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What Could “Fair Allocation” during the Covid‐19 Crisis Possibly Mean in Sub‐Saharan Africa?

Keymanthri Moodley, Laurent Ravez, Adetayo Emmanuel Obasa, Alwyn Mwinga, Walter Jaoko, Darius Makindu, Frieda Behets , Stuart Rennie
The Hastings Center
2020

The Covid‐19 pandemic has sparked rapid and voluminous production of bioethics commentary in popular media and academic publications. Many of the discussions are new twists on an old theme: how to fairly allocate scarce medical resources, such as ventilators and … Continued

Selecting Participants Fairly for Controlled Human Infection Studies

Douglas MacKay, Nancy S. Jecker, Punnee Pitisuttithum, Katherine W. Saylor
Bioethics
2020

Controlled human infection (CHI) studies involve the deliberate exposure of healthy research participants to infectious agents to study early disease processes and evaluate interventions under controlled conditions with high efficiency. Although CHI studies expose participants to the risk of infection, … Continued

Parallel but connected: Nuances of conducting behavioral and social science research alongside ethically challenging HIV remission trials

Gail E. Henderson, Stuart Rennie, Amy Corneli, Karen Meagher, R. Jean Cadigan, Eugène Kroon, Jintanat Ananworanich, Holly L. Peay
Contemporary Clinical Trials Communications
2020

Collaborations between clinical investigators and behavioral and social science researchers (BSSR) produce many benefits, but also may generate challenges and complexities. Ongoing relationships between teams may affect the research carried out by the BSSR team and the way they interpret … Continued

Incidental Enhancements: A Neglected Governance Challenge for Human Genome Editing Research

The increasing pace and international diffusion of developments in human genome editing research have prompted ongoing efforts to develop responsible governance for such research. One point of broad agreement across these efforts is that human genome editing research should prioritize … Continued

Suicide Behaviour Among Adolescents in a High HIV Prevalence Region of Western Kenya: A Mixed-Methods Study

Susannah Zietz, Bonita J. Iritani, Florence Anyango Otieno, Barrack Otieno Ongili, Fredrick S. Odongo, Stuart Rennie, Winnie Kavulani Luseno
Global Public Health
2020

The study purpose was to determine the prevalence and determinants of suicidal thoughts and behaviours in a rural community sample of 15–19-year-old Kenyan adolescents in a region with high HIV burden. Data were from an observational study examining ethical issues … Continued

Views among Malawian Women about Joining HIV Prevention Clinical Trials When Pregnant

Kristen Sullivan, Tiwonge Mtande , Elana Jaffe, Nora Rosenberg, Chifundo Zimba, Irving Hoffman, Maggie Little, Ruth Faden, Anne Drapkin Lyerly
AIDS Research and Therapy
2020

Background: The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized.  Women’s views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed … Continued

Impact of Implementing an Online Interactive Educational Tool for Future HIV “Cure” Research in an HIV Clinic Waiting Room in Cape Town, South Africa

M. Hendricks, O. Varathan, F. Cassim, M. Kidd, K. Moodley
AIDS Care
2020

Access to antiretroviral treatment (ART) in South Africa is suboptimal and erratic. For those on treatment, compliance remains a significant challenge. Interruptions to ART have negative implications for the individual and the epidemic. ART is therefore not a sustainable solution … Continued

Do Groups Have Moral Standing in Unregulated mHealth Research?

Joon-Ho Yu, Eric Juengst
Journal of Law, Medicine & Ethics
2020

For the most part, discussions of the ethical, legal, and social implications (ELSI) of mHealth research have been preoccupied with the welfare and interests of individual participants — i.e., those who carry the devices running the programs that provide their … Continued

“‘Informed and Empowered’: A Mixed Method Study of Crowdsourcing Contests to Promote Uptake of HIV Self-Testing Kits among African Americans.

