IU Center for Bioethics Faculty Scholarship
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Item Adding Natural Frequency Data to a Decision Aid for Colorectal Cancer Screening: Results of a Randomized Trial(2013-10-22) Schwartz, Peter H.; Muriello, Paul F.; Perkins, Susan M.; Schmidt, Karen K.; Rawl, Susan M.Guidelines recommend that decision aids provide natural frequency data regarding baseline risk, risk reduction, and chances of false positives and negatives. Such quantitative information may confuse patients, especially those with low numeracy. We conducted a randomized trial to compare effects of 2 colorectal cancer (CRC) screening decision aids—one with and one without natural frequency data.Item An alternative to conceptual analysis in the function debate(2004) Schwartz, Peter H.Item Anticipatory Waivers of Consent for Pediatric Biobanking(Wiley, 2019-03) Hartsock, Jane A.; Schwartz, Peter H.; Waltz, Amy C.; Ott, Mary A.; Medicine, School of MedicineAs pediatric biobank research grows, additional guidance will be needed about whether researchers should always obtain consent from participants when they reach the legal age of majority. Biobanks struggle with a range of practical and ethical issues related to this question. We propose a framework for the use of anticipatory waivers of consent that is empirically rooted in research that shows that children and adolescents are often developmentally capable of meaningful deliberation about the risks and benefits of participation in research. Accordingly, bright‐line legal concepts of majority or competency do not accurately capture the emerging capacity for autonomous decision‐making of many pediatric research participants and unnecessarily complicate the issues about contacting participants at the age of majority to obtain consent for the continued or first use of their biospecimens that were obtained during childhood. We believe the proposed framework provides an ethically sound balance between the concern for potential exploitation of vulnerable populations, the impetus for the federal regulations governing research with children, and the need to conduct valuable research in the age of genomic medicine.Item Aquinas on the Nature of Human Beings(Philosophy Education Society, 2004-12) Eberl, Jason T.In this paper, I provide a formulation of Thomas Aquinas’s account of the nature of human beings for the purpose of comparing it with other accounts in both the history of philosophy and contemporary analytic philosophy. I discuss how his apparently dualistic understanding of the relationship between soul and body yields the conclusion that a human being exists as a unified substance composed of a rational soul informing, that is, serving as the specific organizing principle of, a physical body. I further address the issue of Aquinas’s contention that a human rational soul can exist without being united to a body and show how this ability of a human soul does not contradict the thesis that a human being exists naturally as embodied. I will also respond to two related questions. First, what accounts for the individuation of human beings as distinct members of the human species?Second, what is the principle of identity by which a human being persists through time and change?Item Aquinas's Account of Human Embryogenesis and Recent Interpretations(University of Chicago Press, 2005-08) Eberl, Jason T.In addressing bioethical issues at the beginning of human life, such as abortion, in vitro fertilization, and embryonic stem cell research, one primary concern regards establishing when a developing human embryo or fetus can be considered a person. Thomas Aquinas argues that an embryo or fetus is not a human person until its body is informed by a rational soul. Aquinas’s explicit account of human embryogenesis has been generally rejected by contemporary scholars due to its dependence upon medieval biological data, which has been far surpassed by current scientific research. A number of scholars, however, have attempted to combine Aquinas’s basic metaphysical account of human nature with current embryological data to develop a contemporary Thomistic account of a human person’s beginning. In this paper, I discuss two recent interpretations in which it is argued that a human person does not begin to exist until a fetus has developed a functioning cerebral cortex.Item Autonomy and consent in biobanks(2010-02) Schwartz, Peter H.Item The Beginning of Personhood: A Thomistic Biological Analysis(Wiley-Blackwell Publishing Ltd., 2000-04) Eberl, Jason T.