Reconstructive allografts using Vascularized Composite Allotransplantation are providing individuals living with upper limb loss and facial disfigurement with new opportunities for a sensate, esthetically acceptable, and functional alternative to current treatment strategies. Important research attention is being paid to how best to assess and screen candidates for VCA, measure optimal patient outcomes, and support patient adherence to lifelong behaviors and medical regimens. Far less attention, however, has been dedicated to the team science required for these complex VCA teams to form, (...) prepare, and provide the highest quality clinical and psychosocial care to those receiving VCA. VCA teams are unique in that they require specialized team members whose scope of practice may not otherwise overlap. The team also needs to constantly negotiate balancing patient safety with multiple risks throughout the transplant process. This study aimed to elucidate the team science needed for this highly innovative and complex area of medicine. Using in-depth qualitative interviews with 14 VCA team members and observations at team meetings, we found that careful consideration of team composition, team structure, and organizational commitment influences team performance and patient outcomes, but that to be efficient and truly effective, teams need to commit to developing processes that foster collaboration. These processes are action-oriented, strategic and interpersonal. Dedication and commitment to team science allows teams to manage conflict under stress and exercise ways to leverage strengths to provide optimal performance or patient psychosocial and clinical outcomes. This study can provide insight into quality improvement efforts for VCA teams and guidance for other transplant programs that wish to consider expansion into VCA. (shrink)

The past two decades have seen an outpouring of work in legal theory that is self-consciously critical of aspects of American law and the institutions of the liberal state. In this lively volume, eminent scholars in philosophy, law, and political science respond to this recent scholarship by exploring what constitutes a "radical" critique of the law, examining such theories as critical legal studies, feminist theory and theories of "difference," and critical race theory. The authors consider whether the critiques advanced in (...) recent legal theory can truly be called radical and what form a radical critique of American law should take. Writing at the cutting edge of the critique of critical legal theory, they offer insights first on critical legal scholarship, then on feminist political and legal theory. A third group of contributions questions the radicalness of these approaches in light of their failure to challenge fundamental aspects of liberalism, while a final section focuses on current issues of legal reform through critical views on criminal punishment, including observations on rape and hate speech. Each major essay describes the underlying principles in the development of a radical legal theory and addresses unresolved questions relating to it, while accompanying commentaries present conflicting views. The resulting dialogue explores wide-ranging issues like equity, value relativism, adversarial and empathic legal advocacy, communitarianism and the social contract, impartiality and contingency, "natural" law, and corrective justice. A common thread for many of the articles is a focus on the social dimension of society and law, which finds the individualism of prevailing liberal theories too limiting. Radical Critiques of the Law is particularly unique in presenting critical and feminist approaches in one volume-along with skeptical commentary about just how radical some critiques really are. Proposing alternative critiques that embody considerably greater promise of being truly radical, it offers provocative reading for both philosophers and legal scholars by showing that many claims to radicalism are highly problematic at best. (shrink)

The goals of vascular composite allotransplantation for hand are to maximize functional status and psychosocial wellbeing and to improve quality of life. Candidates are carefully vetted by transplant programs through an extensive evaluation process to exclude those patients with contraindications and to select those that are most likely to attain functional or quality of life benefit from transplant. Patient choice for any treatment, however, requires that candidates be able to understand the risks, benefits, and alternatives before choosing to proceed. This (...) study aimed to understand patients’ knowledge and perceptions about treatment options for hand loss, including hand transplant. This study will be used to inform a standardized education approach and develop conversation aids for use by clinicians and patients throughout the treatment decision process. Ten individuals who had experienced hand amputation or had congenital limb loss were interviewed to better understand previous and current decisions about treatment, experiences in adjusting to their treatment, and perceptions about hand VCA. From this qualitative interview data, four findings emerged: knowledge and education around VCA as a treatment option; adaptation of individuals with limb loss; fear of risk associated with transplantation; issues of aging and overuse injuries to existing limbs. Results suggests that there is opportunity for expanding education about all treatment options for patients with new loss, long-term loss, and congenital limb loss. Establishing a baseline of knowledge about all options–prosthetics, rehabilitative strategies, and VCA—can help patients evaluate their values and goals of treatment. Issues associated with aging, including overuse and injury, and adaptability over the life course should be included in considerations about treatment choices. Data indicate the need for routinely assessing patient preferences about treatment choice so patients can plan for their future as they adapt and age and as technology for treatments change. To assure that thorough information is provided for current and future decision-making, education about treatment choices and selection procedures for VCA should be standardized. (shrink)

