I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and (...) Women’s Hospital and Harvard University (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

We argue that in implanted neurotechnology research, participants and researchers experience what Henry Richardson has called “moral entanglement.” Participants partially entrust researchers with access to their brains and thus to information that would otherwise be private, leading to created intimacies and special obligations of beneficence for researchers and research funding agencies. One of these obligations, we argue, is about continued access to beneficial technology once a trial ends. We make the case for moral entanglement in this context through exploration (...) of participants’ vulnerability, uncompensated risks and burdens, depth of relationship with the research team, and dependence on researchers in implanted neurotechnology trials. (shrink)

There is a growing recognition that the ongoing use of investigational neural implants requires continued access to clinical expertise and specialized healthcare (e.g., Hendriks et al., 2019). Howe...

The need for continuing provision of beneficial experimental interventions after research is concluded remains a controversial topic in bioethics for research. Based on the principle of beneficence, justice as reciprocity, concerns about exploitation and fair benefits, participants should be able to have continuing access to benefits beyond the research period. However, there is no consensus about whether or not post-trial provision of beneficial interventions should be mandatory for participants from developing countries. This paper summarises recommendations from international and (...) national guidelines. Ethical principles and practical issues relating to post-trial provision are also discussed. In conclusion, post-trial provision is not necessary in all situations and a set of criteria are proposed to identify the situations that beneficial interventions should be provided beyond the research period. However, mandatory post-trial supply of beneficial experimental interventions should be assured for those who still need and are able to benefit from them but have no alternative access. Mandatory provision is based on universal bioethical principles such as beneficence and justice. Furthermore, difficulties associated with implementation of post-trial provision are not unmanageable. Careful advanced planning and a comprehensive partnership among relevant parties would be very helpful in solving these difficulties in practice, which therefore should not be taken as an excuse to escape post-trial responsibility. (shrink)

The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial (...) obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. (shrink)

Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors’ groups, respectively. 54 patients answered the (...) questionnaire through their doctors. The least informative item in the consent form was how to obtain the study medication after trial. If a benefit were demonstrated in the study, 60% of research participants and 35% of EC answered that all patients should continue receiving study medication after trial; 43% of investigators believed the medication should be given to participants, and 40% to subjects who participated and benefited from treatment. For 50% of the sponsors, study medication should be assured to participants who had benefited from treatment. The majority of responders answered that medication should be provided free by sponsors; investigators and sponsors believed the medication should be kept until available in the public health sector; EC members said that the patient should keep the benefit; patients answered that benefits should be assured for life. Conclusions Due to the study limitations, the results cannot be generalised; however, the data can contribute to discussion of this complex topic through analysing the views of stakeholders in clinical research in Brazil. (shrink)

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National (...) Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. (shrink)

This book begins the discourse on post-trial access to drugs in developing countries. Underlying ethical issues in global health inequalities and global health research serve as the context of the debate. Due to rampant allegations of violations of rights of research participants, especially in developing countries, it discusses the regulatory infrastructure and ethical oversight of international clinical research, thus emphasizing the priority of safeguarding the rights of research participants and host populations as desiderata in conducting clinical trials in (...) developing countries. This is the first book that analyzes the major obstacles of affordable access to drugs in developing countries - patent and non-patent factors and how they can be overcome through a middle ground approach and a new paradigm to establish global health justice which includes national and global health responsibilities. The book also deals extensively with all complex aspects of the discourse on affordable access to drugs in developing countries, including intellectual property law, international regulations, political and cultural systems, international trade agreements. Furthermore it contains a robust ethical debate and in-depth analysis. The book crafts a paradigm of global health justice involving a sliding scale of national and global responsibilities for the realization of the right to health in general and access to drugs in particular. (shrink)

This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for (...) pharmaceutical products in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs. (shrink)

Purpose We examine the levels of post-trial responsibility ascribed to different stakeholders, following a community-based clinical trial and how the ‘responsibility’ is understood. Methods We employed photovoice, unstructured observations and key informant interviews to gain insights into contexts of access to care following transition to the public health system post trial. We used an inductive narrative analysis to explore experiences and understandings of post-trial access. Results In their photovoice stories, many participants (...) expressed a sense of abandonment after the trial. This was viewed as a contributing factor to failing to re-engage with care available in the public health system. This led to the experiences of loss as some trial participants defaulted and died. Research investigators, department of health participants and sponsor agreed that PTA was especially important for communities in resource-limited settings. The government has an obligation towards its citizens while researchers have a responsibility to ensure a smooth transition of patients to public clinics. Sponsors have a responsibility to ensure that the trial is conducted in accordance with the protocol and post-trial agreements are in place and adhered to. Research partnerships among stakeholders were affected by power imbalances making it difficult to negotiate and plan for post-trial care responsibilities. Conclusions The research community still struggles with understanding the scope of PTA responsibilities. Power dynamics between public health actors and research sponsors need to be managed to ensure that government involvement is not tokenistic. The responsibility of trial participants and ethics committees needs to be investigated further. Data are available upon request. (shrink)

