Research with Pregnant Women: New Insights on Legal Decision‐Making

Abstract

Although pregnant women rely on medical interventions to treat and prevent a wide variety of health conditions, they are frequently excluded or underrepresented in clinical research. The resulting dearth of pregnancy-specific evidence to guide clinical decisionmaking routinely exposes pregnant women, and their future offspring, to risk of uncertain harms for uncertain benefits. The two legal factors regularly cited as obstacles to such research are the federal regulatory scheme and fear of liability. This article reveals a far more nuanced and complex view of the legal context. First, legal professionals may—at any time from product conception to marketing—influence decisions about research with pregnant women. Second, factors not previously articulated in the literature may prompt legal professionals to slow or halt such research. They include: financial interests, regulatory ambiguity, obstacles to risk management, and site-specific laws unrelated to research. Any efforts to promote the ethical inclusion of pregnant women in research must acknowledge the role of legal decisionmakers and address their professional concerns.

Protection Versus Progress: The Challenge of Research on Cannabis Use During Pregnancy

“…36 In addition, research involving pregnant women is subject to an increased degree of legal, ethical, and regulatory scrutiny dating back to the days of thalidomide. 37 Together, these two factors can make conducting even observational research on prenatal cannabis exposure difficult (as discussed below) and randomized trials impossible. 27 The legal status of cannabis also has real consequences for pregnant women.…”

Ethics, regulation, and beyond: the landscape of research with pregnant women

“…Stakeholders often articulate their protectionist stance as a desire to avoid “the next thalidomide,” a reference to the tragedy in which more than 10,000 children were born with birth defects resulting from in utero exposure to the drug [27, 28]. Notably, however, the thalidomide tragedy was not the result of pregnant women’s participation in research, but rather their use of a prescription drug that was never tested for safety or efficacy in pregnant women.…”

“…Evidence from the 1970s that linked diethylstilbestrol (DES)—a drug prescribed to pregnant women to prevent miscarriage—with subsequent cancer in young women prenatally exposed to DES, amplified liability concerns by demonstrating that the period of legal risk was longer than previously understood [27]. …”

“…More than 90% of medications approved by the FDA between 1980 and 2011 are reported to lack sufficient data to determine maternal and fetal risk [30]. The absence of safety and efficacy information does not, however, preclude physicians from prescribing—and pregnant women from taking—those medications “off-label” [27, 31]. Studies have revealed that as many as 93.9% of pregnant women in the United States take at least one medication [32, 33].…”

Ethical challenges posed by clinical trials in preterm labor: a case study

“…Accordingly, present debates have moved from justifying the inclusion of pregnant women in clinical trials to justifying their exclusion in what has been called the “second wave” [ 6 ]. A critical question is how to balance potential risks to the fetus with respect to benefits to the pregnant woman, particularly if she is enrolled in life-saving trials that could provide evidence based effective treatment [ 7 , 8 ]. Pregnant women do require special protections as research participants due to a legitimate concern about the protection of both the woman and her fetus [ 9 , 10 ].…”