Any study in which women of childbearing potential are possible participants may inadvertently include pregnant women. When participants of childbearing age are recruited, it is important to consider whether to utilize pregnancy testing if there is a reasonable potential risk to the fetus. If appropriate, investigators should also consider whether to conduct testing during screening procedures or throughout the duration of study activities as part of their study plan. Detecting a pregnancy as early as possible prevents or reduces embryo/fetal exposure to potentially harmful study interventions.
COUHES applications must explain the reason for asking pregnancy status, the procedures for determining pregnancy status such as conducting pregnancy testing, and how the result of pregnancy testing will be returned to participants.
If pregnancy testing is conducted to determine eligibility status, study screening forms should include if the data is collected solely for the purpose of determining eligibility or whether the results will be retained as part of the study record. Generally, COUHES recommends that if a participant is found eligible, the investigators should retain the screening data including pregnancy status. If a participant is determined ineligible, test results should not be retained unless the investigator provides additional justification within their application.
If pregnancy status is recorded as part of routine study procedures, this data should be retained as part of the study record in accordance with described data retention procedures. All related procedures and data retention plans should be clearly described in the application and the consent form.
Participant who Become Pregnant During Research
It may be appropriate for some research studies to ensure that non-pregnant participants avoid pregnancy for a certain amount of time during or following their participation. The consent form should include a statement explaining if participants should avoid becoming pregnant, what they are expected to do to avoid pregnancy and how their participation may be impacted as a result of becoming pregnant (ex. Being withdrawn by the investigator).
If a participant becomes pregnant during the course of the study where pregnancy is an exclusion criterion, all research procedures with the pregnant participant, including interactions and interventions and collection of identifiable private information, must stop immediately, except when necessary to eliminate apparent immediate hazards to subjects. The investigator must inform COUHES immediately and submit a Protocol Event Reporting Form.
Risk to Fertility
When appropriate, both female and male participants should be provided a statement in the consent form that a particular intervention may involve potential risks to their fertility. These risks may be known or currently unforeseeable at the time of the informed consent process. A description of these risks and how they will be mitigated should be clearly described in the application and the consent form.
Updated December 6, 2023