Allison Mathews, Donaldson Conserve , Hailey Mason, Le’Marus Alston, Stuart Rennie, Joseph Tucker
Journal of Virus Eradication
2020

Objective: HIV self-testing (HIVST) kits are a viable alternative to testing in clinical settings, but research on the effective ways of promoting uptake of HI VST kits has been lacking. The present study examines crowdsourcing contests as community engagement to … Continued

Ethics of Controlled Human Infection to Study COVID-19

Seema K. Shah, Franklin G. Miller, Thomas C. Darton, Devan Duenas, Claudia Emerson, Holly Fernandez Lynch, Euzebiusz Jamrozik, Nancy S. Jecker, Dorcas Kamuya, Melissa Kapulu, Jonathan Kimmelman, Douglas MacKay, Matthew J. Memoli, Sean C. Murphy, Ricardo Palacios, Thomas L. Richie, Meta Roestenberg, Abha Saxena, Katherine Saylor, Michael J. Selgelid, Vina Vaswani, Annette Rid
Science
2020

Development of an effective vaccine is the clearest path to controlling the coronavirus disease 2019 (COVID-19) pandemic. To accelerate vaccine development, some researchers are pursuing, and thousands of people have expressed interest in participating in, controlled human infection studies (CHIs) … Continued

Professionalism and Ethics: A Standardized Patient Observed Standardized Clinical Examination to Assess ACGME Pediatric Professionalism Milestones

Margaret Waltz, Arlene Davis, R. Jean Cadigan, Rohit Jaswaney, Melissa Smith, Benny Joyner
MedEdPORTAL
2020

Introduction: The ethical skills fundamental to medical practice encompass a large portion of the Accreditation Council for Graduate Medical Education (ACGME) professionalism milestones. Yet many ethical practices are difficult to reduce to milestone frameworks given the variety of traditions of … Continued

Is Real-Time ELSI Realistic?

John M. Conley, Anya E.R. Prince, Arlene M. Davis, Jean Cadigan, Gabriel Lazaro-Munoz
AJOB Empirical
2020

Background: A growing literature has raised—skeptically—the question of whether cutting-edge scientific research can identify and address broader ethical and policy considerations in real time. In genomics, the question is: Can ELSI contribute to genomics in real time, or will it … Continued

Assessing the Implications of Positive Genomic Screening Results

Margaret Waltz, Karen M. Meagher , Gail E. Henderson , Katrina AB Goddard , Kristin Muessig , Jonathan S. Berg , Karen E. Weck , R. Jean Cadigan
Personalized Medicine
2020

Aim: Before population screening of ‘healthy’ individuals is widely adopted, it is important to consider the harms and benefits of receiving positive results and how harms and benefits may differ by age. Subjects & methods: Participants in a preventive genomic … Continued

Expert Stakeholders’ Perspectives on a Data-to-Care Strategy for Improving Care Among HIV-Positive Individuals Incarcerated in Jails

Mara Buchbinder , Colleen Blue , Eric Juengst , Lauren Brinkley-Rubinstein, Stuart Rennie,, David L. Rosen
AIDS Care
2020

Data-to-Care (D2C) uses surveillance data (e.g., laboratory, Medicaid billing) to identify out-of-care HIV-positive persons to re-link them to care. Most US states are implementing D2C, yet few studies have explored stakeholders’ perspectives on D2C, and none have addressed these perspectives … Continued

Expanding Community Engagement in HIV Clinical Trials a Pilot Study Using Crowdsourcing

Suzanne Day , Allison Mathews , Meredith Blumberg , Thi Vu , Hailey Mason , Stuart Rennie , JoAnne D. Kuruc , Cynthia L. Gay , David M. Margolis, Joseph D. Tucker
AIDS
2020

Abstract Objective: To assess the potential for crowdsourcing to complement and extend community advisory board (CAB) feedback on HIV clinical trials. Crowdsourcing involves community members attempting to solve a problem and then sharing solutions. Methods: CAB and crowdsourced approaches were … Continued

