Matching Items (21)
Description
ABSTRACT Whole genome sequencing (WGS) and whole exome sequencing (WES) are two comprehensive genomic tests which use next-generation sequencing technology to sequence most of the 3.2 billion base pairs in a human genome (WGS) or many of the estimated 22,000 protein-coding genes in the genome (WES). The promises offered from WGS/WES are: to identify suspected yet unidentified genetic diseases, to characterize the genomic mutations in a tumor to identify targeted therapeutic agents and, to predict future diseases with the hope of promoting disease prevention strategies and/or offering early treatment. Promises notwithstanding, sequencing a human genome presents several interrelated challenges: how to adequately analyze, interpret, store, reanalyze and apply an unprecedented amount of genomic data (with uncertain clinical utility) to patient care? In addition, genomic data has the potential to become integral for improving the medical care of an individual and their family, years after a genome is sequenced. Current informed consent protocols do not adequately address the unique challenges and complexities inherent to the process of WGS/WES. This dissertation constructs a novel informed consent process for individuals considering WGS/WES, capable of fulfilling both legal and ethical requirements of medical consent while addressing the intricacies of WGS/WES, ultimately resulting in a more effective consenting experience. To better understand components of an effective consenting experience, the first part of this dissertation traces the historical origin of the informed consent process to identify the motivations, rationales and institutional commitments that sustain our current consenting protocols for genetic testing. After understanding the underlying commitments that shape our current informed consent protocols, I discuss the effectiveness of the informed consent process from an ethical and legal standpoint. I illustrate how WGS/WES introduces new complexities to the informed consent process and assess whether informed consent protocols proposed for WGS/WES address these complexities. The last section of this dissertation describes a novel informed consent process for WGS/WES, constructed from the original ethical intent of informed consent, analysis of existing informed consent protocols, and my own observations as a genetic counselor for what constitutes an effective consenting experience.
ContributorsHunt, Katherine (Author) / Hurlbut, J. Benjamin (Thesis advisor) / Robert, Jason S. (Thesis advisor) / Maienschein, Jane (Committee member) / Northfelt, Donald W. (Committee member) / Marchant, Gary (Committee member) / Ellison, Karin (Committee member) / Arizona State University (Publisher)
Created2013
Description
Lung Cancer Alliance, a nonprofit organization, released the "No One Deserves to Die" advertising campaign in June 2012. The campaign visuals presented a clean, simple message to the public: the stigma associated with lung cancer drives marginalization of lung cancer patients. Lung Cancer Alliance (LCA) asserts that negative public attitude toward lung cancer stems from unacknowledged moral judgments that generate 'stigma.' The campaign materials are meant to expose and challenge these common public category-making processes that occur when subconsciously evaluating lung cancer patients. These processes involve comparison, perception of difference, and exclusion. The campaign implies that society sees suffering of lung cancer patients as indicative of moral failure, thus, not warranting assistance from society, which leads to marginalization of the diseased. Attributing to society a morally laden view of the disease, the campaign extends this view to its logical end and makes it explicit: lung cancer patients no longer deserve to live because they themselves caused the disease (by smoking). This judgment and resulting marginalization is, according to LCA, evident in the ways lung cancer patients are marginalized relative to other diseases via minimal research funding, high- mortality rates and low awareness of the disease. Therefore, society commits an injustice against those with lung cancer. This research analyzes the relationship between disease, identity-making, and responsibilities within society as represented by this stigma framework. LCA asserts that society understands lung cancer in terms of stigma, and advocates that society's understanding of lung cancer should be shifted from a stigma framework toward a medical framework. Analysis of identity-making and responsibility encoded in both frameworks contributes to evaluation of the significance of reframing this disease. One aim of this thesis is to explore the relationship between these frameworks in medical sociology. The results show a complex interaction that suggest trading one frame for another will not destigmatize the lung cancer patient. Those interactions cause tangible harms, such as high mortality rates, and there are important implications for other communities that experience a stigmatized disease.
