Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods: Data on the descriptive characteristics of bioethics consultations were collected from (...) 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results: Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions: Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues. (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)

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)

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 (concepts, principles, and rules) 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: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) 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)

This volume contains new and original papers on Martin Heidegger's complex relation to Friedrich Nietzsche's philosophy. The authors not only critically discuss the many aspects of Heidegger's reading of Nietzsche, they also interpret Heidegger's thought from a Nietzschean perspective. Here is presented for the first time an overview of not only Heidegger's and Nietzsche's philosophy but also an overview of what is alive - and dead - in their thinking. Many authors through a reading of Heidegger and Nietzsche deal with (...) current issues such as technology, ecology, and politics. This volume is of interest for everyone interested in Heidegger's and Nietzsche's thought. Contributors include: Babette Babich, Charles Bambach, Robert Bernasconi, Virgilio Cesarone, Stuart Elden, Michael Eldred, Markus Enders, Charles Feitosa, Véronique Fóti, Luanne T. Frank, Jeffery Kinlaw, Theodore Kisiel, William D. Melaney, Eric Sean Nelson, Abraham Olivier, Friederike Rese, Karlheinz Ruhstorfer, Harald Seubert, Robert Sinnerbrink, Robert Switzer, Jorge Uscatescu Barrón, Nancy A. Weston, Dale Wilkerson, Angel Xolocotzi, Jens Zimmermann. (shrink)

"When you find yourself neck deep in shit, start making bricks," or so I was advised by Luanne T. Frank, a faculty member during my graduate days, who was deftly "translating" Heidegger for us during one class session. And now, decades later, I look around and think, "I'd better get busy, really busy."With that prelude, and apologies to those weak of stomach or imagination—but this is not the time to be queasy—I approach Barbara Cassin's Sophistical Practice: Toward a Consistent (...) Relativism. Indeed, the paperback cover image is of a man knee deep in water, at the least, and he looks down reflectively, somberly, as if to ask: "Really? What to do?"When I first read Cassin's volume—a collection of previously... (shrink)