“Meet People Where They Are”: A Qualitative Study of Community Barriers and Facilitators to HIV Testing and HIV Self-Testing Among African Americans in Urban and Rural Areas in North Carolina

Allison Mathews, Samantha Farley, Donaldson F. Conserve, Kimberly Knight, Alston Le’Marus, Meredith Blumberg, Stuart Rennie, Joseph Tucker
BMC Public Health
2020

HIV testing programs in the United States aim to reach ethnic minority populations who experience high incidence of HIV, yet 40% of African Americans have never been tested for HIV. The objective of this study is to identify community-based strategies … Continued

Scraping the Web for Public Health Gains: Ethical Considerations from a ‘Big Data’ Research Project on HIV and Incarceration

Stuart Rennie, Mara Buchbinder, Eric Juengst, Lauren Brinkley-Rubinstein, David L Rosen
Public Health Ethics
2020

Web scraping involves using computer programs for automated extraction and organization of data from the Web for the purpose of further data analysis and use. It is frequently used by commercial companies, but also has become a valuable tool in … Continued

Open to the Public: Paywalls and the Public Rationale for Open Access Medical Research Publishing

Suzanne Day, Stuart Rennie, Danyang Luo, Joseph D. Tucker
Research Involvement and Engagement
2020

Public voices have largely been absent from the discussions about open access publishing in medical research. Yet the public have a strong interest in ensuring open access of medical research findings because of their roles as funders, advocates, research participants, … Continued

Commentary 1: How Should Community Members be Paid when they Go Off Script?

Stuart Rennie
The Journal of Empirical Research on Human Research Ethics
2019

The role of money in health research has been debated in bioethics for many years, particularly with regard to resource-poor settings and populations. Much of the debate has focused on two key stakeholders in the research enterprise: research ethics committees … Continued

Broadening Community Engagement in Clinical Research: Designing and Assessing a Pilot Crowdsourcing Project to Obtain Community Feedback on an HIV Clinical Trial

Suzanne Day, Allison Mathews, Meredith Blumberg, Thi Vu, Stuart Rennie, Joseph D Tucker
Clinical Trials
2020

Community engagement is widely acknowledged as an important step in clinical trials. One underexplored method for engagement in clinical trials is crowdsourcing. Crowdsourcing involves having community members attempt to solve a problem and then publicly sharing innovative solutions. We designed … Continued

Referencing BRCA in Hereditary Cancer Risk Discussions: In Search of an Anchor in a Sea of Uncertainty

Margaret Waltz, Anya E. R. Prince, Julianne M. O'Daniel, Ann Katherine M. Foreman, Bradford C. Powell, Jonathan S. Berg
Journal of Genetic Counseling
2020

As panel testing and exome sequencing are increasingly incorporated into clinical care, clinicians must grapple with how to communicate the risks and treatment decisions surrounding breast cancer genes beyond BRCA1 and BRCA2. In this paper, we examine clinicians’ practice of … Continued

Clinicians’ Perspectives on the Duty to Inform Patients About Medical Aid-in-Dying

Elizabeth R. Brassfield, Mara Buchbinder
AJOB Empirical Bioethics
2019

Background: As of 2019, ten jurisdictions in the United States have authorized physicians to prescribe a lethal dose of medication to a terminally ill patient for the purpose of hastening death. Relatively little bioethics scholarship has addressed the question of … Continued

Four Faces of Fair Subject Selection

Doug MacKay, Katherine Witte Saylor
The American Journal of Bioethics
2020

Although the principle of fair subject selection is a widely recognized requirement of ethical clinical research, it often yields conflicting imperatives, thus raising major ethical dilemmas regarding participant selection. In this paper, we diagnose the source of this problem, arguing … Continued

Voluntary Medical Male Circumcision for HIV Prevention Among Adolescents in Kenya: Unintended Consequences of Pursuing Service-Delivery Targets

Adam Gilbertson, Barrack Ongili, Frederick S. Odongo, Denise D. Hallfors, Stuart Rennie, Daniel Kwaro, Winnie K. Luseno
PLoS ONE
2019

