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Experiences of Menopause During Incarceration

Elana F. Jaffe, Aunchalee E.L. Palmquist, Andrea K. Knittel
Menopause: The Journal of The North American Menopause Society

Objective: Despite increasing representation of older women in US jail and prison facilities, their menopause experiences and access to related care remain uncharacterized. Our objective is to explore the menopause experiences of women incarcerated in jail and prison facilities. Methods: … Continued

Prioritization of Pregnant Individuals in State Plans for COVID-19 Vaccination

Matthew A. Crane, Elana Jaffe, Richard H. Beigi, Ruth A. Karron, Carleigh B. Krubiner, Chizoba B. Wonodi, Ruth R. Faden
American Journal of Obstetrics and Gynecology
2021

Hospital Policies During COVID-19: An Analysis of Visitor Restrictions

Rohit Jaswaney, Arlene Davis, R Jean Cadigan, Margaret Waltz, Elizabeth R Brassfield, Bex Forcier, Benny L Joyner Jr.
Journal of Public Health Management and Practice
2021

Abstract Objective: In response to the COVID-19 pandemic, hospitals have developed visitor restriction policies in order to mitigate spread of infection. We reviewed hospital visitor restriction policies for consistency and to develop recommendations to highlight fair and transparent restrictions, exceptions, … Continued

Clinical Discussion of Medical Aid-in-Dying: Minimizing Harms and Ensuring Informed Choice

Elizabeth R. Brassfield, Mara Buchbinder
Patient Education and Counseling
2021

Objective The implementation of medical aid-in-dying (MAID) poses new challenges for clinical communication and counseling. Among these, health care providers must consider whether to initiate a discussion of MAID with eligible patients who do not directly ask about it. Norms … Continued

Paying for Fairness? Incentives and Fair Subject Selection

Douglas MacKay, Rebecca L. Walker
Paying for Fairness? Incentives and Fair Subject Selection
2021

Reconsidering Scarce Drug Rationing: Implications for Clinical Research

Zev M Nakamura, Douglas P MacKay, Arlene M. Davis, Elizabeth R Brassfield, Benny L Joyner Jr, Donald L Rosenstein
Journal of Medical Ethics
2021

Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who … Continued

Clarifying a Clinical Ethics Service’s Value, the Visible and the Hidden

Laura Guidry-Grimes, Marika Warre, Hannah I Lipman, Kelly Kent, Kaarkuzhali Babu Krishnamurthy, Arlene M Davis, Thomas May, Marycon Chin Jiro, Jane Jankowski
Journal Clinical Ethics
2019

Our aim in this article is to define the difficulties that clinical ethics services encounter when they are asked to demonstrate the value a clinical ethics service (CES) could and should have for an institution and those it serves. The … Continued

Membership Recruitment and Training in Health Care Ethics Committees: Results from a National Pilot Survey

Anya E. R. Prince, R. Jean Cadigan, Warren Whipple, Arlene M. Davis
AJOB Empirical Bioethics

This pilot study reports on a survey regarding recruitment, appointment, and training of members for health care ethics committees (HCECs). Background: Past studies have examined HCECs, but have focused on the roles of the committees and the broad makeup of … Continued

“Forward-Thinking” in U.S. Biobanking

R. Jean Cadigan, Teresa P. Edwards, Dragana Lassiter, Arlene M. Davis, Gail E. Henderson
Genetic Testing and Molecular Biomarkers
2017

Aims: Do biobanks enact policies and plans that allow them to anticipate and respond to potential challenges? If a biobank has one such policy or plan, is it likely to have more? Using survey data from 456 U.S. biobanks, we … Continued

A Critical Review of Health Research Ethical Guidelines Regarding Caregiver Consent for HIV Research Involving Minors in South Africa: Ethical and Legal Issues

Eshetu Bekle Worku, Arlene M Davis, Brenda Morrow
South African Journal of Bioethics and Law
2016

Background. Over the past decades there have been tremendous efforts to improve the ethical conduct of research involving humans throughout the world. As a one-size-fits-all philosophy can no longer work, most countries have developed specific legal and ethical guidelines for … Continued

An Evaluation of the Middle East Research Training Initiative Tool in Assessing Effective Functioning of Research Ethics Committees

Walter Jaoko, Elizabeth Bukusi, Arlene M. Davis
Journal of Empirical Research on Human Research Ethics
2016

The effective functioning of a research ethics committee (REC) can be evaluated using self-assessment tools. The Middle East Research Ethics Training Initiative (MERETI) tool can be used by one member, typically the Chair, to score an REC. The consistency of … Continued

Navigating Professional Norms in an Interprofessional Environment: The Practice of Healthcare Ethics Committees

Prince, Anya E. R., Davis, Arlene M.
Connecticut Public Interest Law Journal
2016

Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?

