Transfers of critically ill neonates are frequent phenomena. Even though parents’ participation is regarded as crucial in neonatal care, a transfer often means that parents and neonates are separated. A systematic review of the parents’ experiences of neonatal transfer is lacking. This paper describes a meta‐study addressing qualitative research about parents’ experiences of neonatal transfer. Through deconstruction and reflections of theories, methods, and empirical data, the aim was to achieve a deeper understanding of theoretical, (...) empirical, contextual, historical, and methodological issues of qualitative studies concerning parents’ experiences of neonatal transfer over the course of this meta‐study (2000–2017). Meta‐theory and meta‐method analyses showed that caring, transition, and family‐centered care were main theoretical frames applied and that interviewing with a small number of participants was the preferred data collection method. The meta‐data‐analysis showed that transfer was a scary, unfamiliar, and threatening experience for the parents; they were losing familiar context, were separated from their neonate, and could feel their parenthood disrupted. We identified ‘wavering and wandering’ as a metaphoric representation of the parents’ experiences. The findings add knowledge about meta‐study as an approach for comprehensive qualitative research and point at the value of meta‐theory and meta‐method analyses. (shrink)

Neonatal behavioral data support the argument that multiple relations exist between vision and touch. Looking at an object triggers the motion of a neonate's arm and hand towards it. A textured surface that is seen can be recognized tactilely, but not a volumetric shaped object in cross-modal transfer tasks. These data are supported by adult neuroimaging data.

In current practice, decisions regarding whether or not to resuscitate infants born at the limits of viability are generally made with expectant parents during a prenatal consultation with a neonatologist. This article reviews the current practice of prenatal consultation and describes three areas in which current practice is ethically problematic: (1) risks to competence, (2) risks to information, and (3) risks to trust. It then reviews solutions that have been suggested in the literature, and the drawbacks to each. Finally, it (...) suggests that the model of prenatal consultation be altered in three ways: (1) that the prenatal consultation be viewed as a process over time, rather than a onetime event; (2) that decision making in the prenatal consultation be framed as a choice between nonresuscitation and a trial of neonatal intensive care, rather than a choice between “doing nothing” and “doing everything”; and (3) that the prenatal consultation process devote serious attention to both the transfer of information and the non-informational needs of families, rather than focus on the transfer of information alone. (shrink)

Background: The intrauterine hearing experience differs from the extrauterine hearing exposure within a neonatal intensive care unit (NICU) setting. Also, the listening experience of a neonate drastically differs from that of an adult. Several studies have documented that the sound level within a NICU exceeds the recommended threshold by far, possibly related to hearing loss thereafter. The aim of this study was, firstly, to precisely define the dynamics of sounds within an incubator and, secondly, to give clinicians and caregivers (...) an idea about what can be heard “inside the box.” Methods: Audio recordings within an incubator were conducted at the Pediatric Simulation Center of the Medical University Vienna. They contained recorded music, speech and synthesized sounds. To understand the dynamics of sounds around and within the incubator the following stimuli were used: broadband noise with decreasing sound level in ten steps of 6 dB, sine waves (62.5, 125, 250, 500, 1000, 2000, 4000, 8000 and 16000 Hz), logarithmic sweep (Chirp) over the frequency band 20 Hz to 21 kHz, singing male voice, singing and whispering female voice. Results: Our results confirm a protective effect of the incubator from noises above 500 Hz in conditions of “no-flow” and show almost no protective effect of an incubator cover. We, furthermore, observed a strong boost of low frequencies below 125 Hz within the incubator, as well as a notable increase of higher frequency noises with open access doors, a significant resonant effect of the incubator, and a considerable masking effect of the respiratory support against any other source of noise or sound stimulation even for “low-flow” conditions. Conclusion: Our study reveals high noise levels of air supply at high flow rates and the boost of low frequencies within the incubator. Education of medical staff and family members as well as modifications of the physical environment should aim at reducing noise exposure of preterm infants in the incubator. Audiovisual material is provided as supplementary material. (shrink)

