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)
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)
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)
Background Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects. Method We performed a conceptual and empirical analysis of vulnerability applied to pregnant women. Analysis A conceptual analysis supports Hurst's definition (...) of vulnerability. Consequently, we argue that pregnant women are vulnerable if they encounter an identifiably increased likelihood of incurring additional or greater wrong. According to the literature, this increased likelihood could exist of four alleged features for pregnant women's vulnerability: informed consent, susceptibility to coercion, higher exposure to risk due to lack of knowledge, vulnerability of the fetus. Discussion Testing the features against Hurst's definition demonstrates that they all concern the same issue: pregnant women are only vulnerable because a higher exposure to risk due to lack of scientific knowledge comprises an increased wrong. Research Ethics Committees have a responsibility to protect the vulnerable, but a higher exposure to risk due to lack of scientific knowledge is a much broader issue and also needs to be addressed by other stakeholders. Conclusions The only reason why pregnant women are potentially vulnerable is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge. Accordingly, the discussion can advance to the development of practical strategies to promote fair inclusion of pregnant women in clinical research. (shrink)
The Danish theologian-philosopher K. E. Løgstrup is second in reputation in his homeland only to Søren Kierkegaard. He is best known outside Europe for his _The Ethical Demand_, first published in Danish in 1956 and published in an expanded English translation in 1997. _Beyond the Ethical Demand_ contains excerpts, translated into English for the first time, from the numerous books and essays Løgstrup continued to write throughout his life. In the first essay, he engages the critical response to _The Ethical (...) Demand,_ clarifying, elaborating, or defending his original positions. In the next three essays, he extends his contention that human ethics “demands” that we are concerned for the other by introducing the crucial concept of “sovereign expressions of life.” Like Levinas, Løgstrup saw in the phenomenon of “the other” the ground for his ethics. In his later works he developed this concept of “the sovereign expressions of life,” spontaneous phenomena such as trust, mercy, and sincerity that are inherently other-regarding. The last two essays connect his ethics with political life. Interest in Løgstrup in the English-speaking academic community continues to grow, and these important original sources will be essential tools for scholars exploring the further implications of his ethics and phenomenology. “K. E. Løgstrup’s work undoubtedly made in his time an original contribution to the field of moral philosophy and philosophy of religion. This translation makes extracts from his later publications on moral philosophy accessible to an English-speaking audience. I am again impressed by the depth of his ideas, which are certainly not outdated and still relevant for contemporary debates in moral philosophy.” —_Bert Musschenga, Vrije Universiteit, Amsterdam _ “Making a large part of Knud Løgstrup’s legacy accessible to the English-speaking public is an event of enormous cultural, philosophical and political importance—and we are all in debt to his disciple, Kies van Kooten Niekerk, and the University Press of Notre Dame, for making it happen. Løgstrup, alongside few other giants of 20th Century ethical thought, like Emmanuel Levinas or Hans Jonas, anticipated and articulated all the major challenges and urgent tasks with which the coming century is likely to confront the moral self. Our ethical discourse was all the poorer so far for being barred access to his findings and proposition. This will no longer be the case.” —_Zygmunt Bauman, emeritus, University of Leeds_ “The publication of an English translation of Knut Eljert Løgstrup's later works in ethics provides a wider readership with the opportunity to better understand his important contribution to ethics in the second half of the last century. With his notion of the _Sovereign Expressions of Life_ Løgstrup articulates his rejection of moral atomism that has become influential in recent times. The introduction and annotation by Kees van Kooten Niekerk are very helpful to see how Løgstrup's thought developed beyond _The Ethical Demand.” —__Hans S. Reinders, Vrije Universiteit, Amsterdam_. (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)
The late Arthur Fox has left us a very fine book on the difficult subject of the relation between faith and philosophy in Spinoza's thought. The attention is focussed on the Theological-Political Treatise, concerned with public policy, the freedom to philosophize, and religious faith. The shift of focus in the interpretation of Spinoza's philosophy, from the Ethics to the Theological-Political Treatise, enables Fox to show his deep involvement in questions regarding the links between philosophy and theology on the one hand (...) and the morality of private and public life on the other. The analysis and interpretation of Spinoza's philosophy thus also throws an interesting light on contemporary problems of moral pluralism, religious faith, and rational political strategy. (shrink)
