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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 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.
ContributorsMeek, Caroline Jane (Author) / Maienschein, Jane (Thesis director) / Brian, Jennifer (Committee member) / School of Life Sciences (Contributor) / Sanford School of Social and Family Dynamics (Contributor) / Barrett, The Honors College (Contributor)
Created2018-05
Description
This project will explain the positive impact and effectiveness of Sarbanes-Oxley on corporate responsibility, and through that lens, examine how to make certain subchapters of Title 42, "the Sunshine Act", concerning healthcare fund tracking more transparent and without conflicts of interest. There will be an analysis of the implementation of the Sarbanes-Oxley Act in corporate America and the impact it had on corporate responsibility. There will be a comprehensive review of the history of both the Sarbanes-Oxley Act and the Sunshine Act, along with their origins, stakeholders, and impact on their respective industries. Suggestions to improve certain current United States Code subchapters and subsequent regulations will be announced considering the success that has come from Section 404 of Sarbanes-Oxley.
ContributorsRogers, Anne Marie (Author) / Brian, Jennifer (Thesis director) / Agne, Sara (Committee member) / School of Accountancy (Contributor) / Hugh Downs School of Human Communication (Contributor) / Barrett, The Honors College (Contributor)
Created2017-05
Description
Given its impact on the accounting profession and public corporations, Sarbanes-Oxley Act of 2002(SOX) is a widely researched regulation among accounting scholars. Research typically focuses on the impact it has had on corporations, executives and auditors, however, there is limited research that illustrates the impact SOX may have on average Americans. There were several US criminal code sections that resulted from the passing of SOX. Statute 1519, which is often referred to as the "anti-shredding provision", penalizes anyone who "knowingly alters, destroys, mutilates, conceals, covers up, falsifies, or makes a false entry in any record, document, or tangible object with the intent to" obstruct a current or foreseeable federal investigation. This statute, although intended to punish behavior similar to that which occurred in the early 2000s by corporations and auditors, has been used to charge people beyond its original intent. Several issues with the crafting of the statute cause its broad application and some litigation even reached the Supreme Court due to its vague wording. Not only is the statute being applied beyond the intent, there are other issues that legal scholars have critiqued it for. This statute is far from being the only law facing these issues as the same issues and critiques are found in the 14th amendment. Rewriting the statute seems to be the most effective way to address the concerns of judges, lawyers and defendants regarding the statute. In addition, Congress could have passed this statute outside of SOX to avoid being seen as overreaching if obstruction of justice related to documents was actually an issue outside of corporate fraud.
ContributorsGonzalez, Joana (Author) / Samuelson, Melissa (Thesis director) / Lowe, Jordan (Committee member) / School of Accountancy (Contributor) / Barrett, The Honors College (Contributor)
Created2016-12
Description
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.
ContributorsBremer, Michelle Nichole (Author) / Hurlbut, Ben (Thesis director) / Robert, Jason (Committee member) / Brian, Jennifer (Committee member) / School of Life Sciences (Contributor) / Barrett, The Honors College (Contributor)
Created2016-12