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)

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)

Somatic awareness is bodily sensation imbued with consciousness. Directing and cultivating somatic awareness is a practice fundamental to many therapeutic and spiritual enterprises. Recent developments in neuroscience attempt to explain the operational aspects of somatic awareness. But it has long been a topic of conversation in other paradigms, from philosophy to health care. Somatic input provides information for use in wellness treatment applications, including therapeutic bodywork. Yet few massage therapy scholarly investigations aim to capture the quality of body awareness experience. (...) The essence of the experience and its associated language remain imprecise and under-explored holistically.This article implements the therapeutic practice technique of the Body Scan to capture the essence of an inner body exploration (proprioception and interoception). Based on a narrative collected during a verbally self-directed exercise, a phenomenological description is explicated to represent one incidentof internal body experience. The pilot study suggests that the Body Scan offers potential as a research tool, as well as a modality for therapeutic intervention. (shrink)

Somatic awareness is bodily sensation imbued with consciousness. Directing and cultivating somatic awareness is a practice fundamental to many therapeutic and spiritual enterprises. Recent developments in neuroscience attempt to explain the operational aspects of somatic awareness. But it has long been a topic of conversation in other paradigms, from philosophy to health care. Somatic input provides information for use in wellness treatment applications, including therapeutic bodywork. Yet few massage therapy scholarly investigations aim to capture the quality of body awareness experience. (...) The essence of the experience and its associated language remain imprecise and under-explored holistically.This article implements the therapeutic practice technique of the Body Scan to capture the essence of an inner body exploration. Based on a narrative collected during a verbally self-directed exercise, a phenomenological description is explicated to represent one incidentof internal body experience. The pilot study suggests that the Body Scan offers potential as a research tool, as well as a modality for therapeutic intervention. (shrink)

The parables of Jesus: Allegories or symbols of social transformation? This article reflects on a possible methodology that can be used to interpret the parables of Jesus preserved in the Synoptics. It is argued that the available versions of the parables of Jesus have already been allegorised, and that this should be taken into consideration when the extant versions of parables are interpreted as parables of the historical Jesus. The parables should also, as far as possible, be interpreted against the (...) social realia evoked by the parables. In this endeavour, Roman-Egypt inscriptions and papyri are in most cases the only sources available. The article concludes with a few examples, illustrating the possibilities of interpretation when the proposed methodology is applied. (shrink)

Peacemakers as children of God : A pragmatic-linguistic reading. The article investigates different options of the pragmatic meaning of the beatitude in the Gospel of Matthew, ‘blessed are the peacemakers, for they shall be called children of God’. It also explores this Jesus logion’s seemingly contradiction with Jesus’ remark in die Matthean mission discourse, ‘Do not think that I have come to bring peace on earth; I have not come to bring peace, but a sword’. The pragmatic use of the (...) concept ‘peace’ in Matthew is probed against the background of scribal activity in the context of the restoration of villages in north-Galilee and south-Syria after the destruction of the temple in Jerusalem by the Romans. The pax Romana and Josephus’ appeal to the inhabitants of these villages to collaborate with the Romans is described as the context of these Matthean Jesus-logia. It argues that Matthew interprets Jesus as a ‘Mosaic Joshua’ in continuum with the Judaic tradition of Solomon as the ‘king of peace’, especially 1 Chronicles 22:5-11. The macarism about the ‘peacemakers as children of God’ is interpreted in correlation with the macarism ‘blessed are those who mourn, for they shall be comforted’. The article concludes with the finding that the sword-motif in Matthew 10:4 does not contradict the beatitude on peace in Matthew 5:9. (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)

Hoewel misschien minder dan vroeger, zijn velen van ons op zoek naar waarheid, of ‘de’ waarheid . We beseffen dat het ‘hebben’ van waarheid een groot goed is. We beseffen ook dat waarheid, of ‘de’ waarheid, soms of vaak, moeilijk te achterhalen is: het is een soms of vaak ongrijpbaar goed. Wie echter geen volslagen scepticus is kan in beginsel lijsten aanleggen van beweringen waarvan hij weet dat ze waar zijn, beweringen waarvan hij weet dat ze onwaar zijn, maar ook (...) van beweringen waarvan hij niet weet of ze waar dan wel onwaar zijn. (shrink)

One of the key concepts of Paul Ricoeur’s hermeneutics is the notion of distanciation. In this article we show that Ricoeur introduces this notion as a correction of Heidegger’s focus on being-in and Gadamer’s emphasis on belonging . Ricoeur argues that distanciation does not lead to the uprooting of our belonging to a tradition. Rather, distanciation is an integral part of the dynamics that constitutes tradition. We discuss the different senses in which Ricoeur understands distanciation as a positive and productive (...) aspect of tradition. In particular, we discuss the ontological aspect of distanciation. In his discussion of both the long way of hermeneutics and the creative dimension of distanciation in fiction, Ricoeur argues that it is distanciation that opens up the possibility of understanding our own being-in-the-world. This involvement of distanciation in the disclosure and understanding of being allows us to show that distanciation determines what “kind” of being is understood: what is interpreted in hermeneutics and disclosed in poetics is never being as such, but “being-interpreted” and “being-as,” respectively. This leads us to a description of the difference between Ricoeur’s and Heidegger’s thought concerning the ontological dimension of their hermeneutics. (shrink)