Surrogate Decision Making for Incarcerated Patients

Sara Scarlet, Erin S. DeMartino, Mark Siegler
JAMA Internal Medicine
2019

When patients are too ill to make their own health care decisions and lack a previously designated decision maker, identifying the appropriate surrogate can be a complex process. For example, clinicians may use surrogacy ladders (hierarchical lists of individuals who … Continued

Women’s views about contraception requirements for biomedical research participation

Kristen A. Sullivan, Margaret Olivia Little, Nora E. Rosenberg, Chifundo Zimba, Elana Jaffe, Sappho Gilbert, Jenell S. Coleman, Irving Hoffman , Tiwonge Mtande, Jean Anderson, Marielle S. Gross, Lisa Rahangdale, Ruth Faden, Anne Drapkin Lyerly
PLOS ONE
2019

The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies–often irrespective of risks … Continued

Attitudes Toward Genetics and Genetic Testing Among Participants in the Jackson and Framingham Heart Studies

Katherine W. Saylor, Lynette Ekunwe, Donna Antoine-LaVigne, Deborah E. Sellers, Sarah McGraw, Daniel Levy , Greta Lee Splansky , Steven Joffe
Journal of Empirical Research on Human Research Ethics
2019

Genetic analysis has become integral to many large cohort studies. However, little is known about longitudinal cohort study participants’ attitudes toward genetics and genetic testing. We analyzed data from a survey of participants in the Jackson Heart Study (n = … Continued

Sharing with Strangers: Governance Models for Borderless Genomic Research in a Territorial World

Eric T. Juengst, Eric M. Meslin
Kennedy Institute of Ethics Journal,
2019

ABSTRACT. One of the practices that has defined the ethos of genomic research to date is a commitment to open and rapid sharing of genomic data and resources. As genomic research evolves into an international enterprise, this commitment is being … Continued

Educating Resident and Fellow Physicians on the Ethics of Mechanical Circulatory Support

Elizabeth A. Sonntag , Keyur B. Shah, Jason N. Katz
AMA Journal of Ethics
2019

Mechanical circulatory support (MCS) such as extracorporeal membrane oxygenation, left ventricular assist devices and total artificial hearts have altered the natural history of heart failure, and specialists in the fields of cardiology and cardiothoracic surgery are faced with more complex … Continued

When Clinical Advances Outpace Ethics

Elizabeth A. Sonntag
AMA Journal of Ethics
2019

In the United States, about 6.5 million adults are living with heart failure, and about half of those patients will die within 5 years of diagnosis.1 For patients with advanced chronic heart failure or acute unrecoverable decompensation, heart transplantation offers … Continued

Responding to Requests for Aid-in-Dying: Rethinking the Role of Conscience

Elizabeth Brassfield, Manisha Mishra, Mara Buchbinder
Narrative Inquiry in Bioethics
2019

This case study illustrates the complex role that a physician’s conscience can play in end-of-life care. We examine a case in which a terminally ill Vermont patient requests aid-in-dying from her primary care physician under Vermont’s “Patient Choice and Control … Continued

Delineating the role of penile transplantation when traditional male circumcisions go wrong in South Africa

Stuart Rennie, Keymanthri Moodley
Journal of Medical Ethics
2019

Back in 2017, Moodley and Rennie published a paper in the Journal of Medical Ethics entitled ‘Penile transplantation as an appropriate response to botched traditional circumcisions in South Africa: an argument against.’1 As the title suggests, we took a critical … Continued

Statutory Restrictions on Advance Care Planning and Pregnancy

Anne Drapkin Lyerly
JAMA
2019

Honoring a person’s wishes at the end of life is widely recognized as profoundly important to humane, ethical care.1 To that end, efforts to help individuals make their preferences about end-of-life care known have involved advance care planning, including the … Continued

Convergence Despite Divergence: Views of Academic and Community Stakeholders about the Ethics of Community-Engaged Research

Stephanie M. Hoover, Shristi Tiwari , Jimin Kim, Melissa Green, Al Richmond, Mysha Wynn, Kyle Simone Nisbeth, Stuart Rennie, Giselle Corbie-Smith
Ethnicity & Disease
2019

Purpose: Stakeholder engagement and community-engaged research (CEnR) are recognized as approaches necessary to promote health equity. Few studies have examined variations in stakeholder perspec­tives on research ethics despite the potential for meaningful differences. Our study exam­ines the association between stakeholders’ … Continued

Access to Pregnancy-Related Health Services: Public Health Ethics Issues

Anne Drapkin Lyerly, Elana Jaffe, Margaret Olivia Little
The Oxford Handbook of Public Health Ethics
2019

As large-scale biobanks are developed for translational genomic research and health care quality improvement, they are also becoming attractive as sites for public health interventions, such as population-based preventive sequencing for actionable variants. With the rapid advance of next-generation sequencing, … Continued

Public Health Genomics, Biobanking, and Ethics

Karen M. Meagher, R. Jean Cadigan, Gail E. Henderson, Eric T. Juengst
The Oxford Handbook of Public Health Ethics
2019