Recently, I argued that human subjects in artificial wombs (AWs) “share the same moral status as newborns” and so, deserve the same treatment and protections as newborns. This thesis rests on two claims: (A) “Subjects of partial ectogenesis—those that develop in utero for at time before being transferred to AWs—are newborns,” and (B) “Subjects of complete ectogenesis—those who develop in AWs entirely—share the same moral status as newborns.” In response, Elizabeth Chloe Romanis argued that the subject in an AW is (...) “a unique human entity…rather than a fetus or a newborn.” She provides four lines of response to my essay. First, she argues that I have “misconstrued” what birth is. Once we correct that error, it becomes clear that subjects of partial ectogenesis have not been born. Second, she argues that my claims imply that non-implanted embryos (existing in vivo) “would also be ‘born.’” But that is absurd. Third, she claims I fail to “meaningfully respond” to distinctions she draws between subjects of ectogenesis and neonates. Finally, she criticizes my essay for focusing on subjects of AWs rather than focusing on pregnant persons (who should be at the “centre” of debates over AWs). I respond to each of these charges. In doing so, I reaffirm that (contra Romanis) some subjects of ectogenesis are newborns and all subjects of ectogenesis—even those that have not been born—share the same moral status as newborns. (shrink)

As clinicians, this case1 raises both personal and professional challenges. A key issue is who carries legal parental responsibility for the difficult decisions that may be required around life-sustaining care in baby T. Medicolegally, we understand that the surrogate mother holds legal parental responsibility for baby T until this can be transferred to the intended parents.2 But this process can take many months to complete, after the birth of baby. As M is now critically ill and unable to engage in (...) any discussion around the care of her baby, who becomes the legal guardian of the baby, for complex decision making that involves either reorientation of care away from intensive care with the inevitable consequence of death in this extremely premature baby, or continuing this life-sustaining treatment with a high likelihood for major neonatal morbidity and longer term disability? Does it pass onto one of the IPs as the genetic father, or does this responsibility fall on the neonatal consultant managing the baby in intensive care? And if an antenatal surrogacy agreement had existed, is it legally binding for inclusion of the IPs perspectives in the decision-making, especially if our medical decision making turns out to be at discord with the beliefs and wishes of the IPs for baby T? Box 1 ### Current surrogacy proceedings in the UK.2 6–8 The Law Commission UK5 is currently reviewing the decision on whether legal parenthood to intended parents can be effected immediately at the time of birth of the baby. Parental orders. (shrink)

BackgroundBreakthroughs in animal studies make the topic of human application of ectogenesis for medical and non-medical purposes more relevant than ever before. While current data do not yet demonstrate a reasonable expectation of clinical benefit soon, several groups are investigating the feasibility of artificial uteri for extracorporeal human gestation.Main textThis paper offers the first comprehensive and up to date discussion of the most important pros and cons of human ectogenesis in light of clinical application, along with an examination of crucial (...) ethical (and legal) issues that continued research into, and the clinical translation of, ectogenesis gives rise to. The expected benefits include advancing prenatal medicine, improving neonatal intensive care, and providing a novel pathway towards biological parenthood. This comes with important future challenges. Prior to human application, important questions have to be considered concerning translational research, experimental use of human fetuses and appropriate safety testing. Key questions are identified regarding risks to ectogenesis’ subjects, and the physical impact on the pregnant person when transfer from the uterus to the artificial womb is required. Critical issues concerning proportionality have to be considered, also in terms of equity of access, relative to the envisaged application of ectogenesis. The advent of ectogenesis also comes with crucial issues surrounding abortion, extended fetal viability and moral status of the fetus.ConclusionsThe development of human ectogenesis will have numerous implications for clinical practice. Prior to human testing, close consideration should be given to whether (and how) ectogenesis can be introduced as a continuation of existing neonatal care, with due attention to both safety risks to the fetus and pressures on pregnant persons to undergo experimental and/or invasive procedures. Equally important is the societal debate about the acceptable applications of ectogenesis and how access to these usages should be prioritized. It should be anticipated that clinical availability of ectogenesis, possibly first as a way to save extremely premature fetuses, may spark demand for non-medical purposes, like avoiding physical and social burdens of pregnancy. (shrink)

