This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze – as an example – the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US (...) or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. (shrink)

ABSTRACT This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze – as an example – the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the (...) US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non‐uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. (shrink)

We propose that institutions consider establishing a position of “Ombudsman for Research Practice”. This person would assume several roles: as asounding board to those needing confidential consultation about research issues — basic, applied or clinical; as afacilitator for those wishing to pursue a formal grievance process; and as aneducator to distribute guidelines and standards, to raise the consciousness regarding sloppy or irregular practices in order to prevent misconduct and to promote the responsible conduct of research. While there are compelling features (...) to this position, many complex issues need to be considered and resolved. We invite readers to respond to questions we raise in the text. (shrink)

We propose that institutions consider establishing a position of “Ombudsman for Research Practice”. This person would assume several roles: as asounding board to those needing confidential consultation about research issues — basic, applied or clinical; as afacilitator for those wishing to pursue a formal grievance process; and as aneducator to distribute guidelines and standards, to raise the consciousness regarding sloppy or irregular practices in order to prevent misconduct and to promote the responsible conduct of research. While there are compelling features (...) to this position, many complex issues need to be considered and resolved. We invite readers to respond to questions we raise in the text. (shrink)

The bioethical principle of autonomy is problematic regarding the future of the embryo who lacks the ability to self-advocate but will develop this defining human capacity in time. Recent experiments explore the use of clustered regularly interspaced short palindromic repeats /Cas9 for germline engineering in the embryo, which alters future generations. The embryo’s inability to express an autonomous decision is an obvious bioethical challenge of germline engineering. The philosopher Joel Feinberg acknowledged that autonomy is developing in children. He advocated that (...) to reserve this future autonomy, parents should be guided to make ethical decisions that provide children with open futures. Here, Feinberg’s 1980 open future theory is extended to the human embryo in the context of CRISPR germline engineering. Although the embryo does not possess the autonomous decision-making capacity at the time of germline engineering, the parental decision to permanently change the unique genetic fabric of the embryo and subsequent generations disregards future autonomy. Therefore, germline engineering in many instances is objectionable considering Feinberg’s open future theory. (shrink)

Controversy and activism have long been linked to the subject of primate research. Even in the midst of raging ethical debates surrounding fertility treatments, genetically modified foods and stem-cell research, there has been no reduction in the campaigns of activists worldwide. Plying their trade of intimidation aimed at ending biomedical experimentation in all animals, they have succeeded in creating an environment where research institutions, often painted as guilty until proven innocent, have avoided addressing the issue for fear of becoming targets. (...) One area of intense debate is the use of primates in stroke research. Despite the fact that stroke kills more people each year than AIDS and malaria, and less than 5% of patients are candidates for current therapies, there is significant opposition to primate stroke research. A balanced examination of the ethics of primate stroke research is thus of broad interest to all areas of biomedical research. (shrink)

Controversy and activism have long been linked to the subject of primate research. Even in the midst of raging ethical debates surrounding fertility treatments, genetically modified foods and stem-cell research, there has been no reduction in the campaigns of activists worldwide. Plying their trade of intimidation aimed at ending biomedical experimentation in all animals, they have succeeded in creating an environment where research institutions, often painted as guilty until proven innocent, have avoided addressing the issue for fear of becoming targets. (...) One area of intense debate is the use of primates in stroke research. Despite the fact that stroke kills more people each year than AIDS and malaria, and less than 5% of patients are candidates for current therapies, there is significant opposition to primate stroke research. A balanced examination of the ethics of primate stroke research is thus of broad interest to all areas of biomedical research. (shrink)

Numerous studies have shown almost uniformly positive opinions among patients and physicians regarding theconceptof advance directives (either a healthcare proxy or living will). Several of these studies have also shown that the actual use of advance directives is significantly lower than this enthusiasm would suggest, but they have not explained the apparent discordance. Nor have researchers explained why members of minority groups are much less likely to complete advance directives than are white patients. In this study, we used a focus (...) group methodology to examine the ways in which diverse populations of patients view the medical, philosophical, and practical issues surrounding advance directives. We were motivated by the significantly lower prevalence of advance directives among African-American and Hispanic patients at one urban teaching hospital (18% for Caucasians, 4% for African-Americans, and 2% for Hispanics). Our premise was that African-American and Hispanic populations, who have had higher rates of morbidity and mortality across numerous disease categories, and historically have had limited access to care and opportunities to discuss health concerns, may be more suspicious about the right of autonomy that an advance directive is designed to ensure. (shrink)

