Too Pregnant to Participate

The ethical dilemma of pregnant women taking part in clinical trials has created something of a catch-22 for the research community; the lack of knowledge surrounding pregnant women as subjects in clinical studies prevents them for taking part in studies, so the lack of knowledge is never addressed.

By analyzing 13 clinical studies, a research group from the Netherlands has identified a number of rationales for why women are excluded from clinical trials: the issue of informed consent, pregnant women’s susceptibility to coercion, a heightened risk because of a lack of scientific knowledge, and the safety of the developing fetus. More broadly, pregnant women are often designated as “vulnerable” – a term typically applied to populations whose ability to make decisions for themselves in a research context is considered compromised; for example, children, or people with learning disabilities.

But how much truth is there in the notion that pregnant women are “vulnerable” or somehow unable to consent to participation in research? According to the authors, not much. “There is no immediately obvious reason to assume that pregnant women are incapacitated during pregnancy,” the authors wrote (1). Tackling the issue of coercion, the notion that women will feel coerced by their own or society’s wish to protect the developing fetus is problematic – and rather paternalistic, according to the authors. The lack of scientific knowledge available is certainly an issue, but one that can only be tackled by allowing pregnant women access to appropriate clinical studies. And finally, the argument regarding the vulnerability of the fetus is (or at least perhaps should be) addressed by a woman’s ability to act as a surrogate for her unborn child. Women make decisions – both medical and otherwise – for their children, born and unborn, every day. Which makes the notion that the state of pregnancy renders them unable to make these decisions rather patronizing, at best.

“There is a desperate need to shift the paradigm to protect pregnant women through research, not just from research,” states a linked commentary on the article (2). “With the recent emergence of the Zika crisis and the rapid pace of vaccine development, we have a crucial opportunity to demonstrate what proactive and intentional inclusion of pregnant women’s interests in the R&D agenda looks like.”

It is increasingly being recognized that current approaches to clinical research all too often inadequately account for gender differences (3). Many women face health issues when pregnant and are prescribed drugs to treat them. Of the 172 drugs approved by the FDA between 2000 and 2010, 97 percent had an “undetermined” risk for pregnancy – which highlights just how important it is to ensure that the latest medicines work for all patients. Allowing pregnant women to make their own decisions regarding research participation – and thus giving them more agency – is a crucial first step.