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1 – 10 of 688Debates regarding patient claims to extant tissue samples are often cited as beginning with the infamous US case of John Moore vs. the Regents of the University of California…
Abstract
Debates regarding patient claims to extant tissue samples are often cited as beginning with the infamous US case of John Moore vs. the Regents of the University of California (1984–1990) – where the plaintiff unsuccessfully tried to claim title in a cell line derived from his excised spleen. Following the 1990 Supreme Court verdict, the issue of patient property in excised tissue was held by certain bioethicists as the ethical problem inhering in biomedical research from the 1980s onward: encompassing debates about a newly-avaricious biotechnology, consent, autonomy and identity. I show here that the concept of patient property was first mooted during the 1970s, some 10 years before Moore, as a response to US-based criticism of the use of foetal and human tissues in research. Rather than representing a struggle between an avaricious science and misled patients, it evolved as a result of debates between philosophers, lawyers, scientists and members of the public, amidst broader debates regarding human experimentation and abortion. Moreover, the first person to assert a patient's right to their own, or their family's tissue, in a legal arena was a scientist. This article attempts to investigate, through the evolution of ownership debates, how bioethicists and scientists themselves construct what counts as ‘public opinion’.
Charlotte Kroløkke, Thomas Søbirk Petersen, Janne Rothmar Herrmann, Anna Sofie Bach, Stine Willum Adrian, Rune Klingenberg and Michael Nebeling Petersen
This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After…
Abstract
This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.
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Teacher burnout is a persistent challenge for school principals, complicated by the lack of a proven, repeatable strategy to mitigate burnout. If left unresolved, burnout can…
Abstract
Teacher burnout is a persistent challenge for school principals, complicated by the lack of a proven, repeatable strategy to mitigate burnout. If left unresolved, burnout can adversely affect school culture and student learning, leading to turnover that can compound these harmful effects. Since burnout can vary in severity and frequency, principals can work to mitigate burnout in the moment, seizing the opportunity when burnout is first observed. In this narrative sketch, I provide an overview of my experiences in my development as a principal and how this informed my approach to supporting teachers. I also discuss my experiences as principal in working with teachers at different stages of burnout severity, sharing specific stories and reflecting on both the successes and failures of my efforts, including the use of chocolates and tissues to create an individualized safe space to initiate open dialogue. The title, “Chocolates or Tissues,” is a metaphor that represents my momentary burnout mitigation strategy but may also serve as a metaphor for the need for principals to seek individualized opportunities for resolution in a burnout moment when working with teachers.
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This chapter addresses the alienability or inalienability of the bodily self by looking at continuing legal, economic, and cultural issues surrounding three case studies: the…
Abstract
This chapter addresses the alienability or inalienability of the bodily self by looking at continuing legal, economic, and cultural issues surrounding three case studies: the growth of cell lines, live organ transfer, and the practices of “forced prostitution” as a contemporary form of slavery. The essay contends that it is, ironically, Locke and Hegel's shared hyperliberal notion of the self as inalienable property that sustains a potential basis, in law and in culture, for troubling cases of self-alienation which persist in the case studies offered.
Charlotte Kroløkke, Thomas Søbirk Petersen, Janne Rothmar Herrmann, Anna Sofie Bach, Stine Willum Adrian, Rune Klingenberg and Michael Nebeling Petersen
Madhulika Bhatia, Shubham Sharma, Madhurima Hooda and Narayan C. Debnath
Recent research advances in artificial intelligence, machine learning, and neural networks are becoming essential tools for building a wide range of intelligent applications…
Abstract
Recent research advances in artificial intelligence, machine learning, and neural networks are becoming essential tools for building a wide range of intelligent applications. Moreover, machine learning helps to automate analytical model building. Machine learning based frameworks and approaches allow making well-informed and intelligent choices for improving daily eating habits and extension of healthy lifestyle. This book chapter presents a new machine learning approach for meal classification and assessment of nutrients values based on weather conditions along with new and innovative ideas for further study and research on health care-related applications.
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Martine Lappé and Hannah Landecker
This study analyzes the rise of genome instability in the life sciences and traces the problematic of instability as it relates to the sociology of health. Genome instability is…
Abstract
Purpose
This study analyzes the rise of genome instability in the life sciences and traces the problematic of instability as it relates to the sociology of health. Genome instability is the study of how genomes change and become variable between generations and within organisms over the life span. Genome instability reflects a significant departure from the Platonic genome imagined during the Human Genome Project. The aim of this chapter is to explain and analyze research on copy number variation and somatic mosaicism to consider the implications of these sciences for sociologists interested in genomics.
Methodology/approach
This chapter draws on two multi-sited ethnographies of contemporary biomedical science and literature in the sociology of health, science, and biomedicine to document a shift in thinking about the genome from fixed and universal to highly variable and influenced by time and context.
Findings
Genomic instability has become a framework for addressing how genomes change and become variable between generations and within organisms over the life span. Instability is a useful framework for analyzing changes in the life sciences in the post-genomic era.
Research implications
Genome instability requires life scientists to address how differences both within and between individuals articulate with shifting disease categories and classifications. For sociologists, these findings have implications for studies of identity, sociality, and clinical experience.
Originality/value
This is the first sociological analysis of genomic instability. It identifies practical and conceptual implications of genomic instability for life scientists and helps sociologists delineate new approaches to the study of genomics in the post-genomic era.
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Like all tribes, bioethics has its own origin myths. According to these myths, bioethics emerged in the latter half of the twentieth century when new technologies and scientific…
Abstract
Like all tribes, bioethics has its own origin myths. According to these myths, bioethics emerged in the latter half of the twentieth century when new technologies and scientific developments challenged the norms that had traditionally governed clinical practice. Theologians, philosophers, clergy, judges, lawyers, journalists and ordinary people – the “strangers at the bedside” in David J. Rothman's memorable phrasing – began to take an interest in moral matters that previously had been the realm of physicians alone. Codes of research ethics were formulated in response to the Nazi atrocities; hospital ethics committees were established in sensitivity to the emerging notion of “patients’ rights.” Bioethics was born.