As UNC geneticist Jonathan Berg gears up to lead a $9.7-million renewal of the NCGENES project, we look at a story from the original study and how it changed the fortunes of a woman from Goldsboro, NC.
CHAPEL HILL, NC – When she was six, a mysterious ailment caused Elizabeth Davis to walk on her toes. Kids began making fun of her. Doctors couldn't figure out why she walked like this. Then her condition got worse. She began using crutches. Eventually, she didn't want to leave the house and would rely on a wheel chair. She went on a diagnostic odyssey for decades and her condition never improved despite various treatments and even surgeries until she came to Jane Fan, MD, a neurologist at UNC who thought Elizabeth's condition had an underlying genetic component that typical diagnostics couldn't find. Fan thought Elizabeth might benefit from enrolling in NCGENES – North Carolina Clinical Genomic Evaluation by NextGen Exome Sequencing.
This was a four-year $6.4-million NIH-funded initiative led by Jim Evans, MD, PhD, the Bryson Distinguished Professor of Genetics and Medicine. Researchers sequenced the genomes of hundreds of people to develop best practices for diagnostic tools, some of which clinical geneticists now use to help guide health care for North Carolinians and people around the world.
The William R. Kenan, Jr. Charitable Trust has awarded the School of Medicine at the University of North Carolina at Chapel Hill $1.5 million to establish interprofessional clinical experiences for health professions students in rural areas of the state, launching the UNC Rural Interprofessional Health Initiative (RIPHI).
The University of North Carolina at Chapel Hill, the nation's first public university, serves North Carolina, the United States, and the world through teaching, research, and public service. The proposed UNC Rural Interprofessional Health Initiative is a joint effort of the health professions schools at UNC, each of which has a similar mission – improve and promote the health and wellbeing of North Carolinians, improve public health and eliminate health inequities, advance and advocate for health care through education, practice, research, innovation and collaboration.
The inclusion of pregnant women in Zika virus vaccine research is crucial to solving the international health crisis, according to new guidance published by UNC's Center for Bioethics and two other universities.
UNC's Center for Bioethics, the Johns Hopkins Berman Institute of Bioethics and Georgetown University's Kennedy Institute for Ethics were awarded a $1.55 million grant from the Wellcome Trust in 2016 to develop ethical guidance to responsibly and equitably include pregnant women in research related to public health emergencies. The most devastating consequence of the Zika virus – Congenital Zika Syndrome (CZS) – is caused by infection with the virus during pregnancy.
"People tend to think first about the ethical problems of including pregnant women in research." says Anne Lyerly, MD, MA, professor of social medicine and associate director of the UNC Center for Bioethics. "In this case, the gravest ethical problem would be if we failed to include them, since it is pregnant women – and their babies – who will face the most serious consequences of infection."
According to the Centers for Disease Control and Prevention, Texas and Florida are among the areas with a high risk for the Zika virus, along with parts of Central and South America, Africa and Asia.
MORAL IMPERATIVES The guidance centers around three moral imperatives that provide the ethical urgency for pursuing Zika virus vaccine research with pregnant women:
To develop a Zika virus vaccine that can be responsibly and effectively used during pregnancy
To collect data that are specific to safety and the ability of a vaccine to effect an immune response in pregnant women for all Zika virus vaccines to which pregnant women may be exposed
To ensure pregnant women have fair access to participate in vaccine trials that offer a reasonably favorable ratio of research-related risks to potential benefits
The research team convened a 15-person working group of experts in science, health policy and research ethics from around the globe who in turn consulted with 60 leading experts in vaccine science and immunology to deliver the ethics guidance for including the needs and interests of pregnant women in the Zika research agenda.
FAIR TREATMENT "We argue that in order to ethically respond to global Zika virus crisis, clinical research that includes pregnant women is critical," Lyerly says. "Such research will help to ensure that they have access to safe, effective and evidence-based ways to protect themselves and the children they will bear from Zika. It is a priority for public health and a matter of justice."
The universities' multiyear project, called PREVENT (Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies) will continue to address emerging epidemic threats. "Historically the health needs of pregnant women and their offspring have been largely neglected in research responding to public health emergencies," Lyerly says. "The Zika crisis presents a clarion call that paradigm needs to change. We hope our guidance shows that it is not just necessary, but very possible.
Lyerly is also the principal investigator of the PHASES project, a six-year National Institutes of Health-funded project to ethically advance research in pregnancy in the context of HIV infection.
Originally published at UNC Health Care Newsroom.