bluuebunny/crossref_metadata_2025_split huggingface dataset:
Research Involving Those at Risk for Impaired Decision-Making Capacity
Authors: Rosenstein Donald L , Miller Franklin G 
Published: November 2023

Abstract
Medical conditions that impair a person’s ability to make decisions (e.g., dementia, stroke, schizophrenia) are devastating for affected individuals and their families. Too often, modern medicine provides only modest symptomatic improvement for patients with these disorders. Much-needed progress in the diagnosis, treatment, and prevention of these illnesses depends on clinical advances through research. However, the conduct of research exposes these individuals to the possibility of exploitation precisely because they may not be able to make informed decisions about participation. This chapter employs a process-oriented and practical approach to the ethics of research with adults who may not be able to provide informed consent because of impaired decision-making capacity (DMC). Neither emergency research nor research with children will be addressed. The chapter is organized into the following sections: a brief history of ethical aspects of research with those who are decisionally impaired; our conceptualization of DMC as it relates to the ethics of clinical research; a review of empirical data on research subjects who have, or are at risk for, impaired DMC; policy and study design implications; and unresolved empirical issues regarding the ethics of DMC and clinical research. Throughout the chapter, we emphasize the integral relationship between research methodology (i.e., subject selection, the nature of the proposed research interventions, and specific protocol details) and the ethical analysis of a given research proposal.
Risk-Benefit Analysis and the Net Risks Test
Authors: Wendler David , Miller Franklin G 
Published: November 2023

Abstract
The goal of clinical research is to develop scientific knowledge that can guide the improvement of medical care for future patients. A central concern in research ethics is to protect participants from exploitation in the course of this socially valuable activity. To avoid exploitation, the risks to which research participants are exposed must be reasonable in relation to anticipated benefits. This requirement raises a host of difficult questions. Must the potential clinical benefits to participants outweigh the risks they face? Or is it ethically acceptable to expose participants to some risks for the benefit of society? Assuming it is ethical to expose participants to some risks for the benefit of society, are there limits on the level of these risks? And if there are such limits, to what extent do they vary depending upon the participants in question, whether they can consent or not, whether they are children or not?
Evaluating the Effectiveness of Institutional Review Boards
Authors: Speers Marjorie A 
Published: November 2023

Abstract
All research studies involving people need ongoing oversight. For many, probably most, clinical research studies, this oversight is provided by the investigators, under the aegis of the local institution in which the research is being conducted, and with the oversight of the institutional review board (IRB) or its equivalent. Certain kinds of clinical research studies, though, might require different kinds of oversight. This oversight is not necessarily more intensive, but the features specific to the study might call for modifications in the oversight.
The Food and Drug Administration and Drug Development
Authors: Temple Robert , Goldkind Sara F 
Published: November 2023

Abstract
The regulation of drug development, especially human clinical trials and the evidence needed for drug marketing, has major implications for research ethics. Food and Drug Administration (FDA) oversight and direction derives from federal legislation— principally the Federal Food, Drug, and Cosmetic Act of 1938, as amended in 1962—from the regulations written under that law, and from FDA guidance and policy documents that interpret the law and regulations. In this chapter, we provide a historical review of those rules and policies, noting both their obvious ethical implications and some of the less apparent, but critically important, ethical aspects of drug regulation. Table 54.1, below, summarizes the important FDA milestones.
Legal and Regulatory Standards of Informed Consent in Research
Authors: Capron Alexander M 
Published: November 2023

Abstract
Legal rules embodied in judicial decisions and in statutes and regulations are at the heart of modern bioethics, and nowhere more clearly than in research with humans. Of the basic ethical principles associated with clinical research, autonomy—in the guise of “informed consent”—is, in its origins as well as its content, the most legal. Whereas other aspects of bioethics, such as the principles of nonmaleficence and beneficence, can be traced to ancient medical texts as well as to the professional orientation of modern physicians, informed consent was first articulated in legal documents, and it has been further elaborated by judges, legislators, and regulators over many decades.
The Therapeutic Misconception
Authors: Appelbaum Paul S , Lidz Charles W 
Published: November 2023

Abstract
A 25-year-old woman, who was participating in a randomized, double-blind, placebo-controlled study of two medications for borderline personality disorder, was interviewed shortly after consenting to enter the project. At the time of the interview she displayed no apparent psychiatric symptoms, and her intellectual ability seemed consistent with her history of having completed three years of college. Her understanding of the research was generally excellent. She recognized that the purpose of the research project was to find out which treatment worked best for the class of patients of which she was a member. She spontaneously described the three groups, including the placebo group, and indicated that assignment would be random. She understood that dosages would be adjusted according to blood levels, not her level of symptomatology, and that a double-blind would be used. When she was asked directly, however, how her medication would be selected, she said that she had no idea. She then added, “I hope it isn’t by chance,” and suggested that each subject would probably receive the medication he or she needed.
Liability and Compensation for Injury of Research Subjects
Authors: Mariner Wendy K 
Published: November 2023

