Abstract
I examine how equipoise and uncertainty ought to be managed in ethically sound and scientifically valid clinical research involving pregnant women. Drawing on recent work in philosophy of science, I argue that it is built into the internal nature of practical reason that equipoise and uncertainty are always relative to a set of values and interests. In brief, this is because a higher evidence bar will raise the risk of false negatives exactly as much as it will lower the risk of false positives, and typically both kinds of errors have costs. Furthermore, interventions during pregnancy are likely to engage sets of values and interests that are deeply held, particularly prone to intense ideological and cultural pressures, and highly variable. Pregnant women have interests and agency of their own, and are caretakers of their foetuses’ well-being. As such, they have an especially important role in determining what counts as legitimate equipoise for the purposes of clinical research in which they may participate. I conclude that for both epistemological and ethical reasons, pregnant women should be given the epistemic tools to make informed, value-relative determinations of scientific uncertainty, and they should be included in the initial process of determining research questions and designing trials.
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Notes
- 1.
90 % of medications fall under what the FDA, up until June 30, 2015, classified as ‘Category C.’ This means that either studies in animals have revealed adverse effects on foetuses (teratogenic or embryocidal or other) and there are no controlled studies in women, or studies in women and animals are not available.
- 2.
Although the so-called ‘thalidomide disaster’ is often cited as a reason to be wary of doing research involving pregnant women , it seems better interpreted as a lesson in the risks of this sort of post-market experimentation (see Langston 2016).
- 3.
An excellent concrete example of their point is discussed by Ballantyne et al. (2016). A placebo trial on the effect of probiotics during pregnancy had trouble recruiting participants, because women who found out about the trial wanted to use the product rather than risk being assigned to the placebo arm. It appears that the cultural meanings surrounding ‘natural’ supplements made the intervention preferable despite a lack of evidence concerning safety or efficacy. One can assume that the reaction to a trial involving a prescription medication would have been quite different (see Ballantyne et al. 2016).
- 4.
As I have argued (2007), this reading of the principle of equipoise requires that we also add on a separate ‘Minimum Standard Requirement,’ which is that nobody in a clinical trial receive care that we have good reason to think is inferior to what they would be entitled to receive outside of the trial.
- 5.
Historically, other groups, most notably women in general, were routinely excluded from research out of a similar protectionist, anti-interventionist impulse. However, this tendency was explicitly counteracted by changes in the National Institutes of Health (NIH) guidelines in 1992. By 2001, women’s participation in research already outpaced men’s (Prout and Fish 2001).
- 6.
It is an incontestable fact that interventions during pregnancy can affect two beings. This is so completely independently of whether we think the foetus is a person, or more generally what its moral status is. At least potentially, the foetus will become a person eventually, who will have been affected by what was done to the body in which it gestated.
- 7.
Ubel and Silbergleit (2011) have defended this claim as well, although they do not draw on the philosophy of science toolbox to make this argument, nor do they consider how this applies to the case of research on pregnant women in particular.
- 8.
The idea that science is governed by a ‘value-free ideal’ has been standard for over a century, and has been explicitly debated and upheld since Weber’s (original) publication of “‘Objectivity ’in social science and social policy ” in 1904 (Weber 1949). For a good overview of the picture of science as having a value-free core even while its entry and exit conditions, as it were, are clearly value driven, see Kitcher (2011). See also the Stanford Encyclopedia of Philosophy entry on “Scientific Objectivity.”
- 9.
A similar argument was foreshadowed in Churchman (1948).
- 10.
Hempel (1965) first coined the term ‘inductive risk ’ and framed the problem in this precise way.
- 11.
This has been extensively documented and discussed. See, for instance, Randal (2002).
- 12.
- 13.
- 14.
- 15.
They add on the important point that people’s prior background beliefs will properly affect how quickly they are willing to accept or reject a hypothesis, because their Bayesian priors will shape their probability updating.
- 16.
In certain contexts with specific ideological charges and cultural meanings, however, internalised values may push women towards, rather than away from, interventions; see the dexamethasone case discussed above, as well as the probiotics case identified in fn. 3 (see Ballantyne et al. 2016).
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Kukla, R. (2016). Equipoise, Uncertainty, and Inductive Risk in Research Involving Pregnant Women. 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_10
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