Research Involving Pregnant Women, Fetuses, & Human In Vitro Fertilization
Introduction
Research involving women who are or may become pregnant requires special attention from IRBs because of women's additional health concerns during pregnancy and because of the need to avoid unnecessary risk to the fetus.
Federal Regulations
For research activities directed toward pregnant women as subjects, the federal regulations provide that no pregnant woman may be involved as a subject unless either: (1) the purpose of the activity is to meet the health needs of the mother, and the fetus will be placed at risk only to the minimum extent necessary to meet such needs; or (2) the risk to the fetus is minimal [45 CFR 46.207].
Any study in which women of childbearing potential are possible subjects may inadvertently include pregnant women. DHHS regulations require that, when appropriate, subjects be provided a "statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable" as part of the informed consent process [Federal Policy-46.116(b)(1)].
45 CFR 46 Subpart B
IRB Considerations
IRBs must judge whether the mother's participation would pose any risk to the fetus or nursing infant. In some studies, IRBs may need to ensure that nonpregnant subjects are advised to avoid pregnancy or nursing for a time during or following the research. Furthermore, where appropriate, subjects should be advised to notify the investigator immediately should they become pregnant. In some instances there may be potential risk sufficient to justify requiring that pregnant women either be specifically excluded from the research or studied separately.
Points to Consider
- For all studies, is there reason to exclude pregnant or lactating women? If so, how strict should the screening measures be?
- For all studies involving pregnant women, have appropriate studies on animals and nonpregnant humans been conducted? Is any special monitoring of the informed consent process needed?
- For studies directed toward maternal health, is the risk to the fetus the least possible consistent with the research objectives? Will the mother be adequately informed of the potential risk to the fetus and of alternative treatments and their risks and benefits?
