OBJECTIVE: To describe the issues faced, and how they were addressed, by the University of Toronto Critical Care Medicine Program/Joint Centre for Bioethics Task Force on Appropriate Use of Life-Sustaining Treatment. The clinical problem addressed by the Task Force was dealing with requests by patients or substitute decision makers for life-sustaining treatment that their healthcare providers believe is inappropriate. DESIGN: Case study. SETTING: The University of Toronto Joint Centre for Bioethics/Critical Care Medicine Program Task Force on Appropriate Use of Life-Sustaining (...) Treatment. PARTICIPANTS: The 24-member Task Force included physician and nursing leaders from five critical care units, bioethicists, a legal scholar, a health administration expert, a social worker, and a hospital public relations professional. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Our specific lessons learned include a) a policy focus on process; b) use of a negotiation and mediation model, rather than a hospital ethics committee model, for this process; and c) the policy development process is itself a negotiation, so we recommend equal involvement of interested groups including patients, families, and the public. CONCLUSIONS: This article describes the key issues faced by the Task Force while developing its policy. It will provide a useful starting point for other groups developing policy on appropriate use of life-sustaining treatment. (shrink)

Discussions of William Lambarde’s interests as a reader have usually focused on his strategies of tracing place names and etymologies in the margins of his books, tying him in with a larger subsection of the Tudor reading public who annotated books in a similar fashion. This article surveys the annotations in Lambarde’s early books to trace the evolution of his reading over time and in collaboration with his contemporaries. In so doing, it explores the uses that Lambarde found for his (...) books beyond organising information within them or excerpting material for publication. The process, as well as the products, of Lambarde’s reading, was shared among his fellow antiquarians and members of the Inns of Court, for whom reading was both a professional practice and a means to communicate privileged information. When juxtaposed with the equally collaborative drafting and reception of his published work the annotations preserved in Lambarde’s books paint a dynamic and evolving picture of his reading practices. Over the course of his lifetime, Lambarde returned to the books in his library, with new questions or acquisitions prompting the re-reading of earlier acquisitions and occasioning new discoveries in them. Lambarde’s habit of marking up and circulating copies of his own published works, as well as the books he owned, publicised both his reading practices and the knowledge they generated about the past to his scholarly and professional companions. (shrink)

James A. Anderson and Charles Weijer take the wage payment model proposed by Neil Dickert and Christine Grady and extend the analogy of research participation to unskilled wage labor to include just working conditions. Although noble in its intentions, this moral extension generates unsavory outcomes. Most notably, Anderson and Weijer distinguish between two types of research subjects: occasional and professional. The latter, in this case, receives benefits beyond the moral minima in the form of “the right to (...) meaningful work.” The problem is that meaningful work can itself be a form of inducement, and consequently, may in fact increase the incidence of inducement contrary to the intentions of the wage payment model. (shrink)

The Taming of the True poses a broad challenge to realist views of meaning and truth that have been prominent in recent philosophy. Neil Tennant argues compellingly that every truth is knowable, and that an effective logical system can be based on this principle. He lays the foundations for global semantic anti-realism and extends its consequences from the philosophy of mathematics and logic to the theory of meaning, metaphysics, and epistemology.

What is morality? In Practical Expressivism, I argue that morality is a purely natural interpersonal co-ordination device, whereby human beings express their attitudes in order to influence the attitudes and actions of others. -/- The ultimate goal of these expressions is to find acceptable ways of living together. This 'expressivist' model for understanding morality faces well-known challenges concerning 'saving the appearances' of morality, because morality presents itself to us as a practice of objective discovery, not pure expression. -/- This book (...) demonstrates how a properly developed expressivist view can overcome this objection, by showing that even if moral practice is fundamentally expressive, it can still come to possess those features that make it appear objective (features such as talk and thought of moral disagreement, truth and belief, and the applicability of logical notions to moral sentences). The key to this development is to emphasise the unique and intricate practical role that morality plays in our lives. Practical expressivism is also practical in the further sense that it provides repeatable patterns that expressivists can deploy in coming to understand the apparently objective features of morality. (shrink)

