Ethical Issues of Clinical Trials that Exclude Pregnant Women

Abstract

    Under the COVID-19 pandemic, medical researchers have been striving to develop drugs and vaccines against the novel coronavirus. Currently, almost all curative treatments and vaccines are contraindicated for pregnant patients due to unknown efficacy and safety. Moreover, being excluded from studies related to COVID-19, pregnant women are likely to be left behind in the use of new vaccines as well. Historically, pregnant women have thoroughly been excluded from clinical trials due to ethical reasons, such as to ensure their protection, and researchers and regulation officers have taken it for granted that pregnant women should be excluded from clinical trials given their vulnerability. In fact, FDA guidelines issued in 1977 recommended that all fertile women be prevented from participating in clinical trials. According to a previous study, pregnant women were excluded from 95% of all industry-funded clinical studies conducted in the US between 2010 and 2011. In the present paper, we discuss ethical issues of exclusion of pregnant women from clinical trials, mainly by referring to the historical background and current situations in the US. In the first section, we present an overview of present COVID-19-realated drug and vaccine studies that broadly exclude pregnant women from participation. In the second section, we investigate the historical background that led to the exclusion of pregnant women from studies in the US. In turn, the third section takes a quick look at social and academic movements toward the inclusion. Drugs and vaccines suitable for pregnant women cannot be developed without clinical trials that include both pregnant and non-pregnant participants. To this end, from 2008 to 2010, many bioethics researchers advocated the importance of including pregnant women in clinical trials, leading to a radical revision of FDA guidelines and publication of the 2018 PRGLAC report that demanded additive justification on biomedical researchers for not inclusion but exclusion. Despite these changes, COVID-19 studies that began in 2020 broadly excluded pregnant women, raising alarms among researchers. In the last section, we examine philosophical arguments that justify and promote the inclusion of pregnant women in clinical studies in general, highlighting the importance of the principle of justice in research ethics.