The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was formed over 20 years ago with a goal of harmonizing research regulations among the European Union, United States, and Japan. Harmonization was intended to speed approval of pharmaceuticals, avoid unnecessary repetition of studies, and ensure protection of research participants. This paper examines United States, European Union, and ICH pediatric research regulations in five domains: parental permission, assent/dissent, payment, risk/benefit and inclusion of disabled children/wards (...) of state. The purpose is to examine similarities and differences among the regulations to help investigators, policy makers and the public to understand what each regulatory framework can learn from the others. Additionally, the paper suggests philosophical differences in how these entities view pediatric research which may serve as barriers to harmonization in the future. (shrink)
Moving forward rapidly in the clinical research phase, uterus transplantation may be a future treatment option for women with uterine factor infertility, which accounts for three per cent of all infertility in women. This new method of treatment would allow women, who currently rely on gestational surrogacy or adoption, to gestate and birth their own genetic offspring. Since uterus transplantation carries significant risk when compared with surrogacy and adoption as well as when compared with other organ transplants, it requires greater (...) justification because its goals are quality of life, not life-saving, in their scope. It is important to address questions regarding the physical, psychosocial and ethical risks and benefits of uterus transplantation for all three parties involved—the patient, the donor and the potential child—as well as discuss the regulatory implications as research on uterus transplantations moves forward. (shrink)
Le propos est précédé par une illustration, la seule de l’ouvrage, extraite d’une Histoire de l’industrie du coton en Grande-Bretagne parue en 1835. Il s’agit de la reproduction d’un dessin représentant le processus d’impression de motifs sur du calicot. On y voit deux hommes travailler, de façon semble-t-il minutieuse, sur deux grandes machines installées dans un atelier spacieux. L’illustration est égayée par les motifs imprimés sur les pans de tissu, qui occupent une grande partie de l’esp..
This paper is a response to one published in the June 1997 edition of the BJES (Cole, Hill & Rikowski, 1997) which criticises the author's claims about the utility of postmodern analysis for studies in education (Blake, 1997).
1. Among the most striking features of the political arrangements on this planet is its division into sovereign states.1 To be sure, in recent times, globalization has woven together the fates of communities and individuals in distant parts of the world in complex ways. It is partly for this reason that now hardly anyone champions a notion of sovereignty that would entirely discount a state’s liability the effects that its actions would have on foreign nationals. Still, state sovereignty persists as (...) a political fact. The number of states has increased enormously due to upheavals of the 20th century, and there is nothing in principle morally wrong with the existence of states - or so we will assume.2 What must be explored, then, are the limits of normatively plausible sovereignty. How bad does a government have to be for outsiders to be allowed to interfere? What responsibilities does a country incur because of its contribution to global warming? What obligations arise through trading? In this paper, we explore another pertinent question: to what extent is a country allowed to influence who lives on its territory by regulating immigration? The angle from which we approach this question continues to be neglected even now that questions of global justice are receiving much attention. Immigration amounts to a change in political relationships as immigrants alter their standing within one community and acquire a status elsewhere. Yet it also amounts to an alteration in physical relationship, since they acquire a relationship to a territory, making a life for themselves with the resources offered by a part of the earth.3 We base our exploration of.. (shrink)
Your use of the JSTOR archive indicates your acceptance of JSTOR's Terms and Conditions of Use, available at http://www.jstor.org/about/terms.html. JSTOR's Terms and Conditions of Use provides, in part, that unless you have obtained prior permission, you may not download an entire issue of a journal or multiple copies of articles, and you may use content in the JSTOR archive only for your personal, non-commercial use.