ContributorsCalvelage, Victoria (Author) / Hurlbut, J. Benjamin (Thesis advisor) / Maienschein, Jane (Committee member) / Ellison, Karin (Committee member) / Arizona State University (Publisher)
Created2013
Description
Telehealth is the use of information and communications technology by healthcare professionals to provide care to patients. When this technology is being used specifically for genetic services, it is called telegenetics. Previous studies that examine the small-scale use of telegenetics for the field of genetic counseling have shown that the technology may provide a way to address the problem of patient access to genetic counseling services, assuming its efficacy. Patients are satisfied with telegenetics, but genetic counselors hold more reservations. Because of this and the many regulatory barriers in its way, telegenetics was only slowly being adopted when the coronavirus was declared a pandemic in March 2020. The pandemic forced a switch to telegenetics at a scale never seen before. This study begins with a literature review to assess the situation of telegenetics before and during the pandemic. It then surveys practicing genetic counselors in Arizona in order to reveal what they think about telegenetics when it is the encouraged, and sometimes only, modality. Since the literature review revealed that genetic counselors, not patients, are the ones with concerns, it is important to hear their points of view. This study reveals that genetic counselors want telegenetics as an option but not as a replacement for in-person appointments. All respondents agreed that increased patient access is the main benefit of telegenetics. There are reported challenges that must be overcome, but genetic counselors in Arizona overwhelming believe that telegenetics use will be continued in the future.
ContributorsThornton, Gillian Frances (Author) / Hunt Brendish, Katherine (Thesis director) / Frow, Emma (Committee member) / School of International Letters and Cultures (Contributor) / School of Life Sciences (Contributor) / Barrett, The Honors College (Contributor)
Created2021-05
Description
This thesis explores and analyzes the emergence of for-profit stem cell clinics in the United States, specifically in the Phoenix metropolitan area. Stem cell therapy is an emerging field that has great potential in preventing or treating a number of diseases. Certain companies are currently researching the application of stem cells as therapeutics. At present the FDA has only approved one stem cell-based product; however, there are a number of companies currently offering stem cell therapies. In the past five years, most news articles discussing these companies offering stem cell treatments talk of clinics in other countries. Recently, there seems to be a number of stem cell clinics appearing in the United States. Using a web search engine, fourteen stem cell clinics were identified and analyzed in the Phoenix metropolitan area. Each clinic was analyzed by their four key characteristics: business operations, stem cell types, stem cell isolation methods, and their position with the FDA. Based off my analysis, most of the identified clinics are located in Scottsdale or Phoenix. Some of these clinics even share the same location as another medical practice. Each of the fourteen clinics treat more than one type of health condition. The stem clinics make use of four stem cell types and three different isolation methods to obtain the stem cells. The doctors running these clinics almost always treat health conditions outside of their expertise. Some of these clinics even claim they are not subject to FDA regulation.
ContributorsAmrelia, Divya Vikas (Author) / Brafman, David (Thesis director) / Frow, Emma (Committee member) / Harrington Bioengineering Program (Contributor) / Barrett, The Honors College (Contributor)
Created2016-05
Description
Within the last decade, there has been a lot of hype surrounding the potential medical applications of artificial intelligence (AI) and machine learning (ML) technologies. During the same timespan, big tech companies such as Microsoft, Apple, Amazon, and Google have entered the healthcare market as developers of health-based AI and ML technologies. This project aims to create a comprehensive map of the existing health-AI market landscape for the standard biotech reader and to provide a critical commentary on the existing market structure.
ContributorsWehelie, Sumayah A (Author) / Frow, Emma (Thesis director) / Maynard, Andrew (Committee member) / Harrington Bioengineering Program (Contributor) / Barrett, The Honors College (Contributor)
Created2021-05
Description
Homeopathy is a brand of alternative medicine that has enjoyed a unique form of regulation for many years. This work aims to understand the regulation of homeopathic drugs in the United States by performing a literature review focused on three fronts: (i) homeopathy (theory, history in the United States and criticisms), (ii) U.S Food and Drug Administration (history and relationship to homeopathy), and (iii) interpretation of the law through reading guidance documents and the Code of Federal Regulations.
In 2015, the FDA began a process to reevaluate and update the regulations surrounding homeopathic products to better fit their present risk-based model. Past regulations were set in 1938; and as the world evolved, these have been found to set inadequate standards. By reviewing the agency’s guidance drafts and core regulatory documents, we come to understand that these changes are motivated by a desire for homeopathic remedies to follow high standards that apply to other products for the benefit of the U.S. consumers. FDA has made significant advances by proposing new Guidances on homeopathic products, listening to homeopathic community and consumers, and withdrawing the Compliance Policy Guide 400.400 issued in 1988.