: When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of (...) honest, professional disagreement in the community of expert practitioners as to the preferred treatment. FE and CE are widely understood as competing concepts. We argue that FE and CE offer separable and, in themselves, incomplete justifications for the conduct of clinical trials. FE articulates conditions under which the fiduciary duties of physician to patient may be upheld in the conduct of research. CE sets out a standard for the social approval of research by institutional review boards. Viewed in this way, FE and CE are not necessarily competing notions, but rather address complementary moral concerns. (shrink)

The author comments on the article “The Neurobiology of Addiction: Implications for Voluntary Control of Behavior,‘ by S. E. Hyman. Hyman’s article suggests that addicted individuals have impairments in cognitive control of behavior. The author agrees with Hyman’s view that addiction weakens the addict’s ability to align his actions with his judgments. The author states that neuroethics may focus on brains and highlight key aspects of behavior but we still risk missing explanatory elements. Accession Number: 24077912; Authors: Levy, Neil (...) 1,2; Email Address: [email protected]; Affiliations: 1: University of Melbourne, Parkville 3010, Australia; 2: University of Oxford; Subject: ADDICTIONS; Subject: ALCOHOLISM; Subject: COGNITION; Subject: BEHAVIOR; Subject: JUDGMENT; Subject: HYMAN, S. E.; Subject: NEUROBIOLOGY; Number of Pages: 2p. (shrink)

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk (...) in research is required. Component analysis provides such a systematic approach. (shrink)

This paper applies the theory of teleosemantics to the issue of moral content. Two versions of teleosemantics are distinguished: input-based and output-based. It is argued that applying either to the case of moral judgements generates the conclusion that such judgements have both descriptive (belief-like) and directive (desire-like) content, intimately entwined. This conclusion directly validates neither descriptivism nor expressivism, but the application of teleosemantics to moral content does leave the descriptivist with explanatory challenges which the expressivist does not face. Since teleosemantics (...) ties content to function, the paper also offers an account of the evolutionary function of moral judgements. (shrink)

Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the conspicuous absence of an articulated foundation in (...) moral and legal theory of the physician-researcher's duty of care to the patient-subject. We have repeatedly suggested that the requisite foundation is in the ethics of trust and the law of fiduciaries.Curiously, despite the absence of a published thorough exposition of our position, some have preemptively criticized our suggestion that the relationship between physician-researcher and patient-subject is fiduciary. Others have offered their own accounts of the implications of fiduciary law for the relationship. (shrink)

Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) determination of the range of (...) possible community protections, (iv) creation of connections between particular protections and one or more community characteristics necessary for its implementation, and (v) synthesis of community characteristics and possible protections to define protections appropriate for each type of community. Depending on the particular community, consent and consultation, consultation alone, or no added protections may be required for research. (shrink)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit-harm evaluation by research (...) ethics committees (RECs). Clinical equipoise, a standard in component analysis, ensures the treatment arms of a randomised control trial are consistent with competent medical care. It thus serves to protect agent-neutral welfare interests of the patient-subject. But REC review occurs prior to enrolment, highlighting the independent responsibility of the physician-researcher to protect the agent-relative welfare interests of the patient-subject. In a novel interpretation of the duty of care, we argue for a “clinical judgment principle” which requires the physician-researcher to exercise judgment in the interests of the patient-subject taking into account evidence on treatments and the patient-subject‘s circumstances. (shrink)

As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher-community partnership and span the phases of a research project, from protocol development to publication. The complete list of 23 protections may apply to those few non-aboriginal communities, such as the Amish, that are highly cohesive. Although some protections may (...) be applicable to less-cohesive communities, such as Ashkenazi Jews, analysis suggests substantial problems in extending these guidelines in toto beyond the aboriginal communities for which they were developed. (shrink)

This paper presents two cases demonstrating that theories allowing the environment to partially determine the content of moral concepts provide incorrect truth-conditions for moral terms. While typical Moral Twin Earth cases seek to establish that these theories fail to account formoral disagreement, neither case here essentially involves interpersonal disagreement. Both involve a single person retaining moral beliefs despite recognizing actual or potential mismatches with the purportedly content-determining facts. This lets opponents of such theories grant objections that standard Moral Twin Earth (...) cases fail to demonstrate disagreement, and argue more straightforwardly that they generate implausible truth-conditions for moral claims. (shrink)

