of a treatment in pregnant women. Separate trials in pregnant women may be preferable once we assume, or know, that effects of interventions in pregnant women differ from the effects in other subpopulations, or when we assume, or know, that there are no differences. In the latter case, it may be preferable to conduct post-marketing studies or establish registries. If there is no conclusive evidence indicating either differences or equivalence of effects between pregnant and non-pregnant women, yet it seems unlikely that major differences or exact equivalence exist, the inclusion of pregnant women should be sufficient. Depending on the research question, this boils down to representativeness in terms of the proportion of pregnant and non-pregnant women, or to oversampling pregnant women. Fair inclusion of pregnant women in research implies that separate trials in pregnant women should be promoted. Inclusion of pregnant women has to

  14. Ethical and legal questions as regards filling out dental clinical charts

    Directory of Open Access Journals (Sweden)

    Mauro Henrique Nogueira Guimarãe de Abreu

    Full Text Available Objective: Evaluate imperfections in filling out dental clinical history charts of patients attended at the “Universidade Estadual de Montes Claros – Unimontes”, in 2005, from the ethical and legal aspects. Method: Descriptive statistical analysis, Pearson’s correlation, Chi-Square test (p<0.05 with Bonferroni correction in a contingency table (p<0.003 tests were performed, and Anova – Tukey (p<0.05 were calculate using SPSS software. This study was conducted using 881 clinical history charts of 19 subjects. Results: The highest percentage of charts concerned Stomatology (12% and 8 th period of the course (25%. The majority (63.3% of chartshad fields left blank and in 68% the handwriting was illegible. Unjustifiable erasures were found in 74.7% of charts. The majority of charts (98% were filled out in ink. The treatment plan was signed by course tutor in 83% of the cases. The term of consent was signed in the 94.9 % of the charts. As regards mistakes, 5.1% of documents had one error; 42% two errors; 23.5% three or more errors (average 1.89(± 0.9; percentile 25%=1; 50%=2 and 75%=2. The difference in the proportion of errors as regards filling out all fields differed statistically among the periods (p<0.05. Conclusion: It was concluded that an alarming number of documents were filled out incorrectly. The worst filling out performance was shown in the 5th, 6th and 7th periods (p<0.05.

  15. Treatment for gender dysphoria in children: the new legal, ethical and clinical landscape.

    Science.gov (United States)

    Smith, Malcolm K; Mathews, Ben

    2015-02-02

    Gender dysphoria is a condition in which a child's subjectively felt identity and gender are not congruent with her or his biological sex. Because of this, the child suffers clinically significant distress or impairment in social functioning. The Family Court of Australia has recently received an increasing number of applications seeking authorisation for the provision of hormones to treat gender dysphoria in children. Some medical procedures and interventions performed on children are of such a grave nature that court authorisation must be obtained to render them lawful. These procedures are referred to as special medical procedures. Hormonal therapy for the treatment of gender dysphoria in children is provided in two stages occurring years apart. Until recently, both stages of treatment were regarded by courts as special medical treatments, meaning court authorisation had to be provided for both stages. In a significant recent development, courts have drawn a distinction between the two stages of treatment, permitting parents to consent to the first stage. In addition, it has been held that a child who is determined by a court to be Gillick competent can consent to stage 2 treatment. The new legal developments concerning treatment for gender dysphoria are of ethical, clinical and practical importance to children and their families, and to medical practitioners treating children with gender dysphoria. Medical practitioners should benefit from an understanding of the recent developments in legal principles. This will ensure that they have up-to-date information about the circumstances under which treatment may be conducted with parental consent, and those in which they must seek court authorisation.

  16. Addressing ethical dilemmas in the clinical care of adolescents: an international view.

    Science.gov (United States)

    Michaud, Pierre-André; Berg-Kelly, Kristina; Macfarlane, Aidan; Renteria, Saira-Christine; Wyss, Danielle; Benaroyo, Lazare

    2009-12-01

    This chapter reviews some basic concepts underlying ethical issues in adolescence and provides a step-by-step procedure to address ethical dilemmas involving minor adolescents, based on a deliberative approach. "Deliberation" with the patient, along with involving the opinion of relevant stakeholders if possible, allows for a careful, multidisciplinary examination of all options, the medical and psychosocial consequences, and the moral values stressed by each option. Although the final decision regarding which ethical option should be chosen usually belongs to the health care providers and his or her patient, the deliberative approach provides the ingredients for sound, unbiased decision-making.

  17. Clinical governance and research ethics as barriers to UK low-risk population-based health research?

    Directory of Open Access Journals (Sweden)

    Douglas Flora

    2008-11-01

    Full Text Available Abstract Background Since the Helsinki Declaration was introduced in 1964 as a code of practice for clinical research, it has generally been agreed that research governance is also needed in the field of public health and health promotion research. Recently, a range of factors led to the development of more stringent bureaucratic procedures, governing the conduct of low-risk population-based health research in the United Kingdom. Methods Our paper highlights a case study of the application process to medical research ethics committees in the United Kingdom for a study of the promotion of physical activity by health care providers. The case study presented here is an illustration of the challenges in conducting low-risk population-based health research. Results Our mixed-methods approach involved a questionnaire survey of and semi-structured interviews with health professionals (who were all healthy volunteers. Since our study does not involve the participation of either patients or the general population, one would expect the application to the relevant research ethics committees to be a formality. This proved not to be the case! Conclusion Research ethics committees could be counter-productive, rather than protecting the vulnerable in the research process, they can stifle low-risk population-based health research. Research ethics in health services research is first and foremost the responsibility of the researcher(s, and we need to learn to trust health service researchers again. The burden of current research governance regulation to address the perceived ethical problems is neither appropriate nor adequate. Senior researchers/academics need to educate and train students and junior researchers in the area of research ethics, whilst at the same time reducing pressures on them that lead to unethical research, such as commercial funding, inappropriate government interference and the pressure to publish. We propose that non-invasive low

  18. Care of Pediatric Neurosurgical Patients in Iraq in 2007: Clinical and Ethical Experience of a Field Hospital

    Science.gov (United States)

    2010-09-01

    penetrating spine injury      •      bioethics Abbreviations used in this paper: EMDG = Expeditionary Medical Group; GCS = Glasgow Coma Scale; GOS...select group of high-acuity patients capable of consuming significant medical resources in a deployed environment. This information has the potential to...impact medical planning, logistics, and policy. 25 256 Care of pediatric neurosurgical patients in Iraq in 2007: clinical and ethical experience of

  19. Conflicts Between Parents and Health Professionals About a Child's Medical Treatment: Using Clinical Ethics Records to Find Gaps in the Bioethics Literature.

    Science.gov (United States)

    McDougall, Rosalind; Notini, Lauren; Phillips, Jessica

    2015-09-01

    Clinical ethics records offer bioethics researchers a rich source of cases that clinicians have identified as ethically complex. In this paper, we suggest that clinical ethics records can be used to point to types of cases that lack attention in the current bioethics literature, identifying new areas in need of more detailed bioethical work. We conducted an analysis of the clinical ethics records of one paediatric hospital in Australia, focusing specifically on conflicts between parents and health professionals about a child's medical treatment. We identified, analysed, and compared cases of this type from the clinical ethics records with cases of this type discussed in bioethics journals. While the cases from journals tended to describe situations involving imminent risk to the child's life, a significant proportion of the clinical ethics records cases involved different stakes for the child involved. These included distress, poorer functional outcome, poorer psychosocial outcome, or increased risk of surgical complications. Our analysis suggests that one type of case that warrants more detailed ethics research is parental refusal of recommended treatment, where the refusal does not endanger the child's life but rather some other aspect of the child's well-being.

  20. Ethical considerations in the translation of regenerative biofabrication technologies into clinic and society.

    Science.gov (United States)

    Otto, I A; Breugem, C C; Malda, J; Bredenoord, A L

    2016-10-07

    Biofabrication technologies have the potential to improve healthcare by providing highly advanced and personalized biomedical products for research, treatment and prevention. As the combining of emerging techniques and integrating various biological and synthetic components becomes increasingly complex, it is important that relevant stakeholders anticipate the translation of biofabricated 3D tissue products into patients and society. Ethics is sometimes regarded as a brake on scientific progress, yet from our perspective, ethics in parallel with research anticipates societal impacts of emerging technologies and stimulates responsible innovation. For the ethical assessment, the biofabrication field benefits from similarities to regenerative medicine and an increasing ethical awareness in the development of tissue-engineered products. However, the novelty of the technology itself, the increase in attainable structural complexity, and the potential for automation and personalization are distinguishing facets of biofabrication that call for a specific exploration of the ethics of biofabrication. This review aims to highlight important points of existing ethical discussions, as well as to call attention to emerging issues specific to 3D biofabrication in bench and bedside research and the translation to society.

  1. Teaching ethics in the clinic. The theory and practice of moral case deliberation.

    Science.gov (United States)

    Molewijk, A C; Abma, T; Stolper, M; Widdershoven, G

    2008-02-01

    A traditional approach to teaching medical ethics aims to provide knowledge about ethics. This is in line with an epistemological view on ethics in which moral expertise is assumed to be located in theoretical knowledge and not in the moral experience of healthcare professionals. The aim of this paper is to present an alternative, contextual approach to teaching ethics, which is grounded in a pragmatic-hermeneutical and dialogical ethics. This approach is called moral case deliberation. Within moral case deliberation, healthcare professionals bring in their actual moral questions during a structured dialogue. The ethicist facilitates the learning process by using various conversation methods in order to find answers to the case and to develop moral competencies. The case deliberations are not unique events, but are a structural part of the professional training on the work floor within healthcare institutions. This article presents the underlying theory on (teaching) ethics and illustrates this approach with an example of a moral case deliberation project in a Dutch psychiatric hospital. The project was evaluated using the method of responsive evaluation. This method provided us with rich information about the implementation process and effects the research process itself also lent support to the process of implementation.

  2. Guidelines for Teaching Cross-Cultural Clinical Ethics: Critiquing Ideology and Confronting Power in the Service of a Principles-Based Pedagogy.

    Science.gov (United States)

    Brunger, Fern

    2016-03-01

    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 (such as the critique of the universality of the Euro-American construct of "autonomy") within (rather than in opposition to) 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.

  3. Clinical photography in dermatology: ethical and medico-legal considerations in the age of digital and smartphone technology.

    Science.gov (United States)

    Kunde, Lauren; McMeniman, Erin; Parker, Malcolm

    2013-08-01

    Clinical photography has long been an important aspect in the management of dermatological pathology and has many applications in contemporary dermatology practice. With the continuous evolution of digital and smartphone technology, clinicians must maintain ethical and medico-legal standards. This article reviews how dermatology trainees are utilising this technology in their clinical practice and what procedures they follow when taking photos of patients. We review the ethical and legal considerations of clinical photography in dermatology and present a hypothetical medico-legal scenario. Dermatology registrars were surveyed on their use of personal smartphones and digital equipment for photographing patients in their clinical practice. Numerous medico-legal providers were approached to provide medico-legal advice about a hypothetical scenario. We found that the use of these technologies is prevalent among dermatology registrars and all respondents reported regular use. Clinicians should routinely obtain and document adequate patient consent in relation to clinical photography, utilise strict privacy settings on smartphones and other digital devices and ensure that the images are stored on these devices for minimal periods. Express consent documentation in the clinical file puts the clinician in a more defensible position if a complaint is made to the medical board or privacy commissioner. © 2013 The Authors. Australasian Journal of Dermatology © 2013 The Australasian College of Dermatologists.

  4. Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

    Science.gov (United States)

    Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

    2018-02-15

    There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

  5. Consent, Refusal, and Waivers in Patient-Centered Dysphagia Care: Using Law, Ethics, and Evidence to Guide Clinical Practice.

    Science.gov (United States)

    Horner, Jennifer; Modayil, Maria; Chapman, Laura Roche; Dinh, An

    2016-11-01

    When patients refuse medical or rehabilitation procedures, waivers of liability have been used to bar future lawsuits. The purpose of this tutorial is to review the myriad issues surrounding consent, refusal, and waivers. The larger goal is to invigorate clinical practice by providing clinicians with knowledge of ethics and law. This tutorial is for educational purposes only and does not constitute legal advice. The authors use a hypothetical case of a "noncompliant" individual under the care of an interdisciplinary neurorehabilitation team to illuminate the ethical and legal features of the patient-practitioner relationship; the elements of clinical decision-making capacity; the duty of disclosure and the right of informed consent or informed refusal; and the relationship among noncompliance, defensive practices, and iatrogenic harm. We explore the legal question of whether waivers of liability in the medical context are enforceable or unenforceable as a matter of public policy. Speech-language pathologists, among other health care providers, have fiduciary and other ethical and legal obligations to patients. Because waivers try to shift liability for substandard care from health care providers to patients, courts usually find waivers of liability in the medical context unenforceable as a matter of public policy.

  6. Science, humanism, judgement, ethics: person-centered medicine as an emergent model of modern clinical practice.

    Science.gov (United States)

    Miles, Andrew

    2013-01-01

    The Medical University of Plovdiv (MUP) has as its motto 'Committed to humanity". But what does humanity in modern medicine mean? Is it possible to practise a form of medicine that is without humanity? In the current article, it is argued that modern medicine is increasingly being practised in a de-personalised fashion, where the patient is understood not as a unique human individual, a person, but rather as a subject or an object and more in the manner of a complex biological machine. Medicine has, it is contended, become distracted from its duty to care, comfort and console as well as to ameliorate, attenuate and cure and that the rapid development of medicine's scientific knowledge is, paradoxically, principally causative. Signal occurrences in the 'patient as a person' movement are reviewed, together with the emergence of the evidence-based medicine (EBM) and patient-centered care (PCC) movements. The characteristics of a model of medicine evolving in response to medicine's current deficiencies--person-centered healthcare (PCH)--are noted and described. In seeking to apply science with humanism, via clinical judgement, within an ethical framework, it is contended that PCH will prove to be far more responsive to the needs of the individual patient and his/her personal circumstances than current models of practice, so that neither a reductive anatomico-pathological, disease-centric model of illness (EBM), nor an aggressive patient-directed, consumerist form of care (PCC) is allowed continued dominance within modern healthcare systems. In conclusion, it is argued that PCH will enable affordable advances in biomedicine and technology to be delivered to patients within a humanistic framework of clinical practice that recognises the patient as a person and which takes full account of his/her stories, values, preferences, goals, aspirations, fears, worries, hopes, cultural context and which responds to his/her psychological, emotional, spiritual and social necessities

  7. Ethical, legal and clinical aspects of live surgery in urology - contemporary issues and a glimpse of the future.

    Science.gov (United States)

    Cumpanas, Alin Adrian; Ferician, Ovidiu Catalin; Latcu, Silviu Constantin; Pricop, Catalin; Bardan, Razvan Tiberiu

    2017-01-01

    Beside dry and wet lab training, simulators, video tapes, fellowships and clinical visits, live surgery has gained popularity during the last years, being an attraction point at large scientific meetings and at postgraduate courses as well. This type of surgical training raises both ethical and legal issues. Thus, there are professional societies that have banned such meetings, mainly due to safety reasons for the patient. The current article aims to identify and to discuss ethical and legal issues related to the topic, advantages, disadvantages and weak points of this emerging challenge for modern medicine, trying to analyze the issues from all relevant points of view: those of the patient, the surgeon and the session attendant.

  8. Nothing New (Ethically Under the Sun: Policy & Clinical Implications of Nanomedicine

    Directory of Open Access Journals (Sweden)

    MacDonald, Chris

    2012-06-01

    Full Text Available Nanotechnology research is beginning to see widespread coverage in the media and popular science literatures, but discussions of hopes and fears about nanotechnology have already become polarised into utopian and dystopian visions. More moderate discussions focus on the near-term applications of nanotechnologies, and on potential benefits and harms. However, in exploring the social and ethical implications of nanotechnology (or nanomedicine, the focus of this paper, important lessons should be learned from experiences in other fields. In particular, studies of the ethical, legal, and social issues (ELSI of genetics research have successfully mapped out many of the issues (and social and political responses that arise when new technologies are deployed. It is our contention that, for the most part, the ethical and social issues arising in nanomedicine are not altogether new, and thus do not require novel ethical principles or frameworks, nor a massive investment in ‘NELSI’ research. Instead, what is needed is support for the development of a culture of ethics amongst scientists and clinicians, basic scientific and medical knowledge for bioethicists, and a social competency for citizens to participate actively in debates about the implications of new technologies in general.

  9. Clinical review: Ethics and end-of-life care for critically ill patients in China.

    Science.gov (United States)

    Li, Li Bin

    2013-12-04

    Critical care medicine in China has made great advances in recent decades. This has led to an unavoidable issue: end-of-life ethics. With advances in medical technology and therapeutics allowing the seemingly limitless maintenance of life, the exact time of death of an individual patient is often determined by the decision to limit life support. How to care for patients at the end of life is not only a medical problem but also a social, ethical, and legal issue. A lot of factors, besides culture, come into play in determining a person's ethical attitudes or behaviors, such as experience, education, religion, individual attributes, and economic considerations. Chinese doctors face ethical problems similar to those of their Western counterparts; however, since Chinese society is different from that of Western countries in cultural traditions, customs, religious beliefs, and ethnic backgrounds, there is a great difference between China and the Western world in regard to ethics at the end of life, and there is also a huge controversy within China.

  10. Ethical and social implications of microdosing clinical trial (3). Radiological protection of human subjects in research

    International Nuclear Information System (INIS)

    Kurihara, Chieko

    2008-01-01

    Internal irradiation of human subjects in research is discussed. Radiological protection of human subjects in medical research in a framework of radiation protection is surveyed from a viewpoint of general life-ethics and research-ethics. A workshop 'On the internal irradiation of human subjects' to summarize special and systematic knowledge was organized by Research Center for Radiation Protection, National Institute of Radiological Sciences in the beginning of 2008. Activities of this workshop are introduced. Discussion covers also (1) Research ethics and radiation protection, (2) Fundamentals and applications of risk-benefit assessment, (3) Human subjects risk assessment in ICRP recommendation, (4) Mechanism of human subjects internal irradiation assessment, and (5) Present status and future prospects in Japan. (K.Y.)

  11. Clinical review: Ethics and end-of-life care for critically ill patients in China

    OpenAIRE

    Li, Li Bin

    2013-01-01

    Critical care medicine in China has made great advances in recent decades. This has led to an unavoidable issue: end-of-life ethics. With advances in medical technology and therapeutics allowing the seemingly limitless maintenance of life, the exact time of death of an individual patient is often determined by the decision to limit life support. How to care for patients at the end of life is not only a medical problem but also a social, ethical, and legal issue. A lot of factors, besides cult...

  12. Engineer Ethics

    International Nuclear Information System (INIS)

    Lee, Dae Sik; Kim, Yeong Pil; Kim, Yeong Jin

    2003-03-01

    This book tells of engineer ethics such as basic understanding of engineer ethics with history of engineering as a occupation, definition of engineering and specialized job and engineering, engineer ethics as professional ethics, general principles of ethics and its limitation, ethical theory and application, technique to solve the ethical problems, responsibility, safety and danger, information engineer ethics, biotechnological ethics like artificial insemination, life reproduction, gene therapy and environmental ethics.

  13. Nurses serving on clinical ethics committees: A qualitative exploration of a competency profile

    NARCIS (Netherlands)

    dr. Bart Cusveller

    2014-01-01

    The competency profile underlying higher nursing education in the Netherlands states that bachelor-prepared nurses are expected to be able to participate in ethics committees. What knowledge, skills and attitudes are involved in this participation is unclear. In five consecutive years, groups of two

  14. The Gray Area: Ethics in Providing Clinical Services to Deaf and Hard of Hearing Individuals.

    Science.gov (United States)

    Guthmann, Debra S.

    Information on issues related to professional competence, moral and legal standards, the use of professional codes of ethics and guidelines, a decision-making model, the power differential, and appropriate uses of supervision and peer support are provided for professionals who work with deaf and hard of hearing individuals. Most human services…

  15. Discussing End-of-Life Decisions in a Clinical Ethics Committee: An Interview Study of Norwegian Doctors' Experience.

    Science.gov (United States)

    Bahus, Marianne K; Førde, Reidun

    2016-09-01

    With disagreement, doubts, or ambiguous grounds in end-of-life decisions, doctors are advised to involve a clinical ethics committee (CEC). However, little has been published on doctors' experiences with discussing an end-of-life decision in a CEC. As part of the quality assurance of this work, we wanted to find out if clinicians have benefited from discussing end-of-life decisions in CECs and why. We will disseminate some Norwegian doctors' experiences when discussing end-of-life decisions in CECs, based on semi-structured interviews with fifteen Norwegian physicians who had brought an end-of-life decision case to a CEC. Almost half of the cases involved conflicts with the patients' relatives. In a majority of the cases, there was uncertainty about what would be the ethically preferable solution. Reasons for referring the case to the CEC were to get broader illumination of the case, to get perspective from people outside the team, to get advice, or to get moral backing on a decision already made. A great majority of the clinicians reported an overall positive experience with the CECs' discussions. In cases where there was conflict, the clinicians reported less satisfaction with the CECs' discussions. The study shows that most doctors who have used a CEC in an end-of-life decision find it useful to have ethical and/or legal aspects illuminated, and to have the dilemma scrutinized from a new perspective. A systematic discussion seems to be significant to the clinicians.

  16. Clinical social work practice and technology: personal, practical, regulatory, and ethical considerations for the twenty-first century.

    Science.gov (United States)

    Dombo, Eileen A; Kays, Lisa; Weller, Katelyn

    2014-10-01

    The world that social work exists in is no longer defined by traditional physical settings and boundaries, such as schools, agencies, or even offices. With the advent of the Internet and digital communications, social work now exists in a far more complex reality, with clients and social workers engaging across multiple platforms, and sometimes even unintentionally and without one another's awareness. The implications of this can be ethical, practical, regulatory, and personal. This article explores these areas of concern and suggests strategies professionals can use to navigate these complex issues related to technology and clinical practice.

  17. The impact of an interprofessional problem-based learning curriculum of clinical ethics on medical and nursing students' attitudes and ability of interprofessional collaboration: a pilot study.

    Science.gov (United States)

    Lin, Yu-Chih; Chan, Te-Fu; Lai, Chung-Sheng; Chin, Chi-Chun; Chou, Fan-Hao; Lin, Hui-Ju

    2013-09-01

    Clinical ethic situations in modern multiprofessional healthcare systems may involve different healthcare professions who work together for patient care. The undergraduate interprofessional education of clinical ethics would help to incubate healthcare students' ability of interprofessional collaboration in solving ethical problems. However, the impact from an interprofessional educational model on student's attitudes and confidence of interprofessional collaboration should be carefully evaluated during the process of curricular development. This study aimed to conduct a pilot interprofessional PBL curriculum of clinical ethics and evaluate the curricular impact on interprofessional students' attitude and confidence of collaborative teamwork. Thirty-six medical and nursing students volunteered to participate in this study and were divided into three groups (medical group, nursing group, and mixed group). Tutors were recruited from the Medical School and the College of Nursing. The pilot curriculum included one lecture of clinical ethics, one PBL case study with two tutorial sessions, and one session of group discussion and feedback. A narrative story with multiple story lines and a multiperspective problem analysis tool were used in the PBL tutorials. The students' self-evaluation of learning questionnaire was used to evaluate students' learning of clinical ethics and interprofessional collaborative skills and attitude. The internal consistency of the questionnaire was measured by Cronbach α, and the criterion-related validity of the questionnaire was evaluated through associations between the dimension scores with the student group by one-way analysis of variance test (ANOVA) test and Tukey-Kramer honestly significant difference (HSD) comparison. There was significant difference among different groups in students' ability and attitudes about "interprofessional communication and collaboration" (p = 0.0184). The scores in the mixed group (37.58 ± 3.26) were higher

  18. Ethical and legal issues in the clinical practice of primary health care.

    Science.gov (United States)

    Maestro, Francisco Javier; Martinez-Romero, Marcos; Vazquez-Naya, Jose Manuel; Pereira, Javier; Pazos, Alejandro

    2013-01-01

    Since it was conceived, the notion of primary care has been a crucial concept in health services. Most health care is provided at this level and primary care clinicians have an essential role, both in terms of disease prevention and disease management. During the last decades, primary health care has evolved from a traditional paternalistic model, in which patients played the role of passive recipient of care, towards a situation in which patients are partners involved in the decision making-process. This new context opened a considerable number of new ethical and legal aspects, which need to be comprehensively analyzed and discussed in order to preserve the quality of primary health care all around the world. This work reviews the most important ethical and legal issues in primary health care. Legislation issues are explained in the context of the Spanish Health Services.

  19. Exercising restraint: clinical, legal and ethical considerations for the patient with Alzheimer's disease.

    Science.gov (United States)

    McBrien, Barry

    2007-04-01

    The number of older people using emergency care is increasing steadily and older people account for over half of all emergency admissions. In the emergency setting, nurses caring for older people with Alzheimer's disease can be faced with many complex ethical and legal challenges. Moreover, challenges such as the use of physical restraint can precipitate conflict when the nurse is placed in the precarious position of doing good, respecting autonomy and avoiding paternalism. Although, there is no complete set of "rules" that can provide nurses with an answer to each dilemma, it is of significant value for nurses to have sound knowledge of ethical and legal positions in order to analyse the many complex situations that they may encounter.