Numerous studies have shown almost uniformly positive opinions among patients and physicians regarding theconceptof advance directives (either a healthcare proxy or living will). Several of these studies have also shown that the actual use of advance directives is significantly lower than this enthusiasm would suggest, but they have not explained the apparent discordance. Nor have researchers explained why members of minority groups are much less likely to complete advance directives than are white patients. In this study, we used a focus (...) group methodology to examine the ways in which diverse populations of patients view the medical, philosophical, and practical issues surrounding advance directives. We were motivated by the significantly lower prevalence of advance directives among African-American and Hispanic patients at one urban teaching hospital (18% for Caucasians, 4% for African-Americans, and 2% for Hispanics). Our premise was that African-American and Hispanic populations, who have had higher rates of morbidity and mortality across numerous disease categories, and historically have had limited access to care and opportunities to discuss health concerns, may be more suspicious about the right of autonomy that an advance directive is designed to ensure. (shrink)

It is always possible to construct a real function f, given random quantities X and Y with continuous distribution functions F and G, respectively, in such a way that f(X) and f(Y), also random quantities, have both the same distribution function, say H. This result of De Finetti introduces an alternative way to somehow describe the `opinion' of a group of experts about a continuous random quantity by the construction of Fields of coincidence of opinions (FCO). A Field of coincidence (...) of opinions is a finite union of intervals where the opinions of the experts coincide with respect to that quantity of interest. We speculate on (dis)advantages of Fields of Opinion compared to usual `probability' measures of a group and on their relation with a continuous version of the well-known Allais' paradox. (shrink)

It is always possible to construct a real function φ, given random quantities X and Y with continuous distribution functions F and G, respectively, in such a way that φ(X) and φ(Y), also random quantities, have both the same distribution function, say H. This result of De Finetti introduces an alternative way to somehow describe the `opinion' of a group of experts about a continuous random quantity by the construction of Fields of coincidence of opinions (FCO). A Field of coincidence (...) of opinions is a finite union of intervals where the opinions of the experts coincide with respect to that quantity of interest. We speculate on (dis)advantages of Fields of Opinion compared to usual `probability' measures of a group and on their relation with a continuous version of the well-known Allais' paradox. (shrink)

This paper examines the ethical and legal duties of confidentiality owed by the nurse, with special reference to obligation to the employer. The main focus is on exploring the parameters of that duty and determining circumstances in which it might be ethically and legally justifiable to disclose confidential information. It is submitted that the obli gation to preserve the confidence of the patient or employer is relative rather than abso lute. In exceptional cases, disclosure is permissible in order to prevent (...) harm to others or to promote a greater public good. A number of suggestions for reform are also made, with a view to reinforcing nurses' ethical and legal rights to exercise discretion to dis close confidential information in appropriate cases in order to protect themselves from victimization by employers. Cet article passe à l'examen les devoirs éthiques et légales de la confidence que les infirmiers/ères doivent obligatoirement à leur employeur. Le point de mire est l'exploration des donnés de cette obligation, et la détermination des circonstances dans lesquelles il est légitime, éthiquement et légalement, d'exposer de l'information confidentielle. Il est suggéré que l'obligation de préserver la confiance du malade ou de l'employeur est relative plutôt qu'absolu. Dans des cas exceptionels pourtant, la révélation d'information est permisible pour prévenir le mal des autres ou pour promouvoir un plus grand bien public. Quelques suggestions pour réformes sont proposées en vue du renforcement des droits éthiques et légales des infirmiers/ères d'exercer la discretion en ce qui concerne la révélation d'information dans des cas bien choisis, et de les protéger des représailles de l'employeur. Dieser Artikel prüft die ethischen und legalen Pflichten des Vertrauens, die das Pflegepersonal dem Arbeitsgeber schuldet. Das Zentrum des Arguments ist eine Untersuchung dieser Pflichten, und eine Festsetzung der Umstände, in welchen es ethisch und rechtlich möglich ist, Information bekannt zu machen. Es ist anerkennt, dass die Pflicht des Vertrauens des Patienten oder des Arbeitsgebers zu behalten, eher relativ als absolut ist. In aussergewöhnlichen Fällen jedoch ist die Bekanntgabe von Information erlaubt, um das Böse zu verhindern und das Gute aller zu fördern. Eine Anzahl von Vorschlägen für Reformen sind gemacht, mit der Absicht, die ethischen und legalen Rechte des Pflegepersonals, in gegebenen Fällen Information bekannt zu machen, zu verstärken, und es von ungerechter Behandlung eines Arbeitsgebers zu schützen. (shrink)

