When males are enrolled in clinical studies, researchers are often interested in evaluating whether the investigational drugs, devices, or procedures have effects on female partners who become pregnant, and their fetuses. Pregnant partners who are not participants in the research must be consented for this purpose.

Should a partner of a study participant become pregnant, the following must occur prior to collecting data on the pregnant partner:

• A modification must be submitted that includes the Pregnant Partner consent form (the form is only compliant/valid if the form is IRB approved).
• A report must be submitted to inform the IRB of the pregnancy, including a safety plan for that pregnant partner, moving forward.

The GUI-C47 is available at https://researchcompliance.stanford.edu/panels/hs/policies/guidances