As large-scale biobanks are developed for translational genomic research and health care quality improvement, they are also becoming attractive as sites for public health interventions, such as population-based preventive sequencing for actionable variants. With the rapid advance of next-generation sequencing, … Continued

Clinical Ethics Discussion Group Spring 2019 Event

On April 2nd student groups from CEDG and Cardiology had a discussion about how the historical development of the artificial heart and other means of mechanical circulatory support (MCS) inform contemporary practice and of the ethical issues that follow from … Continued

Eric Juengst, Bioethics, UNC, genetic modification,

Eric Juengst was a featured expert in The New York Times

Eric Juengst was a featured expert on the potential pitfalls of gene editing in The New York Time’s article  “One Day There May Be a Drug to Turbocharge the Brain. Who Should Get It?” by Carl Zimmer.

Health Care Providers’ Experiences with Implementing Medical Aid-in-Dying in Vermont: a Qualitative Study

Mara Buchbinder, Elizabeth R. Brassfield, Manisha Mishra
Journal of General Internal Medicine
2019

The legal landscape for medical aid-in-dying (AID) in theUSA has shifted dramatically over the past 5 years. Vermont(2013), California (2015), Colorado (2016), the District ofColumbia (2016), and Hawaii (2018) have joined Oregon(1997), Washington (2008), and Montana (2009) in permittingphysicians to … Continued

Advancing Ethics and Policy for Healthy‐Volunteer Research through a Model‐Organism Framework

Jill A. Fisher, Rebecca L. Walker
Ethics & Human Research
2019

Nonhuman animal research and phase I healthy‐volunteer clinical trials are both critical components of testing the safety of investigational drugs as part of the development of new pharmaceuticals. In addition, these types of research share important structural features, as both … Continued

Beyond Our Beginnings: 50 Years of Bioethics

“Beyond Our Beginnings:  50 Years of Bioethics”. We are hosting it at the Mews location at the  Graylyn International Conference Center In recognition of the Hastings Center’s 50th anniversary, this conference surveys the past, present, and future of bioethics scholarship, … Continued

Basic Income, Cash Transfers, and Welfare State Paternalism

Douglas MacKay
The Journal of Political Philosophy
2019

Much of the discussion concerning the permissibility of government paternalism has focused on laws and policies that either (1) ban or mandate the use or purchase of particular products;1 or (2) structure choice contexts to “nudge” people to make one … Continued

Journal of Pain and Symptom Management

Caregivers’ Experiences With Medical Aid-In-Dying in Vermont: A Qualitative Study

Mara Buchbinder, Enioluwafe Ojo, Laila Knio, Elizabeth R. Brassfield
Journal of Pain and Symptom Management
2018

Context Eight jurisdictions in the U.S. currently permit medical aid-in-dying (AID), yet little is known about the direct experience of caregivers in supporting a loved one through the process. Objectives To explore the experiences of lay caregivers involved with AID … Continued

How Biomedical HIV Prevention Trials Incorporate Behavioral and Social Sciences Research: A Typology of Approaches

Amy Corneli, Karen Meagher, Gail Henderson, Holly Peay, Stuart Rennie
AIDS and Behavior
2018

In the field of biomedical HIV prevention, researchers have meaningfully incorporated behavioral and social sciences research (BSSR) into numerous clinical trials, though the timing and degree of integration have been highly variable. The literature offers few frameworks that systematically characterize … Continued

Companion Animal Studies: Slipping Through a Research Oversight Gap

Rebecca L. Walker, Jill A. Fisher
The American Journal of Bioethics
2018

In human subject research ethics, we appeal to principles of respect for persons, beneficence, and justice. In laboratory animal studies, the three Rs (reduce, refine, replace) are key touchstones, along with an overarching principle of promoting animal welfare—when consistent with … Continued

Choreographing Death: A Social Phenomenology of Medical Aid-in-dying in the United States

Mara Buchbinder
Medical Anthropology Quarterly
2018

This article draws on ethnographic research on the implementation of Vermont’s 2013 medical aid-in-dying (AID) law to explore a fundamental paradox: While public discourse characterizes AID as a mechanism for achieving an individually controlled autonomous death, the medico–legal framework that … Continued

Sara Stathas for NPR

Anne Drapkin Lyerly interviewed by NPR

Rethinking Bed Rest For Pregnancy “The bottom line is that there’s never been any proven benefit of bed rest,” says Dr. Anne Drapkin Lyerly, an OB-GYN and professor of bioethics at the University of North Carolina at Chapel Hill. Lyerly … Continued

Is Enhancement the Price of Prevention in Human Gene Editing?

Eric T. Juengst, Gail E. Henderson, Rebecca L. Walker, John M. Conley, Karen M. Meagher, Katherine Saylor, Margaret Waltz, Kristine J. Kuczynski, R. Jean Cadigan
The CRISPR Journal
2018

New gene-editing tools challenge conventional policy proscriptions of research aimed at either human germline gene editing or human enhancement by potentially lowering technical barriers to both kinds of intervention. Some recent gene-editing reports have begun to take up the prospect … Continued

The American Journal of Bioethics

Health Research Priority Setting: A Duty to Maximize Social Value?

