KIE Director Maggie Little and Senior Research Scholar Rebecca Kukla both published chapters in a recent Springer publication, titled Clinical Research Involving Pregnant Women and edited by Françoise Baylis and Angela Ballantyne. The book argues for a new default position whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion, builds a framework for the ethical and practical integration of pregnancy in the biomedical research agenda, and provides modern examples of the successful inclusion of pregnant women in research and a critique of the challenges encountered, including research on HIV/AIDS, probiotics, uterine transplant, maternal gene transfer to improve foetal growth, and abortion.
Dr. Little’s chapter, co-authored with members of the PHASES grant team, is titled “Ethics and Research with Pregnant Women: Lessons from HIV/AIDS.” The segment describes two key lessons about research in pregnancy from the context of HIV/AIDS: first, why addressing the health needs of pregnant women, not just the needs of their offspring, is so critical; and second, why doing so is immediately possible, even as we work to resolve certain ethical and regulatory debates, particularly about when it is appropriate to impose fetal risk without the prospect of fetal benefit. In particular, the HIV/AIDS context is leveraged to show how treatment or prevention of maternal disease often entails not just risk – but the prospect of benefit – to the fetus; and creative trial designs can advance no-benefit studies without imposing fetal risk in the first place. For all the challenges that research with pregnant women entails, the HIV/AIDS context reveals that it is possible to conduct a wide range of important research during pregnancy that is both ethically responsible and consonant with U.S. regulations.
Dr. Kukla’s chapter is titled “Equipoise, Uncertainty, and Inductive Risk in Research Involving Pregnant Women.” The segment focuses on the place where epistemological concerns and ethical constraints and participation of pregnant women in research intersect and argues that we are in a state of equipoise with respect to these two options. That is, we are genuinely uncertain which option has a better risk-benefit profile. If we are in such a state, then, with other conditions remaining the same, there is no problematic ‘added risk’ from running a trial comparing these two arms. Kukla that argues our unwillingness to run such trials draws upon an unstated pregnancy exceptionalism, in which normal epistemic and ethical standards for the acceptability of a trial are irrationally discarded.