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A History and Analysis of Drug Labeling Policy for Pregnant and Lactating Women and Women's Involvement in Clinical Drug Research from 1970 to 2014

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The inherent risk in testing drugs has been hotly debated since the government first started regulating the drug industry in the early 1900s. Who can assume the risks associated with trying new pharmaceuticals is unclear when looked at through society's

The inherent risk in testing drugs has been hotly debated since the government first started regulating the drug industry in the early 1900s. Who can assume the risks associated with trying new pharmaceuticals is unclear when looked at through society's lens. In the mid twentieth century, the US Food and Drug Administration (FDA) published several guidance documents encouraging researchers to exclude women from early clinical drug research. The motivation to publish those documents and the subsequent guidance documents in which the FDA and other regulatory offices established their standpoints on women in drug research may have been connected to current events at the time. The problem of whether women should be involved in drug research is a question of who can assume risk and who is responsible for disseminating what specific kinds of information. The problem tends to be framed as one that juxtaposes the health of women and fetuses and sets their health as in opposition. That opposition, coupled with the inherent uncertainty in testing drugs, provides for a complex set of issues surrounding consent and access to information.

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2018-05

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The Market For Bodies: Investigating the Landscape of Nontransplant Anatomical Donation Organizations

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While there is extensive information available about organizations that receive donated organs for transplant, much less is known about those that accept tissue and whole bodies for medical education and research. Throughout the United States, nontransplant anatomical donation organizations exist

While there is extensive information available about organizations that receive donated organs for transplant, much less is known about those that accept tissue and whole bodies for medical education and research. Throughout the United States, nontransplant anatomical donation organizations exist within an ambiguous sector of the donation industry, unencumbered by federal regulations. Although these companies adhere to the Uniform Anatomical Gift Act, the lack of a single entity responsible for overseeing their operations has led to public skepticism and animosity among competing businesses. Legislation has the potential to legitimize the industry. For it to be successful, however, the intricacies of a complex market that deals directly with the movement of human remains and intangible issues of human integrity and morality, must be thoroughly understood.

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2015-05

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Diagnosing Autism Spectrum Disorder: Implications for Research, Medicine, and Patients

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Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental disorder that is becoming increasingly common. Autism does not yet have a known etiology, nor a definitive diagnostic test, thus making diagnosis a difficult and rarely uniform task. Currently, ASD is behaviorally

Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental disorder that is becoming increasingly common. Autism does not yet have a known etiology, nor a definitive diagnostic test, thus making diagnosis a difficult and rarely uniform task. Currently, ASD is behaviorally diagnosed based on criteria defined by the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders (DSM). Recently, a change was made in the criteria from more lenient criteria in DSM-IV-TR, to more narrow criteria laid out by the DSM-V, which supersedes the DSM-IV-TR. This drastic change raised many questions and debates about which set of criteria are better. The more lenient criteria offers a more inclusive diagnosis giving greater access to therapies; while the narrow diagnostic criteria excludes some individuals, creating a more uniform diagnosis that's easier to use in research. This thesis analyzes the change in diagnostic criteria from the DSM-IV-TR to the DSM-V and the effects of these changes on the practices of diagnosis. In addition, it explores the implications of this change for the families of children with autism and for those involved in autism research, examining their respective opinions and interests pertaining to narrow verses broad diagnostic criteria. Building on this analysis, the thesis offers recommendations about diagnostic criteria should be set. It argues that the wellbeing of patients takes priority over the interests of researchers, and thus diagnosis should be done in a way that offers the best prognosis for all children who suffer from autistic symptoms.

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2016-12