Sustained attention, a key cognitive skill that improves during childhood and adolescence, tends to be worse in some emotional and behavioural disorders. Sustained attention is typically studied in non-affective task contexts; here, we used a novel task to index performance in affective versus neutral contexts across adolescence (N = 465; ages 11–18). We asked whether: (i) performance would be worse in negative versus neutral task contexts; (ii) performance would improve with age; (iii) affective interference would be greater in younger adolescents; (...) (iv) adolescents at risk for depression and higher in anxiety would show overall worse performance; and (v) would show differential performance in negative contexts. Results indicated that participants performed more poorly in negative contexts and showed age-related performance improvements. Those at risk of depression performed more poorly than those at lower risk. However, there was no difference between groups as a result of affective context. For anxiety there was no difference in performance as a function of severity. However, those with higher anxiety showed less variance in their reaction times to negative stimuli than those with lower anxiety. One interpretation is that moderate levels of emotional arousal associated with anxiety make individuals less susceptible to the distracting effects of negative stimuli. (shrink)

Three impo r tant tasks in the f i eld of human rights w e re achi e v ed in the Enlightenment: the secularization of ancient natural rights, d r a wing up a list of rights and co n v e r ting them into an inst r ument of political demands. Since then there has been no fu r ther theoretical d e v elopment of the idea. In our d a ys, the concept of human rights (...) is much more indete r minate than in the eighteenth centu r y because w e lack consensus about the e xamples that ma k e that abstract idea specific. In our time the task in the f ield of human rights m a y w ell be that of correcting that indete r mina c y , so completing the labour of the Enlightenment. (shrink)

This article examines the development of Russell's treatment of propositions, in relation to the topic of psychologism. In the first section, we outline the concept of psychologism, and show how it can arise in relation to theories of the nature of propositions. Following this, we note the anti-psychologistic elements of Russell's thought dating back to his idealist roots. From there, we sketch the development of Russell's theory of the proposition through a number of its key transitions. We show that Russell, (...) in responding to a variety of different problems relating to the proposition, chose to resolve these problems in ways that continually made concessions to psychologism. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:'kvieuJs SELECTED· LETTERS KATHARINE TAIT Carn Voel Porthcurno,- Cornwall TRI9 6LN, England Nicholas Griffin. The Selected Letters ofBertrand Russel~ Vol. I: The Private Years, I884-I9I4. London: Allen Lane the Penguin PreSs, 1992. Pp. xxi, 553.£25.00; C$47.99; US$35·00. Nicholas Griffin has done an admirable job of selecting and explaining the letters in this first volume. It is amazingly to his credit that he 'manages to be so well (...) acquainted with and to understand so well a world so remote from his own. In the whole volume, I found only two small points on which to augment his knowledge. If he had looked up Shakespeare's poem about greasy Joan, which we all know in part, he would have solved for himself the mystery of Marian's nose, referred to on page 93. It was red and raw from the cold, as Russell's always was from sunburn in the summer-and usually peeling besides. And on page 217, perhaps a more esoteric mystery: Milligan is a game of patience played with two packs of cards, which I have seen him playing with a special small set capable of being spread out on a small table. My only other quibble is that I think perhaps Griffin is a trifle too hard on Grandmother Russell, who may have been less calculating and more sentimental than he supposes. That she was not above emotional blackmail is clear from Russell's letter to Alys of 17 August 1894: I went to· my Grandmother, and found her on the sofa in her sitting-room. We embraced in silence for some time and then I looked at her sadly with tears in my eyes and she said "Well I'm worse than you thought I was": not with an air of triumph, but of mild reproof for my heartlessness in having felt so little anxiery. She besought me to consent to an absence; she says everybody who comes thinks it strange I should not be here when she is so ill, and that both thee and I are suffering in reputation in consequence. She gave repeated assurances (which I didn't need) of her absolute unselfishness in urging my home-duties; she really does care only about my moral welfare, which she feels to be imperilled by such neglect. (P. 98) Awful stuff, yet I think she may have rather been seizing any weapon that came to hand than laying deeply cunning schemes; but this is only opinion and I would bow to Griffin's greater knowledge of the facts. His analysis of Evelyn Whitehead's "attacks",their effect on Russell and his relations with russell: me Journal of me Bemand Russell Archives McMaster University Libraty Pr... n.s. I> (winter 1992-9~): 211-24 ISSN OO~6-O1631. 212 Reviews her, on the other hand, I found enlightening and quite the best thing I have read on the subject. Some other fine items must be singled out for special mention. First, the generous tribute to Russell's integrity over Frege on page 245. Russell had spent five years working in almost complete isolation on the Principles only to find, when it had gone to press, that much of what was best and most original in it had been anticipated by Frege. Yet, even in his private correspondence, he never gave so much as a hint of any concern about his loss of priority, but only his delight at having found a thinker with similar ideas. It required an integrity beyond the call of duty to add to the Principles an appendix drawing attention to Frege's work and generally to do what he could to make it better known. Griffin's editorial work is for the most part adlJIirably dispassionate, always informative, sometimes speculative, occasionally critical; but when the occasion warrants (usually over professional matters), he is unstinting in his praise. Russell's comments about The Principles ofMathematics in his letters seem absurdly modest. The book was undoubtedly a wotk of genius; in some ways, the greatest thing he ever wrote.... (I]r offered not merely a new philosophy ofmathematics bur a new way of doing philosophy. Yet Russell... (shrink)

