Code of Federal Regulations Requirements for Inclusion of Pregnant Women and Their Fetuses in Clinical Research
| a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses. |
| b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means. |
| c) Any risk is the least possible for achieving the objectives of the research. |
| d) If the research holds out the prospect of direct benefit to the pregnant woman, to the pregnant woman and the fetus, or no prospect of benefit for the woman or the fetus when risk to the fetus is not greater than minimal and the biomedical knowledge cannot be obtained by any other means, her consent is obtained. |
| e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest. |
| f) Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate. |
| g) For children who are pregnant, assent and permission are obtained in accord with the provisions of Subpart D (Research Protection for Children). |
| h) No inducements will be offered to terminate a pregnancy. |
| i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy. |
| j) Individuals engaged in the research will have no part in determining the viability of a neonate. |
Note: Text is adapted from 45 CFR 46 Subpart B ยง46.204.12