Abstract

How should the definition of “minimal risk” in the federal research regulations be interpreted in regard to pregnant women and fetuses? Surprisingly, there has been little discussion of this question. There is, after all, a substantial amount of published work addressing the question of how “minimal risk” should be interpreted. Similarly, there is a large body of literature on the ethics of research involving pregnant women and fetuses, particularly maternal-fetal surgery. However, in neither of these bodies of work can one find an analysis of minimal risk in regard to fetuses or pregnant women.The concept of minimal risk is defined in the regulations as follows:Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.