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)

BackgroundThe biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.Main textAny institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that (...) arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context “specification” substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: dual missions; timely and pragmatic guidance; resource stewardship; multiple stakeholders; and operational complexity.ConclusionUnderstanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society. (shrink)

The senses can be powerful triggers for memories of our past, eliciting a range of both positive and negative emotions. In this book we explore what is so special about sense memories, how they work in the brain, how they can enrich our daily life, and even how they can help those suffering from problems involving memory.

Since Karl Rahner, mystagogia has been considered one of the Christian pastoral practices which can approach the need felt for experimental faith. Practical theologians who have indulged in the new mystagogia have placed its foundation in the mystagogical practices of third and fourth century church fathers. It seems as though the authority of the church fathers is used in defense of the legitimacy of mystagogia in our time. In this article, the patristic foundation of the new mystagogia is studied. In (...) this way, the context, contents and methods of current mystagogia are compared to the practices of the church fathers. It appears that Christian mystagogia is understood as a form of initiation into personal faith and the Christian community. In this, the social context plays a part. The initiation is also connected to a process of conversion, where the patristic mystagogia is but a phase, while the new mystagogia can be seen as a process in its own right. In contents and method, mystagogia emphasizes theology, rites and catechesis. The elaboration of these items occurs differently with the church fathers than with modern theologians. These differences between patristic mystagogia and the current time conjure up questions concerning modern pastorate. These questions will lead to a further analysis of current mystagogia. (shrink)

The key to action control is one’s ability to adequately predict the consequences of one’s actions. Predictive processing theories assume that forward models enable rapid “preplay” to assess the match between predicted and intended action effects. Here we propose the novel hypothesis that “reading” another’s action intentions requires a rich forward model of that agent’s action. Such a forward model can be obtained and enriched through learning by either practice or simulation. Based on this notion, we ran a series of (...) studies on soccer goalkeepers and novices, who predicted the intended direction of penalties being kicked at them in a computerized penalty-reading task. In line with hypotheses, extensive practice in penalty kicking improved performance in penalty reading among goalkeepers who had extensive prior experience in penalty blocking but not in penalty kicking. A robust benefit in penalty reading did not result from practice in kinesthetic motor imagery of penalty kicking in novice participants. To test whether goalkeepers actually use such penalty-kicking imagery in penalty reading, we trained a machine-learning classifier on multivariate fMRI activity patterns to distinguish motor-imagery-related from attention-related strategies during a penalty-imagery training task. We then applied that classifier to fMRI data related to a separate penalty-reading task and showed that 2/3 of all correctly read penalty kicks were classified as engaging the motor-imagery circuit rather than merely the attention circuit. This study provides initial evidence that, in order to read our opponent’s action intention, it helps to observe their action kinematics, and use our own forward model to predict the sensory consequences of “our” penalty kick if we were to produce these action kinematics ourselves. In sum, it takes practice as a penalty kicker to become a penalty killer. (shrink)

Phenomenological inquiry offers a vehicle for transcending conventional disciplinary boundaries and investigative settings. Van Manen's protocol writing offers a hermeneutic tool for human scientific phenomenological research that is ideal for the empirical realm of everyday lived experience. Underlying this approach is the tenet that interpretative phenomenological research and theorizing cannot be separated from the textual practice of writing. The entirety of this paper is a protocol, in the form of a phenomenological self-study. It describes one experience in an unfamiliar environment (...) as a criminal trial juror. It represents data capture that can stand alone for purposes of independent interpretation. Since qualitative research in the venue described is limited by protective judicial restrictions, this phenomenological protocol captures unique data in an otherwise inaccessible setting. It suggests that protocol writing offers potential as a research tool in a myriad situations where conventional data collection techniques are impractical or unavailable. (shrink)

NG van Kampen is a well-known theoretical physicist who has had a long and distinguished career. His research covers scattering theory, plasma physics, statistical mechanics, and various mathematical aspects of physics. In addition to his scientific work, he has written a number of papers about more general aspects of science. An indefatigable fighter for intellectual honesty and clarity, he has pointed out repeatedly that the fundamental ideas of physics have been needlessly obscured. As those papers appeared in various journals, partly (...) in Dutch, it was felt that it would be worthwhile to collect them and make them available to a larger audience. This is a book of major importance to scientists and university teachers. (shrink)