Doug MacKay
The American Journal of Bioethics
2018

Leah Pierson and Joseph Millum’s article “Health Research Priority Setting: The Duties of Individual Funders” (2018) tackles an important question that has not received the attention it deserves from bioethics scholars: How should funders of research set priorities among competing … Continued

Healthy volunteers’ perceptions of risk in US Phase I clinical trials: A mixed-methods study

Jill A. Fisher, Lisa McManus, Marci D. Cottingham, Julianne M. Kalbaugh, Megan M. Wood, Torin Monahan, Rebecca L. Walker
PLoS Medicine
2018

There is limited research on healthy volunteers’ perceptions of the risks of Phase I clinical trials. In order to contribute empirically to long-standing ethical concerns about healthy volunteers’ involvement in drug development, it is crucial to assess how these participants … Continued

HEC Members participated in the 1st Annual UNC Story Slam

HEC Members Rimma Osipov, Sara Scarlet, and Gary Winzelberg participated in the 1st Annual UNC Story Slam. Story Slam began as a wellness event sponsored by the Annals of Internal Medicine at the annual meeting for the American College of Physicians. … Continued

MS4 clinical ethics student

MS4 Clinical Ethics Student Presentations

On October 16th our 4 students taking the Clinical Ethics MS4 Elective presented their final projects. These projects are intended to become resources for the HEC and reflect the students’ interests as they prepare for residency next year. The Presentation … Continued

Journal of Ethics & Social Philosophy

Immigrant Selection, Health Requirements, and Disability Discrimination

Doug MacKay
Journal of Ethics & Social Philosophy
2018

Australia, Canada, and New Zealand currently apply health requirements to prospective immigrants, denying residency to those with health conditions that are likely to impose an “excessive demand” on their publicly funded health and social service programs. In this paper, I … Continued

AIDS Research and Human Retroviruses

Indirect Benefits in HIV Cure Clinical Research: A Qualitative Analysis.

Adam Gilbertson, Elizabeth Poole Kelly , Stuart Rennie, Gail Henderson, JoAnn Kuruc, Joseph D. Tucker
AIDS Research and Human Retroviruses
2018

.Currently, much of early phase HIV cure research involves unknown and potentially serious risks, with little or no chance of direct health benefits. During informed consent, researchers emphasize this lack of personal medical benefit to minimize misconceptions that undermine genuine … Continued

Hastings center special report

Are Parents Really Obligated to Learn as Much as Possible about Their Children’s Genomes?

Josephine Johnston, Eric Juengst
Hastings Center Special Report
2018

As new parents quickly learn, parenting always involves choosing your battles. Ideally, parents have the freedom to make those moral choices without the prejudice of an unreasonable or premature inflicted ought. Resolving the predictive uncertainties of genomic information is the … Continued

Ethics Consult Workshop June 2019

Registration for the workshop will open in early 2019.

CEDG and HEC Welcome Mark Baumgarten and Tyler Clay

Mark Baumgarten and Tyler Clay will join the Clinical Ethics Discussion Group as student leaders, and the Hospital Ethics Committee as student members, in January 2019. Center for Bioethics faculty members Arlene Davis and Eric Juengst are advisors to the student … Continued

Doug MacKay

Public Issues and Public Reason Conference selected Douglas MacKay as the Keynote Speaker

“Government Policy Experiments and the Ethics of Randomization” November 8–9, 2018 A Conference of Applied Ethics and Critical Social Sciences Carleton University Ottawa, Canada The Public Issues and Public Reason (PIPR) conference is a multidisciplinary conference at which graduate students from … Continued

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

Suzanne Day, Meredith Blumberg, Thi Vu, Yang Zhao, Stuart Rennie, Joseph D. Tucker
Journal of the International AIDS Society
2018

Stakeholder engagement is an essential component of HIV clinical trials. We define stakeholder engagement as an input by individuals or groups with an interest in HIV clinical trials to inform the design or conduct of said trials. Despite its value, … Continued

“I think the parent should be there because no one was born alone”: Kenyan adolescents’ perspectives on parental involvement in HIV research

Allison K Groves, Denise D Hallfors, Bonita J Iritani, Stuart Rennie, Fredrick S Odongo, Daniel Kwaro, Nyaguara Amek, Winnie K Luseno
African Journal of AIDS Research
October, 2018

Despite a pressing need for adolescent HIV research in sub-Saharan Africa, ethical guidance for conducting research among minor adolescents is lacking. One ethical issue is the degree to which parents should be involved in the research process. The existing discourse … Continued

Disadvantaged, outnumbered, and discouraged: women’s experiences as healthy volunteers in U.S. Phase I trials

Nupur Jain, Marci D. Cottingham , Jill A. Fisher
Critical Public Health
2018

While enormous strides have been made in the representation of women in clinical trials, the percentage of women enrolling in Phase I trials still remains low, which both raises public health concerns about the safety of new drugs and social … Continued

Healthy Volunteers’ Perceptions of the Benefits of Their Participation in Phase I Clinical Trials