We suggest a model that describes how counterfactuals are constructed and justified. The model can describe how counterfactual beliefs are updated given the unfolding of actual history. It also allows us to examine the use of counterfactuals in prediction, and to show that a logically omniscient reasoner gains nothing from using counterfactuals for prediction.

Abstract. Following the tracks of Ryle and based upon the theory of complex systems, we shall develop a characterization of action-based consciousness as an embodied, embedded, selforganized process in which action and dispositions occupy a special place. From this perspective, consciousness is not a unique prerogative of humans, but it is spread all around, throughout the evolution of life. We argue that artificial systems such as robots currently lack the genuine embodied embeddedness that allows the type of self-organization that is (...) relevant to consciousness. -/- Sommario. Seguendo la linea tracciata da Ryle e basata sulla teorie dei sistemi complessi, svilupperemo una caratterizzazione della coscienza basata sull’azione come un processo incarnato, situato e auto organizzante nel quale le azioni e le disposizioni occupano un ruolo decisivo. Da questo punto di vista, la coscienza non è una prerogativa esclusiva degli esseri umani, ma è diffusa nel mondo naturale grazie ai processi evolutivi. Noi sosteniamo che i sistemi artificiali come i robot attualmente sono carenti del tipo di relazione con la corporeità e con l’ambiente che consente quel tipo di auto-organizzazione indispensabile per l’emergenza della coscienza. (shrink)

The aim of this article is to analyse the internal mechanisms of corporate governance (board of directors and ownership structure), which influence voluntary disclosure of intangibles. The results appear to corroborate the view that an increase in institutional investor shareholding has a negative effect on voluntary disclosure, supporting the hypothesis of entrenchment, whereas an excessive ownership by institutional investors may have adverse effects on strategic disclosure decisions. The results also indicate that an increase in the number of members of the (...) board to up to 15 has a beneficial effect on the disclosure of intangibles. However, as this number increases, the effect inverts and becomes adverse to improving the capacity for supervision and control in the decision-making process regarding the voluntary disclosure of intangibles. The findings endorse the recommendation of the most of the Corporate Governance Codes regarding an advisable maximum of 15 members on a board to ensure its effectiveness and internal cohesion. (shrink)

L’idea che vi sia una netta dicotomia tra fatti e valori è uno dei dogmi dell’empirismo. Secondo questa concezione, i giudizi fattuali, in quanto verificabili o falsificabili empiricamente, riguardano le aree di razionalità «pura» e omogenea e sono ancorati naturalisticamente al mondo. Gli enunciati di valore, invece, sarebbero da relegare nella sfera di ciò che è semplicemente «soggettivo», emotivo, irrazionale. Questo assunto, che ha dominato per molto tempo le scienze e la filosofia, è stato messo in dubbio dai pragmatisti e (...) da alcuni dei più influenti pensatori contemporanei, che, intervenendo al dibattito sull’oggettività dell’etica, hanno mostrato come la presunta eterogeneità tra giudizi descrittivi e giudizi valutativi sia ormai insostenibile. Sulla scia della prospettiva inaugurata da questi pensatori, gli autori di questo libro mostrano come la dicotomia fatto/valore abbia corrotto il nostro pensiero, impedendoci di rivolgere l’attenzione alle intersezioni, le sinergie e le relazioni che esistono tra processi cognitivi e coefficienti valutativi, tra scienza e etica. Con saggi di S. Clough, D. Copp, D. Davidson, G. Marchetti, H. Putnam, R. A. Putnam B. Stroud, K. A. Taylor, V. Walsh. (shrink)

