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Variation in the design of Do Not Resuscitate orders and other code status options: a multi-institutional qualitative study. BMJ quality & safety Batten, J. N., Blythe, J. A., Wieten, S., Cotler, M. P., Kayser, J. B., Porter-Williamson, K., Harman, S., Dzeng, E., Magnus, D. 2020
Abstract

BACKGROUND: US hospitals typically provide a set of code status options that includes Full Code and Do Not Resuscitate (DNR) but often includes additional options. Although US hospitals differ in the design of code status options, this variation and its impacts have not been empirically studied.DESIGN AND METHODS: Multi-institutional qualitative study at 7 US hospitals selected for variability in geographical location, type of institution and design of code status options. We triangulated across three data sources (policy documents, code status ordering menus and in-depth physician interviews) to characterise the code status options available at each hospital. Using inductive qualitative methods, we investigated design differences in hospital code status options and the perceived impacts of these differences.RESULTS: The code status options at each hospital varied widely with regard to the number of code status options, the names and definitions of code status options, and the formatting and capabilities of code status ordering menus. DNR orders were named and defined differently at each hospital studied. We identified five key design characteristics that impact the function of a code status order. Each hospital's code status options were unique with respect to these characteristics, indicating that code status plays differing roles in each hospital. Physician participants perceived that the design of code status options shapes communication and decision-making practices about resuscitation and life-sustaining treatments, especially at the end of life. We identified four potential mechanisms through which this may occur: framing conversations, prompting decisions, shaping inferences and creating categories.CONCLUSIONS: There are substantive differences in the design of hospital code status options that may contribute to known variability in end-of-life care and treatment intensity among US hospitals. Our framework can be used to design hospital code status options or evaluate their function.

View details for DOI 10.1136/bmjqs-2020-011222

View details for PubMedID 33082165
"I don't want to be Henrietta Lacks": diverse patient perspectives on donating biospecimens for precision medicine research. Genetics in medicine : official journal of the American College of Medical Genetics Lee, S. S., Cho, M. K., Kraft, S. A., Varsava, N., Gillespie, K., Ormond, K. E., Wilfond, B. S., Magnus, D. 2018
Abstract

PURPOSE: To determine whether patients distinguish between biospecimens and electronic health records (EHRs) when considering research participation to inform research protections.METHODS: We conducted 20 focus groups with individuals who identified as African American, Hispanic, Chinese, South Asian, and non-Hispanic white on the collection of biospecimens and EHR data for research.RESULTS: Our study found that many participants did not distinguish between biospecimens and EHR data. However, some participants identified specific concerns about biospecimens. These included the need for special care and respect for biospecimens due to enduring connections between the body and identity; the potential for unacceptable future research, specifically the prospect of human cloning; heightened privacy risks; and the potential for unjust corporate profiteering. Among those who distinguished biospecimens from EHR data, many supported separate consent processes and would limit their own participation to EHR data.CONCLUSION: Considering that the potential misuse of EHR data is as great as, if not greater than, for biospecimens, more research is needed to understand how attitudes differ between biospecimens and EHR data across diverse populations. Such research should explore mechanisms beyond consent that can address diverse values, perspectives, and misconceptions about sources of patient information to build trust in research relationships.

View details for PubMedID 29887604
Implementing Machine Learning in Health Care - Addressing Ethical Challenges NEW ENGLAND JOURNAL OF MEDICINE Char, D. S., Shah, N. H., Magnus, D. 2018; 378 (11): 981?83
View details for PubMedID 29539284

View details for PubMedCentralID PMC5962261
Ethical Challenges Confronted When Providing Nusinersen Treatment for Spinal Muscular Atrophy. JAMA pediatrics Burgart, A. M., Magnus, D., Tabor, H. K., Paquette, E. D., Frader, J., Glover, J. J., Jackson, B. M., Harrison, C. H., Urion, D. K., Graham, R. J., Brandsema, J. F., Feudtner, C. 2018; 172 (2): 188?92
Abstract

The US Food and Drug Administration's December 2016 approval of nusinersen for the treatment of patients with all subtypes of spinal muscular atrophy ushered in a new era for patients with spinal muscular atrophy, their families, and all those involved in their care. The extreme cost of the medication and the complicated logistical requirements for administering nusinersen via lumbar puncture have created practical challenges that raise important ethical considerations. We discuss 6 challenges faced at the institutional level in the United States: cost, limited evidence, informed consent, treatment allocation, fair distribution of responsibilities, and transparency with stakeholders. These challenges must be understood to ensure that patients with spinal muscular atrophy benefit from treatment, are protected from harm, and are treated fairly.

View details for PubMedID 29228163
Alterations in Spanish Language Interpretation During Pediatric Critical Care Family Meetings CRITICAL CARE MEDICINE Sinow, C. S., Corso, I., Lorenzo, J., Lawrence, K. A., Magnus, D. C., Van Cleave, A. C. 2017; 45 (11): 1915?21
Abstract

To characterize alterations in Spanish language medical interpretation during pediatric critical care family meetings.Descriptive, observational study using verbatim transcripts of nine PICU family meetings conducted with in-person, hospital-employed interpreters.A single, university-based, tertiary children's hospital.Medical staff, family members, ancillary staff, and interpreters.None.Interpreted speech was compared with original clinician or family speech using the qualitative research methods of directed content analysis and thematic analysis. Alterations occurred in 56% of interpreted utterances and included additions, omissions, substitutions, editorializations, answering for the patient/clinician, confessions, and patient advocacy. Longer utterances were associated with more alterations.To minimize interpreter alterations during family meetings, physicians should speak in short utterances (fewer than 20 words) and ask interpreters to interrupt in order to facilitate accurate interpretation. Because alterations occur, physicians may also regularly attempt to assess the family's understanding.

View details for PubMedID 28777199
Consent and engagement, security, and authentic living using wearable and mobile health technology NATURE BIOTECHNOLOGY Kreitmair, K. V., Cho, M. K., Magnus, D. C. 2017; 35 (7): 617?20
View details for PubMedID 28700542
Early Experience With the California End of Life Option Act: Balancing Institutional Participation and Physician Conscientious Objection. JAMA internal medicine Harman, S. M., Magnus, D. 2017
View details for DOI 10.1001/jamainternmed.2017.1485

View details for PubMedID 28531248
Genomic Contraindications for Heart Transplantation. Pediatrics Char, D. S., L�zaro-Mu�oz, G., Barnes, A., Magnus, D., Deem, M. J., Lantos, J. D. 2017
Abstract

Genome sequencing raises new ethical challenges. Decoding the genome produces new forms of diagnostic and prognostic information; however, the information is often difficult to interpret. The connection between most genetic variants and their phenotypic manifestations is not understood. This scenario is particularly true for disorders that are not associated with an autosomal genetic variant. The analytic uncertainty is compounded by moral uncertainty about how, exactly, the results of genomic testing should influence clinical decisions. In this Ethics Rounds, we present a case in which genomic findings seemed to play a role in deciding whether a patient was to be listed as a transplant candidate. We then asked experts in bioethics and cardiology to discuss the implications of such decisions.

View details for DOI 10.1542/peds.2016-3471

View details for PubMedID 28255068

View details for PubMedCentralID PMC5369679
CPR and Ventricular Assist Devices: The Challenge of Prolonging Life Without Guaranteeing Health. American journal of bioethics Magnus, D., Char, D. 2017; 17 (2): 1-2
View details for DOI 10.1080/15265161.2016.1276752

View details for PubMedID 28112616
A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent CLINICAL TRIALS Kraft, S. A., Constantine, M., Magnus, D., Porter, K. M., Lee, S. S., Green, M., Kass, N. E., Wilfond, B. S., Cho, M. K. 2017; 14 (1): 94-102
Abstract

Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices.We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms.There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p?
View details for DOI 10.1177/1740774516669352

View details for Web of Science ID 000394652700010
A comparison of institutional review board professionals' and patients' views on consent for research on medical practices. Clinical trials Kraft, S. A., Cho, M. K., Constantine, M., Lee, S. S., Kelley, M., Korngiebel, D., James, C., Kuwana, E., Meyer, A., Porter, K., Diekema, D., Capron, A. M., Alicic, R., Wilfond, B. S., Magnus, D. 2016; 13 (5): 555-565
Abstract

In the context of research on medical practices, which includes comparative effectiveness research and pragmatic clinical trials, empirical studies have begun to raise questions about the extent to which institutional review boards' interpretations and applications of research regulations align with patients' values. To better understand the similarities and differences between these stakeholder groups, we compare and contrast two surveys: one of institutional review board professionals and one of patients, which examine views on consent for research on medical practices.We conducted online surveys of two target populations between July 2014 and March 2015. We surveyed 601 human subjects research professionals out of 1500 randomly selected from the Public Responsibility in Medicine and Research membership list (40.1% response rate), limiting analysis to 537 respondents who reported having had institutional review board experience. We also surveyed 120 adult patients out of 225 approached at subspecialty clinics in Spokane, Washington (53.3% response rate). Our survey questions probed attitudes about consent in the context of research on medical practices using medical record review and randomization. The patient survey included three embedded animated videos to explain these concepts.A majority of institutional review board professionals distinguished between consent preferences for medical record review and randomization, ranked clinicians as the least preferred person to obtain participant consent (54.6%), and viewed written or verbal permission as the minimum acceptable consent approach for research on medical practices using randomization (87.3%). In contrast, most patients had similar consent preferences for research on medical practices using randomization and medical record review, most preferred to have consent conversations with their doctors rather than with researchers for studies using randomization (72.6%) and medical record review (67.0%), and only a few preferred to see research involving randomization (16.8%) or medical record review (13.8%) not take place if obtaining written or verbal permission would make the research too difficult to conduct. Limitations of our post hoc analysis include differences in framing, structure, and language between the two surveys and possible response bias.Our findings highlight a need to identify appropriate ways to integrate patient preferences into prevailing regulatory interpretations as institutional review boards increasingly apply research regulations in the context of research on medical practices. Dialogue between institutional review boards and research participants will be an important part of this process and should inform future regulatory guidance.

View details for DOI 10.1177/1740774516648907

View details for PubMedID 27257125

View details for PubMedCentralID PMC5025342
A Flawed Revision of the Common Rule. Annals of internal medicine Joffe, S., Magnus, D. C. 2016; 165 (2): 143-144
View details for DOI 10.7326/M16-0119

View details for PubMedID 27043302
Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey. Annals of internal medicine Cho, M. K., Magnus, D., Constantine, M., Lee, S. S., Kelley, M., Alessi, S., Korngiebel, D., James, C., Kuwana, E., Gallagher, T. H., Diekema, D., Capron, A. M., Joffe, S., Wilfond, B. S. 2015; 162 (10): 690-696
Abstract

The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants.To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices.Cross-sectional survey conducted in August 2014.Web-based questionnaire.1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290).Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices.97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%).Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population.Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance.National Center for Advancing Translational Sciences at the National Institutes of Health.