Voluntary medical male circumcision (VMMC) provides significant reductions in the risk of female-to-male HIV transmission. Since 2007, VMMC has been a key component of the United States President’s Emergency Plan for AIDS Relief’s (PEPFAR) strategy to mitigate the HIV epidemic … Continued

Public Health Research, Practice, and Ethics for Justice-Involved Persons in the Big Data Era

David L. Rosen, Mara Buchbinder, Eric Juengst, Stuart Rennie
American Journal of Public Health
2020

We are living in an era of “big data,” which is characterized by tremendous growth in data production, linkage, and analysis. This growth is shifting the landscape of possible opportunities and harms for public health research and practice, particularly for … Continued

From Mice to Monkeys? Beyond Orthodox Approaches to the Ethics of Animal Model Choice

Rebecca L. Walker, Matthias Eggel
Animals
2020

Recent developments in genome editing tools, along with limits in the translational potential of rodent models of human disease, have spurred renewed biomedical research interest in large mammals like nonhuman primates, pigs, and dogs. Such scientific developments raise ethical issues … Continued

“My Body is One of the Best Commodities”: Exploring the Ethics of Commodification in Phase I Healthy Volunteer Clinical Trials

Rebecca L. Walker, Jill A. Fisher
Kennedy Institute of Ethics Journal
2020

In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures while they are confined to clinic spaces. In exchange, they are paid. These participants are, in a direct … Continued

Sacrificial Labor: Social Inequality, Identity Work, and the Damaging Pursuit of Elusive Futures.

Torin Monahan, Jill A. Fisher
Work, Employment & Society
2019

This article explores the relationship between personal sacrifice and identity work within conditions of profound structural insecurity. We develop the concept of sacrificial labour to describe how individual self-sacrifice aligns workers’ identities to the needs of organizations while gradually foreclosing … Continued

Picking and Choosing Among Phase I Trials: A Qualitative Examination of How Healthy Volunteers Understand Study Risks.

Jill A. Fisher, Torin Monahan, Rebecca L. Walker
Journal of Bioethical Inquiry
2019

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from … Continued

Voluntary Medical Male Circumcision for HIV Prevention Among Adolescents in Kenya: Unintended Consequences of Pursuing Service-Delivery Targets.

Adam Gilbertson, Barrack Ongil, Frederick S. Odongo, Denise D. Hallfors, Stuart Rennie, Daniel Kwaro, Winnie K. Luseno
PLoS ONE
2019

Voluntary medical male circumcision (VMMC) provides significant reductions in the risk of female-to-male HIV transmission. Since 2007, VMMC has been a key component of the United States President’s Emergency Plan for AIDS Relief’s (PEPFAR) strategy to mitigate the HIV epidemic … Continued

Bioethics

Mara Buchbinder
Oxford Bibliographies in Anthropology
2019

The discipline of bioethics emerged in the United States in the 1960s as a response to several prominent controversies in medical research and practice, including the aftermath of the Tuskegee syphilis experiments and the development of kidney dialysis and associated … Continued

Perils of the Hidden Curriculum: Emotional Labor and “Bad” Pediatric Proxies

Margaret Waltz, R. Jean Cadigan, Benny Joyner, Paul Ossman, Arlene Davis
The Journal of Clinical Ethics
2019

Today’s medical training environment exposes medical trainees to many aspects of what has been called “the hidden curriculum.” In this article, we examine the relationship between two aspects of the hidden curriculum, the performance of emotional labor and the characterization … Continued

Research Payment and Its Social Justice Concerns.

Jill A. Fisher
American Journal of Bioethics
2019

The field of bioethics has had a long preoccupation with payment for research participation. The end result of these debates has largely been consensus that there is nothing ethically wrong with paying people to participate in research and yet it … Continued

Commentary on Zvonareva et al.: Exploring the Many Meanings of ‘Professional’ in Research Participation.