Prince, A., Conley, J., Davis, A., Lázaro-Muñoz, G., Cadigan, R.
Journal of Law, Medicine & Ethics
2016

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
2021

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

Recommendations from Thai Stakeholders About Protecting HIV Remission (‘cure’) Trial Participants: Report from a Participatory Workshop

Holly L Peay, Nuchanart Q Ormsby, Gail E Henderson,, Thidarat Jupimai, Stuart Rennie, Krittaecho Siripassorn, Kunakorn Kanchawee, Sinéad Isaacson, R Jean Cadigan, Kriste Kuczynski, Udom Likhitwonnawut
nternational Health
2020

Background The social/behavioral HIV Decision-Making Study (DMS) assesses informed consent and trial experiences of individuals in HIV remission trials in Thailand. We convened a 1-d multi-stakeholder participatory workshop in Bangkok. We provide a meeting summary and reactions from DMS investigators. … Continued

The Ethics of Stigma in Medical Male Circumcision Initiatives Involving Adolescents in Sub-Saharan Africa

Stuart Rennie, Adam Gilbertson, Denise Hallfors, Winnie K Luseno
Public Health Ethics
2021

Ongoing global efforts to circumcise adolescent and adult males to reduce their risk of acquiring HIV constitute the largest public health prevention initiative, using surgical means, in human history. Voluntary medical male circumcision (VMMC) programs in Africa have significantly altered … Continued

Adolescent Perceptions about Participating in HIV-Related Research Studies.

Simons-Rudolph, A. P., Iritani, B. J., Odongo, F. S., Rennie, S., Gilbertson, A., Kwaro, D., Luseno, W. K
Children and Youth Services Review
2020

The rising incidence of infection among youth in sub-Saharan Africa makes HIV-related research among younger people a top priority. There remains, however, a lack of consistent and unambiguous ethical principles and guidance for researchers wishing to conduct HIV studies with … Continued

Public Health, Private Names: Ethical Considerations of Branding Schools of Public Health in the United States

Mike D. Fliss, Danielle R. Gartner, Elizabeth S. McClure, Julia B. Ward, Stuart Rennie
Critical Public Health
2020

In a resource limited environment, universities may increasingly need to conceive themselves as ‘brands’ and to mobilize capitalist marketing strategies to enhance institutional reputations. Between 1994 and July 2018, 24% of accredited United States public health schools were renamed for … Continued

Enhancing Ethics Review of Social and Behavioral Research Involving Human Subjects: A Template for Use in Low- and Middle-Income Countries

Liya Wassie, Senkenesh Gebre-Mariam, Geremew Tarekegne, Stuart Rennie
1-23

Background: Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory capacities, in terms of ethical review processes, are also generally weak. The ethical assessment … Continued

Les grèves de médecins en République Démocratique du Congo : quels repères éthiques généralisables?

Ravez, L. J.-C., Rennie, S., Yemesi, R., Chalachala, J.-L., Makindu, D., Behets, F., Fox, A., Kashamuka, M., Kayembé, P.
Can. J. Bioeth
2019

For several years, the Democratic Republic of Congo has been the scene of strikes by the country’s doctors. The strikers’ demands are essentially financial and statutory and are intended to put pressure on the government. In this country, as is … Continued

Stakeholder-Driven, Consensus Development Methods to Design an Ethical Framework and Guidelines for Engaged Research

Corbie-Smith G, Wynn M, Richmond A, Rennie S, Green M, Hoover SM, Watson-Hopper S, Niebeth KS
PLoS ONE
2018

Increasingly, researchers seek to engage communities, patients, and stakeholders as partners in the process and products of health research. However, there is no existing stakeholder-driven ethical framework for such engaged scholarship. We employed an iterative, stakeholder-engaged method to develop a … Continued

An Adapted Instrument to Assess Informed Consent Comprehension Among Youth and Parents in Rural Western Kenya: A Validity Study

Afolabi MO, , Rennie S, Halifors DD, Kline T, Zeitz S, Odongo FS, Amek NO, Luseno WK
BMJ Open
2018