View details for DOI 10.7326/M15-0166

View details for PubMedID 25868119
Attitudes Toward Risk and Informed Consent for Research on Medical Practices A Cross-sectional Survey ANNALS OF INTERNAL MEDICINE Cho, M. K., Magnus, D., Constantine, M., Lee, S. S., Kelley, M., Alessi, S., Korngiebel, D., James, C., Kuwana, E., Gallagher, T. H., Diekema, D., Capron, A. M., Joffe, S., Wilfond, B. S. 2015; 162 (10): 690-?
Abstract

The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants.To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices.Cross-sectional survey conducted in August 2014.Web-based questionnaire.1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290).Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices.97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%).Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population.Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance.National Center for Advancing Translational Sciences at the National Institutes of Health.

View details for DOI 10.7326/M15-0166

View details for Web of Science ID 000355015200018

View details for PubMedID 25868119
Whole genome sequencing in critically ill children LANCET RESPIRATORY MEDICINE Char, D. S., Cho, M., Magnus, D. 2015; 3 (4): 264-266
View details for DOI 10.1016/S2213-2600(15)00006-5

View details for Web of Science ID 000353079000006

View details for PubMedID 25704991
Genomics in the clinic: ethical and policy challenges in clinical next-generation sequencing programs at early adopter USA institutions PERSONALIZED MEDICINE Milner, L. C., Garrison, N. A., Cho, M. K., Altman, R. B., Hudgins, L., Galli, S. J., Lowe, H. J., Schrijver, I., Magnus, D. C. 2015; 12 (3): 269-282
View details for DOI 10.2217/PME.14.88

View details for Web of Science ID 000355751600011
Accepting brain death. New England journal of medicine Magnus, D. C., Wilfond, B. S., Caplan, A. L. 2014; 370 (10): 891-894
View details for DOI 10.1056/NEJMp1400930

View details for PubMedID 24499177
A content analysis of posthumous sperm procurement protocols with considerations for developing an institutional policy. Fertility and sterility Bahm, S. M., Karkazis, K., Magnus, D. 2013; 100 (3): 839-843 e6
View details for DOI 10.1016/j.fertnstert.2013.05.002

View details for PubMedID 23773314
Risk, consent, and SUPPORT. New England journal of medicine Magnus, D., Caplan, A. L. 2013; 368 (20): 1864-1865
View details for DOI 10.1056/NEJMp1305086

View details for PubMedID 23597408
Ethical issues in using ambient intelligence in health-care settings. The Lancet. Digital health Martinez-Martin, N., Luo, Z., Kaushal, A., Adeli, E., Haque, A., Kelly, S. S., Wieten, S., Cho, M. K., Magnus, D., Fei-Fei, L., Schulman, K., Milstein, A. 2020
Abstract

Ambient intelligence is increasingly finding applications in health-care settings, such as helping to ensure clinician and patient safety by monitoring staff compliance with clinical best practices or relieving staff of burdensome documentation tasks. Ambient intelligence involves using contactless sensors and contact-based wearable devices embedded in health-care settings to collect data (eg, imaging data of physical spaces, audio data, or body temperature), coupled with machine learning algorithms to efficiently and effectively interpret these data. Despite the promise of ambient intelligence to improve quality of care, the continuous collection of large amounts of sensor data in health-care settings presents ethical challenges, particularly in terms of privacy, data management, bias and fairness, and informed consent. Navigating these ethical issues is crucial not only for the success of individual uses, but for acceptance of the field as a whole.

View details for DOI 10.1016/S2589-7500(20)30275-2

View details for PubMedID 33358138
Making Medical Treatment Decisions for Unrepresented Patients in the ICU An Official American Thoracic Society/American Geriatrics Society Policy Statement AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE Pope, T. M., Bennett, J., Carson, S. S., Cederquist, L., Cohen, A. B., DeMartino, E. S., Godfrey, D. M., Goodman-Crews, P., Kapp, M. B., Lo, B., Magnus, D. C., Reinke, L. F., Shirley, J. L., Siegel, M. D., Stapleton, R. D., Sudore, R. L., Tarzian, A. J., Thornton, J., Wicclair, M. R., Widera, E. W., White, D. B., Amer Thoracic Soc, Amer Geriatrics Soc 2020; 201 (10): 1182?92
Abstract

Background and Rationale: ICU clinicians regularly care for patients who lack capacity, an applicable advance directive, and an available surrogate decision-maker. Although there is no consensus on terminology, we refer to these patients as "unrepresented." There is considerable controversy about how to make treatment decisions for these patients, and there is significant variability in both law and clinical practice.Purpose and Objectives: This multisociety statement provides clinicians and hospital administrators with recommendations for decision-making on behalf of unrepresented patients in the critical care setting.Methods: An interprofessional, multidisciplinary expert committee developed this policy statement by using an iterative consensus process with a diverse working group representing critical care medicine, palliative care, pediatric medicine, nursing, social work, gerontology, geriatrics, patient advocacy, bioethics, philosophy, elder law, and health law.Main Results: The committee designed its policy recommendations to promote five ethical goals: 1) to protect highly vulnerable patients, 2) to demonstrate respect for persons, 3) to provide appropriate medical care, 4) to safeguard against unacceptable discrimination, and 5) to avoid undue influence of competing obligations and conflicting interests. These recommendations also are intended to strike an appropriate balance between excessive and insufficient procedural safeguards. The committee makes the following recommendations: 1) institutions should offer advance care planning to prevent patients at high risk for becoming unrepresented from meeting this definition; 2) institutions should implement strategies to determine whether seemingly unrepresented patients are actually unrepresented, including careful capacity assessments and diligent searches for potential surrogates; 3) institutions should manage decision-making for unrepresented patients using input from a diverse interprofessional, multidisciplinary committee rather than ad hoc by treating clinicians; 4) institutions should use all available information on the patient's preferences and values to guide treatment decisions; 5) institutions should manage decision-making for unrepresented patients using a fair process that comports with procedural due process; 6) institutions should employ this fair process even when state law authorizes procedures with less oversight.Conclusions: This multisociety statement provides guidance for clinicians and hospital administrators on medical decision-making for unrepresented patients in the critical care setting.

View details for DOI 10.1164/rccm.202003-0512ST

View details for Web of Science ID 000535260100009

View details for PubMedID 32412853

View details for PubMedCentralID PMC7233335
Dimensions of Research-Participant Interaction: Engagement is Not a Replacement for Consent. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics Shearer, E., Martinez, N., Magnus, D. 2020; 48 (1): 183?84
View details for DOI 10.1177/1073110520917008

View details for PubMedID 32342787
Frontiers in Bioethics. The American journal of bioethics : AJOB Magnus, D. 2020; 20 (1): 1?2
View details for DOI 10.1080/15265161.2019.1695485

View details for PubMedID 31896333
Clinical Application of Computational Methods in Precision Oncology: A Review. JAMA oncology Panagiotou, O. A., H�gg, L. H., Hricak, H., Khleif, S. N., Levy, M. A., Magnus, D., Murphy, M. J., Patel, B., Winn, R. A., Nass, S. J., Gatsonis, C., Cogle, C. R. 2020
Abstract

There is an enormous and growing amount of data available from individual cancer cases, which makes the work of clinical oncologists more demanding. This data challenge has attracted engineers to create software that aims to improve cancer diagnosis or treatment. However, the move to use computers in the oncology clinic for diagnosis or treatment has led to instances of premature or inappropriate use of computational predictive systems.To evaluate best practices for developing and assessing the clinical utility of predictive computational methods in oncology.The National Cancer Policy Forum and the Board on Mathematical Sciences and Analytics at the National Academies of Sciences, Engineering, and Medicine hosted a workshop to examine the use of multidimensional data derived from patients with cancer and the computational methods used to analyze these data. The workshop convened diverse stakeholders and experts, including computer scientists, oncology clinicians, statisticians, patient advocates, industry leaders, ethicists, leaders of health systems (academic and community based), private and public health insurance carriers, federal agencies, and regulatory authorities. Key characteristics for successful computational oncology were considered in 3 thematic areas: (1) data quality, completeness, sharing, and privacy; (2) computational methods for analysis, interpretation, and use of oncology data; and (3) clinical infrastructure and expertise for best use of computational precision oncology.Quality control was found to be essential across all stages, from data collection to data processing, management, and use. Collecting a standardized parsimonious data set at every cancer diagnosis and restaging could enhance reliability and completeness of clinical data for precision oncology. Data completeness refers to key data elements such as information about cancer diagnosis, treatment, and outcomes, while data quality depends on whether appropriate variables have been measured in valid and reliable ways. Collecting data from diverse populations can reduce the risk of creating invalid and biased algorithms. Computational systems that aid clinicians should be classified as software as a medical device and thus regulated according to the potential risk posed. To facilitate appropriate use of computational methods that interpret high-dimensional data in oncology, treating physicians need access to multidisciplinary teams with broad expertise and deep training among a subset of clinical oncology fellows in clinical informatics.Workshop discussions suggested best practices in demonstrating the clinical utility of predictive computational methods for diagnosing or treating cancer.

View details for DOI 10.1001/jamaoncol.2020.1247

View details for PubMedID 32407443
Using Implementation Science to Enact Specific Ethical Norms: The Case of Code Status Policy. The American journal of bioethics : AJOB Shearer, E., Magnus, D. 2020; 20 (4): 6?7
View details for DOI 10.1080/15265161.2020.1735874

View details for PubMedID 32208071
Ethics of Using and Sharing Clinical Imaging Data for Artificial Intelligence: A Proposed Framework. Radiology Larson, D. B., Magnus, D. C., Lungren, M. P., Shah, N. H., Langlotz, C. P. 2020: 192536
Abstract

In this article, the authors propose an ethical framework for using and sharing clinical data for the development of artificial intelligence (AI) applications. The philosophical premise is as follows: when clinical data are used to provide care, the primary purpose for acquiring the data is fulfilled. At that point, clinical data should be treated as a form of public good, to be used for the benefit of future patients. In their 2013 article, Faden et al argued that all who participate in the health care system, including patients, have a moral obligation to contribute to improving that system. The authors extend that framework to questions surrounding the secondary use of clinical data for AI applications. Specifically, the authors propose that all individuals and entities with access to clinical data become data stewards, with fiduciary (or trust) responsibilities to patients to carefully safeguard patient privacy, and to the public to ensure that the data are made widely available for the development of knowledge and tools to benefit future patients. According to this framework, the authors maintain that it is unethical for providers to "sell" clinical data to other parties by granting access to clinical data, especially under exclusive arrangements, in exchange for monetary or in-kind payments that exceed costs. The authors also propose that patient consent is not required before the data are used for secondary purposes when obtaining such consent is prohibitively costly or burdensome, as long as mechanisms are in place to ensure that ethical standards are strictly followed. Rather than debate whether patients or provider organizations "own" the data, the authors propose that clinical data are not owned at all in the traditional sense, but rather that all who interact with or control the data have an obligation to ensure that the data are used for the benefit of future patients and society.