  20. Clinical ethics and patient advocacy: the power of communication in health care.

    Science.gov (United States)

    Emrich, Inken Annegret; Fröhlich-Güzelsoy, Leyla; Bruns, Florian; Friedrich, Bernd; Frewer, Andreas

    2014-06-01

    In recent years, the rights of patients have assumed a more pivotal role in international discussion. Stricter laws on the protection of patients place greater priority on the perspective and the status of patients. The purpose of this study is to emphasize ethical aspects in communication, the role of patient advocates as contacts for the concerns and suggestions of patients, and how many problems of ethics disappear when communication is highlighted. We reviewed 680 documented cases of consultation in a 10-year period of patient advocates' activity at a big German university hospital with 1,300 beds. On the basis of this extensive material, the article will focus on the intersection of the advocate's work with the problems of patients in hospitals. Deficits in the level of communication between health care professionals and patients were frequently uncovered. Patients primarily complain about the lack of dialogue and empathy. Middle-aged patients consulted the patients' advocate disproportionately more often. Measured against this baseline, the group of 65 and older complained less frequently. Besides complaints the advocate was asked in more than one-third of all cases for information about medical matters, hospital regulations or administrative problems. Patients obviously see the advocate as a well-connected and ideally unbiased contact person for uncertainties concerning their malady or a potential stay in hospital. Those seeking help often set hope in the information given by the voluntary patient representative. It should be highly recommended for every German hospital to establish the position of a patient advocate. Furthermore, patients can profit from regular exchange between the advocate and the Ethics Committee, also, to help ensure that their rights are taken into account and implemented in an ethically desirable context.

  1. The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2015-06-01

    To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. Genomics and infectious disease: a call to identify the ethical, legal and social implications for public health and clinical practice.

    Science.gov (United States)

    Geller, Gail; Dvoskin, Rachel; Thio, Chloe L; Duggal, Priya; Lewis, Michelle H; Bailey, Theodore C; Sutherland, Andrea; Salmon, Daniel A; Kahn, Jeffrey P

    2014-01-01

    Advances in genomics are contributing to the development of more effective, personalized approaches to the prevention and treatment of infectious diseases. Genetic sequencing technologies are furthering our understanding of how human and pathogen genomic factors - and their interactions - contribute to individual differences in immunologic responses to vaccines, infections and drug therapies. Such understanding will influence future policies and procedures for infectious disease management. With the potential for tailored interventions for particular individuals, populations or subpopulations, ethical, legal and social implications (ELSIs) may arise for public health and clinical practice. Potential considerations include balancing health-related benefits and harms between individuals and the larger community, minimizing threats to individual privacy and autonomy, and ensuring just distribution of scarce resources. In this Opinion, we consider the potential application of pathogen and host genomic information to particular viral infections that have large-scale public health consequences but differ in ELSI-relevant characteristics such as ease of transmission, chronicity, severity, preventability and treatability. We argue for the importance of anticipating these ELSI issues in advance of new scientific discoveries, and call for the development of strategies for identifying and exploring ethical questions that should be considered as clinical, public health and policy decisions are made.

  3. Evaluation of clinical trials by Ethics Committees in Germany: Experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA

    Directory of Open Access Journals (Sweden)

    Russ, Hagen

    2009-07-01

    Full Text Available The review of requests for a positive opinion of the ethics committees (application procedure as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12th Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation.With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee, the type and frequency of formal and content-related objections to applications according to § 7 of the German Good Clinical Practice (GCP Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I–IV studies submitted between January and December 2007 to 40 ethics committees were evaluated.This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to

  4. Giving voice to study volunteers: comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research.

    Science.gov (United States)

    Roberts, Laura Weiss; Kim, Jane Paik

    2014-09-01

    Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical

  5. Ethics Training in Psychiatry

    Directory of Open Access Journals (Sweden)

    Sinan Guloksuz

    2009-09-01

    Full Text Available Although ethics training is one of the core components of psychiatric education, it is not sufficiently addressed in the curricula of many educational institutions. It is shown that many of the psychiatry residents received no ethics training in both residency and medical school. Predictably, over half of the psychiatry residents had faced an ethical dilemma that they felt unprepared to meet, and nearly all of them indicated ethics education would have helped them to solve this dilemma. In addition to learning about the fundamental topics of ethics like confidentiality, boundary violations, justice, benefience and nonmaleficence, psychiatrists must also learn to deal with other hidden ethical dilemmas which are mostly due to the changing world order. It is obvious that residency training should include a well developed ethics curriculum. However, some still believe that ethical principles cannot be taught and are formed in one’s early moral development. Accepting the fact that teaching ethics is difficult, we believe that it is getting easier with the new methods for teaching in medicine. These methods are clinical supervisions, rol-models, case studies, role playing, small group discussions, team based learning and “let’s talking medicine” groups which is a useful methods for discussing ethics dilemmas on daily practice and C.A.R.E (Core Beliefs, Actions, Reasons, Experience which is a special training method for teaching ethics. In this review, the need of ethics training in residency curriculum will be discussed and new methods for teaching ethics will be proposed.

  6. [The impact of researchers loyal to Big Pharma on the ethics and quality of clinical trials in Latin America].

    Science.gov (United States)

    Ugalde, Antonio; Homedes, Núria

    2015-03-01

    This article explains the difficulties innovative pharmaceutical firms have in repaying shareholders with attractive dividends. The problem is the result of the expiration of the patents of blockbuster drugs and the difficulties that the firms have in bringing new blockbuster drugs to the market. One of the solutions companies have found has been to accelerate the implementation of clinical trials in order to expedite the commercialization of new drugs. Doing so increases the period in which they can sell drugs at monopoly prices. We therefore discuss how innovative pharmaceutical firms shorten the implementation time of clinical trials in Latin America and the consequences such actions have on the quality of the collected data, the protection of human rights of the subjects of experimentation, and compliance with the ethical principles approved in international declarations.

  7. Outcomes of moral case deliberation--the development of an evaluation instrument for clinical ethics support (the Euro-MCD).

    Science.gov (United States)

    Svantesson, Mia; Karlsson, Jan; Boitte, Pierre; Schildman, Jan; Dauwerse, Linda; Widdershoven, Guy; Pedersen, Reidar; Huisman, Martijn; Molewijk, Bert

    2014-04-08

    Clinical ethics support, in particular Moral Case Deliberation, aims to support health care providers to manage ethically difficult situations. However, there is a lack of evaluation instruments regarding outcomes of clinical ethics support in general and regarding Moral Case Deliberation (MCD) in particular. There also is a lack of clarity and consensuses regarding which MCD outcomes are beneficial. In addition, MCD outcomes might be context-sensitive. Against this background, there is a need for a standardised but flexible outcome evaluation instrument. The aim of this study was to develop a multi-contextual evaluation instrument measuring health care providers' experiences and perceived importance of outcomes of Moral Case Deliberation. A multi-item instrument for assessing outcomes of Moral Case Deliberation (MCD) was constructed through an iterative process, founded on a literature review and modified through a multistep review by ethicists and health care providers. The instrument measures perceived importance of outcomes before and after MCD, as well as experienced outcomes during MCD and in daily work. A purposeful sample of 86 European participants contributed to a Delphi panel and content validity testing. The Delphi panel (n = 13), consisting of ethicists and ethics researchers, participated in three Delphi-rounds. Health care providers (n = 73) participated in the content validity testing through 'think-aloud' interviews and a method using Content Validity Index. The development process resulted in the European Moral Case Deliberation Outcomes Instrument (Euro-MCD), which consists of two sections, one to be completed before a participant's first MCD and the other after completing multiple MCDs. The instrument contains a few open-ended questions and 26 specific items with a corresponding rating/response scale representing various MCD outcomes. The items were categorised into the following six domains: Enhanced emotional support, Enhanced

  8. Outcomes of Moral Case Deliberation - the development of an evaluation instrument for clinical ethics support (the Euro-MCD)

    Science.gov (United States)

    2014-01-01

    Background Clinical ethics support, in particular Moral Case Deliberation, aims to support health care providers to manage ethically difficult situations. However, there is a lack of evaluation instruments regarding outcomes of clinical ethics support in general and regarding Moral Case Deliberation (MCD) in particular. There also is a lack of clarity and consensuses regarding which MCD outcomes are beneficial. In addition, MCD outcomes might be context-sensitive. Against this background, there is a need for a standardised but flexible outcome evaluation instrument. The aim of this study was to develop a multi-contextual evaluation instrument measuring health care providers’ experiences and perceived importance of outcomes of Moral Case Deliberation. Methods A multi-item instrument for assessing outcomes of Moral Case Deliberation (MCD) was constructed through an iterative process, founded on a literature review and modified through a multistep review by ethicists and health care providers. The instrument measures perceived importance of outcomes before and after MCD, as well as experienced outcomes during MCD and in daily work. A purposeful sample of 86 European participants contributed to a Delphi panel and content validity testing. The Delphi panel (n = 13), consisting of ethicists and ethics researchers, participated in three Delphi-rounds. Health care providers (n = 73) participated in the content validity testing through ‘think-aloud’ interviews and a method using Content Validity Index. Results The development process resulted in the European Moral Case Deliberation Outcomes Instrument (Euro-MCD), which consists of two sections, one to be completed before a participant’s first MCD and the other after completing multiple MCDs. The instrument contains a few open-ended questions and 26 specific items with a corresponding rating/response scale representing various MCD outcomes. The items were categorised into the following six domains: Enhanced

  9. Ethics in research: from science fairs to clinical trials, the same golden rules apply

    CSIR Research Space (South Africa)

    Wright, C

    2011-07-01

    Full Text Available opinion and not causing anyone physical harm. Similar ?golden rules? apply when you do research and these are called research ethics. When you decide to do a research project that involves humans or animals, whether you are at school, at university... or a professor, there are important steps and rules that you need to follow. Why? Most importantly the steps and rules are there to protect you, the researcher, from making a mistake that may harm a person or an animal. There are important...

  10. Moral agency as enacted justice: a clinical and ethical decision-making framework for responding to health inequities and social injustice.

    Science.gov (United States)

    Edwards, Ian; Delany, Clare M; Townsend, Anne F; Swisher, Laura Lee

    2011-11-01

    This is the second of 2 companion articles in this issue. The first article explored the clinical and ethical implications of new emphases in physical therapy codes of conduct reflecting the growing evidence regarding the importance of social determinants of health, epidemiological trends for health service delivery, and the enhanced participation of physical therapists in shaping health care reform in a number of international contexts. The first article was theoretically oriented and proposed that a re-thinking of ethical frameworks expressed in codes of ethics could both inform and underpin practical strategies for working in primary health care. A review of the ethical principle of "justice," which, arguably, remains the least consensually understood and developed principle in the ethics literature of physical therapy, was provided, and a more recent perspective-the capability approach to justice-was discussed. The current article proposes a clinical and ethical decision-making framework, the ethical reasoning bridge (ER bridge), which can be used to assist physical therapy practitioners to: (1) understand and implement the capability approach to justice at a clinical level; (2) reflect on and evaluate both the fairness and influence of beliefs, perspectives, and context affecting health and disability through a process of "wide reflective equilibrium" and assist patients to do this as well; and (3) nurture the development of moral agency, in partnership with patients, through a transformative learning process manifest in a mutual "crossing" and "re-crossing" of the ER bridge. It is proposed that the development and exercise of moral agency represent an enacted justice that is the result of a shared reasoning and learning experience on the part of both therapists and patients.

  11. Reframing in dentistry: Revisited

    Directory of Open Access Journals (Sweden)

    Sivakumar Nuvvula

    2013-01-01

    Full Text Available The successful practice of dentistry involves a good combination of technical skills and soft skills. Soft skills or communication skills are not taught extensively in dental schools and it can be challenging to learn and at times in treating dental patients. Guiding the child′s behavior in the dental operatory is one of the preliminary steps to be taken by the pediatric dentist and one who can successfully modify the behavior can definitely pave the way for a life time comprehensive oral care. This article is an attempt to revisit a simple behavior guidance technique, reframing and explain the possible psychological perspectives behind it for better use in the clinical practice.

  12. [Are we still our patients' keepers?: James Drane's contribution to clinical ethics in the current context].

    Science.gov (United States)

    Herreros, B; Real de Asua, D; Palacios, G

    The current article analyzes the figure of the American bioethicist James Drane (1930). Drane not only played a crucial role in the birth of Bioethics in the United States, but was also instrumental in the inception and development of the field in Spain and Latin America. His «sliding scale» was the first dynamic tool encouraging a systematic evaluation of a patient's capacity to make healthcare-related decisions. However Drane's major contribution to the field was his application of virtue Ethics to the doctor-patient relationship. His proposal rests on the physician's compromise with the patient in all his/her dimensions. This goal will guide the physician's character and serve as compass, with which to exercise a virtuous practice, since only by exercising these virtues can doctors become truly good. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  13. Vaginal Birth After Caesarean Section in Low Resource Settings: The Clinical and Ethical Dilemma.

    Science.gov (United States)

    Wanyonyi, Sikolia; Muriithi, Francis G

    2015-10-01

    Vaginal birth after Caesarean section (VBAC) has long been practised in low resource settings using unconventional methods. This not only poses danger to the woman and her baby, but could also have serious legal and ethical implications. The adoption of this practice has been informed by observational studies with many deficiencies; this is so despite other studies from settings in which the standard of care is much better that show that elective repeat Caesarean section (ERCS) may actually be safer than VBAC. This raises questions about whether we should insist on a dangerous practice when there are safer alternatives. We highlight some of the challenges faced in making this decision, and discuss why the fear of ERCS may not be justified after all in low resource settings. Since a reduction in rates of Caesarean section may not be applicable in these regions, because their rates are already low, the emphasis should instead be on adequate birth spacing and safer primary operative delivery.

  14. Ethics and experiment

    DEFF Research Database (Denmark)

    Addison, Courtney Page

    . However, social scientists have yet to devote much attention to this ethically contentious and medically complex field. This project aimed to identify and explore social and ethical factors shaping gene therapy practice in clinical settings. It is based on six months of participant observation in a London...... children’s hospital (the UKCH), thirty-two interviews with key actors in the gene therapy field, and scientific and policy document analysis. One of the main interests of this research is with the politics of ethics. The thesis shows that ‘ethical boundary work’ was central to establishing the credibility...... of gene therapy, and the authority of its practitioners. The politics of ethics can also be discerned in practice: the UK research ethics system structures scientific work but cannot account for the various, complex, and on-going ethical dilemmas that patients and practitioners face when undertaking gene...

  15. Self-assessment of clinical nurse mentors as dimensions of professional development and the capability of developing ethical values at nursing students: A correlational research study.

    Science.gov (United States)

    Skela-Savič, Brigita; Kiger, Alice

    2015-10-01

    Providing adequate training for mentors, fostering a positive mentorship culture and establishing the necessary operational procedures for ensuring mentorship quality are the keys to effective clinical mentoring of nursing students. The purpose of the research was to explain different dimensions of clinical mentors' professional development and their capability of developing ethical values in nursing students. A non-experimental quantitative research design was employed. Data were collected by means of a questionnaire administered to the population of clinical mentors (N=143). The total number of questions was 36. Descriptive statistics were used, and bivariate analysis, factor analysis, correlation analysis and linear regression analysis were performed. The professional development of clinical nurse mentors was explained (R(2)=0.256) by career advancement (p=0.000), research and learning (p=0.024) and having a career development plan (p=0.043). Increased professional self-confidence (R(2)=0.188) was explained by career advancement (p=0.000) and the time engaged in record keeping (p=0.028). Responsibility for the development of ethical values in nursing students (R(2)=0.145) was explained by the respondents' level of education (p=0.020) and research and learning (p=0.024). Applying ethical principles and norms into practice (R(2)=0.212) was explained by self-assessed knowledge in ethics (p=0.037) and research and learning (p=0.044). Clinical nurse mentors tended to lack a career development plan, had low work time spent on research and insufficiently participated in education and training activities, which turned out to be significant explanatory factors of their professional development and their capability of developing ethical values in nursing students. The research showed that nursing and higher education managers often failed to assume responsibility for the professional development of clinical nurse mentors. Copyright © 2015 Elsevier Ltd. All rights

  16. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences.

    NARCIS (Netherlands)

    Vries, M.C. de; Houtlosser, M.; Wit, J.M.; Engberts, D.P.; Bresters, D.; Kaspers, G.J.L.; Leeuwen, E. van

    2011-01-01

    BACKGROUND: Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences

  17. Ethical issues in cesarean delivery.

    Science.gov (United States)

    Chervenak, Frank A; McCullough, Laurence B

    2017-08-01

    Cesarean delivery is the most common and important surgical intervention in obstetric practice. Ethics provides essential guidance to obstetricians for offering, recommending, recommending against, and performing cesarean delivery. This chapter provides an ethical framework based on the professional responsibility model of obstetric ethics. This framework is then used to address two especially ethically challenging clinical topics in cesarean delivery: patient-choice cesarean delivery and trial of labor after cesarean delivery. This chapter emphasizes a preventive ethics approach, designed to prevent ethical conflict in clinical practice. To achieve this goal, a preventive ethics approach uses the informed consent process to offer cesarean delivery as a medically reasonable alternative to vaginal delivery, to recommend cesarean delivery, and to recommend against cesarean delivery. The limited role of shared decision making is also described. The professional responsibility model of obstetric ethics guides this multi-faceted preventive ethics approach. Copyright © 2017. Published by Elsevier Ltd.

  18. Ethical and clinical practice considerations for genetic counselors related to direct-to-consumer marketing of genetic tests.

    Science.gov (United States)

    Wade, Christopher H; Wilfond, Benjamin S

    2006-11-15

    Several companies utilize direct-to-consumer (DTC) advertising for genetic tests and some, but not all, bypass clinician involvement by offering DTC purchase of the tests. This article examines how DTC marketing strategies may affect genetic counselors, using available cardiovascular disease susceptibility tests as an illustration. The interpretation of these tests is complex and includes consideration of clinical validity and utility, and the further complications of gene-environment interactions and pleiotropy. Although it is unclear to what extent genetic counselors will encounter clients who have been exposed to DTC marketing strategies, these strategies may influence genetic counseling interactions if they produce directed interest in specific tests and unrealistic expectations for the tests' capacity to predict disease. Often, a client's concern about risk for cardiovascular diseases is best addressed by established clinical tests and a family history assessment. Ethical dilemmas may arise for genetic counselors who consider whether to accept clients who request test interpretation or to order DTC-advertised tests that require a clinician's authorization. Genetic counselors' obligations to care for clients extend to interpreting DTC tests, although this obligation may be fulfilled by referral or consultation with specialists. Genetic counselors do not have an obligation to order DTC-advertised tests that have minimal clinical validity and utility at a client's request. This can be a justified restriction on autonomy based on consideration of risks to the client, the costs, and the implications for society. Published 2006 Wiley-Liss, Inc.

  19. Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.

    Science.gov (United States)

    Newcombe, J P; Kerridge, I H

    2007-01-01

    Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

  20. Ethics in clinical research: need for assessing comprehension of informed consent form?

    Science.gov (United States)

    Shafiq, Nusrat; Malhotra, Samir

    2011-03-01

    Comprehension of informed consent form has not achieved the attention it deserves. We made a 24-item questionnaire to assess clinical research participants' comprehension of informed consent form (Contemp Clin Trials 2009;30:427-30). Due to repeated requests by clinical researchers in our country and abroad, we are publishing the questionnaire in this article. Copyright © 2010 Elsevier Inc. All rights reserved.

  1. Risk management in clinical practice. Part 5. Ethical considerations for dental enhancement procedures.

    Science.gov (United States)

    Ahmad, I

    2010-09-11

    After the demise of the Industrial Age, we currently live in an 'Information Age' fuelled mainly by the Internet, with an ever-increasing medically and dentally literate population. The media has played its role by reporting scientific advances, as well as securitising medical and dental practices. Reality television such as 'Extreme makeovers' has also raised public awareness of body enhancements, with a greater number of people seeking such procedures. To satiate this growing demand, the dental industry has flourished by introducing novel cosmetic products such as bleaching kits, tooth coloured filling materials and a variety of dental ceramics. In addition, one only has to browse through a dental journal to notice innumerable courses and lectures on techniques for providing cosmetic dentistry. The incessant public interest, combined with unrelenting marketing by companies is gradually shifting the balance of dental care from a healing to an enhancement profession. The purpose of this article is to endeavour to answer questions such as, What is aesthetic or cosmetic dentistry? Why do patients seek cosmetic dentistry? Are enhancement procedures a part of dental practice? What, if any, ethical guidelines and constraints apply to elective enhancement procedures? What is the role of the dentist in providing or encouraging this type of 'therapy'? What treatment modalities are available for aesthetic dental treatment?

  2. Hemangiomas revisited: the useful, the unusual and the new. Pt. 1. Overview and clinical and imaging characteristics

    International Nuclear Information System (INIS)

    Restrepo, Ricardo; Cervantes, Luisa F.; Altman, Nolan R.; Palani, Rajaneeshankar; Duarte, Ana-Margarita; Amjad, Ibrahim

    2011-01-01

    Hemangiomas are common vascular tumors occurring in children. Though most of the lesions present in infants and young children with a typical appearance, it is important to understand that they all do not behave in the same way. Rather, they are a group of vascular lesions with different clinico-pathological subtypes, with their clinical behavior varying with the stage of the tumor as well. As such, they can and do have a varied clinical, imaging and pathological appearance according to the location of the tumor and also the stage at which the patient is seen. In this pictorial essay, the classification, pathogenesis, clinical appearance, natural history and imaging characteristics of hemangiomas are reviewed and illustrated. (orig.)

  3. The impact of an interprofessional problem-based learning curriculum of clinical ethics on medical and nursing students' attitudes and ability of interprofessional collaboration: A pilot study

    Directory of Open Access Journals (Sweden)

    Yu-Chih Lin

    2013-09-01

    Full Text Available Clinical ethic situations in modern multiprofessional healthcare systems may involve different healthcare professions who work together for patient care. The undergraduate interprofessional education of clinical ethics would help to incubate healthcare students' ability of interprofessional collaboration in solving ethical problems. However, the impact from an interprofessional educational model on student's attitudes and confidence of interprofessional collaboration should be carefully evaluated during the process of curricular development. This study aimed to conduct a pilot interprofessional PBL curriculum of clinical ethics and evaluate the curricular impact on interprofessional students' attitude and confidence of collaborative teamwork. Thirty-six medical and nursing students volunteered to participate in this study and were divided into three groups (medical group, nursing group, and mixed group. Tutors were recruited from the Medical School and the College of Nursing. The pilot curriculum included one lecture of clinical ethics, one PBL case study with two tutorial sessions, and one session of group discussion and feedback. A narrative story with multiple story lines and a multiperspective problem analysis tool were used in the PBL tutorials. The students' self-evaluation of learning questionnaire was used to evaluate students' learning of clinical ethics and interprofessional collaborative skills and attitude. The internal consistency of the questionnaire was measured by Cronbach α, and the criterion-related validity of the questionnaire was evaluated through associations between the dimension scores with the student group by one-way analysis of variance test (ANOVA test and Tukey-Kramer honestly significant difference (HSD comparison. There was significant difference among different groups in students' ability and attitudes about “interprofessional communication and collaboration” (p = 0.0184. The scores in the mixed group (37

  4. Clinical ethics residency for nurses: an education model to decrease moral distress and strengthen nurse retention in acute care.

    Science.gov (United States)

    Grace, Pamela J; Robinson, Ellen M; Jurchak, Martha; Zollfrank, Angelika A; Lee, Susan M

    2014-12-01

    The experience of unaddressed moral distress can lead to nurse attrition and/or distancing from patients, compromising patient care. Nurses who are confident in their ethical decision making abilities and moral agency have the antidote to moral distress for themselves and their colleagues and can act as local or institutional ethics resources. We describe a grant-funded model education program designed to increase ethics competence throughout the institution.

  5. Ethics rounds: An appreciated form of ethics support.

    Science.gov (United States)

    Silén, Marit; Ramklint, Mia; Hansson, Mats G; Haglund, Kristina

    2016-03-01

    Ethics rounds are one way to support healthcare personnel in handling ethically difficult situations. A previous study in the present project showed that ethics rounds did not result in significant changes in perceptions of how ethical issues were handled, that is, in the ethical climate. However, there was anecdotal evidence that the ethics rounds were viewed as a positive experience and that they stimulated ethical reflection. The aim of this study was to gain a deeper understanding of how the ethics rounds were experienced and why the intervention in the form of ethics rounds did not succeed in improving the ethical climate for the staff. An exploratory and descriptive design with a qualitative approach was adopted, using individual interviews. A total of 11 healthcare personnel, working in two different psychiatry outpatient clinics and with experience of participating in ethics rounds, were interviewed. The study was based on informed consent and was approved by one of the Swedish Regional Ethical Review Boards. The participants were generally positive about the ethics rounds. They had experienced changes by participating in the ethics rounds in the form of being able to see things from different perspectives as well as by gaining insight into ethical issues. However, these changes had not affected daily work. A crucial question is whether or not increased reflection ability among the participants is a good enough outcome of ethics rounds and whether this result could have been measured in patient-related outcomes. Ethics rounds might foster cooperation among the staff and this, in turn, could influence patient care. By listening to others during ethics rounds, a person can learn to see things from a new angle. Participation in ethics rounds can also lead to better insight concerning ethical issues. © The Author(s) 2014.

