Guidance

For some research protocols, women of childbearing age are advised to avoid pregnancy or nursing for a time during or following the research to protect the health and safety of the mother and/or child. Males must also be warned if there is a risk arising from the transfer of an investigational product via semen. Participants need to be clearly warned regarding any known risks (e.g., birth defects) should pregnancy occur. Additionally, investigators must inform female participants of childbearing age that if she was to become pregnant, the particular treatment or procedure may involve risks to the embryo or fetus which are currently unforeseeable.

The University of Utah IRB requires that both male and female participants must be informed of the appropriate precautions to prevent pregnancy (see Points to Consider). Despite the warnings provided and precautions taken, pregnancy may occur during research participation. Investigators must be aware of the requirements related to reporting and follow-up in the event a research participant or a research participant’s partner becomes pregnant.

This guidance is intended to clarify IRB requirements and what information should be provided to the IRB to ensure the protocol has a process for monitoring and managing pregnancy occurrences.

Follow-Up Guidelines

Information may only be collected on a research participant who becomes pregnant, a partner of a research participant who becomes pregnant and/or the newborn infant if the IRB-approved protocol, consent forms and data collection forms contain provisions for collection of information on the pregnancy and outcome.

Investigators may update the ERICA (Electronic Research Integrity and Compliance) application to include the vulnerable population(s) and any consent forms via amendment, should the need arise.  Researchers should describe the rationale for collection of pregnancy information (e.g., discovery of any reproductive risks related to an investigational drug, etc.). Researchers should outline what data, if any, will be collected about the pregnancy, and the length of time data be collected (outcome of pregnancy only, infant at 3 months, infant at 6 months, etc.).

Research Participant

The research participant must provide consent for collection of follow-up pregnancy data in accordance with the IRB approved consent process and the ERICA application should be amended to include pregnant women as a vulnerable population. Information cannot be collected if the woman’s participation is terminated, or she has withdrawn.

Pregnant Partners

Researchers that plan to collect pregnancy outcome data from pregnant partners of research participants must obtain informed consent from the pregnant partner and amend the ERICA application to include pregnant women (see Points to Address below). A pregnant partner informed consent document must adhere to the general requirements of informed consent.  Where HIPAA regulations apply, the pregnant partner must also sign an authorization for use of their protected health information (PHI). In cases where the pregnant partner is a minor (i.e., age 17 or younger), parental permission may also be required. Please see the Pregnant Partner Consent Template on the IRB website.

Newborn Infant

Before collecting any information from the newborn infant, the investigator must include provisions for studying the newborn infant in the research protocol, the informed consent form, obtain approval from the IRB, and then obtain appropriate parental permission from the newborn infant’s parent or legal guardian. If the study is a VA study, the VA facility director must approve participation of children in research prior to collection of data about the newborn infant following IRB review and approval.

Monitoring Pregnancy Occurrences

Investigators conducting research that advises participants to use an effective method of birth control to protect the health and safety of the mother and/or child must have a safety monitoring plan. The following information is required in either the Company Protocol or IRB Application to ensure that an adequate plan exists to report this safety information.

• Specify what data points will be sought from pregnant research participants or pregnant partners. Identify if follow-up information will be self-reported or if it will be acquired via chart review.
• The frequency and length of follow-up should be clearly defined.
• Describe the mechanism to track the mother’s expected delivery date (and thus obtain follow-up data).
• Describe the plan to ensure the reporting of a pregnancy, an abnormal outcome for the fetus/child, or adverse reactions suspected in infants following exposure to breast milk to the appropriate entities (IRB, sponsor, FDA, etc.) as applicable.
• In cases where it is necessary to monitor the pregnancy of a woman whose male partner is the trial participant, partner privacy may become an issue in follow-up for certain situations (e.g., cases where the pregnant partner is a minor, where the partner does not wish to be identified, where paternity is in question, etc.). The protocol should describe the process for monitoring and managing special circumstances regarding partner privacy.

Reporting Guidelines

Although pregnancy itself is not considered an adverse event or a serious adverse event, the pregnant participant or the partner of a male participant should be followed until termination or to term to ensure absence of congenital anomaly or birth defect that may have resulted from maternal exposure or transmission of the study drug via semen following paternal exposure.

Investigators conducting research that advises participants to use an effective method of birth control to protect the health and safety of the mother and/or child must report the pregnancy of a participant or a participant’s partner to the University of Utah IRB. The following are reporting guidelines for the University of Utah IRB. Reports should be submitted using the Report Form in ERICA:

• Pregnancy should be reported as “Information” (not as an “Adverse Event” or “Other Problem or Event”).
• Pregnancy does NOT have to be reported to the IRB if the subject is receiving follow-up only, and conception occurred outside of the time period that the study protocol requires contraception (e.g., protocol specifies that contraception is required for 6 months after the last dose of the study drug and the pregnancy occurred after that time).
• Subsequent reports containing follow-up information regarding a pregnancy is not required unless the pregnancy results in a congenital anomaly. The congenital anomaly should be promptly reported as an Adverse Event on the Report Form in ERICA.

NOTE: If you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child, it must be reported to the FDA.

Documents and References

Pregnancy Follow-Up Consent and Release of Information Authorization: https://irb.utah.edu/informed-consent/forms-templates-cpt/

Guidance on Collecting Data on Pregnancy and Outcomes of Pregnancy from VA Research Subjects and Pregnant Partners of VA Research Subjects for Safety Monitoring: https://www.research.va.gov/resources/policies/guidance/pregnancy.pdf 

Points to Consider