View details for DOI 10.1148/radiol.2020192536

View details for PubMedID 32208097
Genetic disease and intellectual disability as contraindications to transplant listing in the United States: A survey of heart, kidney, liver, and lung transplant programs. Pediatric transplantation Wall, A., Lee, G. H., Maldonado, J., Magnus, D. 2020: e13837
Abstract

Discrimination based on disability is prohibited in organ transplantation, yet studies suggest it continues in listing practices for intellectual disability and genetic diseases. It is not known if this differs between adult and pediatric programs, or by organ type. We performed an online, forced-choice survey of psychosocial listing criteria for adult and pediatric heart, kidney, liver, and lung transplant programs in the United States. Of 650 programs contacted, 343 (52.8%) submitted complete. A minority of programs had formal listing guidelines for any condition considered (Down Syndrome, Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, DiGeorge Syndrome, and Wolf Hirschhorn Syndrome; and mild [IQ�<�70] and severe [IQ�<�35] intellectual disability), although a majority had encountered most. Pediatric programs were significantly (P�<�.02) more lenient in the level of contraindication to listing for all genetic conditions considered except Duchenne Muscular Dystrophy, and for mild and severe intellectual disability. Level of contraindication differed significantly by organ type (heart, lung, liver, and kidney) for Duchenne Muscular dystrophy (P�=�<.001), Becker Muscular Dystrophy (P�<�.001), DiGeorge Syndrome (P�<�.001), Wolf-Hirschhorn syndrome (P�=�.0012), and severe intellectual disability (P�<�.001). There is significant variation among transplant programs in availability of guidelines for as well as listing practices regarding genetic diseases and intellectual disability, differing by both adult vs pediatric program, and organ type. Programs with absolute contraindications to listing for specific genetic diseases or intellectual disability should reframe their approach, ensuring individualized assessments and avoiding elimination of patients based on membership in a particular group.

View details for DOI 10.1111/petr.13837

View details for PubMedID 32997378
The Limits of Individualism: Potential Societal Harms from the EAP for Convalescent Plasma The American Journal of Bioethics Magnus, D. 2020; 20 (9): 1-3
View details for DOI 10.1080/15265161.2020.1798673
Recognizing the Role of Language in the Hidden Curriculum of Undergraduate Medical Education: Implications for Equity in Medical Training. Academic medicine : journal of the Association of American Medical Colleges Wong, B. O., Blythe, J. A., Batten, J. N., Turner, B. E., Lau, J. N., Hosamani, P., Hanks, W. F., Magnus, D. 2020
Abstract

Medical education involves a transition from "outsider" to "insider" status, which entails both rigorous formal training and an inculturation of values and norms via a "hidden curriculum." Within this transition, the ability to "talk the talk" designates an individual as an insider, and learning to talk this talk is a key component of professional socialization. This article uses the framework of "patterns of medical language" to explore the role of language in the hidden curriculum of medical education, exploring how students must learn to recognize and participate fluently within patterns of medical language in order to be acknowledged and evaluated as competent trainees. The authors illustrate this by reframing the objectives for medical education which are outlined by the Association of American Medical Colleges as a series of overlapping patterns of medical language which students are expected to master before residency. We propose that many of these patterns of medical language are learned through trial-and-error, taught via a hidden curriculum rather than through explicit instruction. Medical students come from increasingly diverse backgrounds and therefore begin medical training further from or closer to insider status. Thus, evaluative practices based on patterns of medical language, which are not explicitly taught, may exacerbate and perpetuate existing inequities in medical education. This article aims to bring awareness to the importance of medical language within the hidden curriculum of medical education, to the role of medical language as a marker of "insider" status, and to the centrality of medical language in evaluative practices. We conclude by offering possible approaches to ameliorate the inequities that may exist due to current evaluative practices, and call for further discussion and innovation to explicitly address the role of language in the hidden curriculum of medical education.

View details for DOI 10.1097/ACM.0000000000003657

View details for PubMedID 32769473
Treatability Statements in Serious Illness: The Gap Between What is Said and What is Heard CAMBRIDGE QUARTERLY OF HEALTHCARE ETHICS Batten, J. N., Wong, B. O., Hanks, W. F., Magnus, D. C. 2019; 28 (3): 394?404
Abstract

Empirical work has shown that patients and physicians have markedly divergent understandings of treatability statements (e.g., "This is a treatable condition," "We have treatments for your loved one") in the context of serious illness. Patients often understand treatability statements as conveying good news for prognosis and quality of life. In contrast, physicians often do not intend treatability statements to convey improvement in prognosis or quality of life, but merely that a treatment is available. Similarly, patients often understand treatability statements as conveying encouragement to hope and pursue further treatment, though this may not be intended by physicians. This radical divergence in understandings may lead to severe miscommunication. This paper seeks to better understand this divergence through linguistic theory-in particular, H.P. Grice's notion of conversational implicature. This theoretical approach reveals three levels of meaning of treatability statements: (1) the literal meaning, (2) the physician's intended meaning, and (3) the patient's received meaning. The divergence between the physician's intended meaning and the patient's received meaning can be understood to arise from the lack of shared experience between physicians and patients, and the differing assumptions that each party makes about conversations. This divergence in meaning raises new and largely unidentified challenges to informed consent and shared decision making in the context of serious illness, which indicates a need for further empirical research in this area.

View details for DOI 10.1017/S096318011900029X

View details for Web of Science ID 000477671000003

View details for PubMedID 31368425
Response to Commentaries: When "Everyday Language" Contributes to Miscommunication in Serious Illness CAMBRIDGE QUARTERLY OF HEALTHCARE ETHICS Batten, J. N., Wong, B. O., Magnus, D. C. 2019; 28 (3): 433?38
View details for DOI 10.1017/S0963180119000355

View details for Web of Science ID 000477671000009

View details for PubMedID 31298189
Introduction: Through the Lens of Linguistic Theory CAMBRIDGE QUARTERLY OF HEALTHCARE ETHICS Batten, J. N., Magnus, D. C. 2019; 28 (3): 392?93
View details for DOI 10.1017/S0963180119000288

View details for Web of Science ID 000477671000002

View details for PubMedID 31364573
Use of genetic risks in pediatric organ transplantation listing decisions: A national survey PEDIATRIC TRANSPLANTATION Graf, M., Char, D., Hanson-Kahn, A., Magnus, D. 2019; 23 (4)
View details for DOI 10.1111/petr.13402

View details for Web of Science ID 000470844700003
Medical Contraindications to Transplant Listing in the USA: A Survey of Adult and Pediatric Heart, Kidney, Liver, and Lung Programs. World journal of surgery Wall, A., Lee, G. H., Maldonado, J., Magnus, D. 2019
Abstract

INTRODUCTION: Listing practices for solid organ transplantation are variable across programs in the USA. To better characterize this variability, we performed a survey of psychosocial listing criteria for pediatric and adult heart, lung, liver, and kidney programs in the USA. In this manuscript, we report our results regarding listing practices with respect to obesity, advanced age, and HIV seropositivity.METHODS: We performed an online, forced-choice survey of adult and pediatric heart, kidney, liver, and lung transplant programs in the USA.RESULTS: Of 650 programs contacted, 343 submitted complete responses (response rate=52.8%). Most programs have absolute contraindications to listing for BMI>45 (adult: 67.5%; pediatric: 88.0%) and age>80 (adult: 55.4%; pediatric: not relevant). Only 29.5% of adult programs and 25.7% of pediatric programs consider HIV seropositivity an absolute contraindication to listing. We found that there is variation in absolute contraindications to listing in adult programs among organ types for BMI>45 (heart 89.8%, lung 92.3%, liver 49.1%, kidney 71.9%), age>80 (heart 83.7%, lung 76.9%, liver 68.4%, kidney 29.2%), and HIV seropositivity (heart 30.6%, lung 59.0%, kidney 16.9%, liver 28.1%).CONCLUSIONS: We argue that variability in listing enhances access to transplantation for potential recipients who have the ability to pursue workup at different centers by allowing different programs to have different risk thresholds. Programs should remain independent in listing practices, but because these practices differ, we recommend transparency in listing policies and informing patients of reasons for listing denial and alternative opportunities to seek listing at another program.

View details for DOI 10.1007/s00268-019-05030-x

View details for PubMedID 31111229
Use of genetic risks in pediatric organ transplantation listing decisions: A national survey. Pediatric transplantation Graf, M., Char, D., Hanson-Kahn, A., Magnus, D. 2019: e13402
Abstract

There is a limited supply of organs for all those who need them for survival. Thus, careful decisions must be made about who is listed for transplant. Studies show that manifesting genetic disease can impact listing eligibility. What has not yet been studied is the impact genetic risks for future disease have on a patient's chance to be listed. Surveys were emailed to 163 pediatric liver, heart, and kidney transplant programs across the United States to elicit views and experiences of key clinicians regarding each program's use of genetic risks (ie, predispositions, positive predictive testing) in listing decisions. Response rate was 42%. Sixty-four percent of programs have required genetic testing for specific indications prior to listing decisions. Sixteen percent have required it without specific indications, suggesting that genetic testing may be used to screen candidates. Six percent have chosen not to list patients with secondary findings or family histories of genetic conditions. In hypothetical scenarios, programs consider cancer predispositions and adult-onset neurological conditions to be relative contraindications to listing (61%, 17%, and 8% depending on scenario), and some consider them absolute contraindications (5% and 3% depending on scenario). Only 3% of programs have formal policies for these scenarios, but all consult genetic specialists at least "sometimes" for results interpretation. Our study reveals that pediatric transplant programs are using future onset genetic risks in listing decisions. As genetic testing is increasingly adopted into pediatric medicine, further study is needed to prevent possible inappropriate use of genetic information from impacting listing eligibility.

View details for PubMedID 31012250
Privacy and ethical challenges in next-generation sequencing EXPERT REVIEW OF PRECISION MEDICINE AND DRUG DEVELOPMENT Martinez-Martin, N., Magnus, D. 2019; 4 (2): 95?104
View details for DOI 10.1080/23808993.2019.1599685

View details for Web of Science ID 000473707900001
Citizen Science and Gamification HASTINGS CENTER REPORT Kreitmair, K. V., Magnus, D. C. 2019; 49 (2): 40?46
Abstract

According to the mainstream conception of research involving human participants, researchers have been trained scientists acting within institutions and have been the individuals doing the studying, while participants, who are nonscientist members of the public, have been the individuals being studied. The relationship between the public and scientists is evolving, however, giving rise to several new concepts, including crowdsourcing and citizen science. In addition, the practice of gamification has been applied to research protocols. The role of gamified, crowdsourced citizen scientist is new in the domain of scientific research and does not fit into the existing taxonomy of researchers and participants. We delineate and explicate this role and show that, while traditional roles are governed by well-established norms and regulations, individuals engaged in gamified, crowdsourced citizen science-gamers-fall through the cracks of research protections and regulations. We consider the issues this raises, including exploitation and the absence of responsibility and accountability. Finally, we offer suggestions for how the current lack of appropriate norms may be rectified.