Abstract
Most clinical research with human subjects takes place out of public view without complaint or controversy. Yet the legal history of biomedical research highlights the occasional shocking catastrophe. Scandals in particular periodically rouse public outrage, recommendations for law reform, and lawsuits, which refine the legal principles governing research. More than 30 years ago, revelations of the Tuskegee Syphilis study led to the adoption of federal regulations to protect research subjects in federally funded research. More recently, the deaths of research subjects at renowned academic research institutions, most famously that of 18-year-old Jesse Gelsinger at the University of Pennsylvania in 1999, revived calls for reform. So far, neither the legislation nor regulations governing research with human subjects has changed significantly, perhaps because public attention was diverted in the aftermath of September 11, 2001. However, lawsuits against researchers may have gained more visibility, both applying and refining fundamental legal principles.12
Benefits to Host Countries
Authors: Emanuel Ezekiel J 
Published: November 2023

Abstract
One of the major ethical issues in biomedical research relates to access to drugs and other interventions after a trial has been completed. If the ultimate purpose of research studies is to improve health, then somehow ensuring access to interventions proven safe and effective would seem to be a necessary step. Yet, as is well documented, adoption of any new intervention or technology is haphazard at best. In part this is because after research studies, the drugs or devices might not be submitted for regulatory approval or, if submitted, might not be approved. In addition, health-care providers might not implement the interventions because of inertia or lack of training. And, in both developing and developed countries, the high cost of the interventions might preclude access to these interventions. Historically, a commonly identified problem—which may or may not have been common— has been so-called helicopter or “briefcase” research. The researchers, concerned about the data and publication, came, conducted their study, obtained the relevant data, and left the research area, unconcerned about what subsequently transpired for the research participants and their community.
Scleroderma And The Lungs
Authors: Mayes Maureen D 
Published: November 2023

Abstract
Before I begin to discuss how scleroderma can affect the lungs, it is helpful to describe normal lung structure and function. The purpose of the lungs is pretty simple: to extract oxygen from the air we breathe (normal room airis 21 percent oxygen) and to get rid of carbon dioxide (CO2), which is a byproduct of metabolism, the process of converting food products to energy. To do this, the lungs consist of thousands of tiny air sacs (one air sac is an alveolus, more than one are called alveoli), which are arranged around breathing tubes like grapes on a stalk. Air is brought in through the nose and mouth, pulled into the main breathing tube through the voice box, or larynx, and into the trachea, or windpipe (see Figure 2). This divides into the right and left main-stem bronchi, large tubes that in turn branch into smaller and smaller air tubes until they reach the smallest tubes, called bronchioles, which have clusters of alveoli around them. The exchange of oxygen for carbon dioxide occurs only in the alveoli. Each alveolus has a very thin lining or wall composed of a mucous membrane cell on the inside, where the air is, and a capillary (the smallest type of blood vessel) on the outside. Separating the lining cell and the capillary is a very thin structure called a basement membrane, which is made up of collagen.
Going to the Courtesans: Transit to the Pleasure District of Edo Japan
Authors: Screech Timon 
Published: November 2023

Abstract
This essay addresses the process by which males accessed female courtesan enclaves during Japan’s Edo Period (1603–1868). It proposes that men were transformed and so prepared for the transient joys of the pleasure world through rituals of transit from the city proper to the pleasure districts, and were reconnected to civic life upon their return home the following morning. In tracing this transit, I dwell more on the culture of proleptic expectation than on the courtesans per se, and the voices heard are more male than female, the subjectivities of the courtesans them-selves existing in the hinterland.
Tawa’if, Tourism, and Tales: The Problematics of Twenty-First-Century Musical Patronage for North India’s Courtesans
Authors: Maciszewski Amelia 
Published: November 2023

Abstract
The couplet Chandni sang with the grace and feeling of someone much older seemed to speak of “the pain of longing and . . . the silence of isolation . . . in the kothas [courtesans’ salons]”—not unlike the atmosphere where she was growing up. Yet, she and others in her community remain dedicated to their means of survival, which many of them consider their duty.
Advances and Retreats
Authors: Blakeman Edward 
Published: November 2023

Abstract
Verdi dubbed the Paris Opéra the “grande boutique,” and Saint-Saëns called the Société des concerts du Conservatoire the “sanctuaire.”1 Both neatly summed up the attitudes of Parisian society in the 1860s, when music as a consumer luxury coexisted with music as a cultural icon. The Opéra, moving between thirteen buildings on twelve sites since its foundation in 1670, had always been located in the most fashionable area of Paris. In 1864 it occupied the Salle Le Peletier at the intersection of the present rue Rossini and rue Drouot in the ninth arrondissement. Here it was indeed surrounded by a complex of smart boutiques, and as a world within a world —”a paradise of Mahommed on earth” — it supported an equally complex society of singers, dancers, musicians, artists, entrepreneurs, claqueurs, Jockey Club members, ticket touts, and others.
The Wind Society
Authors: Blakeman Edward 
Published: November 2023

