IU Center for Bioethics Faculty Scholarship
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In support of open access, free culture and the progression of scholarship in the field of bioethics, the Indiana University Center for Bioethics is committed to sharing products of scholarly activities, teaching and community engagement.
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Item Genetic Data Aren't So Special: Causes and Implications of Reidentification(Wiley, 2020-10-23) Kasperbauer, T.J.; Schwartz, Peter H.; Philosophy, School of Liberal ArtsGenetic information is widely thought to pose unique risks of reidentifying individuals. Genetic data reveals a great deal about who we are and, the standard view holds, should consequently be treated differently from other types of data. Contrary to this view, we argue that the dangers of reidentification for genetic and nongenetic data—including health, financial, and consumer information—are more similar than has been recognized. Before different requirements are imposed around sharing genetic information, proponents of the standard view must show that they are in fact necessary. We further argue that the similarities between genetic and nongenetic information have important implications for communicating risks during consent for health care and research. While patients and research participants need to be more aware of pervasive data-sharing practices, consent forms are the wrong place to provide this education. Instead, health systems should engage with patients throughout patient care to educate them about data-sharing practices.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 Supporting breast cancer screening decisions for caregivers of older women with dementia: study protocol for a randomized controlled trial(Biomed Central, 2018-12-12) Fowler, Nicole R.; Schonberg, Mara A.; Sachs, Greg A.; Schwartz, Peter H.; Gao, Sujuan; Lane, Kathleen A.; Inger, Lev; Torke, Alexia M.; Medicine, School of MedicineBACKGROUND: Alzheimer's disease and related dementias (ADRD) impact a woman's life expectancy and her ability to participate in medical decision-making about breast cancer screening, necessitating the involvement of family caregivers. Making decisions about mammography screening for women with ADRD is stressful. There are no data that suggest that breast cancer screening helps women with ADRD live longer or better. Decision aids may improve the quality of decision-making about mammography for ADRD patients and may inform family caregivers about the risks, benefits, and need for decision-making around mammography screening. METHODS/DESIGN: The Decisions about Cancer Screening in Alzheimer's Disease (DECAD) trial, a randomized controlled clinical trial, will enroll 426 dyads of older women with ADRD (≥75 years) and a family caregiver from clinics and primary-care practices in Indiana to test a novel, evidence-based decision aid. This decision aid includes information about the impact of ADRD on life expectancy, the benefit of mammograms, and the impact on the quality of life for older women with ADRD. Dyads will be randomized to receive the decision aid or active control information about home safety. This trial will examine the effect on the caregiver's decisional conflict (primary outcome) and the caregiver's decision-making self-efficacy (secondary outcome). A second follow-up at 15 months will include a brief, semi-structured interview with the caregiver regarding the patient's experience with mammograms and decision-making about mammograms. At the same time, a review of the patient's electronic medical record (EMR) will look at discussions about mammography with their primary-care physician and mammogram orders, receipt, results, and burden (e.g., additional diagnostic procedures due to false-positive results, identification of an abnormality on the screening exam but further work-up declined, and identification of a clinically unimportant cancer). A third follow-up at 24 months will extract EMR data on mammogram orders, occurrences, results, and the burden of mammograms. DISCUSSION: We hypothesize that caregivers who receive the decision aid will have lower levels of decisional conflict and higher levels of decision-making self-efficacy compared to the control group. We also hypothesize that the DECAD decision aid will reduce mammography use among older women with ADRD.Item Strange Bedfellows: Torture and Medical Professionals(2018-02-21) Gaffney, Margaret M.Item Impact of including quantitative information in a decision aid for colorectal cancer screening: A randomized controlled trial(Elsevier, 2019) Schwartz, Peter H.; Imperiale, Thomas F.; Perkins, Susan M.; Schmidt, Karen K.; Althouse, Sandra; Rawl, Susan M.; Medicine, School of MedicineObjective: Guidelines recommend that decision aids provide quantitative information about risks and benefits of available options. Impact of providing this information is unknown. Methods: Randomized trial comparing two decision aids about colorectal cancer (CRC) screening with colonoscopy or fecal immunochemical test (FIT). 688 primary care patients due for CRC screening viewed a decision aid that uses words only (Verbal arm) vs. one that provides quantitative information (Quantitative arm). Main outcomes included perceived CRC risk, intent to be screened, and test preference, measured before and after viewing decision aid, and screening uptake at six months. Analyses were performed with ANCOVA and logistic regression. Results: Compared to the Verbal arm, those in the Quantitative arm had a larger increase in intent to undergo FIT (p = 0.011) and were more likely to switch their preferred test from non-FIT to FIT (28% vs. 19%, p = .010). There were decreases in perceived risk in the Verbal Arm but not the Quantitative Arm (p = 0.004). There was no difference in screening uptake. Numeracy did not moderate any effects. Conclusions: Quantitative information had relatively minor impact and no clearly negative effects, such as reducing uptake. Practice implications: Quantitative information may be useful but not essential for patients viewing decision aids.Item Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial(SAGE, 2017-08-01) Schwartz, Peter H.; Perkins, Susan M.; Schmidt, Karen K.; Muriello, Paul F.; Althouse, Sandra; Rawl, Susan M.; Medicine, School of MedicineBackground. Guidelines recommend that patient decision aids should provide quantitative information about probabilities of potential outcomes, but the impact of this information is unknown. Behavioral economics suggests that patients confused by quantitative information could benefit from a “nudge” towards one option. We conducted a pilot randomized trial to estimate the effect sizes of presenting quantitative information and a nudge. Methods. Primary care patients (n = 213) eligible for colorectal cancer screening viewed basic screening information and were randomized to view (a) quantitative information (quantitative module), (b) a nudge towards stool testing with the fecal immunochemical test (FIT) (nudge module), (c) neither a nor b, or (d) both a and b. Outcome measures were perceived colorectal cancer risk, screening intent, preferred test, and decision conflict, measured before and after viewing the decision aid, and screening behavior at 6 months. Results. Patients viewing the quantitative module were more likely to be screened than those who did not (P = 0.012). Patients viewing the nudge module had a greater increase in perceived colorectal cancer risk than those who did not (P = 0.041). Those viewing the quantitative module had a smaller increase in perceived risk than those who did not (P = 0.046), and the effect was moderated by numeracy. Among patients with high numeracy who did not view the nudge module, those who viewed the quantitative module had a greater increase in intent to undergo FIT (P = 0.028) than did those who did not. Limitations. The limitations of this study were the limited sample size and single healthcare system. Conclusions. Adding quantitative information to a decision aid increased uptake of colorectal cancer screening, while adding a nudge to undergo FIT did not increase uptake. Further research on quantitative information in decision aids is warranted.Item "Translational Bioethics: From Patient to Philosophy And Back"(2016-02-29) Schwartz, Peter H.Item Comparative Risk: Good or Bad Heuristic?(Taylor & Francis, 2016-05) Schwartz, Peter H.; Department of Medicine, School of MedicineHeuristics 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.*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 RESEARCH ETHICS. Ethics review for international data-intensive research(American Association for the Advancement of Science, 2016-03-25) Dove, Edward S.; Townend, David; Meslin, Eric M.; Bobrow, Martin; Littler, Katherine; Nicol, Dianne; de Vries, Jantina; Junker, Anne; Garattini, Chiara; Bovenberg, Jasper; Shabani, Mahsa; Lévesque, Emmanuelle; Knoppers, Bartha M.; Indiana University Center for Bioethics, IU School of Medicine