We recommend for homeopathic manufacturers and practitioners to see the FDA as an ally and cooperate fully with the proposed changes for the regulation the agency gives out. Doing so will give the homeopathic community the best chance at continuing to sell their products and reach their consumers in the United States. In the same token, the FDA should do their best to involve homeopathic professionals in some way in this regulatory process, to encourage participation and compliance by the broader homeopathic community. Doing so ensures a climate of teamwork among different facets of the medical community in the United States.
In 2015, the FDA began a process to reevaluate and update the regulations surrounding homeopathic products to better fit their present risk-based model. Past regulations were set in 1938; and as the world evolved, these have been found to set inadequate standards. By reviewing the agency’s guidance drafts and core regulatory documents, we come to understand that these changes are motivated by a desire for homeopathic remedies to follow high standards that apply to other products for the benefit of the U.S. consumers. FDA has made significant advances by proposing new Guidances on homeopathic products, listening to homeopathic community and consumers, and withdrawing the Compliance Policy Guide 400.400 issued in 1988.
We recommend for homeopathic manufacturers and practitioners to see the FDA as an ally and cooperate fully with the proposed changes for the regulation the agency gives out. Doing so will give the homeopathic community the best chance at continuing to sell their products and reach their consumers in the United States. In the same token, the FDA should do their best to involve homeopathic professionals in some way in this regulatory process, to encourage participation and compliance by the broader homeopathic community. Doing so ensures a climate of teamwork among different facets of the medical community in the United States.
ContributorsRobayo, Juan Pablo (Author) / Pizziconi, Vincent (Thesis director) / Feigal, David (Committee member) / Frow, Emma (Committee member) / School of International Letters and Cultures (Contributor) / Harrington Bioengineering Program (Contributor) / Barrett, The Honors College (Contributor)
Created2020-05
Description
This thesis examines congressional discussions of media technologies at two distinct historical moments in order to see how Congress evaluated and sought to regulate technologies with the potential to reshape public modes of thought and communication. Specifically, it examines congressional discussions centered around Television and the Fairness Doctrine, as well as Facebook and the recent scandal involving Cambridge Analytica by asking how Congress has understood what is at stake while attempting to regulate emerging media technologies. Specifically, it probes questions such as: What is assumed about the technologies while attempting to legislate them? What is treated as subject to assessment and revision; what is given priority for consideration over other alternate angles? How do the legal and political contexts in which these discussions are framed impact legislative proceedings and society’s ways of knowing and relating to the world?
While these moments are only a subset of such moments in US history, and Congress is only one of a range of forums in which such political discussions can take place, the thesis focuses on these cases because not only are they important in themselves, but also they reveal issues and approaches that are not unique to these moments. The thesis draws on the on the work of Neil Postman, who argues that the emergence and subsequent dominance of media like television have the capacity to alter the manner in which we think and thus have profound effects on the texture and character of American civic life. In this vein it uses a comparison of how lawmakers attempted to regulate television and social media platforms like Facebook to explore whether and how lawmakers have attended to the capacity of these media to shape public thought.
The thesis demonstrates that understanding of media’s epistemological influence is only ever tacitly acknowledged by lawmakers and is not regarded as an important consideration during evaluative legislative efforts. Instead, Congress tends to focus on matters that are of immediate concern and pragmatic in nature, eclipsing questions about how these technologies fundamentally alter our perceptions of the world and the ways we as individuals and as a society relate to it. By not taking such questions into account during our legislative proceedings, the thesis argues, we cede opportunities to employ and regulate technologies to better serve our cultural ideals and remain susceptible to unwanted forms of cultural erosion mediated by technologies.
While these moments are only a subset of such moments in US history, and Congress is only one of a range of forums in which such political discussions can take place, the thesis focuses on these cases because not only are they important in themselves, but also they reveal issues and approaches that are not unique to these moments. The thesis draws on the on the work of Neil Postman, who argues that the emergence and subsequent dominance of media like television have the capacity to alter the manner in which we think and thus have profound effects on the texture and character of American civic life. In this vein it uses a comparison of how lawmakers attempted to regulate television and social media platforms like Facebook to explore whether and how lawmakers have attended to the capacity of these media to shape public thought.
The thesis demonstrates that understanding of media’s epistemological influence is only ever tacitly acknowledged by lawmakers and is not regarded as an important consideration during evaluative legislative efforts. Instead, Congress tends to focus on matters that are of immediate concern and pragmatic in nature, eclipsing questions about how these technologies fundamentally alter our perceptions of the world and the ways we as individuals and as a society relate to it. By not taking such questions into account during our legislative proceedings, the thesis argues, we cede opportunities to employ and regulate technologies to better serve our cultural ideals and remain susceptible to unwanted forms of cultural erosion mediated by technologies.
