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The perils of protection: vulnerability and women in clinical research

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Abstract

Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring “additional protections,” often referred to as “vulnerable populations.” The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential research subjects needing additional protections. In this paper, I assess critically the role of this categorization of pregnant women involved in research as “vulnerable,” both as separate entities and in combination with the fetuses they carry. In particular, I do three things: (1) demonstrate that pregnant women qua pregnancy are either not “vulnerable” according to any meaningful definition of that term or that such vulnerability is irrelevant to her status as a research participant; (2) argue that while a fetus may be vulnerable in terms of dependency, this categorization does not equate to the vulnerability of the pregnant woman; and (3) suggest that any vulnerability that appends to women is precisely the result of federal regulations and dubious public perceptions about pregnant women. I conclude by demonstrating how this erroneous characterization of pregnant women as “vulnerable” and its associated protections have not only impeded vital research for pregnant women and their fetuses, but have also negatively affected the inclusion of all women in clinical research.

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Notes

  1. In his earlier, more general, work on vulnerabilities in research [7], Kipnis identifies six exhaustive categories. However, in a later work on pediatric vulnerability [8], Kipnis identifies seven varieties of vulnerability. All but one of those varieties are either included or subsumed in the work presented to the National Bioethics Advisory Commission [7]. However, since the one type of vulnerability not expressly included—social vulnerability—is crucial to my analysis of the inclusion of women in research, I have included it in both the table and the narrative account of analytic vulnerabilities. Since I take Kipnis to be concerned with the same fundamental project in both works, this strikes me as a legitimate move.

  2. It may also not preclude research conducted during this window, provided that adequate safeguards (consent discussions during prenatal care, etc.) are in place.

  3. Obviously, there are cases when this is explicitly not the case, as when one parent has motives other than the child’s best interests at heart, or when the parent is abusive, neglectful, or absent.

  4. See, e.g., [37], under the heading “Understanding cultural differences in clinical trials.”

  5. It is impossible to know the magnitude of the risk on either side, especially because pregnant women are routinely excluded from clinical trials. Investigators worry about liability for fetal harm conferred during research, however, women can also sue drug manufacturers and physicians for drugs prescribed in clinical care that are not well studied [33]. In either case, disclosure of known information about teratogens—as well as gaps in knowledge—are essential.

  6. This variety of vulnerability is described in Kipnis’s work on pediatric vulnerability but has clear implications for a much wider group of participants in clinical trials (see footnote 1).

  7. For instance, consider the physician who refuses to perform standard imaging on a pregnant woman with an indication of appendicitis for fear of harming the fetus, when evidence demonstrates that “delayed diagnosis and appendicle rupture carries a tenfold risk of miscarriage” [17, p. 5].

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Acknowledgments

I am grateful to Anne Drapkin Lyerly, to participants at the 2011 Annual Meeting of the American Society for Bioethics and Humanities, and to the anonymous reviewers of this journal for helpful comments on earlier drafts of this paper.

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  1. Center for Ethics, Emory University, 1531 Dickey Drive, 1st Floor, Atlanta, GA, 30322, USA

    Toby Schonfeld

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Schonfeld, T. The perils of protection: vulnerability and women in clinical research. Theor Med Bioeth 34, 189–206 (2013). https://doi.org/10.1007/s11017-013-9258-0

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