  6. A four-part working bibliography of neuroethics: Part 4 - Ethical issues in clinical and social applications of neuroscience.

    Science.gov (United States)

    Becker, Kira; Shook, John R; Darragh, Martina; Giordano, James

    2017-05-31

    As a discipline, neuroethics addresses a range of questions and issues generated by basic neuroscientific research (inclusive of studies of putative neurobiological processes involved in moral and ethical cognition and behavior), and its use and meanings in the clinical and social spheres. Here, we present Part 4 of a four-part bibliography of the neuroethics literature focusing on clinical and social applications of neuroscience, to include: the treatment-enhancement discourse; issues arising in neurology, psychiatry, and pain care; neuroethics education and training; neuroethics and the law; neuroethics and policy and political issues; international neuroethics; and discourses addressing "trans-" and "post-" humanity. To complete a systematic survey of the literature, 19 databases and 4 individual open-access journals were employed. Searches were conducted using the indexing language of the U.S. National Library of Medicine (NLM). A Python code was used to eliminate duplications in the final bibliography. When taken with Parts 1-3, this bibliography aims to provide a listing of international peerreviewed papers, books, and book chapters published from 2002 through 2016. While seeking to be as comprehensive as possible, it may be that some works were inadvertently and unintentionally not included. We therefore invite commentary from the field to afford completeness and contribute to this bibliography as a participatory work-in-progress.

  7. Revisiting QTL Affecting Clinical Mastitis by High-Density GWAS and Resequencing in the Finnish Ayrshire Dairy Cattle

    DEFF Research Database (Denmark)

    Vilkki, Johanna; Iso-Touru, Terhi; Schulman, Nina F

    Mastitis is the most common disease of dairy cattle, causing high economic losses each year. Studies to locate QTL affecting clinical mastitis and milk somatic cell counts have been carried out to increase our understanding of the disease. As part of the EU FP7 Quantomics project, we have used most...... recent genomic tools to characterize QTL affecting mastitis incidence in the Finnish Ayrshire cattle. Clinical mastitis diagnoses from -15 to 50 days and 51 to 300 days of first lactation and SCC (geometric mean of SCS observations between 5 to 170 days of first lactation) were included. In total, 1920...... progeny tested bulls were genotyped with the Illumina BovineSNP50 chip. After quality control, 38473 SNPs were analyzed using a mixed linear model (software package DMU). Associations (5% Bonferroni threshold) were detected in 9 peaks on 5 chromosomes. A set of 238 of the bulls were re...

  8. Revisiting the Heidenhain Variant of Creutzfeldt-Jakob Disease: Evidence for Prion Type Variability Influencing Clinical Course and Laboratory Findings.

    Science.gov (United States)

    Baiardi, Simone; Capellari, Sabina; Ladogana, Anna; Strumia, Silvia; Santangelo, Mario; Pocchiari, Maurizio; Parchi, Piero

    2016-01-01

    The Heidenhain variant defines a peculiar clinical presentation of sporadic Creutzfeldt-Jakob disease (sCJD) characterized by isolated visual disturbances at disease onset and reflecting the early targeting of prions to the occipital cortex. Molecular and histopathological typing, thus far performed in 23 cases, has linked the Heidenhain variant to the MM1 sCJD type. To contribute a comprehensive characterization of cases with the Heidenhain variant, we reviewed a series of 370 definite sCJD cases. Eighteen patients (4.9%) fulfilled the selection criteria. Fourteen of them belonging to sCJD types MM1 or MM1+2C had a short duration of isolated visual symptoms and overall clinical disease, a high prevalence of periodic sharp-wave complexes in EEG, and a marked increase of cerebrospinal fluid proteins t-tau and 14-3-3 levels. In contrast, three cases of the MM 2C or MM 2+1C types showed a longer duration of isolated visual symptoms and overall clinical disease, non-specific EEG findings, and cerebrospinal fluid concentration below threshold for the diagnosis of "probable" CJD of both 14-3-3 and t-tau. However, a brain DWI-MRI disclosed an occipital cortical hyperintensity in the majority of examined cases of both groups. While confirming the strong linkage with the methionine genotype at the polymorphic codon 129 of the prion protein gene, our results definitely establish that the Heidenhain variant can also be associated with the MM 2C sCJD type in addition to the more common MM1 type. Likewise, our results highlight the significant differences in clinical evolution and laboratory findings between cases according to the dominant PrPSc type (type 1 versus type 2).

  9. Individualist Biocentrism vs. Holism Revisited

    Directory of Open Access Journals (Sweden)

    Katie McShane

    2014-06-01

    Full Text Available While holist views such as ecocentrism have considerable intuitive appeal, arguing for the moral considerability of ecological wholes such as ecosystems has turned out to be a very difficult task. In the environmental ethics literature, individualist biocentrists have persuasively argued that individual organisms—but not ecological wholes—are properly regarded as having a good of their own . In this paper, I revisit those arguments and contend that they are fatally flawed. The paper proceeds in five parts. First, I consider some problems brought about by climate change for environmental conservation strategies and argue that these problems give us good pragmatic reasons to want a better account of the welfare of ecological wholes. Second, I describe the theoretical assumptions from normative ethics that form the background of the arguments against holism. Third, I review the arguments given by individualist biocentrists in favour of individualism over holism. Fourth, I review recent work in the philosophy of biology on the units of selection problem, work in medicine on the human biome, and work in evolutionary biology on epigenetics and endogenous viral elements. I show how these developments undermine both the individualist arguments described above as well as the distinction between individuals and wholes as it has been understood by individualists. Finally, I consider five possible theoretical responses to these problems.

  10. Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach

    NARCIS (Netherlands)

    van der Graaf, Rieke; van der Zande, Indira S. E.; den Ruijter, Hester M.; Oudijk, Martijn A.; van Delden, Johannes J. M.; Oude Rengerink, Katrien; Groenwold, Rolf H. H.

    2018-01-01

    Background: Since pregnant women are severely underrepresented in clinical research, many take the position that the exclusion of pregnant women from research must be justified unless there are compelling "scientific reasons" for their exclusion. However, it is questionable whether this approach

  11. Ethics of Ancillary Care in Clinical Trials in Low Income Countries: A ...

    African Journals Online (AJOL)

    AJRH Managing Editor

    income countries where HIV incidence is high, but the benefits of research are ... provision of ancillary care – medical care provided to clinical trial participants during a ... to or use of quality delivery services is an issue of ... with drastically reduced costs, questions arise over .... The 'partial entrustment' model differentiates.

  12. Fair inclusion of pregnant women in clinical trials : an integrated scientific and ethical approach

    NARCIS (Netherlands)

    van der Graaf, Rieke; van der Zande, Indira S E; den Ruijter, Hester M; Oudijk, Martijn A; van Delden, Johannes J M; Oude Rengerink, Katrien; Groenwold, Rolf H H

    2018-01-01

    BACKGROUND: Since pregnant women are severely underrepresented in clinical research, many take the position that the exclusion of pregnant women from research must be justified unless there are compelling "scientific reasons" for their exclusion. However, it is questionable whether this approach

  13. Thyroglobulin (Tg) Testing Revisited: Tg Assays, TgAb Assays, and Correlation of Results With Clinical Outcomes.

    Science.gov (United States)

    Netzel, Brian C; Grebe, Stefan K G; Carranza Leon, B Gisella; Castro, M Regina; Clark, Penelope M; Hoofnagle, Andrew N; Spencer, Carole A; Turcu, Adina F; Algeciras-Schimnich, Alicia

    2015-08-01

    Measurement of thyroglobulin (Tg) by mass spectrometry (Tg-MS) is emerging as a tool for accurate Tg quantification in patients with anti-Tg autoantibodies (TgAbs). The objective of the study was to perform analytical and clinical evaluations of two Tg-MS assays in comparison with immunometric Tg assays (Tg-IAs) and Tg RIAs (Tg-RIAs) in a cohort of thyroid cancer patients. A total of 589 samples from 495 patients, 243 TgAb-/252 TgAb+, were tested by Beckman, Roche, Siemens-Immulite, and Thermo-Brahms Tg and TgAb assays, two Tg-RIAs, and two Tg-MS assays. The frequency of TgAb+ was 58%, 41%, 27%, and 39% for Roche, Beckman, Siemens-Immulite, and Thermo-Brahms, respectively. In TgAb- samples, clinical sensitivities and specificities of 100% and 74%-100%, respectively, were observed across all assays. In TgAb+ samples, all Tg-IAs demonstrated assay-dependent Tg underestimation, ranging from 41% to 86%. In TgAb+ samples, the use of a common cutoff (0.5 ng/mL) for the Tg-MS, three Tg-IAs, and the USC-RIA improved the sensitivity for the Tg-MSs and Tg-RIAs when compared with the Tg-IAs. In up to 20% of TgAb+ cases, Tg-IAs failed to detect Tg that was detectable by Tg-MS. In Tg-RIAs false-high biases were observed in TgAb+ samples containing low Tg concentrations. Tg-IAs remain the method of choice for Tg quantitation in TgAb- patients. In TgAb+ patients with undetectable Tg by immunometric assay, the Tg-MS will detect Tg in up to 20% additional cases. The Tg-RIA will detect Tg in approximately 35% cases, but a significant proportion of these will be clinical false-positive results. The undetectable Tg-MS seen in approximately 40% of TgAb+ cases in patients with disease need further evaluation.

  14. Ethics of clinical science in a public health emergency: drug discovery at the bedside.

    Science.gov (United States)

    Edwards, Sarah J L

    2013-01-01

    Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiveness. To inform current policy, I reexamine the philosophical rationale for restricting new medicines to clinical trials, at any stage and for any population of patients (which resides in the precautionary principle), to show that its objective to protect public health, now or in the future, could soon be defeated in a pandemic. Providing wider therapeutic access and coordinating observations and natural experiments, including service delivery by cluster (wedged cluster trials), may provide such a balance. However, there are important questions of fairness to resolve before any such research can proceed.

  15. If Ethics in Psychiatry is the Answer - What was the Question? Exploring Social Space and the Role of Clinical Chaplaincy

    Directory of Open Access Journals (Sweden)

    Helen Kohlen

    2014-01-01

    Full Text Available Over the last twenty years, ethics has been expanding in health care and chaplains comprise one of the key groups that provide ethics consultation services in the German arena of psychiatry. Like all professional actors in the practical arena, chaplains perform their role. Performance happens in relation to others who occupy positions that allow more or less exercise of power. This architecture of relational positioning and territory constitutes the social space. The question is, whether ethics in psychiatry can overcome the determination of positioning within the social space, and if yes: what is the scope of ethics? This article investigates into the role of chaplaincy as ethical agents (in Germany on the basis of theoretical and empirical studies over the last 10 years. The meaning of social space in the field of psychiatry is explored by taking Pierre Bourdieu’s work into account. For illustration, a case study is given.

  16. Use of amyloid PET across the spectrum of Alzheimer's disease: clinical utility and associated ethical issues.

    Science.gov (United States)

    Leuzy, Antoine; Zimmer, Eduardo Rigon; Heurling, Kerstin; Rosa-Neto, Pedro; Gauthier, Serge

    2014-09-01

    Abstract Recent advances have made possible the in vivo detection of beta-amyloid (Aβ) pathology using positron emission tomography. While the gold standard for amyloid imaging, carbon-11 labeled Pittsburgh compound B is increasingly being replaced by fluorine-18 labeled radiopharmaceuticals, with three already approved for clinical use by US and European regulatory bodies. Appropriate use criteria proposed by an amyloid imaging taskforce convened by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging recommend restricting use of this technology to the evaluation of patients with mild cognitive impairment or atypical dementia syndromes. While use among asymptomatic individuals is currently viewed as inappropriate due prognostic uncertainty, elevated levels of brain Aβ among asymptomatic individuals may represent preclinical Alzheimer's disease. Amyloid imaging is likewise expected to play a role in the design of clinical trials. Though preliminary results suggest amyloid imaging to possess clinical utility and cost-effectiveness, both domains have yet to be assessed systematically. As the field moves toward adoption of a pro-disclosure stance for amyloid imaging findings, it is imperative that a broad range of stakeholders be involved to ensure the appropriateness of emerging policies and protocols.

  17. An Interdisciplinary Approach to Lesbian, Gay, Bisexual, and Transgender Clinical Competence, Professional Training, and Ethical Care: Introduction to the Special Issue.

    Science.gov (United States)

    Bidell, Markus P; Stepleman, Lara M

    2017-01-01

    There are exigent reasons to foster lesbian, gay, bisexual, and transgender (LGBT) competence, training, and ethical care for health professionals within an interdisciplinary paradigm. LGBT individuals experience serious health and psychosocial disparities; moreover, these inequalities can be amplified when other aspects of diversity such as race, ethnicity, age, gender, religion, disability, and socioeconomic status intersect with sexual orientation and gender identity (Institute of Medicine [IOM], 2011). While the origins of LGBT health and psychosocial disparities are manifold, deficiencies in professional training, ethical care, and clinical competence are underlying contributors (IOM, 2011). In addition, LGBT clinical competency advancements are often siloed within the various health care disciplines-thus advances by one group of health professionals often have limited impact for those practicing in different health and human service fields. This special issue explores LGBT clinical competence, professional training, and ethical care within an interdisciplinary context and, to our knowledge, represents the first attempt to address LGBT clinical competence from a multidisciplinary health care perspective.

  18. Oxidative phosphorylation revisited

    DEFF Research Database (Denmark)

    Nath, Sunil; Villadsen, John

    2015-01-01

    The fundamentals of oxidative phosphorylation and photophosphorylation are revisited. New experimental data on the involvement of succinate and malate anions respectively in oxidative phosphorylation and photophosphorylation are presented. These new data offer a novel molecular mechanistic...

  19. Emotions, narratives, and ethical mindfulness.

    Science.gov (United States)

    Guillemin, Marilys; Gillam, Lynn

    2015-06-01

    Clinical care is laden with emotions, from the perspectives of both clinicians and patients. It is important that emotions are addressed in health professions curricula to ensure that clinicians are humane healers as well as technical experts. Emotions have a valuable and generative role in health professional ethics education.The authors have previously described a narrative ethics pedagogy, the aim of which is to develop ethical mindfulness. Ethical mindfulness is a state of being that acknowledges everyday ethics and ethically important moments as significant in clinical care, with the aim of enabling ethical clinical practice. Using a sample narrative, the authors extend this concept to examine five features of ethical mindfulness as they relate to emotions: (1) being sensitized to emotions in everyday practice, (2) acknowledging and understanding the ways in which emotions are significant in practice, (3) being able to articulate the emotions at play during ethically important moments, (4) being reflexive and acknowledging both the generative aspects and the limitations of emotions, and (5) being courageous.The process of writing and engaging with narratives can lead to ethical mindfulness, including the capacity to understand and work with emotions. Strategies for productively incorporating emotions in narrative ethics teaching are described. This can be a challenging domain within medical education for both educators and health care students and thus needs to be addressed sensitively and responsibly. The potential benefit of educating health professionals in a way which addresses emotionality in an ethical framework makes the challenges worthwhile.

  20. Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional, Descriptive Study.

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2016-01-01

    The implications of conducting clinical trials in low and middle income countries on the financial accessibility and safety of the pharmaceutical products available in those markets have not been studied. Regulatory practices and ethical declarations lead to the commercialization of the new products, referred to as New Molecular Entities (NMEs), in the countries where tested as soon as they are approved in high surveillance countries. Patients and patients' associations use the Latin American courts to access new and expensive treatments, regardless of their safety profile and therapeutic value. Cross-sectional, descriptive study. To determine the therapeutic value and safety profile of the NMEs approved by the Food and Drug Administration (FDA) in 2011 and 2012 that had been tested in Latin America, and the implications of their market approval for the pharmaceutical budgets in the countries where tested. Latin America. To assess the therapeutic value and safety of the NMEs commercialized in the different countries we used f independent drug bulletins. The prices of the NMEs for the consumers were obtained from the pharmaceutical price observatories of the countries were the medicines had been tested. If the price was not available in the observatories, it was obtained from pharmaceutical distributors. We used the countries' minimum wage and per capita income to calculate the financial accessibility of a course of treatment with the NMEs. We found that 33 NMEs approved by the FDA in 2011 and 2012 have been tested in Latin America. Of these, 26 had been evaluated by independent drug bulletins and only five were found to add some value to a subset of patients and had significant side-effects. The pharmaceutical prices were very high, varied widely across countries and were unrelated to the countries' income per capita or minimum wage. The implementation of clinical trials in Latin America results in the commercialization of medicines with questionable safety

  1. Current issues in medically assisted reproduction and genetics in Europe: research, clinical practice, ethics, legal issues and policy

    Science.gov (United States)

    Harper, Joyce C; Geraedts, Joep; Borry, Pascal; Cornel, Martina C; Dondorp, Wybo; Gianaroli, Luca; Harton, Gary; Milachich, Tanya; Kääriäinen, Helena; Liebaers, Inge; Morris, Michael; Sequeiros, Jorge; Sermon, Karen; Shenfield, Françoise; Skirton, Heather; Soini, Sirpa; Spits, Claudia; Veiga, Anna; Vermeesch, Joris Robert; Viville, Stéphane; de Wert, Guido; Macek, Milan

    2013-01-01

    In March 2005, a group of experts from the European Society of Human Genetics and European Society of Human Reproduction and Embryology met to discuss the interface between genetics and assisted reproductive technology (ART), and published an extended background paper, recommendations and two Editorials. Seven years later, in March 2012, a follow-up interdisciplinary workshop was held, involving representatives of both professional societies, including experts from the European Union Eurogentest2 Coordination Action Project. The main goal of this meeting was to discuss developments at the interface between clinical genetics and ARTs. As more genetic causes of reproductive failure are now recognised and an increasing number of patients undergo testing of their genome before conception, either in regular health care or in the context of direct-to-consumer testing, the need for genetic counselling and preimplantation genetic diagnosis (PGD) may increase. Preimplantation genetic screening (PGS) thus far does not have evidence from randomised clinical trials to substantiate that the technique is both effective and efficient. Whole-genome sequencing may create greater challenges both in the technological and interpretational domains, and requires further reflection about the ethics of genetic testing in ART and PGD/PGS. Diagnostic laboratories should be reporting their results according to internationally accepted accreditation standards (International Standards Organisation – ISO 15189). Further studies are needed in order to address issues related to the impact of ART on epigenetic reprogramming of the early embryo. The legal landscape regarding assisted reproduction is evolving but still remains very heterogeneous and often contradictory. The lack of legal harmonisation and uneven access to infertility treatment and PGD/PGS fosters considerable cross-border reproductive care in Europe and beyond. The aim of this paper is to complement previous publications and

  2. Business Ethics

    OpenAIRE

    Duong, Thi

    2016-01-01

    The goal of this paper is to present examples of business ethics issues. What is business ethics, things concerned in this field are and why it is needed and important when doing business? The concept of business ethics has connotations to provision, rules and standards in directing the behavior of actors in the business. Business ethics involves compliance with the law, the implementation of ethical responsibilities of a business, the protection of the rights of those who are related to the ...

  3. Ethical and social implications of microdosing clinical trial (2). The draft guidance and the future tasks

    International Nuclear Information System (INIS)

    Kurihara, Chieko

    2008-01-01

    Draft of the guidance (GD) for conducting the trial in the title (MCT) was officially announced by Ministry of Health, Labour and Welfare (MHLW) in Dec., 2007, but where the trial part alone was described without the research purposes involved in the starting idea of MCT. The authority invited opinions on the draft until Feb., 2008. This paper describes the detailed content of GD draft and discusses problems in future. GD draft contains: basic concept, range of non-clinical studies necessary for beginning MCT, methods to decide the maximal dose, concept for internal exposure of volunteers when radio-labeled compound is to be administered (for methods by accelerator mass spectrometry (AMS) and positron emission tomography (PET)), quality assurance of the test compound, other notices, and references. The last item contains outlines of concerned laws and regulations (e.g., The Law Concerning Prevention from Radiation Hazards due to Radioisotopes, Etc. and Medical Law); nuclides for AMS (mainly, 14 C) (manufacturing and transporting the test compound containing 14 C, its distribution from MCT client to hospitals, handling in the hospital, and transporting of samples from hospital to AMS facility); and nuclides for PET. Public opinions collected by MHLW will decide the directions hereafter of GD, i.e. the omitted research purposes are additionally incorporated in the present GD draft or are independently described in another newer GD. (R.T.)

  4. Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.

    Science.gov (United States)

    Armstrong, Stephanie; Langlois, Adele; Laparidou, Despina; Dixon, Mark; Appleton, Jason P; Bath, Philip M; Snooks, Helen; Siriwardena, A Niroshan

    2017-09-16

    We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

  5. Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review

    Directory of Open Access Journals (Sweden)

    Stephanie Armstrong

    2017-09-01

    Full Text Available Abstract Background We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. Methods A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. Results In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Conclusions Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent. Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

  6. Ethical problems arising from the use of placebo in clinical trials with drugs for migraine. Their analysis by the moral deliberation method.

    Science.gov (United States)

    Frías, J; Pascual, J; Lahuerta, J; Gracia, D; Dal-Ré, R

    2011-03-01

    Migraine is characterised as episodes of headache plus a variety of accompanying symptoms. Its pharmacological control remains unsatisfactory for some patients. The use of placebo in drug clinical trials on migraine commonly leads to numerous ethical uncertainties. The purpose of this paper is to illustrate how the deliberation method helps in analysing the issues and finding solutions to selected ethical problems. Ethical decisions that try to solve conflicts arising from placebo use in clinical trials may be adopted using the moral deliberation method. Thus, the conflict is systematically assessed by identifying the following: Relevant facts; Values in conflict; Duties, or in other words, possible courses of action. Moral duty is following the optimal course of action. To identify this, it is recommended to state extreme courses of action, then intermediate courses of action, and then to proceed to the optimal course(s) of action. In this paper, the application of this method is shown in several conflicting situations arising in two placebo-controlled clinical trials with drugs under development for the prophylaxis and acute treatment of migraine. Copyright © 2010 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

  7. 'Counterfeit deviance' revisited.

    Science.gov (United States)

    Griffiths, Dorothy; Hingsburger, Dave; Hoath, Jordan; Ioannou, Stephanie

    2013-09-01

    The field has seen a renewed interest in exploring the theory of 'counterfeit deviance' for persons with intellectual disability who sexually offend. The term was first presented in 1991 by Hingsburger, Griffiths and Quinsey as a means to differentiate in clinical assessment a subgroup of persons with intellectual disability whose behaviours appeared like paraphilia but served a function that was not related to paraphilia sexual urges or fantasies. Case observations were put forward to provide differential diagnosis of paraphilia in persons with intellectual disabilities compared to those with counterfeit deviance. The brief paper was published in a journal that is no longer available and as such much of what is currently written on the topic is based on secondary sources. The current paper presents a theoretical piece to revisit the original counterfeit deviance theory to clarify the myths and misconceptions that have arisen and evaluate the theory based on additional research and clinical findings. The authors also propose areas where there may be a basis for expansion of the theory. The theory of counterfeit deviance still has relevance as a consideration for clinicians when assessing the nature of a sexual offence committed by a person with an intellectual disability. Clinical differentiation of paraphilia from counterfeit deviance provides a foundation for intervention that is designed to specifically treat the underlying factors that contributed to the offence for a given individual. Counterfeit deviance is a concept that continues to provide areas for consideration for clinicians regarding the assessment and treatment of an individual with an intellectual disability who has sexually offended. It is not and never was an explanation for all sexually offending behavior among persons with intellectual disabilities. © 2013 John Wiley & Sons Ltd.

  8. E-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research.

    Science.gov (United States)

    Dainesi, Sonia Mansoldo; Goldbaum, Moisés

    2012-12-01

    The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. Along with the questionnaire, participants received a message explaining the survey and also the informed consent. Returning the questionnaire meant the consent of the participant was given. No incentive was offered; two reminders were sent. The response rate was 21% (124/599), 20% (58/290) and 45% (24/53) respectively for Ethics Committees, Researchers and Sponsors. The percentage of return before the two reminders was about 62%. Reasons for non-response: participant not found, refusal to participate, lack of experience in clinical research or in the therapeutic field. Characteristics of participants: 45% of Ethics Committee participants, 64% of Researchers and 63% of Sponsors were male; mean age (range), respectively: 47 (28-74), 53 (24-72) and 40 (29-65) years. Among Researchers and Sponsors, all respondents had at least a university degree and, in the Ethics Committees group, only two (1.7%) did not have one. Most of the questionnaires in all groups came from the Southeast Region of Brazil, probably reflecting the highest number of clinical trials and research professionals in this region. Despite the potential limitations of a survey done through the Internet, this study led to a response rate similar to what has been observed with other models, efficiency in obtaining responses (speed and quality), convenience for respondents and low cost.

  9. Ethical, social, and cultural issues related to clinical genetic testing and counseling in low- and middle-income countries: protocol for a systematic review.

