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 of the 2BeatHIV project and HIV Cure Research Day, reflected on its importance, “HIV Cure Research Day marks the one year anniversary of the founding of the 2BeatHIV project, which has far reaching impact in North Carolina and across the world. I’m excited and proud to announce that Durham is the first city in the world to proclaim this day.” The purpose of HIV Cure Research Day is to promote community involvement in shaping the future of HIV cure research. To date, one man named Timothy Ray Brown (also known as “The Berline Patient”) has been cured of HIV. Scientists are examining multiple strategies to develop long-lasting therapies to completely eradicate HIV from the body and/or achieve HIV remission. To celebrate the 2017 proclamation, the 2BeatHIV project hosted “HIV Cure Research Proclamation Day” on Thursday, December 14th from 6-8pm at Eastway Elementary School located at 610 N Alston Ave. Durham, NC.
Author Archives: Warren Whipple
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 genomic screening programs do not mention an upper age limit. Should such programs employ upper age limits, as occurs in other clinical screenings, on the assumption that older individuals would not benefit clinically? To address this question, our Genetics in Medicine paper analyzed data from GeneScreen, a research study of preventive genomic screening aimed at adults. We focused on how the researchers who designed the study and 50 individuals who joined the study understood and valued age in relation to screening…
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 highlighting one of their articles in its current collection.
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 and Arlene Davis co-chairs the Hospital Ethics Committee.
Kelly Olsen is a first year MD/PhD student at UNC. She is from Saratoga Springs, NY, and before coming to UNC, did a combined BS/MS program in Biology at Villanova University working in zebrafish developmental genetics. She plans to do her PhD in immunology, as her research interests include genetics, immunotherapy, and blood cancers, and she is tentatively planning to go into hematology/oncology as her clinical field. Her ultimate career goal is to split her time between running a lab that does translational research on blood cancers, and seeing patients relevant to her research. In her free time she plays ice hockey and enjoys outdoor activities like hiking.
Austin Bath is a first-year medical student at the UNC School of Medicine. He attended North Carolina State University as a Park Scholar, where he earned a BS in the Biological Sciences. While at NC State, Austin was named the university’s “Leader of the Pack,” was awarded the Walter J. Mathews Medal, and served as a Chancellor’s Aide. Before coming to the UNC School of Medicine, Austin served as an Emergency Medical Technician in Durham, North Carolina. In his free time Austin enjoys fish-keeping, skiing, and playing the drums.
Four highly promising Carolina faculty members in diverse fields have been awarded the Philip and Ruth Hettleman Prizes for Artistic and Scholarly Achievement by Young Faculty.
The recipients, who were recognized at the Sept. 8 Faculty Council meeting, are: Mara Buchbinder, associate professor in the Department of Social Medicine; James Cahoon, associate professor in the Department of Chemistry; Spencer L. Smith, associate professor in the Department of Cell Biology and Physiology; and Stephanie B. Wheeler, associate professor in the Department of Health Policy Management in the Gillings School of Global Public Health.
Buchbinder, who is also adjunct associate professor of anthropology and a core faculty member in the UNC Center for Bioethics, has published on a range of critical issues that hold significance for medicine, the social sciences and bioethics.
Much of her research explores the sociocultural and ethical dimensions of clinical encounters in the United States, with a particular interest in the role of language in medicine. Her recent work focuses on how patients, families, and healthcare providers navigate social and ethical challenges resulting from changes in medical technology, law, and health policy.
She is the author of two books, Saving Babies? The Consequences of Newborn Genetic Screening (with UCLA sociology professor Stefan Timmermans, 2013, University of Chicago Press) and All in Your Head: Making Sense of Pediatric Pain (2015, University of California Press).
Buchbinder joined the Carolina faculty in 2010 after receiving her her Ph.D in anthropology at the University of California, Los Angeles. She was selected for a Greenwall Faculty Scholars Award (2015-2018), a career development award that enables junior faculty to carry out innovative bioethics research.
Jonathan Oberlander, professor and chair of Social Medicine, said Buchbinder’s scholarship is “original, impactful and noteworthy for its remarkable blend of social science theory and ethical inquiry with careful empirical investigation.”
“Dr. Buchbinder has investigated intimate contexts of suffering and care, family dynamics, and local clinical cultures,” Oberlander said “She has chosen to work on problems of vital importance to medical care delivery, illness experiences, health care ethics and policy.”
Comparative Research Ethics and Policy for Phase I Trials
This project addresses the need for a novel evidence-based approach to the protection of Phase I healthy volunteers. Phase I clinical trials test the safety of investigational drugs that eventually may be used in affected patients. These trials have distinctive features that may undermine the validity of data gathered and lead to ethics and policy gaps in protecting healthy volunteers. One such feature is that healthy volunteers must stay in the clinic during the trial where they are given a prescribed diet and experience other restrictions. Another feature of Phase I trials is they rely on repeat volunteers who do not mirror the health or sociodemographic characteristics of typical patient populations. Given these unique features of Phase I trials, we contend that valuable insights may be gained through a comparison with non-human animal “model organism” research. We will investigate this comparison and generate new ethics and policy guidance that addresses the problems of risk, subject selection, validity, and translation that are particular to healthy volunteer trials.
