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- Creators: Arizona State University
- Creators: Lindor, Keith
Description
In the university setting, when a person wants to conduct research that deals with human subjects, they are required to receive the approval of their Institutional Review Board (IRB). This process takes place to ensure the proposed research is ethical and poses minimal risks to the willing subject. In Indian Country, there is a growing trend where American Indian nations are taking control over regulating research that is conducted within their jurisdictional boundaries.
In my thesis, I discuss the historical background that has led to the IRBs academics are familiar within universities they see today. In addition, I discuss the body of literature that addresses IRBs, human subjects, and the debate on which research should or should not be regulated by universities. I will then, critically analyze the established research protocols that exist in Arizona American Indian tribes. I use Darrell Posey's (1996) idea of Community Controlled Research (CCR) as the framework for my analysis. CCR dictates the people of the community decide the ways in which research is conducted. The purpose of my research is to create recommendations that will assist and inform tribes how to either, strengthen their existing protocols, or create a research protocol that will promotes Community Controlled Research.
In my thesis, I discuss the historical background that has led to the IRBs academics are familiar within universities they see today. In addition, I discuss the body of literature that addresses IRBs, human subjects, and the debate on which research should or should not be regulated by universities. I will then, critically analyze the established research protocols that exist in Arizona American Indian tribes. I use Darrell Posey's (1996) idea of Community Controlled Research (CCR) as the framework for my analysis. CCR dictates the people of the community decide the ways in which research is conducted. The purpose of my research is to create recommendations that will assist and inform tribes how to either, strengthen their existing protocols, or create a research protocol that will promotes Community Controlled Research.
ContributorsTom, Naomi (Author) / Vicenti Carpio, Myla (Thesis advisor) / Killsback, Leo (Committee member) / Tippeconnic, John (Committee member) / Arizona State University (Publisher)
Created2015
Description
This paper will chronicle my personal experience in trying to design and initiate a retrospective patient data study to determine the prevalence of Primary Sclerosing Cholangitis (“PSC”) in certain races/ethnic groups in Arizona. This experience will also be the basis for my proposed roadmap for a more successful future study.
My nearly 10 month thesis project of trying to complete a study yielded considerable ‘learning opportunities’ in large part due to my inexperience. I made numerous errors in sequencing tasks, grossly under-scoping elapsed time and hours for other tasks, completely overlooking other critical tasks, and being insensitive to how irrelevant I and my project were to the many professionals whose help I needed to complete the study. Based upon the knowledge I gained through this process, I will describe the design of a future study of retrospective patient data that will assess whether PSC patients in Phoenix, Arizona follow racial/ethnic trends. I chose Phoenix as an ideal location to perform this proposed study because of the diverse racial/ethnic population in the greater Phoenix area. The goal will be to obtain and review 20 years of retrospective patient data from three large hospital groups in Phoenix, identify the races/ethnicities of PSC patients, and quantify the prevalence and incidence of PSC in such races/ethnicities. The lack of IRB uniformity among the subject hospitals/clinics will pose a challenge, but a detailed outline of how to approach the IRB approval process and obtain PSC patient data from each institution is provided.
My nearly 10 month thesis project of trying to complete a study yielded considerable ‘learning opportunities’ in large part due to my inexperience. I made numerous errors in sequencing tasks, grossly under-scoping elapsed time and hours for other tasks, completely overlooking other critical tasks, and being insensitive to how irrelevant I and my project were to the many professionals whose help I needed to complete the study. Based upon the knowledge I gained through this process, I will describe the design of a future study of retrospective patient data that will assess whether PSC patients in Phoenix, Arizona follow racial/ethnic trends. I chose Phoenix as an ideal location to perform this proposed study because of the diverse racial/ethnic population in the greater Phoenix area. The goal will be to obtain and review 20 years of retrospective patient data from three large hospital groups in Phoenix, identify the races/ethnicities of PSC patients, and quantify the prevalence and incidence of PSC in such races/ethnicities. The lack of IRB uniformity among the subject hospitals/clinics will pose a challenge, but a detailed outline of how to approach the IRB approval process and obtain PSC patient data from each institution is provided.