Features include a comprehensive review of existing material, combined with new perspectives to equip students for the challenges in the work environment; chapter overviews and student learning objectives offer a solid and useful framework in which to organise study; diagrams and charts present overviews and contexts for the subject to act as useful revision aids; effective pedagogy including a review of the arguments considered, a menu of seminar topics, and questions in every chapter, serving as an ideal basis for seminar (...) study; and additional open-ended simulations to allow students to work through unfolding scenarios. (shrink)

The dominant conventionalist view explains the wrong of breaking a promise as failing to do our fair share in supporting the practice of promise-keeping. Yet, this account fails to explain any unique moral standing that a promisee has to demand that the promisor keep the promise. In this paper, I provide a conventionalist response to this problem. In any cooperative practice, participants stand as both beneficiary and contributor. As a beneficiary, they are morally required to follow the rules of the (...) practice. As a contributor, they have claims on other participants to follow the rules. According to the rules of promise-keeping, a promisee has a unique claim on the promisor, and the personal wrong of breaking a promise should be understood as the violation of this unique and practice-dependent claim. (shrink)

Most liberals agree that governments should protect certain basic liberties, such as freedom of speech, freedom of religion and freedom of the person. Liberals disagree, however, about whether free market rights should also be protected. By “free market rights,” we mean those rights typically associated with laissez-faire economic systems such as freedom of contract, a right to market returns, and claims to privately own the means of production.We do not use the phrase “economic liberties,” as Tomasi does, because it does (...) not distinguish between the “economic rights” defended by classical liberal and those defended by socialists. Those on the right often see such freedoms as core liberal commitments, while those on the left argue that an economic system should be organized to protect the interests of the less advantaged members of society. If free market rights should be protected, then most existing societies are unjust. These societies fail the liberal standard in the same ways as th .. (shrink)

Autism is a neurodevelopmental condition characterized by difficulties in social interaction. Successful social interaction relies, in part, on determining the thoughts and feelings of others, an ability commonly attributed to our faculty of folk or common-sense psychology. Because the symptoms of autism should be present by around the second birthday, it follows that the study of autism should tell us something about the early emerging mechanisms necessary for the development of an intact faculty of folk psychology. Our aims in this (...) chapter are threefold; to examine the literature on "socialunderstanding" mechanisms in autism, particularly those assumed to develop in the first years of life; to examine the related literature on typically developing infants and toddlers, and to examine the theoretical approaches that attempt to characterize the early stages and development of this impressive skill. In doing so, we hope to help resolve some of the disagreements and sticking points that riddle the topic. In particular we will attempt to shift the focus from whether children have this or that specific mental-state concept to a more developmentally friendly approach centered around the notion of reasons, recognizing that they may well exist before they are represented, and hence before they can be appreciated, or expressed. The peer commentary in Behavioral and Brain Sciences following Premack and Woodruff - "Does the chimpanzee have a theory of mind'" - not only introduced the "falsebelief' task, but addressed a host of issues surrounding the characterization of second-order intentional systems, systems that may be interpreted as having beliefs about beliefs (or desires or intentions... (shrink)

