Browsing by Author "Schwartz, Peter H."

Now showing 1 - 10 of 48
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    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.
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    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 Medicine
    As 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.
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    Autonomy and consent in biobanks
    (2010-02) Schwartz, Peter H.
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    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 Arts
    Relationships 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.
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    Building a Central Repository for Research Ethics Consultation Data: A Proposal for a Standard Data Collection Tool
    (ACTS, 2015-08-01) Cho, Mildred K.; Taylor, Holly; McCormick, Jennifer B.; Anderson, Nick; Barnard, David; Boyle, Mary B.; Capron, Alexander M.; Dorfman, Elizabeth; Havard, Kathryn; Reider, Carson; Sadler, John; Schwartz, Peter H.; Sharp, Richard R.; Danis, Marion; Wilfond, Benjamin S.; Department of Philosophy, IU School of Liberal Arts
    Clinical research ethics consultation services have been established across academic health centers over the past decade. This paper presents the results of collaboration within the CTSA consortium to develop a standard approach to the collection of research ethics consultation information to serve as a foundation for quality improvement, education, and research efforts. This approach includes categorizing and documenting descriptive information about the requestor, research project, the ethical question, the consult process, and describing the basic structure for a consult note. This paper also explores challenges in determining how to share some of this information between collaborating institutions related to concerns about confidentially, data quality, and informatics. While there is much still to be learned to improve the process of clinical research ethics consultation, these tools can advance these efforts, which, in turn, can facilitate the ethical conduct of research.
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    Child safety, absolute risk, and the prevention paradox
    (2012) Schwartz, Peter H.
    While child-saftey proposals aim to improve child safety, their possible impact is unclear since there’s been so little discussion of the amount of absolute risk and risk reduction involved in each. And while precise figures are lacking, rough estimates indicate that the magnitudes are quite small. I will argue that this risk and benefit data raises important questions about the proposals, including whether parents might reasonably believe that the small absolute risk reduction offered by the proposed changes does not justify the attendant burdens. This possibility – termed the “prevention paradox” in other contexts – highlights ethical and theoretical challenges in this area of public health.
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    Collecting Biospecimens and Obtaining Biobank Consent From Patients in an Academic Health Care Setting: Practical and Ethical Considerations
    (Wolters Kluwer, 2022-01) Kasperbauer, T. J.; Waltz, Amy; Hudson, Brenda; Hawryluk, Bridget; Moore, Courtney; Schmidt, Karen; Schwartz, Peter H.; Medicine, School of Medicine
    Academic health centers and health systems increasingly ask patients to enroll in research biobanks as part of standard care, raising important practical and ethical questions for integrating biobank consent processes into health care settings. This article aims to assist academic health centers and health systems considering implementing these integrated consent processes by outlining the 5 main issues—and the key practical and ethical considerations for each issue—that Indiana University Health and the Indiana Biobank faced when integrating biobank consent into their health system, as well as the key obstacles encountered. The 5 main issues to consider include the specimen to collect (leftover, new collection, or add-ons to clinical tests), whether to use opt-in or opt-out consent, where to approach patients, how to effectively use digital tools for consent, and how to appropriately simplify consent information.
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    Comparative Risk: Good or Bad Heuristic?
    (Taylor & Francis, 2016-05) Schwartz, Peter H.; Department of Medicine, School of Medicine
    Heuristics and biases infect all human thought, leading to irrational thinking and behavior. Bioethics must recognize this psychological reality and develop new models for evaluating and supporting autonomous choice, as Blumenthal-Barby (2016) argues (Blumenthal-Barby 2016). Simply trying to eradicate heuristics and biases from medical decisions will not work and is deeply misguided. In many situations, a heuristic or bias can provide a shortcut to an effective decision (Gigerenzer 2008) or can counter the impact of other heuristics and biases. It is often impossible to determine whether a heuristic or bias harms or helps a decision, because of the complexity of thought and the difficulty of defining and measuring the quality of a decision or its rationality. The debate over whether patients should receive comparative risk information highlights these practical, ethical, and conceptual quandaries. Some experts have argued that patients facing certain types of choices should not be told whether their risk is above or below average, because this information may trigger a bias (Fagerlin et al. 2007). But careful consideration shows that the comparative risk heuristic can usefully guide decisions and improve their quality or rationality. Building on an earlier paper of mine (Schwartz 2009), I will argue here that doctors and decision aids should provide comparative risk information to patients, even while further research is conducted.*
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    Decision and discovery in defining 'disease'
    (Springer, 2007) Schwartz, Peter H.
    The debate over how to analyze the concept of disease has often centered on the question of whether to include a reference to values, in particular the ‘disvalue’of diseases, or whether to avoid such notions. ‘Normativists,’such as King ([1954], 1981) and Culver and Gert (1982) emphasize the undesirability of diseases, while ‘Naturalists,’ most prominently Christopher Boorse (1977, 1987, 1997), instead require just the presence of biological dysfunction. The debate between normativism and naturalism often deteriorates into stalemate, with each side able to point out significant problems with the other. It starts to look as if neither approach can work. In this paper, I argue that the standoff stems from deeply questionable assumptions that have been used to formulate the opposing positions and guide the debate. In the end, I propose an alternative set of guidelines that offer a more constructive way to devise and compare theories.