Jill A. Fisher, Lisa McManus, Megan M. Wood, Marci D. Cottingham, Julianne M. Kalbaugh, Torin Monahan, Rebecca L. Walker
Journal of Empirical Research on Human Research Ethics
2018

Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we … Continued

Pregnant women’s attitudes toward Zika virus vaccine trial participation

Ilona Telefus Goldfarb, Elana Jaffe, Kaitlyn James, Anne Drapkin Lyerly
Vaccine
2018

As Zika virus infection during pregnancy can cause a range of congenital anomalies, pregnant women may be a target population for vaccination in future outbreaks. Their inclusion in vaccine trials is critical to ensure safe and effective vaccines in pregnancy. … Continued

Why Does the Shift from “Personalized Medicine” to “Precision Health” and “Wellness Genomics” Matter?

Eric T. Juengst, PhD, Michelle L. McGowan, PhD
AMA Journal of Ethics
2018

Efforts to conceptualize the application of human genomics to health care have displayed an evolving set of translational research goals. Under personalized genomic medicine, the aim was to individualize treatment and empower patients to take more responsibility for their own … Continued

Rawlsian Justice and the Social Determinants of Health

Jayna Fishman, Douglas MacKay
Journal Applied Philosophy
2018

In this article, we suggest that the evidence regarding the social determinants of health calls for a deep re‐thinking of our understanding of distributive justice. Focusing on John Rawls’s theory of distributive justice in particular, we argue that a full … Continued

Formation à la bioéthique en République Démocratique du Congo : expériences et défis

S. Rennie, L. Ravez, D. Makindu, A. Fox, B. Grauls, R. Yemesi, P. Kayembe, J. L. Chalachala, M. Kashamuka, F. Behets
Éthique & Santé
2018

In regions marked by socio-economic turmoil, the task of teaching bioethics to health professionals and researchers can be more challenging than elsewhere. To demonstrate this, in this article we describe some of our teaching experiences in the Democratic Republic of … Continued

Medical Aid In Dying In Hawaii: Appropriate Safeguards Or Unmanageable Obstacles?

Mara Buchbinder, Thaddeus M. Pope
Health Affairs Blog
2018

On April 5, 2018, Hawaii became the eighth jurisdiction in the United States to affirmatively authorize medical aid in dying (MAID). The Our Care, Our Choice Act (OCOCA), which takes effect on January 1, 2019, permits Hawaii physicians to write … Continued

Government Policy Experiments and Informed Consent

Douglas MacKay, Averi Chakrabarti
Public Health Ethics
2018

Governments are increasingly making use of field experiments to evaluate policy interventions in the spheres of education, public health and welfare. However, the research ethics literature is largely focused on the clinical context, leaving investigators, institutional review boards and government … Continued

Women’s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy

Kristen A. Sullivan, Maggie Little, Nora E. Rosenberg, Tiwonge Mtande, Chifundo Zimba, Elana Jaffe, Jean Anderson, Jenell S. Coleman, Sappho Gilbert, Marielle S. Gross Wolf, Irving Hoffman, Lisa Rahangdale, Ruth Faden, Anne Drapkin Lyerly
Journal of Empirical Research on Human Research Ethics
2018

Clinical research to inform the evidence base to guide nonobstetrical care during pregnancy is critically important for the well-being of women and their future offspring. Conversations about regulations for such research, including whether paternal consent should ever be required, should … Continued

Returning Incidental Findings in Low‐Resource Settings: A Case of Rescue?

Douglas Mackay
The Hastings Center Report
2018

In a carefully argued article, Haley K. Sullivan and Benjamin E. Berkman address the important question of whether investigators have a duty to report incidental findings to research participants in low‐resource settings. They suggest that the duty to rescue offers … Continued

Returning negative results to individuals in a genomic screening program: lessons learned

Butterfield, Rita M., Evans, James P., Rini, Christine, Kuczynski, Kristine J., Waltz, Margaret, Cadigan, R. Jean, Goddard, Katrina A. B., Muessig, Kristin R., Henderson, Gail E.
Genetics in Medicine
2018

In genomics, the return of negative screening results for rare, medically actionable conditions in large unselected populations with low prior risk of disease is novel and may involve important and nuanced concerns for communicating their meaning. Recruitment may result in … Continued

Virtue, Vice, and “Voracious” Science: How should we approach the ethics of primate research?

