Abstract

The institutional review board at the University of Nebraska Medical Center has a policy on contraceptive use in research that aims to balance the protection of potential fetuses from potential harm resulting from drug exposure in research against respect for the autonomy of women research participants. The policy draws on the U.S. Food and Drug Administration’s Use-in-Pregnancy categories in an innovative way. These categories are meant to help prevent the exposure of fetuses to harmful drugs when used for therapy by pregnant women. The UNMC IRB policy applies the FDA categories as a guideline for mandating contraceptive use among research participants. Clinical trials of drugs in the different FDA categories require different levels of contraceptive protection under the UNMC IRB policy. Though we agree with the insight that contraceptive requirements in research could helpfully be guided by the current and future FDA Use-in-Pregnancy guidelines, we argue that in several places, the UNMC IRB policy unjustifiably prioritizes the protection of potential fetuses from potential harm at the expense of respecting the autonomy and well-being of women research participants. In response to the deficiencies we identify in the UNMC IRB policy, we formulate an alternative, ideal policy on contraceptive use in research