The considerable attention to financial interests in clinical research has focused mostly on academic medical centers, even though the majority of clinical research is conducted in community practice settings. To fill this gap, this article maps the practices and policies in 73 community hospitals and several hundred specialized facilities around the country for reviewing clinical investigators’ financial relationships with research sponsors. Community hospitals face a substantially different mix of issues than academic medical centers do because their physician researchers are usually (...) not employees, and more of their studies are later-phase, multicenter trials. Accordingly, community physicians stand to benefit personally from per capita payments, but they tend to have less direct influence over research findings when compared with their academic peers. These and other contrasts require separate guidance for community-based organizations that takes into account their particular needs, circumstances, and institutional capacities. (shrink)

As part of a larger research study, we present model language for disclosing financial interests in clinical research to potential research participants, and we describe the empirical basis and theoretical assumptions used in developing the language. The empirical process for creating appropriate disclosure language resulted in a generic disclosure statement for cases in which no risk to participants’ welfare or the scientific integrity of the research is expected, and nine more specific disclosure statements for cases in which some risk is (...) expected. The disclosure statements are not meant to be canonical, but were instead designed to reflect the typical situations in which disclosure of financial interest might be considered by an institutional review board or conflict of interest committee. Individual institutions could modify key phrases to suit their purposes, and others could use the language in future empirical work on informed consent to better refine the options for disclosing financial interests in clinical research. (shrink)

Although many of the congenital syndromes that used to be lethal no longer are, they are still routinely referred to as “lethal anomalies.” But the label is not only inaccurate, it is also dangerous: by portraying as a medical determination what is in fact a judgment about the child's quality of life, it wrests from the parents a decision that only the parents can make.

Investigator and institutional financial conflicts of interest have raised concerns about both the integrity of clinical research and protecting the rights and welfare of research participants. In response, professional groups and governmental bodies have issued guidance for managing conflicts of interest to minimize their potential untoward effects. Although a variety of approaches have been offered, a common protection is to disclose financial interests in research to potential research participants as part of the recruitment and informed consent process. This approach reinforces (...) a basic norm of candor, ideally allowing potential research participants to evaluate whether financial interests should affect their decision to participate in research. Disclosure to potential research participants is viewed as an alternative to having regulators or research institutions limit or prohibit all financial interests in research, assuming that not all such interests are unacceptable. (shrink)

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general (...) attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants. (shrink)

Based on the relevant logic R, the system R# was proposed as a relevant Peano arithmetic. R# has many nice properties: the most conspicuous theorems of classical Peano arithmetic PA are readily provable therein; it is readily and effectively shown to be nontrivial; it incorporates both intuitionist and classical proof methods. But it is shown here that R# is properly weaker than PA, in the sense that there is a strictly positive theorem QRF of PA which is unprovable in R#. (...) The reason is interesting: if PA is slightly weakened to a subtheory P+, it admits the complex ring C as a model; thus QRF is chosen to be a theorem of PA but false in C. Inasmuch as all strictly positive theorems of R# are already theorems of P+, this nonconservativity result shows that QRF is also a nontheorem of R#. As a consequence, Ackermann's rule γ is inadmissible in R#. Accordingly, an extension of R# which retains its good features is desired. The system R##, got by adding an omega-rule, is such an extension. Central question: is there an effectively axiomatizable system intermediate between R# and R##, which does formalize arithmetic on relevant principles, but also admits γ in a natural way? (shrink)

Alexander Moritzi is one of the most obscure figures in the early history of evolutionary thought. Best known for authoring a flora of Switzerland, Moritzi also published Réflexions sur l’espèce en histoire naturelle, a remarkable book about evolution with an overtly materialist viewpoint. In this work, Moritzi argues that the generally accepted line between species and varieties is artificial, that varieties can over time give rise to new species, and that deep time and turnover of species in the fossil record (...) clearly support an evolutionary interpretation of biological diversity. Moritzi was also a gradualist and viewed relationships between taxa as best represented by a ramifying tree. Although Réflexions was the first full book to be written on the topic of evolution following Lamarck’s Philosophie zoologique, Moritzi’s evolutionist contribution was stillborn, read by almost no one in his lifetime and ultimately absent from the many historiographies of evolutionary thought. This is unfortunate since many of the arguments Moritzi marshaled on behalf of an evolutionary explanation of life can be found in subsequent transmutationist writings by Frédéric Gérard, Robert Chambers, Henri Lecoq, Baden Powell, Charles Naudin, Herbert Spencer, Alfred Russel Wallace, and Charles Darwin—none of whom is likely to have ever known of the existence of Réflexions. Finally, Moritzi’s arguments, along with those found in Darwin’s private essay on evolution of the same year, provide an excellent window into the state of evolutionary thought and debate over the nature of species at the beginning of the 1840s. (shrink)

