Under the co-leadership of C:B Associate Director Annie Lyerly, the Welcome Trust-funded PREVENT (Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies) has released ethical guidelines for investigators conducting ZIKA research with pregnant women
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.
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.
The guidance, called “Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion and Evidence Generation,” is the work of the Ethics Working Group on ZIKV Research & Pregnancy. Lyerly says the new guidance gives policymakers, funders, researchers, oversight bodies, regulatory authorities and the global public health community concrete steps needed to address the issue.
“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.