Progress has also been made in regulations that further expand the options for pregnant women to be included in research. The updated “Common Rule,” which is the set of federal regulations for the ethical conduct of human subject research in the US, clearly delineates that pregnant women or fetuses may be involved in research if several conditions are met, including the prior conduct, when scientifically appropriate, of preclinical studies, including studies on pregnant animals (such as reproductive toxicology studies), and clinical studies, including studies on non-pregnant women (30). The document also delineates the risk categories for research based on the prospect of benefit for the women or the fetus, indicating that the risk of the research needs to be balanced with the prospect for benefit for the women OR the fetus, or if there is no such prospect of benefit, the risk to the fetus should be not greater than minimal when the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means. The pregnant mother is given the right to provide consent for herself and for her baby, unless the prospect of direct benefit is solely to the fetus, then the consent of the pregnant mother and the father should be obtained, with exceptions allowed based on specific situations that would prevent the father from signing. These provisions help guide the Institutional Review Boards in their decision making regarding the participation of pregnant women in research.