Pregnant Participants & Fetuses

Under 45 CFR 46.204, pregnant individuals or fetuses may be involved in research if all of the following are met:

• Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies on non-pregnant individuals, have been conducted and provide data for assessing potential risks to pregnant individuals and fetuses;
• The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the pregnant individual or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means;
• Any risk is the least possible for achieving the objectives of the research;
• If the research holds out the prospect of direct benefit to the pregnant individual, the prospect of a direct benefit to the pregnant individual and the fetus, or no prospect of benefit for the pregnant individual nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means, her consent is obtained;
• If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant individual and the father is obtained, except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest;
• Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;
• For children who are pregnant, assent and permission are obtained in accord with 46 CFR 45 subpart D;
• No monetary or other inducements will be offered to terminate a pregnancy;
• Individuals engaged in the research will have no part in determining the viability of a neonate.

Clinical researchers are often interested in evaluating whether the investigational drugs, devices, or procedures have effects on the pregnant partners of enrolled participants,and fetuses. Based on HHS and FDA  definitions, and consistent with the Secretary’s Advisory Committee on Human Research Protections (SACHRP), the Stanford IRB does not consider the collection of safety data from an individual who becomes pregnant during their partner’s research participation, in and of itself, to constitute human subjects research. IRB protocols do not need to indicate that pregnant individuals will be included as research participants.

• HHS regulations: the collection of data from the pregnant partner and child solely for safety purposes would not contribute to generalizable knowledge, and therefore, does not meet the definition of research. However, if other activities occur for research purposes, then they may be considered a research participant.
• FDA regulations: the pregnant partner and child are not the recipients of the test article(s), thus the pregnant partner and child do not meet the definition of a human subject under FDA regulations.

If a partner of a research participant becomes pregnant, a prompt Report Form should be submitted to the IRB at the time the study team becomes aware of the event and the pregnancy has been confirmed. If the pregnant partner’s involvement is limited to the collection of safety data, a HIPAA Authorization will need to be obtained for the collection of protected health information (PHI). The HIPAA Authorization should state the purpose of the activity as the collection of information about the pregnant partner, fetus and/or child, not the purpose of the clinical investigation. Please consult with Stanford University Privacy for guidance on the HIPAA Authorization and use of PHI before proceeding with the collection of data from the pregnant partner.

Pregnant individuals and fetuses may only be involved in research if all the requirements outlined in the VHA Directive 1200.05 are met.

• For interventional or invasive monitoring studies, this includes certification from the VA medical facility Director that the VA medical facility has sufficient expertise in reproductive health to conduct the proposed research.
• Research on either a fetus or human fetal tissue cannot be conducted by VA investigators while on official duty, or at VA facilities, or at approved off-site facilities.
• Research related to in vitro fertilization may be conducted by VA investigators while on official duty, or at VA facilities, or at approved off-site facilities.
• Research on neonates must be limited to minimal risk and noninvasive monitoring and cannot include interventions while VA investigators are on official VA duty, at VA facilities, or at approved off-site facilities.

Potential participants should be informed of any reasonably foreseeable risks related to the research.  Pregnancy testing and outcomes are often tracked in treatment and interventional studies for participant safety monitoring. Disclosure of this information may result in potential legal risks for pregnant participants and participants who can become pregnant. The consent form should disclose what pregnancy related information will be recorded, who it may be shared with, any limitations on confidentiality, and if legal concerns could arise from the disclosure of this information.