Research with Pregnant Women, Fetuses, and Neonates

Complete and submit Appendix D.Research with Pregnant Women.Neonates Request with the protocol application. Include the appendix as a separate file labeled LASTNAME.Pregnant.DATE.

Women who are or may become pregnant during a research study are considered by Federal Regulations and SU IRB policy to be a "vulnerable population" that requires additional considerations to avoid unnecessary risk to the fetus. The SU IRB supports providing pregnant women the same opportunities as non-pregnant women in research participation, unless the exclusion of pregnant women is appropriately justified due to risk concerns.

The IRB must review a protocol to determine whether participation as a research subject could pose potential risks to pregnant female volunteers and/or their fetuses, and whether involving pregnant women could yield any benefit that would outweigh such risks. In some cases, potential or suspected risks could justify excluding pregnant women from the research or require consultation from a primary care physician or other qualified health-care provider before being permitted to participate in the research.

If pregnant women will be included, the IRB must assess whether subjects who are or suspect they are pregnant should be advised to consult with a primary care physician when considering whether or not to participate.

For purposes of this policy and Appendix D, the following definitions apply in accordance with federal regulations:

Fetus: the product of conception from implantation until delivery.

Neonate: a newborn.