Recently, I argued that human subjects in artificial wombs ‘share the same moral status as newborns’ and so, deserve the same treatment and protections as newborns. This thesis rests on two claims: subjects of partial ectogenesis—those that develop in utero for at time before being transferred to AWs—are newborns and subjects of complete ectogenesis—those who develop in AWs entirely—share the same moral status as newborns. In response, Elizabeth Chloe Romanis argued that the subject in an AW is ‘a unique human (...) entity…rather than a fetus or a newborn’. She provides four lines of response to my essay. First, she argues that I have ‘misconstrued’ what birth is. Once we correct that error, it becomes clear that subjects of partial ectogenesis have not been born. Second, she argues that my claims imply that non-implanted embryos ‘would also be “born”’. But that is absurd. Third, she claims I fail to ‘meaningfully respond’ to distinctions she draws between subjects of ectogenesis and neonates. Finally, she criticises my essay for focusing on subjects of AWs rather than focusing on pregnant persons. I respond to each of these charges. In doing so, I reaffirm that some subjects of ectogenesis are newborns and all subjects of ectogenesis—even those that have not been born—share the same moral status as newborns. (shrink)

In their paper, Romanis and Adkins delve into the potential impact of artificial amnion and placenta technology (AAPT) on cases of pregnancy loss1 that do not involve procreative loss. First, they call for more recognition of the negative feelings a person might have due to the premature end of their pregnant state. They claim that, should AAPT minimise concerns about prematurity as anticipated, individuals might feel pressured to opt for partial ectogestation to preserve their or their fetus’ well-being; moreover, they (...) point out that the feelings of loss in the context of AAPT are likely to be worse than the ones reported in neonatal intensive care units cases. Finally, they advocate for care pathways focusing on how the transfer of a fetus to the AAPT could affect the pregnant person, with particular attention to managing the grief potentially caused by the pregnancy loss. I praise the authors for such a call to action—especially since partial ectogestation is expected to become a reality in the short-term future—and I share their demands for additional and more attentive care of (formerly) pregnant patients. However, I am concerned that their approach is so focused on negative feelings towards pregnancy loss that it risks becoming …. (shrink)

Differences in perception and potential disagreements between parents and professionals regarding the attitude for resuscitation at the limit of viability are common. This study evaluated in healthcare professionals whether the decision to resuscitate at the limit of viability are influenced by the way information on incurred risks is given or received. This is a prospective randomized controlled study. This study evaluated the attitude of healthcare professionals by testing the effect of information given through graphic fact sheets formulated either optimistically or (...) pessimistically. The written educational fact sheet included three graphical presentations of survival and complication/morbidity by gestational age. The questionnaire was submitted over a period of 4 months to 5 and 6-year medical students from the Geneva University as well as physicians and nurses of the neonatal unit at the University Hospitals of Geneva. Our sample included 102 healthcare professionals. Forty-nine responders were students, 32 paediatricians and 21 nurses in NICU. The received risk tended to be more severe in both groups compared to the graphically presented facts and current guidelines, although optimistic representation favoured the perception of “survival without disability” at 23 to 25 weeks. Therapeutic attitudes did not differ between groups, but healthcare professionals with children were more restrained and students more aggressive at very low gestational ages. Written information on mortality and morbidity given to healthcare professionals in graphic form encourages them to overestimate the risk. However, perception in healthcare staff may not be directly transferable to parental perception during counselling as the later are usually naïve to the data received. This parental information are always communicated in ways that subtly shape the decisions that follow. (shrink)

The case of Twin B involves the decision to send a newborn to a less intensive Level 2 special care nursery (SCN) than to the Level 3 neonatal intensive care unit (NICU) that is considered optimal by the physician. The physician’s acceptance of the transfer is against the child’s best interest and is due to parental convenience. In analyzing the case, we reject the best interest standard. Our rejection is partly supported by the views of Douglas Diekema, John (...) Hardwig, and Lannie Ross. Instead of the best interest standard, we offer and defend an approach we base on a microeconomic analysis of externalities, such as those involved with automobile emissions. This extends our previously presented general microeconomic approach to patient decision-making. It provides a clearer way to evaluate situations, like those of Twin B, in which burdens faced by family members may be used to determine the appropriate level of treatment for a decisionally incapable patient. (shrink)