View details for DOI 10.1002/hast.992

View details for Web of Science ID 000465156800010

View details for PubMedID 30998274
Assessing genetic counselors' experiences with physician aid-in-dying and practice implications. Journal of genetic counseling D'Angelo, A., Ormond, K. E., Magnus, D., Tabor, H. K. 2019
Abstract

Physician aid-in-dying (PAD) is now legalized in more than half a dozen states across the United States yet remains controversial among health care providers and the general public. Previous studies have described physicians' and nurses' experiences with and attitudes about PAD; however, there is no data about PAD in the context of genetic counseling. This study explores genetic counselors' experiences, understanding, training, and perspectives about PAD. Fifteen participants were recruited to complete semistructured telephone interviews. Five participants had received patient inquiries about PAD. Most participants (n=10) did not feel prepared to discuss PAD with patients and felt that they did not have adequate knowledge to answer patient questions about the practice. Participants described how the unique training, skills, and experiences of genetic counselors could be beneficial for discussing PAD with patients, in comparison to other providers. All participants supported training for genetic counselors about PAD, with many suggesting integration with education about palliative care and end-of-life planning. This is the first study to investigate PAD in the context of genetic counseling. Genetic counselors have had patients ask questions about PAD, want education and access to resources about PAD, and believe they can provide important support and guidance to patients considering PAD in some genetic counseling contexts.

View details for PubMedID 30688387
Informed Consent: A Matter of Aspiration Since 1966 (At Least). The American journal of bioethics : AJOB Wieten, S., Blythe, J., Magnus, D. 2019; 19 (5): 3?5
View details for PubMedID 31068110
THE RELATIONSHIP BETWEEN DO-NOT-RESUSCITATE AND NO ESCALATION OF TREATMENT Batten, J., Taylor, G., Blythe, J., Porter-Williamson, K., Dzeng, E., Cotler, M., Kayser, J., Harman, S., Magnus, D. LIPPINCOTT WILLIAMS & WILKINS. 2019
View details for Web of Science ID 000498593400363
"I don't want to be Henrietta Lacks": diverse patient perspectives on donating biospecimens for precision medicine research GENETICS IN MEDICINE Lee, S., Cho, M. K., Kraft, S. A., Varsava, N., Gillespie, K., Ormond, K. E., Wilfond, B. S., Magnus, D. 2019; 21 (1): 107?13
View details for DOI 10.1038/s41436-018-0032-6

View details for Web of Science ID 000455403400016
Privacy and ethical challenges in next-generation sequencing. Expert review of precision medicine and drug development Martinez-Martin, N., Magnus, D. 2019; 4 (2): 95?104
Abstract

Next-generation sequencing (NGS) is expected to revolutionize health care. NGS allows for sequencing of the whole genome more cheaply and quickly than previous techniques. NGS offers opportunities to advance medical diagnostics and treatments, but also raises complicated ethical questions that need to be addressed.This article draws from the literature on research and clinical ethics, as well as next-generation sequencing, in order to provide an overview of the ethical challenges involved in next-generation sequencing. This article includes a discussion of the ethics of NGS in research and clinical contexts.The use of NGS in clinical and research contexts has features that pose challenges for traditional ethical frameworks for protecting research participants and patients. NGS generates massive amounts of data and results that vary in terms of known clinical relevance. It is important to determine appropriate processes for protecting, managing and communicating the data. The use of machine learning for sequencing and interpretation of genomic data also raises concerns in terms of the potential for bias and potential implications for fiduciary obligations. NGS poses particular challenges in three main ethical areas: privacy, informed consent, and return of results.

View details for DOI 10.1080/23808993.2019.1599685

View details for PubMedID 32775691

View details for PubMedCentralID PMC7413244
Informed Consent: A Matter of Aspiration Since 1966 (At Least) AMERICAN JOURNAL OF BIOETHICS Wieten, S., Blythe, J., Magnus, D. 2019; 19 (5): 3?5
View details for DOI 10.1080/15265161.2019.1600903

View details for Web of Science ID 000467836100004
"Not Shared" Need Not Mean "Not Patient Centered": Deciding That a Patient Is Not a Candidate. JAMA internal medicine Blythe, J. A., Batten, J. N., Magnus, D. C. 2019; 179 (6): 851?52
View details for DOI 10.1001/jamainternmed.2019.1227

View details for PubMedID 31157845
What Does the Word "Treatable" Mean? Implications for Communication and Decision-Making in Critical Illness. Critical care medicine Batten, J. N., Kruse, K. E., Kraft, S. A., Fishbeyn, B., Magnus, D. C. 2018
Abstract

OBJECTIVES: To explore how nonphysicians and physicians interpret the word "treatable" in the context of critical illness.DESIGN: Qualitative study using in-depth interviews.SETTING: One academic medical center.SUBJECTS: Twenty-four nonphysicians (patients and community members) purposively sampled for variation in demographic characteristics and 24 physicians (attending physicians and trainees) purposively sampled from four specialties (critical care, palliative care, oncology, and surgery).INTERVENTIONS: None.MEASUREMENTS AND MAIN RESULTS: We identified two distinct concepts that participants used to interpret the word "treatable": 1) a "good news" concept, in which the word "treatable" conveys a positive message about a patient's future, thereby inspiring hope and encouraging further treatment and 2) an "action-oriented" concept, in which the word "treatable" conveys that physicians have an action or intervention available, but does not necessarily imply an improved prognosis or quality of life. The overwhelming majority of nonphysicians adopted the "good news" concept, whereas physicians almost exclusively adopted the "action-oriented" concept. For some nonphysicians, the word "treatable" conveyed a positive message about prognosis and/or further treatment, even when this contradicted previously stated negative information.CONCLUSIONS: Physician use of the word "treatable" may lead patients or surrogates to derive unwarranted good news and false encouragement to pursue treatment, even when physicians have explicitly stated information to the contrary. Further work is needed to determine the extent to which the word "treatable" and its cognates contribute to widespread decision-making and communication challenges in critical care, including discordance about prognosis, misconceptions that palliative treatments are curative, and disputes about potentially inappropriate or futile treatment.

View details for PubMedID 30585833
The One Health Approach to Zoonotic Emerging Infectious Diseases. The American journal of bioethics : AJOB Nichol, A., Magnus, D. 2018; 18 (10): 1?2
View details for PubMedID 30354866
We Convey More Than We (Literally) Say. The American journal of bioethics : AJOB Batten, J. N., Wong, B. O., Hanks, W. F., Magnus, D. 2018; 18 (9): 1?3
View details for PubMedID 30265601
A Qualitative Study on Inappropriate ICU Admissions: One Step Closer to Preventing Inappropriate ICU Care Harman, S., Marks, N., Kruse, K., Bruce, J., Magnus, D. ELSEVIER SCIENCE INC. 2018: 686
View details for Web of Science ID 000425399300304
Building a Trustworthy Precision Health Research Enterprise AMERICAN JOURNAL OF BIOETHICS Magnus, D., Batten, J. N. 2018; 18 (4): 1?2
View details for PubMedID 29621462
INAPPROPRIATE ICU ADMISSIONS: ONE STEP CLOSER TO ADDRESSING INAPPROPRIATE ICU CARE FOR PATIENTS Marks, R., Kruse, K., Magnus, D., Bruce, J., Harman, S. LIPPINCOTT WILLIAMS & WILKINS. 2018: 229
View details for DOI 10.1097/01.ccm.0000528506.64775.d8

View details for Web of Science ID 000436794300452
Transplant Listing Decisions: A National Survey of Adult and Pediatric Heart, Lung, Liver and Kidney Programs Wall, A., Magnus, D., Lee, G., Maldonado, J. WILEY. 2018: 95
View details for Web of Science ID 000419034500199
Managing Expectations: Delivering the Worst News in the Best Way? The American journal of bioethics : AJOB Burgart, A. M., Magnus, D. 2018; 18 (1): 1?2
View details for PubMedID 29313792
Anticipating uncertainty and irrevocable decisions: provider perspectives on implementing whole-genome sequencing in critically ill children with heart disease. Genetics in medicine : official journal of the American College of Medical Genetics Char, D. S., Lee, S. S., Magnus, D., Cho, M. 2018
Abstract

PurposeTo investigate the potential impacts of whole-genome sequencing (WGS) in the pediatric critical-care context, we examined how clinicians caring for critically ill children with congenital heart disease (CHD) anticipate and perceive the impact of WGS on their decision-making process and treatment recommendations.MethodsWe conducted semistructured in-person and telephone interviews of clinicians involved in the care of critically ill children with CHD at a high-volume pediatric heart center. We qualitatively analyzed the transcribed interviews.ResultsIn total, 34 clinicians were interviewed. Three themes emerged: (i) uncertainty about the accuracy of WGS testing and adequacy of testing validation; (ii) the use of WGS to facilitate life-limiting decisions such as futility, rationing, and selective prenatal termination; and (iii) moral distress over using WGS with a lack of decision support.ConclusionDespite uncertainty about WGS testing, the interviewed clinicians were using, and anticipated expanding the use of, WGS results to justify declarations of futility, withdrawal of care, and rationing in critically ill children with CHD. This situation is causing moral distress in providers who have to make high-stakes decisions involving WGS results, with only partial understanding of them. Decision support for clinicians, and discussion with families of the risks of using WGS for rationing or withdrawal, is needed.Genet Med advance online publication, 1 March 2018; doi:10.1038/gim.2018.25.

View details for PubMedID 29493583
Challenges to code status discussions for pediatric patients PLOS ONE Kruse, K. E., Batten, J., Constantine, M. L., Kache, S., Magnus, D. 2017; 12 (11): e0187375
Abstract

In the context of serious or life-limiting illness, pediatric patients and their families are faced with difficult decisions surrounding appropriate resuscitation efforts in the event of a cardiopulmonary arrest. Code status orders are one way to inform end-of-life medical decision making. The objectives of this study are to evaluate the extent to which pediatric providers have knowledge of code status options and explore the association of provider role with (1) knowledge of code status options, (2) perception of timing of code status discussions, (3) perception of family receptivity to code status discussions, and (4) comfort carrying out code status discussions.Nurses, trainees (residents and fellows), and attending physicians from pediatric units where code status discussions typically occur completed a short survey questionnaire regarding their knowledge of code status options and perceptions surrounding code status discussions.Single center, quaternary care children's hospital.203 nurses, 31 trainees, and 29 attending physicians in 4 high-acuity pediatric units responded to the survey (N = 263, 90% response rate). Based on an objective knowledge measure, providers demonstrate poor understanding of available code status options, with only 22% of providers able to enumerate more than two of four available code status options. In contrast, provider groups self-report high levels of familiarity with available code status options, with attending physicians reporting significantly higher levels than nurses and trainees (p = 0.0125). Nurses and attending physicians show significantly different perception of code status discussion timing, with majority of nurses (63.4%) perceiving discussions as occurring "too late" or "much too late" and majority of attending physicians (55.6%) perceiving the timing as "about right" (p<0.0001). Attending physicians report significantly higher comfort having code status discussions with families than do nurses or trainees (p?0.0001). Attending physicians and trainees perceive families as more receptive to code status discussions than nurses (p<0.0001 and p = 0.0018, respectively).Providers have poor understanding of code status options and differ significantly in their comfort having code status discussions and their perceptions of these discussions. These findings may reflect inherent differences among providers, but may also reflect discordant visions of appropriate care and function as a potential source of moral distress. Lack of knowledge of code status options and differences in provider perceptions are likely barriers to quality communication surrounding end-of-life options.

