Pregnant Women, Fetuses, Neonates or In Vitro Fertilization

Overview

Pregnant women, fetuses and neonates are vulnerable populations, and additional protections are described in the regulations (45 CFR 46 Subpart B) enforced by the Office for Human Research Protections (OHRP). These regulations also cover research using human in vitro fertilization, as well as human fetal tissue, placenta or post delivery fetal material.

UCSF supports a policy of providing pregnant women the same opportunities as non-pregnant women to participate in research, unless the individual meets legitimate exclusionary criteria or the study poses more than minimal risk to the fetus.

Inclusion of Pregnant Women or Women of Childbearing Potential

During the course of a clinical study, pregnant women or women of childbearing potential may be encountered coincidentally as potential participants. Alternatively, pregnant women and fetuses may be the target study population(s).

Some common types of research involving pregnant women include the following:

The Risk of Reproductive Harm and Contraception Requirements

Prospective study participants should be warned about possible reproductive or lactation risks from study treatments. Discuss these risks and the steps to be taken to minimize them in both the consent form and IRB Application.

The points that follow are adapted from a more specific discussion in the NIH Informed Consent Guidance for Human Gene Transfer Research: Reproductive Considerations, which also contains sample consent form language.

Sample Consent Form Wording: The sample consent form wording that follows is adapted from the NIH Gene Transfer guidelines cited above. The NIH guidelines include a number of additional examples that will be useful in many different kinds of studies and for both women and men. The wording in any example will need to be adapted to the particular study and subject population.

Regulatory Requirements

    Click on the link to expand the regulatory requirements for research involving each participant population.

     

    Last updated: June 4, 2021