<p> <b>Introduction:</b> Human biospecimens such as surgical tissue and blood are essential for some types of biomedical research because they contain genetic material (genes contained in living organisms). Because of their genetic content, biospecimens are able to add great value to fields of study such as genomics, molecular biology and biological chemistry. Increasing knowledge in these fields holds promise for improving healthcare for individual patients (precision medicine), as well as the broader healthcare community. These genetic materials obtained from patient donors are procured, stored and dispersed through a complex operation called biobanking. Biobanking systems are involved with two primary functions, 1) procure sufficient quantities of human biospecimens allowing researchers the materials required to answer scientific questions, and 2) capture relevant corresponding clinical and phenotypic information for eventual correlation with scientific results. This capture and manipulation of corresponding information (e.g. clinical, pathological, and environmental) are where the value of the biospecimens are maximized for research purposes. The complexity of biobanking requires informatics to integrate the biospecimen-related information with corresponding clinical and phenotypic data. In designing biobanking systems, informatics must be considered as they play a vital role in managing the samples and data in a timely fashion as well as reducing the costs associated with biobanking. </p><p> <b>Background:</b> Biobanks are resources that play a key role in the procurement, processing, storage and dispersal of human biospecimens. Collections of human tissue have been a common place in hospitals and specialist clinics since the nineteenth century when preservation techniques were introduced. Governance concerning these human biobanks has evolved and is set by institutional, regional, national and international policy. They can be public (e.g. non-profit, academic, governmental), private (e.g. for-profit or pharmaceutical industry) or public-private partnerships. Regardless of the governance level or specific research focus of the biobank, the next generation of biobanking resources will require interdisciplinary collaborations and integrated informatics approaches to accelerate the procurement and use of the research biospecimens. </p><p> <b>Methods:</b> A literature search was conducted to explore biobanking informatics configurations and architecture to determine the context and extent of the software applications utilized in current biobanking systems. There were a substantial number of publications describing informatics architecture and their export of data to a Virtual Data Warehouse or Centralized Research Data Repository. However, there was a lack of published literature specifically describing use of an enterprise-wide electronic health record (EHR) in the initial three upstream workflows (i.e. clinical, pathology and biobank) involved with most institutional biobanking systems. Patient data generated/utilized in these three workflows are manually double-entered into separate information applications as there is no direct data exchange/export between EHR and the Laboratory Information System (LIS) or the Biorepository Information Management System (BIMS) specifically to assist with biobank procurement. Therefore, an EHR integrated-access informatics model was designed that would maximize benefits created by the EHRs capabilities in the upstream workflows of an institutional biobanking system. The approach described in the thesis was designed and documented using a model driven UML tool and incorporates an EHR integrated-access approach along with inter-departmental workflow processes. Interoperability gaps were identified that could take advantage of institutional EHR software existing at most large academic healthcare institutions or teaching hospitals. This model synergistically integrates the EHR, LIS and BIMS to maximize information exchange during the upstream biospecimen procurement workflow. This informatics model for institutional biobanking is based on the premise that commercial software applications are already implemented at most large academic healthcare facilities and they can be utilized within their biobanking systems. </p><p> <b>Conclusion:</b> This EHR integrated-access model would enhance sharing of key research data between three software applications (EHR, LIS, BIMS) that are available at most large academic medical centers that perform research biobanking. The informatics model would promote data exchange between processes of three primary biobanking steps in the clinic, pathology department and biobank improving efficiency and increasing biospecimen procurement. Large healthcare facilities who have EHR, LIS and BIMS applications available could utilize this EHR integrated-access model as a first-step in improving their biobanking informatics workflow to increase high-quality biospecimen collections. New methodologies that improve the success of biobanks can eventually lead to institutional biobanking systems playing a major role in a path to personalized medicine.</p>

