Ethics, regulation, and beyond: the landscape of research with pregnant women.
Scarce research with pregnant women has led to a dearth of evidence to guide medical decisions about safe and effective treatment and preventive interventions for pregnant women and their potential offspring. In this paper, we highlight three aspects of the landscape in which pregnant women are included or, more frequently, excluded from research: international ethics guidance, regional and national regulatory frameworks, and prevailing practices. Our paper suggests that, in some cases, regulatory frameworks can be more restrictive than international ethics guidance, and that even when regulations permit research with pregnant women, practical challenges-as well as the prevailing practices of stakeholders, such as ethics review committees and investigators-may lead to the generalized exclusion of pregnant women from research.
['Saenz|Carla|C|', 'Cheah|Phaik Yeong|PY|', 'van der Graaf|Rieke|R|', 'Henry|Leslie Meltzer|LM|', 'Mastroianni|Anna C|AC|']
D035843:Biomedical Research D064420:Drug-Related Side Effects and Adverse Reactions D005260:Female D006801:Humans D018579:Patient Selection D011247:Pregnancy D011248:Pregnancy Complications D014481:United States
Medication Pregnancy Pregnancy research Research ethics Research regulation