Rebecca L. Walker
Perspectives in Biology and Medicine,
2018

Philosophical approaches to animal research have typically asked whether nonhuman animals have rights that would prohibit such research or whether the benefit of such research on the whole balances out the harms to animals. The professional ethics approach instead promotes … Continued

To report or not to report: Exploring healthy volunteers’ rationales for disclosing adverse events in Phase I drug trials

Lisa McManus, Jill A. Fisher
AJOB Empirical Bioethics
2018

Background: Phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants. Adverse events (AEs) are collected in part through participants’ self-reports of any symptoms they experience during the trial. In some … Continued

Access to Aid-in-Dying in the United States: Shifting the Debate From Rights to Justice

Mara Buchbinder
American Journal of Public Health
2018

Much of the literature on aid-in-dying (AID) has drawn heavily on rights-based ethical and legal frameworks that emphasize patients’ rights of self-determination in end-of-life decision-making. Less attention has focused on how terminally ill people actually experience such putative rights once … Continued

New Visiting Scholar:  Pablo Garcia Barranquero

The UNC Center for Bioethics would like to welcome our new Visiting Scholar from the University of Malaga, Pablo Garcia Barranquero. He will be with us from May 3 – July 31, 2018, working with Eric Juengst on conceptual issues in longevity … Continued

Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

Quintin Williams, Jill A. Fisher
Sociological Inquiry
2018

This article develops the concept of temporal total institutions to describe how and why individuals voluntarily submit to highly controlled and often dehumanizing environments. We focus empirically on Phase I clinical trials, which offer compensation to healthy people in exchange … Continued

Navigating Ethics Review of Human Infection Trials With Zika

Franklin G. Miller, Anne Drapkin Lyerly
The Hastings Center
2018

Human infection challenge studies, which deliberately expose healthy volunteers to disease-causing infectious agents under carefully controlled conditions, offer a valuable method of biomedical research aimed at efficient initial efficacy testing of vaccine candidates, among other possible uses. They can be … Continued

Grudging Trust and the Limits of Trustworthy Biorepository Curation

Karen M Meagher, Eric T Juengst, Gail E. Henderson
The American Journal of Bioethics
2018

Kraft and colleagues (2018) present an analysis of focus groups assembled to provide guidance on governance practices for biorepository-based research initiatives like the National Institutes of Health (NIH) All of Us Research Program of the Precision Medicine Initiative. They emphasize respondents’ … Continued

Caring for the Wounded—the Ethics of Trauma Surgery

Sara Scarlet
AMA Journal of Ethics
2018

In a fraction of a second, trauma changes us. Trauma injures organs, fractures bones, and makes us bleed, but it also leads to suffering, demoralization, and fear. While physical injuries can often be neatly classified, emotional and spiritual injuries cannot. … Continued

Lack of Information on Surgical Care for Incarcerated Persons

Viewpoint

Sara Scarlet, Anthony A. Meyer, Elizabeth B. Dressen
JAMA Surg
2018

With 2.2 million incarcerated people, the United States imprisons more people than any other country in the world.1 This mass incarceration is recent, arising from the war on drugs and punitive sentencing policies that began in the 1970s.1 Ethnic minorities … Continued

Bystander risk, social value, and ethics of human research

Contentious risks demand a new approach

S. K. Shah, J. Kimmelman, A. D. Lyerly, H. F. Lynch, F. G. Miller, R. Palacios, C. A. Pardo, C. Zorrilla
Science
April, 2018

Two critical, recurring questions can arise in many areas of research with human subjects but are poorly addressed in much existing research regulation and ethics oversight: How should research risks to “bystanders” be addressed? And how should research be evaluated … Continued

Mara Buchbinder to present at Hettleman Lecture

Congratulation to  Mara Buchbinder on winning the UNC Hettleman prize! Please join us for Mara’s presentation of her Hettleman Lecture at 1:00pm on Tuesday, May 1st in the Tate Turner Kuralt auditorium, with reception following. We hope to see you there! Hettleman … Continued

Recrutement-engagement dans des essais cliniques en prévention Contextes, logiques sociales et médiations

Exceptional Risk: Healthy Volunteers’ Perceptions of HIV/AIDS Clinical Trials

Marci D. Cottingham, Julianne M. Kalbaugh, Teresa Swezey, Jill A. Fisher
2018

Exceptional Risk: Healthy Volunteers’ Perceptions of HIV/AIDS Clinical Trials. As with all early-stage testing of investigational drugs, clinical trials targeting HIV/AIDS can pose unknown risks to research subjects. Unlike sick participants seeking a therapeutic benefit, the motivations and barriers for healthy volunteers … Continued

Harm Reduction Protocols for Early Abortion: A Middle Way?

Anne Drapkin Lyerly , Margaret Olivia Little
Obstetrics & Gynecology
April, 2018

Excerpt One late evening in the 1990s when I (Dr. Lyerly) was a resident, our gynecology team was called to evaluate a young woman in shock. According to her husband, she had not been herself for a couple of days, … Continued

Including All Voices in International Data-Sharing Governance

Jane Kaye, Sharon F. Terry, Eric Juengst, Sarah Coy, Jennifer R. Harris, Don Chalmers, Edward S. Dove, Isabelle Budin-Ljøsne, Clement Adebamowo, Emilomo Ogbe, Louise Bezuidenhout, Michael Morrison, Joel T. Minion, Madeleine J. Murtagh, Jusaku Minari, Harriet Teare, Rosario Isasi, Kazuto Kato, Emmanuelle Rial-Sebbag, Patricia Marshall, Barbara Koenig, Anne Cambon-Thomsen
Human Genomics
March 7, 2018