    Science.gov (United States)

    Zhong, Adrina; Darren, Benedict; Dimaras, Helen

    2017-07-11

    There has been little focus in the literature on how to build genetic testing and counseling services in low- and middle-income countries in a responsible, ethical, and culturally appropriate manner. It is unclear to what extent this area is being explored and what form further research should take. The proposed knowledge synthesis aims to fill this gap in knowledge and mine the existing data to determine the breadth of work in this area and identify ethical, social, and cultural issues that have emerged. An integrated knowledge translation approach will be undertaken by engaging knowledge users throughout the review to ensure relevance to their practice. Electronic databases encompassing various disciplines, such as healthcare, social sciences, and public health, will be searched. Studies that address clinical genetic testing and/or counseling and ethical, social, and/or cultural issues of these genetic services, and are performed in low- and middle-income countries as defined by World Bank will be considered for inclusion. Two independent reviewers will be involved in a two-stage literature screening process, data extraction, and quality appraisal. Studies included in the review will be analyzed by thematic analysis. A narrative synthesis guided by the social ecological model will be used to summarize findings. This systematic review will provide a foundation of evidence regarding ethical, social, and cultural issues related to clinical genetic testing and counseling in low- and middle-income countries. Using the social ecological model as a conceptual framework will facilitate the understanding of broader influences of the sociocultural context on an individual's experience with clinical genetic testing and counseling, thereby informing interdisciplinary sectors in future recommendations for practice and policy. PROSPERO CRD42016042894.

  10. Current issues in medically assisted reproduction and genetics in Europe: research, clinical practice, ethics, legal issues and policy.

    Science.gov (United States)

    Harper, Joyce; Geraedts, Joep; Borry, Pascal; Cornel, Martina C; Dondorp, Wybo J; Gianaroli, Luca; Harton, Gary; Milachich, Tanya; Kääriäinen, Helena; Liebaers, Inge; Morris, Michael; Sequeiros, Jorge; Sermon, Karen; Shenfield, Françoise; Skirton, Heather; Soini, Sirpa; Spits, Claudia; Veiga, Anna; Vermeesch, Joris Robert; Viville, Stéphane; de Wert, Guido; Macek, Milan

    2014-08-01

    How has the interface between genetics and assisted reproduction technology (ART) evolved since 2005? The interface between ART and genetics has become more entwined as we increase our understanding about the genetics of infertility and we are able to perform more comprehensive genetic testing. In March 2005, a group of experts from the European Society of Human Genetics and European Society of Human Reproduction and Embryology met to discuss the interface between genetics and ART and published an extended background paper, recommendations and two Editorials. An interdisciplinary workshop was held, involving representatives of both professional societies and experts from the European Union Eurogentest2 Coordination Action Project. In March 2012, a group of experts from the European Society of Human Genetics, the European Society of Human Reproduction and Embryology and the EuroGentest2 Coordination Action Project met to discuss developments at the interface between clinical genetics and ART. As more genetic causes of reproductive failure are now recognized and an increasing number of patients undergo testing of their genome prior to conception, either in regular health care or in the context of direct-to-consumer testing, the need for genetic counselling and PGD may increase. Preimplantation genetic screening (PGS) thus far does not have evidence from RCTs to substantiate that the technique is both effective and efficient. Whole genome sequencing may create greater challenges both in the technological and interpretational domains, and requires further reflection about the ethics of genetic testing in ART and PGD/PGS. Diagnostic laboratories should be reporting their results according to internationally accepted accreditation standards (ISO 15189). Further studies are needed in order to address issues related to the impact of ART on epigenetic reprogramming of the early embryo. The legal landscape regarding assisted reproduction is evolving, but still remains very

  11. Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional, Descriptive Study

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2016-01-01

    Introduction The implications of conducting clinical trials in low and middle income countries on the financial accessibility and safety of the pharmaceutical products available in those markets have not been studied. Regulatory practices and ethical declarations lead to the commercialization of the new products, referred to as New Molecular Entities (NMEs), in the countries where tested as soon as they are approved in high surveillance countries. Patients and patients’ associations use the Latin American courts to access new and expensive treatments, regardless of their safety profile and therapeutic value. Design and Objectives Cross-sectional, descriptive study. To determine the therapeutic value and safety profile of the NMEs approved by the Food and Drug Administration (FDA) in 2011 and 2012 that had been tested in Latin America, and the implications of their market approval for the pharmaceutical budgets in the countries where tested. Setting Latin America. Measures To assess the therapeutic value and safety of the NMEs commercialized in the different countries we used f independent drug bulletins. The prices of the NMEs for the consumers were obtained from the pharmaceutical price observatories of the countries were the medicines had been tested. If the price was not available in the observatories, it was obtained from pharmaceutical distributors. We used the countries’ minimum wage and per capita income to calculate the financial accessibility of a course of treatment with the NMEs. Results We found that 33 NMEs approved by the FDA in 2011 and 2012 have been tested in Latin America. Of these, 26 had been evaluated by independent drug bulletins and only five were found to add some value to a subset of patients and had significant side-effects. The pharmaceutical prices were very high, varied widely across countries and were unrelated to the countries’ income per capita or minimum wage. Conclusion The implementation of clinical trials in Latin America

  12. The ethics of gene therapy.

    Science.gov (United States)

    Chan, Sarah; Harris, John

    2006-10-01

    Recent developments have progressed in areas of science that pertain to gene therapy and its ethical implications. This review discusses the current state of therapeutic gene technologies, including stem cell therapies and genetic modification, and identifies ethical issues of concern in relation to the science of gene therapy and its application, including the ethics of embryonic stem cell research and therapeutic cloning, the risks associated with gene therapy, and the ethics of clinical research in developing new therapeutic technologies. Additionally, ethical issues relating to genetic modification itself are considered: the significance of the human genome, the distinction between therapy and enhancement, and concerns regarding gene therapy as a eugenic practice.

  13. Developing Abilities to Navigate Through the Grey Zones in Complex Environments: Nurses' Reasons for Applying to a Clinical Ethics Residency for Nurses.

    Science.gov (United States)

    Jurchak, Martha; Grace, Pamela J; Lee, Susan M; Willis, Danny G; Zollfrank, Angelika A; Robinson, Ellen M

    2017-07-01

    Nurses face complex ethical issues in practice and have to determine appropriate actions. An inability to conceptualize or follow a preferred course of action can give rise to moral uncertainty or moral distress. Both moral uncertainty and moral distress are problematic for nurses and their patients. A program designed to increase nurse confidence in moral decision making, the clinical ethics residency for nurses (CERN), was offered selectively to nurses affiliated with two academic medical centers. This is a report of the analysis of their application essays. Over a 3-year period, 67 application essays were analyzed using conventional content analysis. Applicants comprised one third advanced practice nurses (APNs) and two thirds staff nurses. They were asked to describe their reasons for interest in the CERN and how they would apply the knowledge gained. For conventional content analyses, no theoretical presumptions are used; rather, codes are identified from the data in an iterative manner and eventually collapsed into themes. Initially, broad themes were identified by the CERN team. Subsequently, in-depth and recursive readings were completed by a subset of three members, resulting in refinement of themes and subthemes. The overarching theme identified was "developing abilities to navigate through the 'grey zones' in complex environments." Three subthemes were: (a) nurses encountering patients who are chronically critically ill, culturally diverse, and presenting with complex circumstances; (b) nurses desiring enhanced ethics knowledge and skills to improve quality of care, understand different perspectives, and act as a resource for others; and (c) nurses supporting and facilitating patient-centered ethical decision making. Findings are consistent with those appearing in the international literature but provide a more cohesive and comprehensive account than previously, and hold promise for the development of educational and policy strategies to address moral

  14. Ethical Implications of an Experiment in Artificial Intelligence.

    Science.gov (United States)

    Levinson, Stephen E.

    2003-01-01

    Revisits the classic debate on whether there can be an artificial creation that behaves and uses language with intelligence and agency. Argues that many moral and spiritual objections to this notion are not grounded either ethically or empirically. (Author/VWL)

  15. Perspectives on Applied Ethics

    OpenAIRE

    2007-01-01

    Applied ethics is a growing, interdisciplinary field dealing with ethical problems in different areas of society. It includes for instance social and political ethics, computer ethics, medical ethics, bioethics, envi-ronmental ethics, business ethics, and it also relates to different forms of professional ethics. From the perspective of ethics, applied ethics is a specialisation in one area of ethics. From the perspective of social practice applying eth-ics is to focus on ethical aspects and ...

  16. Project ethics

    CERN Document Server

    Jonasson, Haukur Ingi

    2013-01-01

    How relevant is ethics to project management? The book - which aims to demystify the field of ethics for project managers and managers in general - takes both a critical and a practical look at project management in terms of success criteria, and ethical opportunities and risks. The goal is to help the reader to use ethical theory to further identify opportunities and risks within their projects and thereby to advance more directly along the path of mature and sustainable managerial practice.

  17. Why ethics?

    OpenAIRE

    Wolfgang, Huber

    2015-01-01

    In this address, the author explores the necessity of ethical reflection on our moral responsibility regarding the challenges of today's globalized world and the future of humankind in the midst of God's creation. In this context, the differentiation of modern ethics is seen as accompanied by the task to reintegrate the ethical discourse by means of an interdisciplinary exchange and to further especially the dialogue between theological and philosophical ethics. By agreeing on Hans-Richard Re...

  18. [Responsibilities of ethics committees].

    Science.gov (United States)

    von Bergmann, K

    2000-05-01

    Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.

  19. Medical Ethics

    Science.gov (United States)

    ... area in medicine that doesn't have an ethical aspect. For example, there are ethical issues relating to End of life care: Should ... orders? Abortion: When does life begin? Is it ethical to terminate a pregnancy with a birth defect? ...

  20. Ethical leadership

    NARCIS (Netherlands)

    den Hartog, D.N.

    2015-01-01

    High-profile cases of leaders’ ethical failure in different settings and sectors have led to increased attention to ethical leadership in organizations. In this review, I discuss the rapidly developing field of ethical leadership from an organizational behavior/psychology perspective, taking a

  1. Revisiting Cementoblastoma with a Rare Case Presentation

    Directory of Open Access Journals (Sweden)

    Vijayanirmala Subramani

    2017-01-01

    Full Text Available Cementoblastoma is a rare benign odontogenic neoplasm which is characterized by the proliferation of cellular cementum. Diagnosis of cementoblastoma is challenging because of its protracted clinical, radiographic features, and bland histological appearance; most often cementoblastoma is often confused with other cementum and bone originated lesions. The aim of this article is to overview/revisit, approach the diagnosis of cementoblastoma, and also present a unique radiographic appearance of a cementoblastoma lesion associated with an impacted tooth.

  2. An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

    Directory of Open Access Journals (Sweden)

    Subhrojyoti Bhowmick

    2014-01-01

    Full Text Available Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals in Kolkata conducting active clinical research and having functional Ethics Committees (ECs in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors′ collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43% was found to be more than that of the medical members (68.75%, though the figure was not statistically significant. Majority of the members (75% felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding

  3. The Ethics of Doing Ethics.

    Science.gov (United States)

    Hansson, Sven Ove

    2017-02-01

    Ethicists have investigated ethical problems in other disciplines, but there has not been much discussion of the ethics of their own activities. Research in ethics has many ethical problems in common with other areas of research, and it also has problems of its own. The researcher's integrity is more precarious than in most other disciplines, and therefore even stronger procedural checks are needed to protect it. The promotion of some standpoints in ethical issues may be socially harmful, and even our decisions as to which issues we label as "ethical" may have unintended and potentially harmful social consequences. It can be argued that ethicists have an obligation to make positive contributions to society, but the practical implications of such an obligation are not easily identified. This article provides an overview of ethical issues that arise in research into ethics and in the application of such research. It ends with a list of ten practical proposals for how these issues should be dealt with.

  4. The Moral of the Tale: Stories, Trust, and Public Engagement with Clinical Ethics via Radio and Theatre.

    Science.gov (United States)

    Bowman, Deborah

    2017-03-01

    Trust is frequently discussed with reference to the professional-patient relationship. However, trust is less explored in relation to the ways in which understanding of, and responses to, questions of ethics are discussed by both the "public" and "experts." Public engagement activity in healthcare ethics may invoke "trust" in analysing a moral question or problem but less frequently conceives of trust as integral to "public engagement" itself. This paper explores the relationship between trust and the ways in which questions of healthcare ethics are identified and negotiated by both "experts" and the public. Drawing on two examples from the author's "public engagement" work-a radio programme for the British Broadcasting Corporation and work with a playwright and theatre-the paper interrogates the ways in which "public engagement" is often characterized. The author argues that the common approach to public engagement in questions of ethics is unhelpfully constrained by a systemic disposition which continues to privilege the professional or expert voice at the expense of meaningful exchange and dialogue. By creating space for novel interactions between the "expert" and the "public," authentic engagement is achieved that enables not only the participants to flourish but also contributes to trust itself.

  5. [Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].

    Science.gov (United States)

    Gonorazky, Sergio E

    2008-01-01

    The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.

  6. Beyond a code of ethics: phenomenological ethics for everyday practice.

    Science.gov (United States)

    Greenfield, Bruce; Jensen, Gail M

    2010-06-01

    Physical therapy, like all health-care professions, governs itself through a code of ethics that defines its obligations of professional behaviours. The code of ethics provides professions with a consistent and common moral language and principled guidelines for ethical actions. Yet, and as argued in this paper, professional codes of ethics have limits applied to ethical decision-making in the presence of ethical dilemmas. Part of the limitations of the codes of ethics is that there is no particular hierarchy of principles that govern in all situations. Instead, the exigencies of clinical practice, the particularities of individual patient's illness experiences and the transformative nature of chronic illnesses and disabilities often obscure the ethical concerns and issues embedded in concrete situations. Consistent with models of expert practice, and with contemporary models of patient-centred care, we advocate and describe in this paper a type of interpretative and narrative approach to moral practice and ethical decision-making based on phenomenology. The tools of phenomenology that are well defined in research are applied and examined in a case that illustrates their use in uncovering the values and ethical concerns of a patient. Based on the deconstruction of this case on a phenomenologist approach, we illustrate how such approaches for ethical understanding can help assist clinicians and educators in applying principles within the context and needs of each patient. (c) 2010 John Wiley & Sons, Ltd.

  7. The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

    Directory of Open Access Journals (Sweden)

    Roger A. Barker

    2018-05-01

    Full Text Available Stem cell-based clinical interventions are increasingly advancing through preclinical testing and approaching clinical trials. The complexity and diversity of these approaches, and the confusion created by unproven and untested stem cell-based “therapies,” create a growing need for a more comprehensive review of these early-stage human trials to ensure they place the patients at minimal risk of adverse events but are also based on solid evidence of preclinical efficacy with a clear scientific rationale for that effect. To address this issue and supplement the independent review process, especially that of the ethics and institutional review boards who may not be experts in stem cell biology, the International Society for Stem Cell Research (ISSCR has developed a set of practical questions to cover the major issues for which clear evidence-based answers need to be obtained before approving a stem cell-based trial. Keywords: human stem cell-derived interventions, early phase clinical trials, institutional review and ethics boards, review process, guidelines

  8. Medical Ethics in Radiology

    International Nuclear Information System (INIS)

    Kim, Kyung Won; Park, Jae Hyung; Yoon, Soon Ho

    2010-01-01

    According to the recent developments in radiological techniques, the role of radiology in the clinical management of patients is ever increasing and in turn, so is the importance of radiology in patient management. Thus far, there have been few open discussions about medical ethics related to radiology in Korea. Hence, concern about medical ethics as an essential field of radiology should be part of an improved resident training program and patient management. The categories of medical ethics related with radiology are ethics in the radiological management of patient, the relationship of radiologists with other medical professionals or companies, the hazard level of radiation for patients and radiologists, quality assurance of image products and modalities, research ethics, and other ethics issues related to teleradiology and fusion imaging. In order to achieve the goal of respectful progress in radiology as well as minimizing any adverse reaction from other medical professions or society, we should establish a strong basis of medical ethics through the continuous concern and self education

  9. Business ethics in ethics committees?

    Science.gov (United States)

    Boyle, P

    1990-01-01

    The "Ethics committees" column in this issue of the Hastings Center Report features an introduction by Cynthia B. Cohen and four brief commentaries on the roles hospital ethics committees may play in the making of institutional and public health care policy in the 1990s. The pros and cons of a broader, more public role for ethics committees in reconciling the business and patient care aspects of health care delivery are debated by Cohen in "Ethics committees as corporate and public policy advocates," and by Philip Boyle in this article. Boyle is an associate for ethical studies at The Hastings Center.

  10. Revisiting Okun's Relationship

    NARCIS (Netherlands)

    Dixon, R.; Lim, G.C.; van Ours, Jan

    2016-01-01

    Our paper revisits Okun's relationship between observed unemployment rates and output gaps. We include in the relationship the effect of labour market institutions as well as age and gender effects. Our empirical analysis is based on 20 OECD countries over the period 1985-2013. We find that the

  11. Revisiting the Okun relationship

    NARCIS (Netherlands)

    Dixon, R. (Robert); Lim, G.C.; J.C. van Ours (Jan)

    2017-01-01

    textabstractOur article revisits the Okun relationship between observed unemployment rates and output gaps. We include in the relationship the effect of labour market institutions as well as age and gender effects. Our empirical analysis is based on 20 OECD countries over the period 1985–2013. We

  12. Bounded Intention Planning Revisited

    OpenAIRE

    Sievers Silvan; Wehrle Martin; Helmert Malte

    2014-01-01

    Bounded intention planning provides a pruning technique for optimal planning that has been proposed several years ago. In addition partial order reduction techniques based on stubborn sets have recently been investigated for this purpose. In this paper we revisit bounded intention planning in the view of stubborn sets.

  13. A Hydrostatic Paradox Revisited

    Science.gov (United States)

    Ganci, Salvatore

    2012-01-01

    This paper revisits a well-known hydrostatic paradox, observed when turning upside down a glass partially filled with water and covered with a sheet of light material. The phenomenon is studied in its most general form by including the mass of the cover. A historical survey of this experiment shows that a common misunderstanding of the phenomenon…

  14. The Faraday effect revisited

    DEFF Research Database (Denmark)

    Cornean, Horia; Nenciu, Gheorghe

    2009-01-01

    This paper is the second in a series revisiting the (effect of) Faraday rotation. We formulate and prove the thermodynamic limit for the transverse electric conductivity of Bloch electrons, as well as for the Verdet constant. The main mathematical tool is a regularized magnetic and geometric...

  15. Research as an Act of Love: Ethics, Émigrés, and the Praxis of Becoming Human

    Science.gov (United States)

    Ibrahim, Awad

    2014-01-01

    Conceptual in nature, this paper revisits the debate on the nature and ethical implication of what it means to conduct research with/in immigrant communities. The view from "inside" is different from the view from "outside," I am contending, and both are mediated by what I am calling "I-Thou Research Ethics." This is…

  16. Ethics in research.

    Science.gov (United States)

    Bevan, Joan C

    2007-04-01

    This review will examine research ethics in the context of globalization of clinical trials and recent rapid developments in bioscience. It will focus on international ethical guidelines and the functions of research ethics review boards in research governance. Consent issues in genetic research, which must comply with privacy laws by protecting confidentiality and privacy of personal health data, will be discussed. There has been a rapid expansion of genomic and proteonomic research and biotechnology in the last decade. International ethical guidelines have been updated and the bioscience industry has developed ethics policies. At the same time, problems in academic anesthesia in the US and UK have been identified, leading to recommendations to train physician-scientists in anesthesia to stimulate research activity in the future. Anesthesiologists are joining interdisciplinary research teams and the concept of evidence-based translational research is emerging. Anesthesiologists are moving towards participation in interdisciplinary research teams. They are well placed to speed the translation of research discovery into clinical practice and provide evidence-based perioperative care. This review provides the ethical framework that anesthesiologists will need to meet the challenges of this changing pattern of practice.

  17. 'Wicked' ethics: Compliance work and the practice of ethics in HIV research.

    Science.gov (United States)

    Heimer, Carol A

    2013-12-01

    Using ethnographic material collected between 2003 and 2007 in five HIV clinics in the US, South Africa, Uganda, and Thailand, this article examines "official ethics" and "ethics on the ground." It compares the ethical conundrums clinic staff and researchers confront in their daily work as HIV researchers with the dilemmas officially identified as ethical issues by bioethicists and people responsible for ethics reviews and compliance with ethics regulations. The tangled relation between ethical problems and solutions invites a comparison to Rittel and Webber's "wicked problems." Official ethics' attempts to produce universal solutions often make ethics problems even more wickedly intractable. Ethics on the ground is in part a reaction to this intractability. Copyright © 2012 Elsevier Ltd. All rights reserved.

  18. A deviation from standard design? Clinical trials, research ethics committees, and the regulatory co-construction of organizational deviance.

    Science.gov (United States)

    Hedgecoe, Adam

    2014-02-01

    Focusing on the high-profile drug disaster at London's Northwick Park Hospital in 2006, this article explores how such an event can be seen as an example of organizational deviance co-constructed between the company running the research and the research ethics committee which approved the trial. This deviance was the result of the normalization of a specific dosing practice in the broader regulatory field, allowing the researchers and regulators to take a risky dosing strategy for granted as best practice. Drawing on the work of Diane Vaughan, this article uses interview data with researchers and members of the research ethics committee concerned as well as documentary material, to show how work group cultures between regulators and those they are intended to oversee are maintained, and how the culturally embedded assumptions of such work groups can result in organizational and regulatory deviance.

  19. Clinical Ethics of the Do-Not-Resuscitate (DNR Order and Other Advanced Directives in Anesthesia and ICU

    Directory of Open Access Journals (Sweden)

    J. M. Berger

    2017-01-01

    Full Text Available Closed chest cardiopulmonary resuscitation (CPR, having been so successful after its introduction in the operating room for saving lives of anesthetized patients, was adopted for use in the intensive care units, then hospital-wide, and finally to out of hospital patients. This has lead to ethical dilemmas involving patients who must themselves request discontinuation of artificial organ function devices and treatments, or placing family members in the difficult positions of having to make those decisions for their unconscious and suffering relatives. In this review, the Ethical principles on which physicians, hospitals, patients, and surrogate decision makers rely in order to apply their perceived moral obligations to provide patient safety, comfort, and treatment are examined with particular emphasis on do not resuscitate orders (DNR. It is clear that DNR does not equate with do not treat.

  20. Machine medical ethics

    CERN Document Server

    Pontier, Matthijs

    2015-01-01

    The essays in this book, written by researchers from both humanities and sciences, describe various theoretical and experimental approaches to adding medical ethics to a machine in medical settings. Medical machines are in close proximity with human beings, and getting closer: with patients who are in vulnerable states of health, who have disabilities of various kinds, with the very young or very old, and with medical professionals. In such contexts, machines are undertaking important medical tasks that require emotional sensitivity, knowledge of medical codes, human dignity, and privacy. As machine technology advances, ethical concerns become more urgent: should medical machines be programmed to follow a code of medical ethics? What theory or theories should constrain medical machine conduct? What design features are required? Should machines share responsibility with humans for the ethical consequences of medical actions? How ought clinical relationships involving machines to be modeled? Is a capacity for e...

  1. Imaginative ethics--bringing ethical praxis into sharper relief.

    Science.gov (United States)

    Hansson, Mats G

    2002-01-01

    The empirical basis for this article is three years of experience with ethical rounds at Uppsala University Hospital. Three standard approaches of ethical reasoning are examined as potential explanations of what actually occurs during the ethical rounds. For reasons given, these are not found to be satisfying explanations. An approach called "imaginative ethics", is suggested as a more satisfactory account of this kind of ethical reasoning. The participants in the ethical rounds seem to draw on a kind of moral competence based on personal life experience and professional competence and experience. By listening to other perspectives and other experiences related to one particular patient story, the participants imagine alternative horizons of moral experience and explore a multitude of values related to clinical practice that might be at stake. In his systematic treatment of aesthetics in the Critique of Judgement, Kant made use of an operation of thought that, if applied to ethics, will enable us to be more sensitive to the particulars of each moral situation. Based on this reading of Kant, an account of imaginative ethics is developed in order to bring the ethical praxis of doctors and nurses into sharper relief. The Hebraic and the Hellenic traditions of imagination are used in order to illuminate some of the experiences of ethical rounds. In conclusion, it is argued that imaginative ethics and principle-based ethics should be seen as complementary in order to endow a moral discourse with ethical authority. Kantian ethics will do the job if it is remembered that Kant suggested only a modest, negative role of principle-based deliberation.

  2. 药物临床试验伦理委员会运作实践%The Operation of Ethics Committees in Drug Clinical Trials

    Institute of Scientific and Technical Information of China (English)

    鲁瑞萍; 单志桂; 申洁

    2013-01-01

    在药物临床试验的过程中,必须对受试者的个人权益给予充分的保障,并确保试验的科学性和可靠性.伦理委员会与知情同意书是保障受试者权益的主要措施.为确保临床试验中受试者的权益,须成立独立的伦理委员会,并向国家食品药品监督管理局备案.介绍了某医院药物临床试验伦理委员会的组成及备案、规范伦理委员会运作、存在的问题以及解决的对策与方法.%In the process of drug clinical trials,it is necessary to give full guarantee of personal rights of the subjects,and ensure the scientific nature and reliability of the test.Ethics committee and informed consent are the main measures to safeguard the rights and interests of the subjects.In order to protect the clinical trial subjects'rights and interests,it should set up an independent ethics committee,and put on records in the State Food and Drug Administration.In this paper,the authors also introduced the construction and records,standard business,existing problems and solving countermeasures in a hospital ethics committee.