In E.N. I. c. 5 Aristotle is considering divers views as to what constitutes Eudaimonia. He told us in c. 4, 2–3 that there are many conflicting opinions on the subject. The Many identify Happiness with some palpable good, such as pleasure, wealth, honour, but the Wise identify it with something beyond the Many, while [Plato] denied it to be any specific good at all. Of all these views we should consider such as have many adherents or are considered to (...) be reasonable. Accordingly, the Universal Good is considered in c. 6 after consideration in c. 5 of five particular goods—pleasure in the form of bodily pleasure, honour, wealth, virtue [and, implied in the theoretic Life, wisdom]. These five goods are brought into relation with four Lives—viz. pleasure with the apolaustic; honour and virtue with the political; [wisdom] with the theoretic; wealth with the business or money-making Life; and the first three Lives are called προέχοντες. There is nothing in this introduction of the Lives to astonish us; for, as Aristotle himself tells us, τò ληθς ν τοȋς πρακτικοȋς κ τν ργων κα τοû βίου κρίνεται . But there is much difference of opinion as to the argument he draws from the Lives. According to the view now submitted for consideration, the argument is that when a specific good, which some suppose to be Eudaimonia, is also the end of a ‘pre-eminent’ Life, then there is some prima facie probability in the view that that specific good is Eudaimonia. (shrink)

I argue that acknowledging Hume as a doxastic naturalist about belief in a deity allows an elegant, holistic reading of his Dialogues. It supports a reading in which Hume's spokesperson is Philo throughout, and enlightens many of the interpretive difficulties of the work. In arguing this, I perform a comprehensive survey of evidence for and against Philo as Hume's voice, bringing new evidence to bear against the interpretation of Hume as Cleanthes and against the amalgamation view while correcting several standard (...) mistakes. I ultimately isolate the interpretation of Philo's Reversal at the end of the Dialogues as of paramount importance, and show how my naturalistic interpretation makes this, and other notoriously difficult passages, unproblematic. (shrink)

There is already a copious literature comparing Claudius' oration on the admission of the primores Galliae into the Roman Senate with Tacitus’ account of the speech and of the opposition's case in Annals 11. 23–4. Yet the Emperor's own purpose in speaking as he did still needs some illumination. Scholarly concentration on technical points about the citizenship, on Claudius’ antiquarianism and on his debt to Livy has been fruitful, but it has often distracted attention from Claudius’ immediate aim. Meanwhile, Tacitus’ (...) interpretation has been insidious in colouring our view of what course of action the imperial orator was trying to defend before the Senate. (shrink)

To be a conventionalist about a specific obligation or right is to believe that the obligation or right is dependent on the existence of a social practice. A conventionalist about property, for example, believes that a moral right to property is generated by conventional norms rather than by any natural right. One problem with dominant conventionalist theories is that they do not adequately justify conventional moral claims. They can justify why it is wrong to steal, for example, but they do (...) not justify the claim that you have on me to not steal from you. As a remedy, this article develops and defends the Principle of Legitimate Expectations. Suggested by John Rawls, this principle grants individuals a moral claim to what the rules of morally justified practices entitle them. This article addresses common objections to the principle to show how it can ground a wide range of conventional moral claims. (shrink)

Sleep onset is associated with marked changes in behavioral, physiological, and subjective phenomena. In daily life though subjective experience is the main criterion in terms of which we identify it. But very few studies have focused on these experiences. This study seeks to identify the subjective variables that reflect sleep onset. Twenty young subjects took an afternoon nap in the laboratory while polysomnographic recordings were made. They were awakened four times in order to assess subjective experiences that correlate with the (...) (1) appearance of slow eye movement, (2) initiation of stage 1 sleep, (3) initiation of stage 2 sleep, and (4) 5 min after the start of stage 2 sleep. A logistic regression identified control over and logic of thought as the two variables that predict the perception of having fallen asleep. For sleep perception, these two variables accurately classified 91.7% of the cases; for the waking state, 84.1%. (shrink)

