4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)

Last Revised: 9/25/2024

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for IRB review and approval of research involving pregnant women, fetuses, and neonates (nonviable or of uncertain viability).


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 IRB Review

In addition to review of research under HHS regulations at 45 CFR 46 (Subpart A) and FDA regulations at 21 CFR 50, 56 as applicable, the IRB must assure additional protections are in place for pregnant women, fetuses and/or neonates involved in research in accordance with the following:


5.0. Non-pregnant subjects who become pregnant during research


6.0 Documentation of Compliance with Subpart B


DOCUMENT HISTORY:

 Written: 1/6/2016 (Approved: 1/6/2016) - original author not recorded

 Revised: 2/20/2018 - revision not documented

 Revised: 12/22/2022 – clarified exceptions to requirements under subpart B for research not subject to subpart B (section 4.1.2); deleted specific language related to 45 CFR 46.207 (section 4.5); stylistic changes for clarity.

 Revised: 9/25/2024 – added that research involving fetuses and neonates (nonviable or of uncertain viability) will be reviewed and conducted in accordance with applicable state law (section 2.3).


Revision #11
Created 24 October 2019 21:35:50 by Autumn M Eberly
Updated 17 April 2025 15:59:37 by Robert A Lewis