Elsevier

The Lancet

Volume 375, Issue 9715, 20–26 February 2010, Pages 632-633
The Lancet

Perspectives
Enrolling pregnant women in biomedical research

https://doi.org/10.1016/S0140-6736(10)60257-7Get rights and content

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  • Maternal vaccination: a review of current evidence and recommendations

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    The first documented vaccine trial in pregnant women was conducted in Papua New Guinea in 1961, during which administration of 2 or more doses of fluid formalinized tetanus toxoid vaccine during pregnancy was shown to be protective against neonatal tetanus.6 At the time, the United States Food and Drug Administration (FDA) guidelines excluded pregnant women from all drug and vaccine trials, and following the thalidomide tragedy in the 1950s to 60s, this exclusion was expanded to all women of childbearing potential.7 This decision was subsequently reversed by the FDA in 1993 after it was deemed that exclusion of this group of women had led to a substantial lack of safety data for a number of drugs in women of childbearing age.7

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    These strict guidelines were reversed in 1993, again permitting the inclusion of women of childbearing potential in early phase research per the discretion of local institutional review boards, researchers, and women themselves (71). Despite this guideline reversal, the FDA remains cautious about the inclusion of pregnant women in clinical trials (72). The Declaration of Helsinki does not mention research in pregnancy, and the 2002 International Ethical Guidelines for Biomedical Research Involve in Human Subjects of the Council for International Organizations of Medical Sciences states that “research in [pregnant women] should be performed only if it is relevant to the particular health needs of a pregnant woman or her fetus” (72).

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