Ethics

There is growing recognition of the need to gather evidence to guide the use of medications in pregnancy and during the breastfeeding period. Largely due to ethical concerns about imposing uncertain risk to the fetus or infant (or sometimes to the pregnant woman), most studies leading to authorization of drugs and vaccines have excluded women who are, or who may become, pregnant, leading to a dearth of evidence to inform their care. Given the ethical complexities that pregnancy and breastfeeding introduce to biomedical research, ethics has historically been viewed as a barrier to the conduct of research in pregnant and lactating women.

Ethics is not only a barrier to research with people who are pregnant or lactating; however, it is also a powerful reason to pursue such research, and offers strong justifications for advancing research despite the ethical, regulatory and other challenges of doing so. As such, many organizations and groups have called for advancing research in pregnant and lactating women as both a critical public health need and an ethical imperative.

The resources contained in this knowledge portal reflect the growing literature on, and guidance for, conducting research with pregnant and lactating women. They address both the role of ethics in advancing research as well as the need to consider carefully the ethical complexities of conducting research within these populations. These resources may be used to support the ethical inclusion of pregnant and lactating women and their interests in the biomedical research agenda.