IU Center for Bioethics Faculty Scholarship
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Item A Conscience Sensitive Approach To Ethics and Teaching Caring Attitudes (presentation)(2005-11-18T16:01:17Z) Gaffney, Margaret M.; Litzelman, D; Galvin, Matthew R.; Stilwell, B; Cottingham, AAn I.U. Conscience Project and HELP Collaboration. The presentation describes models for teaching ethics and caring attitudes to undergraduate medical students in both formal and informal medical education curriculum. Competency based curriculum is discussed.Item A Conscience Sensitive Approach To Ethics and Teaching Caring Attitudes(2005-10) Gaffney, Margaret M.; Galvin, Matthew R.; Stilwell, BAn I.U. Conscience Project and HELP Collaboration. The article describes models for teaching ethics and caring attitudes to undergraduate medical students in both formal and informal medical education curriculum. Competency based curriculum is discussed.Item What Makes International Research Ethical (Or Unethical)?(2006-02-06T16:05:25Z) Meslin, Eric M.First lecture in a series: International Research Ethics. February 3, 2006.Item A Needs Assessment to Build International Research Ethics Capacity at Moi University(University of California Press Caliber (Online service), 2006-06) Sidle, JE; Were, E; Wools-Kaloustian, K; Chuani, C; Salmon, K; Tierney, WM; Meslin, Eric M.International collaborators in biomedical sciences face ethical challenges in the design,review, and conduct of research. Challenges include differences in research ethics capacity, cultural differences in interpretation and application of ethical principles, and cooperation between ethics review boards at collaborating institutions. Indiana University School of Medicine (Indianapolis, USA) and Moi University Faculty of Health Sciences (Eldoret, Kenya)developed a Memorandum of Understanding (MOU) to establish greater cooperation between their ethics review boards, followed by a joint needs assessment to assess barriers to implementing the MOU. Focus groups and interviews at each institution revealed that while each side verbalized understanding and respect for the other's culture, there were misunderstandings deeply rooted in each culture that could potentially derail the collaboration. Although the participants at each university agreed on the major principles and issues in research ethics and on the importance attributed to them, a more in-depth evaluation of the responses revealed important differences. Methods to address these misunderstandings are outlined in the recommended Best Practices.Item What Will It Take to Reap the Clinical Benefits of Pharmacogenomics?(Food & Drug Law Journal, 2006) Evans, Barbara J.Genetically targeted drug and biologic therapies promise a new era of personalized medicine, but there has been frustration with how slowly these therapies are moving from concept to actual clinical application. Various legal and regulatory barriers threaten to delay translation of basic discoveries into approved products and to slow the clinical uptake of new therapeutic products as they become available. There is a pressing need to reach consensus on what these barriers are, so that they can be addressed in a timely and effective manner. This paper explores what some of the key barriers may be. It examines: (1) legal, regulatory, and commercial barriers to “successive improvement” of existing drugs through improved targeting strategies; (2) barriers to cooperative, multi-party development of targeted therapies; (3) methodological problems in assessing the incremental health and economic benefits of an improved targeting strategy; (4) limitations of traditional product labeling as a medium for communicating timely, clear information about drug targeting to clinicians and the need to create new mechanisms within the medical profession to manage and communicate this information; and (5) difficulty defining the appropriate line between regulation of medical products and regulation of medical practice, in the case of targeted therapies.Item The Unfinished Business of US Drug Safety Regulation(Food & Drug Law Journal, 2006) Evans, Barbara J.; Flockhart, David A.Various proposals have been advanced in response to recent problems with the safety of Food and Drug Administration (FDA)-approved drugs. Many call for incremental change, such as new safety oversight bodies or minor expansions of FDA's existing powers. "Fixing" FDA may not fix the problem, without related reform of the broader legal framework in which FDA operates. Key reform challenges include promoting clinical compliance with important safety warnings while preserving needed flexibility for physicians to adapt drug use to the individual patient; developing a clearer distinction between pre- and postapproval safety regulation; and devising mechanisms for funding investments in safety improvements. Until these fundamental problems are addressed, the United States will face ongoing problems with drug safety and patients will be denied the full measure of safety and therapeutic benefit that today's technologies could support. This article proposes a new direction to address these problems in the context of an insurance-based framework for promoting drug safety.Item A proposal for comprehensive biobank research laws to promote translational medicine in Indiana(Indiana University, 2008) Girod, Jennifer; Drabiak, KatherineItem Pediatric assent for a study of antiretroviral therapy dosing for children in western Kenya: a case study in international research collaboration(Regents of the University of California, 2009-03) Vreeman, Rachel C.; Nyandiko, Winstone M.; Meslin, Eric M.Multinational collaborators in health research face particular ethical challenges when conducting studies involving vulnerable populations such as children. We use an example from our first attempt to implement pediatric assent in the context of a longstanding research and clinical partnership between Kenyan and American medical schools to highlight the ethical and procedural issues related to pediatric assent that must be considered for multinational, pediatric studies. We consider relevant domestic, professional, and international guidelines for assent in pediatric research subjects, and we discuss the particular ethical challenges related to pediatric assent in the Kenyan context. Finally, we propose a way forward for approaching pediatric assent within our collaborative research program in Kenya that may apply to other multinational research partnerships.Item Disclosure and rationality: comparative risk information and decision-making about prevention(Theoretical medicine and bioethics, 2009) Schwartz, Peter H.With the growing focus on prevention in medicine, studies of how to describe risk have become increasing important. Recently, some researchers have argued against giving patients "comparative risk information," such as data about whether their baseline risk of developing a particular disease is above or below average. The concern is that giving patients this information will interfere with their consideration of more relevant data, such as the specific chance of getting the disease (the "personal risk"), the risk reduction the treatment provides, and any possible side effects. I explore this view and the theories of rationality that ground it, and I argue instead that comparative risk information can play a positive role in decision-making. The criticism of disclosing this sort of information to patients, I conclude, rests on a mistakenly narrow account of the goals of prevention and the nature of rational choice in medicine.Item The ethics of information: absolute risk reduction and patient understanding of screening(Journal of General Internal Medicine, 2008-06) Meslin, Eric M.; Schwartz, Peter H.Some experts have argued that patients should routinely be told the specific magnitude and absolute probability of potential risks and benefits of screening tests. This position is motivated by the idea that framing risk information in ways that are less precise violates the ethical principle of respect for autonomy and its application in informed consent or shared decision-making. In this Perspective, we consider a number of problems with this view that have not been adequately addressed. The most important challenges stem from the danger that patients will misunderstand the information or have irrational responses to it. Any initiative in this area should take such factors into account and should consider carefully how to apply the ethical principles of respect for autonomy and beneficence.