211. Research with Pregnant Women or Women with the Potential to Become Pregnant
Coincidental Inclusion of Pregnant Women or Unintended Pregnancy in a Research Project
If sample populations include women who could become pregnant (henceforth referenced as women of childbearing potential), researchers and the IRB must consider the possibilities that
- pregnant women may be enrolled in a research project,
- participants may become pregnant while enrolled in a research project, or
- female partners of research participants may become pregnant while their male partners are enrolled in a research study.
For research that presents no additional risks to pregnant women or to women of childbearing potential, the research plan should specifically state that there are no known or suspected risks to the woman or fetus if pregnant women may be coincidentally enrolled.
For treatment and intervention studies that pose potential risks to pregnant women or fetuses sufficient to justify requiring that pregnant women either be specifically excluded or studied separately, prospective study participants should be tested for pregnancy and warned about possible and/or unknown reproductive or lactation risks from study treatments. The project plan should specify the risks, and the conditions for the exclusion or withdrawal of pregnant women, and for non-pregnant women of childbearing potential, requirements for contraception.
Some studies find it useful to provide special consent forms for research participants who become pregnant and wish to continue in the study. The special consent form should discuss the research activities that will continue, risks of continuing in the study, and additional precautions or follow-up activities.
Investigator's plans for documenting birth outcomes or for long-term monitoring of any offspring must be described in the research plan and consent documents.
For research that poses an unacceptable risk to a pregnant woman or fetus, investigators must identify reproductive risks, describe how these risks will be mitigated, and specify how non-pregnant participants of childbearing potential will be informed of these risks. This information should be noted in research plans and consent materials.
Reproductive harms include:
- Direct teratogenic effects (i.e., malformations of an embryo or fetus)
- Possible germline effects (i.e., changes to cells that may be passed through sexual reproduction)
- Effects on a woman's ability to continue the current pregnancy
- Effects on fertility and future pregnancies
NOTE: Researchers must also consider reproductive risks for non-pregnant, female partners of participants in investigational research.
Mitigating Reproductive Risks
Pregnancy as an Exclusion Criterion
National Institutes of Health (NIH) policy requires the inclusion of women in research study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study [PHS Grant Application form 398, pp. 21-22]. Generally, after they have been fully informed of the risks and possible benefits of study participation, prospective participants have the right to make their own choices about the level of risk they will tolerate.
When the research may pose risks to pregnant women, embryos, or fetuses; or when risks to pregnant women, embryos or fetuses are unknown, excluding pregnant women and women of childbearing potential may be warranted. Under these circumstances, the principal investigator should specify the exclusion criteria and provide scientific or risk-based reasons for the exclusion, or when applicable, state that pregnancy is exclusionary due to a lack of knowledge of risks.
When pregnancy is an exclusion criterion, investigators commonly screen for pregnancy during the research. Information about the screening processes, including pregnancy testing when applicable, should be commensurate with the risks to the pregnant woman and the fetus.
Requiring Contraception for Women of Childbearing Potential
When applicable to the research, investigators may require women of childbearing potential to employ methods to minimize the possibility of conception during their or their partners' research participation. The methods may be unique to one gender and may be different for men and women. The research plan and consent materials should be written to address concerns appropriate to the study population, and to female partners of research participants when applicable.
The research application and consent forms should specify when contraceptive steps are required, and specify the time frame for contraception before, during, or after treatment.
Investigators requiring contraception must describe the requirements in the research plan and informed consent materials. Choices of methods should be as broad as possible and must be consistent with participant safety. Participants should be told the short- and long-term advantages and disadvantages of the allowable methods. Barrier methods are advised where body fluids may transfer infectious agents, vectors, or medications.
- Reviewing Plans for Avoiding Pregnancy. During the consent process, investigators should review with each female participant her plans to avoid becoming pregnant (or, with each male participant, his plans to avoid impregnating his partner). If in the judgment of the investigator, the plans are inadequate, the investigator should discuss options for improving the adequacy of the plans or excluding the participant from the research.
- Testing for Pregnancy: Investigators must describe requirements and procedures for pregnancy testing when it is required before, during, or after a woman's (or her partner's) participation in the study. The information should include the frequency of testing.
- Notifying the Investigator: Investigators must include processes for female participants (or female partners of male participants) to promptly notify the PI or study coordinator if she departs from the plans for avoiding pregnancy or if in spite of adherence to the plans, she thinks she might be pregnant.