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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.
    Theoretical Medicine and Bioethics 05/2013; 34(3). DOI:10.1007/s11017-013-9258-0 · 0.78 Impact Factor
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    ABSTRACT: The lack of human data available to inform evidence-based treatment for illness during pregnancy has led to calls for greater inclusion of pregnant women in research, but the extent of their current representation is poorly characterized. Our objective was to measure the current exclusion of pregnant women from industry-sponsored clinical trials as a baseline for future comparison. We compiled data from studies enrolling women of childbearing potential posted on www.ClinicalTrials.gov between 1 October 2011 and 31 January 2012. The review was limited to open United States-based phase IV interventional studies sponsored by the pharmaceutical industry evaluating treatment of conditions that may be experienced by but are not limited to pregnant women and did not involve a medication classified as potentially teratogenic. If there was no mention of pregnancy in the inclusion or exclusion criteria, we contacted a study representative to confirm that pregnant women could be enrolled. Of 558 qualifying industry-sponsored studies, five (1%) were designed specifically for pregnant women. Of 367 phase IV clinical trials with verified inclusion and exclusion criteria, 348 (95%) excluded pregnant women and 19 (5%) did not. We found the exclusion of pregnant women from industry-sponsored clinical trials to be common practice. Moving beyond reflexive exclusion and developing thoughtful criteria for inclusion of pregnant women in clinical research would likely advance the evidence base to inform treatment decisions during pregnancy and lead to better health outcomes for women and children.
    Obstetrics and Gynecology 10/2013; 122(5). DOI:10.1097/AOG.0b013e3182a9ca67 · 4.37 Impact Factor
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    ABSTRACT: Pregnant women with illness require efficacious and safe drug therapy during pregnancy; however, their treatment is often hindered by a lack of information regarding the use of medications during pregnancy. Ethical challenges are encountered in conducting drug trials in pregnant women, who are often excluded from participation due to fear of harm to the fetus. However, as the health of the fetus is ultimately affected by that of the pregnant woman, inclusion of pregnant women in studies of medications that they may require for their own benefit may also benefit the unborn child. The principle of autonomy argues for the pregnant woman being able to make an informed choice to take part in a clinical trial, and the principle of justice dictates that she not be denied the benefits of drug research.
    Paediatric Drugs 11/2014; 17(1). DOI:10.1007/s40272-014-0104-2 · 1.72 Impact Factor