Christine Korsgaard argues that Humean views of both action and rationality jointly imply the impossibility of irrational action, allowing us only to perform actions that we deem rational. Humeans can answer Korsgaard’s objection if their views of action and rationality measure agents’ actual desires differently. What determines what the agent does are the motivational forces that desires produce in the agent at the moment when she decides to act, as these cause action. What determines what it is rational to do (...) should be the agent’s dispositional desire strengths, as our normative intuitions respond to these. (shrink)

Nietzsche takes moral judgments to be false beliefs, and encourages us to pursue subjective nonmoral value arising from our passions. His view that strong and unified passions make one virtuous is mathematically derivable from this subjectivism and a conceptual analysis of virtue, explaining his evaluations of character and the nature of the Overman.

Patient outcome after serious brain injury is highly variable. Following a period of coma, some patients recover while others progress into a vegetative state (unresponsive wakefulness syndrome) or minimally conscious state. In both cases, assessment is difficult and misdiagnosis may be as high as 43%. Recent advances in neuroimaging suggest a solution. Both functional magnetic resonance imaging and electroencephalography have been used to detect residual cognitive function in vegetative and minimally conscious patients. Neuroimaging may improve diagnosis and prognostication. These techniques (...) are beginning to be applied to comatose patients soon after injury. Evidence of preserved cognitive function may predict recovery, and this information would help families and health providers. Complex ethical issues arise due to the vulnerability of patients and families, difficulties interpreting negative results, restriction of communication to “yes” or “no” answers, and cost. We seek to investigate ethical issues in the use of neuroimaging in behaviorally nonresponsive patients who have suffered serious brain injury. The objectives of this research are to: (1) create an approach to capacity assessment using neuroimaging; (2) develop an ethics of welfare framework to guide considerations of quality of life; (3) explore the impact of neuroimaging on families; and, (4) analyze the ethics of the use of neuroimaging in comatose patients. (shrink)

In this issue of the Journal of Law, Medicine & Ethics Peter Clark provides a comprehensive and sound ethical analysis of clinical trials examining the treatment of advanced Parkinson's disease with fetal tissue transplantation. These studies raise profound questions about how clinical trials of surgical interventions ought to be conducted. At stake is not only the ethical basis of such trials, but differing views as to the proper role of science in medicine and its limitations.Experience with the broader debate on (...) the ethical permissibility of placebo controls has taught us that the choice of control treatment is an aspect of trial design in which ethical and scientific issues overlap. Accordingly, I will highlight, and perhaps expand upon, three issues raised by Clark: What scientific questions ought clinical trials of surgical interventions ask? How should the ethical analysis of risk for such trials be conceived? And, are surgical patients a vulnerable population? (shrink)

I argue that Frank Jackson's knowledge argument cannot succeed in showing that qualia are epiphenomenal. The reason for this is that there is, given the structure of the argument, an irreconcilable tension between his support for the claim that qualia are non-physical and his conclusion that they are epiphenomenal. The source of the tension is that his argument for the non-physical character of qualia is plausible only on the assumption that they have causal efficacy, while his argument for the epiphenomenal (...) character of qualia is plausible only on the assumption that they are non-physical. Since these two arguments cannot be combined coherently, the most Jackson's argument can establish is that qualia are non-physical. (shrink)

In this issue of the Journal of Law, Medicine & Ethics Peter Clark provides a comprehensive and sound ethical analysis of clinical trials examining the treatment of advanced Parkinson's disease with fetal tissue transplantation. These studies raise profound questions about how clinical trials of surgical interventions ought to be conducted. At stake is not only the ethical basis of such trials, but differing views as to the proper role of science in medicine and its limitations.Experience with the broader debate on (...) the ethical permissibility of placebo controls has taught us that the choice of control treatment is an aspect of trial design in which ethical and scientific issues overlap. Accordingly, I will highlight, and perhaps expand upon, three issues raised by Clark: What scientific questions ought clinical trials of surgical interventions ask? How should the ethical analysis of risk for such trials be conceived? And, are surgical patients a vulnerable population? (shrink)

The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The (...) authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research. (shrink)

The historiography of the ‘dark age’ of biochemistry between 1910–1930 is examined. The biochemistry of the period is located within a larger contemporary debate on the interrelationship between structure and function on a submicroscopic level. It is suggested that biocolloid science was an understandable part of the historical development of biochemistry, representing a conceptual bridge between the cell biology of the late nineteenth century, and the era of structural macromolecular studies of proteins that began after 1930.

