KIE Director Maggie Little and Senior Research Scholar Rebecca Kukla each published papers in a new volume edited by prominent international bioethicists Françoise Baylis and Angela Ballantyne. The book, Missed Trials: Clinical Research Involving Pregnant Women, discusses how to respectfully and responsibly include pregnant women in clinical trials.
[T]he existing literature on research involving pregnant women predominantly focuses on the reasons ‘why’ the inclusion of pregnant women in research is necessary – viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default position, whereby pregnant women are included in clinical trials unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research.
Dr. Little’s paper, co-authored with members of the PHASES grant team, is titled “Ethics & Research with Pregnant Women: Lessons from HIV/AIDS.” The paper works to leverage the treatment context of HIV/AIDS to demonstrate that it is possible to conduct a wide range of important research during pregnancy that is both ethically responsible and consonant with US regulations.
Dr. Kukla’s paper, “Equipoise and the Ethical Management of Uncertainty,” examines the ethical basis for medical research that involves assigning patients to different treatment arms of a clinical trial.