  3. Aspectos Éticos de la Investigación Clínica en seres humanos Clinic research in human beings: Ethical aspect

    Directory of Open Access Journals (Sweden)

    Carlos M Albornoz López del Castillo

    2003-08-01

    Full Text Available La ética de la experimentación con seres humanos no es sólo una de las áreas fundamentales de la bioética, sino también una de las problemáticas que le dieron origen. Se describen en este trabajo algunas implicaciones éticas de la experimentación en seres humanos; se analizan el origen y evolución de la bioética, los aspectos regulatorios para la realización de ensayos clínicos y su valoración moral, los tipos de experimentación; la realidad mundial y cubana en cuanto a investigación clínica y tecnología y el consentimiento informado. Se concluye que el criterio ético fundamental de las investigaciones en seres humanos es su disposición al servicio del hombreThe ethics of experimentation with human beings is not only one of the fundamental areas of bioethics, but also one of the problems that originated this field. In this work some ethical implications of experimentation in human beings are described; the origin and evolution of bioethics are analyzed, the regulatory aspects for the realization of clinical trials and their moral valuation, the experimentation types; international and Cuban reality as for clinical investigation and technology and the informed consent. It is assumed that the fundamental ethical approach of the investigations with human beings is its disposition to serve mankind

  4. After Ethics

    DEFF Research Database (Denmark)

    Shepherd, Nick; Haber, Alejandro

    While books on archaeological and anthropological ethics have proliferated in recent years, few attempt to move beyond a conventional discourse on ethics to consider how a discussion of the social and political implications of archaeological practice might be conceptualized differently....... The conceptual ideas about ethics posited in this volume make it of interest to readers outside of the discipline; in fact, to anyone interested in contemporary debates around the possibilities and limitations of a discourse on ethics. The authors in this volume set out to do three things. The first is to track...... the historical development of a discussion around ethics, in tandem with the development and “disciplining” of archaeology. The second is to examine the meanings, consequences and efficacies of a discourse on ethics in contemporary worlds of practice in archaeology. The third is to push beyond the language...

  5. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences

    Directory of Open Access Journals (Sweden)

    de Vries Martine C

    2011-09-01

    Full Text Available Abstract Background Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. Methodology An empirical ethical approach, combining (1 a narrative review of (primarily qualitative studies on parents' and physicians' experiences of the pediatric oncology research practice, and (2 comparison of these experiences with existing theoretical ethical concepts about (pediatric research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Results Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist. True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the

  6. Ethical considerations

    International Nuclear Information System (INIS)

    Knoppers, B.M.

    1996-01-01

    Some ethical questions about molecular biology and human radiation studies are raised. The questions relate to the following: genetic epidemiology leading to possible stigmatization of certain groups; protection of medical information, including samples, and respect for privacy; effect of genetic characterization on standards and procedures relating to occupational exposure; exclusion of vulnerable groups from research studies. On the positive side, there is increased funding within Canada for studies of ethical, legal and social issues, and internationally ethical standards are being developed

  7. Medical ethics and ethical dilemmas.

    Science.gov (United States)

    Iyalomhe, G B S

    2009-01-01

    Ethical problems routinely arise in the hospital and outpatient practice settings and times of dilemma do occur such that practitioners and patients are at cross-roads where choice and decision making become difficult in terms of ethics. This paper attempts a synopsis of the basic principles of medical ethics, identifies some ethical dilemmas that doctors often encounter and discusses some strategies to address them as well as emphasizes the need for enhanced ethics education both for physicians and patients particularly in Nigeria. Literature and computer programmes (Medline and PsychoInfo databases) were searched for relevant information. The search showed that the fundamental principles suggested by ethicists to assist doctors to evaluate the ethics of a situation while making a decision include respect for autonomy, beneficence, non-maleficence and justice. Although the above principles do not give answers as to how to handle a particular situation, they serve as a guide to doctors on what principles ought to apply to actual circumstances. The principles sometimes conflict with each other leading to ethical dilemmas when applied to issues such as abortion, contraception, euthanasia, professional misconduct, confidentiality truth telling, professional relationship with relatives, religion, traditional medicine and business concerns. Resolution of dilemmas demand the best of the doctor's knowledge of relevant laws and ethics, his training and experience, his religious conviction and moral principles as well as his readiness to benefit from ethics consultation and the advice of his colleagues. Ethics education should begin from the impressionable age in homes, continued in the medical schools and after graduation to ensure that doctors develop good ethical practices and acquire the ability to effectively handle ethical dilemmas. Also, education of patients and sanction of unethical behaviour will reduce ethical dilemmas.

  8. The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

    Science.gov (United States)

    Barker, Roger A; Carpenter, Melissa K; Forbes, Stuart; Goldman, Steven A; Jamieson, Catriona; Murry, Charles E; Takahashi, Jun; Weir, Gordon

    2018-05-08

    Stem cell-based clinical interventions are increasingly advancing through preclinical testing and approaching clinical trials. The complexity and diversity of these approaches, and the confusion created by unproven and untested stem cell-based "therapies," create a growing need for a more comprehensive review of these early-stage human trials to ensure they place the patients at minimal risk of adverse events but are also based on solid evidence of preclinical efficacy with a clear scientific rationale for that effect. To address this issue and supplement the independent review process, especially that of the ethics and institutional review boards who may not be experts in stem cell biology, the International Society for Stem Cell Research (ISSCR) has developed a set of practical questions to cover the major issues for which clear evidence-based answers need to be obtained before approving a stem cell-based trial. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  9. Research Ethics

    Science.gov (United States)

    Dooly, Melinda; Moore, Emilee; Vallejo, Claudia

    2017-01-01

    Qualitative research, especially studies in educational contexts, often brings up questions of ethics because the study design involves human subjects, some of whom are under age (e.g. data collected in primary education classrooms). It is not always easy for young researchers to anticipate where ethical issues might emerge while designing their…

  10. Large ethics.

    Science.gov (United States)

    Chambers, David W

    2008-01-01

    This essay presents an alternative to the traditional view that ethics means judging individual behavior against standards of right and wrong. Instead, ethics is understood as creating ethical communities through the promises we make to each other. The "aim" of ethics is to demonstrate in our own behavior a credible willingness to work to create a mutually better world. The "game" of ethics then becomes searching for strategies that overlap with others' strategies so that we are all better for intending to act on a basis of reciprocal trust. This is a difficult process because we have partial, simultaneous, shifting, and inconsistent views of the world. But despite the reality that we each "frame" ethics in personal terms, it is still possible to create sufficient common understanding to prosper together. Large ethics does not make it a prerequisite for moral behavior that everyone adheres to a universally agreed set of ethical principles; all that is necessary is sufficient overlap in commitment to searching for better alternatives.

  11. BUSINESS ETHICS

    Directory of Open Access Journals (Sweden)

    Nelu BURCEA

    2014-12-01

    Full Text Available Through this study we seek to explore the concept of business ethics, in those aspects that we consider to be essential and concrete. We started from a few questions: Could the two concepts be compatible? If not, why not? If yes, could they be complementary? How real is the use of ethics in the profits of a business? How can be business ethics be exemplified and what principles are essential in doing business? How does the business environment react to the concept? These are some of the elements that will form the basis of this scientific study. Lately, business ethics has been becoming an increasingly popular topic. Set against the global economic crisis, the companies’ credibility could become a major concern. Business ethics also becomes a challenge for training and informing employees and employers, in order to make not only economical, but also ethical decisions regarding their profits. In the study we shall also address the ethical standards required in a business world interested in fundamental values that can make the difference in 21st century business. Also, according to a study conducted by the authors, we shall address the two most important ethical values that prove to be essential to a business.

  12. "Systematizing" ethics consultation services.

    Science.gov (United States)

    Bruce, Courtenay R; Eves, Margot M; Allen, Nathan G; Smith, Martin L; Peña, Adam M; Cheney, John R; Majumder, Mary A

    2015-03-01

    While valuable work has been done addressing clinical ethics within established healthcare systems, we anticipate that the projected growth in acquisitions of community hospitals and facilities by large tertiary hospitals will impact the field of clinical ethics and the day-to-day responsibilities of clinical ethicists in ways that have yet to be explored. Toward the goal of providing clinical ethicists guidance on a range of issues that they may encounter in the systematization process, we discuss key considerations and potential challenges in implementing system-wide ethics consultation services. Specifically, we identify four models for organizing, developing, and enhancing ethics consultation activities within a system created through acquisitions: (1) train-the-trainer, (2) local capacity-building, (3) circuit-riding, and (4) consolidated accountability. We note each model's benefits and challenges. To our knowledge, this is the first paper to consider the broader landscape of issues affected by consolidation. We anticipate that clinical ethicists, volunteer consultants, and hospital administrators will benefit from our recommendations.

  13. Locating Ethics

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2013-01-01

    Research ethics has become integrated into what it means to conduct good science. This thesis is about the nature of that integration, which I argue is not neutral, carrying with it ideas of duty, moral obligations, organisational mechanisms, and processes of monitoring. For developing countries...... to participate in global research, the pre-requisite of ethical review has necessitated a growth in capacity building exercises. The chapters aim to elucidate ethnographically the activities and implications of 'capacity building' activities in biomedical research ethics, through following the trainings......, assessments and networking of the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a Non-Governmental Organisation. The work provides a critical reflection on the spread and uptake of ethics, contributing particularly to literatures in medical anthropology, organisational studies...

  14. Intelligence Ethics:

    DEFF Research Database (Denmark)

    Rønn, Kira Vrist

    2016-01-01

    Questions concerning what constitutes a morally justified conduct of intelligence activities have received increased attention in recent decades. However, intelligence ethics is not yet homogeneous or embedded as a solid research field. The aim of this article is to sketch the state of the art...... of intelligence ethics and point out subjects for further scrutiny in future research. The review clusters the literature on intelligence ethics into two groups: respectively, contributions on external topics (i.e., the accountability of and the public trust in intelligence agencies) and internal topics (i.......e., the search for an ideal ethical framework for intelligence actions). The article concludes that there are many holes to fill for future studies on intelligence ethics both in external and internal discussions. Thus, the article is an invitation – especially, to moral philosophers and political theorists...

  15. Virtue Ethics and Rural Professional Healthcare Roles

    Science.gov (United States)

    Crowden, Andrew

    2010-01-01

    Because rural populations are at risk not only for clinically disparate care but also ethically disparate care, there is a need to enhance scholarship, research, and teaching about rural health care ethics. In this paper an argument for the applicability of a virtue ethics framework for professionals in rural healthcare is outlined. The argument…

  16. Fostering nursing ethics for practical nursing

    OpenAIRE

    森田, 敏子; モリタ, トシコ; Morita, Toshiko

    2014-01-01

    Higher nursing ethics can raise nursing quality. The author attempts to define theproblem from the seedling of sensibility in practical nursing and focuses on the clinical environment surrounding nursing ethics from its pedagogical and historicalaspects. On the basis of these standpoints, the author discusses issues on the practical nursing as a practitioner of nursing ethics.

  17. 'Felson Signs' revisited

    International Nuclear Information System (INIS)

    George, Phiji P.; Irodi, Aparna; Keshava, Shyamkumar N.; Lamont, Anthony C.

    2014-01-01

    In this article we revisit, with the help of images, those classic signs in chest radiography described by Dr Benjamin Felson himself, or other illustrious radiologists of his time, cited and discussed in 'Chest Roentgenology'. We briefly describe the causes of the signs, their utility and the differential diagnosis to be considered when each sign is seen. Wherever possible, we use CT images to illustrate the basis of some of these classic radiographic signs.

  18. Time functions revisited

    Science.gov (United States)

    Fathi, Albert

    2015-07-01

    In this paper we revisit our joint work with Antonio Siconolfi on time functions. We will give a brief introduction to the subject. We will then show how to construct a Lipschitz time function in a simplified setting. We will end with a new result showing that the Aubry set is not an artifact of our proof of existence of time functions for stably causal manifolds.

  19. Seven Issues, Revisited

    OpenAIRE

    Whitehead, Jim; De Bra, Paul; Grønbæk, Kaj; Larsen, Deena; Legget, John; schraefel, monica m.c.

    2002-01-01

    It has been 15 years since the original presentation by Frank Halasz at Hypertext'87 on seven issues for the next generation of hypertext systems. These issues are: Search and Query Composites Virtual Structures Computation in/over hypertext network Versioning Collaborative Work Extensibility and Tailorability Since that time, these issues have formed the nucleus of multiple research agendas within the Hypertext community. Befitting this direction-setting role, the issues have been revisited ...

  20. Deterministic Graphical Games Revisited

    DEFF Research Database (Denmark)

    Andersson, Daniel; Hansen, Kristoffer Arnsfelt; Miltersen, Peter Bro

    2008-01-01

    We revisit the deterministic graphical games of Washburn. A deterministic graphical game can be described as a simple stochastic game (a notion due to Anne Condon), except that we allow arbitrary real payoffs but disallow moves of chance. We study the complexity of solving deterministic graphical...... games and obtain an almost-linear time comparison-based algorithm for computing an equilibrium of such a game. The existence of a linear time comparison-based algorithm remains an open problem....

  1. The strange case of Mr. H. Starting dialysis at 90 years of age: clinical choices impact on ethical decisions.

    Science.gov (United States)

    Piccoli, Giorgina Barbara; Sofronie, Andreea Corina; Coindre, Jean-Philippe

    2017-11-09

    Starting dialysis at an advanced age is a clinical challenge and an ethical dilemma. The advantages of starting dialysis at "extreme" ages are questionable as high dialysis-related morbidity induces a reflection on the cost- benefit ratio of this demanding and expensive treatment in a person that has a short life expectancy. Where clinical advantages are doubtful, ethical analysis can help us reach decisions and find adapted solutions. Mr. H is a ninety-year-old patient with end-stage kidney disease that is no longer manageable with conservative care, in spite of optimal nutritional management, good blood pressure control and strict clinical and metabolic evaluations; dialysis is the next step, but its morbidity is challenging. The case is analysed according to principlism (beneficence, non-maleficence, justice and respect for autonomy). In the setting of care, dialysis is available without restriction; therefore the principle of justice only partially applied, in the absence of restraints on health-care expenditure. The final decision on whether or not to start dialysis rested with Mr. H (respect for autonomy). However, his choice depended on the balance between beneficence and non-maleficence. The advantages of dialysis in restoring metabolic equilibrium were clear, and the expected negative effects of dialysis were therefore decisive. Mr. H has a contraindication to peritoneal dialysis (severe arthritis impairing self-performance) and felt performing it with nursing help would be intrusive. Post dialysis fatigue, poor tolerance, hypotension and intrusiveness in daily life of haemodialysis patients are closely linked to the classic thrice-weekly, four-hour schedule. A personalized incremental dialysis approach, starting with one session per week, adapting the timing to the patient's daily life, can limit side effects and "dialysis shock". An individualized approach to complex decisions such as dialysis start can alter the delicate benefit/side-effect balance

  2. Balancing high accrual and ethical recruitment in paediatric oncology: a qualitative study of the 'look and feel' of clinical trial discussions

    Directory of Open Access Journals (Sweden)

    Eden Tim OB

    2010-10-01

    Full Text Available Abstract Background High accrual to clinical trials enables new treatment strategies to be tested rapidly, accurately and with generalisability. Ethical standards also must be high so that participation is voluntary and informed. However, this can be difficult to achieve in trials with complex designs and in those which are closely embedded in clinical practice. Optimal recruitment requires a balance of both ethical and accrual considerations. In the context of a trial of stratified treatments for children with acute lymphoblastic leukaemia (UKALL2003 we examined how recruitment looked to an observer and how it felt to the parents, to identify how doctors' communication could promote or inhibit optimal recruitment. Methods We audio-recorded, transcribed and analysed routine doctor-patient consultations (n = 20 and interviews between researchers and parents (n = 30 parents across six UK treatment centres. Analysis was informed by the constant comparative method. For consultation transcripts, analysis focussed on how doctors presented the trial. We compared this with analysis of the interview transcripts which focussed on parents' perceptions and understanding of the trial. Results Parents and doctors discussed the trial in most consultations, even those that did not involve a decision about randomisation. Doctors used language allying them both with the trial and with the parent, indicating that they were both an 'investigator' and a 'clinician'. They presented the trial both as an empirical study with a scientific imperative and also as offering personalisation of treatment for the child. Parents appeared to understand that trial involvement was voluntary, that it was different from routine care and that they could withdraw from the trial at any time. Some were confused about the significance of the MRD test and the personalisation of treatment. Conclusions Doctors communicated in ways that generally promoted optimal recruitment, indicating that

  3. Relational ethics and psychosomatic assessment.

    Science.gov (United States)

    Barbosa, António

    2012-01-01

    The main ethical perspective in the clinical relationship takes into consideration the vulnerability of the clinical condition before threats and risks that can undermine the integrity and dignity of the person. Psychosomatic medicine faces complex cases whose ethical problems cannot only be solved by applying top-down deontological or utilitarian approaches, principlism, which is limited mainly to easing ethical tensions, or a bottom-up approach, the casuistic model, case-based reasoning. In introducing vulnerability as the core of ethical questioning as a principle ontological priority over other principles, relational ethics refers to the appreciation of the responsibility of health professionals through which a health care professional and the patient 'together' can construct more reasonable and prudential courses of action with, for, and by the patient. The model of relational ethics is based on three main aspects, clinically integrated approach, science/philosophy partnership, and deliberative process, that when taken together, form an intermediate model that ensures prudent and reasonable decision-making. The three structural elements and characteristics of relational ethics create and maintain a responsible relationship between the professional and the patient being aware that the mutual vulnerability of health professional and the patient has a moral value and recognizing that their relationship will allow for personal development of each. I conceptualized the model of relational ethics as one that embraces the meta-ethical principles of vulnerability, dignity, responsibility, and respect for autonomy as they are considered by many international declarations or conventions. This model integrates three key polarities: ensure conditions of authenticity, facilitate a process of cooperative mutuality, and promote opportunities for growth and development. Relational ethics can be used to solve major ethical problems in psychosomatic medicine, capacity

  4. Hidden Curricula, Ethics, and Professionalism: Optimizing Clinical Learning Environments in Becoming and Being a Physician: A Position Paper of the American College of Physicians.

    Science.gov (United States)

    Lehmann, Lisa Soleymani; Sulmasy, Lois Snyder; Desai, Sanjay

    2018-04-03

    Much of what is formally taught in medicine is about the knowledge, skills, and behaviors required of a physician, including how to express compassion and respect for patients at the bedside. What is learned, however, includes not only admirable qualities but also behaviors and qualities that are inconsistent with ethics and professionalism. Positive role models may reinforce the character and values the profession seeks to cultivate; negative ones directly contradict classroom lessons and expectations of patients, society, and medical educators. These positive and negative lessons, which are embedded in organizational structure and culture, are the hidden curricula conveyed in medical schools, residency programs, hospitals, and clinics. This position paper from the American College of Physicians focuses on ethics, professionalism, and the hidden curriculum. It provides strategies for revealing what is hidden to foster the development of reflective and resilient lifelong learners who embody professionalism and clinicians who are, and are perceived as, positive role models. Making the hidden visible and the implicit explicit helps to create a culture reflecting medicine's core values.

  5. [Is it ethically acceptable to invite a pregnant woman to enroll in a clinical trial with Tdap if it could entail not being vaccinated with Tdap before delivery?

    Science.gov (United States)

    Dal-Ré, Rafael

    2017-02-01

    Pertussis incidence has increased in recent years, especially among infants aged <2months. A number of Spanish regions have started a vaccination program with Tdap vaccine to all pregnant women in the third trimester of pregnancy. An observational study has shown that this strategy reduces the number of cases of pertussis by 90% in infants aged <2months. Mathematical models showed that a cocooning strategy (i.e. vaccination of the mother at immediate postpartum, and other adults and adolescents who have close contact with the newborn and caregivers) will reduce the incidence of pertussis by 70% in infants aged <2months. It is intended to conduct a clinical trial in which 340 pregnant women will receive Tdap vaccine, whereas another 340 pregnant woman will be vaccinated soon after delivery. Vaccination with Tdap will be offered to all partners and caregivers of the newborn. After assessing both the ethical and scientific reasons supporting the trial, it is concluded that it is ethically and legally acceptable to invite pregnant women living in communities where Tdap vaccination has been implemented to participate in the trial. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  6. Ethics rounds do not improve the handling of ethical issues by psychiatric staff.

    Science.gov (United States)

    Silén, Marit; Haglund, Kristina; Hansson, Mats G; Ramklint, Mia

    2015-08-01

    One way to support healthcare staff in handling ethically difficult situations is through ethics rounds that consist of discussions based on clinical cases and are moderated by an ethicist. Previous research indicates that the handling of ethically difficult situations in the workplace might have changed after ethics rounds. This, in turn, would mean that the "ethical climate", i.e. perceptions of how ethical issues are handled, would have changed. To investigate whether ethics rounds could improve the ethical climate perceived by staff working in psychiatry outpatient clinics. In this quasi-experimental study, six inter-professional ethics rounds led by a philosopher/ethicist were conducted at two psychiatry outpatient clinics. Changes in ethical climate were measured at these clinics as well as at two control clinics at baseline and after the intervention period using the instrument Hospital Ethical Climate Survey. Within-groups comparisons of median sum scores of ethical climate showed that no statistically significant differences were found in the intervention group before or after the intervention period. The median sum scores for ethical climate were significantly higher, both at baseline and after the intervention period (P ≤ 0.001; P = 0.046), in the intervention group. Ethics rounds in psychiatric outpatient clinics did not result in significant changes in ethical climate. Outcomes of ethics rounds might, to a higher degree, be directed towards patient-related outcomes rather than towards the staff's working environment, as the questions brought up for discussion during the ethics rounds concerned patient-related issues.

  7. BUSINESS ETHICS

    OpenAIRE

    Nelu BURCEA; Ion CROITORU

    2014-01-01

    Through this study we seek to explore the concept of business ethics, in those aspects that we consider to be essential and concrete. We started from a few questions: Could the two concepts be compatible? If not, why not? If yes, could they be complementary? How real is the use of ethics in the profits of a business? How can be business ethics be exemplified and what principles are essential in doing business? How does the business environment react to the concept? These are some of the eleme...

  8. Claiming an Ethic of Care for midwifery.

    Science.gov (United States)

    MacLellan, Jennifer

    2014-11-01

    The public domain of midwifery practice, represented by the educational and hospital institutions could be blamed for a subconscious ethical dilemma for midwifery practitioners. The result of such tension can be seen in complaints from maternity service users of dehumanised care. When expectations are not met, women report dehumanising experiences that carry long term consequences to both them and their child. To revisit the ethical foundation of midwifery practice to reflect the feminist Ethic of Care and reframe what is valuable to women and midwives during the childbirth experience. A comprehensive literature review is presented from the midwifery and feminist ethics discourse. Nil to report. Women are vulnerable during childbirth as they need care, yet they prioritise elements of relationship in their experience. The Ethic of Care approach equalises the relationship between the midwife and the woman, providing the space for relationship building and allowing midwives to meet the expectations of their accepted responsibility. Some midwives manage to balance the demands of the institution with the needs of the woman. This is described as both an emotional and professionally challenging balancing act. Until there is a formal acknowledgement of the different ethical approach to midwifery practice from within the profession and the Institution, midwifery identity and practice will continue to be compromised. © The Author(s) 2014.

  9. Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States.

    Science.gov (United States)

    Hemminki, Elina

    2016-01-19

    The aim of this paper is to compare common features and variation in the work of research ethics committees (RECs) in Finland to three other countries - England, Canada, the United States of America (USA) - in the late 2000s. Several approaches and data sources were used, including semi- or unstructured interviews of experts, documents, previous reports, presentations in meetings and observations. A theoretical framework was created and data from various sources synthesized. In Finland, RECs were regulated by a medical research law, whereas in the other countries many related laws and rules guided RECs; drug trials had specific additional rules. In England and the USA, there was a REC control body. In all countries, members were voluntary and included lay-persons, and payment arrangements varied. Patient protection was the main ethics criteria, but other criteria (research advancement, availability of results, payments, detailed fulfilment of legislation) varied. In all countries, RECs had been given administrative duties. Variations by country included the mandate, practical arrangements, handling of multi-site research, explicitness of proportionate handlings, judging scientific quality, time-limits for decisions, following of projects, role in institute protection, handling conflicts of interests, handling of projects without informed consent, and quality assurance research. The division of work between REC members and secretariats varied in checking of formalities. In England, quality assurance of REC work was thorough, fairly thorough in the USA, and not performed in Finland. The work of RECs in the four countries varied notably. Various deficiencies in the system require action, for which international comparison can provide useful insights.