In 2004 a survey was conducted in the member states of the European Union designed to gain greater insight into the views on control strategies for foot and mouth disease, classical swine fever, and avian influenza with respect to the epidemiological, economic and social-ethical consequences of each of these animal diseases. This article presents the results of the social-ethical survey. A selection of stakeholders from each member state was asked to prioritize issues for the prevention and control of these diseases. (...) A majority of stakeholders chose preventive measures as the preferred issue. An analysis was done to determine whether there were differences in views expressed by stakeholders from member states with a history of recent epidemics and ones without such a history, and whether there were regional differences. There were no differences between member states with or without a history of recent epidemics. There were indeed regional differences between the priority orders from Northern and Southern Europe on the one hand, and from Eastern Europe on the other. (shrink)
The current proxy voting system in the United States has become the subject of considerable controversy. Because institutional investment managers have the authority to vote their clients’ proxies, they have a fiduciary obligation to those clients. Frequently, in an attempt to fulfill that obligation, these institutional investors employ proxy advisory services to manage the thousands of votes they must cast. However, many proxy advisory services have conflicts of interest that inhibit their utility to those seeking to discharge their fiduciary duties. (...) In this article, we describe the current proxy advisory network as an example of how current notions of conflicts of interest fall short when explaining the behavior of an interconnected set of market players whose remit is to act in the best interests of their investors. We discuss what participants in this system should do to bring transparency and accuracy to the proxy advice industry. (shrink)
The development of neonatology and the establishment of neonatal intensive care units has led to a vast array of new medical ethical problems and dilemmas centered around discontinuing treatment or nontreatment decisions. Neonatology has become one of the fields that has made clear that medical success is only rarely nonproblematic. The new technology can be a blessing for some, but it may also become a sad experience to others, with life-long repercussions.The ethical problems of neonatology transcend national boundaries. Nevertheless, there (...) are differences in approach among various countries. In The Netherlands, the ethical deliberations have been a matter of public debate, but most of the decision making is left to the medical profession; these decisions are considered too harsh for the general public. Recently, two developments have emerged. The Royal Dutch Medical Association and the Dutch Pediatrics Society have published reports with guidelines and ethical reflections. Over the same period of time, cases have been brought to court for legal analysis and the development of case precedence. (shrink)
There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as (...) a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women. (shrink)
The rational-agent frame of reference for the analysis of corporate strategic decision-making may be expanded to a moral-agent perspective where decision content is seen as comprising both commercial and ethical factors. Relevant factors may then be classified on the basis of the ethical decision principles to which they relate: rational-egoism, self-referential altruism or deontology. This approach is then applied to the problem of decision support for strategic divestment by MNCs.
ABSTRACTBesides physiological, behavioural, and affective effects, romantic love also has cognitive effects. In this study, we tested whether individual differences in infatuation and/or attachment level predict impaired interference control even in the absence of a love booster procedure, and whether individual differences in attachment level predict reduced adaptive cognitive control as measured by conflict adaptation and post-error slowing. Eighty-three young adults who had recently fallen in love completed a Stroop-like task, which yielded reliable indices of interference control and adaptive cognitive (...) control. We did not observe the predicted negative association between infatuation or attachment level and interference control. It might be that reduced interference control with love only happens when people are actively thinking about their beloved. In addition, we observed only weak evidence for the prediction t... (shrink)
Policymakers need to start considering the impact smart connected toys have on children. Equipped with sensors, data processing capacities, and connectivity, SCTs targeting children increasingly penetrate pervasively personal environments. The network of SCTs forms the Internet of Toys and often increases children's engagement and playtime experience. Unfortunately, this young part of the population and, most of the time, their parents are often unaware of SCTs’ far-reaching capacities and limitations. The capabilities and constraints of SCTs create severe side effects at the (...) technical, individual, and societal level. These side effects are often unforeseeable and unexpected. They arise from the technology's use and the interconnected nature of the IoToys, without necessarily involving malevolence from their creators. Although existing regulations and new ethical guidelines for artificial intelligence provide remedies to address some of the side effects, policymakers did not develop these redress mechanisms having children and SCTs in mind. This article provides an analysis of the arising side effects of SCTs and contrasts them with current regulatory redress mechanisms. We thereby highlight misfits and needs for further policymaking efforts. (shrink)