346 results match your criteria: "Center for Biomedical Ethics and Society.[Affiliation]"

USMLE Step 1 Scoring Changes and the Urology Residency Application Process: Program Directors' Perspectives.

Urology

November 2020

Department of Plastic Surgery, Vanderbilt University Medical Center, Nashville, TN; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN; Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, TN. Electronic address:

Objective: To capture the perspectives of urology program directors (PDs) regarding the change in United States Medical Licensing Examination (USMLE) Step 1 scoring to pass/fail (binary) and the impact of this change on the urology residency application process.

Methods: A validated survey was developed and distributed via email to urology PDs at all Accreditation Council for Graduate Medical Education-accredited programs.

Results: A total of 65 PDs completed the survey, for a response rate of 49.

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COVID-19 - Implications on and of Surgical Practices: Where Do We Draw the Line?

Ann Surg

August 2020

Department of Plastic Surgery, Department of Biomedical Informatics, Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tennessee.

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The Change of USMLE Step 1 to Pass/Fail: Perspectives of the Surgery Program Director.

J Surg Educ

June 2021

Department of Plastic Surgery, Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tennessee. Electronic address:

Objective: This study sought to evaluate the perspectives of surgical program directors regarding the change of USMLE Step 1 to pass/fail grading.

Design: Validated electronic survey.

Setting: Vanderbilt University Medical Center Department of Plastic Surgery.

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Objective Measures Needed - Program Directors' Perspectives on a Pass/Fail USMLE Step 1.

N Engl J Med

June 2020

From the School of Medicine, Vanderbilt University (A.T.M.), and the Department of Plastic Surgery (M.E.P., B.C.D.), the Department of Biomedical Informatics (B.C.D.), and the Center for Biomedical Ethics and Society (B.C.D.), Vanderbilt University Medical Center - both in Nashville; and the Department of Surgery, Section of Plastic Surgery, University of Michigan Health System, Ann Arbor (N.G.K.).

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Purpose: The Electronic Medical Records and Genomics (eMERGE) Consortium integrated biorepository-based research with electronic health records (EHR) to return results from large-scale genetic tests to participants and uploaded those data into the EHR. This article explores the ethical issues investigators encountered in that process.

Methods: We conducted in-depth, semistructured interviews with study personnel of the eMERGE-III Consortium sites that returned results.

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Coronavirus Disease 2019: Withdrawing Mechanical Ventilation to Reallocate Life Support Under Crisis Standards of Care-Nonequivalence of the Equivalence Thesis.

Crit Care Med

October 2020

Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University, Nashville, TN, VA Tennessee Valley Healthcare System, Geriatric Research, Education and Clinical Center (GRECC), Nashville, TN, and Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center at Vanderbilt, Nashville, TN.

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The urgent drive for vaccine development in the midst of the current COVID-19 pandemic has prompted public and private organisations to invest heavily in research and development of a COVID-19 vaccine. Organisations globally have affirmed the commitment of fair global access, but the means by which a successful vaccine can be mass produced and equitably distributed remains notably unanswered. Barriers for low-income countries include the inability to afford vaccines as well as inadequate resources to vaccinate, barriers that are exacerbated during a pandemic.

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Characterizing the Global Need for Plastic Surgery Service.

Plast Reconstr Surg

September 2020

Department of Plastic Surgery, Department of Biomedical Informatics, Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tenn.

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Developing model biobanking consent language: what matters to prospective participants?

BMC Med Res Methodol

May 2020

Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, 2525 West End Avenue, Suite 400, Nashville, TN, 37203, USA.

Background: Efforts to improve informed consent have led to calls for providing information a reasonable person would want to have, in a way that facilitates understanding of the reasons why one might or might not want to participate. At the same time, advances in large-scale genomic research have expanded both the opportunities and the risks for participants, families, and communities. To advance the use of effective consent materials that reflect this landscape, we used empirical data to develop model consent language, as well as brief questions to assist people in thinking about their own values relative to participation.

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Importance: Parents who receive a prenatal diagnosis of congenital heart disease may experience more short- and long-term stress than those who receive a postnatal diagnosis. To identify potential interventions to ameliorate that stress, the longitudinal emotional experience of parents must first be understood.

Objective: To better understand parents' accounts of their own prenatal experience, particularly aspects they found to be stressful or challenging, and to identify strategies to improve support.