To do so, this project has 3 primary aims:
- Describe and normatively evaluate the limitations of current research oversight in Phase I trials by analyzing data on healthy volunteers’ perceptions of clinical trials, including through a non-human animal research “model organism” lens;
- Compare the ways in which Phase I researchers, non-human animal researchers, bioethicists and policymakers, regulatory and research oversight staff, and healthy volunteers conceptualize: a.) similarities and differences between healthy volunteer and non-human animal research and b.) ethical, policy, and translational science problems particular to each arena; and
- Develop ethics and policy guidance for Phase I healthy volunteer research that a.) extrapolates from the model organism framework in Specific Aims 1 and 2, b.) is attentive to the structural features of Phase I research, and c.) is vetted by expert stakeholders.
This 4-year project is a renewal of our current longitudinal R01 study of 180 healthy volunteers (the HealthyVOICES Project). To address the new aims, we will analyze the current grant’s dataset to identify ethics and policy gaps and generate empirically-grounded points of comparison between Phase I trials and animal research (Aim 1). We will also conduct 60 interviews and 300 surveys with expert informants from Phase I healthy volunteer research, animal studies, and bioethics and regulatory perspectives about the key ethical, policy, and translational issues at stake (Aim 2). Finally, we will develop ethics and policy guidance to protect Phase I subjects and improve the translational science pipeline. Four stakeholder forums across the US will provide a vetting process for our draft guidance and initiate dissemination for our final recommendations (Aim 3). We expect the contribution of the proposed project to be significant because it will generate ethics and policy guidance that can provide advances in healthy volunteer welfare and the translational efficacy of Phase I trials.
Drew Cutshaw and Keren Eyal, second year medical students who are members of the Hospital Ethics Committee and leaders of the Clinical Ethics Discussion Group, launched a new academic year for CEDG at the 2017 Student Activities Fair. More than 50 first year medical students signed up for the group, indicating their interest in the various ethical issues that arise in the care of patients. Drew and Keren, with assistance from their Center mentors, will be organizing a series of ethics events, and the opportunity for first year students to join the HEC and to direct this longstanding interest group.
The Stellenbosch Bioethics Leadership Program has selected it’s first trainees.
Dr Geremew T. Tsegaye has a doctoral degree in medicine (MD). He specialized in public health (MPH) and bioethics (EMMB) and advance Research Ethics.
Dr Theresa Burgess started her career with a BSc (Physiotherapy), followed by a BSc (Med)(Hons) and PhD in Exercise Science, all from the University of Cape Town. In 2011 she was awarded a NIH Fogarty Fellowship in Bioethics and with this support, successfully completed a MHSc (Bioethics) at the University of Toronto in 2012.
Dr Shenuka Singh is a Senior Lecturer in the Discipline of Dentistry at UKZN. She has a doctoral degree (PhD) in the field of Dental Public Health. Dr Singh was a recipient of the NIH Fogarty Fellowship grant in the ARESA Programme (Stellenbosch University) in 2015 and obtained a PG Diploma in Health Research Ethics (Cum Laude).
Nyanyukweni Pandeni Tshifugula, BNSc (University of Namibia), PG Dip Public Health (MEDUNSA), MPH (MEDUNSA), MSc Bioethics Magna cum laude (Erasmus Mundus Master of Bioethics program at KU Leuven, Radboud Universiteit Nijmegen, and Universita degli Studi di Padova), PG Dip Health Research Ethics (Stellenbosch University).
The Centre for Medical Ethics and Law, Stellenbosch University, South Africa and the Center for Bioethics, University of North Carolina at Chapel Hill, United States have been awarded a D43 capacity development grant from the Fogarty International Center of the U.S. National Institutes of Health (NIH) to develop a leadership program in Bioethics in Southern Africa from 2017-2022. Successful applicants are awarded partial scholarships to obtain a PhD (Clinical & Research Ethics).
Despite the high social value of adolescent HIV prevention research in sub-Saharan Africa, investigators are reluctant to involve adolescents in studies with HIV testing and disclosure of results because of ethical concerns about the risks of their participation. This study examines four inter-related ethical issues essential to adolescent HIV research: the effects of disclosure of HIV test results on adolescent psychosocial well-being, health-seeking, or risk behavior; minimizing harms in the recruitment of adolescents; comprehension of informed consent among parents, children, and adolescents 18 years and older; and the appropriate use of compensatory payments for youth and parent participation. The study setting is Siaya County in western Kenya.
- To examine the effects of HIV testing and disclosure on adolescent behavior and psychosocial well-being in the context of a research study. About 4,200 adolescents aged 15-19 will participate in an empirical study of HIV testing and disclosure per the standard of care to inform ethical guidelines.
- To examine stakeholder perceptions about adolescent HIV research methods for recruitment, informed consent, HIV testing and disclosure of results, and compensation/inducements for study participation.
- To develop guidelines for the ethical conduct of adolescent HIV research and to refine them in consultation with key stakeholders. Findings from Aims 1 and 2 will be used to develop preliminary guidelines for conducting ethical adolescent HIV research. Perceptions about the guidelines from the Kenya advisory boards, and from comparable focus group participants and local ethicists from two additional sub-Saharan countries will be analyzed and used to refine the guidelines and assess their generalizability.
- Winfred Luseno, PhD, Pacific Institute for Research and Evaluation (PIRE)
- Stuart Rennie, PhD, University of North Carolina at Chapel Hill
- Denise Hallfors, PhD, PIRE
- Hyunsan Cho, PhD, PIRE
- Daniel Kwaro, MBChB, MPH, Kenya Medical Research Institute (KEMRI)
- Amek Nyaguara, PhD, KEMRI
- David Ayuku, PhD, Moi University
- Muhammed Afolabi, PhD, Gambia, Medical Research Council
- Arthur Caplan, PhD, New York University
- NIH-National Institute of Mental Health (R01 MH102125, 9/1/2014 – 8/31/2019)