Psillos has recently argued that van Fraassen’s arguments against abduction fail. Moreover, he claimed that, if successful, these arguments would equally undermine van Fraassen’s own constructive empiricism, for, Psillos thinks, it is only by appeal to abduction that constructive empiricism can be saved from issuing in a bald scepticism. We show that Psillos’ criticisms are misguided, and that they are mostly based on misinterpretations of van Fraassen’s arguments. Furthermore, we argue that Psillos’ arguments for his claim that constructive empiricism itself (...) needs abduction point up to his failure to recognize the importance of van Fraassen’s broader epistemology for constructive empiricism. Towards the end of our paper we discuss the suspected relationship between constructive empiricism and scepticism in the light of this broader epistemology, and from a somewhat more general perspective. (shrink)

The thesis developed and defended in this paper is that is it false that all knowledge is founded on experience. Much of our knowledge (or alleged knowledge), it is argued, is based on testimony. Still, many philosophers have either not dealt with testimony at all, or treated it very unkindly. One of the reasons for this is that those philosophers (such as Descartes and Locke) work with a concept of knowledge according to which knowledge is certain, indubitable, and/or self-evident. And (...) if knowledge is what these philosophers say it is, then there is no such thing as knowledge based on testimony indeed. Thomas Reid is introduced as holding that we do have testimonial knowledge and that therefore Descartes' and Locke's concept of knowledge is untenable. Reid furthermore holds that human beings are endowed with a disposition to accept or believe what otherstell us („the principle of credulity”). The working of this principle is refined through all kinds of experience. What Reid says or shows is how this disposition in fact operates. Many epistemologists, however, have higher aspirations and look for reasons or arguments that can justify our factual acceptance of testimony. The inductive argument Hume offers, it is argued, is unconvincing. There is even reason to think that the principle of credulity can never be justified by adducing reasons. This does not imply, however, that acceptance of testimony is unjustified. Whether or not it is depends, among other things, on the concept of justification one uses. On an internalist concept of justification (as Locke's or Hume's) this disposition may never be justified. But on an externalist conception it may. This may be disappointing, given some widely held philosophical aspirations, but at the same time it is, as Alston has said, a lesson in intellectual humility. (shrink)

Managing education during the pandemic in the Netherlands and South Africa: A comparative study. Optimism has reigned supreme for a long time regarding the potential of education to address the many societal ailments that humankind has had to deal with. The outbreak of the COVID-19 pandemic in March 2020 shifted all such aspirations to the back-burner. Now, after just more than a year after the initial outbreak of the pandemic, the question can be raised whether those who managed the pandemic (...) in the educational context followed the correct policies and instituted the correct measures in combatting the pandemic. This comparison between the situation in the Netherlands and South Africa reveals that although the role-players in both countries had a good understanding of the situation and of their duties in such conditions, they tended to treat education as just another facet of society, thereby demonstrating a lack of empathy with the unique demands of education.Contribution: In this article, the authors investigate the governance performance of two different countries during the first year of the COVID-19 pandemic concerning education and judge that performance based on a Biblically driven ethical-moral-pedagogical framework. (shrink)

Scientific representation: A long journey from pragmatics to pragmatics Content Type Journal Article DOI 10.1007/s11016-010-9465-5 Authors James Ladyman, Department of Philosophy, University of Bristol, 9 Woodland Rd, Bristol, BS8 1TB UK Otávio Bueno, Department of Philosophy, University of Miami, Coral Gables, FL 33124, USA Mauricio Suárez, Department of Logic and Philosophy of Science, Complutense University of Madrid, 28040 Madrid, Spain Bas C. van Fraassen, Philosophy Department, San Francisco State University, 1600 Holloway Avenue, San Francisco, CA 94132, USA Journal Metascience Online (...) ISSN 1467-9981 Print ISSN 0815-0796. (shrink)

ABSTRACTThough many studies of the contemporary Buddhist literature exist, such studies often limit their purview to canonised, ‘high-brow’ authors. In this article, I read Janwillem van de Wetering’s The Japanese Corpse, a detective novel, for how it portrays Zen Buddhism. I show that The Japanese Corpse portrays Zen as non-dualist and amoral: good and bad are arbitrary categories that impede spiritual freedom. Likewise, characters’ identities are fluid, not fixed. The novel shows this by insistently associating Zen with sex and violence, (...) and by the use of dramatic motifs. However, the novel also excludes women, particularly Japanese women, from spiritual attainment, instead essentialising them as the sexual objects of the hard-boiled detective story. As a matrix of conflicting values, The Japanese Corpse thus turns out to be a case study of Buddhist modernism, and of challenges of detective fiction as world literature. (shrink)