The considerable attention to financial interests in clinical research has focused mostly on academic medical centers, even though the majority of clinical research is conducted in community practice settings. To fill this gap, this article maps the practices and policies in 73 community hospitals and several hundred specialized facilities around the country for reviewing clinical investigators’ financial relationships with research sponsors. Community hospitals face a substantially different mix of issues than academic medical centers do because their physician researchers are usually (...) not employees, and more of their studies are later-phase, multicenter trials. Accordingly, community physicians stand to benefit personally from per capita payments, but they tend to have less direct influence over research findings when compared with their academic peers. These and other contrasts require separate guidance for community-based organizations that takes into account their particular needs, circumstances, and institutional capacities. (shrink)

As part of a larger research study, we present model language for disclosing financial interests in clinical research to potential research participants, and we describe the empirical basis and theoretical assumptions used in developing the language. The empirical process for creating appropriate disclosure language resulted in a generic disclosure statement for cases in which no risk to participants’ welfare or the scientific integrity of the research is expected, and nine more specific disclosure statements for cases in which some risk is (...) expected. The disclosure statements are not meant to be canonical, but were instead designed to reflect the typical situations in which disclosure of financial interest might be considered by an institutional review board or conflict of interest committee. Individual institutions could modify key phrases to suit their purposes, and others could use the language in future empirical work on informed consent to better refine the options for disclosing financial interests in clinical research. (shrink)

The ethical treatment of cancer patientsparticipating in clinical trials requiresthat patients are well-informed about thepotential benefits and risks associated withparticipation. When patients enrolled in phaseI clinical trials report that their chance ofbenefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected (...) outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type can be confused with expressionsof uncertainty of the belief type. Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subservemultiple speech acts, some of which may beindirect. For example, a patient reporting ahigh expected benefit may be reporting a beliefabout the future, reassuring family members,and/or attempting to improve his or her outcome by apublic assertion of optimism. These sources oflinguistic confusion should be considered injudging whether the patient's reported expectation isgrounds for a bioethical concern that there hasbeen a failure in the informed consent process. (shrink)

How (Not) to Be Secular is what Jamie Smith calls "your hitchhiker's guide to the present" -- it is both a reading guide to Charles Taylor's monumental work A Secular Age and philosophical guidance on how we might learn to live in our times. Taylor's landmark book A Secular Age (2007) provides a monumental, incisive analysis of what it means to live in the post-Christian present -- a pluralist world of competing beliefs and growing unbelief. Jamie Smith's book is a (...) compact field guide to Taylor's insightful study of the secular, making that very significant but daunting work accessible to a wide array of readers. Even more, though, Smith's How (Not) to Be Secular is a practical philosophical guidebook, a kind of how-to manual on how to live in our secular age. It ultimately offers us an adventure in self-understanding and maps out a way to get our bearings in today's secular culture, no matter who "we" are -- whether believers or skeptics, devout or doubting, self-assured or puzzled and confused. This is a book for any thinking person to chew on. (shrink)

Ethical and legal traditions recognize prenatal duties to avoid harm to offspring. However, applying the harm principle to pregnancy requires a careful balancing of a baby's welfare with a pregnant woman's interest in liberty and bodily integrity. In the case of maternal PKU the mother can prevent harm to her baby by returning to the admittedly unpleasant diet that prevented her from being retarded. Informing, counseling, and access to medical care should be the primary policy. Seizures and forced treatment cannot (...) be justified in this case, and only rarely in other situations. (shrink)

that Buddhism is best understood as a philosophy of practice-or a.

A formal Ethics Consultation Service (ECS) can provide significant help to patients, families and hospital staff. As with any other form of clinical consultation, documentation of the process and the advice rendered is very important. Upon review of the published consult documentation practices of other ECSs, we judged that none of them were sufficiently detailed or structured to meet the needs and purposes of a clinical ethics consultation. Thus, we decided to share our method in order to advance the practice (...) of ethics consultation. Here, we describe a method of ECS documentation practice, including use of a formal consult report template, as well as a log for maintaining a chronological record of the consultations performed. These two documents facilitate order and organisation of the ECS. They also enable the ECS to keep an account of professional time and experience, enable quick consult trend assessments (by consult theme or ward, for example) and establish a potential registry of consults for future research study. This method of documentation, we believe, not only contributes significantly to the primary purpose of the consultation—namely, the evincing and sharing of ethical opinion about a case—but also enables consultants to improve their practice and to pursue research on clinical ethics consultation. (shrink)