Governments, funding bodies, institutions, and publishers have developed a number of strategies to encourage researchers to facilitate access to datasets. The rationale behind this approach is that this will bring a number of benefits and enable advances in healthcare and … Continued

Disparate Compensation Policies for Research Related Injury in an Era of Multinational Trials

A Case Study of Brazil, Russia, India, China and South Africa

George Rugare Chingarande, Keymanthri Moodley
BMC Medical Ethics
February 17, 2018

Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper … Continued

Mara Buchbinder to speak at the National Academies of Medicine Workshop on Physician-Assisted Death

Physician-Assisted Death: Scanning the Landscape and Potential Approaches– A Workshop February 12–13, 2018 National Academy of Sciences Building 2101 Constitution Avenue NW, Washington, DC This National Academies of Sciences, Engineering, and Medicine workshop will explore the evidence base and research … Continued

New Visiting Scholar: Matthias Eggel

The UNC Center for Bioethics would like to welcome our new Visiting Scholar from the University of Zurich, Institute for Bioethics, Matthias Eggel. Dr. Eggel will be with us from January 16 – March 10, 2018. Currently, Dr. Eggel is … Continued

Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research

Rebecca L. Walker, Marci D. Cottingham, Jill A. Fisher
The Journal of Medicine and Philosophy
January 12, 2018

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials … Continued

The Ethics of General Population Preventive Genomic Sequencing

Rights and Social Justice

Clair Morrissey, Rebecca L. Walker
The Journal of Medicine and Philosophy
January 12, 2018

Advances in DNA sequencing technology open new possibilities for public health genomics, especially in the form of general population preventive genomic sequencing (PGS). Such screening programs would sit at the intersection of public health and preventive health care, and thereby … Continued

Brandy Elsenrath, our new Center Coordinator

The UNC Center for Bioethics would like to welcome our new Center Coordinator, Brandy Elsenrath, starting with us on January 8. Brandy started working at UNC-CH in 1999. She has held positions within the UNC School of Medicine, UNC Property … Continued

New Clinical Ethics MS4 Elective for Spring 2018

A new clinical ethics elective joins the TEC Individualization Phase curriculum this spring. It offers medical students an opportunity to focus their interests in clinical ethics on a particular practice area, using mentorship, scholarly readings, and practical experience with the hospital ethics committee … Continued

Of Pain and Childbirth

Anne Drapkin Lyerly
Narrative Inquiry in Bioethics
2017

Childbirth is often understood as a paradigmatically “happy” event where good outcomes are expected and the process anticipated as a reason for celebration. Yet the narratives in this volume reflect sadness and grief, even when a healthy child is born. … Continued

2nd Annual HIV Cure Research Day

The Durham County Board of Commissioners and the state of North Carolina officially proclaimed December 14, 2017 as HIV Cure Research Day. This is the second year celebrating the official proclamation of HIV Cure Research Day. Dr. Allison Mathews, founder … Continued

Ethical Considerations in Developing an Evidence Base for Pre-Exposure Prophylaxis in Pregnant Women

Kristen A. Sullivan, Anne D. Lyerly
Reproductive Health
December 14, 2017

Though many women in need of access to HIV preventive regimes are pregnant, there is a dearth of data to guide these care decisions. While oral pre-exposure prophylaxis (PrEP) has been shown to prevent HIV infection in numerous high-risk populations, … Continued

Genomic Screening: What’s Age Got To Do With It?

Harvard Law Bill of Health Blog Margaret Waltz, PhD R. Jean Cadigan, PhD Anya E. R. Prince, JD, MPP Debra Skinner, PhD Gail E. Henderson, PhD Age is an important consideration in medical screening, but calls for population based preventive … Continued

Traditional, Complementary, and Alternative Medical Cures for HIV

Rationale and Implications for HIV Cure Research

Xin Pan, Alice Zhang, Gail E. Henderson, Stuart Rennie, Chuncheng Liu, Weiping Cai, Feng Wu, Joseph D. Tucker
Global Public Health
December 13, 2017

Traditional, complementary, and alternative medicine (TCAM) has been used by some people living with HIV (PLHIV) in an attempt to cure HIV. This article reviews the main factors influencing their decision to choose TCAM to cure HIV and discusses implications … Continued

Prince and Davis Article Honored by JOTWELL

The Journal of Things We Like A lot (JOTWELL), a compendium of law review articles designed to select and recognize the best recent academic legal literature, has honored former C:B trainee Anya Prince and C:B faculty member Arlene Davis by … Continued

ELSI 2.0 meetings in Kyoto, Nov. 13-16, 2017

Eric Juengst participated in two workshops on behalf of the ELSI 2.0 International Collaboratory for Genomics and Society Research in Kyoto, to discuss cross-cultural perspectives on clinical genomic sequencing, research data-sharing, and dynamic consent, with colleagues from Japan, Australia, Singapore, … Continued

Dr. Stuart Rennie Presents Paper at 2nd Annual Kenya Bioethics Society conference

In a recent trip to Kenya, Professor Stuart Rennie visited the capital city of Nairobi with the purpose of participating in and presenting a paper at the 2nd Annual Kenya Bioethics Society conference. The paper was entitled ‘Perceptions of benefit among … Continued