“When did I, a human person, begin to exist?” In developing an answer to this question, I utilize a Thomistic framework which holds that the human person is a composite of a biological organism and an intellective soul. Eric Olson and Norman Ford both argue that the beginning of an individual human biological organism occurs at the moment when implantation of the zygote in the uterus occurs and the “primitive streak” begins to form. Prior to this point, there does not exist an individual human organism, but a cluster of biological cells which has the potential to split and develop as one or more separate human organisms (identical twinning). Ensoulment (the instantiation of a human intellective soul in biological matter) does not occur until the point of implantation. This conception of the beginning of human personhood has moral implications concerning the status of pre-implantation biological cell clusters. A new understanding of the beginning of human personhood entails a new understanding of the morality of certain medical procedures which have a direct affect on these cell clusters which contain human DNA. Such procedures discussed in this article are embryonic stem cell research, in vitro fertilization, procured abortion, and the use of abortifacient contraceptives.Item Benchmarks for ethically credible partnerships between industry and academic health centers: beyond disclosure of financial conflicts of interest(Springer (Biomed Central Ltd.), 2015-12) Meslin, Eric M.; Rager, Joshua B.; Schwartz, Peter H.; Quaid, Kimberly A.; Gaffney, Margaret M.; Duke, Jon; Tierney, William H.; Department of Philosophy, IU School of Liberal ArtsRelationships between industry and university-based researchers have been commonplace for decades and have received notable attention concerning the conflicts of interest these relationships may harbor. While new efforts are being made to update conflict of interest policies and make industry relationships with academia more transparent, the development of broader institutional partnerships between industry and academic health centers challenges the efficacy of current policy to effectively manage these innovative partnerships. In this paper, we argue that existing strategies to reduce conflicts of interest are not sufficient to address the emerging models of industry-academic partnerships because they focus too narrowly on financial matters and are not comprehensive enough to mitigate all ethical risk. Moreover, conflict-of-interest strategies are not designed to promote best practices nor the scientific and social benefits of academic-industry collaboration. We propose a framework of principles and benchmarks for "ethically credible partnerships" between industry and academic health centers and describe how this framework may provide a practical and comprehensive approach for designing and evaluating such partnerships.Item Biobanks and Electronic Health Records: Ethical and Policy Challenges in the Genomic Age(IU Center for Applied Cybersecurity Research, 2009-10) Meslin, Eric M.; Goodman, KennethIn this paper we discuss the ethical and policy challenges presented by the construction and use of biobanks and electronic health records systems, with a particular focus on how these resources implicate certain types of security concerns for patients, families, health care providers and institutions. These two technology platforms are selected for special emphasis in this paper for two reasons. First and foremost, there is a close connection between them. Indeed, of the many accepted definitions, this one from the German National Bioethics Commission provides a sense of this close connection and the great power and reflects the great power these two separate platforms provide to probe more deeply the connection between genotype and phenotype: "...[B]iobanks are defined as collections of samples of human bodily substances (e.g., cells, tissues, blood or DNA as the physical medium of genetic information) that are or can be associated with personal data and information on their donors." Second, these two topics implicate both clinical ethics issues (those arising at the bedside for health care providers and patients), and human research ethics issues (issues arising for scientists, research subjects, ethics review bodies and regulatory authorities). Both of these sub-specialty areas confront similar and complementary ethical issues; for example, issues arising from the nature and adequacy of informed consent, the sufficiency of systems to protect personal privacy and confidentiality, or the need to balance concerns relating to data security and the need to know. A growing research base supports calls for more attention to these issues, and yet current professional ethics frameworks and policy consultation methods are poorly organized and ill-equipped to anticipate and fully address ethical issues in health information technology generally, or to provide adequate ethical assessment of the tools that elicit these issues. Our strategy is to orient readers to the history and context of these issues, to frame several key challenges for researchers and policy makers, and then to close with several recommendations for next steps.Item Building a data sharing model for global genomic research(Genome Biology, 2014) Kosseim, Patricia; Edward, Dove; Baggaley, Carman; Meslin, Eric M.; Cate, Fred H.; Kaye, Jane; Harris, Jennifer R.; Knoppers, Bartha M.Data sharing models designed to facilitate global business provide insights for improving transborder genomic data sharing. We argue that a flexible, externally endorsed, multilateral arrangement , combined with an objective third-party assurance mechanism, can effectively balance privacy with the need to share genomic data globally.