Clinical Research Involving Pregnant Women ed. by Françoise Baylis and Angela Ballantyne (review)

As a feminist bioethicist, I have frequently wondered why the exclusion of pregnant women has been the default position for most clinical research and how social values have influenced this decision. Relatedly, I wonder what responsible research involving pregnant women would look like. As a theorist who conducts research on the concept of vulnerability, I have often wanted to know why there has been so little research into the harmful effects of the routine exclusion of pregnant women, including questions such as: What do pregnant women actually think about participating in research? How should we treat pregnant women and their fetuses for the purposes of consent (are they two separable persons or one complex unit)? How can we overcome the stigma associated with research involving pregnant women? How are we to calculate the risks and benefits to women and the fetuses they carry when considering their inclusions in research? What kinds of ethical complications come along with uterine transplantation? These are only a few of the questions addressed in this remarkable collection of essays edited by Françoise Baylis and Angela Ballantyne.

This sixteen-chapter collection builds on the wealth of literature produced throughout the last decade, which argues for the inclusion of pregnant women and women of childbearing potential in clinical research (Lyerly et al. 2008; Lyerly et al. 2009; Baylis 2010; Maklin 2010; Baylis and Halperin 2012). Overly precautious principles and restrictive guidelines, while motivated by concern for the wellbeing of pregnant women and their fetuses, result in the exclusion of pregnant women from research and little guidance or treatment for underlying or acute health conditions during pregnancy (e.g., heart disease, hypertension, diabetes, depression, asthma, cancer, or appendicitis) (Little 2011). This unique book brings together a range of perspectives and topics into one coherent collection. Together bioethicists, clinicians, researchers, research ethics review committees, and health policy experts provide one comprehensive analysis of not only why pregnant women and their fetuses ought to be included in research but also of how such research can be organized to ensure responsible research design and minimize the risks to the woman and her fetus.

The book is divided into four parts, which include a wide range of topics, case studies, and perspectives. The first part of the book focuses on the fair, respectful, and responsible inclusion of pregnant women in appropriate clinical research. The three essays in this part present an interwoven narrative about how the history of Thalidomide and DES gave rise to an overly precautious principle of women avoiding any pharmaceutical use during pregnancy; how this caution resulted in excluding women from clinical research and encouraged a stigma associated with pregnant women who participate in research; why this status quo is problematic for both physicians and pregnant women; and why the default position for clinical research should be presumptive inclusion, as well as how presumptive inclusion should be structured. Françoise Baylis and Robyn MacQuarrie begin part one by arguing for the importance of clinical trials in pregnancy for both the physician and the pregnant woman. The status quo, argue Baylis and MacQuarrie, leaves physicians providing advice on the use of over-the-counter and prescription medications without high quality clinical trial data and leaves pregnant women who take or stop taking medication in an effective "trial of one." This essay sets the tone for the rest of the section and echoes throughout the volume. In subsequent sections, essays return to the touchstone argument that regulatory positions should by default presume that pregnant women are eligible to participate in research and that de facto exclusion results in harm. Lucy Langston, for example, argues that precaution often conflates with inaction, resulting in the stigmatization of any pharmaceutical use (over-the-counter or by prescription) by pregnant women. She concludes her essay by suggesting how risk communication can be altered to educate different stakeholder groups about risk related to research during pregnancy. Chris Kaposy's essay bridges parts one...