This paper examines whether there are moral differences between the mitochondrial replacement techniques that have been recently developed in order to help women afflicted by mitochondrial DNA diseases to have genetically related children absent such conditions: maternal spindle transfer and pronuclear transfer. Firstly, it examines whether there is a moral difference between MST and PNT in terms of the divide between somatic interventions and germline interventions. Secondly, it considers whether PNT and MST are morally distinct under a therapy/creation (...) optic. Finally, it investigates whether there is a moral difference between MST and PNT from a human embryo destruction point of view. I conclude, contra recent arguments, that regarding the first two points there is no moral differences between PNT and MST; and that regarding the third one MST is morally preferable to PNT, but only if we hold a gradualist account of the moral value of human embryos where zygotes have slight moral value. (shrink)

We discuss the impact of horizontal gene transfer (HGT) on phylogenetic reconstruction and taxonomy. We review the power of HGT as a creative force in assembling new metabolic pathways, and we discuss the impact that HGT has on phylogenetic reconstruction. On one hand, shared derived characters are created through transferred genes that persist in the recipient lineage, either because they were adaptive in the recipient lineage or because they resulted in a functional replacement. On the other hand, taxonomic patterns (...) in microbial phylogenies might also be created through biased gene transfer. The agreement between different molecular phylogenies has encouraged interpretation of the consensus signal as reflecting organismal history or as the tree of cell divisions; however, to date the extent to which the consensus reflects shared organismal ancestry and to which it reflects highways of gene sharing and biased gene transfer remains an open question. Preferential patterns of gene exchange act as a homogenizing force in creating and maintaining microbial groups, generating taxonomic patterns that are indistinguishable to those created by shared ancestry. To understand the evolution of higher bacterial taxonomic units, concepts usually applied in population genetics need to be applied. (shrink)

This paper investigates logical aspects of combining linear orders as semantics for modal and temporal logics, with modalities for possible paths, resulting in a variety of branching time logics over classes of trees. Here we adopt a unified approach to the Priorean, Peircean and Ockhamist semantics for branching time logics, by considering them all as fragments of the latter, obtained as combinations, in various degrees, of languages and semantics for linear time with a modality for possible paths. We then consider (...) a hierarchy of natural classes of trees and bundled trees arising from a given class of linear orders and show that in general they provide different semantics. We also discuss transfer of definability from linear orders to trees and introduce a uniform translation from Priorean to Peircean formulae which transfers definability of properties of linear orders to definability of properties of all paths in trees. (shrink)

A simple definition of consciousness is sensory awareness of the body, the self, and the world. The fetus may be aware of the body, for example by perceiving pain. It reacts to touch, smell, and sound, and shows facial expressions responding to exter- nal stimuli. However, these reactions are probably preprogrammed and have a subcortical nonconscious origin. Furthermore, the fetus is almost continuously asleep and unconscious partially due to endog- enous sedation. Conversely, the newborn infant can be awake, exhibit sensory (...) awareness, and process memorized mental representations. It is also able to differentiate between self and nonself touch, express emotions, and show signs of shared feelings. Yet, it is unreflective, present oriented, and makes little reference to concept of him/herself. Newborn infants display features characteristic of what may be referred to as basic consciousness and they still have to undergo considerable maturation to reach the level of adult consciousness. The preterm infant, ex utero, may open its eyes and establish minimal eye contact with its mother. It also shows avoidance reactions to harmful stimuli. However, the thalamocortical connections are not yet fully established, which is why it can only reach a minimal level of consciousness. (shrink)