Abstract
The story of Taffanel’s Société de musique de chambre pour instruments à vent begins and ends with two eye-catching press reviews. In 1893, fifteen years after its founding, the Society had become such a fixture in the Parisian musical calendar that the critic Guy de Charnacé decided the time had come to recommend it to the refined female readership of the “fashionable, cosmopolitan” magazine La Grande dame. And so, after the latest news on the arts and spring hats, and in between advice on choosing the best perfumes and behaving with le dernier chic, an article appeared praising the Society’s excellent performances and noting how it had grown from modest beginnings to become a force that had raised the whole level of awareness of chamber music.
Mutualisms as Consumer-Resource Interactions
Authors: Holland J Nathaniel , Ness Joshua H , Boyle Alice , Bronstein Judith L 
Published: November 2023

Abstract
Recognition that predator-prey interactions involve consumer-resource interactions has served as a conceptual foundation for mechanistic understanding of the influences of predation on patterns and processes in ecology and evolutionary biology. Conversely, although mutualism is increasingly recognized as important in nature, it is still often perceived as an eccentric case of interspecific interactions with little relevance to major patterns and processes in ecology. This perspective stems, in part, from the paucity of general principles that can unify mutualistic systems varying greatly in natural history. In this chapter, we develop one such principle, which is that mutualism, like predator-prey interactions, is a consumer resource interaction.
Patterns of Inheritance of Foraging Traits in Predators
Authors: Riechert Susan E 
Published: November 2023

Abstract
Optimal foraging theory predicts that animals will be opportunistic toward prey, taking advantage of complex and often changing prey availability. Yet a review of studies that have investigated potential patterns of inheritance of foraging traits in predators has identified genetic influences on morphological traits that affect the nature of attack, the ease of taking prey, discrimination of prey among diet specialists, resistance to prey defense mechanisms, and the search patterns used during foraging. Genes even determine whether individuals will exhibit solitary or aggregative feeding (in, e.g., nematode worms), as well as whether they adjust foraging effort in response to local prey availability. No evidence, however, has been found for genetic determination of patch staying time, which may simply reflect the fact that it has not been subjected to genetic study. In this chapter, the constraints and consequences of genetically controlled foraging decisions are considered, as is the extent to which patterns of inheritance of foraging traits are conserved throughout the animal kingdom. Some evidence is provided for the contention that phenotypic plastic responses are a first step toward increased foraging success gained with subsequent canalization of traits. More detailed studies are needed to test the generality of these findings.
Acoustic Interactions Between Insects And Bats: A Model For The Interplay Of Neural And Ecological Specializations
Authors: Triblehorn Jeffrey D , Yager David D 
Published: November 2023

Abstract
Whether belonging to a predator or prey, an animal’s central nervous system (CNS) and sensory systems have evolved to maximize its chances of survival. This evolution is rarely an optimization of structure and function, but rather a compromise, as demonstrated in one of the best-studied cases of the coevolution of CNS and sensory capabilities: echolocating bats and the flying insects they hunt at night. The bats echolocate using ultrasonic (frequencies over 20 kHz) sonar cries, and the nature of the cries and the way their echoes are processed in the CNS depend on the ecology of the particular species. The CNS processing of echolocation cries for swift and efficient prey capture must be balanced against the needs for obstacle avoidance, predator avoidance, and distinguishing their own pulse-echo pairs from those of nearby conspecifics. A partial solution may lie in auditory scene analysis, a CNS strategy of grouping and segregating complex sounds to facilitate their analysis.
The Visual Ecology of Predator-Prey Interactions
Authors: Cronin Thomas W 
Published: November 2023

Abstract
Vision is the sensory modality that normally provides the greatest awareness of events far removed from an animal’s current location. Thus, it is often the most effective sense for early detection of predators or prey, as well as for enabling decisions about appropriate actions to take upon such detection. Indeed, it has been argued that the early appearance of good visual systems fueled the evolution of complex animals. Visual tasks of predators and prey require rather different specializations, reflecting the quite different role of each animal in the predator-prey relationship. Because the risk of overlooking prey involves slight relative costs to a predator, compared to the cost to a prey animal of overlooking the presence of a predator, prey visual systems tend to sample a broad spatial field relatively uniformly, searching for predators at virtually any location.
Perception of Predation Risk:The Foundation Of Nonlethal Predator-Prey Interactions
Authors: Lima Steven L , Steury Todd D 
Published: November 2023