Objective To adapt and validate a questionnaire originally developed in a research setting for assessment of comprehension of consent information in a different cultural and linguistic research setting. Design The adaptation process involved development and customisation of a questionnaire for … Continued

Crowdsourcing and Community Engagement: A Qualitative Analysis of the 2BeatHIV Contest

Mathews A, Farley S, Hightow-Weidman L, Muessig K, Rennie S, Tucker JD
Journal of Virus Eradication
2018

Background: As HIV cure research advances, it is important to engage local communities. Crowdsourcing may be an effective, bottom-up approach. Crowdsourcing contests elicit public contributions to solve problems and celebrate finalists. We examine the development of a crowdsourcing contest to … Continued

North Carolina Medical Student Views on Abortion

Christopher L. Bennett, , David A. McDonald, Alex Finch, Stuart Rennie, Jessica E. Morse
North Carolina Medical Journal
2018

BACKGROUND Abortion is a controversial yet common procedure within the United States and North Carolina. Although much effort has been directed at understanding the views of physicians and the general public, the views of medical students on abortion are understudied. … Continued

Ethics of Treatment Interruption in HIV Cure Research: Addressing the Conundrum of Risk/Benefit Assessment.

Henderson GE, Peay HL, Kroon E, Cadigan RJ, Meagher K, Jupimai T, Gilbertson A, Fisher J, Ormsby NQ, Chomchey N, Phanuphak N, Anaworanich J, Rennie S
Journal of Medical Ethics
2018

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

Ethical Concerns of and Risk Mitigation Strategies for Crowdsourcing Contests and Innovation Challenges: Scoping Review

Tucker JD, Pan SW, Mathews A, Stein G, Bayus B, Rennie S
J Med Internet Res
2018

Background: Crowdsourcing contests (also called innovation challenges, innovation contests, and inducement prize contests) can be used to solicit multisectoral feedback on health programs and design public health campaigns. They consist of organizing a steering committee, soliciting contributions, engaging the community, … Continued

Where Is the Community Dimension in the Updated Common Rule?

Raquel Reyes, Carol E Lorenz, Stuart Rennie, Alan Richmond, Giselle Corbie-Smith
Prog Community Health Partnersh
2018

The problem: Changes to the Federal Policy for the Protection of Human Subjects (the Common Rule) as presented in the Notice of Proposed Rulemaking (NPRM) are both logical and necessary. However, the proposed changes continue to focus entirely on the … Continued

‘I Can Coexist with HIV’: A Qualitative Study of Perceptions of HIV Cure Among People Living with HIV in Guangzhou, China

Ma Q, Wu F, Henderson G, Rennie S, Rich ZC, Cheng Y, Hu F, Cai W, Tucker JD
Journal of Virus Eradication
2016

Little is known about perceptions of HIV cure among people living with HIV (PLHIV), despite them being crucial stakeholders in ongoing HIV cure research. A qualitative research study was conducted in Guangzhou, China, to explore the perceptions of HIV cure … Continued

Doug MacKay

Doug MacKay Interviewed for UNC’s The Well

Doug Makay was interviewed by Logan Ward for the February 23rd issue of UNC’s The Well on “The Pros and Cons of Universal Basic Income.” The idea of governments giving residents no-strings-attached cash payments is picking up steam, due in … Continued

Ethics Essay Writing Workshop

Clinical Ethics Discussion Group is hosting an Ethics Essay Writing Workshop on February 18th, 12:00 – 1:00 pm. If you would like to attend please email: Konan Beke konan_beke@med.unc.edu  Celia Mizelle cecelia_mizelle@med.unc.edu

HIV Prevention Research and COVID-19: Putting Ethics Guidance to the Test

Stuart Rennie, Wairimu Chege, Leah A. Schrumpf, Florencia Luna, Robert Klitzman, Ernest Moseki, Brandon Brown, Steven Wakefield , Jeremy Sugarman
BMC Medical Ethics

Background Critical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these … Continued

The Costs of Contradictory Messages About Live Vaccines in Pregnancy

Elana Jaffe, Ilona Telefus Goldfarb, Anne Drapkin Lyerly
American Journal of Public Health

The increased risk of harm from COVID-19 infection in pregnancy highlights the importance of including pregnant people in COVID-19 vaccine development and deployment. Promising vaccines being developed include replication-competent platforms, which are typically contraindicated during pregnancy because of theoretical risk. … Continued

Personal Prenatal Ultrasound Use by Women’s Health Professionals: An Ethical Analysis