The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, (...) especially where government bodies, sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. (shrink)

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. (...) Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

Ecologists traditionally regard time as part of the background against which ecological interactions play out. In this book, Eric Post argues that time should be treated as a resource used by organisms for growth, maintenance, and offspring production. Post uses insights from phenology -- the study of the timing of life-cycle events -- to present a theoretical framework of time in ecology that casts long-standing observations in the field in an entirely new light. Combining conceptual models with field (...) data, he demonstrates how phenological advances, delays, and stasis, documented in an array of taxa, can all be viewed as adaptive components of an organism's strategic use of time. Post shows how the allocation of time by individual organisms to critical life history stages is not only a response to environmental cues but also an important driver of interactions at the population, species, and community levels. To demonstrate the applications of this exciting new conceptual framework, Time in Ecology uses meta-analyses of previous studies as well as Post's original data on the phenological dynamics of plants, caribou, and muskoxen in Greenland.--Back cover. (shrink)

While the HVTN 505 trial showed no overall efficacy of the tested vaccine to prevent HIV infection over placebo, markers measuring immune response to vaccination were strongly correlated with infection. This finding generated the hypothesis that some marker-defined vaccinated subgroups were partially protected whereas others had their risk increased. This hypothesis can be assessed using the principal stratification framework (Frangakis and Rubin, 2002) for studying treatment effect modification by an intermediate response variable, using methods in the sub-field of principal (...) surrogate (PS) analysis that studies multiple principal strata. Unfortunately, available methods for PS analysis require an augmented study design not available in HVTN 505, and make untestable structural risk assumptions, motivating a need for more robust PS methods. Fortunately, another sub-field of principal stratification, survivor average causal effect (SACE) analysis (Rubin, 2006) – which studies effects in a single principal stratum – provides many methods not requiring an augmented design and making fewer assumptions. We show how, for a binary intermediate response variable, methods developed for SACE analysis can be adapted to PS analysis, providing new and more robust PS methods. Application to HVTN 505 supports that the vaccine partially protected individuals with vaccine-induced T-cells expressing certain combinations of functions. (shrink)

This essay argues that Knafo and Teschke fundamentally misread Brenner’s original contribution to the transition debate. They equate his rejection of trans-historical or trans-modal laws of motion with the notion that social-property relations do not have strong rules of reproduction that structure the actions of agents and give rise to ‘developmental patterns’ specific to each form of social labour. Knafo and Teschke’s critique of Brenner’s analysis of capitalist expansion and crisis is also theoretically and empirically questionable.

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires as a condition of accreditation that every health care institution -- hospital, nursing home, or home care agency -- have a standing mechanism to address ethical issues. Most organizations have chosen to fulfill this requirement with an interdisciplinary ethics committee. The best of these committees are knowledgeable, creative, and effective resources in their institutions. Many are wellmeaning but lack the information, experience, and skills to negotiate adequately the complex ethical (...) issues that arise in clinical and organizational settings. Handbook for Health Care Ethics Committees is the first resource designed to address the range of work performed by ethics committees as part of their multiple responsibilities, including education, case consultation, and policy development. It features an eight-chapter curriculum reviewing the content of contemporary health care bioethics and discussing the ethical foundations of clinical practice, with each subsequent section focusing on a set of ethical issues that commonly arise in the clinical setting. Through case studies, the authors explore issues such as informed consent and refusal, decision making and decisional capacity, truth telling, decision-making concerns of minors, end-of-life issues, palliation, justice in and access to health care services, and organizational ethics. They offer sample policies and procedures, draft guidelines and protocols, and key legal cases. Providing both a strong theoretical foundation and practical applications, this handbook will be essential reading for every member of a health care ethics committee. (shrink)

