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Clinical Research Involving Pregnant Women pp 33–50Cite as

Better Safe Than Sorry: Risk, Stigma, and Research During Pregnancy

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Part of the book series: Research Ethics Forum ((REFF,volume 3))

Abstract

Choosing to act within a precautionary paradigm is often the smart choice for pregnant women and for healthcare practitioners and researchers who interact with them. However, during pregnancy precaution is often conflated with inaction. This norm is identified in the literature as ‘better safe than sorry/inaction is better than action.’ I argue that the origin of this norm can be traced to the thalidomide and DES tragedies that mark the beginning of the stigmatisation of both prescription and over-the-counter pharmaceutical use during pregnancy. Conceptualising pharmaceutical use during pregnancy as ‘stigmatised’ is important because it helps explain the distorted perception of risk during pregnancy that arises from the norm of inaction. When reluctance to conduct pharmaceutical research during pregnancy is understood in terms of mistaken risk perception, then new tools of risk communication become available to support, critique and evaluate research during pregnancy.

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Notes

  1. 1.

    The author “Watkins” is Olive Waktins Smith and is identified as “Smith” in other publications cited in this chapter.

  2. 2.

    Further adverse effects have subsequently been identified in both male and female, first and second generation, offspring of DES -treated women – including increased cancer risks, and a range of issues that make conceiving and carrying their own pregnancies more difficult (Swan 2000). Monitoring of, and research on, the health of children and grandchildren of DES patients continues today. As a result of this, new health issues continue to be identified and researched.

  3. 3.

    The United States was one of the few countries to exclude thalidomide and insist on further testing. The FDA’s concern was with the incidence of peripheral neuropathy in pregnant women prescribed thalidomide rather than with any potential foetal impacts. The FDA’s progress in determining the rate of this side-effect was very slow and in the United States clinical research was still ongoing when the foetal malformations were first made public five years after the FDA was first approached to approve thalidomide (Archer 1979).

  4. 4.

    Personal communication with Ruth Macklin April 2 2015.

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  1. Department of Philosophy, McMaster University, Hamilton, Canada

    Lucy Langston MA

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  1. Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada

    Françoise Baylis

  2. University of Otago, Wellington, New Zealand

    Angela Ballantyne

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Langston, L. (2016). Better Safe Than Sorry: Risk, Stigma, and Research During Pregnancy. In: Baylis, F., Ballantyne, A. (eds) Clinical Research Involving Pregnant Women. Research Ethics Forum, vol 3. Springer, Cham. https://doi.org/10.1007/978-3-319-26512-4_3

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