We revisit the flight-to-quality and flight-from-quality occurrences vis-à-vis the stock-bond nexus across differing investment time scales in the COVID-19 era, using a novel technique hinged on a denoised frequency-domain transfer entropy. Our findings divulge that flights, both FTQ and FFQ, could be attained during stress periods. Generally, in the intermediate term of the COVID-19 pandemic, both Islamic and conventional bonds could act as safe havens, diversifiers, and hedges for international equities, and the same could be observed for international equities. (...) We reiterate empirically that flights may improve the financial system’s stability and robustness by allowing diversity to be effective when it is most required. The findings have financial and portfolio implications for investors considering how to deploy their investments in the COVID-19 era. Our findings may impact policymakers’ responses to changes in various asset classes, allowing them to better monitor financial markets and adjust macroeconomic policies. (shrink)

BackgroundWhenever South African research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health.Main bodyThe article offers a legal analysis of the SA MTA and focuses on its substantive fit with the broader legal environment in South Africa, and the clarity and practicality of its terms. The following (...) problematic aspects of the SA MTA are highlighted: Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; the SA MTA’s consent provisions are not aligned with extant law; and, similarly, its provision on donor ownership is misaligned with extant law; its creation of fictitious performance can only cause frustration on the part of an injured party; its benefit-sharing provision is vague and will have little practical effect; its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, its data privacy provision is insufficiently specific, is overbroad, and fails to provide terms that in general would facilitate the international sharing of human biological material and associated data in terms of existing privacy law.ConclusionsWhile some of the problematic aspects of the SA MTA are intricate and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the problematic aspects can be resolved immediately through amendments by the South African Minister of Health. The formulation of such amendments is proposed and, where possible, interim measures are suggested that may ameliorate the problems presented by the SA MTA. (shrink)

This article begins by exploring a lost topic in the philosophy of science:the properties of the relations evidence confirming h confirmsh'' and, more generally, evidence confirming each ofh1, h2, ..., hm confirms at least one of h1, h2,ldots;, hn''.The Bayesian understanding of confirmation as positive evidential relevanceis employed throughout. The resulting formal system is, to say the least, oddlybehaved. Some aspects of this odd behaviour the system has in common withsome of the non-classical logics developed in the twentieth century. Oneaspect (...) – its ``parasitism'''' on classical logic – it does not, and it is this featurethat makes the system an interesting focus for discussion of questions in thephilosophy of logic. We gain some purchase on an answer to a recently prominentquestion, namely, what is a logical system? More exactly, we ask whether satisfaction of formal constraints is sufficient for a relation to be considered a (logical) consequence relation. The question whether confirmation transfer yields a logical system is answered in the negative, despite confirmation transfer having the standard properties of a consequence relation, on the grounds that validity of sequents in the system is not determined by the meanings of the connectives that occur in formulas. Developing the system in a different direction, we find it bears on the project of ``proof-theoretic semantics'''': conferring meaning on connectives by means of introduction (and possibly elimination) rules is not an autonomous activity, rather it presupposes a prior, non-formal,notion of consequence. Some historical ramifications are alsoaddressed briefly. (shrink)

I propose an approach that expands philosophical views of scientific change, on the basis of an analysis of contemporary biomedical research and recent developments in the philosophy of scientific change. Focusing on the establishment of the exposome in epidemiology as a case study and the role of data as a context for contrasting views on change, I discuss change at conceptual, methodological, material, and social levels of biomedical epistemology. Available models of change provide key resources to discuss this type of (...) change, but I present the need for an approach that models transfer, alignment, and influence as key processes of change. I develop this as a pragmatic approach to scientific change, where processes might change substantially depending on specific circumstances, thus contributing to and complementing the debate on a crucial epistemological issue. (shrink)

This paper argues that a successful philosophical analysis of models and simulations must accommodate an account of mathematically rigorous results. Such rigorous results may be thought of as genuinely model-specific contributions, which can neither be deduced from fundamental theory nor inferred from empirical data. Rigorous results provide new indirect ways of assessing the success of models and simulations and are crucial to understanding the connections between different models. This is most obvious in cases where rigorous results map different models on (...) to one another. Not only does this put constraints on the extent to which performance in specific empirical contexts may be regarded as the main touchstone of success in scientific modelling, it also allows for the transfer of warrant across different models. Mathematically rigorous results can thus come to be seen as not only strengthening the cohesion between scientific strategies of modelling and simulation, but also as offering new ways of indirect confirmation. (shrink)