This article explores how the diversity of board resources and the number of women on boards affect firms' corporate social responsibility (CSR) ratings, and how, in turn, CSR influences corporate reputation. In addition, this article examines whether CSR ratings mediate the relationships among board resource diversity, gender composition, and corporate reputation. The OLS regression results using lagged data for independent and control variables were statistically significant for the gender composition hypotheses, but not for the resource diversitybased hypotheses. CSR ratings (...) had a positive impact on reputation and mediated the relationship between the number of women on the board and corporate reputation. (shrink)

Abstract: This paper discusses global corporate citizenship in the twenty-first century. The primary focus is on the responsibility of management educators to foster among students an understanding of the causes and consequences of business activitiy that creates organizational wealth, including the role of stakeholders. The modern corporation is a stakeholder enterprise: stakeholders enable the business to create wealth and require that it distribute wealth appropriately. The stakeholder enterprise model, which has been so economically successful, also implies corporate citizenship responsibilities. (...) The Clarkson Principles are discussed as a means through which educators and managers can better understand and address the challenges of corporate citizenship in the modern world. (shrink)

This paper discusses global corporate citizenship in the twenty-first century. The primary focus is on the responsibility of managementeducators to foster among students an understanding of the causes and consequences of business activitiy that creates organizationalwealth, including the role of stakeholders. The modern corporation is a stakeholder enterprise: stakeholders enable the business to create wealth and require that it distribute wealth appropriately. The stakeholder enterprise model, which has been so economically successful, also implies corporate citizenship responsibilities. The Clarkson Principles (...) are discussed as a means through which educators and managers can better understand and address the challenges of corporate citizenship in the modern world. (shrink)

This book draws from previously unpublished letters and interviews with physicists, theologians, and Sir John’s close associates and family to present Sir John’s ideas on pure unlimited love. Post, who was in dialogue with Sir John for fifteen years on this topic and who had founded the Institute for Research on Unlimited Love, addresses how John Templeton arrived at his philosophy as a youth growing up in Tennessee. Post also shares how classical Presbyterian ideas came to synergize in (...) his mind with the more eastern influences of American transcendentalism and the Unity School of Christianity and ponders if Sir John truly believed that science and spiritualty might fully converge on the same view of Ultimate Reality with their very different ways of knowing. _Is Ultimate Reality Unlimited Love?_ presents Sir John’s hope for spiritual progress with the eventual convergence of ultimate reality and unlimited love at its very center. (shrink)

The increased recognition and reported prevalence of autism spectrum disorders combined with the associated societal and clinical impact call for a broad grassroots community-based dialogue on treatment related ethical and social issues. In these Stony Brook Guidelines, which were developed during a full year of community dialogue with affected individuals, families, and professionals in the field, we identify and discuss topics of paramount concern to the ASD constituency: treatment goals and happiness, distributive justice, managing the desperate hopes for a cure, (...) sibling responsibilities, intimacy and sex, diagnostic ethics, and research ethics. The members of the dialogue core committee included doctors, ethicists, administrators, social workers, ministers, disability experts, and many family members of individuals with autism who were especially engaged in community activities on behalf of their constituency, including siblings, parents, and grandparents. Our guidelines are not based on “top-down” imposition of professional expertise, but rather on a “bottom-up” grass roots attention to the voices of affected individuals and families speaking from experience. These guidelines can inform clinical practice, but they also are meaningful for the wider social conversation emerging over the treatment of individuals with ASD. (shrink)

This article focuses on the elderly patient with a progressive and irreversible dementia, most often of the Alzheimer type. However dementia, the decline in mental function from a previous state, can occur in all ages. For example, if Alzheimer's disease is the dementia of the elderly, increasingly AIDS is the dementia of many who are relatively young. I will not present the major ethical issues relating to dementia care following the progression of disease from the mild to the severe stages, (...) for I have done this elsewhere. Among the issues included are: presymptomatic testing, both psychological and genetic; responsible diag- nostic disclosure and use of support groups; restrictions on driving and other activities; preemptive assisted suicide; advance directives for research and treatment; quality of life in relation to the use of life-extending technologies; and euthanasia. (shrink)

Adoption, from the Latin opiate, “to choose,” means “to take into a relationship, especially another's child as one's own”. The word implies a permanent taking of responsibility. While the assumption that biological parents should rear their children is vital to society, adoption provides an alternative that is sometimes necessary.

The interface between religion, psychiatry, and ethics is often a locus for considerable controversy. This article focuses on the response of American psychiatry to religious nonconformism, and to religious conversion generally. At issue is the societal pressure against unpopular religious movements. The author argues for an ethic that conserves the freedom of religious conscience, and that guards against inquisitions in the guise of medical expertise and nosology.