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Article Synopsis
  • The eMERGE3 Network aimed to study how to return actionable genetic test results for over 100 genes to participants and their healthcare providers.
  • Each of the 10 eMERGE sites created customized plans focusing on three key aspects: informing participants, notifying healthcare providers, and incorporating results into electronic health records (EHR).
  • The variation in RoR processes across sites highlights the need for different approaches in genomic medicine, accounting for diverse patient needs and specific institutional requirements.
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The Implementation Chasm Hindering Genome-informed Health Care.

J Law Med Ethics

March 2020

Kevin B. Johnson, M.D., M.S., is Cornelius Vanderbilt Professor and Chair of Biomedical Informatics, with a joint appointment in the Department of Pediatrics at Vanderbilt University Medical Center. He received his M.D. from Johns Hopkins Hospital in Baltimore and his M.S. in Medical Informatics from Stanford University in 1992. Ellen Wright Clayton, M.D., J.D., is the Craig-Weaver Professor of Pediatrics, Professor of Health Policy in the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center, and Professor of Law at Vanderbilt University. She has been studying the ethical, legal, and social implications of genetics research and its translation to the clinic for many years. She is currently a PI of LawSeq as well as GetPreCiSe, a Center of Excellence in ELSI Research focused on genetic privacy and identity, and has been an investigator in the eMERGE Network since its inception. Justin Starren, M.D., M.S., Ph.D., is Professor of Preventive Medicine and Medical Social Sciences and Chief of the Division of Health and Biomedical Informatics at the Northwestern University Feinberg School of Medicine. He received his M.D. and M.S. in Immunogenetics from Washington University in St. Louis in 1987, and his Ph.D. in Biomedical Informatics from Columbia University in 1997. Josh Peterson, M.D., M.P.H., is an Associate Professor of Biomedical Informatics and Medicine at Vanderbilt University Medical Center. He received his M.D. from Vanderbilt University in 1997 and his M.P.H. from Harvard University School of Public Health in 2002.

The promises of precision medicine are often heralded in the medical and lay literature, but routine integration of genomics in clinical practice is still limited. While the "last mile' infrastructure to bring genomics to the bedside has been demonstrated in some healthcare settings, a number of challenges remain - both in the receptivity of today's health system and in its technical and educational readiness to respond to this evolution in care. To improve the impact of genomics on health and disease management, we will need to integrate both new knowledge and new care processes into existing workflows.

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Protecting Participants in Genomic Research: Understanding the "Web of Protections" Afforded by Federal and State Law.

J Law Med Ethics

March 2020

Leslie E. Wolf, J.D., M.P.H., is a Distinguished University Professor and Professor of Law at Georgia State University College of Law in Atlanta, Georgia and Director of the GSU Center for Law, Health & Society. Catherine M. Hammack, J.D., M.A., is an Associate in Health Policy and a member of the core faculty of the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center in Nashville, Tennessee. Erin Fuse Brown, J.D., M.P.H., is an Associate Professor of Law at the Georgia State University College of Law in Atlanta, Georgia. Kathleen M. Brelsford, M.A., Ph.D., M.P.H., is a Research Assistant Professor in the Department of Health Policy and a member of the core faculty of the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center in Nashville, Tennessee. Laura M. Beskow, M.P.H., Ph.D. is a Professor of Health Policy and the Anne Geddes Stahlman Chair in Medical Ethics in the Center for Biomedical Ethics & Society at the Vanderbilt University Medical Center in Nashville, Tennessee.

Researchers now commonly collect biospecimens for genomic analysis together with information from mobile devices and electronic health records. This rich combination of data creates new opportunities for understanding and addressing important health issues, but also intensifies challenges to privacy and confidentiality. Here, we elucidate the "web" of legal protections for precision medicine research by integrating findings from qualitative interviews with structured legal research and applying them to realistic research scenarios involving various privacy threats.

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Ethical Considerations in the Conduct of Unregulated mHealth Research: Expert Perspectives.

J Law Med Ethics

March 2020

Catherine M. Hammack-Aviran, M.A., J.D., is an Associate in Health Policy in the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center (Nashville, TN). Kathleen M. Brelsford, M.P.H., Ph.D., is a Research Assistant Professor in the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center (Nashville, TN). Laura M. Beskow, M.P.H., Ph.D., is a Professor and the Ann Geddes Stahlman Chair in Medical Ethics in the Center for Biomedical Ethics & Society at Vanderbilt University Medical Center (Nashville, TN).