In the United States today, the human body defines a lucrative site of reusable parts, ranging from whole organs to minuscule and even microscopic tissues. Although the medical practices that enable the transfer of parts from one body to another most certainly relieve suffering and extend lives, they have also irrevocably altered perceptions of the cultural values assigned to the body. Organ transfer is rich terrain to investigate—especially in the American context, where sophisticated technological interventions have significantly shaped (...) understandings of health and well-being, suffering, and death. In _Bodies, Commodities, and Biotechnologies_, Lesley Sharp probes the ideological assumptions underlying the transfer of body parts, the social significance of donors' deaths, and the medico-scientific desires surrounding complex forms of body repair. Sharp also considers the experimental realm, in which nonhuman species and artificial devices present further opportunities for recovery and for controversy. A compelling scientific investigation and social critique, _Bodies, Commodities, and Biotechnologies_ explores the pervasive, and at times pernicious, practices shaping American biomedicine in the twenty-first century. (shrink)

Recent studies of Nyäya’s account of testimony have illustrated its anticipation of contemporary testimonial antireductionism, the position that testimony cannot be reduced to a more fundamental means of knowledge like inference or perception. This paper discusses another relevant but less discussed anticipation of current debate, involving the status of speaker belief in testimonial exchange. Is a speaker’s veridical apprehension of the content of his utterance a necessary condition on testimonial exchange? This was a source of much disputation among Indian epistemologists, (...) particularly Naiyäyikas (adherents of the Nyäya, or “Logic” school) and Mimamsakas(adherents of the Mimamsa, or “Exegete” school). (shrink)

Community group-buying platforms are increasingly relying on the interaction between the group-buying leader and consumers, thereby achieving the customer lock-in. In view of this, it is crucial to understand how the group-buying leader to establish a long-term transaction relationship with consumers. In this study, we construct a model based on the role theory and trust transfer theory, and identify two types of interactions of the group-buying leader and two types of consumer trust. Then, the mechanism that how different role (...) interactions of the group-buying leader can be transformed into the lock-in purchasing intention of consumers is further clarified. By interviewing 430 consumers with community group-buying experience in the community through offline questionnaire, the research model has been proven to be effective. To be specific, both role interactions of the merchant and friend can impose a positive impact on interpersonal trust, which will also lead to the trust in community group-buying, and thus enhance the lock-in purchasing intension of consumers from a fixed leader. Overall, this study has made certain contributions to the study of customer relationship. In theory, this study further explains the explanation mechanism of the “acquaintance marketing” phenomenon. Moreover, this study adopts the role theory to analyze the differences of different role interactions of the group-buying leader in relationship quality and purchase decision making, and employs the trust transfer theory to expand the trust transfer effect from the interpersonal trust of the group-buying leader to the trust in community group-buying. In practice, this study provides a new perspective and practical reference for community group-buying enterprises and the group-buying leader on how to better manage customers and maintain a long-term and stable customer relationship. (shrink)

A phylogeny that allows for lateral gene transfer (LGT) can be thought of as a strictly branching tree (all of whose branches are vertical) to which lateral branches have been added. Given that the goal of phylogenetics is to depict evolutionary history, we should look for the best supported phylogenetic network and not restrict ourselves to considering trees. However, the obvious extensions of popular tree-based methods such as maximum parsimony and maximum likelihood face a serious problem—if we judge networks (...) by fit to data alone, networks that have lateral branches will always fit the data at least as well as any network that restricts itself to vertical branches. This is analogous to the well-studied problem of overfitting data in the curve-fitting problem. Analogous problems often have analogous solutions and we propose to treat network inference as a case of model selection and use the Akaike Information Criterion (AIC). Strictly tree-like networks are more parsimonious than those that postulate lateral as well as vertical branches. This leads to the conclusion that we should not always infer LGT events whenever it would improve our fit-to-data, but should do so only when the improved fit is larger than the penalty for adding extra lateral branches. (shrink)