ObjectiveCo-morbid insomnia and sleep apnea is a common and debilitating condition that is more difficult to treat compared to insomnia or sleep apnea-alone. Emerging evidence suggests that cognitive behavioral therapy for insomnia is effective in patients with COMISA, however, those with more severe sleep apnea and evidence of greater objective sleep disturbance may be less responsive to CBTi. Polysomnographic sleep study data has been used to predict treatment response to CBTi in patients with insomnia-alone, but not in patients with COMISA. (...) We used randomized controlled trial data to investigate polysomnographic predictors of insomnia improvement following CBTi, versus control in participants with COMISA.MethodsOne hundred and forty five participants with insomnia and sleep apnea [apnea-hypopnea index ≥ 15] were randomized to CBTi or no-treatment control. Mixed models were used to investigate the effect of pre-treatment AHI, sleep duration, and other traditional, and novel [quantitative electroencephalography ] polysomnographic predictors of between-group changes in Insomnia Severity Index scores from pre-treatment to post-treatment.ResultsCompared to control, CBTi was associated with greater ISI improvement among participants with; higher AHI, less wake after sleep onset, and less N3 sleep. No quantitative electroencephalographic, or other traditional polysomnographic variables predicted between-group ISI change.DiscussionAmong participants with COMISA, higher OSA severity predicted a greater treatment-response to CBTi, versus control. People with COMISA should be treated with CBTi, which is effective even in the presence of severe OSA and objective sleep disturbance. (shrink)

Richard Gale and Alexander Pruss raise a number of excellent questions in their separate responses to my comments on Gale’s book, On the Nature and Existence of God. They focus on aspects of my discussion that need at least to be clarified, if not retracted, in ways I explain in this reply.

This study presents findings from an ontological and contextual determination of the concept of dignity. The study had a caritative and caring science perspective and a hermeneutical design. The aim of this study was to increase caring science knowledge of dignity and to gain a determination of dignity as a concept. Eriksson’s model for conceptual determination is made up of five part-studies. The ontological and contextual determination indicates that dignity can be understood as absolute dignity, the spiritual dimension characterized by (...) responsibility, freedom, duty, and service, and relative dignity, characterized by the bodily, external aesthetic dimension and the psychical, inner ethical dimension. Dignity exists in human beings both as absolute and relative dignity. (shrink)

One of the major roadblocks in conducting Environmental Corporate Social Responsibility (ECSR) research is operationalization of the construct. Existing ECSR measurement tools either require primary data gathering or special subscriptions to proprietary databases that have limited replicability. We address this deficiency by developing a transparent ECSR measure, with an explicit coding scheme, that strictly relies on publicly available data. Our ECSR measure tests favorably for internal consistency and inter-rater reliability, as well as convergent and discriminant validity.

Health care decision making has changed profoundly during the past several decades. Advances in scientific knowledge, technology, and professional skill enable medical providers to extend and enhance life by increasing the ability to cure disease, manage disability, and palliate suffering. Ironically, the same interventions can prolong painful existence and protract the dying process. Recognizing that medical interventions, especially lifesustaining measures, are not always medically appropriate or even desired by a patient or family, health care professionals endeavor to determine who should (...) make health care decisions and according to what standards. The importance that Western culture places on individual rights and self-determination is reflected in the growing advocacy for patient autonomy and the discrediting of physician paternalism. However, the question of autonomy becomes more complex when patients lack the capacity to decide for themselves.Advance directives represent one response to the dilemma of decision making for incapacitated patients. The original advance directive, the living will, is a written list of instructions reflecting the individual's wishes about care, usually at the end of life. (shrink)

Health care decision making has changed profoundly during the past several decades. Advances in scientific knowledge, technology, and professional skill enable medical providers to extend and enhance life by increasing the ability to cure disease, manage disability, and palliate suffering. Ironically, the same interventions can prolong painful existence and protract the dying process. Recognizing that medical interventions, especially lifesustaining measures, are not always medically appropriate or even desired by a patient or family, health care professionals endeavor to determine who should (...) make health care decisions and according to what standards. The importance that Western culture places on individual rights and self-determination is reflected in the growing advocacy for patient autonomy and the discrediting of physician paternalism. However, the question of autonomy becomes more complex when patients lack the capacity to decide for themselves.Advance directives represent one response to the dilemma of decision making for incapacitated patients. The original advance directive, the living will, is a written list of instructions reflecting the individual's wishes about care, usually at the end of life. (shrink)