Jill A. Fisher
Clincial Trials
2019

Within the field of bioethics and among many clinical trialists, the term “professional” has come to have a very specific meaning when referring to research participants. As highlighted by Roberto Abadie’s book The Professional Guinea Pig,2 the focus is largely … Continued

CENNC 2019 Conference

Ethical Issues in Caring for the Underserved: The Vulnerable, Marginalized, and Forgotten September 20, 2019 co-sponsored by the Center for Bioethics, ECU Brody School of Medicince, CENN, Eastern AHEC and UNC Eshelman School of Pharmacy

CEDG and HEC Welcome Sara Meyers and Lisa Michelson

Sara Meyers and Lisa Michelson have been selected as the new student leaders for the School of Medicine’s  Clinical Ethics Discussion Group This position also entails appointment to the UNC Hospital Ethics Committee. Outgoing leaders are Tyler Clay and Mark Baumgarten. … Continued

Parenting the Parents: The Ethics of Parent-Targeted Paternalism in the Context of Anti-poverty Policies

Doug MacKay
Philosophy and Child Poverty
2019

Governments often aim to improve children’s wellbeing by targeting the decision-making of their parents. In this paper, I explore this phenomenon, providing an ethical evaluation of the ways in which governments target parental decision-making in the context of anti-poverty policies. … Continued

Social Medicine faculty featured in Oxford Handbook of Public Health Ethics

Congratulations to Center for Bioethics’s Jean Cadigan, Elana Jaffe, Eric Juengst, Anne Lyerly and Social Medicine’s Gail Henderson, Karen Meagher, and Tonia Poteat. The Oxford Handbook of Public Health Ethics is a prestigious international reference collection that publishes reviews of ethical … Continued

Consent Challenges and Psychosocial Distress in the Scale‑up of Voluntary Medical Male Circumcision Among Adolescents in Western Kenya

Winnie K. Luseno, Samuel H. Field, Bonita J. Iritani, Stuart Rennie, Adam Gilbertson, Fredrick S. Odongo, Daniel Kwaro, Barrack Ongili, Denise D. Hallfors
2019

In priority sub-Saharan African countries, on the ground observations suggest that the success of voluntary medical male circumcision (VMMC) programs should not be based solely on numbers of males circumcised. We identify gaps in the consent process and poor psychosocial … Continued

Appraising Harm in Phase I Trials: Healthy Volunteers’ Accounts of Adverse Events

Lisa McManus, Arlene Davis, Rebecca L. Forcier, Jill A. Fisher
The Journal of Law, Medicine & Ethics
2019

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the … Continued

Geographic Location and Moral Arbitrariness in the Allocation of Donated Livers

Doug MacKay, Samuel Fitz
The Journal of Law, Medicine & Ethics
2019

The federal system for allocating donated livers in the United States is often criticized for allowing geographic disparities in access to livers. Critics argue that such disparities are unfair on the grounds that where one lives is morally arbitrary and … Continued

The Role of Inclusion Benefits in Ethics Committee Assessment of Research Studies

Stuart Rennie, Suzanne Day, Allison Mathews, Adam Gilbertson, Winfred K. Luseno, Joseph D. Tucker, Gail E. Henderson
Ethics & Human Research
2019

The relationship between risks and benefits is central to the ethics of research involving human participants. Traditionally, to be ethically justifiable, risks should be reasonable in relation to anticipated benefits (if any) to subjects and to the potential social benefits … Continued

The Power of Suggestion Disclosure Ideologies and Medically Assisted Death

Mara Buchbinder
Medicine Anthropology Theory
2019

This article examines an ethical controversy that has received relatively little attention in public debates about the legalization of medical aid-in-dying (AID): should physicians inform patients that they have the option of hastening death? Drawing on ethnographic research about the … Continued

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 R. 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, Douglas MacKay, 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 Goldfarba, 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, Michelle L. McGowan
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. Makindude, A. Fox, B. Grauls, R. Yemesie, P. Kayembég, J.L. Chalachalah, M. Kashamukag, 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

Doug 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

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