In recent years there has been an increased awareness with regards to ethics in business. More specifically, the abundance of well-publicized examples of cheating, greed, and hypocrisy has created some alarm about the general state of personal ethics. Recent examples include the Oliver North, Ivan Boesky, and Jimmy Swaggart cases. The tax practitioner probably has little direct concern for matters of misconduct and ethical improprieties as mentioned above. Adherence to a code of conduct appears to circumvent the ethical conflict typically (...) found in the business environment. The tax practitioner's ultimate goal is tax minimization for clients. This goal has the blessings of the courts and the writers of tax law.The present day dynamic global economic system includes organizations which have extensive international activity. In an effort to enhance the performance of these organizations, there is typically decentralization of operations. When decentralization exists it is necessary to evaluate the decentralized units. Profit centers are commonly used for this purpose. With profit centers comes the need for transfer pricing between profit centers. The transfer price should be determined in some objective fashion. However, tax minimization often is the driving force in the transfer price decision. (shrink)

Despite the therapeutic potential of human embryonic stem (HES) cells, many people believe that HES cell research should be banned. The reason is that the present method of extracting HES cells involves the destruction of the embryo, which for many is the beginning of a person. This paper examines a number of compromise solutions such as parthenogenesis, the use of defective embryos, genetically creating a "pseudo embryo" that can never form a placenta, and determining embryo death, and argues that none (...) of these proposals are likely to satisfy embryoists, that is, those who regard the embryo as a person. This paper then proposes a method of extracting HES cells, what might be called the Blastocyst Transfer Method, that meets the ethical requirements of embryoists, and it considers some possible concerns regarding this method. It concludes by encouraging future HES cell research to investigate this method. (shrink)

The aim of this study was to explore the obligations of nurses and physicians in providing end-of-life care. Nineteen nurses and 11 physicians from a single newborn intensive care unit participated. Using content analysis, an overarching obligation of creating the best possible experience for infants and parents was identified, within which two categories of obligations (decision making and the end of life itself) emerged. Obligations in decision making included talking to parents and timing withdrawal. End-of-life obligations included providing options, preparing (...) parents, being with, advocating, creating peace and normalcy, and providing comfort. Nurses and physicians perceived obligations in both categories, although nurse obligations centered on the end of life while physician obligations focused on decision making. The findings demonstrate that, although the ultimate goal is shared by both disciplines, the paths to achieving that goal are often different. This has important implications for collaboration, communication, and improving the end of life. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated (...) in the United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

Background: “Therapeutic misconception” arises when human subjects interpret a clinical trial as aimed primarily at therapy rather than producing knowledge. Therapeutic misconceptions may be more prevalent in trials enrolling gravely ill subjects or involving novel and well publicised investigational agents.Objective: To examine the extent to which investigators express therapeutic optimism in phase 1 human gene transfer consent documents, whether highly active gene transfer researchers are more prone to expressing therapeutic optimism, and whether consent forms have grown more optimistic (...) in their descriptions of personal benefit over the last decade.Design: Content analysis was performed on 277 consent documents to measure the number of sentences describing possibility of benefit, terminology used for experimental agents, the proportion of statements describing personal versus societal benefits, and whether investigators attempted to thwart therapeutic misconceptions.Results: Consent forms generally used therapeutic terminology to describe study agents, devoted more sentences to describing possible personal benefits than to describing benefits to society, and infrequently explained that a particular benefit was unlikely. Consent documents used by highly active gene transfer researchers tended to portray significantly greater optimism about personal benefit than less active investigators, though they were also significantly more cautious with agent terminology. Finally, therapeutic optimism expressed in consent forms has declined over the past decade.Conclusions: Consent documents used in phase 1 gene transfer trials, although increasingly attentive to possible therapeutic misconceptions, are inappropriately optimistic about direct benefits of trial participation. Such optimism is expressed more emphatically in trials involving highly active gene transfer researchers as principal investigators. (shrink)