  10. Response to written feedback of clinical data within a longitudinal study: a qualitative study exploring the ethical implications

    Directory of Open Access Journals (Sweden)

    Wyke Sally

    2011-01-01

    Full Text Available Abstract Background There is a growing ethical imperative to feedback research results to participants but there remains a striking lack of empirical research on how people respond to individualised feedback. We sought to explore longitudinal study participants' response to receiving individual written feedback of weight-related and blood results, and to consider the balance of harms against benefits. Methods A qualitative study with face-to-face and telephone interviews conducted with 50 men and women who had participated in the fifth and most recent wave of the cohort study 'West of Scotland Twenty-07' and received a feedback letter containing body mass index (BMI, body fat percentage, cholesterol and glycated haemoglobin A1c (HbA1c results. Results Expectations of, and response to, the feedback of their individual results varied. Whilst half of the participants were on the whole 'pleased' with their results or held neutral views, half reported negative responses such as 'shock' or 'concern', particularly in relation to the weight-related results. Participants who were overweight and obese used the most negative language about their results, with some being quite distressed and reporting feelings of powerlessness, low self-image and anxiety over future health. Nevertheless, some people reported having implemented lifestyle changes in direct response to the feedback, resulting in significant weight-loss and/or dietary improvements. Others reported being motivated to change their behaviour. Age and gender differences were apparent in these narratives of behaviour change. Conclusions The potential harm caused to some participants may be balanced against the benefit to others. More evaluation of the impact of the format, content and means of individualised feedback of research findings in non-trial studies is required given the growing ethical imperative to offer participants a choice of receiving their results, and the likelihood that a high

  11. Machine Ethics: Creating an Ethical Intelligent Agent

    OpenAIRE

    Anderson, Michael; Anderson, Susan Leigh

    2007-01-01

    The newly emerging field of machine ethics (Anderson and Anderson 2006) is concerned with adding an ethical dimension to machines. Unlike computer ethics -- which has traditionally focused on ethical issues surrounding humans' use of machines -- machine ethics is concerned with ensuring that the behavior of machines toward human users, and perhaps other machines as well, is ethically acceptable. In this article we discuss the importance of machine ethics, the need for machines that represent ...

  12. Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company.

    Science.gov (United States)

    Beran, Roy G

    2004-01-01

    Most multi-centre trials are both financed and sponsored by the pharmaceutical company involved. What follows will map the path adopted for an investigator initiated and sponsored study for a new indication of an established medication. The chief investigators of a company-sponsored, investigator-initiated, multi-centre, placebo-controlled study of an established medication, Pharmaceutical Benefit Scheme (PBS) listed for treatment of one condition but trialled in the management of another condition (trial of off-label use), were approached to submit a protocol to repeat the type of study with a different compound. The new study would test a different agent, also PBS listed, for the same condition as in the initial study and with the same off-licence application. The company would finance the study, provide the medication and matched placebo but only review the investigator-initiated protocol which would be sponsored by the principal investigator. This required the investigator to implement the trial, as would normally be done by the pharmaceutical company, yet also act as its principal investigator. The principal investigator, with colleagues and a Clinical Research Organisation (CRO), developed a protocol, adapted for the new agent, and submitted it for approval. Upon acceptance a contract was negotiated with the pharmaceutical company which had to overcome jurisdictional conflicts between common law and civil law legal systems. A CRO was contracted to undertake administrative functions which dictated special contractual agreements to overcome possible conflicts of interest for a sponsor/investigator to protect patient interests. There was need to find indemnification insurance with jurisdictional problems, co-investigators, ethics committee approvals and finance management as just some of the difficulties encountered. The paper will outline how these obstacles were overcome and how ethical and legal issues were respected through compromise. The ethical and legal

  13. Abusing ethics

    DEFF Research Database (Denmark)

    Olivares Bøgeskov, Benjamin Miguel

    This paper presents the result from our research on how nurse managers use and occasionally misuse inconclusive ethical arguments to engage their personnel in current reforms. The Danish health care system has undergone a series of reforms inspired by New Public Management theories, which have......, paying special attention to the way in which ethical arguments are used in relation to engagement. Our research shows that ethical arguments are extremely common, and they are used either to elicit engagement, or to demand engagement considering the result of a duty. However, most interestingly...... it was possible for us to find recurrence of fallacious arguments of different kinds. Based on these findings, I will argue that the use of fallacious arguments in order to generate engagement is in reality an abusive use of ethics, which raises important questions. I argue that depending on the degree...

  14. Transplant Ethics.

    Science.gov (United States)

    Altınörs, Nur; Haberal, Mehmet

    2016-11-01

    The aim of this study was to review and discuss the great variety of ethical issues related to organ donation, organ procurement, transplant activities, and new ethical problems created as a result of technologic and scientific developments. An extensive literature survey was made, and expert opinions were obtained. The gap between demand and supply of organs for transplant has yielded to organ trafficking, organ tourism, and commercialism. This problem seems to be the most important issue, and naturally there are ethical dilemmas related to it. A wide number of ideas have been expressed on the subject, and different solutions have been proposed. The struggle against organ trafficking and commercialism should include legislation, efforts to increase deceased-donor donations, and international cooperation. China's policy to procure organs from prisoners sentenced to death is unethical, and the international community should exert more pressure on the Chinese government to cease this practice. Each particular ethical dilemma should be taken separately and managed.

  15. Ethics fundamentals.

    Science.gov (United States)

    Chambers, David W

    2011-01-01

    Ethics is about studying the right and the good; morality is about acting as one should. Although there are differences among what is legal, charitable, professional, ethical, and moral, these desirable characteristics tend to cluster and are treasured in dentistry. The traditional approach to professionalism in dentistry is based on a theory of biomedical ethics advanced 30 years ago. Known as the principles approach, general ideals such as respect for autonomy, nonmaleficence, beneficence, justice, and veracity, are offered as guides. Growth in professionalism consists in learning to interpret the application of these principles as one's peers do. Moral behavior is conceived as a continuous cycle of sensitivity to situations requiring moral response, moral reasoning, the moral courage to take action when necessary, and integration of habits of moral behavior into one's character. This essay is the first of two papers that provide the backbone for the IDEA Project of the College--an online, multiformat, interactive "textbook" of ethics for the profession.

  16. Ethical leadership.

    Science.gov (United States)

    Keselman, David

    2012-01-01

    In today's climate and environment, the conventional relationship between caring, economic, and administrative practices no longer serves the interest of patients, clinicians, or systems. A shift toward human caring values and an ethic of authentic healing relationships is required as systems now have to value human resources and life purposes, inner meaning, and processes for providers and patients alike. The costs of unethical behavior can be even greater for followers. When we assume the benefits of leadership, we also assume ethical burdens. It is the assertion and experience of the author that the triangle of ethics and ethical behavior, followers, and patient's outcomes are closely interrelated and affect each other in a very intimate and direct way. Unethical leadership may lead to follower disappointment and distrust, leading to lack of interest and commitment, consequently negatively impacting patient outcomes and organizational effectiveness.

  17. "I think we've got too many tests!": Prenatal providers' reflections on ethical and clinical challenges in the practice integration of cell-free DNA screening.

    Science.gov (United States)

    Gammon, B L; Kraft, S A; Michie, M; Allyse, M

    2016-01-01

    The recent introduction of cell-free DNA-based non-invasive prenatal screening (cfDNA screening) into clinical practice was expected to revolutionize prenatal testing. cfDNA screening for fetal aneuploidy has demonstrated higher test sensitivity and specificity for some conditions than conventional serum screening and can be conducted early in the pregnancy. However, it is not clear whether and how clinical practices are assimilating this new type of testing into their informed consent and counselling processes. Since the introduction of cfDNA screening into practice in 2011, the uptake and scope have increased dramatically. Prenatal care providers are under pressure to stay up to date with rapidly changing cfDNA screening panels, manage increasing patient demands, and keep up with changing test costs, all while attempting to use the technology responsibly and ethically. While clinical literature on cfDNA screening has shown benefits for specific patient populations, it has also identified significant misunderstandings among providers and patients alike about the power of the technology. The unique features of cfDNA screening, in comparison to established prenatal testing technologies, have implications for informed decision-making and genetic counselling that must be addressed to ensure ethical practice. This study explored the experiences of prenatal care providers at the forefront of non-invasive genetic screening in the United States to understand how this testing changes the practice of prenatal medicine. We aimed to learn how the experience of providing and offering this testing differs from established prenatal testing methodologies. These differences may necessitate changes to patient education and consent procedures to maintain ethical practice. We used the online American Congress of Obstetricians and Gynecologists Physician Directory to identify a systematic sample of five prenatal care providers in each U.S. state and the District of Columbia. Beginning

  18. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research.

    Science.gov (United States)

    Megone, Christopher; Wilman, Eleanor; Oliver, Sandy; Duley, Lelia; Gyte, Gill; Wright, Judy

    2016-09-09

    Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? In a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental 'consent' to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental 'consent' in a perinatal context, parents are authorising infant participation, not giving 'proxy consent'. Finally, there are reasons for giving weight to both parental 'consent' and the infant's best interests in

  19. Ethical dilemmas

    DEFF Research Database (Denmark)

    Aabro, Christian

    2015-01-01

    What are the characteristics of an ethical dilemma? And how do we handle them in the area of early childhood education? These are some of the questions that will be dealt with in this chapter.......What are the characteristics of an ethical dilemma? And how do we handle them in the area of early childhood education? These are some of the questions that will be dealt with in this chapter....

  20. Capability ethics

    OpenAIRE

    Robeyns, Ingrid

    2012-01-01

    textabstractThe capability approach is one of the most recent additions to the landscape of normative theories in ethics and political philosophy. Yet in its present stage of development, the capability approach is not a full-blown normative theory, in contrast to utilitarianism, deontological theories, virtue ethics, or pragmatism. As I will argue in this chapter, at present the core of the capability approach is an account of value, which together with some other (more minor) normative comm...

  1. Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee

    Science.gov (United States)

    2012-01-01

    Background Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies. Methods The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning. Results The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research. Conclusion The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. PMID:22873761

  2. Ethical issues in research.

    Science.gov (United States)

    Artal, Raul; Rubenfeld, Sheldon

    2017-08-01

    Biomedical research is currently guided by ethical standards that have evolved over many centuries. Historical and political events, social and legal considerations, and continuous medical and technological advances have led to the prevailing research ethics and practice. Currently, patients and research subjects have complete autonomy while under medical care or when volunteering as research subjects. Enrolling volunteers in human subjects research includes a detailed and meaningful informed consent process that follows the cardinal principles of ethics: autonomy, beneficence, nonmaleficence, and justice. These principles were gradually adopted after World War II, primarily in response to the unethical behavior of German physicians and scientists during the Third Reich. This review emphasizes the importance of historical milestones and the essential role that ethics has in contemporary medical research. Research protocols should achieve maximum benefits for the society, have clinical and scientific value, be subject to independent review, respect human dignity, and follow the principles of informed consent, and most importantly, subjects should have complete autonomy. However, current principles and regulations cannot cover every conceivable situation, particularly in view of the new advances in science and technology. New and evolving medical technology, genetic research, therapeutic interventions, and innovations challenge society to maintain the highest moral and ethical principles. Copyright © 2017. Published by Elsevier Ltd.

  3. Ethical Orientations for Understanding Business Ethics.

    Science.gov (United States)

    Lewis, Phillip V.; Speck, Henry E., III

    1990-01-01

    Argues that history provides the necessary framework in which both to discuss and to seek answers to the three necessary and sequential questions about business ethics: (1) What is ethics and what does it mean to be ethical? (2) Why be ethical?; and (3) How can one be ethical? (SG)

  4. [Public health, genetics and ethics].

    Science.gov (United States)

    Kottow, Miguel H

    2002-10-01

    Genetics research has shown enormous developments in recent decades, although as yet with only limited clinical application. Bioethical analysis has been unable to deal with the vast problems of genetics because emphasis has been put on the principlism applied to both clinical and research bioethics. Genetics nevertheless poses its most complex moral dilemmas at the public level, where a social brand of ethics ought to supersede the essentially interpersonal perspective of principlism. A more social understanding of ethics in genetics is required to unravel issues such as research and clinical explorations, ownership and patents, genetic manipulation, and allocation of resources. All these issues require reflection based on the requirements of citizenry, consideration of common assets, and definition of public policies in regulating genetic endeavors and protecting the society as a whole Bioethics has privileged the approach to individual ethical issues derived from genetic intervention, thereby neglecting the more salient aspects of genetics and social ethics.

  5. Deterministic Graphical Games Revisited

    DEFF Research Database (Denmark)

    Andersson, Klas Olof Daniel; Hansen, Kristoffer Arnsfelt; Miltersen, Peter Bro

    2012-01-01

    Starting from Zermelo’s classical formal treatment of chess, we trace through history the analysis of two-player win/lose/draw games with perfect information and potentially infinite play. Such chess-like games have appeared in many different research communities, and methods for solving them......, such as retrograde analysis, have been rediscovered independently. We then revisit Washburn’s deterministic graphical games (DGGs), a natural generalization of chess-like games to arbitrary zero-sum payoffs. We study the complexity of solving DGGs and obtain an almost-linear time comparison-based algorithm...

  6. Bottomonium spectrum revisited

    CERN Document Server

    Segovia, Jorge; Entem, David R.; Fernández, Francisco

    2016-01-01

    We revisit the bottomonium spectrum motivated by the recently exciting experimental progress in the observation of new bottomonium states, both conventional and unconventional. Our framework is a nonrelativistic constituent quark model which has been applied to a wide range of hadronic observables from the light to the heavy quark sector and thus the model parameters are completely constrained. Beyond the spectrum, we provide a large number of electromagnetic, strong and hadronic decays in order to discuss the quark content of the bottomonium states and give more insights about the better way to determine their properties experimentally.

  7. Metamorphosis in Craniiformea revisited

    DEFF Research Database (Denmark)

    Altenburger, Andreas; Wanninger, Andreas; Holmer, Lars E.

    2013-01-01

    We revisited the brachiopod fold hypothesis and investigated metamorphosis in the craniiform brachiopod Novocrania anomala. Larval development is lecithotrophic and the dorsal (brachial) valve is secreted by dorsal epithelia. We found that the juvenile ventral valve, which consists only of a thin...... brachiopods during metamorphosis to cement their pedicle to the substrate. N. anomala is therefore not initially attached by a valve but by material corresponding to pedicle cuticle. This is different to previous descriptions, which had led to speculations about a folding event in the evolution of Brachiopoda...

  8. Ética organizacional: um estudo em clínicas oftalmológicas Organizational ethics: a study in ophthalmologic clinics

    Directory of Open Access Journals (Sweden)

    Maria Aparecida Sanches

    2005-12-01

    Full Text Available OBJETIVO: Pesquisar no campo da ética organizacional para averiguar até que ponto as clínicas oftalmológicas, imersas no ambiente competitivo, na condição de organizações em busca de sobrevivência, subordinam a ética à competitividade na práxis gerencial, isto é, na esfera da administração. MÉTODOS: Toma Kohlberg como referencial teórico, abordando o tema da subordinação ética à competitividade. Aplicou instrumento para avaliar comportamentos morais das organizações, elaborado por Licht. Faz uso de método quantitativo, adotando instrumentos analíticos, tais como Q de Yule e testes não paramétricos, no tratamento dos dados de 41 clínicas oftalmológicas. RESULTADOS: Os resultados da pesquisa parecem indicar que administradores de clínicas oftalmológicas de maior desempenho, subjugam os princípios éticos à competitividade, com vistas a assegurar a sobrevivência da empresa e, quando aferidos pelo instrumento para avaliar seu comportamento moral, proposto por Kohlberg, têm presença significativamente menor no estágio pós-convencional do que administradores de clínicas oftalmológicas de menor desempenho. Pode-se afirmar, de acordo com os testes não paramétricos, que, ao nível de significância de 0,05, os níveis de desenvolvimento moral dos dois grupos diferem significativamente. CONCLUSÕES: Os resultados obtidos estão conforme a literatura, especialmente no tocante ao "paradoxo da subordinação ética e competitividade". Vão também ao encontro de que a garantia da sobrevivência da empresa tende a diminuir a percepção dos grupos no poder no que se refere aos problemas ocorridos na comunidade e que ocorre redução dos valores éticos subordinados à competição, redução esta que provoca sentimentos crescentes de disputas econômicas na esfera social.PURPOSE: Research on the field of organizational ethics to investigate to which extent ophthalmologic clinics, inserted in the competitive atmosphere

  9. Ecological Ethics

    International Nuclear Information System (INIS)

    Oughton, Deborah

    2013-01-01

    Deborah Oughton started with a view of the work in progress by the ICRP TG 94 on ethics, from the historical context and the principles-based ethics in RP, to continue with an overview of the ethical theories and with the main area of elaboration which concerns the common values, to conclude with considerations about the implementation in different area such as biomedicine, nuclear safety and workers, ecological aspects, and environmental health and society. By reading again the ICRP and IAEA publications on the ethical aspects in the protection of environment from the effects of ionizing radiation, the presentation covers the various and different cultures within the history of environmental ethics, the perception of Nature and the theories of environmental ethics, in particular by focusing on anthropocentrism, biocentrism and ecocentrism, as philosophical worldwide views, and on conservation, biodiversity, sustainability, environmental justice and human dignity, as primary principles of environmental protection. The influence of western Christianity, with a view of man dominating over every creeping thing on earth, and of the non-western ideas, the human perception of Nature has been analyzed and discussed to conclude that, in reality then, the anthropocentrism, biocentrism and ecocentrism, as reflected in many cultures and religions, they all support the need to protect the environment and to recognise and preserve the diversity. Three challenges were then discussed in the presentation: the ecosystem approach and ecological economics, for example in the case of Fukushima by asking what is the economic cost of marine contamination; the ecosystem changes with attention to what harms, as in the case of the environment in the contaminated areas around Chernobyl; and the environmental consequences of remediation, which can be considered a source of controversy for environmental ethics and policy

  10. Under the shelter of ethics.

    Science.gov (United States)

    Lichterman, Boleslav L

    2005-01-01

    Problems of ethics committees in post-communist Russia are briefly discussed. The first ethics committees were established in 1980s upon the initiative of international pharmaceutical companies involved in clinical trials. Generally, such committees exist at hospitals conducting these trials and at research institutions dealing with human experimentation. They are bureaucratic structures heavily dependent on hospital or institution administration. Publication of research results in international periodicals is the main reason for their existence. An officially recognized National Ethics Committee is non-existent although there are several competing ethics committees at a national level (at the Ministry of Health, Academy of Sciences, Academy of Medical Sciences, Russian Medical association etc.). There is no federal legislation on the structure and status of ethics committees.

  11. Revisiting Nursing Research in Nigeria

    African Journals Online (AJOL)

    2016-08-18

    Aug 18, 2016 ... health care research, it is therefore pertinent to revisit the state of nursing research in the country. .... platforms, updated libraries with electronic resource ... benchmarks for developing countries of 26%, [17] the amount is still ...

  12. Ethical issues in neurogenetics.

    Science.gov (United States)

    Uhlmann, Wendy R; Roberts, J Scott

    2018-01-01

    Many neurogenetic conditions are inherited and therefore diagnosis of a patient will have implications for the patient's relatives and can raise ethical issues. Predictive genetic testing offers asymptomatic relatives the opportunity to determine their risk status for a neurogenetic condition, and professional guidelines emphasize patients' autonomy and informed, voluntary decision making. Beneficence and nonmaleficence both need to be considered when making decisions about disclosure and nondisclosure of genetic information and test results. There can be disclosure concerns and challenges in determining whose autonomy to prioritize when a patient makes a genetic testing decision that can reveal the genetic status of a relative (e.g., testing an adult child when the at-risk parent has not been tested). Ethical issues are prominent when genetic testing for neurogenetic conditions is requested prenatally, on minors, adoptees, adult children at 25% risk, and for individuals with psychiatric issues or cognitive impairment. Neurogenetic conditions can result in cognitive decline which can affect decisional capacity and lead to ethical challenges with decision making, informed consent, and determining the patient's ability to comprehend test results. The ethical implications of genetic testing and emerging issues, including direct-to-consumer genetic testing, disclosure of secondary findings from genomic sequencing, and use of apolipoprotein E testing in clinical and research settings, are also discussed. Resources for information about genetic testing practice guidelines, insurance laws, and directories of genetics clinics are included. Copyright © 2018 Elsevier B.V. All rights reserved.

  13. Ethics and research in critical care.

    Science.gov (United States)

    Silverman, Henry J; Lemaire, Francois

    2006-11-01

    The past few years have witnessed several controversies regarding the ethics of conducting research involving critically ill patients, and such research is ethically challenging. Research ethics is a changing field, one that is influenced by empirical data, contemporary events, and new ideas regarding aspects of clinical trial design and protection of human subjects. We describe recent thoughts regarding several aspects of research ethics in the critical care context. The ability of the research community to conduct research ethically and to maintain public trust would benefit from heightened awareness to the principles and requirements that govern such research.

  14. Predictors and Outcomes of Revisits in Older Adults Discharged from the Emergency Department.

    Science.gov (United States)

    de Gelder, Jelle; Lucke, Jacinta A; de Groot, Bas; Fogteloo, Anne J; Anten, Sander; Heringhaus, Christian; Dekkers, Olaf M; Blauw, Gerard J; Mooijaart, Simon P

    2018-04-01

    To study predictors of emergency department (ED) revisits and the association between ED revisits and 90-day functional decline or mortality. Multicenter cohort study. One academic and two regional Dutch hospitals. Older adults discharged from the ED (N=1,093). At baseline, data on demographic characteristics, illness severity, and geriatric parameters (cognition, functional capacity) were collected. All participants were prospectively followed for an unplanned revisit within 30 days and for functional decline and mortality 90 days after the initial visit. The median age was 79 (interquartile range 74-84), and 114 participants (10.4%) had an ED revisit within 30 days of discharge. Age (hazard ratio (HR)=0.96, 95% confidence interval (CI)=0.92-0.99), male sex (HR=1.61, 95% CI=1.05-2.45), polypharmacy (HR=2.06, 95% CI=1.34-3.16), and cognitive impairment (HR=1.71, 95% CI=1.02-2.88) were independent predictors of a 30-day ED revisit. The area under the receiver operating characteristic curve to predict an ED revisit was 0.65 (95% CI=0.60-0.70). In a propensity score-matched analysis, individuals with an ED revisit were at higher risk (odds ratio=1.99 95% CI=1.06-3.71) of functional decline or mortality. Age, male sex, polypharmacy, and cognitive impairment were independent predictors of a 30-day ED revisit, but no useful clinical prediction model could be developed. However, an early ED revisit is a strong new predictor of adverse outcomes in older adults. © 2018 The Authors. The Journal of the American Geriatrics Society published by Wiley Periodicals, Inc. on behalf of The American Geriatrics Society.

  15. Ethical issues in the marketisation of education: the case for social ...

    African Journals Online (AJOL)

    commodification of higher education in Uganda. It argues that in order to underscore ethical issues posed by educational markets particularly in the area of social justice, it is prudent to revisit the salient principles of social justice as well as the ideological ...

  16. Visual Form, Ethics, and a Typology of Purpose: Teaching Effective Information Design

    Science.gov (United States)

    Rosenquist, Christina

    2012-01-01

    Stallworth Williams introduces concepts of visual rhetoric and ethics for a classroom exercise in the analysis and revision of a sales letter. This article revisits Stallworth Williams's proposed teaching strategies, suggesting that not only do students need to be instructed in elements of visual design, but they must also be taught to link those…

  17. Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs is yet unclear.To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval.We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why.Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs. NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14% versus 78/288 (27%, p<0.001, missing data excluded. Poor recruitment was the most frequent reason for discontinuation in both NPSs (36% and RCTs (37%.Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs.

  18. Data Ethics

    DEFF Research Database (Denmark)

    Hasselbalch, Gry; Tranberg, Pernille

    Respect for privacy and the right to control one’s own data are becoming key parameters to gain a competitive edge in today’s business world. Companies, organisations and authorities which view data ethics as a social responsibility, giving it the same importance as environmental awareness...... and respect for human rights, are tomorrow’s winners. Digital trust is paramount to digital growth and prosperity. This book combines broad trend analyses with case studies to examine companies which use data ethics to varying degrees. The authors make the case that citizens and consumers are no longer just...... concerned about a lack of control over their data, but they also have begun to act. In addition, they describe alternative business models, advances in technology and a new European data protection regulation, all of which combine to foster a growing market for data-ethical products and services...

  19. Research ethics consultation: ethical and professional practice challenges and recommendations.

    Science.gov (United States)

    Sharp, Richard R; Taylor, Holly A; Brinich, Margaret A; Boyle, Mary M; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

    2015-05-01

    The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.

  20. Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations

    Science.gov (United States)

    Sharp, Richard R.; Taylor, Holly A.; Brinich, Margaret A.; Boyle, Mary M.; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

    2015-01-01

    The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include: assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical Translational Science Award (CTSA) Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: 1) managing multiple institutional roles and responsibilities, 2) managing sensitive information, and 3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services. PMID:25607942

  1. "Measuring up" to ethical standards in service delivery to college students on the Autism Spectrum: A practical application of Powell's model for ethical practices in clinical phonetics and linguistics.

    Science.gov (United States)

    Weiss, Amy L; Rohland, Pamela

    2014-01-01

    This paper examined an interdisciplinary college-based support programme, the Communication Coaching Program (CCP), designed for students diagnosed on the autism spectrum in light of six ethical constructs described by Powell. Collecting data to monitor the successes and ongoing needs of individual participants in the programme is of vital importance, of course, but only addresses a portion of the efficacy question. In addition, the authors, who co-direct the programme and represent different professional expertise and perspectives, recognize the importance of determining whether their evolving intervention model has also been successful in meeting the ethical standards of their respective professions. Careful review of the 4 years of the CCP's operation in terms of ethical constructs has yielded evidence that the CCP, although based on sound principles of theory and scholarship, should be further individualized to meet the particular needs of participants diagnosed with deficits in social communication and executive functioning skills.

