Amelia Haj, a fourth-year medical student at the University of Wisconsin School of Medicine and Public Health, received the 2019 Dr. Norman Fost Award for the Best Medical Student Bioethics Essay.

Her essay explored the theme of the 11th annual Bioethics Symposium, sponsored by the School of Medicine and Public Health and its Department of Medical History and Bioethics.

Not vulnerable: pregnant women and autonomy in clinical trials

In the United States, considerable value is placed on individual freedom, but the ongoing discussions in this country about the bodily rights of women can at times feel like an entirely different world. Differing opinions on the humanity of a growing fetus are at the ideological heart of the difficulty in coming to moral and political consensuses on everything from whether employers should be required to pay for insurance covering birth control to whether a woman should have the right to terminate an unwanted or unviable pregnancy.

Amelia Haj photo
Amelia Haj

While pregnancy does introduce the additional consideration of the possible rights of the fetus, when it comes to pregnant women’s participation in clinical trials, classifying them as a “vulnerable population” serves as a misguided attempt to center the presumed rights of the fetus over the autonomy of the woman. The designation of pregnant women as a “vulnerable population” is therefore unethical, and has the potential to cause greater harm than it prevents by reducing their participation in clinical trials necessary for improving maternal/fetal health.

Pregnant women do not have key characteristics shared among other vulnerable populations. The designation of these groups in clinical trials is intended to protect individuals who may not have the capacity to make decisions in their own best interest, or who might be unusually susceptible to coercion. Children, people who are incarcerated, and people who are intellectually disabled, for instance, are clear examples of true vulnerable populations. Their inability to independently give consent, and/or their reliance on others to meet their daily needs, puts them in a position where their ability to give informed consent should rightfully receive careful attention. In these cases, protections are intended to preserve and respect the individuals’ autonomy.

The classification of pregnant women as a 'vulnerable population' in the context of clinical trials does not actually serve to protect pregnant women or their fetuses, and in fact likely reduces their participation in much-needed research.

Pregnant women, on the other hand – barring intellectual disability, incarceration, or minor status – have the capacity to consent, and in no other area of their medical care are they treated as vulnerable. The vulnerable population in this case, therefore, is not actually pregnant women but their fetuses, and the “protection” offered is not truly intended to be protection from researchers or caregivers, but protection of the fetus from the pregnant woman herself.

The argument can be made thus that the most important goal is not actually preserving the woman’s autonomy, but ensuring non-maleficence towards the fetus. What this argument ignores is that it is impossible to orchestrate the perfect gestation. Even if we knew exactly what constitutes the ideal in-utero experience, we would need to severely limit the independence of all pregnant women in order to achieve anything approaching a standardized “ideal” pregnancy.

As it stands, we allow women to make countless choices about their behaviors and medical care during pregnancy. Decisions regarding diet and exercise, prenatal testing, and delivery method are all more likely – on an individual but especially on a population level – to impact a baby’s health than choosing to participate in a clinical trial. In spite of this, we recognize the importance of allowing, or, more cynically perhaps, the impracticality of disallowing, women the latitude to make these decisions for themselves.

Many have rightly argued that the inclusion of pregnant women in research is in fact a moral imperative1. While clinical trials certainly do have the potential to result in adverse events, exclusion of pregnant women, either explicitly or through the introduction of restrictions on inclusion, ultimately causes greater harm by impeding research progress on maternal/fetal health.

The American College of Obstetricians and Gynecologists suggests designating pregnant women as “scientifically complex” rather than “vulnerable,” a description that acknowledges their medical complexity while avoiding the suggestion that their participation in trials be limited due to an inability to consent2. Instead of seeking to protect pregnant women and their fetuses by limiting their participation in trials, protection should come in the form of full disclosures regarding potential risks and benefits, up-front discussions regarding the process for reporting and addressing potential negative effects of trial participation, and careful monitoring during the trial3.

The classification of pregnant women as a “vulnerable population” in the context of clinical trials does not actually serve to protect pregnant women or their fetuses, and in fact likely reduces their participation in much-needed research. The designation suggests reduced decision-making capacity, which in incongruent with the myriad choices women make during their pregnancies, and ultimately limits their autonomy. Rather than limiting their participation in clinical trials, pregnant women should be empowered to make informed choices about their participation and thereby help increase their representation in clinical research.

By Amelia Haj
This essay appears in Quarterly magazine.

References

1. Goldkind SF, Sahin L, Gallauresi B. Enrolling pregnant women in research — lessons from the H1N1 influenza pandemic. N Engl J Med. 2010;362(24):2241-3.

2. Ethical considerations for including women as research participants. Committee Opinion No. 646. American College of Obstetricians and Gynecologists. Obstet Gynecol 2015;126:e100–7.

3. Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry. Food and Drug Administration. April 2018.