Ethical Inclusion of Pregnant Women in the HIV/AIDS Research Agenda workshop in Bangkok

In November 2017, the Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) project convened an international workshop in Bangkok, Thailand to address ethical issues in the inclusion of pregnant woman in HIV/AIDS research. This one-day series facilitated sessions and discussions in … Continued

Research on HIV Cure

Mapping the Ethics Landscape

Karine Dubé, Laurie Sylla, Lynda Dee, Jeff Taylor, David Evans, Carl Dean Bruton, Adam Gilberston, Lisa Gralinski, Brandon Brown, Asheley Skinner, Bryan J. Weiner, Sandra B. Greene, Amy Corneli, Adaora A. Adimora, Joseph D. Tucker, Stuart Rennie
PLoS medicine
December 8, 2017

In an essay, Karine Dubé and coauthors discuss the ethics of preclinical and clinical studies relevant to achieving an HIV cure.

Age and Perceived Risks and Benefits of Preventive Genomic Screening

Margaret Waltz, R. Jean Cadigan, Anya E. R. Prince, Debra Skinner, Gail E. Henderson
Genetics in Medicine
December 7, 2017

PurposeAs genome sequencing moves from research to clinical practice, sequencing technologies focused on “medically actionable” targets are being promoted for preventive screening despite the dearth of systematic evidence of risks and benefits and of criteria for selection of screening subjects. … Continued

CEDG and HEC Welcome Kelly Olsen and Austin Bath

Kelly Olsen and Austin Bath will join the Clinical Ethics Discussion Group as student leaders, and Hospital Ethics Committee as student members, in January 2018. Center for Bioethics faculty members Arlene Davis and Eric Juengst are advisors to the student group … Continued

Ethics of Treatment Interruption Trials in HIV Cure Research

Addressing the Conundrum of Risk/Benefit Assessment

Gail E. Henderson, Holly L. Peay, Eugene Kroon, Rosemary Jean Cadigan, Karen Meagher, Thidarat Jupimai, Adam Gilbertson, Jill Fisher, Nuchanart Q. Ormsby, Nitiya Chomchey, Nittaya Phanuphak, Jintanat Ananworanich, Stuart Rennie
Journal of Medical Ethics
November 10, 2017

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve … Continued

Online Education and E-Consent for GeneScreen, a Preventive Genomic Screening Study

R. Jean Cadigan, Rita Butterfield, Christine Rini, Margaret Waltz, Kristine J. Kuczynski, Kristin Muessig, Katrina A. B. Goddard, Gail E. Henderson
Public Health Genomics
November, 2018

BACKGROUND: Online study recruitment is increasingly popular, but we know little about the decision making that goes into joining studies in this manner. In GeneScreen, a genomic screening study that utilized online education and consent, we investigated participants’ perceived ease … Continued

Responsible Care in the Face of Shifting Recommendations and Imperfect Diagnostics for Zika Virus

Ilona Telefus Goldfarb, Elana Jaffe, Anne Drapkin Lyerly
JAMA
October 30, 2017

The US Centers for Disease Control and Prevention (CDC) recently released updated interim guidance for when pregnant women should receive serologic testing for the Zika virus. The circumstances within which these recommendations emerge are complex: the public concern about the … Continued

Center for Bioethics Intramural Faculty Workshop (at the beach!)

On September 18-21, 2017, the C:B faculty decamped to Emerald Isle,  NC,  for three days of intellectual engagement with each other’s work in progress.   Participants submitted manuscripts in advance and, after a “reading day” on Thursday, spent Friday and Saturday … Continued

Wylie Burke, MD., Ph.D., Delivers 2017 UNC Merrimon Lecture

The Center was honored to host Wylie Burke, MD, Ph.D., Emeritus Professor and former Chair of the University of Washington Department of  Bioethics and Humanities, as our 2017 Merrimon Lecturer,  the School of Medicine’s oldest and most prestigious endowed lectureship.,  … Continued

From Fantasy to Reality

Managing Biomedical Risk Emotions In and Through Fictional Media

Marci D Cottingham, Jill A Fisher, Marci D. Cottingham, Jill A. Fisher
Health, Risk & Society
October, 2017

In this article, we explore the role that fictional media (film and television) play in evoking and managing collective and individual anxieties towards biomedical research. We draw on two data sets: fictional media depictions of human research subjects and interviews … Continued

Center for Bioethics Trainees Enhance ASBH 2017 Program

UNC C:B trainees and former fellows were ubiquitous at the 19th Annual Meeting of the American Society for Bioethics and Humanities in Kansas City on Oct. 18-22! Their contributions included: Elana Jaffe, BA participated in a “Forging a New Paradigm for Public Health Emergency Research that Includes Pregnant … Continued

Current Second Year Medical Student Electives by C:B faculty members

This semester UNC Center for Bioethics faculty members Stuart Rennie, Jill Fisher, Mara Buchbinder, and Eric Juengst are all teaching Advanced Seminars in the Humanities and Social Sciences for MS2 students in the UNC School of Medicine. These seminars offer … Continued

