Can a pregnant woman take part in a survey study involving questionnaires if the IRB hasn’t specifically approved participation of pregnant women?
No. If the research is federally funded, pregnant women may take part in research only when the IRB has approved the research under Subpart B.
However, if the research is not federally funded and if the risks are not greater than minimal, then under IRB SOP 502, approval under Subpart B is not required. The most frequent procedures where this applies include questionnaires, surveys and reviews of medical records of women who are pregnant.
What if it isn't obvious that the woman is pregnant, do we still need to ask?
Most studies that involve interventions or procedures will be required to include questions about possible pregnancy and/or pregnancy tests.
However, if the study involves a simple questionnaire and it is not obvious that the prospective participant is pregnant, the IRB may, under these circumstances not require the investigator to add this question when it is not appropriate to the research in question.
What do I need to do if a subject becomes pregnant during a study?
There are issues that may require review. The IRB should be contacted as soon as possible to discuss these potential issues.
- Unless pregnancy is included as an anticipated event in the study protocol (e.g., a study about fertility); the pregnancy must be reported as an unanticipated problem to the IRB;
- If the IRB has not approved the participation of pregnant women, the study intervention should be stopped immediately unless continuing the study intervention would be in the woman's or the fetus's best interest;
- If there are no study interventions (an observational study), the investigator may amend the study and request that the study be approved under Subpart B;
- If there are any interventions or procedures which could negatively impact fetal development, the subject should be followed until delivery and possibly beyond to ensure that there are no serious adverse events that have been sustained, such as birth defects. For some interventional studies, this may also apply to the partner of a male subject. This plan must be included in the protocol and application.