Abstract

An ethical concern for fetal safety has led to the exclusion of pregnant women from clinical trials for nearly sixty years, resulting in a lack of safety and efficacy data that pregnant women with chronic diseases and their physicians can use to make informed treatment decisions. Here, we employ Catholic moral frameworks, which emphasize respect for human life and dignity, to argue that inclusion of pregnant women in clinical trials, when there is convincing preclinical evidence that the trial is safe for fetal development, is morally justified, because exclusion imposes unacceptable risks on both women and their fetuses.