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