The moral use of irony cannot be made a universal critical tool isolated from its situatedness in history and disconnected from the social conventions shared by ironists and their audiences. Linking irony with alienation, Reinhold Niebuhr and Richard Rorty attribute to irony an inherently critical stance, yet in practice they limit the voices that can articulate moral irony and they reinforce modernist notions of agency. The author rejects their positions and turns to humorous irony to identify more complex and ambiguous (...) relations between morals and ironies and to challenge the rhetorical history of modernist alienated agency. (shrink)

Spinoza's avowed aim is to discover and present the essential stages in achieving the life of human blessedness. The most important element in this progression is knowledge, of one's own nature as man, and of one's place in the universe. Utility as opposed to truth of belief will not serve Spinoza's purpose. Spinoza assumes the unity of the human individual without question, and it is doubtful whether this assumption is justified on his own principles. The concept of the human individual (...) is examined first as a system of modifications of substance under the attributes of extension and thought, then as enduring and finally as an agent. The conclusion is reached that unity and self?identity are illusions, but the question then arises: Who or what could be under such illusions ? The possibility of false claims to self?identity is examined and found to be difficult to accept. Nevertheless, if Spinoza is taken as speaking suitably at varying levels of discourse, he has enlightening things to say about the human person, even though from one point of view his enterprise may be seen as self?stultifying. (shrink)

This paper examines the outcomes of Preserving the Past Together, a workshop series designed to build the capacity of local heritage managers to engage in collaborative and community-based approaches to archaeology and historic preservation. Over the past two decades practitioners of these approaches have demonstrated the interpretive, methodological, and ethical value of integrating Indigenous perspectives and methods into the process and practice of heritage management and archaeology. Despite these benefits, few professional resources exist to support the development of collaborative relationships (...) between local heritage managers and Tribal nations. Filling this need, Preserving the Past Together’s interactive workshops and keynote lectures involved participants in a discussion of the central themes in collaborative and Indigenous approaches to archaeology today, highlighting the local challenges and opportunities that exist for archaeologists, heritage managers, and Tribal nations to work together to care for the past. This paper presents an overview of the event series’ goals, the strategies it used to foster collaboration among the diverse stakeholders of the Salish Sea, and the next steps the project’s co-directors are taking to further support communication and collaboration between stewards and stakeholders in the Pacific Northwest. (shrink)

Montague’s theory of language is used to present a formal system that can be impIemented directly using PROLOG to obtain a semantic interpreter capable of analysing an im portant fragment of the Spanish language.

Directional deep brain stimulation contacts provide greater spatial flexibility for therapy than traditional ring-shaped electrodes, but little is known about longitudinal changes of impedance and orientation. We measured monopolar and bipolar impedance of DBS contacts in 31 patients who underwent unilateral subthalamic nucleus deep brain stimulation as part of a randomized study. At different follow-up visits, patients were assigned new stimulation configurations and impedance was measured. Additionally, we measured the orientation of the directional lead during surgery, immediately after surgery, and (...) 1 year later. Here we contrast impedances in directional versus ring contacts with respect to local anatomy, active stimulation contact, and over time. Directional contacts display larger impedances than ring contacts. Impedances generally increase slightly over the first year of therapy, save for a transient decrease immediately post-surgery under general anesthesia during pulse generator placement. Local impedances decrease at active stimulation sites, and contacts in closest proximity to internal capsule display higher impedances than other anatomic sites. DBS leads rotate slightly in the immediate postoperative period but otherwise remain stable over the following year. These data provide useful information for setting clinical stimulation parameters over time. (shrink)