Determining whether or not pregnant women are involved in research can seem complicated. However, by answering a few questions, the process to determine inclusion of this population under the regulatory requirements of 45 CFR 46 Subpart B is relatively simple.
One of the first questions to ask is whether pregnant women will be included in the anticipated subject population (either specifically or incidentally). If not, Subpart B does not apply.
If pregnant women could be subjects because of the age range of the population, etc., the next question to resolve is whether their pregnancies will be revealed through the screening procedures.. Now keep in mind this applies either incidentally, through taking part in open-ended study procedures like focus groups or interviews where a participant may volunteer this information, or by asking explicitly, testing, or checking medical records for pregnancy.
If you identify that a women is pregnant as part of the screening process, the next question to ask is whether she will be removed from the study because of her pregnancy. If yes, you are not including pregnant women. If no, pregnant women will be included, and Subpart B does apply to the research project.
With a retrospective data-only project, pregnant women are considered to be included only if they are pregnant at the time of data collection. Thus, if the date range for the project is not prospective or you have to wait until post-pregnancy to collect the information, pregnant women would not be considered part of the research.
We have created a decision chart for pregnant women. The chart also includes prisoners. It can be found on our website on the Recruitment and Consent Page under Research Involving Vulnerable Populations.
As always, if you need assistance determining whether pregnant women are included in your study, please contact RSPO, we are always glad to help!