To assist in resolving ethical questions surrounding unregulated mHealth research, we conducted in-depth qualitative interviews with experts from four key stakeholder groups: patient/research advocates, researchers, regulatory professionals, and mobile app/device developers. They discussed challenges and potential solutions in the context of two hypothetical scenarios involving unregulated mHealth research, including notifications/permissions for research use of mHealth data, data access procedures, new primary data collection, offering individual research results, and data sharing and dissemination.

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Online Pediatric Research: Addressing Consent, Assent, and Parental Permission.

J Law Med Ethics

March 2020

Kyle B. Brothers, M.D., Ph.D., is an Associate Professor in the Department of Pediatrics at the University of Louisville, where he is also affiliated with the Institute for Bioethics, Health Policy, and Law. Ellen Wright Clayton, M.D., J.D., is the Craig-Weaver Professor of Pediatrics, Professor of Health Policy, and Member of the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center, and Professor of Law at the Vanderbilt University School of Law. Aaron J. Goldenberg, Ph.D., is an Associate Professor and Vice Chair for the Department of Bioethics at Case Western Reserve University (CWRU). He is also Co-Director of the Center for Genetic Research Ethics and Law at CWRU.

This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.

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Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary.

J Law Med Ethics

March 2020

Laura M. Beskow, M.P.H., Ph.D., is a Professor and the Ann Geddes Stahlman Chair in Medical Ethics in the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center (Nashville, TN). Catherine M. Hammack-Aviran, M.A., J.D., is an Associate in Health Policy in the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center (Nashville, TN). Kathleen M. Brelsford, M.P.H., Ph.D., was a Research Assistant Professor in the Center for Biomedical Ethics and Society at Vanderbilt University Medical Center (Nashville, TN). P. Pearl O'Rourke, M.D., was the Director of Human Research Affairs at Partners HealthCare Systems in Boston and an Associate Professor of Pediatrics at Harvard Medical School (Somerville, MA).

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight.

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Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations.

J Law Med Ethics

March 2020

Mark A. Rothstein, J.D., is Herbert F. Boehl Chair of Law and Medicine and Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine. John T. Wilbanks is Chief Commons Officer of Sage Bionetworks. Laura M. Beskow, M.P.H., Ph.D., is Professor and Ann Geddes Stahlman Chair in Medical Ethics at the Center for Biomedical Ethics and Society, Vanderbilt University Medical Center Kathleen M. Brelsford, Ph.D., M.P.H., is Research Assistant Professor at the Center for Biomedical Ethics and Society, Vanderbilt University Medical Center. Kyle B. Brothers, M.D., Ph.D., is Endowed Chair of Pediatric Clinical and Translational Research, University of Louisville School of Medicine. Megan Doerr, M.S., L.G.C., is Principal Scientist, Governance at Sage Bionetworks. Barbara J. Evans, J.D., Ph.D., is Mary Ann and Lawrence E. Faust Professor of Law, Professor of Electrical and Computer Engineering, and Director of the Center for Biotechnology and Law, University of Houston. Catherine M. Hammack-Aviran, M.A., J.D., is Associate in Health Policy at the Center for Biomedical Ethics and Society, Vanderbilt University Medical Center. Michelle L. McGowan, Ph.D., is Associate Professor, Department of Pediatrics and Department of Women's, Gender, and Sexuality Studies, Cincinnati Children's Hospital Medical Center. Stacey A. Tovino, J.D., Ph.D., is Judge Jack and Lulu Lehman Professor of Law at the William S. Boyd School of Law, University of Nevada-Las Vegas.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry.

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: The increased use of electronic health records (EHRs) has resulted in new opportunities for research, but also raises concerns regarding privacy, confidentiality, and patient awareness. Because public trust is essential to the success of the research enterprise, patient perspectives are essential to the development and implementation of ethical approaches to the research use of EHRs. Yet, little is known about patients' views and expectations regarding various approaches to seeking permission for research use of their EHR data.

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Unnecessary Interfacility Transfers for Craniomaxillofacial Trauma.

Plast Reconstr Surg

May 2020

From the Department of Plastic Surgery and the Department of Biomedical Informatics, Center for Biomedical Ethics and Society, Vanderbilt University Medical Center; and Vanderbilt University School of Medicine.

Background: Patients with craniomaxillofacial injuries are frequently transferred for specialist evaluation. Although transfer guidelines have improved outcomes for trauma care, no standards exist for craniomaxillofacial injuries. As a result, many patients are unnecessarily transferred emergently between facilities, resulting in high costs to patients and the health care system.

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