In his own writings, Rawls purposively used only a loose characterization of the basic structure, but two prominent misinterpretations highlight the current need for a more detailed account. First, G.A. Cohen argues that the Rawlsian focus on the basic structure is arbitrary due to the Rawlsian appeal to profound effects. Second, some theorists conflate the justification of coercion with the assessment of a basic structure by defining the basic structure as the coercive structure. Both misinterpretations can be corrected by carefully (...) specifying what social institutions are and explaining which social institutions come together to form the basic structure of society. (shrink)

Critical care as a discipline has become so expensive that some have proposed extensive limitations on the amount of money devoted to it by society. In this paper that issue is examined with respect to pediatric and neonatal intensive care. Initially, a case is presented which includes many of the ethical and economic issues. The neonatal population at present has a tolerable median cost, with a distinctly higher average cost created by many special cases such as the one described with (...) very high costs. The pediatric population is served by an intensive care system costing approximately one billion dollars. This contrasts with the adult costs which are markedly higher and yet do not meet the total preceived need. Different theories of justice would concede differing allocations to individuals and to the problem of critical care as a whole based on their view of the obligations of societal membership. The authors argue that in fact critical care might be analyzed from the view-point of economics more effectively by breaking down the cost allocations for different components for that care, and argue that labor is the major cost in its provision. They then argue that that labor component may be a necessary and affordable cost for a post industrial society. It may be that libertarians, Rawlsians, and utilitarians could accept such an allocation of resources. Further, it is argued that triage is not an appropriate approach to limiting expenses, and that other methodologies such as cost effectiveness are the only appropriate ones to invoke in pediatric critical care. Recognition of the economic realities present in a given case may be the key to clinicians' demonstrated reluctance to participate in the gatekeeper role through the use of triage. (shrink)

The 1896-1899 papers, few of which were published in Russell's lifetime, concentrate primarily on physics, arithmetic and the concept of quantity. Several views that later became well-known in his The Principles of Mathematics actually originate in his earlier work, and though incomplete, An Analysis of Mathematical Reasoning , forms a centrepiece of the volume.

Theories of truth and vagueness are closely connected; in this article, I draw another connection between these areas of research. Gupta and Belnap’s Revision Theory of Truth is converted into an approach to vagueness. I show how revision sequences from a general theory of definitions can be used to understand the nature of vague predicates. The revision sequences show how the meaning of vague predicates are interconnected with each other. The approach is contrasted with the similar supervaluationist approach.

Recent evaluation of the practice of euthanasia and related medical decisions at the end of life in the Netherlands has shown a slight decrease in the frequency of physician-assisted death since the enactment of the Euthanasia Law in 2002. This paper focuses on the absence of euthanasia cases concerning patients with dementia and a written advance euthanasia directive, despite the fact that the only real innovation of the Euthanasia Law consisted precisely in allowing physicians to act upon such directives. The (...) author discusses two principal reasons for this absence. One relates to the uncertainty about whether patients with advanced dementia truly experience the suffering they formerly feared. There is reason to assume that they don’t, as a consequence of psychological adaptation and progressive unawareness (anosognosia). The second, more fundamental reason touches upon the ethical relevance of shared understanding and reciprocity. The author argues that, next to autonomy and mercifulness, “reciprocity” is a condition sine qua non for euthanasia. The absence thereof in advanced dementia renders euthanasia morally inconceivable, even if there are signs of suffering and notwithstanding the presence of an advance euthanasia directive. This does not mean, however, that advance euthanasia directives of patients with dementia are worthless. They might very well have a role in the earlier stages of certain subtypes of the disease. To illustrate this point the author presents a case in which the advance directive helped to create a window of opportunity for reciprocity and shared decision-making. (shrink)

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 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. (shrink)