View details for PubMedID 29095938
Justice and Bioethics: Who Should Finance Academic Publishing? AMERICAN JOURNAL OF BIOETHICS Schuklenk, U., Magnus, D. 2017; 17 (10): 1?2
View details for DOI 10.1080/15265161.2017.1371995

View details for Web of Science ID 000414001500002

View details for PubMedID 29020551
Research on Medical Practices: Why Patients Consider Participating and the Investigational Misconception. IRB Kraft, S. A., Porter, K. M., Korngiebel, D. M., James, C., Constantine, M., Kelley, M., Capron, A. M., Diekema, D., Lee, S. S., Cho, M. K., Magnus, D., Wilfond, B. S. 2017; 39 (4): 10?16
Abstract

Understanding how patients decide whether to enroll in research can help improve educational materials, protocols, and recruitment rates. However, little is known about patients' willingness to participate in research on medical practices (ROMP), or studies comparing interventions within usual care. We assessed willingness to consider participating in ROMP by surveying 1095 adults in the United States, of whom 834 answered at least one open-ended question about their reasons for being willing or unwilling to consider participating in two scenarios involving ROMP. Most respondents were willing to consider participating in the research scenarios. The most commonly cited reasons for being willing to consider participating included benefit to others and oneself; the top reasons for being unwilling to consider participating included belief that the research was unsafe and an unfavorable view of experimentation. Responses also revealed misconceptions about ROMP among both those who were willing and unwilling to consider participating. Because these misconceptions may present an obstacle to recruiting participants in ROMP, there may be a need for educational initiatives to clarify the nature of these types of studies.

View details for PubMedID 30387977
Metaphors matter: from biobank to a library of medical information. Genetics in medicine : official journal of the American College of Medical Genetics Cho, M. K., Varsava, N., Kraft, S. A., Ashwal, G., Gillespie, K., Magnus, D., Ormond, K. E., Thomas, A., Wilfond, B. S., Lee, S. S. 2017
View details for PubMedID 29267267
A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent. Clinical trials Kraft, S. A., Constantine, M., Magnus, D., Porter, K. M., Lee, S. S., Green, M., Kass, N. E., Wilfond, B. S., Cho, M. K. 2016
Abstract

Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices.We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms.There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p?
View details for PubMedID 27625314
Can Destination Therapy be implemented in children with heart failure? A study of provider perceptions. Pediatric transplantation Char, D. S., Lee, S. S., Ikoku, A. A., Rosenthal, D., Magnus, D. 2016; 20 (6): 819-824
Abstract

DT is an established final therapeutic choice in adult patients with severe heart failure who do not meet criteria for cardiac transplantation. Patients are given VADs, without the prospect of care escalation to transplantation. VADs are now established therapy for children and are currently used as a bridge until transplantation can be performed or heart failure improves. For children who present in severe heart failure but do not meet transplantation criteria, the question has emerged whether DT can be offered. This qualitative study aimed to elicit the perspectives of early adopters of DT at one of the few institutions where DT has been provided for children. Responses were recorded and coded and themes extracted using grounded theory. Interviewees discussed: envisioning of the DT candidate; approach to evaluation for DT; contraindications to choosing DT; and concerns about choosing DT. Providers articulated two frameworks for conceptualizing DT: as a long bridge through resolution of problems that would initially contraindicate transplantation or, alternatively, as a true destination instead of transplantation. True destination, however, may not be the lasting concept for long-term VAD use in children given improvement in prognosis for current medical contraindications and improving VAD technology.

View details for DOI 10.1111/petr.12747

View details for PubMedID 27357389
Randomized n-of-1 Trials: Quality Improvement, Research, or Both? Pediatrics Samuel, J. P., Burgart, A., Wootton, S. H., Magnus, D., Lantos, J. D., Tyson, J. E. 2016; 138 (2)
Abstract

The regulatory demarcations between clinical research and quality improvement (QI) are ambiguous and controversial. Some projects that were undertaken as a form of QI were deemed by regulatory agencies to be research and thus to require institutional review board approval. In the era of personalized medicine, some physicians may ask some patients to participate in n-of-1 trials in an effort to personalize and optimize each patient's medical treatment. Should such activities be considered research, QI, or just excellent personalized medicine? Experts in research, research regulation, and bioethics analyze these issues.

View details for DOI 10.1542/peds.2016-1103

View details for PubMedID 27385811
Compassionate deactivation of ventricular assist devices in pediatric patients JOURNAL OF HEART AND LUNG TRANSPLANTATION Hollander, S. A., Axelrod, D. M., Bernstein, D., Cohen, H. J., Sourkes, B., Reddy, S., Magnus, D., Rosenthal, D. N., Kaufman, B. D. 2016; 35 (5): 564-567
Abstract

Despite greatly improved survival in pediatric patients with end-stage heart failure through the use of ventricular assist devices (VADs), heart failure ultimately remains a life-threatening disease with a significant symptom burden. With increased demand for donor organs, liberalizing the boundaries of case complexity, and the introduction of destination therapy in children, more children can be expected to die while on mechanical support. Despite this trend, guidelines on the ethical and pragmatic issues of compassionate deactivation of VAD support in children are strikingly absent. As VAD support for pediatric patients increases in frequency, the pediatric heart failure and palliative care communities must work toward establishing guidelines to clarify the complex issues surrounding compassionate deactivation. Patient, family and clinician attitudes must be ascertained and education regarding the psychological, legal and ethical issues should be provided. Furthermore, pediatric-specific planning documents for use before VAD implantation as well as deactivation checklists should be developed to assist with decision-making at critical points during the illness trajectory. Herein we review the relevant literature regarding compassionate deactivation with a specific focus on issues related to children.

View details for DOI 10.1016/j.healun.2016.03.020

View details for Web of Science ID 000376951900004

View details for PubMedID 27197773
Toward clinical genomics in everyday medicine: perspectives and recommendations. Expert review of molecular diagnostics Delaney, S. K., Hultner, M. L., Jacob, H. J., Ledbetter, D. H., McCarthy, J. J., Ball, M., Beckman, K. B., Belmont, J. W., Bloss, C. S., Christman, M. F., Cosgrove, A., Damiani, S. A., Danis, T., Delledonne, M., Dougherty, M. J., Dudley, J. T., Faucett, W. A., Friedman, J. R., Haase, D. H., Hays, T. S., Heilsberg, S., Huber, J., Kaminsky, L., Ledbetter, N., Lee, W. H., Levin, E., Libiger, O., Linderman, M., Love, R. L., Magnus, D. C., Martland, A., McClure, S. L., Megill, S. E., Messier, H., Nussbaum, R. L., Palaniappan, L., Patay, B. A., Popovich, B. W., Quackenbush, J., Savant, M. J., Su, M. M., Terry, S. F., Tucker, S., Wong, W. T., Green, R. C. 2016; 16 (5): 521-532
Abstract

Precision or personalized medicine through clinical genome and exome sequencing has been described by some as a revolution that could transform healthcare delivery, yet it is currently used in only a small fraction of patients, principally for the diagnosis of suspected Mendelian conditions and for targeting cancer treatments. Given the burden of illness in our society, it is of interest to ask how clinical genome and exome sequencing can be constructively integrated more broadly into the routine practice of medicine for the betterment of public health. In November 2014, 46 experts from academia, industry, policy and patient advocacy gathered in a conference sponsored by Illumina, Inc. to discuss this question, share viewpoints and propose recommendations. This perspective summarizes that work and identifies some of the obstacles and opportunities that must be considered in translating advances in genomics more widely into the practice of medicine.

View details for DOI 10.1586/14737159.2016.1146593

View details for PubMedID 26810587
Finding the Right Tools for Assessing Quality of Clinical Ethics Consultation AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2016; 16 (3): 1?2
View details for PubMedID 26913650
Professional Judgment and Justice: Equal Respect for the Professional Judgment of Critical-Care Physicians AMERICAN JOURNAL OF BIOETHICS Magnus, D., Rizk, N. 2016; 16 (1): 1?2
View details for PubMedID 26734733
Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System. AJOB empirical bioethics Lee, S. S., Kelley, M., Cho, M. K., Kraft, S. A., James, C., Constantine, M., Meyer, A. N., Diekema, D., Capron, A. M., Wilfond, B. S., Magnus, D. 2016; 7 (2): 125-134
Abstract

Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research.We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments.Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act, between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician-patient relationship.Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician-patient relationship is necessary to realize the full benefits of the learning health system.

View details for PubMedID 27917391

View details for PubMedCentralID PMC5130156
Commentary on Kim Miller. Clinical trials Magnus, D., Wilfond, B. 2015; 12 (6): 564-566
View details for DOI 10.1177/1740774515607368

View details for PubMedID 26419904

View details for PubMedCentralID PMC4643440
Informed Consent for Research on Medical Practices Response ANNALS OF INTERNAL MEDICINE Cho, M. K., Magnus, D., Wilfond, B. S. 2015; 163 (9): 725?26
View details for DOI 10.7326/L15-5152-2

View details for Web of Science ID 000365610600015

View details for PubMedID 26524577
Persistent Problems in Death and Dying AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2015; 15 (8): 1-2
View details for Web of Science ID 000359804500001

View details for PubMedID 26225502
Ethics of Disclosure Regarding Drug Shortages That Affect Patient Care. Anesthesia and analgesia Char, D. S., Magnus, D. 2015; 121 (2): 262-263
View details for DOI 10.1213/ANE.0000000000000842

View details for PubMedID 26197365
The Proper Locus of Professionalization: The Individual or the Institutions? AMERICAN JOURNAL OF BIOETHICS Magnus, D., Fishbeyn, B. 2015; 15 (5): 1-2
View details for DOI 10.1080/15265161.2015.1038936

View details for Web of Science ID 000354545400001

View details for PubMedID 25970381
Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations ACADEMIC MEDICINE Sharp, R. R., Taylor, H. A., Brinich, M. A., Boyle, M. M., Cho, M., Coors, M., Danis, M., Havard, M., Magnus, D., Wilfond, B. 2015; 90 (5): 615-620
Abstract

The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.

