Special research protections required for pregnant women and fetus include:
- In research where women of childbearing potential will be subjects and they should neither be pregnant nor become pregnant because of potential risks to the fetus, special protections include how the investigator will screen for pregnancy and inform subjects about preventing pregnancy.
- In research targeting pregnant women for inclusion that is greater than minimal risk, special protections include minimizing risks to the woman and her fetus and informing the woman (and possibly the father) about the risks to her and her fetus.
- In research where women of childbearing potential will have one or more MRI (magnetic resonance imaging) scan conducted solely for research purposes, special protections include informing the women that they should not have the MRI scan unless they are certain they are not pregnant.
- In research on drugs where there is a concern about the female partners of male subjects receiving the drugs, special protections include provisions for informing males of the precautions they should take to prevent pregnancy in their female partners.