The founders of reformational philosophy, H. Dooyeweerd and D.H.Th. Vollenhoven, each published in short succession, viz. 1949 and 1950, a voluminous study in the history of philosophy. Whoever reads both works is struck by the remarkable differences in treatment. In this contribution these differences are analysed, but there is also indication of agreement. The article ends with a number of conclusions based on the analysis.

★ Publishers Weekly starred review One of the Top 100 Books and One of the 5 Best Books in Religion for 2019, Publishers Weekly Christianity Today 2020 Book Award Winner (Spiritual Formation) Outreach 2020 Resource of the Year (Spiritual Growth) Foreword INDIES 2019 Honorable Mention for Religion This is not a book about Saint Augustine. In a way, it's a book Augustine has written about each of us. Popular speaker and award-winning author James K. A. Smith has spent time on (...) the road with Augustine, and he invites us to take this journey too, for this ancient African thinker knows far more about us than we might expect. Following Smith's successful You Are What You Love, this book shows how Augustine can be a pilgrim guide to a spirituality that meets the complicated world we live in. Augustine, says Smith, is the patron saint of restless hearts--a guide who has been there, asked our questions, and knows our frustrations and failed pursuits. Augustine spent a lifetime searching for his heart's true home and he can help us find our way. "What makes Augustine a guide worth considering," says Smith, "is that he knows where home is, where rest can be found, what peace feels like, even if it is sometimes ephemeral and elusive along the way." Addressing believers and skeptics alike, this book shows how Augustine's timeless wisdom speaks to the worries and struggles of contemporary life, covering topics such as ambition, sex, friendship, freedom, parenthood, and death. As Smith vividly and colorfully brings Augustine to life for 21st-century readers, he also offers a fresh articulation of Christianity that speaks to our deepest hungers, fears, and hopes. (shrink)

This is a review of the biographic drama Love and Mercy. More than a story of the evolution of The Beach Boys, it is the story of the lead Beach Boy, Brian Wilson, and his struggle with substance abuse, mental illness, family stress, emerging love, and a controlling psychologist. Interwoven are many bioethics themes, including the doctor–patient relationship, conflict of interest, autonomy, and patient welfare. For those unaware of the sadness and torment running directly alongside the sunny, bubbly life of (...) The Beach Boys, this film is an eye-opener. It is also a great reminder of the importance of boundaries between clinicians and their patients. (shrink)

Malgré l’accent porté sur les aspects publics, ritualistes de la pratique ancienne, les images et les objets grecs attestent des rencontres privées et personnelles avec des dieux. Cet article recourt à la documentation archéologique pour explorer les traits personnels, vécus, de la vie religieuse de l’Athènes attique. Bien qu’elles soient parfois décrites comme des « transactions », le développement des relations personnelles avec les dieux et de la manipulation de choses matérielles semble être l’un des éléments les plus saillants de (...) l’expérience religieuse des Grecs. Cette étude examine la matérialité religieuse et l’attitude dévotionnelle telle qu’elle existait en dehors de systèmes rituels organisés et des espaces sacrés. La documentation grecque suggère que la culture matérielle était « de la religion » sous forme physique et une part des méthodes des dévots pour développer des relations remarquablement intimes avec des figures sacrées dans un processus appelé « dévotionalisme ». Les femmes athéniennes utilisaient un objet commun de la vie quotidienne comme une forme de médium religieux: la tainia (ruban). Les femmes l’employaient dans tous les lieux de leur vie, y compris les maisons, les lieux de fêtes et les sanctuaires. La céramique suggère que les Athéniens ont employé de tels média dévotionnels pour interagir avec les défunts dans les cimetières. (shrink)

