KIE Senior Research Scholar Maggie Little last week presented new ethics guidance at AIDS 2020 on behalf of the Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group. The Guidance represents the culmination of a seven-year, NIH-funded project — for which Little is a Co-Principal Investigator — to find ethical pathways for addressing the critical lack of research with pregnant women in HIV and its co-infections.
“Pregnant women are among those most in need of medical treatment and prevention in HIV and its deadly co-infections, such as malaria and tuberculosis. Yet because pregnant women have been so often excluded from clinical research, they are among those with the least evidence to guide their care,” says Little.
The new report, Ending the Evidence Gap for Pregnant Women around HIV and Co-infections: A Call to Action, was authored by a 26-person international Working Group that included experts in bioethics, public health, law, obstetrics and maternal-fetal medicine, pediatrics, HIV research, infectious disease, and pharmacology, in addition to community advocates for women living with HIV.
“The Guidance gives immediately actionable steps for research to help ensure that pregnant women get equitable protection, access, and respect,” says Little.
Leadership of the PHASES project also includes Anne Lyerly, MD, MA (Principal Investigator) from the University of North Carolina Chapel Hill, and Ruth Faden, PhD, MPH (co-Principal Investigator) from The Johns Hopkins University. Little, Lyerly, and Faden have long collaborated on issues around equitable research with pregnant women.
The new Guidance, has been endorsed by the International Community of Women Living with HIV Global and East Africa, follows from previous reports and publications of the group focused on legal decision-making, consent in biomedical research, women’s views on contraception requirements for clinical research participation, and feminist positions in biomedical research.