All women should be presumed to be eligible for participation in clinical studies. The potential for pregnancy should not automatically exclude a woman for participating in a clinical study, although the use of contraception may be required for participation. Research objectives should not interfere with appropriate clinical management. If a conflict arises between medically appropriate patient care and research objectives, patient care should prevail. Consent of the pregnant woman alone is sufficient for most research. Pregnant women considering participation in a research study should determine the extent to which the father is to be involved in the process of informed consent and the decision.