View details for DOI 10.1097/ACM.0000000000000640

View details for Web of Science ID 000353879700022

View details for PubMedID 25607942

View details for PubMedCentralID PMC4414686
The potential harms and benefits from research on medical practices. Hastings Center report Wilfond, B. S., Magnus, D. C. 2015; 45 (3): 5-6
View details for DOI 10.1002/hast.440

View details for PubMedID 25944197
Whole genome sequencing in critically ill children. The Lancet. Respiratory medicine Char, D. S., Cho, M., Magnus, D. 2015; 3 (4): 264-266
View details for DOI 10.1016/S2213-2600(15)00006-5

View details for PubMedID 25704991
Research on medical practices and the ethics of disclosure. Pediatrics Magnus, D., Wilfond, B. S. 2015; 135 (2): 208-210
View details for DOI 10.1542/peds.2014-3578

View details for PubMedID 25583909
Clinical Ethics Consultation: A Need for Evidence AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2015; 15 (1): 1-2
View details for DOI 10.1080/15265161.2015.987577

View details for Web of Science ID 000347528200001

View details for PubMedID 25562213
Genomics in the clinic: ethical and policy challenges in clinical next-generation sequencing programs at early adopter USA institutions. Personalized medicine Milner, L. C., Garrison, N. A., Cho, M. K., Altman, R. B., Hudgins, L., Galli, S. J., Lowe, H. J., Schrijver, I., Magnus, D. C. 2015; 12 (3): 269?82
Abstract

Next-generation sequencing (NGS) technologies are poised to revolutionize clinical diagnosis and treatment, but raise significant ethical and policy challenges. This review examines NGS program challenges through a synthesis of published literature, website and conference presentation content, and interviews at early-adopting institutions in the USA. Institutions are proactively addressing policy challenges related to the management and technical aspects of program development. However, ethical challenges related to patient-related aspects have not been fully addressed. These complex challenges present opportunities to develop comprehensive and standardized regulations across programs. Understanding the strengths, weaknesses and current practices of evolving NGS program approaches are important considerations for institutions developing NGS services, policymakers regulating or funding NGS programs and physicians and patients considering NGS services.

View details for PubMedID 29771644
Lift NIH restrictions on chimera research. Science (New York, N.Y.) Sharma, A., Sebastiano, V., Scott, C. T., Magnus, D., Koyano-Nakagawa, N., Garry, D. J., Witte, O. N., Nakauchi, H., Wu, J. C., Weissman, I. L., Wu, S. M. 2015; 350 (6261): 640
View details for PubMedID 26542560
Wrongful Termination: Lessons From the Geron Clinical Trial STEM CELLS TRANSLATIONAL MEDICINE Scott, C. T., Magnus, D. 2014; 3 (12): 1398-1401
Abstract

SUMMARYGeron Corporation is a publically traded company that launched a phase I clinical trial of a human embryonic stem cell-based therapy for spinal cord injury. The company enrolled the first patient in October 2010 and stopped the trial 1 year later. The fifth patient had been enrolled but not transplanted when the company announced the trial's end. After discussions with clinical staff and family, an agreement was reached to add her to the cohort and proceed with the transplant. Two and half years later, the research is still waiting to restart. With this background in mind, we discuss the major ethical and social questions raised by the Geron case. We offer recommendations for institutional review boards and clinical sites as they deliberate approvals of early-phase trials in frontier medicine.

View details for DOI 10.5966/sctm.2014-0147

View details for Web of Science ID 000346460900014

View details for PubMedID 25298371

View details for PubMedCentralID PMC4250218
Compassion and Research in Compassionate Use AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2014; 14 (11): 1-2
View details for DOI 10.1080/15265161.2014.969968

View details for Web of Science ID 000343211500002

View details for PubMedID 25325800
Innocent Fun or "Microslavery"? AN ETHICAL ANALYSIS OF BIOTIC GAMES HASTINGS CENTER REPORT Harvey, H., Havard, M., Magnus, D., Cho, M. K., Riedel-Kruse, I. H. 2014; 44 (6): 38-46
View details for DOI 10.1002/hast.386

View details for Web of Science ID 000345510900014
Innocent fun or "microslavery"? An ethical analysis of biotic games. Hastings Center report Harvey, H., Havard, M., Magnus, D., Cho, M. K., Riedel-Kruse, I. H. 2014; 44 (6): 38-46
View details for DOI 10.1002/hast.386

View details for PubMedID 25412975
AJOB 2.0: Taking Bioethics to a New Level. American journal of bioethics Magnus, D., Parsi, K., Sharp, R. 2014; 14 (8): 1-2
View details for DOI 10.1080/15265161.2014.936788

View details for PubMedID 25046284
Quality of Communication in Interpreted Versus Noninterpreted PICU Family Meetings*. Critical care medicine Van Cleave, A. C., Roosen-Runge, M. U., Miller, A. B., Milner, L. C., Karkazis, K. A., Magnus, D. C. 2014; 42 (6): 1507-1517
Abstract

To describe the quality of physician-family communication during interpreted and noninterpreted family meetings in the PICU.Prospective, exploratory, descriptive observational study of noninterpreted English family meetings and interpreted Spanish family meetings in the pediatric intensive care setting.A single, university-based, tertiary children's hospital.Participants in PICU family meetings, including medical staff, family members, ancillary staff, and interpreters.Thirty family meetings (21 English and nine Spanish) were audio-recorded, transcribed, de-identified, and analyzed using the qualitative method of directed content analysis.Quality of communication was analyzed in three ways: 1) presence of elements of shared decision-making, 2) balance between physician and family speech, and 3) complexity of physician speech. Of the 11 elements of shared decision-making, only four occurred in more than half of English meetings, and only three occurred in more than half of Spanish meetings. Physicians spoke for a mean of 20.7 minutes, while families spoke for 9.3 minutes during English meetings. During Spanish meetings, physicians spoke for a mean of 14.9 minutes versus just 3.7 minutes of family speech. Physician speech complexity received a mean grade level score of 8.2 in English meetings compared to 7.2 in Spanish meetings.The quality of physician-family communication during PICU family meetings is poor overall. Interpreted meetings had poorer communication quality as evidenced by fewer elements of shared decision-making and greater imbalance between physician and family speech. However, physician speech may be less complex during interpreted meetings. Our data suggest that physicians can improve communication in both interpreted and noninterpreted family meetings by increasing the use of elements of shared decision-making, improving the balance between physician and family speech, and decreasing the complexity of physician speech.

View details for DOI 10.1097/CCM.0000000000000177

View details for PubMedID 24394631
The SUPPORT Controversy and the Debate Over Research Within the Standard of Care AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2013; 13 (12): 1-2
View details for DOI 10.1080/15265161.2013.857257

View details for Web of Science ID 000327155300001

View details for PubMedID 24256521
A content analysis of posthumous sperm procurement protocols with considerations for developing an institutional policy. Fertility and sterility Bahm, S. M., Karkazis, K., Magnus, D. 2013; 100 (3): 839-843
Abstract

OBJECTIVE: To identify and analyze existing posthumous sperm procurement (PSP) protocols in order to outline central themes for institutions to consider when developing future policies. DESIGN: Qualitative content analysis. SETTING: Large academic institutions across the United States. PATIENT(S): N/A. INTERVENTION(S): We performed a literature search and contacted 40 institutions to obtain nine full PSP protocols. We then performed a content analysis on these policies to identify major themes and factors to consider when developing a PSP protocol. MAIN OUTCOME MEASURE(S): Presence of a PSP policy. RESULT(S): We identified six components of a thorough PSP protocol: Standard of Evidence, Terms of Eligibility, Sperm Designee, Restrictions on Use in Reproduction, Logistics, and Contraindications. We also identified two different approaches to policy structure. In the Limited Role approach, institutions have stricter consent requirements and limit their involvement to the time of procurement. In the Family-Centered approach, substituted judgment is permitted but a mandatory wait period is enforced before sperm use in reproduction. CONCLUSION(S): Institutions seeking to implement a PSP protocol will benefit from considering the six major building blocks of a thorough protocol and where they would like to fall on the spectrum from a Limited Role to a Family-Centered approach.

View details for DOI 10.1016/j.fertnstert.2013.05.002

View details for PubMedID 23773314
Best ethical practices for clinicians and laboratories in the provision of noninvasive prenatal testing. Prenatal diagnosis Allyse, M. A., Sayres, L. C., Havard, M., King, J. S., Greely, H. T., Hudgins, L., Taylor, J., Norton, M. E., Cho, M. K., Magnus, D., Ormond, K. E. 2013; 33 (7): 656-661
Abstract

OBJECTIVE: The goal of this study is to provide an ethical framework for clinicians and companies providing noninvasive prenatal testing using cell-free fetal DNA or whole fetal cells. METHOD: In collaboration with a National Institutes of Health-supported research ethics consultation committee together with feedback from an interdisciplinary group of clinicians, members of industry, legal experts, and genetic counselors, we developed a set of best practices for the provision of noninvasive prenatal genetic testing. RESULTS: Principal recommendations include the amendment of current informed consent procedures to include attention to the noninvasive nature of new testing and the potential for a broader range of results earlier in the pregnancy. We strongly recommend that tests should only be provided through licensed medical providers and not directly to consumers. CONCLUSION: Prenatal tests, including new methods using cell-free fetal DNA, are not currently regulated by government agencies, and limited professional guidance is available. In the absence of regulation, companies and clinicians should cooperate to adopt responsible best ethical practices in the provision of these tests. � 2013 John Wiley & Sons, Ltd.

View details for DOI 10.1002/pd.4144

View details for PubMedID 23613322
Overthrowing the tyranny of the journal impact factor. American journal of bioethics Magnus, D. 2013; 13 (7): 1-2
View details for DOI 10.1080/15265161.2013.807709

View details for PubMedID 23767427
The OHRP and SUPPORT NEW ENGLAND JOURNAL OF MEDICINE Wilfond, B. S., Magnus, D., Antommaria, A. H., Appelbaum, P., Aschner, J., Barrington, K. J., Beauchamp, T., Boss, R. D., Burke, W., Caplan, A. L., Capron, A. M., Cho, M., Clayton, E., Cole, F., Darlow, B. A., Diekema, D., Faden, R. R., Feudtner, C., Fins, J. J., Fost, N. C., Frader, J., Hester, D., Janvier, A., Joffe, S., Kahn, J., Kass, N. E., Kodish, E., Lantos, J. D., McCullough, L., McKinney, R., Meadow, W., O'Rourke, P., Powderly, K. E., Pursley, D. M., Ross, L., Sayeed, S., Sharp, R. R., Sugarman, J., Tarnow-Mordi, W. O., Taylor, H., Tomlinson, T., Truog, R. D., Unguru, Y. T., Weise, K. L., Woodrum, D., Youngner, S. 2013; 368 (25): E36-+
View details for DOI 10.1056/NEJMc1307008

View details for Web of Science ID 000320601700038

View details for PubMedID 23738513
Parental refusal of vaccination and transplantation listing decisions: A nationwide survey. Pediatric transplantation Ladd, J. M., Karkazis, K., Magnus, D. 2013; 17 (3): 244-250
Abstract

Many professional societies and research studies recommend complete vaccination before pediatric solid organ transplantation. Nevertheless, incompletely vaccinated children often receive transplants. As the number of parents refusing to vaccinate children for nonmedical reasons increases, pediatric transplantation programs face difficult listing decisions. Given the importance of psychosocial criteria in listing decisions, this study explores how parental refusal of vaccination affects those listing decisions. Surveys were emailed to individuals at 195 pediatric solid organ transplantation programs in the United States, with a 71% response rate. Forty-four respondents (39%) reported that their programs have had cases involving parental refusal of vaccination. In response to hypothetical scenarios, 93 respondents (82%) would list a child not vaccinated for medical reasons, whereas only 54 respondents (47%) would list a child whose parents refused vaccination. Only five respondents (4%) reported that their programs had written policies regarding parental refusal of vaccination. These data reveal inconsistencies across pediatric transplantation programs regarding how parental refusal of vaccination affects listing decisions and raise the issue of whether and how the reason for incomplete vaccination should be factored into listing decisions. We recommend further discussion and the development of written guidelines to unify programs' assessments of incompletely vaccinated pediatric transplantation candidates.

