WCG IRB Policy on Pregnant Partners

Effective Aug. 1, 2022, WCG policy on collection of outcome data on partners of study participants has changed. WCG policy is now as follows: the collection of outcome data on partners of study participants who become pregnant does meet the HHS definition of research, as it is a systematic investigation designed to develop or contribute to generalizable knowledge. As a result, the IRB will make 45 CFR 46 Subpart B and D determinations for follow up of pregnant partners and their children.

If the protocol states that this procedure will occur, consent documents should inform participants of the plan to collect data if their partner becomes pregnant.

If you submit a consent document or HIPAA authorization for pregnant partners, the IRB will review the document as a research consent form. However, if you do not submit a consent document for pregnant partners, the IRB will not require one unless/until one is needed to consent a pregnant partner.

This change does not affect the follow-up of participants who become pregnant. Those individuals are human participants. Such data collection needs to be described in the consent document. Subpart B determinations are required to collect data about the pregnancy. Subpart D determinations are required to collect data about children resulting from the pregnancy.