This book should be required reading for anyone who cares about the realism/antirealism issue, but also, and perhaps above all, for those who have tired of the dispute because they suspect it is meaningless. In response to those who thus turn their backs on the issue, Professor Cortens argues at length, and with great clarity and rigor, that “unless they give up on philosophy altogether” they will likely be unable “to avoid discussing the issues that give life to these labels”. (...) The reason is that for some time philosophy has been characterized by all-encompassing struggles over the nature of thought, language, and their relation to the world. In these struggles, “one party will naturally view the other as repudiating everything all at once,” especially when the dispute is about “whether it is we who... ‘divide the world into objects,’” or about “the reality of reference,” or about “whether meaning and psychological content are objective matters of fact”. We friends of metaphysics run the risk that “we might wake up one day to discover, much to our horror, that our best philosophers of mind and language have robbed us of the ability to say or think anything at all, much less to speculate about the fundamental features of reality that concern the metaphysician.... Small comfort to be told that, once we become fully converted to the strange new conception of thought and language, we may continue to speak as though we believed in a world”. (shrink)

This collection of eleven critical essays, together with Plantinga's replies, examines his evolutionary argument against naturalism (EAAN). All but one of the eleven are printed here for the first time, all are of high quality, and all receive Plantinga's trademark treatment -- rigorous, perceptive, thorough. In view of the numerous arguments, sub-arguments and observations advanced by the eleven against EAAN, his responses amount to a tour de force . It would take too long to sort through the point-counterpoint with a (...) view to laying out the many interconnections, valuable though that would be. Instead, after a sketch of EAAN, I summarize some of the key objections raised by the eleven, together with Plantinga's replies, then conclude with an objection of my own to what Plantinga calls the heart of his argument. (shrink)

The Clinton administration's revised rules regulating but not prohibiting the common practice in managed care of linking physician compensation with cost cutting and control of services demonstrates the complexity of ethical issues in managed care. As originally proposed, the federal guidelines on payment for Medicare and Medicaid services would have precluded any interrelationship between payment to physicians and delivery of services. Such a restriction would have gutted the primary mechanism in managed care plans to curb the unacceptably high cost of (...) healthcare delivery: making physicians directly responsible for cost control by placing them at direct financial risk. At first blush such a linkage seems to involve an obvious and irreconcilable conflict of interest. How can a physician be responsible for the well-being of a patient while at the same time aware that a proportion of his or her income is linked to the provision of cost-conscious care? (shrink)

In this article I argue that Part II of the Family LawAct 1996 gives expression to a new form ofresponsibility. I begin by suggesting thatresponsible behaviour has shifted from prohibiting orrequiring particular actions: we now exhibitresponsibility by our attitude towards our actions. I then examine where this new conception ofresponsibility has come from. Through an examinationof the work of post-liberal theorists, principallyMichael Sandel, I argue that a changing view ofpersonhood within post-liberal theory has led to aquestioning of the (...) possibility of choice, and that theabsence of choice necessitates a shift in thedefinition of responsible behaviour. If we are createdby our decisions then we cannot be held to account forour decisions, but only for the care we have takenover them. Responsibility is therefore measured notby our level of self-control but by our level ofself-awareness. Finally I examine the consequences ofthis shift in the meaning of responsibility. Withinthis framework autonomy is illusory thereforedecisions do not need to be respected. This explainswhy the implementation of Part II of the Family LawAct 1996 has been called into question. Within thisframework responsibility is relative therefore itextends indefinitely. This enables the Family Law Actto be uniquely intrusive and judgmental: everydivorcing couple, on being held up to scrutiny, isfound lacking. (shrink)

There is a gap of knowledge about the extent to which gratitude is indeed the working mechanism of change in gratitude interventions aiming to promote mental well-being. This study explores the mediational role of gratitude as mood in the context of a recently conducted randomized controlled trial on the effects of a 6-week gratitude intervention on mental well-being in comparison with a waitlist control group. Gratitude as mood was measured at 2, 4, and 6 weeks. Both simple and multiple (...) mediation models were conducted as well as various sensitivity analyses. Results showed a gradual increase of gratitude as mood during the intervention. The effects of the 6-week gratitude intervention on mental well-being were mediated by increases of gratitude as mood at 4 weeks but not at 2 weeks. These findings suggest a dose-response relationship for gratitude interventions, but more research is warranted. (shrink)