  2. Reconsidering 'ethics' and 'quality' in healthcare research: the case for an iterative ethical paradigm.

    Science.gov (United States)

    Stevenson, Fiona A; Gibson, William; Pelletier, Caroline; Chrysikou, Vasiliki; Park, Sophie

    2015-05-08

    UK-based research conducted within a healthcare setting generally requires approval from the National Research Ethics Service. Research ethics committees are required to assess a vast range of proposals, differing in both their topic and methodology. We argue the methodological benchmarks with which research ethics committees are generally familiar and which form the basis of assessments of quality do not fit with the aims and objectives of many forms of qualitative inquiry and their more iterative goals of describing social processes/mechanisms and making visible the complexities of social practices. We review current debates in the literature related to ethical review and social research, and illustrate the importance of re-visiting the notion of ethics in healthcare research. We present an analysis of two contrasting paradigms of ethics. We argue that the first of these is characteristic of the ways that NHS ethics boards currently tend to operate, and the second is an alternative paradigm, that we have labelled the 'iterative' paradigm, which draws explicitly on methodological issues in qualitative research to produce an alternative vision of ethics. We suggest that there is an urgent need to re-think the ways that ethical issues are conceptualised in NHS ethical procedures. In particular, we argue that embedded in the current paradigm is a restricted notion of 'quality', which frames how ethics are developed and worked through. Specific, pre-defined outcome measures are generally seen as the traditional marker of quality, which means that research questions that focus on processes rather than on 'outcomes' may be regarded as problematic. We show that the alternative 'iterative' paradigm offers a useful starting point for moving beyond these limited views. We conclude that a 'one size fits all' standardisation of ethical procedures and approach to ethical review acts against the production of knowledge about healthcare and dramatically restricts what can be

  3. Transgressive ethics

    DEFF Research Database (Denmark)

    Hoeyer, Klaus; Jensen, Anja Marie Bornø

    2013-01-01

    of treatment norms, we must move close to everyday work practices and appreciate the importance of material–technical treatment options as well as the interplay of professional ethics and identity. The cardiac treatment of brain-dead donors may thereby illuminate how treatment norms develop on the ground...

  4. Animal ethics

    DEFF Research Database (Denmark)

    Palmer, Clare; Sandøe, Peter

    2011-01-01

    This chapter describes and discusses different views concerning our duties towards animals. First, we explain why it is necessary to engage in thinking about animal ethics and why it is not enough to rely on feelings alone. Secondly, we present and discuss five different kinds of views about...

  5. Capability ethics

    NARCIS (Netherlands)

    I.A.M. Robeyns (Ingrid)

    2012-01-01

    textabstractThe capability approach is one of the most recent additions to the landscape of normative theories in ethics and political philosophy. Yet in its present stage of development, the capability approach is not a full-blown normative theory, in contrast to utilitarianism, deontological

  6. [The ethical reflection approach, a source of wellbeing at work].

    Science.gov (United States)

    Bréhaux, Karine; Grésyk, Bénédicte

    2014-01-01

    Clinical nursing practice, beyond its application to care procedures, can be expressed in terms of ethical added value in the support of patients. In Reims university hospital, where a clinical ethics and care think-tank was created in June 2010, the ethical reflection approach is encouraged in order to reemphasise the global meaning of care as a source of wellbeing at work.

  7. A Plutocratic Proposal: an ethical way for rich patients to pay for a place on a clinical trial.

    Science.gov (United States)

    Masters, Alexander; Nutt, Dominic

    2017-11-01

    Many potential therapeutic agents are discarded before they are tested in humans. These are not quack medications. They are drugs and other interventions that have been developed by responsible scientists in respectable companies or universities and are often backed up by publications in peer-reviewed journals. These possible treatments might ease suffering and prolong the lives of innumerable patients, yet they have been put aside. In this paper, we outline a novel mechanism-the Plutocratic Proposal-to revive such neglected research and fund early phase clinical trials. The central idea of the Proposal is that any patient who rescues a potential therapeutic agent from neglect by funding early phase clinical trials (either entirely or in large part) should be offered a place on the trial. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. Life quality index revisited

    DEFF Research Database (Denmark)

    Ditlevsen, Ove Dalager

    2004-01-01

    The derivation of the life quality index (LQI) is revisited for a revision. This revision takes into account the unpaid but necessary work time needed to stay alive in clean and healthy conditions to be fit for effective wealth producing work and to enjoyable free time. Dimension analysis...... at birth should not vary between countries. Finally the distributional assumptions are relaxed as compared to the assumptions made in an earlier work by the author. These assumptions concern the calculation of the life expectancy change due to the removal of an accident source. Moreover a simple public...... consistency problems with the standard power function expression of the LQI are pointed out. It is emphasized that the combination coefficient in the convex differential combination between the relative differential of the gross domestic product per capita and the relative differential of the expected life...

  9. Quantum duel revisited

    International Nuclear Information System (INIS)

    Schmidt, Alexandre G M; Paiva, Milena M

    2012-01-01

    We revisit the quantum two-person duel. In this problem, both Alice and Bob each possess a spin-1/2 particle which models dead and alive states for each player. We review the Abbott and Flitney result—now considering non-zero α 1 and α 2 in order to decide if it is better for Alice to shoot or not the second time—and we also consider a duel where players do not necessarily start alive. This simple assumption allows us to explore several interesting special cases, namely how a dead player can win the duel shooting just once, or how can Bob revive Alice after one shot, and the better strategy for Alice—being either alive or in a superposition of alive and dead states—fighting a dead opponent. (paper)

  10. Satellite failures revisited

    Science.gov (United States)

    Balcerak, Ernie

    2012-12-01

    In January 1994, the two geostationary satellites known as Anik-E1 and Anik-E2, operated by Telesat Canada, failed one after the other within 9 hours, leaving many northern Canadian communities without television and data services. The outage, which shut down much of the country's broadcast television for hours and cost Telesat Canada more than $15 million, generated significant media attention. Lam et al. used publicly available records to revisit the event; they looked at failure details, media coverage, recovery effort, and cost. They also used satellite and ground data to determine the precise causes of those satellite failures. The researchers traced the entire space weather event from conditions on the Sun through the interplanetary medium to the particle environment in geostationary orbit.

  11. Logistics Innovation Process Revisited

    DEFF Research Database (Denmark)

    Gammelgaard, Britta; Su, Shong-Iee Ivan; Yang, Su-Lan

    2011-01-01

    Purpose – The purpose of this paper is to learn more about logistics innovation processes and their implications for the focal organization as well as the supply chain, especially suppliers. Design/methodology/approach – The empirical basis of the study is a longitudinal action research project...... that was triggered by the practical needs of new ways of handling material flows of a hospital. This approach made it possible to revisit theory on logistics innovation process. Findings – Apart from the tangible benefits reported to the case hospital, five findings can be extracted from this study: the logistics...... innovation process model may include not just customers but also suppliers; logistics innovation in buyer-supplier relations may serve as an alternative to outsourcing; logistics innovation processes are dynamic and may improve supplier partnerships; logistics innovations in the supply chain are as dependent...

  12. Klein's double discontinuity revisited

    DEFF Research Database (Denmark)

    Winsløw, Carl; Grønbæk, Niels

    2014-01-01

    Much effort and research has been invested into understanding and bridging the ‘gaps’ which many students experience in terms of contents and expectations as they begin university studies with a heavy component of mathematics, typically in the form of calculus courses. We have several studies...... of bridging measures, success rates and many other aspects of these “entrance transition” problems. In this paper, we consider the inverse transition, experienced by university students as they revisit core parts of high school mathematics (in particular, calculus) after completing the undergraduate...... mathematics courses which are mandatory to become a high school teacher of mathematics. To what extent does the “advanced” experience enable them to approach the high school calculus in a deeper and more autonomous way ? To what extent can “capstone” courses support such an approach ? How could it be hindered...

  13. Ethics in Turkish nursing education programs.

    Science.gov (United States)

    Görgülü, Refia Selma; Dinç, Leyla

    2007-11-01

    This descriptive study investigated the current status of ethics instruction in Turkish nursing education programs. The sample for this study comprised 39 nursing schools, which represented 51% of all nursing schools in Turkey. Data were collected through a postal questionnaire. The results revealed that 18 of these nursing schools incorporated an ethics course into undergraduate and three into graduate level programs. Most of the educators focused on the basic concepts of ethics, deontological theory, ethical principles, ethical problems in health care, patient rights and codes of ethics for nurses. More than half of the educators believed that students' theoretical knowledge of ethics is applied to their clinical experiences. The teaching methods used included discussion in class, lectures, case studies, small group discussion, dramatization and demonstration. Assessment was carried out by means of written essays and written examinations.

  14. Morality, ethics, and law: introductory concepts.

    Science.gov (United States)

    Horner, Jennifer

    2003-11-01

    The purpose of this article is to differentiate morality, ethics, and law. Morality refers to a set of deeply held, widely shared, and relatively stable values within a community. Ethics as a philosophical enterprise involves the study of values, and the justification for right and good actions, as represented by the classic works of Aristotle (virtue ethics), Kant (duty-based ethics), and Bentham and Mill (utilitarian and consequentialist ethics). Applied ethics, in contrast, is the use of ethics principles (e.g., respect for autonomy, beneficence, and nonmaleficence, justice) in actual situations, such as in professional and clinical life. Finally, law is comprised of concrete duties established by governments that are necessary for maintaining social order and resolving disputes, as well as for distributing social resources according to what people need or deserve.

  15. Physiotherapy devices able to generate ethical dilemmas

    Directory of Open Access Journals (Sweden)

    Roman Nadinne

    2017-01-01

    Full Text Available Physical therapy is a medical specialty where the professionals help restore movement and function when someone is affected by injury, illness or disability. This paper wishes to establish the connection between ethics, physiotherapy and bioengineering. The research method was achieved using academic database searches based on specific keywords. A SWOT analysis of the physiotherapy devices utilization and design was made, for extracting ethical considerations. The main results suggest that physiotherapy devices are able to generate ethical dilemmas, classified in 4 main items: (1 Bioengineering in physical therapy, ethical and clinical standards for manufacturers; (2 Social impact of physical therapy devices and ethical issues; (3 Inter-professional lack of communication and ethical concerns; (4 Bioengineering ethical research and education. As conclusions, for the physical therapy or electrotherapy research equipment development, a multidisciplinary team is needed. The equipment used in rehabilitation must fulfil specific technical and scientific requirements drafted by the professionals.

  16. [Accreditation of Independent Ethics Committees].

    Science.gov (United States)

    Ramiro Avilés, Miguel A

    According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated. National and regional legislation governing biomedical research was analysed. No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation. Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. Ethics Requirement Score: new tool for evaluating ethics in publications.

    Science.gov (United States)

    Santos, Lígia Gabrielle dos; Costa e Fonseca, Ana Carolina da; Bica, Claudia Giuliano

    2014-01-01

    To analyze ethical standards considered by health-related scientific journals, and to prepare the Ethics Requirement Score, a bibliometric index to be applied to scientific healthcare journals in order to evaluate criteria for ethics in scientific publication. Journals related to healthcare selected by the Journal of Citation Reports™ 2010 database were considered as experimental units. Parameters related to publication ethics were analyzed for each journal. These parameters were acquired by analyzing the author's guidelines or instructions in each journal website. The parameters considered were approval by an Internal Review Board, Declaration of Helsinki or Resolution 196/96, recommendations on plagiarism, need for application of Informed Consent Forms with the volunteers, declaration of confidentiality of patients, record in the database for clinical trials (if applicable), conflict of interest disclosure, and funding sources statement. Each item was analyzed considering their presence or absence. The foreign journals had a significantly higher Impact Factor than the Brazilian journals, however, no significant results were observed in relation to the Ethics Requirement Score. There was no correlation between the Ethics Requirement Score and the Impact Factor. Although the Impact Factor of foreigner journals was considerably higher than that of the Brazilian publications, the results showed that the Impact Factor has no correlation with the proposed score. This allows us to state that the ethical requirements for publication in biomedical journals are not related to the comprehensiveness or scope of the journal.

  18. Ethics Requirement Score: new tool for evaluating ethics in publications

    Science.gov (United States)

    dos Santos, Lígia Gabrielle; Fonseca, Ana Carolina da Costa e; Bica, Claudia Giuliano

    2014-01-01

    Objective To analyze ethical standards considered by health-related scientific journals, and to prepare the Ethics Requirement Score, a bibliometric index to be applied to scientific healthcare journals in order to evaluate criteria for ethics in scientific publication. Methods Journals related to healthcare selected by the Journal of Citation Reports™ 2010 database were considered as experimental units. Parameters related to publication ethics were analyzed for each journal. These parameters were acquired by analyzing the author’s guidelines or instructions in each journal website. The parameters considered were approval by an Internal Review Board, Declaration of Helsinki or Resolution 196/96, recommendations on plagiarism, need for application of Informed Consent Forms with the volunteers, declaration of confidentiality of patients, record in the database for clinical trials (if applicable), conflict of interest disclosure, and funding sources statement. Each item was analyzed considering their presence or absence. Result The foreign journals had a significantly higher Impact Factor than the Brazilian journals, however, no significant results were observed in relation to the Ethics Requirement Score. There was no correlation between the Ethics Requirement Score and the Impact Factor. Conclusion Although the Impact Factor of foreigner journals was considerably higher than that of the Brazilian publications, the results showed that the Impact Factor has no correlation with the proposed score. This allows us to state that the ethical requirements for publication in biomedical journals are not related to the comprehensiveness or scope of the journal. PMID:25628189

  19. Using best interests meetings for people in a prolonged disorder of consciousness to improve clinical and ethical management.

    Science.gov (United States)

    Wade, Derick T

    2018-05-01

    Current management of people with prolonged disorders of consciousness is failing patients, families and society. The causes include a general lack of concern, knowledge and expertise; a legal and professional framework which impedes timely and appropriate decision-making and/or enactment of the decision; and the exclusive focus on the patient, with no legitimate means to consider the broader consequences of healthcare decisions. This article argues that a clinical pathway based on the principles of (a) the English Mental Capacity Act 2005 and (b) using time-limited treatment trials could greatly improve patient management and reduce stress on families. There needs to be early and continuing use of formal best interests meetings, starting between 7 and 21 days after onset of unconsciousness (from any cause, including progressive disorders). The treatment options need to evolve as the clinical state and prognosis becomes more certain. A formal discussion of treatment withdrawal should occur when the upper bound of predicted recovery falls below a level the patient would have considered acceptable, and it should always be discussed when the condition is considered permanent. Any decision to stop treatment should be contingent on a formal second opinion from an independent expert who should review the clinical situation and expected prognosis, but not the best interests decision. The article also asks how, if at all, the adverse effects on the family and the resource implications of long-term care of people left in a prolonged state of unconsciousness should be incorporated in the process. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Ethical obligations and clinical goals in end-of-life care: deriving a quality-of-life construct based on the Islamic concept of accountability before God (taklīf).

    Science.gov (United States)

    Padela, Aasim; Mohiuddin, Afshan

    2015-01-01

    End-of-life medical decision making presents a major challenge to patients and physicians alike. In order to determine whether it is ethically justifiable to forgo medical treatment in such scenarios, clinical data must be interpreted alongside patient values, as well as in light of the physician's ethical commitments. Though much has been written about this ethical issue from religious perspectives (especially Christian and Jewish), little work has been done from an Islamic point of view. To fill the gap in the literature around Islamic bioethical perspectives on the matter, we derive a theologically rooted rubric for goals of care. We use the Islamic obligation for Muslims to seek medical treatment as the foundation for determining the clinical conditions under which Muslim physicians have a duty to treat. We next link the theological concept of accountability before God (taklīf) to quality-of-life assessment. Using this construct, we suggest that a Muslim physician is not obligated to maintain or continue clinical treatment when patients who were formerly of, or had the potential to be, mukallaf (the term for a person who has taklīf), are now not expected to regain that status by means of continued clinical treatment.

  1. Do Ethics Classes Teach Ethics?

    Science.gov (United States)

    Curzer, Howard J.; Sattler, Sabrina; DuPree, Devin G.; Smith-Genthôs, K. Rachelle

    2014-01-01

    The ethics assessment industry is currently dominated by the second version of the Defining Issues Test (DIT2). In this article, we describe an alternative assessment instrument called the Sphere-Specific Moral Reasoning and Theory Survey (SMARTS), which measures the respondent's level of moral development in several respects. We describe eight…

  2. Association of Clinical Benign Prostate Hyperplasia with Prostate Cancer Incidence and Mortality Revisited: A Nationwide Cohort Study of 3 009 258 Men

    DEFF Research Database (Denmark)

    Ørsted, David Dynnes; Bojesen, Stig E; Nielsen, Sune F

    2011-01-01

    BACKGROUND: Although benign prostate hyperplasia (BPH) and prostate cancer (PCa) share features such as hormone-dependent growth and response to treatment with antiandrogen therapy, BPH is generally not considered a premalignant lesion. OBJECTIVE: To determine whether clinical BPH is associated......), information on PCa mortality (n=25 459), and ascertained clinical BPH (not histologically proven BPH) through hospitalization (n=187 591) and/or surgery (n=77 698) from 1980 to 2006 and the use of a-adrenergic receptor antagonists (n=143 365) and/or the use of 5a-reductase inhibitors (5-ARIs) (n=47 465) from......-matched cohort studies, corresponding HRs for PCa incidence were 3.04 (2.96-3.13) for hospitalization, 2.60 (2.47-2.73) for surgery, 4.49 (4.33-4.65) for a-adrenergic receptor antagonist use, and 2.54 (2.40-2.68) for 5-ARI use. Each category of clinical BPH has limitations, but limitations differ between...

  3. A critical analysis and discussion of clinical research ethics in the Russian Federation and their implications for Western sponsored trials.

    Science.gov (United States)

    Leintz, Christopher

    2014-06-01

    Globalization, political upheavals, and Western economic struggles have caused a geographical reprioritization in the realm of drug development and human clinical research. Regulatory and cost hurdles as well as a saturation of research sites and subjects in Western countries have forced the pharmaceutical industry to place an unprecedented level of importance on emerging markets, injecting Western corporate initiatives into cultures historically and socially isolated from Western-centric value systems. One of the greatest recipients of this onslaught of Western business and research practices is the Russian Federation. Namely, market forces are dictating a focused research initiative in the traditional emerging markets, but this focus may be at the expense of individual and societal dignity. © 2012 John Wiley & Sons Ltd.

  4. The ethics of withdrawal: the case of follow-up from first-in-human clinical trials.

    Science.gov (United States)

    Hug, Kristina; Johansson, Mats

    2017-01-01

    This paper aims to analyze whether patients should be allowed to veto research-related use of medical data collected during routine follow-ups after their withdrawal from first-in-human clinical trials. Forms of withdrawal are identified and it is argued that the right to withdraw might be limited to some of these. The paper concludes that if veto right is denied, then: the research participant should be informed about the potential use of his/her follow-up data in case of his/her withdrawal and consent to it; follow-up should not be initiated for research purposes; compulsory use of follow-up data should imply the use of data anyway collected, requiring no additional effort from the patient; and before deciding about the veto right, investigation of concerned patients' value preferences is needed.

  5. The clinical phenotype associated with myositis-specific and associated autoantibodies: a meta-analysis revisiting the so-called antisynthetase syndrome.

    Science.gov (United States)

    Lega, Jean-Christophe; Fabien, Nicole; Reynaud, Quitterie; Durieu, Isabelle; Durupt, Stéphane; Dutertre, Marine; Cordier, Jean-François; Cottin, Vincent

    2014-09-01

    To describe the clinical spectrum associated with aminoacyl-transfer RNA synthetase (ARS) autoantibodies in patients with idiopathic inflammatory myositis defined according to Peter and Bohan's criteria. Cohort studies were selected from MEDLINE and Embase up to August 2013. Two investigators independently extracted data on study design, patient characteristics, and clinical features (interstitial lung disease [ILD], fever, mechanic's hands [MH], Raynaud's phenomenon [RPh], arthralgia, sclerodactyly, cancer and dermatomyositis-specific rash) according to the presence of myositis-specific (anti-aminoacyl-transfer RNA synthetase [ARS], anti-signal recognition particle [anti-SRP] and anti-Mi2) and myositis-associated (anti-PM/Scl, anti-U1-RNP and anti-Ku) autoantibodies. 27 studies (3487 patients) were included in the meta-analysis. Arthralgia (75%, CI 67-81) and ILD (69%, CI 63-74) were the most prevalent clinical signs associated with anti-ARS autoantibodies. Anti-Mi2 and anti-SRP autoantibodies were associated with few extramuscular signs. ARS autoantibodies were identified in 13% of patients with cancer-associated myositis (5-25). Patients with non-anti-Jo1 ARS had greater odds of presenting fever (RR 0.63, CI 0.52-0.90) and ILD (RR 0.87, CI 0.81-0.93) compared to those with anti-Jo1 autoantibodies. The frequencies of myositis (RR 1.60, CI 1.38-1.85), arthralgia (RR 1.52, CI 1.32-1.76) and MH (RR 1.47, CI 1.11-1.94) were almost 50% higher in patients with anti-Jo1 compared to non-anti-Jo1 ARS autoantibodies. Patients with anti-PM/Scl differed from those with anti-ARS autoantibodies by a greater prevalence of RPh (RR 0.70, CI 0.53-0.94) and sclerodactyly (RR 0.47, CI 0.25-0.89). ILD was less frequent in patients with anti-U1-RNP autoantibodies (RR 3.35, CI 1.07-10.43). No difference was observed between anti-ARS and myositis-associated autoantibodies for other outcomes. The presence of anti-ARS autoantibodies delimits a heterogeneous subset of patients with a high

  6. Ethics and mental illness research.

    Science.gov (United States)

    Roberts, Laura Weiss

    2002-09-01

    There are many tasks ahead in the area of ethics and mental illness research. We face unknown challenges in psychiatric genetics projects, studies of psychopharmacological interventions in children, controversial scientific designs (e.g., symptom challenge, medication-free interval), and cross-disciplinary research incorporating goals and methods of health services, epidemiology, and social and behavioral science endeavors. Boundaries between innovative clinical practices and research-related experimentation will become increasingly difficult to distinguish, as will the roles between clinicians, clinical researchers, and basic scientists. Moreover, the institutions and systems in which research occurs are being rapidly and radically revised, raising new questions about oversight responsibilities and standards. Our ability to identify and respond to the ethical questions arising in this uncharted territory will depend on our willingness to self-reflect, to integrate the observations and insights of the past century, to think with great clarity, and to anticipate novel ethical problems that keep company with scientific advancements. It will also depend on data. Empirical study of ethical dimensions of human research is essential to anchor and attune the intuitions and theoretical constructs that we develop. Science and ethics have changed over the past 100 years, as they will over the next century. It is ironic that the ethical acceptability of psychiatric research is so much in question at this time, when it holds so much promise for advancing our understanding of mental illness and its treatment. The tension between the duty to protect vulnerable individuals and the duty to perform human science will continue to grow, as long as ethics and science are seen as separable, opposing forces with different aims championed by different heroes. The profession of psychiatry is poised to move toward a new, more coherent research ethics paradigm in which scientific and

  7. Anesthesiological ethics: can informed consent be implied?

    Science.gov (United States)

    Spike, Jeffrey R

    2012-01-01

    Surgical ethics is a well-recognized field in clinical ethics, distinct from medical ethics. It includes at least a dozen important issues common to surgery that do not exist in internal medicine simply because of the differences in their practices. But until now there has been a tendency to include ethical issues of anesthesiology as a part of surgical ethics. This may mask the importance of ethical issues in anesthesiology, and even help perpetuate an unfortunate view that surgeons are "captain of the ship" in the operating theater (leaving anesthesiologists in a subservient role). We will have a better ethical understanding if we see surgery and anesthesia as two equal partners, ethically as well as in terms of patient care. Informed consent is one such issue, but it is not limited to that. Even on the topic of what type of anesthesia to use, anesthesiologists have often felt subsumed to the surgeon's preferences. This commentary takes the case study and uses it as a exemplar for this very claim: it is time to give due recognition for a new field in clinical ethics, ethics in anesthesia.

  8. Why Are There So Few Ethics Consults in Children's Hospitals?

    Science.gov (United States)

    Carter, Brian; Brockman, Manuel; Garrett, Jeremy; Knackstedt, Angie; Lantos, John

    2017-10-03

    In most children's hospitals, there are very few ethics consultations, even though there are many ethically complex cases. We hypothesize that the reason for this may be that hospitals develop different mechanisms to address ethical issues and that many of these mechanisms are closer in spirit to the goals of the pioneers of clinical ethics than is the mechanism of a formal ethics consultation. To show how this is true, we first review the history of collaboration between philosophers and physicians about clinical dilemmas. Then, as a case-study, we describe the different venues that have developed at one children's hospital to address ethical issues. At our hospital, there are nine different venues in which ethical issues are regularly and explicitly addressed. They are (1) ethics committee meetings, (2) Nursing Ethics Forum, (3) ethics Brown Bag workshops, (4) PICU ethics rounds, (5) Grand Rounds, (6) NICU Comprehensive Care Rounds, (7) Palliative Care Team (PaCT) case conferences, (8) multidisciplinary consults in Fetal Health Center, and (9) ethics consultations. In our hospital, ethics consults account for only a tiny percentage of ethics discussions. We suspect that most hospitals have multiple and varied venues for ethics discussions. We hope this case study will stimulate research in other hospitals analyzing the various ways in which ethicists and ethics committees can build an ethical environment in hospitals. Such research might suggest that ethicists need to develop a different set of "core competencies" than the ones that are needed to do ethics consultations. Instead, they should focus on their skills in creating multiple "moral spaces" in which regular and ongoing discussion of ethical issues would take place. A successful ethicist would empower everyone in the hospital to speak up about the values that they believe are central to respectful, collaborative practice and patient care. Such a role is closer to what the first hospital philosophers set

  9. A student's perspective on medical ethics education.

    Science.gov (United States)

    Terndrup, Christopher

    2013-12-01

    Despite many efforts to increase ethics education in US medical schools, barriers continue to arise that impede the production of morally driven physicians who practice medicine with ideal empathy. Research has shown that, particularly during the clinical years, medical students lose the ability both to recognize ethical dilemmas and to approach such situations with compassionate reasoning. This article summarizes the current status of ethics education in US medical schools, described through the eyes of and alongside the story of a graduating medical student.

