1,720,984 research outputs found
U.S. Public Health Service STD Experiments in Guatemala (1946–1948) and Their Aftermath
No full textThe U.S. Public Health Serviceâ s sexually transmitted disease (STD) experiments in Guatemala are an important case study not only in human subjects research transgressions but also in the response to serious lapses in research ethics. This case study describes how individuals in the STD experiments were tested, exposed to STDs, and exploited as the source of biological specimensâ all without informed consent and often with active deceit. It also explores and evaluates governmental and professional responses that followed the public revelation of these experiments, including by academic institutions, professional organizations, and the U.S. federal government, pushing us to reconsider both how we prevent such lapses in the future and how we respond when they are first revealed.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/148377/1/eahr500010.pd
From \u3cem\u3ein vivo\u3c/em\u3e to \u3cem\u3ein vitro\u3c/em\u3e: How the Guatemala STD Experiments Transformed Bodies Into Biospecimens
No full textConsuming Genomics: Regulating Direct-to-Consumer Genetic and Genomic Information
Get PDFThis Article is one of the first to analyze the effect of the 23andMe Warning Letter on the industry, to focus on the bifurcation of genetic interpretation and information as an independent medical device, and to analyze future regulatory approaches available to FDA. Part II of this Article offers an overview of public access to genetic information: the significance of genetic information, the transition from discrete genetic testing to large-scale genetic testing and genomic sequencing, and the movement of genetic interpretation from the clinic to DTC. This Part will also discuss government scrutiny of the DTC genetic-testing industry. Part III of this Article will conduct a deeper examination of the agencies poised to regulate DTC genetic testing. This Part analyzes FDA’s Untitled and Warning Letters and highlights four major insights for the industry going forward. But, although FDA is best-positioned to regulate the industry, it is not the only agency with the power to engage. Several other federal agencies—such as the U.S. Federal Trade Commission (FTC) and the U.S. Centers for Medicare and Medicaid Services (CMS)—can also influence access to, and the validity and utility of, DTC genetic testing. Finally, the Supreme Court’s recent decision in Myriad, invalidating patents on human genetic material, eliminates a potential barrier to DTC genetic testing and suggests a way in which the U.S. Patent and Trademark Office (PTO) can help ensure continued access to certain types of genetic interpretation. Part III will clarify the ways these agencies can support access to valid and useful genetic information and will highlight their limitations in this rapidly evolving field. State law provides an additional layer enhancing federal protections. Part IV considers the particular challenges associated with regulating bifurcated genetic data and interpretation entities. Entities that merely provide genetic data are likely to remain unregulated both because they do not satisfy FDA’s definition of a medical device and because FDA officials have explicitly disclaimed interest in their regulation. Entities that interpret genetic data and provide associated medical information, even without access to the underlying biological sample, give rise to a different analysis. Here, comparisons to FDA regulatory approaches taken with WebMD and mobile medical devices will likely fall short, whereas the approach taken with regulating software might be helpful—but even then, regulation of DTC interpretation services will face serious First Amendment scrutiny. Part V offers a risk-based stratification approach to regulate largescale genetic and genomic information as a medical device—treating interpretation of large-scale genetic data and genomic sequences as a compilation of smaller products as opposed to a single device. This would allow FDA to continue its regulatory focus on genetic interpretation that carries the greatest possible risk to the consumer (such as analyzing genes associated with diagnosing a predisposition to breast cancer for which individuals could seek out risky medical interventions such as mastectomy) without allocating time and energy to genetic interpretation that carries little to no risk (such as analyzing genes associated with earwax type). FDA has made clear that it will treat DTC genetic tests, including individual components used to produce patient-specific information, as medical devices falling under its regulations—and that labeling these devices as for educational or research use only while marketing them for health-related indications or knowingly selling them to companies will not shield the manufacturer from enforcement. Also, although FDA might consider some genetic tests as falling into lowerrisk regulatory categories, a manufacturer’s decision not to validate or substantiate individual tests might result in an entire genetic or genomic interpretation device being classified in a higher-risk regulatory category, thereby requiring full FDA premarket approval. However, as companies continue to bifurcate into entities that produce data- or information-only products, including entities that provide Internet-based, open-source genetic and genomic interpretation, FDA will face increasing difficulty enforcing its medical device regulations as typically done. If FDA and the DTC industry approach large-scale genetic and genomic interpretation as a compilation of discrete genetic tests, they can address the riskiest aspects of the product without allowing the evolving field to overwhelm current quality assurances and without limiting consumer access to accurate and valid genetic information
Big data, ethics, and regulations: Implications for consent in the learning health system
Get PDFPeer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/146311/1/mp12707_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/146311/2/mp12707.pd
Going Beyond Counting First Authors in Author Co-citation Analysis
Get PDFThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Get PDF“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Get PDFWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
Dispelling the Myths Behind First-author Citation Counts
Get PDFWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
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