<p> Quality citizen participation in processes of policy development is crucial to a democracy interested in equity of voice for all its citizens. Citizens with less political power, however, are often absent from policy development for a variety of reasons, despite legislative and advocacy efforts for inclusion. In policy development processes, community representatives are a mechanism for traditionally marginalized or disadvantaged citizens to have a voice; yet the question remains how to effectively utilize that voice. This question stems from research demonstrating an increase in quantity citizen participation but not in quality citizen participation, which is more interested in the process of policy development as opposed to a final product. To understand quality citizen participation, a critical ethnography guided by a socio-ecological perspective allowing for the investigation of contextual as well as individual factors impacting policy development processes was conducted to assist in advancing knowledge about the best practices necessary to facilitate quality citizen participation in policy development. The policy development process explored in this qualitative study was the context provided by three CHCs in a Midwestern state. Information was gathered about these three CHC boards from multiple sources to best represent the context surrounding participation on the boards and that participation experience from the perspective of board members. The data analyzed included: descriptive statistics of seven counties which comprised the patient community of the three CHCs participating in the study, descriptive statistics of the patient communities of those three CHCs, interviews with national and state policy experts, the clinic directors and board chairs of the three CHCs and interviews with 16 board members of the three CHCs. Analysis of these data identified individual, relational, organizational, community and public policy level factors which impacted the participation of board members of three CHCs. For example, the education and background experiences of board members (individual) as well as relationships between board members and the management teams of the clinics (relational) facilitated the quality of their participation on the boards. Contextual knowledge of economic, political, and cultural factors were discovered for each of the three clinics, and proved important to understanding the quality of participation of board members. </p><p> Social work educators and practitioners will benefit from the advancement of knowledge about what factors facilitate the quality of citizen participation in policy development processes. The results of this study suggest that practitioners interested in empowering consumers to have a role in the provision of services need to understand what facilitates the quality of citizen participation to ensure that consumers have a legitimate voice in policy development and implementation processes. The results of this study also inform our understanding of citizen participation in multiple policy development processes. For example, because legislators will benefit when barriers to the quality of citizen participation are identified, educators teaching social work students about macro practice will have concrete lessons to draw from; practitioners who work with non-elected members of boards will benefit from barrier identification allowing them to assist in the empowerment of future board members engaged in policy development on a wide variety of boards; and finally actual board members, especially those representing traditionally disadvantaged or marginalized communities, will benefit from knowledge gleaned from similar experiences, and educators teaching social work students about the benefits of advocacy and empowerment could assist to make their participation more effective.</p>

<p> The Health Ontology Mapper (HOM) method is a proposed solution to the semantic gap problem. The HOM Method provides the following functionality to enable the scalable deployment of informatics systems involving data from multiple health systems. The HOM method allows a relatively small population of biomedical ontology experts to describe the interpretation and analysis of biomedical information collected at thousands of hospitals via a cloud based terminology server. As such the HOM Method is focused on the scalability of the human talent required for successful informatics projects. The HOM promotes a means of converting UML based medical data into OWL format via a cloud-based method of controlling the data loading process. HOM subscribes to a means of converting data into a HIPAA Limited Data Set format to lower the risk associated with developing large virtual data repositories. HOM also provides a means of allowing access to medical data over grid computing environments by translating all information via a centralized web-based terminology server technology. </p><p> An integrated data repository (IDR) containing aggregations of clinical, biomedical, economic, administrative, and public health data is a key component of research infrastructure, quality improvement and decision support. But most available medical data is encoded using standard data warehouse architecture that employs arbitrary data encoding standards, making queries across disparate repositories difficult. In response to these shortcomings the Health Ontology Mapper (HOM) translates terminologies into formal data encoding standards without altering the underlying source data. The HOM method promotes inter-institutional data sharing and research collaboration, and will ultimately lower the barrier to developing and using an IDR.</p>

<p> One of the core strategies to transform the United States national healthcare system is the implementation of key technologies such as the electronic patient medical record. Such key technologies improve patient care and help the organization gain competitive advantage. With a high demand for strategic and operational change, healthcare providers are turning to their own internal Healthcare Information Technology (HIT) for integrated technology solutions (e.g., clinical systems, robotics, infrastructure) in order to reduce costs, improve patient care, and unlock new value through innovation. Due to the overreliance on advanced technology solutions for revamping the US Healthcare System, the role of internal HIT needs to evolve into that of an effective strategic business change partner. As such, the purpose of this study was to test an a priori conceptual model of five competencies that would enable HIT to be an effective strategic business change partner. An on-line survey instrument was used to collect data from hospitals across the country and the data was analyzed through quantitative methods. Results suggest that the perception of internal healthcare information technology (HIT) organizations as an effective strategic business change partner is determined by its competence as a <i>Healthcare Strategists, Change Driver, Collaborator, Agile Leader, and Technology Service Provider. </i></p>

This project is an ethnographic investigation of the practices and professional identities of clinical bioethicists working in Canadian and American hospitals. Data collected over a three-year period (September 2000--February 2004) included participant-observation, interviews and the author's own experience working as a clinical bioethicist. Specifically, the author queries the tropes conventionally utilized by clinical bioethicists to describe their emergent profession. Chapter Two examines the trope of the ethics consultant as the paradigmatic moral agent within health care institutions by conceptualizing clinical bioethics as a form of labor, and its practitioners as subjects situated within particular institutions, political economies, social norms and culturally-marked bodies. Chapter Three examines the trope of the clinical bioethicist as an "ethics facilitator" in the practice of ethics consultation through analysis of the emerging standards in ethics consultation, and the opening statements of actual consults. Chapter Four queries the trope of the clinical bioethicist as "cultural broker" by examining the tension between pluralism and normativity in both the clinical bioethics literature and the discourse of ethics consultations. By documenting and analyzing the work of clinical bioethicists ethnographically, this project renders a phenomenology of this emergent profession, as well as a meditation on moral agency within institutional contexts.