Abstract
The ability of animals to perceive changes in predation risk forms the foundation on which the nonlethal effects of predators are transmitted to prey populations and communities. Our goal here is to provide a wide-ranging treatment of risk perception, highlighting the many important issues that are largely unstudied. A key component of the perception of risk is information about risk itself. Animals have available many possible lines of information about risk, but the precise nature of the information used is rarely clear. Of potentially far-reaching ecological importance is “public information” about risk, information that extends across large spatial scales. Public information about risk may generally be more available in aquatic systems than in terrestrial systems because of the diffusion of chemical cues in the aquatic systems. Predators may also attempt to “manage” the perception of risk in their prey by keeping the level of public information about risk as low as possible. Overall, one of the more fruitful avenues of future research will be to better characterize the risk-related information available to prey animals.
Direct and Indirect Effects of Vegetation Structure and Habitat Complexity on Predator-Prey and Predator-Predator Interactions
Authors: Denno Robert F , Finke Deborah L , Langellotto Gail A 
Published: November 2023

Abstract
Our major objective here is to review the direct and indirect effects of vegetation and habitat structural complexity on predator-prey and predator-predator (intraguild predation and cannibalism) interactions and to explore the consequences of such habitat-mediated interactions on prey and food web dynamics. For this assessment, we emphasize interactions involving invertebrate predators (insects, arachnids, and crustaceans) in both terrestrial and aquatic systems. Structural complexity effects on predators were examined at the spatial scales of microhabitat (e.g., leaf surface), habitat (e.g., plant species diversity, plant density, litter diversity, and substrate heterogeneity), and landscape (e.g., patch size and background matrix composition).
Wooden Warships And The Western Frontier The Battle of Lake Erie September 10, 1813
Authors: Symonds Craig L 
Published: November 2023

Abstract
Lake Erie Is The Southernmost Of The Five Great Lakes. At its western end it is fed by the Detroit River, which carries the discharge from the three largest of those lakes (Superior, Michigan, and Huron), and at its eastern end it is drained by the Niagara River, which spills spectacularly into Lake Ontario. Along its southern shore, connected today by the asphalt ribbon of Interstate 90, is a string of cities historically associated with the coal-and-steel-based industry of the late nineteenth century: Buffalo, Erie, Cleveland, Toledo, and Detroit. Modern Americans are likely to conceive of this region as the “rust belt,” an area where the “old economy” flourished in the nineteenth and early twentieth centuries, where brick chimneys spilled black smoke into the sky, and where endless trains of boxcars and flatcars carried the products from a hundred factories to the world’s consumers. Given that, it is difficult to envision Lake Erie the way Americans did in the early nineteenth century: as a distant frontier of dense forests and untracked wilderness, a body of water whose shores were largely unpopulated if not in some areas virtually unexplored. The town of Erie was a tiny frontier settlement on Presque Isle Bay, Cleveland had fewer than a hundred residents, and Detroit was Fort Detroit, a garrisoned western outpost for trappers and traders. In 1813 Lake Erie represented not the East but the West, and it was the key to the great western empire granted to the United States by the British in the Treaty of Paris in 1783.
Scalar Implicatures, Polarity Phenomena, and the Syntax/Pragmatics Interface
Authors: Chierchia Gennaro 
Published: November 2023

Abstract
Negative polarity phenomena, as exemplified in the behavior of English any, and scalar implicatures, as exemplified by, say, the interpretations of some (i.e., “at least one and possibly all” vs. “at least one but not all”), have often been felt to be closely related. However, the exact nature of such a relationship remains as of now not fully understood, insofar as I can tell. And in fact, some important empirical generalizations pertaining to it, if not altogether missed, have perhaps not been properly appreciated. In this chapter, I address the issue of what are the relevant factual connections between scalar implicature and negative polarity and what we can learn from this about the grammatical mechanisms at the basis of these phenomena. One of the features that makes the analysis of negative polarity items (NPIs) and scalar implicatures (SIs) particularly interesting is that they raise a number of key questions concerning how syntax, semantics, and pragmatics interact with each other. We will mostly focus on the interface of pragmatics with syntax and semantics. More specifically, here is a widespread view of the latter.
Beyond Explanatory Adequacy
Authors: Chomsky Noam 
Published: November 2023

Abstract
I will assume here an approach to the study of language that takes the object of inquiry to be an internal property of persons, a subcomponent of (mostly) the brain that is dedicated specifically to language: the human “Faculty of Language” (FL), to adapt a traditional term to a new context. This “biolinguistic approach” was controversial when it took shape almost half a century ago, and remains so, but without warrant, in my opinion. A stronger thesis is that the biolinguistic approach has a kind of privileged status, in that every constructive approach to human language and its use presupposes it, or something similar, at least tacitly. That, too, seems to me tenable, but I will not pursue the issue here.