The existing EELS literature has usefully identified the scope of ethical issues posed by pharmacogenetic and pharmacogenomic research. The time has come for in-depth examination of particular ethical issues. The involvement of racial and ethnic communities in pharmacogenetic and pharmacogenomic research is contentious precisely because it touches upon the science and politics of studying racial and ethnic difference. To date, the ethics literature has not seriously taken account of the fact that such research impinges upon the interests of communities, and (...) that taking such interests seriously requires that we both protect and empower communities in research. We propose a framework that rests upon the recognition that communities are heterogeneous human associations and differing policies are appropriate for differing communities. Community consent and consultation and community consultation alone are neither appropriate nor required for all pharmacogenetic and pharmacogenomic research. Rather, application of these policy protections must take into account particulars of both planned research and the communities involved. (shrink)

The effort to revise the Declaration of Helsinki and the CIOMS Guidelines has sparked a sometimes vitriolic debate centering on the use of placebo controls.

I argue that the explanatory gap is generated by factors consistent with the view that qualia are physical properties. I begin by considering the most plausible current approach to this issue based on recent work by Valerie Hardcastle and Clyde Hardin. Although their account of the source of the explanatory gap and our potential to close it is attractive, I argue that it is too speculative and philosophically problematic. I then argue that the explanatory gap should not concern physicalists because (...) it makes excessive demands on physical theory. (shrink)

Disputes over territory are a major contributing factor to the disruption of international relations. We believe that a cumulative, integrated, and continuously updated resource providing information about such disputes in an easily accessible form would be of benefit to intelligence analysts, military strategists, political scientists, and also to historians and others concerned with international disputes. We propose an ontology-based strategy for creating such a resource. The resource will contain information about territorial disputes, arguments for and against claims pertaining to sovereignty, (...) proffered evidence for such claims, political and military motives (overt or hidden), and associated conflicts. Our approach is designed to address several issues surrounding the representation of geopolitical conflict, including the tracking and individuation of disputes and the validation of disseminated information. (shrink)

Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (1) (...) protect research subjects; (2) allow clinical research to proceed; (3) explain how physicians may offer trial enrolment to their patients; (4) address the challenges posed by research containing a mixture of interventions and (5) define ethical standards according to which the risks and potential benefits of research may be consistently evaluated. This response argues that the net risks test meets none of these criteria and concludes that it is not a viable alternative to component analysis. (shrink)

I propose a new form of epiphenomenalism, 'explanatory epiphenomenalism', the view that the identification of A's mental properties does not provide a causal explanation of A's behaviour. I arrive at this view by showing that although anomalous monism does not entail type epiphenomenalism (despite what many of Davidson's critics have suggested), it does (when coupled with some additional claims) lead to the conclusion that the identification of A's reasons does not causally explain A's behaviour. I then formalize this view and (...) show that it is an attractive position, because it captures the insights of existing forms of epiphenomenalism without their onerous metaphysical commitments. (shrink)

Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention, and (...) the Bill and Melinda Gates Foundation testing the safety and efficacy of tenofovir, an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials. (shrink)

En utilisant le cadre théorique développé par Jaegwon Kim, soit l’opposition entre le réalisme explicatif et l’irréalisme explicatif, ainsi que quelques observations sur la métaphysique et l’épistémologie de l’explication, je réexamine le désaccord opposant Robert Kane à Richard Double au sujet du principe de l’explication rationnelle. Je défends la position de Kane sur la double rationalité et je soutiens que le principe proposé par Double possède un champ d’application plus limité qu’il le prétend. Je montre aussi que, contrairement à ce (...) que suppose Double, la façon dont Kane entend expliquer l’action ne se transforme pas en une forme d’irréalisme explicatif. (shrink)