ContributorsBuness, James Gage (Author) / Lindor, Keith (Thesis director) / Ali, Ahmad (Committee member) / School of Life Sciences (Contributor) / Barrett, The Honors College (Contributor)
Created2016-12
Description
Making significant progress on the U.N. Sustainable Development Goals (SDGs) needs change agents equipped with key competencies in sustainability. While thousands of sustainability programs have emerged at various educational levels over the past decade, there is, as of yet, no reliable way to assess if these programs successfully convey key competencies in sustainability. This dissertation contributes to addressing this gap in three ways. First, it reviews the body of work on key competencies in sustainability. Based on broad agreement around five key competencies as well as an emerging set of three, an extended framework is outlined that can be used as unified set of learning objectives across sustainability programs. The next chapter reviews the scholarly work on assessing sustainability competencies. Based on this review, a typology of assessment tools is proposed offering guidance to both educators and researchers. Finally, drawing on experience of the four-year “Educating Future Change Agents” project, the last chapter explores the results from a diverse set of competency assessments in numerous courses. The study appraises assessment practices and results to demonstrate opportunities and challenges in the current state of assessing key competencies in sustainability. The results of this doctoral thesis are expected to make a practical and scholarly contribution to the teaching and learning in sustainability programs, in particular with regards to reliably assessing key competencies in sustainability.
ContributorsRedman, Aaron (Author) / Wiek, Arnim (Thesis advisor) / Barth, Matthias (Committee member) / Basile, George (Committee member) / Fischer, Daniel (Committee member) / Mochizuki, Yoko (Committee member) / Arizona State University (Publisher)
Created2020
Description
In 2014, the Centers for Medicare and Medicaid Services (CMS), which oversees the federal Clinical Laboratories Improvement Amendments (CLIA) program, issued guidance that the CLIA requirements apply when researchers seek to return individual-level research findings to study participants or their physician (Centers for Medicare & Medicaid Services, 2014). The present study explores the stance of U.S. Institutional Review Boards (IRBs) toward the applicability of and compliance with the CLIA regulations when studies plan to return individual research results (RIRR). I performed a document content analysis of 73 IRB policies and supporting documents from 30 United States (U.S.) institutions funded for biomedical research by the National Institutes of Health in 2017. Documents analyzed included policies, procedures, guidance, protocol and consent templates, and miscellaneous documents (such as IRB presentations) found to address the RIRR to study participants. I used qualitative content and document analysis to identify themes across institutions related to the CLIA regulations and the RIRR. Basic descriptive statistics were used to represent the data quantitatively. The study found that 96.67% (n=29) of institutions had documents that addressed the RIRR to participants. The majority of the institutions had at least one document that referenced the CLIA regulations when discussing the practice of disclosing participant-specific results [76.67% (n=23)]. The majority of institutions [56.67% (n=17)] indicated that they require compliance with the CLIA regulations for returning individual study findings to participants, while 13.33% (n=4) recommended compliance. The intent of two (6.67%) institutions was vague or unclear, while seven (26.67%) institutions were silent on the topic altogether. Of the 23 institutions that referenced “CLIA” in their documents, 52.17% only mentioned CLIA in a one or two-sentence blurb, providing very little guidance to investigators. The study results provide evidence that the majority of U.S. biomedical institutions require or recommend compliance with CLIA stipulations when investigators intend to return individual research results to study participants. However, the data indicates there is heterogeneity and variation in the quality of the guidance provided.
ContributorsBuchholtz, Stephanie (Author) / Robert, Jason S. (Thesis advisor) / Ellison, Karin D. (Committee member) / Carpten, John D. (Committee member) / Craig, David W. (Committee member) / Marchant, Gary E. (Committee member) / Arizona State University (Publisher)
Created2021
Description
Medicine is evolving at an accelerating rate. The needs of the future in medicine are different than the needs of today. With many possible outcomes for the future of medicine, researchers and physicians have tried to predict the future for particular fields. As new healthcare workers enter the medical field, their training must be tailored to provide the best education to prepare healthcare workers for their careers. Therefore, it is imperative to take a closer look into the future in order to better decide how to train doctors, nurses, PA’s, etc. effectively to provide the best care possible.
ContributorsHewlett, Jessica Lynn (Author) / Sklar, David (Thesis director) / Lindor, Keith (Committee member) / College of Health Solutions (Contributor) / Barrett, The Honors College (Contributor)
Created2020-05