The Common Health problems that plague Americans today are often the result of people’s choices and behaviors: obesity, cigarette smoking, accidental pediatric head trauma owing to failure to properly restrain children, and failure to adhere to medication regimens. For each problem, there is a well-studied effective behavioral intervention: a healthy diet and exercise for obesity, smoking cessation programs to overcome cigarette addiction, appropriate car restraints to prevent accidental head trauma, and direct observation of treatment and simplification of medical regimens to (...) improve drug adherence. Traditionally, the physician defined the problem and told the patient what she needed to do. In the modern era of .. (shrink)

Let ℜ be an o-minimal expansion of (ℝ, <+) and (φk)k∈ℕ be a sequence of positive real numbers such that limk→+∞f(φk)/φk+1=0 for every f:ℝ→ ℝ definable in ℜ. (Such sequences always exist under some reasonable extra assumptions on ℜ, in particular, if ℜ is exponentially bounded or if the language is countable.) Then (ℜ, (S)) is d-minimal, where S ranges over all subsets of cartesian powers of the range of φ.

We present here an approach to the fine structure of L based solely on elementary model theoretic ideas, and illustrate its use in a proof of Global Square in L. We thereby avoid the Lévy hierarchy of formulas and the subtleties of master codes and projecta, introduced by Jensen [3] in the original form of the theory. Our theory could appropriately be called ”Hyperfine Structure Theory”, as we make use of a hierarchy of structures and hull operations which refines the (...) traditional Lα -or Jα-sequences with their Σn-hull operations.§1. Introduction. In 1938, K. Gödel defined the model L of set theory to show the relative consistency of Cantor's Continuum Hypothesis. L is defined as a unionof initial segments which satisfy: L0 = ∅, Lλ = ∪α<λLα for limit ordinals λ, and, crucially, Lα + 1 = the collection of 1st order definable subsets of Lα. Since every transitive model of set theory must be closed under 1st order definability, L turns out to be the smallest inner model of set theory. Thus it occupies the central place in the set theoretic spectrum of models.The proof of the continuum hypothesis in L is based on the very uniform hierarchical definition of the L-hierarchy. The Condensation Lemma states that if π : M → Lα is an elementary embedding, M transitive, then some ; the lemma can be proved by induction on α. If a real, i.e., a subset of ω, is definable over some Lα,then by a Löwenheim-Skolem argument it is definable over some countable M as above, and hence over some, < ω1. This allows one to list the reals in L in length ω1 and therefore proves the Continuum Hypothesis in L. (shrink)

We present here an approach to the fine structure of L based solely on elementary model theoretic ideas, and illustrate its use in a proof of Global Square in L. We thereby avoid the Lévy hierarchy of formulas and the subtleties of master codes and projecta, introduced by Jensen [3] in the original form of the theory. Our theory could appropriately be called ”Hyperfine Structure Theory”, as we make use of a hierarchy of structures and hull operations which refines the (...) traditional Lα -or Jα-sequences with their Σn-hull operations.§1. Introduction. In 1938, K. Gödel defined the model L of set theory to show the relative consistency of Cantor's Continuum Hypothesis. L is defined as a unionof initial segments which satisfy: L0 = ∅, Lλ = ∪α<λLα for limit ordinals λ, and, crucially, Lα + 1 = the collection of 1st order definable subsets of Lα. Since every transitive model of set theory must be closed under 1st order definability, L turns out to be the smallest inner model of set theory. Thus it occupies the central place in the set theoretic spectrum of models.The proof of the continuum hypothesis in L is based on the very uniform hierarchical definition of the L-hierarchy. The Condensation Lemma states that if π : M → Lα is an elementary embedding, M transitive, then some ; the lemma can be proved by induction on α. If a real, i.e., a subset of ω, is definable over some Lα,then by a Löwenheim-Skolem argument it is definable over some countable M as above, and hence over some, < ω1. This allows one to list the reals in L in length ω1 and therefore proves the Continuum Hypothesis in L. (shrink)