Marielle S Gross, Gail Geller, Anne Drapkin Lyerly
Clinical Ethics
2021

Prenatal ultrasound use is skyrocketing despite limited evidence of improved outcomes. One factor driving this trend is the widely recognized psychological appeal of real-time fetal imaging. Meanwhile, considering imperfect safety evidence, U.S. professional guidelines dictate that prenatal ultrasound—a screening test—should … Continued

The Need for Inclusion of Pregnant Women in COVID-19 Vaccine Trials

Richard H.Beigi, Carleigh Krubine, Denise J. Jamieson, Anne D. Lyerly, Brenna Hughes, Laura Riley, Ruth Faden, Ruth Karron
Vaccine
2021

Since the recognition of SARS-CoV-2 virus in December 2019 there have been more than seventy-two million cases and greater than 1.6 million deaths globally, as well as more than 300,000 deaths in the United States attributable to COVID-19 [1]. COVID-19 … Continued

Toward Better Governance of Human Genomic Data

Kieran C. O’Doherty, Mahsa Shabani, Edward S. Dove, Heidi Beate Bentzen, Pascal Borry, Michael M. Burgess, Don Chalmers, Jantina De Vries, Lisa Eckstein, Stephanie M. Fullerton, Eric Juengst, Kazuto Kato, Jane Kaye, Bartha Maria Knoppers, Barbara A. Koenig, Spero M. Manson, Kimberlyn M. McGrail, Amy L. McGuire, Eric M. Meslin, Dianne Nicol, Barbara Prainsack, Sharon F. Terry, Adrian Thorogood, Wylie Burke
Nature Genetics
2021

Here, we argue that, in line with the dramatic increase in the collection, storage and curation of human genomic data for biomedical research, genomic data repositories and consortia have adopted governance frameworks to both enable wide access and protect against … Continued

“Prevention” and Human Gene Editing Governance

Eric T. Juengst
AMA Journal of Medical Ethics
2021

The Holocaust and the racial hygiene doctrine that helped rationalize it still overshadow contemporary debates about using gene editing for disease prevention. In part, this is because prevention can mean 3 different things, which are often conflated. Phenotypic prevention involves … Continued

Speculating on Precarious Income: Finance Cultures and the Risky Strategies of Healthy Volunteers in Clinical Drug Trials

Jill A. Fisher, Megan M. Wood, Torin Monahan
Journal of Cultural Economy
2020

Speculation has become a normalized occupational strategy and quotidian economic rationality that extends throughout society. Although there are many contemporary articulations of speculation, this article focuses on contract labor as a domain of financialization. Seen through this lens, contract labor … Continued

A New Governance Overnance Approach to Regulating Human Genome Editing

John M. Conley, Arlene M. Davis, Gail E. Henderson, Eric T. Juengst, Karen M. Meagher, Rebecca L. Walker, Margaret Waltz, Jean Cadigan
North Carolina Journal of Law & Technology
2020

For years, genomic medicine—medicine based on the growing understanding of the genetic contribution to many diseases and conditions—has been hailed as the future of medical treatment, but it has thus far had limited effect on day-to-day medical practice. The ultimate … Continued

Gendered Logics of Biomedical Research: Women in U.S. Phase I Clinical Trials

Marci D. Cottingham, Jill A. Fisher
Social Problems

Despite the importance of including diverse populations in biomedical research, women remain underrepresented as healthy volunteers in the testing of investigational drugs in Phase I trials. Contributing significantly to this are restrictions that pharmaceutical companies place on the participation of … Continued

Evaluating the National Institutes of Health’s Sex as a Biological Variable Policy: Conflicting Accounts from the Front Lines of Animal Research

Margaret Waltz, Jill A. Fisher, Anne Drapkin Lyerly, Rebecca L. Walker
Journal of Women's Health
2020

Background: Since the National Institutes of Health (NIH) Revitalization Act of 1993, focus on the equitable inclusion of women in clinical research has been ongoing. NIH’s 2015 sex as a biological variable (SABV) policy aims to transform research design, analysis, … Continued

Healthy Volunteers

Jill Fisher

This chapter describes the involvement of healthy volunteers in biomedical research. Healthy individuals are valuable to research because they can offer data about biological processes or investigational products that are not distorted by illness or disease. In addition, healthy individuals … Continued

