Review of Pregnant Partner ICs Now Available as Part of Initial Review Process

August 29th, 2017

Schulman IRB now offers review of pregnant partner informed consent forms with initial review documents to equip research sites with the necessary approvals for obtaining consent from pregnant partners.

When the research plans to collect data on the progress or outcome of pregnancies that occur in the partners of male participants, Schulman’s IRB considers the pregnant partner to be a human subject as that term is defined in DHHS regulations 45 CFR 46.102 and also as a “participant” in the research under FDA regulations 21 CFR 50.3(g) involved in clinical research. As such, legally effective informed consent, using an IRB approved consent document, must be obtained from pregnant partners prior to any interaction by an investigator, sponsor or research staff, with a pregnant partner.

Schulman can now review template pregnant partner consents as part of the IRB’s initial study review, so that research sites have the necessary approval material immediately when a pregnancy occurs in a pregnant partner of a research participant. Should a pregnancy occur unexpectedly during the course of the study, a pregnant partner IC can also be reviewed as an amendment to research.

To assist with the development of such informed consents, Schulman offers clients a template pregnant partner consent document.

If you have any questions or would like additional information, please contact your Study Manager or call at 513-761-4100.