We present here an approach to the fine structure of L based solely on elementary model theoretic ideas, and illustrate its use in a proof of Global Square in L. We thereby avoid the Lévy hierarchy of formulas and the subtleties of master codes and projecta, introduced by Jensen [3] in the original form of the theory. Our theory could appropriately be called ”Hyperfine Structure Theory”, as we make use of a hierarchy of structures and hull operations which refines the (...) traditional Lα -or Jα-sequences with their Σn-hull operations.§1. Introduction. In 1938, K. Gödel defined the model L of set theory to show the relative consistency of Cantor's Continuum Hypothesis. L is defined as a unionof initial segments which satisfy: L0 = ∅, Lλ = ∪α<λLα for limit ordinals λ, and, crucially, Lα + 1 = the collection of 1st order definable subsets of Lα. Since every transitive model of set theory must be closed under 1st order definability, L turns out to be the smallest inner model of set theory. Thus it occupies the central place in the set theoretic spectrum of models.The proof of the continuum hypothesis in L is based on the very uniform hierarchical definition of the L-hierarchy. The Condensation Lemma states that if π : M → Lα is an elementary embedding, M transitive, then some ; the lemma can be proved by induction on α. If a real, i.e., a subset of ω, is definable over some Lα,then by a Löwenheim-Skolem argument it is definable over some countable M as above, and hence over some, < ω1. This allows one to list the reals in L in length ω1 and therefore proves the Continuum Hypothesis in L. (shrink)

In this commentary, the author discusses two strengths and two weaknesses of “Better than Best (Interest Standard) in Pediatric Decision-Making,” in which Lainie Friedman Ross critiques the best interest standard and proposes her own model of constrained parental autonomy (CPA) as a preferable replacement for both an intervention principle and a guidance principle in pediatric decision making. The CPA’s strengths are that it detaches from the language and concept of “best” and that it better respects the family as a (...) distinct and intimate decision-making unit. The first weakness of the framework, as an intervention principle, is that because it imports a Rawlsian understanding of basic interests, it neglects certain populations of children (for example, children with intellectual disabilities). The second weakness is that, as a guidance principle, it is unclear what actual guidance the CPA is positioned to offer and how that guidance would be justified. To conclude, this commentary offers suggestions for what should be required of both an intervention principle and a guidance principle in pediatric decision making. (shrink)

In this paper we examine many of the arguments contained in Milton Friedman’s classic essay, in the form of critiques linked with learning objectives forclassroom discussions.

This paper explores one aspect of the political in the early Hegel, that of criminal action and its relationship to the concept of recognition in the System of Ethical Life. While it is clear that in this work Hegel thinks that criminal action plays an important role in the transformation of simple ethical communities, it is not clear that, for Hegel, the formal character of crime in the struggle for recognition is anything but negative. I attempt to show how this (...) role for crime leads Hegel to a legalistic conception of Right that has no solid connection with recognition as a social force. (shrink)

Iyengar Yoga Wisdom & Practice" is a practical and an inspiring anthology of Iyengar's insights into yoga, life and the path to peace and happiness. Yoga practice lies at the heart of the book, and it is illustrated with over 60 new step-by-step sequences of yoga postures specially shot in India and accompanied by Iyengar's illuminating observations on technique, their significance, and their benefits. This book not only presents Iyengar's practical advice on how to perform key yoga postures, but also (...) draws on a wide range of other material taken from interviews and world lecture tours, to the many texts Iyengar has written about yoga and about his own life's journey. (shrink)

The Socio-Cultural pluralism and its fabrics in our society have been under the threat of religious fundamentalism and ideological extremism, which firmly believe that there can only one way of true expression and all other forms, are either substandard or false. This attitude has torn away the world into different isolated islands of human settlements. This state of affair is the outcome of multidimensional causes and one among them, no doubt, is related to one of the central issues of Philosophy, (...) i.e., the relation between ‘one and many’. The ontological dimension of the problem of ‘one and many’ cannot be solved withouthaving the proper understanding of epistemological solutions. The epistemic tools of the Advaita Vedanta are powerful enough to suggest pragmatic solutions to the good old problem of ‘one and many’ that attains new relevance in the era of Globalization. The logic of identity in difference and the logic of difference are the two types of logical systems, which are instrumental for the formulation of various types of claims to know of the western tradition. The logic of identity in difference has been clearly designed and defined by the classical logic or the Aristotelian logic. The symbolic logic encarves the various nuances of the logic of difference. The Advaita System has envisaged a new logic i.e., the logic of identity, which is implicit in the Upanisdic mahavakyya ‘Ayam Āthmam Brahma’. The paper intents to explore the possibility of application of the logic of identity in socio-cultural issues of the present day world. (shrink)

Increasingly, national governments across the globe are prioritizing investments in neuroscience. Currently, seven active or in-development national-level brain research initiatives exist, spanning four continents. Engaging with the underlying values and ethical concerns that drive brain research across cultural and continental divides is critical to future research. Culture influences what kinds of science are supported and where science can be conducted through ethical frameworks and evaluations of risk. Neuroscientists and philosophers alike have found themselves together encountering perennial questions; these questions are (...) engaged by the field of neuroethics, related to the nature of understanding the self and identity, the existence and meaning of free will, defining the role of reason in human behavior, and more. With this Perspective article, we aim to prioritize and advance to the foreground a list of neuroethics questions for neuroscientists operating in the context of these international brain initiatives. (shrink)