  10. Environmental ethics

    International Nuclear Information System (INIS)

    Pautassi G, Jorge

    1994-01-01

    When the Homo Faber; to the beginning of the humanization, overcame the instinct that established a relationship balanced in the ecosphere between the animal and the nature, an interference it began in the relationship man-nature; since that was not adapted this but rather it began its transformation adapting the environment to its necessities. During miles of years the development of this production technique of the Homo Faber could be considered like a progressive and innocuous exploitation of the natural resources. At the present time, kind of a dialectical transformation of the quantity in a new quality characterizes the critical stadium of the new phase of the evolution inaugurated by the Homo Faber. We arrive this way today to that the production force, by means of the science and the technique, outlines us the problem of if for a bigger development in the productivity is necessary a progressive destruction of the ecosphere. That is to say, so that there is progress and will civilization be necessary a progressive interference of the natural balance, with the consequent setting in danger of the life? Moreover this article treats topics about their location and focuses, environmental ethics framed in the talkative ethics and virtues of the environmental ethics, among other topics

  11. Immortal ethics.

    Science.gov (United States)

    Harris, John

    2004-06-01

    This article draws on ideas published in my "Intimations of Immortality" essay in Science (Vol. 288, No. 5463, p. 59, April 7, 2000) and my "Intimations of Immortality-The Ethics and Justice of Life Extending Therapies" in editor Michael Freeman's Current Legal Problems (Oxford University Press 2002: 65-97). This article outlines the ethical issues involved in life-extending therapies. The arguments against life extension are examined and found wanting. The consequences of life extension are explored and found challenging but not sufficiently daunting to warrant regulation or control. In short, there is no doubt that immortality would be a mixed blessing, but we should be slow to reject cures for terrible diseases that may be an inextricable part of life-extending procedures even if the price we have to pay for those cures is increasing life expectancy and even creating immortals. Better surely to accompany the scientific race to achieve immortality with commensurate work in ethics and social policy to ensure that we know how to cope with the transition to parallel populations of mortals and immortals as envisaged in mythology.

  12. Revisiting current “barefoot doctors” in border areas of China: system of services, financial issue and clinical practice prior to introducing integrated management of childhood illness (IMCI

    Directory of Open Access Journals (Sweden)

    Li Xiuyun

    2012-08-01

    Full Text Available Abstract Background Under-5-years child mortality remains high in rural China. Integrated management of childhood illness (IMCI was introduced to China in 1998, but only a few rural areas have been included. This study aimed at assessing the current situation of the health system of rural health care and evaluating the clinical competency of village doctors in management of childhood illnesses prior to implementing IMCI programme in remote border rural areas. Methods The study was carried out in the border areas of Puer prefecture of Yunnan province. There were 182 village doctors in the list of the health bureau in these border areas. Of these, 154 (84.6% were recruited into the study. The local health system components were investigated using a qualitative approach and analyzed with triangulation of information from different sources. The clinical component was assessed objectively and quantitatively presented using descriptive statistics. Results The study found that the New Rural Cooperative Medical Scheme (NRCMS coordinated the health insurance system and the provider service through 3 tiers: village doctor, township and county hospitals. The 30 RMB per person per year premium did not cover the referral cost, and thereby decreased the number of referrals. In contrast to available treatment facilities and drug supply, the level of basic medical education of village doctors and township doctors was low. Discontent among village doctors was common, especially concerning low rates of return from the service, exceptions being procedures such as injections, which in fact may create moral hazards to the patients. Direct observation on the assessment and management of paediatric patients by village doctors revealed inadequate history taking and physical examination, inability to detect potentially serious complications, overprescription of injection and antibiotics, and underprescription of oral rehydration salts and poor quality of counseling

  13. e-Government Ethics : a Synergy of Computer Ethics, Information Ethics, and Cyber Ethics

    OpenAIRE

    Arief Ramadhan; Dana Indra Sensuse; Aniati Murni Arymurthy

    2011-01-01

    Ethics has become an important part in the interaction among humans being. This paper specifically discusses applied ethics as one type of ethics. There are three applied ethics that will be reviewed in this paper, i.e. computer ethics, information ethics, and cyber ethics. There are two aspects of the three applied ethics that were reviewed, i.e. their definition and the issues associated with them. The reviewing results of the three applied ethics are then used for defining e-Government eth...

  14. Intensive care ethics in evolution.

    Science.gov (United States)

    Hall, Katherine

    1997-01-01

    The ethics of treating the seriously and critically ill have not been static throughout the ages. Twentieth century medicine has inherited from the nineteenth century a science which places an inappropriate weight on diagnosis over prognosis and management, combined with a seventeenth century duty to prolong life. However other earlier ethical traditions, both Hippocratic and Christian, respected both the limitations of medicine and emphasised the importance of prognosis. This paper outlines some of the historical precedents for the treatment of the critically ill, and also how the current paradigm limits clinical practice and causes ethical tensions. An understanding that other paradigms have been ethically acceptable in the past allows wider consideration and acceptance of alternatives for the future. However future alternatives will also have to address the role of technology, given its importance in this area of medicine.

  15. Some Basics about Ethics.

    Science.gov (United States)

    Dean, Peter J.

    1994-01-01

    Discussion of ethics focuses on the role of human performance technology professionals in helping corporate ethicists. Highlights include definitions of ethics, morals, values, and business ethics; ethics in academia and in business; and application of the knowledge of ethics to decision-making. (Contains 18 references.) (LRW)

  16. Ethics for life scientists

    NARCIS (Netherlands)

    Korthals, M.J.J.A.A.; Bogers, R.J.

    2004-01-01

    In this book we begin with two contributions on the ethical issues of working in organizations. A fruitful side effect of this start is that it gives a good insight into business ethics, a branch of applied ethics that until now is far ahead of ethics for life scientists. In the second part, ethics

  17. The Ethic of Community

    Science.gov (United States)

    Furman, Gail C.

    2004-01-01

    This article proposes the concept of an ethic of community to complement and extend other ethical frames used in education e.g. the ethics of justice, critique, and care. Proceeding from the traditional definition of ethics as the study of moral duty and obligation, ethic of community is defined as the moral responsibility to engage in communal…

  18. Barriers to Observance of the Codes of Professional Ethics in Clinical Care: Perspectives of Nurses and Midwifery of Hospitals Affiliated with Qom University of Medical Sciences in 2016

    Directory of Open Access Journals (Sweden)

    Imaneh khaki

    2018-02-01

    Conclusion: According to the results of this study, individual care-related factors were among the most important barriers to observing professional ethics from the perspectives of nurses and midwives working in hospitals.  

  19. Facilitated disclosure versus clinical accommodation of infidelity secrets: an early pivot point in couple therapy. Part 1: couple relationship ethics, pragmatics, and attachment.

    Science.gov (United States)

    Butler, Mark H; Harper, James M; Seedall, Ryan B

    2009-01-01

    A critical and potentially polarizing decision in treating infidelity is whether facilitating partner disclosure or accommodating nondisclosure is most beneficial following private disclosure of infidelity to the therapist. Given couple distress and volatility following disclosure, understandably some therapists judge accommodating an infidelity secret both efficient and compassionate. Employing Western ethics and an attachment/intimacy lens, we consider ethical, pragmatic, and attachment intimacy implications of accommodating infidelity secrets. Issues bearing on the decision to facilitate disclosure or accommodate nondisclosure include (a) relationship ethics and pragmatics; (b) attachment and intimacy consequences; and (c) prospects for healing. We conclude that facilitating voluntary disclosure of infidelity, although difficult and demanding, represents the most ethical action with the best prospects for renewed and vital attachment intimacy.

  20. The Medical Ethics Curriculum in Medical Schools: Present and Future.

    Science.gov (United States)

    Giubilini, Alberto; Milnes, Sharyn; Savulescu, Julian

    2016-01-01

    In this review article we describe the current scope, methods, and contents of medical ethics education in medical schools in Western English speaking countries (mainly the United Kingdom, the United States, and Australia). We assess the strengths and weaknesses of current medical ethics curricula, and students' levels of satisfaction with different teaching approaches and their reported difficulties in learning medical ethics concepts and applying them in clinical practice. We identify three main challenges for medical ethics education: counteracting the bad effects of the "hidden curriculum," teaching students how to apply ethical knowledge and critical thinking to real cases in clinical practice, and shaping future doctors' right character through ethics education. We suggest ways in which these challenges could be addressed. On the basis of this analysis, we propose practical guidelines for designing, implementing, teaching, and assessing a medical ethics program within a four-year medical course. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  1. Evaluation of the 8th AJCC staging system for pathologically versus clinically staged pancreatic adenocarcinoma: A time to revisit a dogma?

    Science.gov (United States)

    Abdel-Rahman, Omar

    2018-02-01

    The 8th edition of the American Joint Committee on Cancer (AJCC) staging system for pancreatic exocrine adenocarcinoma has been released. The current study seeks to assess the 7th and 8th editions among patients registered within the surveillance, epidemiology and end results (SEER) database. SEER database (2010-2013) has been accessed through SEER*Stat program and AJCC 8th edition stages were reconstructed utilizing the collaborative stage descriptions. Kaplan-Meier analysis of overall survival and pancreatic cancer-specific survival analyses (according to both 7th and 8th editions and according to whether pathological or clinical staging were conducted) has been performed. Multivariate analysis of factors affecting pancreatic cancer-specific survival was also conducted through a Cox proportional hazard model. A total of 18  948 patients with pancreatic adenocarcinoma were identified in the period from 2010-2013. Pancreatic cancer-specific survival among pathologically staged patients and according to the 8th edition showed significant differences for all pair wise comparisons among different stages (P < 0.0001) except for the comparison between stage IA and stage IB (P = 0.307) and the comparison between stage IB and stage IIA (P = 0.116). Moreover, P value for stage IA vs IIA was 0.014; while pancreatic cancer-specific survival according to the 7th edition among pathologically staged patients showed significant differences for all pair wise comparisons among different stages (P < 0.0001) except for the comparison between IA and IB (P = 0.072), the comparison between stage IIA and stage IIB (P = 0.065), the comparison between stage IIA and stage III (P = 0.059) and the comparison between IIB and III (P = 0.595). Among clinically staged patients (i.e. those who did not undergo initial radical surgery), the prognostic performance of both 7th and 8th stages for both overall survival and pancreatic cancer-specific survival was

  2. The critical catastrophe revisited

    International Nuclear Information System (INIS)

    De Mulatier, Clélia; Rosso, Alberto; Dumonteil, Eric; Zoia, Andrea

    2015-01-01

    The neutron population in a prototype model of nuclear reactor can be described in terms of a collection of particles confined in a box and undergoing three key random mechanisms: diffusion, reproduction due to fissions, and death due to absorption events. When the reactor is operated at the critical point, and fissions are exactly compensated by absorptions, the whole neutron population might in principle go to extinction because of the wild fluctuations induced by births and deaths. This phenomenon, which has been named critical catastrophe, is nonetheless never observed in practice: feedback mechanisms acting on the total population, such as human intervention, have a stabilizing effect. In this work, we revisit the critical catastrophe by investigating the spatial behaviour of the fluctuations in a confined geometry. When the system is free to evolve, the neutrons may display a wild patchiness (clustering). On the contrary, imposing a population control on the total population acts also against the local fluctuations, and may thus inhibit the spatial clustering. The effectiveness of population control in quenching spatial fluctuations will be shown to depend on the competition between the mixing time of the neutrons (i.e. the average time taken for a particle to explore the finite viable space) and the extinction time

  3. Magnetic moments revisited

    International Nuclear Information System (INIS)

    Towner, I.S.; Khanna, F.C.

    1984-01-01

    Consideration of core polarization, isobar currents and meson-exchange processes gives a satisfactory understanding of the ground-state magnetic moments in closed-shell-plus (or minus)-one nuclei, A = 3, 15, 17, 39 and 41. Ever since the earliest days of the nuclear shell model the understanding of magnetic moments of nuclear states of supposedly simple configurations, such as doubly closed LS shells +-1 nucleon, has been a challenge for theorists. The experimental moments, which in most cases are known with extraordinary precision, show a small yet significant departure from the single-particle Schmidt values. The departure, however, is difficult to evaluate precisely since, as will be seen, it results from a sensitive cancellation between several competing corrections each of which can be as large as the observed discrepancy. This, then, is the continuing fascination of magnetic moments. In this contribution, we revisit the subjet principally to identify the role played by isobar currents, which are of much concern at this conference. But in so doing we warn quite strongly of the dangers of considering just isobar currents in isolation; equal consideration must be given to competing processes which in this context are the mundane nuclear structure effects, such as core polarization, and the more popular meson-exchange currents

  4. Lorentz violation naturalness revisited

    Energy Technology Data Exchange (ETDEWEB)

    Belenchia, Alessio; Gambassi, Andrea; Liberati, Stefano [SISSA - International School for Advanced Studies, via Bonomea 265, 34136 Trieste (Italy); INFN, Sezione di Trieste, via Valerio 2, 34127 Trieste (Italy)

    2016-06-08

    We revisit here the naturalness problem of Lorentz invariance violations on a simple toy model of a scalar field coupled to a fermion field via a Yukawa interaction. We first review some well-known results concerning the low-energy percolation of Lorentz violation from high energies, presenting some details of the analysis not explicitly discussed in the literature and discussing some previously unnoticed subtleties. We then show how a separation between the scale of validity of the effective field theory and that one of Lorentz invariance violations can hinder this low-energy percolation. While such protection mechanism was previously considered in the literature, we provide here a simple illustration of how it works and of its general features. Finally, we consider a case in which dissipation is present, showing that the dissipative behaviour does not percolate generically to lower mass dimension operators albeit dispersion does. Moreover, we show that a scale separation can protect from unsuppressed low-energy percolation also in this case.

  5. Ethics in health care: healthcare fraud

    African Journals Online (AJOL)

    Ethics CPD Supplement: Ethics in health care: Healthcare Fraud. S10. Vol 56 No 1 Supplement 1. S Afr Fam Pract 2014. Introduction. Vintage images are easily found depicting a virtuous doctor with a look of honesty and compassion on his or her face bending over a patient, stethoscope in hand, ready to perform a clinical ...

  6. Do ethics committees need a legal framework?

    Science.gov (United States)

    Byk, Christian

    2007-01-01

    The question "do ethics committees need a legal framework" may then raise fundamental discussion in the case of developing countries: will an ethical framework bring them a better capacity to assume their task? And what should this task be if we consider the particularities of clinical research conducted in developing countries?

  7. Ethics support for GPs: what should it look like?

    Science.gov (United States)

    Clark-Grill, Monika

    2016-03-01

    INTRODUCTION Ethics support services for hospital clinicians have become increasingly common globally but not as yet in New Zealand. However, an initiative to change this is gathering momentum. Its slogan 'Clinical ethics is everyone's business' indicates that the aim is to encompass all of health care, not just the hospital sector. General Practitioners (GPs) deal with ethical issues on a daily basis. These issues are often quite different from ethical issues in hospitals. To make future ethics support relevant for primary care, local GPs were interviewed to find out how they might envisage ethics support services that could be useful to them. METHODS A focus group interview with six GPs and semi-structured individual interviews with three GPs were conducted. Questions included how they made decisions on ethical issues at present, what they perceived as obstacles to ethical reflection and decision-making, and what support might be helpful. FINDINGS Three areas of ethics support were considered potentially useful: Formal ethics education during GP training, access to an ethicist for assistance with analysing an ethical issue, and professional guidance with structured ethics conversations in peer groups. CONCLUSION The complex nature of general practice requires GPs to be well educated and supported for handling ethical issues. The findings from this study could serve as input to the development of ethics support services. KEYWORDS General practice; primary care; ethics; support; education.

  8. Medical Ethics in Nephrology: A Jewish Perspective

    Directory of Open Access Journals (Sweden)

    Allon J. Friedman

    2016-04-01

    Full Text Available Jewish medical ethics is arguably the oldest recorded system of bioethics still in use. It should be of interest to practicing nephrologists because of its influence on the ethical systems of Christianity, Islam, and Western secular society; because of the extensive written documentation of rabbinical response in addressing a broad range of bioethical dilemmas; and in understanding the values of patients who choose to adhere to religious Jewish law. The goal of this review is to provide a brief overview of the basic principles underlying mainstream traditional Jewish medical ethics, apply them to common clinical scenarios experienced in nephrology practice, and contrast them with that of secular medical ethics.

  9. Strangers at the Benchside: Research Ethics Consultation

    Science.gov (United States)

    Cho, Mildred K.; Tobin, Sara L.; Greely, Henry T.; McCormick, Jennifer; Boyce, Angie; Magnus, David

    2008-01-01

    Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. PMID:18570086

  10. Interns' perceptions on medical ethics education and ethical issues at the Dokuz Eylul University School of Medicine in Turkey.

    Science.gov (United States)

    Ozan, S; Timbil, S; Semin, S; Musal, B

    2010-11-01

    In Turkey and its neighboring countries, few studies have investigated medical students' reactions to ethics education and ethical issues they encounter. The aim of this study was to investigate interns' perceptions of medical ethics education and ethical issues. In students' first three years at the Dokuz Eylul University School of Medicine, various teaching methods are used in ethics education, including problem-based learning, interactive lectures and movies. During the clinical years, the curriculum helps students consider the ethical dimension of their clinical work, and during the internship period a discussion on ethical issues is held. Data were collected through a questionnaire distributed to interns in the 2005-2006 academic year. Its questions asked about interns' perceived adequacy of their ethics education, any interpersonal ethical problems they had witnessed, their approaches to ethical problems, obstacles they believe prevented them from resolving ethical problems and whether they felt themselves ready to deal with ethical problems. 67.2 % of interns were reached and all of them responded. In the assessment of the adequacy of ethics education, the most favorable score was given to educators. Students' most often mentioned ethical problems encountered were between physicians and students and between physicians and patients. Interns believed that difficult personalities on the team and team hierarchy were important obstacles to resolving ethical problems. There were significant differences between the approaches students currently used in dealing with ethical problems and how they anticipated they would approach these problems in their future professional lives. We obtained information about students' perceptions about ethics education and ethical problems which helped us to plan other educational activities. This study may assist other medical schools in preparing an ethics curriculum or help evaluate an existing curriculum.

  11. The ethics of drug development and promotion: the need for a wider view.

    Science.gov (United States)

    Brody, Howard

    2012-11-01

    Ethical issues at the interface between the medical profession and the pharmaceutical industry have generally been approached from the vantage point of medical professionalism, with a focus on conflict of interest as the key ethical concern. Although conflicts of interest remain important, other ethical issues may be obscured unless a wider perspective is adopted. Besides medical professionalism, the ethics of the clinical therapeutic relationship, ethics of public health, and business ethics all provide additional insights.

  12. Participatory action research: considerations for ethical review.

    Science.gov (United States)

    Khanlou, N; Peter, E

    2005-05-01

    This paper addresses the distinctive nature of participatory action research (PAR) in relation to ethical review requirements. As a framework for conducting research and reducing health disparities, PAR is gaining increased attention in community and public health research. As a result, PAR researchers and members of Research Ethics Boards could benefit from an increased understanding of the array of ethical concerns that can arise. We discuss these concerns in light of commonly held ethical requirements for clinical research (social or scientific value, scientific validity, fair subject/participant selection, favourable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled participants) and refer to guidelines specifically developed for participatory research in health promotion. We draw from our community-based experiences in mental health promotion research with immigrant and culturally diverse youth to illustrate the ethical advantages and challenges of applying a PAR approach. We conclude with process suggestions for Research Ethics Boards.

  13. Leadership and Management Theories Revisited

    DEFF Research Database (Denmark)

    Madsen, Mona Toft

    2001-01-01

    The goal of the paper is to revisit and analyze key contributions to the understanding of leadership and management. As a part of the discussion a role perspective that allows for additional and/or integrated leader dimensions, including a change-centered, will be outlined. Seemingly, a major...

  14. Revisiting Inter-Genre Similarity

    DEFF Research Database (Denmark)

    Sturm, Bob L.; Gouyon, Fabien

    2013-01-01

    We revisit the idea of ``inter-genre similarity'' (IGS) for machine learning in general, and music genre recognition in particular. We show analytically that the probability of error for IGS is higher than naive Bayes classification with zero-one loss (NB). We show empirically that IGS does...... not perform well, even for data that satisfies all its assumptions....

  15. Ethics issues in security hospitals.

    Science.gov (United States)

    Weinstein, Henry C

    2002-01-01

    The term 'security hospital' is used for a variety of facilities including forensic hospitals and prison hospitals, which, because of their mission, the nature of their work, and the populations they serve-or because of the authority under which they operate-place the staff at considerable risk of ethical violations related to either clinical care or to forensic activities. The problem of divided loyalties is of special concern in security hospitals. Ethics principles particularly at risk are confidentiality and informed consent. Where there are cultural disparities between the staff and the patients, differences in background, socioeconomic class, education, and other types of diversity, cultural awareness is required and must be reflected in appropriate treatment and evaluation. To counteract the risks of ethical violations, a security hospital should create an ethical climate and develop means to anticipate, prevent, and deal with ethical violations. These might include detailed and specific policies and procedures, programs of orientation, education, consultation, and liaison as well as its own ethics committee. Copyright 2002 John Wiley & Sons, Ltd.

  16. Institutional Ethics Committee Regulations and Current Updates in India.

    Science.gov (United States)

    Mahuli, Amit V; Mahuli, Simpy A; Patil, Shankargouda; Bhandi, Shilpa

    2017-08-01

    The aim of the review is to provide current updates on regulations for ethics committees and researchers in India. Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question "what makes clinical research ethical" is significant and difficult to answer as multiple factors are involved. The research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country. It is a dynamic process, and updates have to be learned by researcher and committee members. The review highlights the ethical regulation from the Drug Controller General of India, Clinical Trial Registry of India, and Indian Council of Medical Research guidelines. In this article, the updates on Indian scenario of the Ethical Committee and guidelines are compiled. The review comes handy for clinical researchers and ethics committee members in academic institutions to check on the current updates and keep abreast with the knowledge on regulations of ethics in India.

  17. Audit culture revisited

    DEFF Research Database (Denmark)

    Shore, Cris; Wright, Susan

    2015-01-01

    the financial and the moral meet’ we ask, what new kinds of ‘ethics of accountability’ does audit produce? We build on the work of Mitchell (1999), Trouillot (2001) and Merry (2011) to identify five ways in which the techniques and logics of financial accountancy have notable ‘audit effects...... these new financialized techniques of governance, not least through the work of the ‘Big 4’ accountancy firms, and trace their impact across a number of different fields, from administration and the military to business corporations and universities. Following Strathern’s observation that audit is ‘where...

  18. Herbal medicine research and global health: an ethical analysis

    OpenAIRE

    Tilburt, Jon C; Kaptchuk, Ted J

    2008-01-01

    Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal me...

  19. Knowledge and attitude of postgraduate students in Kenya on ethics ...

    African Journals Online (AJOL)

    specialisation in MH that could easily affect their future ethical ... M Pharm, PhD, PG Dip; G C Verster,2 MB ChB, M Med (Psych), FC (Psych), M Phil (Applied Ethics) ... degrees in medicine, clinical psychology, pharmacy and nursing were individually scored ... Low knowledge of international ethics guidelines was observed.

  20. Ethics curriculum for emergency medicine graduate medical education.

    Science.gov (United States)

    Marco, Catherine A; Lu, Dave W; Stettner, Edward; Sokolove, Peter E; Ufberg, Jacob W; Noeller, Thomas P

    2011-05-01

    Ethics education is an essential component of graduate medical education in emergency medicine. A sound understanding of principles of bioethics and a rational approach to ethical decision-making are imperative. This article addresses ethics curriculum content, educational approaches, educational resources, and resident feedback and evaluation. Ethics curriculum content should include elements suggested by the Liaison Committee on Medical Education, Accreditation Council for Graduate Medical Education, and the Model of the Clinical Practice of Emergency Medicine. Essential ethics content includes ethical principles, the physician-patient relationship, patient autonomy, clinical issues, end-of-life decisions, justice, education in emergency medicine, research ethics, and professionalism. The appropriate curriculum in ethics education in emergency medicine should include some of the content and educational approaches outlined in this article, although the optimal methods for meeting these educational goals may vary by institution. Copyright © 2011 Elsevier Inc. All rights reserved.