This dissertation is comprised of three separate essays that share a similar theme: physician private practices. The first essay revisits prior research that has proposed a general framework for physician cost function estimation. The econometric specification is a multi-product cost function, and my model addresses and deals with many measurement problems and data complications in physician practice surveys. In particular, I expand upon existing theory to include those practices that yield zero outputs. This modification allows allow me to utilize a more representative and larger sample. The results of my analysis confirm that previous estimates have yielded a downward bias in reported marginal cost estimates, a point often speculated in the literature but not formally addressed empirically. The second essay uses the econometric specification from the first essay to develop a means for testing market power in physician private practices. Using the 1998 American Medical Association Physician Socioeconomic Monitoring Survey, I test the hypothesis of physician collusion in an oligopolistic setting for five fields of specialty. The collusion hypothesis is tested in a traditional conjectural-variation framework that reveals physicians are not highly collusive. However, a Lerner index shows that physicians do possess a high degree of monopoly power, consistent with many of the claims brought forward by the Department of Justice, primarily due to consumer price insensitivity. The third essay uses the marginal cost estimates of the second paper to revisit the Harberger partial equilibrium approach for computing welfare loss. Deadweight loss estimates are computed by physician, practice, and office visit. The reported losses are indicative of a loss in consumer surplus from the monopoly power that physicians possessed in 1998. The third essay concludes by showing that significant price markups led to substantial losses in welfare by the consumer and third-party payer.

It has been argued that the rationing of medical resources effected by managed care organizations violates the philosophical doctrine of informed consent, which is linked to the principle of respect for patient autonomy. Two models which purport to protect patient autonomy, in consonance with the doctrine of informed consent, and in the face of institutional rationing decisions, via prior disclosure, are examined. It is found that the 'prior global consent' model is less effective at preserving patient autonomy through prior disclosure than is the 'waiver of informed consent' model. The immediate conclusion for managed care is that institutional rationing need not be antithetical to the doctrine of informed consent. The broader philosophical conclusion is that the hierarchical notion of autonomy espoused by the 'waiver' model is, in some cases, more effective than the integrated notion espoused by the 'global consent' model.

Standard approaches to the ethics of managed care fail to capture the complexity of the phenomenon. In particular, the view that managed care aligns with the business side of a fundamental dichotomy between medicine and business is an obstacle to nuanced analysis and to the construction of an ethic that addresses organizations. A version of pragmatism derived from the work of John Dewey is one basis for a more adequate analysis of the ethics of managed care: a method of inquiry oriented to practice, a compelling social vision of democracy and community, a moral psychology built around a holistic concept of individual character, and an appreciation of the importance of organizations as agencies of character formation. Dewey's concept of character can also be applied to organizations, capturing the total complex of formal and informal structures in their internal relations, and in their relations with the external environment. Deweyan pragmatism provides the tools for an analysis of organizational virtues and an evaluation of organizational structures. This analysis is completed in a case study or "character study" of the way in which virtues are displayed and structures are fitted together in the life of a managed care organization, Kaiser Permanente. Kaiser is not free of ethical problems, but it illustrates some of the ways in which some forms of managed care might improve health and health care and contribute to the development of democracy and community.

Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results. / In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the results of an examination of eligibility criteria in two sets of clinical trials, one sponsored by the NSABP, the other sponsored by POG, covering a twenty-year time span are presented. The POG trials had far fewer eligibility criteria than the NSABP studies, suggesting that large numbers of criteria may not be necessary for high quality research. In the third chapter, the impact of subjective eligibility criteria on enrollment and investigator uncertainty is explored. Subjective criteria were associated with more variable enrollment decisions and greater uncertainty. Such criteria represent a threat to the validity, conduct and interpretation of trials and, therefore, should only be included when carefully justified. The fourth chapter examines the accuracy of the reporting of eligibility criteria in sets of corresponding study protocol, methods paper, journal article, and Clinical Alert. Important information is lost at each step in the dissemination of study results. Unnecessary criteria ought to be dropped at a trial's inception; all other criteria must be reported faithfully. The fifth chapter attempts to provide a comprehensive philosophical account of just selection procedures for clinical research using the political philosophy of Michael Walzer. The sixth, and last, chapter, discusses explanatory and pragmatic approaches to clinical trial design, overlapping scientific and ethical concerns related to eligibility criteria, and questions for further study.

Biomedical ethics gave birth to different kinds of ethics committees which pursue essentially a better understanding of the multidisciplinary problems it raises. The present thesis will first elucidate the legal implications related to the emergence of those committees. These preliminary considerations will show the topicality of those legal aspects as to hospital ethics committees. The author will then focus on the potential civil liability of all actors evolving within the hospital setting for the participation of those committees in the medical decision making process. In theory, this participation could arguably entail rather easily the liability of the health care providers and of the hospitals. The ethics committees, on the contrary, seem to be more protected. This thesis suggests nonetheless that the obligations related to the participation of the ethics committees to the medical decision making process are significant. Hence, it stands to reason that the creation of ethics committees should be evaluated with care. The conviction that the ethics committees will protect the health care providers from malpractice suits appears to be incorrect in any event.