View details for DOI 10.1111/petr.12046

View details for PubMedID 23347536
Can Informed Consent Go Too Far? Balancing Consent and Public Benefit in Research AMERICAN JOURNAL OF BIOETHICS Milner, L. C., Magnus, D. 2013; 13 (4): 1-2
View details for DOI 10.1080/15265161.2013.778645

View details for Web of Science ID 000316391200002

View details for PubMedID 23514383
Suicide and the sufficiency of surrogate decision makers. American journal of bioethics Taye, H., Magnus, D. 2013; 13 (3): 1-2
View details for DOI 10.1080/15265161.2013.769827

View details for PubMedID 23428024
100th Issue Anniversary Editorial AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2013; 13 (1): 1-2
View details for DOI 10.1080/15265161.2013.747307

View details for Web of Science ID 000315983000001

View details for PubMedID 23311828
Customers or research participants?: Guidance for research practices in commercialization of personal genomics GENETICS IN MEDICINE Tobin, S. L., Cho, M. K., Lee, S. S., Magnus, D. C., Allyse, M., Ormond, K. E., Garrison, N. A. 2012; 14 (10): 833-835
View details for DOI 10.1038/gim.2012.64

View details for Web of Science ID 000309645900001

View details for PubMedID 22699154
Informational risk, institutional review, and autonomy in the proposed changes to the common rule. IRB Allyse, M., Karkazis, K., Lee, S. S., Tobin, S. L., Greely, H. T., Cho, M. K., Magnus, D. 2012; 34 (3): 17-19
View details for PubMedID 22830179
Triggers for Research Ethics Consultation SCIENCE TRANSLATIONAL MEDICINE Havard, M., Cho, M. K., Magnus, D. 2012; 4 (118)
Abstract

Research ethics consultation services are designed to help scientists address ethical and societal issues that may not be considered in the context of existing regulatory frameworks, such as institutional review boards. Here, we identify some types of biomedical research for which the research process can benefit from consultation with ethicists.

View details for DOI 10.1126/scitranslmed.3002734

View details for Web of Science ID 000299539500001

View details for PubMedID 22277965
Duty-Free: The Non-Obligatory Nature of Preimplantation Genetic Diagnosis AMERICAN JOURNAL OF BIOETHICS Sayres, L. C., Magnus, D. 2012; 12 (4): 1-2
View details for DOI 10.1080/15265161.2012.669269

View details for Web of Science ID 000302916400001

View details for PubMedID 22452462
The Instrumental Role of Hospital Ethics Committees in Policy Work AMERICAN JOURNAL OF BIOETHICS Garrison, N. A., Magnus, D. 2012; 12 (11): 1-2
View details for DOI 10.1080/15265161.2012.729935

View details for Web of Science ID 000310137100001

View details for PubMedID 23072670
Medical and graduate students' attitudes toward personal genomics GENETICS IN MEDICINE Ormond, K. E., Hudgins, L., Ladd, J. M., Magnus, D. M., Greely, H. T., Cho, M. K. 2011; 13 (5): 400-408
Abstract

Medical schools are being approached by direct-to-consumer genotyping companies about genotyping faculty or trainees as a method to "teach" them about the potential implications of genotyping. In thinking about the future incorporation of genotyping into a graduate level genetics course, the purpose of this study was 2-fold: first, to assess knowledge, attitudes, and beliefs of students toward personal genomics as it related to themselves as both as customers and future physicians and as it related to consumers at large, and second, to determine the impact of the course (as taught without genotyping) on knowledge, attitudes, and beliefs.We surveyed first-year medical students and graduate students before and after a core genetics course.After the course, students were less likely to believe that genotyping information would be useful to physicians, patients, or consumers; genotyping would provide information to improve their own personal health; or personal genomic testing services are diagnostic of medical conditions. They were more likely to answer knowledge questions accurately after the course but still had difficulty with clinical interpretation. Despite these changes, a slight majority of students were, and remained, interested in undergoing genotyping themselves. Of note, the number who believed genotyping "would help them understand genetic concepts better than someone else's data" decreased. General curiosity was the most commonly chosen reason for interest in undergoing genotyping, and approximately 50% of respondents expressed concern about confidentiality of results.In conclusion, even without the genotyping process, an educational program about genotyping increased knowledge, particularly about the clinical limitations of genotyping, but student interest in genotyping did not significantly change. Institutions thinking about offering genotyping to their students as part of a learning experience should consider the pros and cons of doing so.

View details for DOI 10.1097/GIM.0b013e31820562f6

View details for Web of Science ID 000290435700005

View details for PubMedID 21270640
Beyond the IRB: Local Service Versus Global Oversight AMERICAN JOURNAL OF BIOETHICS Havard, M., Magnus, D. 2011; 11 (5): 1-2
View details for DOI 10.1080/15265161.2011.576932

View details for Web of Science ID 000290053400002

View details for PubMedID 21534135
Sexless Reproduction: A Status Symbol AMERICAN JOURNAL OF BIOETHICS Havard, M., Magnus, D. 2011; 11 (3): 1-1
View details for DOI 10.1080/15265161.2011.556531

View details for Web of Science ID 000288275900001

View details for PubMedID 21400372
Can the Dead Donor Rule be Resuscitated? AMERICAN JOURNAL OF BIOETHICS Vernez, S. L., Magnus, D. 2011; 11 (8): 1-1
View details for DOI 10.1080/15265161.2011.602260

View details for Web of Science ID 000293843800003

View details for PubMedID 21806426
Translating Stem Cell Research: Challenges at the Research Frontier JOURNAL OF LAW MEDICINE & ETHICS Magnus, D. 2010; 38 (2): 267-?
Abstract

This paper will address the translation of basic stem cell research into clinical research. While "stem cell" trials are sometimes used to describe established practices of bone marrow transplantation or transplantation of primary cells derived from bone marrow, for the purposes of this paper, I am primarily focusing on stem cell trials which are far less established, including use of hESC derived stem cells. The central ethical challenges in stem cell clinical trials arise in frontier research, not in standard, well-established areas of research.

View details for Web of Science ID 000279534400011

View details for PubMedID 20579250
Empirical Methods in Bioethics: A Cautionary Tale ANNALS OF INTERNAL MEDICINE Braddock, C. H., Magnus, D. 2010; 152 (6): 396-?
View details for Web of Science ID 000275905200009

View details for PubMedID 20231572
The History of The American Journal of Bioethics AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2010; 10 (10): 3-3
View details for DOI 10.1080/15265161.2010.527273

View details for Web of Science ID 000282971200002

View details for PubMedID 20945258
Bioethics and President Obama AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2010; 10 (5): 1?2
View details for DOI 10.1080/15265161.2010.488152

View details for Web of Science ID 000277751500001

View details for PubMedID 20461634
Emergency Innovation: Implications for the Trauma Surgeon JOURNAL OF TRAUMA-INJURY INFECTION AND CRITICAL CARE Pretz, J. L., Magnus, D., Spain, D. A. 2009; 67 (6): 1443-1447
Abstract

Experimentation involving human subjects requires careful attention to the protection of their rights. Beginning with the Belmont Report in 1979, the United States has developed various sets of rules and regulations that identify the requirements for performing human subject research. In addition, these standards attempt to define the fundamental difference between what constitutes research versus clinical treatment versus innovation. We explore the intersection between two areas of independent bioethics, surgical innovation and emergency research; the point we refer to as emergency innovation.A systematic literature review in each of the fields of emergency research and surgical innovation was completed. The ethical principles involved in each field were identified. In addition, a recent case of surgical innovation within the context of emergency treatment is evaluated for the ethics invoked.One of the great challenges in emergency innovation is that the main protection offered in innovation (heightened informed consent) is not possible in the emergency context where in fact informed consent is waived. Interestingly, the rest of the protections outlined for each field are not mutually exclusive. They can and should be utilized in any project that takes place at this intersection. However, as there are no strict regulations in place for the collision of these two fields, the possibility of having the majority of the involved ethical principles misinterpreted or ignored is very real.For emergency innovation, where it is unclear what ethical principles and regulatory powers apply, it is imperative to be unambiguous about the purpose of the investigation, to adhere to all applicable ethical principles, and to have utmost consideration for protection of the research subject. To determine intent, the goals of the study must be outlined precisely - and if those include the prospect of publication, institutional review board (IRB) approval should be involved early. If, however, the innovation is subtle and the goal geared toward improved patient care, a small feasibility trial would be an appropriate first step before transitioning to a formal larger study approved by an IRB. In either case, the degree of the change in practice must be carefully evaluated and the vulnerability of the research subjects respected. With careful attention paid to all applicable ethical principles at the emergency innovation intersection, medical progress can continue at minimized risk to the human subject participants.

View details for DOI 10.1097/TA.0b013e3181bba255

View details for Web of Science ID 000272658100060

View details for PubMedID 20009701
Use of neurodevelopmental delay in pediatric solid organ transplant listing decisions: Inconsistencies in standards across major pediatric transplant centers PEDIATRIC TRANSPLANTATION Richards, C. T., Crawley, L. M., Magnus, D. 2009; 13 (7): 843-850
Abstract

Children with NDD present for organ transplant evaluation, but the role of NDD as a listing criterion itself is poorly described. Therefore, we sought to investigate how major pediatric solid organ transplant programs use NDD as a criterion in their listing decisions. We developed a survey that was sent via post to active pediatric solid organ transplant programs across the United States investigating transplant listing decision-making for neurodevelopmentally delayed children. Respondents were medical/surgical directors and transplant coordinators. Descriptive statistics summarize the findings. Programs inconsistently use NDD in listing decisions. Thirty-nine percent of programs stated that they "rarely" or "never" consider NDD in their decisions, whereas 43% of programs "always" or "usually" do. Sixty-two percent of programs report that informal processes guide their use of NDD, and no programs describe their process as "formal, explicit, and uniform." The degree of delay is an additional source of discordance among programs, with 14% of programs reporting mild or moderate NDD as a relative contraindication to listing and 22% reporting that NDD was "irrelevant" to the listing decision. The use of NDD in pediatric solid organ transplant listing decisions is varied and inconsistent across active programs.

View details for DOI 10.1111/j.1399-3046.2008.01072.x

View details for Web of Science ID 000270666600010

View details for PubMedID 19067911
Direct-to-consumer genetic tests: beyond medical regulation? GENOME MEDICINE Magnus, D., Cho, M. K., Cook-Deegan, R. 2009; 1
Abstract

The availability of personalized genomic tests, ordered directly by consumers, is rapidly growing. These tests are unlike other genetic or biochemical tests in the sheer amount of data they provide, but interpretation of these genome-wide analyses for health remains uncertain because of the lack of information about environmental and other factors, and because for the vast majority of genetic loci the associations with disease are weak. Although these tests could provide value to customers by offering tools for social networking or genealogy, there are questions about whether and how to regulate these tests and about the extent to which they provide medical information.