Background and objectives Conscientious refusal of abortion has been discussed widely by medical ethicists but little information on practitioners' opinions exists. The American College of Obstetricians and Gynecologists (ACOG) issued recommendations about conscientious refusal. We used a vignette experiment to examine obstetrician-gynecologists' (OB/GYN) support for the recommendations. Design A national survey of OB/GYN physicians contained a vignette experiment in which an OB/GYN doctor refused a requested elective abortion. The vignette varied two issues recently addressed by the ACOG ethics committee—whether the (...) doctor referred and whether the doctor disclosed their objection to the abortion. Participants and setting 1800 OB/GYN randomly selected physicians were asked to complete a mail survey containing the vignette. The response rate was 66% (n=1154) after excluding 40 ineligible cases. Measurement Physicians indicated their approval for the vignette doctor's decision. Main results Overall, 43% of OB/GYN physicians responded that the conscientious refusal exercised by the vignette physician was appropriate. 70% rated the vignette doctor as acting appropriately when a referral was made. This dropped to 51% when the doctor disclosed objections to the patient, and to 12% when the doctor disclosed objections and refused to make a referral. Consistent with previous research, males were more likely to support disclosure and refusal to refer. Highly religious physicians supported non-referral but not disclosure. Conclusion OB/GYN physicians are less likely to support conscientious refusal of abortion if physicians disclose their objections to patients. This is at odds with ACOG recommendations and with some models of the doctor–patient relationship. (shrink)

In the article, the problem of speech understanding/misunderstanding between non-native speakers using English as lingua franca is discussed. It is argued that the mechanism of EFL discourse comprehensibility and interpretability can be explained basing on Shannon’s model of information exchange, which is constructed of sender and receiver, message, two channels, coding and decoding of information, mutual feedback, noise and context. A malfunction of one or more of these components may result in ‘language noise‘ or interruption of intelligibility of speech. In (...) ELF communication malfunction of these components provokes deviations from language norms in pronunciation, grammar structure and semantics. Recurrent deviations in EFL speech production can increase or reduce noise in the coding and/or decoding channel and, correspondingly, in the information processing. Following Jenkins’ classification of kernel and non-kernel phonological deviations in EFL speech, the author maintains that the kernel deviations increase noise only if they are present in one channel and absent in the other one. If they are inherent to both speakers’ production they don’t hinder intelligibility. Non-kernel deviations affect intelligibility by the same pattern though in a weaker mode. It is claimed that comfortable intelligibility in transnational communication does not necessarily require standardization of norms and high ELF proficiency of speakers. (shrink)

Objective We sought to understand ethics and education needs of emergency nurses and physicians in paediatric and adult emergency departments in order to build ethics capacity and provide a foundation for the development of an ethics education programme. Methods 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. Results 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, conflict management with patients or families and resource issues. 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 was the most desired method. Conclusions 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. (shrink)

Background: The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published.Objective: To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency.Design: Retrospective, observational study.Setting: Online review (...) of five major medical journals.Population: All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine.Measurements: Statement of REB approval and informed consent.Results: Of 1780 articles reviewed, 1133 met inclusion criteria , 36 articles lacked a statement of REB approval, 62 lacked disclosure of informed consent and 15 articles lacked both. Articles that did not state REB approval were associated with not stating informed consent . There were no editorial comments to alert readers to the lack of either REB approval or informed consent statements associated with any of the deficient articles.Conclusions: Articles that lack explicit statements of REB approval and informed consent are infrequent but continue to be published in major medical journals without editorial statements to alert the reader to this deficiency. (shrink)

The idea of moral reform requires that morality be more than a description of what people do value, for there has to be some measure against which to assess progress. Otherwise, any change is not reform, but simply difference. Therefore, I discuss moral reform in relation to two prescriptive approaches to common morality, which I distinguish as the foundational and the pragmatic. A foundational approach to common morality (e.g., Bernard Gert’s) suggests that there is no reform of morality , but (...) of beliefs, values, customs, and practices so as to conform with an unchanging, foundational morality. If, however, there were revision in its foundation (e.g., in rationality), then reform in morality itself would be possible. On a pragmatic view, on the other hand, common morality is relative to human flourishing, and its justification consists in its effectiveness in promoting flourishing. Morality is dependent on what in fact does promote human flourishing and therefore, could be reformed. However, a pragmatic approach, which appears more open to the possibility of moral reform, would need a more robust account of norms by which reform is measured. (shrink)