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.

The C3 Framework encourages ambitious inquiry-based social studies teaching. While inquiry is regularly recommended as a preferred pedagogy, research has shown that social studies teachers rarely engage students in inquiry. This exploratory study surveyed social studies teachers in one school district in a southeastern state to update our understanding of teachers’ instructional beliefs and practices related to inquiry and the C3 Framework. Survey responses were analyzed using descriptive statistics and open coding. Findings indicate that the majority of teachers use instructional (...) practices that may be supportive of the C3 Framework and that the ideas within the C3 Framework resonate with most respondents. At the same time, teachers reported challenges with some key concepts within the Framework, such as taking informed action in the classroom and using questions to initiate an inquiry. While the idea of inquiry as espoused by the C3 Framework resonated with teachers, the extent to which they both believe in and practice inquiry methods is unclear and necessitates further study. This study is an initial step to inform future research and efforts to implement the C3 Framework in K-12 social studies classrooms. (shrink)

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)

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)

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.

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.

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 lieu of an abstract, here is a brief excerpt of the content:Introduction to the Special Issue on Pediatric Decision-MakingErica K. SalterUnlike in the traditional decisional dyad in adult-based care, pediatric decision-making typically involves a triadic relationship among the patient, their parents, and the health-care providers. This complex relationship raises questions and concerns regarding each party’s expectations, obligations, and authority. For example, should a parent be allowed to withhold a poor diagnosis from an adolescent patient? Should an HLA-matched six-year-old sister (...) be permitted to serve as a bone marrow donor for her older sibling with lysosomal storage disease? Or, should parents be given decisional authority to consent to gender-affirming care for an adolescent with gender dysphoria? Cases like these are among the most ethically challenging decisions faced by parents and health-care providers because they present competing interests and values, and it’s not always clear what is in the best interests of the child.In the context of American medicine, the best interest standard has been identified as the primary ethical and legal guide for decision-making. In its most prominent form, the best interest standard requires parents and pediatric practitioners to choose the medical treatment that maximizes benefits and minimizes harms to the particular child in question. However, over the past few decades, the standard has come under significant scrutiny, with discussions and debate in the academic bioethics literature asking whether the standard is able to serve the [End Page 181] purposes it is thought to serve and whether alternative standards might be better suited to the task(s). Despite vigorous interest in these issues, the academic literature did not seem to generate any sense of identifiable consensus about how others ought to make health-care decisions on behalf of children.Thus, in June 2022, 17 scholar-experts on pediatric decision-making standards gathered in St. Louis, MO, for a three-day symposium of discussion and consensus-building. The participating authors represented different disciplinary perspectives and different viewpoints in the debate about guidance principles that underlie pediatrics. Despite apparent disagreement about such standards in the literature, the group was able to generate a set of six consensus-based recommendations (see Table 1) for pediatric decision-making. These recommendations, as well as their application, justification, and limitations, were published as a special article in Pediatrics in August 2023 (Salter et al. 2023), which was composed with the primary goals of accessibility, teachability, and implementability for practicing pediatric clinicians. Click for larger view View full resolutionTable 1.Six consensus recommendations for pediatric decision-makingWhile the group was able to find agreement about these six central principles of pediatric decision-making, there remained several related issues that were outside of the scope of the symposium aims. For example, should these recommendations apply to neonates, children in state custody, or adolescents, and if so, how would their application be operationalized? What specific conditions should justify state intervention on parental authority? How should parents and health-care providers think about obligations to siblings in health-care decisions? This [End Page 182] special issue of Perspectives in Biology and Medicine provides a forum for our authors and collaborators to further explore these, and other, important questions.The issue opens with a piece by the symposium organizers and editors of this special issue, Erica Salter, Lainie Friedman Ross, and D. Micah Hester, describing the symposium’s inspiration and design, its execution, and the implications it might have for pediatric ethics. This contribution compares the six symposium recommendations with existing statements about pediatric decision-making, in particular the statements developed by the American Academy of Pediatrics (AAP). In “How We Found Consensus on Pediatric Decision-Making and Why It Matters,” readers will find a detailed account of the process engaged to develop the six consensus-based recommendations, as well as a discussion of the value and limitations of such a process, which may serve as a model of consensus-building useful for other unsettled topics of interest in the bioethics community.The issue’s second article, “Childhood Interests: What They Are, and Why It Matters,” by Johan Bester and Jeffrey Blustein, dives into the conceptual foundation of the symposium’s first two recommendations. This... (shrink)

We examine the Dual Ramsey Theorem and two related combinatorial principles VW(k,l) and OVW(k,l) from the perspectives of reverse mathematics and effective mathematics. We give a statement of the Dual Ramsey Theorem for open colorings in second order arithmetic and formalize work of Carlson and Simpson [1] to show that this statement implies ACA 0 over RCA 0 . We show that neither VW(2,2) nor OVW(2,2) is provable in WKL 0 . These results give partial answers to questions posed by (...) Friedman and Simpson [3]. (shrink)

The unknown nature of tomorrow’s research makes informed consent in biobank research a challenge. Whether the consent given by biobank participants is ‘broad’ or ‘narrow’, the ever present question remains the same: are new activities covered by the original consent? In this article, we focus on the meaning of, and the relation between, broad consent and re-consent in biobank research. We argue that broad consent should be understood as consenting to a framework—a framework which covers aims, core conditions for acceptable (...) use, governance and how these affect participants. Changes that alter the framework in a fundamental way call for re-consent. Three biobank cases of current international interest are used to debate when re-consent is an ethical necessity: whole-genome sequencing, data sharing and commercial utilization. These reflections give us a more nuanced view on what consent is for. We claim that the introduction of broad consents in biobank research has not represented a betrayal of individual participant interests, as some critics have asserted. Broad consents combined with the possible use of re-consent are in certain settings not inferior, but rather ethically superior to narrow consents. In population-based research biobanks, they allow for a reconciliation between individual interest and public matters in society at large. (shrink)

In the summer of 1997 one could scarcely enter a bookstore in Beijing without encountering Wang Xiaobo's pensive and defiant look on the cover of dozens of books displayed at the entrance. Wang had suddenly died in the spring of that year at the age of forty-five. Born in Beijing in 1952 to a family of intellectuals, he remained attached to China's capital despite periods of separation, such as during the Cultural Revolution, when he was sent to Yunnan to "learn (...) from the peasants" and taught in a "people-run-school" in Shandong, and also during the 1980s, when he studied in the United States . Wang always returned to Beijing, in the late 1970s to study economy and business at the People's University and in the late 1980s to teach there. After retiring in 1993, he devoted his time to writing: poetry, novels, essays, non-fiction, and a movie script. (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)