Fair Subject Selection in Clinical and Social Scientific Research

Doug MacKay
The Oxford Handbook of Research Ethics

This chapter provides a critical overview and interpretation of fair subject selection in clinical and social scientific research. It first provides an analytical framework for thinking about the problem of fair subject selection. It then argues that fair subject selection … Continued

Reconsidering Scarce Drug Rationing: Implications for Clinical Research

Zev M Nakamura, Douglas P MacKay, Arlene M. Davis, Elizabeth R Brassfield, Benny L Joyner Jr., Donald L Rosenstein
Journal of Medical Ethics

Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who … Continued

Scripting Death Stories of Assisted Dying in America

Mara Buchbinder

Buy Book How the legalization of assisted dying is changing our lives. Over the past five years, medical aid-in-dying (also known as assisted suicide) has expanded rapidly in the United States and is now legally available to one in five … Continued

Transparency, Trust, and Community Welfare: Towards a Precision Public Health Ethics Framework for the Genomics Era

Eric T. Juengst, Annelies Van Rie
Genome Medicine

Infectious disease control is experiencing a paradigm shift, as pathogen sequencing technologies and digital applications are increasingly implemented for control of diseases such as tuberculosis, Ebola, and COVID-19. A new ethical framework should be a critical part of this emerging … Continued

Cohorts as Collections of Bodies and Communities of Persons: Insights from the SEARCH010/RV254 Research Cohort

Gail E. Henderson, Stuart Rennie, Amy Corneli, Holly L. Peay
International Health
2020

Longitudinal research cohorts are uniquely suited to answer research questions about morbidity and mortality. Cohorts may be comprised of individuals identified by specific conditions or other shared traits. We argue that research cohorts are more than simply aggregations of individuals … Continued

Ethics of Pursuing Targets in Public Health: The Case of Voluntary Medical Male Circumcision for HIV-Prevention Programs in Kenya

Stuart Rennie, Adam Gilbertson, Denise Hallfors, Winnie K Luseno
Journal of Medical Ethics
2020

The use of targets to direct public health programmes, particularly in global initiatives, has become widely accepted and commonplace. This paper is an ethical analysis of the utilisation of targets in global public health using our fieldwork on and experiences … Continued

Exploring the Emotional Labor of Medical Trainees in the Setting of Ethics Education

Margaret Waltz, R. Jean Cadigan, Arlene M. Davis
The American Journal of Bioethics
2019

Julie Childers and Bob Arnold’s (2019) article, “The Inner Lives of Doctors: Physician Emotion in the Care of the Seriously Ill,” uses Kübler-Ross’s influential work on death and dying to remind us that the experiences contained within her framework relate … Continued

Can We Do without Respect and Justice in Animal Research Ethics?

Rebecca L. Walker
The Hastings Center Report

Abstract This book review essay discusses Principles of Animal Research Ethics (2020), by Tom L. Beauchamp and David DeGrazia. Review Animal research has long been a focus of social controversy and ethical debate. As Tom Beauchamp and David DeGrazia summarize … Continued

Rohit Jaswaney, research collaborator with the Center for Bioethics, presented research findings at ASBH.

Rohit Jaswaney is a member of a UNC research team composed of Jean Cadigan, Arlene Davis, Izzy Brassfield, and Bex Forcier from the Center for Bioethics, as well as Maggie Waltz, Dept of Social Medicine, and Benny Joyner, Department of … Continued

Delaying Pregnancy during a Public Health Crisis — Examining Public Health Recommendations for Covid-19 and Beyond

Sonja A. Rasmusse, Anne Drapkin Lyerly, Denise J. Jamieson
The New England Journal of Medicine
2020

During previous public health emergencies, the issue of whether public health agencies should recommend that women avoid becoming pregnant because of potential risks to themselves and their newborns has been controversial. The ongoing Covid-19 pandemic has again led to questions … Continued

Virtue Ethics and Laboratory Animal Research

Rebecca L. Walker
Institute for Laboratory Animal Research
2020

This article appeals to virtue ethics to help guide laboratory animal research by considering the role of character and flourishing in these practices. Philosophical approaches to animal research ethics have typically focused on animal rights or on the promotion of … Continued

HIV Molecular Epidemiology: Tool of Oppression or Empowerment?