Most criticism and exposition of John Rawls’s political theory has focused on his account of distributive justice rather than on his support for liberalism. Because of this, much of his argument for protecting the basic liberties remains under explained. Specifically, Rawls claims that representative citizens would agree to guarantee those social conditions necessary for the exercise and development of the two moral powers, but he does not adequately explain why protecting the basic liberties would guarantee these social conditions. This gap (...) in his argument leads to two problems. First, the Rawlsian argument for the priority of liberty would fail if the gap could not be filled. His argument would still support the protection of individual freedoms, but these freedoms would be treated like other primary goods and regulated by the difference principle. Second, without a full argument, there is not sufficient reason to favor Rawls’s left-liberal conception of the basic liberties over a more right-leaning conception that would prioritize the protection of free-market rights. To address these two problems, this paper fills in the gap in order to better explain Rawls’s full argument for egalitarian liberalism. (shrink)

Rawlsians argue for principles of justice that apply exclusively to the basic structure of society, but it can seem strange that those who accept these principles should not also regulate their choices by them. Valid moral principles should seemingly identify ideals for both institutions and individuals. What justifies this nonintuitive distinction between institutional and individual principles is not a moral division of labor but Rawls’s dual commitments to conventionalism and constructivism. Conventionalism distinguishes the relevant ideals for evaluating institutions from those (...) for evaluating actions, while constructivism explains why this distinction is morally fundamental. (shrink)

In The Tyranny of the Ideal, Gerald Gaus gives an extended argument on behalf of the “Open Society.” Instead of claiming that it is uniquely best from some privileged moral perspective, he argues for the Open Society by showing why it is acceptable to many perspectives. In this way, Gaus argues for a liberal market-based society in a way that treats deep diversity as a fundamental feature of social life. However, the argument falters at four important points. When taken together, (...) these four problems significantly limit the significance of Gaus’s conclusions. (shrink)

While C. I. Lewis was traditionally interpreted as an epistemological foundationalist throughout his major works, virtually every recent treatment of Lewis's epistemology dissents. But the traditional interpretation is correct: Lewis believed that apprehensions of "the given" are certain independently of support from, and constitute the ultimate warrant for, objective empirical beliefs. This interpretation proves surprisingly capable of accommodating apparently contrary textual evidence. The non-foundationalist reading, by contrast, simply cannot explain Lewis's explicit opposition to coherentism and his insistence that only apprehensions (...) of the given enable us to answer the regress problem -- and so vindicate the possibility of empirical justification. (shrink)

Atheism Considered is a systematic presentation of challenges to the existence of a higher power. Rather than engage in polemic against a religious worldview, C.M. Lorkowski charitably refutes the classical arguments for the existence of god, pointing out flaws in their underlying reasoning and highlighting difficulties inherent to revealed sources. In place of a theistic worldview, he argues for adopting a naturalistic one, highlighting naturalism’s capacity to explain world phenomena and contribute to the sciences. Lorkowski demonstrates that replacing theism with (...) naturalism, contra popular assumptions, sacrifices nothing in terms of ethics or meaning. Instead, morality ultimately proves more important than religion and does not rely on it. Appropriate for classroom use, this book is meant to cultivate understanding, tolerance, and fruitful dialogue between believers and nonbelievers. (shrink)

In this paper I present a range of substructural logics for a conditional connective ↦. This connective was original introduced semantically via restriction on the ternary accessibility relation R for a relevant conditional. I give sound and complete proof systems for a number of variations of this semantic definition. The completeness result in this paper proceeds by step-by-step improvements of models, rather than by the one-step canonical model method. This gradual technique allows for the additional control, lacking in the canonical (...) model method, that is required. (shrink)

Those who teach or are taught medical ethics with a heavy reliance on case studies should be warned first of all that the practice tends to exaggerate the degree to which morality is controversial. Secondly, they ought to realise that it is often quite unclear what problems count as moral problems. Thirdly, they will need to bear in mind that there may be -- and presumably are -- limits to what we may regard as open to discussion. It would be (...) quite superficial to assume that ethics teachers, going along with what is generally accepted by their colleagues in this matter, would never tempt students to disregard these limits. (shrink)

Objective: To examine the current ethical review process of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial between November 2003 and May 2005.Setting: Germany.Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites throughout Germany. 8 ethics (...) committees were located at university medical schools and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required .Results: The duration of the ERP ranged from 1 to 176 days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was €2947. 1 of 8 ethics committees at universities and 8 of 10 at medical chambers charged a median fee of €162 . The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval .Conclusion: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country. (shrink)