View details for DOI 10.1186/gm17

View details for Web of Science ID 000208627000017

View details for PubMedCentralID PMC2664950
Organizational Needs Versus Ethics Committee Practice AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2009; 9 (4): 1?2
View details for DOI 10.1080/15265160902790518

View details for Web of Science ID 000264641800001

View details for PubMedID 19326297
Direct-to-consumer genetic tests: beyond medical regulation? Genome medicine Magnus, D., Cho, M. K., Cook-Deegan, R. 2009; 1 (2): 17-?
Abstract

The availability of personalized genomic tests, ordered directly by consumers, is rapidly growing. These tests are unlike other genetic or biochemical tests in the sheer amount of data they provide, but interpretation of these genome-wide analyses for health remains uncertain because of the lack of information about environmental and other factors, and because for the vast majority of genetic loci the associations with disease are weak. Although these tests could provide value to customers by offering tools for social networking or genealogy, there are questions about whether and how to regulate these tests and about the extent to which they provide medical information.

View details for DOI 10.1186/gm17

View details for PubMedID 19341488
Research ethics consultation: the Stanford experience. IRB Cho, M. K., Tobin, S. L., Greely, H. T., McCormick, J., Boyce, A., Magnus, D. 2008; 30 (6): 1-6
View details for PubMedID 19119757
Strangers at the Benchside: Research ethics consultation AMERICAN JOURNAL OF BIOETHICS Cho, M. K., Tobin, S. L., Greely, H. T., McCormick, J., Boyce, A., Magnus, D. 2008; 8 (3): 4-13
Abstract

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program.

View details for DOI 10.1080/15265160802109322

View details for Web of Science ID 000257030400004

View details for PubMedID 18570086

View details for PubMedCentralID PMC2585006
Response to open peer commentaries on "Strangers at the Beachside: Research Ethics Consultation" AMERICAN JOURNAL OF BIOETHICS Cho, M. K., Tobin, S. L., Greely, H. T., McCormick, J., Boyce, A., Magnus, D. 2008; 8 (3): W4?W6
View details for DOI 10.1080/15265160802132951

View details for Web of Science ID 000257030400002
The green revolution in bioethics AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2008; 8 (8): 1-2
View details for DOI 10.1080/15265160802424135

View details for Web of Science ID 000259331900002

View details for PubMedID 18802846
Federalism & bioethics - States and moral pluralism HASTINGS CENTER REPORT Fossett, J. W., Ouellette, A. R., Philpott, S., Magnus, D., Mcgee, G. 2007; 37 (6): 24-35
Abstract

Bioethicists are often interested mostly in national standards and institutions, but state governments have historically overseen a wide range of bioethical issues and share responsibility with the federal government for still others. States ought to have an important role. By allowing for multiple outcomes, the American federal system allows a better fit between public opinion and public policies.

View details for Web of Science ID 000251116100020

View details for PubMedID 18179102
Stem Cell Research Ethics: Consensus Statement on Emerging Issues JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA Caulfield, T., Ogbogu, U., Nelson, E., Einsiedel, E., Knoppers, B., McDonald, M., Brunger, F., Downey, R., Fernando, K., Galipeau, J., Geransar, R., Grenier, G., Hyun, I., Isasi, R., Kardel, M., Knowles, L., Kucic, T., Lotjonen, S., Lyall, D., Magnus, D., Mathews, D. H., Nisbet, M., Nisker, J., Pare, G., Pattinson, S., Pullman, D., Rudnicki, M., Williams-Jones, B., Zimmerman, S. 2007; 29 (10): 843?48
Abstract

This article is a consensus statement by an international interdisciplinary group of academic experts and Canadian policy-makers on emerging ethical, legal and social issues in human embryonic stem cells (hESC) research in Canada. The process of researching consensus included consultations with key stakeholders in hESC research (regulations, stem cell researchers, and research ethics experts), preparation and distribution of background papers, and an international workshop held in Montreal in February 2007 to discuss the papers and debate recommendations. The recommendations provided in the consensus statement focus on issues of immediate relevance to Canadian policy-makers, including informed consent to hESC research, the use of fresh embryos in research, management of conflicts of interest, and the relevance of public opinion research to policy-making.

View details for DOI 10.1016/S1701-2163(16)32632-9

View details for Web of Science ID 000443012900013

View details for PubMedID 17915069
Playing it safe AMERICAN JOURNAL OF BIOETHICS Magnus, D. 2007; 7 (3): 1?2
View details for DOI 10.1080/15265160701232795

View details for Web of Science ID 000245028900001

View details for PubMedID 17366216
Blood, sweat and tears AMERICAN JOURNAL OF BIOETHICS Magnus, D. C. 2006; 6 (3): 1-2
View details for DOI 10.1080/15265160600781488

View details for Web of Science ID 000238283800001

View details for PubMedID 16754438
Research conduct - Lessons of the stem cell scandal SCIENCE Cho, M. K., McGee, G., Magnus, D. 2006; 311 (5761): 614-615
View details for DOI 10.1126/science.1124948

View details for Web of Science ID 000235257400030

View details for PubMedID 16456065
Stem cell research: The California experience HASTINGS CENTER REPORT Magnus, D. 2006; 36 (1): 26-28
View details for Web of Science ID 000235069900019

View details for PubMedID 16544836
A commentary on oocyte donation for stem cell research in South Korea AMERICAN JOURNAL OF BIOETHICS Magnus, D., Cho, M. K. 2006; 6 (1): W23-W24
View details for DOI 10.1080/15265160500496666

View details for Web of Science ID 000235709600029

View details for PubMedID 16423767
Issues in oocyte donation for stem cell research SCIENCE Magnus, D., Cho, M. K. 2005; 308 (5729): 1747-1748
View details for DOI 10.1126/science.1114454

View details for Web of Science ID 000229926800039

View details for PubMedID 15905363
Stem cell research should be more than a promise HASTINGS CENTER REPORT Magnus, D. 2004; 34 (5): 35-36
View details for Web of Science ID 000224607200019

View details for PubMedID 15553398
Politics and peer review. American journal of bioethics Magnus, D. 2004; 4 (1): 7-8
View details for PubMedID 15035920
New life forms: New threats, new possibilities HASTINGS CENTER REPORT Caplan, A. L., Magnus, D. 2003; 33 (6): 7-7
View details for Web of Science ID 000188390800010

View details for PubMedID 14983550
In focus. Core faculty and their publications at bioethics centers in the United States. American journal of bioethics Magnus, D., Miller, V., Carroll, K. 2002; 2 (4): W20-?
View details for PubMedID 12778940
Evaluating graduate programs in bioethics: what measures should we use? American journal of bioethics Mcgee, G., Magnus, D., Carroll, K. 2002; 2 (4): 1-2
View details for PubMedID 12784805
The meaning of graduate education for bioethics. American journal of bioethics Magnus, D. 2002; 2 (4): 10-12
View details for PubMedID 12762912
Is there a bioethicist in your company? Should there be? DRUG DISCOVERY TODAY Magnus, D. 2002; 7 (7): 385-387
View details for Web of Science ID 000174556700001

View details for PubMedID 11916559
Protecting subjects' interests in genetics research AMERICAN JOURNAL OF HUMAN GENETICS Merz, J. F., Magnus, D., Cho, M. K., Caplan, A. L. 2002; 70 (4): 965-971
Abstract

Biomedical researchers often assume that sponsors, subjects, families, and disease-associated advocacy groups contribute to research solely because of altruism. This view fails to capture the diverse interests of many participants in the emerging research enterprise. In the past two decades, patient groups have become increasingly active in the promotion and facilitation of genetics research. Simultaneously, a significant shift of academic biomedical science toward commercialization has occurred, spurred by U.S. federal policy changes. The concurrent rise in both the roles that subjects play and the commercial interests they have presents numerous ethical challenges. We examine the interests of different research participants, finding that these interests are not addressed by current policies and practices. We conclude that all participants should be given a voice in decisions affecting ownership, access to, and use of commercialized products and services, and that researchers and institutions should negotiate issues relating to control of research results and the sharing of benefits before the research is performed.

View details for Web of Science ID 000174252100013

View details for PubMedID 11870592

View details for PubMedCentralID PMC379126
Who Owns Life? David Magnus, Ed. with Art Caplan, Glenn McGee 2002
NAS cloning hearing disappoints participants SCIENCE Magnus, D., Caplan, A. 2001; 294 (5547): 1651-1651
View details for Web of Science ID 000172307400017

View details for PubMedID 11724062
Reason and repugnance. Medical ethics (Burlington, Mass.) Callahan, D., Magnus, D. 2001: 6-7
View details for PubMedID 15584188
Bioethics programs evolve as they grow - With bioethics squarely in the news comes new scrutiny on exactly what it takes to train a bioethicist. NATURE BIOTECHNOLOGY Magnus, D. 2001; 19 (10): 991-992
View details for Web of Science ID 000171417600031

View details for PubMedID 11581672
Family problems. American journal of bioethics Magnus, D., DAGOSTINO, L. 2001; 1 (3): 1-?
View details for PubMedID 11954574
The AJOB Experiment. American journal of bioethics McGee, G., Magnus, D. 2001; 1 (1): 1-?
View details for DOI 10.1162/152651601750078835

View details for PubMedID 22494011
Ethical issues: from genome to therapy. Novartis Foundation symposium Magnus, D. 2000; 229: 122-125
View details for PubMedID 11084937
Policy forum: genetics. Ethical considerations in synthesizing a minimal genome. Science Cho, M. K., Magnus, D., Caplan, A. L., McGee, D. 1999; 286 (5447): 2087-?
View details for PubMedID 10617419
What is immoral about eugenics? BRITISH MEDICAL JOURNAL Caplan, A. L., McGee, G., Magnus, D. 1999; 319 (7220): 1284-U19
View details for Web of Science ID 000083786900007

View details for PubMedID 10559038
What is immoral about eugenics? WESTERN JOURNAL OF MEDICINE Caplan, A. L., McGee, G., Magnus, D. 1999; 171 (5-6): 335-337
View details for Web of Science ID 000084352100024

View details for PubMedID 18751200
Disease gene patenting: The clinician's dilemma CAMBRIDGE QUARTERLY OF HEALTHCARE ETHICS Magnus, D. 1998; 7 (4): 433-435
View details for Web of Science ID 000075650700016

View details for PubMedID 9752586
HIDDEN ADAPTATIONISM BEHAVIORAL AND BRAIN SCIENCES Magnus, D., Thiel, P. 1990; 13 (1): 26-?
View details for Web of Science ID A1990CT38000020

David Magnus, Ph.D.

Thomas A. Raffin Professor in Medicine and Biomedical Ethics and Professor (Teaching) of Medicine (Primary Care and Population Health)

Pediatrics - Center for Biomedical Ethics

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