Stuart Rennie, Kristen A. Sullivan, Ann Dennis
The American Journal of Bioethcs

Molldrem and Smith (2020) are to be commended for their insightful analysis of a public health practice that has received little attention among bioethicists: the use of molecular HIV surveillance (MHS) and cluster detection and response (CDR) for epidemiology and … Continued

Moral practices shaping HIV disclosure among young gay and bisexual men living with HIV in the context of biomedical advance

Willa Dong, Kathryn E. Muessig, Kelly A. Knudtson, Adam Gilbertson, Stuart Rennie, Karina Soni , Lisa B. Hightow-Weidman
Culture, Health & Sexuality
2020

Biomedical advances in diagnostics, treatment and prevention increase the means available to reduce HIV transmission risk. Subsequent shifts in HIV status disclosure obligation and ethics may impact how those living with HIV view, enact and experience disclosure. We analysed focus … Continued

Comparative strategic approaches to COVID-19 in Africa: Balancing public interest with civil liberties

A E Obasa, S Singh, E Chivunze, T Burgess, F Masiye, T Mtande, J Ochieng, V Chalwe, S Rennie, K Moodley
The South African Medical Journal
2020

As COVID-19 spreads rapidly across Africa, causing havoc to economies and disruption to already fragile healthcare systems, it is becoming clear that despite standardised global health strategies, national and local government responses must be tailored to their individual settings. Some … Continued

Allocation of scarce resources in Africa during COVID‐19: Utility and justice for the bottom of the pyramid?

Keymanthri Moodley, Stuart Rennie, Frieda Behets, Adetayo Emmanuel Obasa, Robert Yemesi, Laurent Ravez, Patrick Kayembe, Darius Makindu, Alwyn Mwinga, Walter Jaoko
Developing World Bioethics
2020

The COVID‐19 pandemic has raised important universal public health challenges. Conceiving ethical responses to these challenges is a public health imperative but must take context into account. This is particularly important in sub‐Saharan Africa (SSA). In this paper, we examine … Continued

CEDG and HEC Welcome Konan Beke and Celia Mizelle

Konan Beke and Celia Mizelle 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

Practical and Ethical Concerns in Implementing Enhanced Surveillance Methods to Improve Continuity of HIV Care: Qualitative Expert Stakeholder Study

Mara Buchbinder, Colleen Blue, Stuart Rennie, Eric Juengst, Lauren Brinkley-Rubinstein, David L Rosen
JMIR Public Health Surveillance
2020

Background: Retention in HIV care is critical to maintaining viral suppression and preventing further transmission, yet less than 50% of people living with HIV in the United States are engaged in care. All US states have a funding mandate to … Continued

Clinical discussion of Medical Aid-in-Dying: minimizing harms and ensuring informed choice

Elizabeth R. Brassfield, Mara Buchbinder
Patient Education and Counseling
2020

Abstract Objective The implementation of medical aid-in-dying (MAID) poses new challenges for clinical communication and counseling. Among these, health care providers must consider whether to initiate a discussion of MAID with eligible patients who do not directly ask about it. … Continued

Government Policy Experiments and the Ethics of Randomization

Douglas MacKay
Philosophy & Public Affairs

Governments are increasingly using randomized controlled trials (RCTs) to evaluate policy interventions.1 RCTs are often understood to provide the highest quality evidence regarding the causal efficacy of an intervention.2 By randomly assigning participants to intervention and control groups, for example, … Continued

Pathways to Depression and Poor Quality of Life Among Adolescents in Western Kenya: Role of Anticipated HIV Stigma, HIV Risk Perception, and Sexual Behaviors

Winnie Kavulani Luseno, Samuel H. Field, Bonita J. Iritani, Fredrick S. Odongo, Daniel Kwaro, Nyaguara Ombek Amek, Stuart Rennie
AIDS and Behavior
2020

Depression is a major cause of disease burden and is linked to poor quality of life (QOL) among adolescents. We examined the roles of sexual behaviors, HIV risk perception, and anticipated HIV stigma on depressive symptomatology and QOL among 4096 … Continued

PHASES Guidance

Health, Bioethics Experts and Advocates Release a Call to Action to the HIV/Co-infections Research Community: “We must work together to give pregnant women the evidence base they deserve.” New Report Lays out Recommendations for Including Pregnant Women in Research on … Continued

The Unfinished Business of Respect for Autonomy: Persons, Relationships, and Nonhuman Animals

Rebecca L. Walker
The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine
2020

Special Issue Celebrating the 40th Anniversary of the First Publication of The Principles of Biomedical Ethics by Tom L. Beauchamp and James F. Childress. This essay explores three issues in respect for autonomy that pose unfinished business for the concept. … Continued

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