Little work has been done to explore the moral foundations of the state’s right to territory.1 In modern times, the state has mostly been assumed to be a territorial unit, and no need was perceived to reflect on precisely what justifies its territorial jurisdiction. The state’s territoriality is related to another topic that has remained under-theorized: immigration. There is, moreover, an obvious relationship between these topics: the more powerful a state’s rights over its territory, the more powerful the right to (...) constrain access to that territory might become – or so, at any rate, we might suppose. Rights to territory and rights to immigration are usefully theorized together.2 Our starting point is a Lockean analysis of the moral foundations of territoriality offered by Simmons (2001). This is a natural starting point not only because Simmons is one of the very few contemporary writers who have taken up philosophical questions about territoriality in the first place, but also because Locke’s thought, as Simmons makes clear, actually allows for the development of a sophisticated account of territoriality. This makes Locke stand out simply because generally modern political.. (shrink)
Among psychologists and vision scientists,binocular rivalry has enjoyed sustainedinterest for decades dating back to the 19thcentury. In recent years, however, rivalry''saudience has expanded to includeneuroscientists who envision rivalry as a tool for exploring the neural concomitants ofconscious visual awareness and perceptualorganization. For rivalry''s potential to berealized, workers using this tool need toknow details of this fascinating phenomenon,and providing those details is the purpose ofthis article. After placing rivalry in ahistorical context, I summarize major findingsconcerning the spatial characteristics and thetemporal dynamics (...) of rivalry, discuss two majortheoretical accounts of rivalry ( eye vs stimulus rivalry) and speculate on possibleneural concomitants of binocular rivalry. (shrink)
Biomedical ontologies are emerging as critical tools in genomic and proteomic research where complex data in disparate resources need to be integrated. A number of ontologies exist that describe the properties that can be attributed to proteins; for example, protein functions are described by Gene Ontology, while human diseases are described by Disease Ontology. There is, however, a gap in the current set of ontologies—one that describes the protein entities themselves and their relationships. We have designed a PRotein Ontology (PRO) (...) to facilitate protein annotation and to guide new experiments. The components of PRO extend from the classification of proteins on the basis of evolutionary relationships to the representation of the multiple protein forms of a gene (products generated by genetic variation, alternative splicing, proteolytic cleavage, and other post-translational modification). PRO will allow the specification of relationships between PRO, GO and other OBO Foundry ontologies. Here we describe the initial development of PRO, illustrated using human proteins from the TGF-beta signaling pathway (http://pir.georgetown.edu/pro). (shrink)
Rawls's Law of Peoples has not gathered a great deal of public support. The reason for this, I suggest, is that it ignores the differences between the international and domestic realms as regards the methodology of reciprocal agreement. In the domestic realm, reciprocity produces both stability and respect for individual moral agency. In the international realm, we must choose between these two values seeking stable relations between states, or respect for individual moral agency. Rawls's Law of Peoples ignores the (...) stark nature of this choice by insisting that the only legitimate extension of liberal toleration abroad is the toleration of different forms of political organization. It is this attempt to overcome liberalism's tragic dilemma which, I suggest, has made Rawls's international theory less attractive than his domestic theory. I also suggest that this difficulty is at the base of the further difficulties identified by Henry Shue and Martha Nussbaum in their accompanying essays. Key Words: Rawls international toleration reciprocity state Nussbaum Shue. (shrink)
Anticipating Mikhail Bakhtin’s appreciation for the unfinalizability of Fedor Dostoevskij’s universe, prominent Protestant theologian Karl Barth celebrates the Russian novelist’s presentation of “the impenetrable ambiguity of human life” characteristic of both the ending of Dostoevsky’s novels and Paul’s Epistle to the Romans. Barth’s unique reading of The Brothers Karamazov not only demonstrates the barrenness of the “theocratic dream” but also complements Bakhtin’s discussion of polyphony with an explicitly theological dimension by focusing on the dialogue between Creator and the created. Dostoevsky’s (...) prophetic voice provides Barth with a poetic expression of the divine command that highlights the ethical dimension inherent in every theological choice. (shrink)
This essay attempts to identify the ethical principles appropriate to a second-order political agent—an agent, that is, whose primary responsibility lies not in the implementation of state power, but in the response to and evaluation of that state power. The specific agent I examine is the human rights non-governmental organization, and the specific context is that of humanitarian military intervention. I argue that the specific role of the human rights NGO gives rise to ethical permissions not available to government agents. (...) In particular, such NGOs may have permissions to ignore the motivation of government agents, and support even substantially unjust interventions, where such interventions would have substantial benefit for the defense and preservation of basic human rights. a Footnotesa Previous versions of this paper were presented at Brown University, the Edmond J. Safra Center for Ethics at Harvard University, and the Carr Center for Human Rights Policy at Harvard University. I am grateful to all participants for their questions and comments. Thanks in particular go to the editors of this volume, whose help with this paper has been especially valuable. Responsibility for errors, of course, remains my own. (shrink)