HIV Cure Research Community Engagement in North Carolina

A Mixed-Methods Evaluation of a Crowdsourcing Contest

Allison Mathews, Samantha Farley, Meredith Blumberg, Kimberley Knight, Lisa Hightow-Weidman, Kate Muessig, Stuart Rennie, Joseph Tucker
Journal of Virus Eradication
October 1, 2017

Objectives The purpose of this study was to evaluate the feasibility of using a crowdsourcing contest to promote HIV cure research community engagement. Methods Crowdsourcing contests are open calls for community participation to achieve a task, in this case to … Continued

Ethics, Pregnancy, and ZIKV Vaccine Research and Development

The Ethics Working Group on ZIKV Research and Pregnancy

Anne D. Lyerly, Ruth R. Faden, Carleigh B. Krubiner, Margaret O. Little, Allison August, Richard H. Beigi, Anna P. Durbin , Ruth A. Karron , Nancy E. Kass , Florencia Luna , Ricardo Palacios , Alexander Roberto Precioso , Carla Saenz, Jeanne S. Sheffield, Beatriz Thomé
Vaccine
October 19, 2017

The rapid spread of the Zika virus (ZIKV) has galvanized the global public health community toward development of ZIKV vaccines. The most dire consequence of ZIKV infection, Congenital ZIKV Syndrome (CZS), results from infection during pregnancy. As a consequence, pregnant … Continued

The Ethics of Public Policy RCTs

The Principle of Policy Equipoise

Douglas MacKay
Bioethics
October 11, 2017

In this article, I ask whether a principle analogous to the principle of clinical equipoise should govern the design and conduct of RCTs evaluating the effectiveness of policy interventions. I answer this question affirmatively, and introduce and defend the principle … Continued

The Paywall as Metaphor and Symptom

Stuart Rennie, Keymanthri Moodley
The American Journal of Bioethics
October, 2017

Chattopadhyay and colleagues basically present two lines of argument in regard to access to bioethics journals by those working in this field in low- and middle-income countries (LMICs). The first is a harm-based argument: poor access to bioethics literature in … Continued

Perceptions of Equipoise, Risk-Benefit Ratios, and “Otherwise Healthy Volunteers” in the Context of Early-Phase HIV Cure Research in the United States

A Qualitative Inquiry

Karine Dubé, Lynda Dee, David Evans, Laurie Sylla, Jeff Taylor, Brandon Brown, Veronica Miller, Amy Corneli, Asheley Skinner, Sandra B. Greene, Joseph D. Tucker, Stuart Rennie
Journal of empirical research on human research ethics: JERHRE
October 1, 2017

Early-phase HIV cure research is conducted against a background of highly effective antiretroviral therapy, and involves risky interventions in individuals who enjoy an almost normal life expectancy. To explore perceptions of three ethical topics in the context of HIV cure … Continued

Mara Buchbinder Receives Hettleman Award

Four highly promising Carolina faculty members in diverse fields have been awarded the Philip and Ruth Hettleman Prizes for Artistic and Scholarly Achievement by Young Faculty. The recipients, who were recognized at the Sept. 8 Faculty Council meeting, are: Mara … Continued

Healthy Volunteers as Model Organisms

Comparative Research Ethics and Policy for Phase I Trials Principal Investigators: Jill A. Fisher and Rebecca L. Walker This project addresses the need for a novel evidence-based approach to the protection of Phase I healthy volunteers. Phase I clinical trials test … Continued

Surgery in Shackles

What Are Surgeons’ Obligations to Incarcerated Patients in the Operating Room?

Sara Scarlet, Elizabeth Dreesen
AMA Journal of Ethics
September, 2017

Incarcerated patients frequently require surgery outside of the correctional setting, where they can be shackled to the operating table in the presence of armed corrections officers who observe them throughout the procedure. In this circumstance, privacy protection—central to the patient-physician … Continued

History of the Merrimon Lecture

“What I have in mind may be briefly expressed. To give to medical students and others interested an insight in the history, traditions, philosophy and ethics of medicine. To help restore, in some degree, a sense of responsibility to medicine’s … Continued

Clinical Ethics Discussion Group CEDG Launches a New Academic Year

Drew Cutshaw and Keren Eyal, second year medical students who are members of the Hospital Ethics Committee and leaders of the Clinical Ethics Discussion Group, launched a new academic year for CEDG at the 2017 Student Activities Fair. More than … Continued

Stellenbosch Bioethics Leadership Program Selects First Trainees

The Stellenbosch Bioethics Leadership Program has selected it’s first trainees. Dr Geremew T. Tsegaye has a doctoral degree in medicine (MD). He specialized in public health (MPH) and bioethics (EMMB) and advance Research Ethics. Dr Theresa Burgess started her career … Continued

Ethics of HIV-Related Research Involving Adolescents in Kenya

Despite the high social value of adolescent HIV prevention research in sub-Saharan Africa, investigators are reluctant to involve adolescents in studies with HIV testing and disclosure of results because of ethical concerns about the risks of their participation. This study … Continued