Some types of studies may include procedures that could potentially harm pregnant women or fetuses. For this reason, federal guidelines identify pregnant women as a group that may warrant additional protections.
Since potential benefits of research may extend to pregnant women, they should not be excluded from participation unless procedures warrant doing so. Justification for exclusion should be provided within the study application.
With regards to potential risk, Investigators should consider if their procedures introduce potential risk specific to pregnant women or fetuses, and steps that will be taken to mitigate that risk.
COUHES may approve research involving pregnant woman or fetuses if the following criteria are met:
- 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;
- The research holds out the prospect of direct benefit to the woman, the fetus, or both; or if there is no prospect of direct benefit, the risk is no more than minimal and results cannot be obtained by any other means.
- The risk of the research is minimized to the greatest extent possible.
- Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate.
- Individuals engaged in the research will have no part in: 1) any decisions as to the timing, method, or procedures used to terminate a pregnancy, and 2) determining the viability of the fetus at the termination of the pregnancy; and
- No inducements, monetary or otherwise, will be offered to terminate the pregnancy.
- In some cases, investigators may be required to obtain consent from both the mother and father.
A more detailed description of regulations pertaining to pregnant women and fetuses is provided in federal guidelines.
For studies which aim to use MRI scanning, see our guidance on MRI and Pregnancy.
For studies which plan to conduct pregnancy testing on participants who are of childbearing age, may be pregnant or planning to become pregnant, see COUHES guidance on Including Women of Childbearing Potential in Research and Pregnancy Testing.
Updated December 6, 2023