Research with Pregnant Women
Little MO., Wickremsinhe MN., Jaffe E., Lyerly AD.
<p>Despite progress in representing various populations in clinical research, one group has been left behind: pregnant women. Though millions of pregnant women annually need to use medication, whether to treat chronic illness or prevent infectious disease, pregnant women have been systematically excluded from the social investment in clinical research required to generate evidence to inform their care. This chapter articulates three models that have been advanced for morally framing research with pregnant women: an unfettered protectionist model, in which pregnant women are categorized as a “vulnerable population” for purposes of clinical research; a model of unrestricted deference to the pregnant woman’s autonomy; and a model that construes the fetus as a pediatric research subject. Each, it is argued, is critically flawed. With lessons learned from their respective limitations, the chapter points toward ways in which research during pregnancy must be given unique consideration, and toward development of an adequate framework.</p>