ContributorsOberhaus, Jack M (Author) / Hurlbut, J. Benjamin (Thesis director) / Zachary, Gregg (Committee member) / Maienschein, Jane (Committee member) / School of Life Sciences (Contributor) / Barrett, The Honors College (Contributor)
Created2019-05
Description
Genetic engineering, a development in science and technology that has enabled the genetic modification of crops among other organisms since the 1970s, has stirred heated debate among various stakeholders in the issue. This struggle is one consisting of two sides set in their own beliefs, refusing to even consider the validity of any opposition. As a result, it is difficult to establish common ground and attempt to develop policies and practices that can best suit all members involved while still being able to utilize a breakthrough technology in beneficial ways to society. This research project was conducted upon one particular case in the timeline of genetic modification of crops: the introduction of the Rainbow papaya in Hawaii in 1998 and its subsequent ramifications. The goal was to establish a more detailed understanding of the landscape of a debate that can appear to be based mainly upon the science of genetic engineering. Upon analysis of 22 news articles spanning the years 1999-2019 it was determined that the types of arguments themselves, both in favor of and against GM, fall into a wide range of categories that span much more than simply the science. Arguments both in favor and in opposition are nuanced and actually often seek similar end goals. There is potential to utilize these common goals and priorities in productive ways once stakeholders in the debate are aware of them. Finding commonalities will enable progress in the safe, effective implementation of a technology that has the potential to provide immense benefit in various ways in a manner that considers all perspectives involved.
ContributorsCartwright, Avery (Author) / Frow, Emma (Thesis director) / Bowman, Diana (Committee member) / Harrington Bioengineering Program (Contributor) / Barrett, The Honors College (Contributor)
Created2020-05
Description
In this paper, I aim to assess the ethical and policy issues at the forefront of developmental biology, mainly, the 14-day guideline dictating human embryo research. Ever since the invention of in vitro fertilization in the 1970s, the research landscape of human embryo research has been well explored. Now, there are new embryonic technologies and human embryonic stem cell based models that many believe do not fit into current guidelines. This paper analyzes four of these new technologies-- stem cell derived gametes, embryoids, 3D printed embryos and synthetic embryos-- in order to explore the impetus for reopening the debate on the 14-day guideline. The paper then explores current research and research projects while comparing and contrasting science as well as the potential for moral status and how that impacts regulation. Current United States policies and regulations as well as current professional society guidelines are broken down to fully grasp the political landscape surrounding human embryo research. Notably, current policies include the complete lack of a federal definition of an embryo as well as the Dickey-Wicker Amendment which restrict funding for human embryo research. It is thus advised that these, along with the 14 day guideline, are updated in order to encapsulate the early human developmental research landscape and promote research. This paper ends with an in depth policy recommendation including (but not limited to) bill language, suggested definitions and potential strategies.
ContributorsNadone, Haley (Author) / Robert, Jason (Thesis director) / Frow, Emma (Committee member) / School of Life Sciences (Contributor) / School of Politics and Global Studies (Contributor) / Barrett, The Honors College (Contributor)
Created2020-05
Description
The direct-to-consumer (DTC) stem cell industry is a novel industry in the United States offering experimental stem cell treatments to patients with little regulatory oversight. The rapid expansion of this industry over the last decade has drawn attention from a number of stakeholders, and there is heated debate about how the industry should be regulated in order to maintain patient safety and treatment efficacy while also promoting innovation. Since 2009, the U.S. Food and Drug Administration (FDA) has been the main regulatory agency within the DTC stem cell industry, but it has been criticized for not taking stricter action. To develop a better understanding of the regulatory landscape in the DTC stem cell industry, this study provides a thorough analysis of five effective regulatory pathways: Food & Drug Administration (FDA), Federal Trade Commission (FTC), litigation, state legislation, and state medical boards. The operation of these pathways as regulatory agencies separately and together provide a clearer picture of future regulation in the DTC stem cell industry.
ContributorsWilliams, Paige (Author) / Frow, Emma (Thesis director) / Bowman, Diana (Committee member) / School of International Letters and Cultures (Contributor) / School of Human Evolution & Social Change (Contributor) / Barrett, The Honors College (Contributor)
Created2019-05