Excluding Pregnant Women From Clinical Studies Because They’re Classed As ‘Vulnerable’ Is ‘Harmful’

Excluding mums-to-be from clinical studies is unfair and
could be potentially harmful, researchers have said.

Pregnant women are often ruled out
of participating in clinical trials because they’re
classified as a “vulnerable” group, and this creates a
knowledge void around the impact of drugs taken during
pregnancy and “unfairly excludes” them from taking part in
clinical studies, concluded researchers writing in the
Journal of
Medical Ethics

“There is a desperate need to shift the paradigm to protect pregnant women through research,
not just from research,” the researchers wrote.

“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 research and development agenda looks like.”

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The researchers stated that of the 172 drugs approved
by the US Food And Drug Administraion
) between 2000 and 2010, nearly all (97%+) had
an “undetermined” risk for pregnancy.

The average length of time to find out how safe drugs are in pregnancy
is 27 years, they stated.

In a bid to explore
to what extent pregnant women
really are “vulnerable”, researchers found published evidence
cited four main themes as reasons for their vulnerability: 1)
informed consent; 2) susceptibility to coercion; 3) heightened risk because of
lack of scientific knowledge; and 4) the vulnerability of the
developing foetus.

Although informed consent could be compromised because of the
need to weigh up the pros
and cons not only for themselves, but also for their
baby, researchers stated: “There is no immediately
obvious reason to assume
that pregnant women are incapacitated during

There is no immediately obvious reason to
assume that pregnant women are incapacitated during
Researchers in
Journal of Medical Ethics.

The idea that pregnant women would be subject to coercion because of their own and
society’s desire to protect
the developing foetus is “paternalistic, and not really
warranted,” the researchers said.

They continued: “The vulnerability of the foetus
may be an issue, primarily
because there isn’t enough scientific data on the potential
impact of drugs taken during pregnancy, particularly new

“But the fact the unborn child can’t speak for him/herself is
no reason for vulnerability; it only means there
should be a surrogate
decision-maker, which is the pregnant woman.”

Therefore, the researchers added: “There is no
reason to assume that the
vulnerability of the foetus renders pregnant women
increasingly vulnerable in comparison with ordinary research

The researchers stated pregnant women’s vulnerability boils
down to the lack of
research carried out in this group, and it’s a dilemma that
can only be overcome by
including them in
future clinical studies.

“Our study once and for all demonstrates that there is no
indication that pregnant women are vulnerable because of
informed consent, susceptibility to coercion, or vulnerability of the
foetus,” they stated.

“The only reason why pregnant women are potentially vulnerable in clinical research is to the extent that they are increasingly
exposed to higher risks
due to a lack of scientific
knowledge which might render them vulnerable as research

“Only a joint effort to promote fair inclusion by funding
agencies, drug authorities, researchers, methodologists,
pharmacologists, guideline committees and [research ethics
committees] can successfully reduce pregnant women’s

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Excluding Pregnant Women From Clinical Studies Because They’re Classed As ‘Vulnerable’ Is ‘Harmful’

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