Research Involving Pregnant Women, Fetuses, and Neonates

You may include pregnant women or fetuses in research if you meet all of the following conditions:

• When it makes sense for your study, you have already done preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women. These studies give you information to help assess possible risks to pregnant women and fetuses.
• The only risk to the fetus comes from procedures or interventions that offer a possible direct benefit to the woman or the fetus. If there is no possible benefit, the risk to the fetus must be no greater than minimal, and your research must aim to develop important biomedical knowledge that you cannot get any other way.
• You keep any risk as low as possible while still reaching the goals of your research.
• If your research offers a possible direct benefit to the pregnant woman, to both the woman and the fetus, or if it offers no benefit to either but the risk to the fetus is minimal and the research aims to develop important biomedical knowledge that cannot be obtained otherwise, you must obtain her informed consent according to the rules in Subpart A.
• If your research offers a possible direct benefit only to the fetus, you must get informed consent from both the pregnant woman and the father, unless the father cannot consent because he is unavailable, incompetent, temporarily incapacitated, or the pregnancy happened because of rape or incest.
• You make sure that everyone giving consent fully understands the possible effects of the research on the fetus or newborn.
• If a pregnant child is a subject, you must get assent from the child and permission from a parent or guardian, following the rules in Subpart D for protecting children in research.
• You do not offer any inducements, money, or other rewards to end a pregnancy.
• If you are involved in the research, you must not take part in any decisions about when, how, or whether to end a pregnancy.
• If you are involved in the research, you must not take part in deciding if a newborn is viable.

• If your research may directly benefit the pregnant woman or the fetus, it can usually be approved, even if it involves more than minimal risk, as long as you meet the other Subpart B requirements.
• If your research may benefit the pregnant woman or both the woman and the fetus, you only need the pregnant woman’s consent.
• If your research may benefit only the fetus, you must get consent from both the pregnant woman and the father. You do not need the father’s consent if he is unavailable, incompetent, temporarily incapacitated, or if the pregnancy resulted from rape or incest.

• If your research does not offer a direct benefit to the mother or the fetus, the IRB can only approve it if the risk to the fetus is no greater than minimal and the purpose of the research is to develop important biomedical knowledge that cannot be obtained by any other means.
• You must explain in your protocol why you need to include pregnant women to get this important biomedical knowledge.
• The IRB must decide that you cannot reach your research goals by enrolling only nonpregnant subjects.
• If your research involves more than minimal risk and does not offer a direct benefit to the pregnant woman or the fetus, the IRB cannot approve it.

You should explain in your protocol what you will do if a participant becomes pregnant during the study.

• For treatment studies:
  • State in your protocol if pregnancy means the participant must stop the treatment.
  • If a participant’s partner becomes pregnant and you want to keep collecting outcome data, you must get IRB approval for a consent form that allows the partner to agree to have pregnancy outcome data collected. Another options, you can also state that you will collect outcome data and enroll the partners in NIH Protocol 000268, the NIH Intramural Research Program's Pregnancy Registry Protocol for Subjects and their Partners.
• For FDA-regulated research, you must collect and report pregnancy outcomes.

If your protocol allows a participant to stay in the study after becoming pregnant, include this information:

• While the participant is pregnant, you will not do any research interventions, tests, or procedures that are greater than minimal risk, because the regulations do not allow this unless there is a possible direct benefit to the pregnant woman or fetus.
• Explain in your protocol why you need to include pregnant women to gain important biomedical knowledge that you cannot get from nonpregnant women.
• If a participant becomes pregnant while in the study and you plan to keep her in the study, you must submit a modification that gives the reason for her continued participation.
• Example:
  • In a natural history study of people with Lupus, the principal investigator explains that the only way to learn about important biological differences between pregnant and nonpregnant participants with this disease is to keep following the women who become pregnant during the study.
  • While these women are pregnant, you will not do any research interventions, tests, or procedures that are greater than minimal risk.
  • In this case, the IRB can approve the continued participation of a woman who becomes pregnant, following the regulations for extra protections for pregnant women.