Pharmaceuticals have benefitted countless lives. New therapies are being developed every day—many prove effective, but many do not. In order to ensure only safe and effective drugs enter the market, the United States' Food and Drug Administration (FDA) approves each treatment based on data garnered from clinical trials. Clinical trials take time, however, and investigational new drugs (INDs) can demonstrate signs of efficacy long before approval. These cases introduce a fundamental question: should the government limit patient access to a drug that has yet to be proven safe and effective? Or do patients have the right to freedom from governmental intervention in their medical decision-making? In this paper, the history of IND regulation will be explored, followed by an examination of the freedom to access from constitutional, ethical, and infrastructural perspectives. Changes to the current system will then be proposed.

Thesis (Ph. D.)--Ohio State University, 2001. / Includes vita. Includes bibliographical references (leaves 588-604). Available online via OhioLINK's ETD Center.

Informed consent procedures are an essential part of the ethical conduct of research, including clinical trials. The principle of autonomy justifies this process. However, it is clear that conventional assumptions about autonomy offer limited guidance in many countries where clinical research on non-Western populations is conducted by Western researchers. Beginning with a brief review of conventional approaches to autonomy, the present research explored feminist alternatives to this principle, drawn from self-in-relation and care theories. / Thesis (M.A.) - University of KwaZulu-Natal, Pietermaritzburg, 2006.

The most ordinary man or woman has means of knowledge concerning his own feelings and circumstances that immeasurably surpass those that anyone else can have.-John Stuart Mill, On Liberty / One feature that varies within competing conceptions of medical shared decision-making is how a patient's values are to be engaged by a physician. One detail that can be overlooked under "shared" decision-making is whether or not a physician ought (or be allowed) to attempt to persuade the patient to adopt particular health-related values. Some argue that it is incumbent on a physician to share her privileged understanding of medicine so as to help her patient embrace "better" values. This thesis argues that it is dangerous to patient autonomy for a physician to exert moral suasion on her patient to attempt to influence or change those values; the danger lies in the power imbalance between patients and physicians that seems inherent in medical encounters, and is exacerbated by the sick role. Thus, while a physician ought to help her patient articulate his health-related values, she ought not try to change them.

Advance Care Planning has been advocated for over 20 years as a way in which individuals who are no longer able to speak for themselves, may still convey their preferences regarding a wide of array of decisions, including medical care. Advance care planning may not be initiated by individuals for many reasons, and even when initiated, may not be specific enough to help guide decision making. Recent advance care planning models have utilized disease specific information to help guide end of life health care decision-making. Persons diagnosed with mild cognitive impairment face an increased possibility of developing dementia at some point in the future, but may retain decision making capability for a window of time, and thus the opportunity to participate in advance care planning. The advance care planning experiences of individuals with mild cognitive impairment have not been extensively studied. This study explored the advance care planning experiences of persons with mild cognitive impairment and their care partners' understanding and views of advance care planning, and if the diagnosis of mild cognitive impairment affects the advance care planning practices of these two groups. A convenience sample of 10 individuals with mild cognitive impairment and their 10 care partners (n=20) were recruited and interviewed. Using a grounded theory qualitative analysis approach, four themes were identified (1) decreased awareness regarding advance care planning from individuals with mild cognitive impairment versus a heightened awareness for the care partners; 2) the preference for comfort care measures only; 3) preferences for future end of life healthcare decisions largely influenced by previous end of life experiences with family and friends; and 4) lack of discussion of end of life healthcare decisions related to dementia and/or artificial nutrition and hydration by physicians or other healthcare providers. In addition two latent themes emerged including from the care partners, the importance of the mild cognitive impairment support group and lawyers for advance care planning and from both care partners and the mild cognitive impairment participants, trying to maintain autonomy, to `hang on' to self were identified. Study implications include the need for structured advance care planning interventions with individuals diagnosed with mild cognitive impairment to focus on common end of life scenarios, such as whether to use artificial nutrition and hydration, which will require future surrogate decision making.

Bibliography: p. 493-562. / iv, 562 p. ; 30 cm. / Title page, contents and abstract only. The complete thesis in print form is available from the University Library. / Provides a philosophical and theological analysis of health care for aged persons, exploring the ways in which Roman Catholic moral theory might contribute to the development of just health care for aged Australians. / Thesis (Ph.D.)--University of Adelaide, Dept. of Public Health, 1998?

Diss. (sammanfattning) Umeå : Univ., 2008. / Härtill 5 uppsatser.

Zugl.: Frankfurt (Main), Univ., Diss., 2006

Thesis (M.A.)--Indiana University, 2008. / Includes vitae. Department of Philosophy, Indiana University-Purdue University Indianapolis (IUPUI) Advisor(s): Peter H. Schwartz. Includes bibliographical references (leaves 61-66)

Thesis (M.A.)--Trinity Evangelical Divinity School, Deerfield, Ill., 1999. / Abstract. Includes bibliographical references (leaves 98-104).