Research Involving Pregnant Women, Fetuses, & Neonates
Policy No. 3.10
Research involving women who are or may become pregnant during research interventions requires special attention from IRBs because of women's additional health considerations during pregnancy and because of the need to avoid unnecessary risk to the fetus. The Virginia Tech IRB supports a policy of providing pregnant women the same opportunities as non-pregnant women to participate in research unless the exclusion of pregnant women is appropriately justified.
During its review of proposed research, the IRB must judge whether participation as a research subject would pose any potential or suspected risks to pregnant female volunteers and/or their fetuses and, if so, whether the involvement of pregnant women would yield any direct or indirect benefit that would outweigh such risks. In some instances there may be potential or suspected risk sufficient to justify that pregnant women either be specifically excluded from the research or advised to seek consultation from their primary care physician or other qualified health-care provider.
If it is determined that pregnant women should be excluded, the IRB must also assess whether the research team may rely on each female's self-report, or whether validation through a negative pregnancy test is required before female subjects of childbearing potential are involved in study-related activities.
If it is determined that pregnant women will be included, the IRB must assess whether female subjects who are or suspect they are pregnant should be advised to seek their primary care physician's consultation when considering whether or not to participate, and whether the research team should make pregnancy test strips available for female subjects who elect to complete a pregnancy test prior to participation.
To assist the IRB with these determinations and to ensure female subjects are provided sufficient information, the IRB protocol and information provided to subjects (within consent documents and recruitment/screening materials, as appropriate) should include the following:
- Identified potential or suspected risks the research may present to pregnant women or fetuses,
- Indication of whether, based on the research team's assessment of risks, pregnant women should be excluded,
- Indication of whether pregnancy tests will be required of or offered to female subjects of childbearing potential, and
- If pregnant women are to be included, discussion of whether it will be recommended to women who are or suspect they might be pregnant that they seek consultation from their primary care physician or other qualified health-care provider to discuss participation.
The below sections provide further discussion and example consent form language.
Per VT's agreement with the Department of Health and Human Services (DHHS), VT is required to comply with 45 CFR 46 Subpart B, "Additional Protections for Pregnant Women, Fetuses and Neonates Involved in Research," for non-Exempt research conducted or supported by the DHHS. For research not conducted or supported by the DHHS, or for Exempt DHHS-supported research, the IRB has flexibility in its decision-making with regard to the inclusion of pregnant women in research.
The IRB will approve non-Exempt DHHS funded research involving pregnant women, fetuses and/or neonates if, in addition to meeting all other requirements and review considerations, the research satisfies the conditions of 45 CFR 46 Subpart B.
As discussed above, pregnant women shall be included in research unless exclusion is sufficiently justified.
When including pregnant women, depending on the nature of the research activities, it may be appropriate to advise women who are or suspect they might be pregnant that they seek guidance from their physician prior to participation. It may also be helpful to provide women with the opportunity to take a pregnancy test prior to participation. The following is sample language to insert into the Risks section of the consent document:
Additional information for women who may be pregnant:
If you know that you are pregnant, or suspect that you may be pregnant, it is recommended that you consult with your personal physician to determine whether you should or should not participate in this study.
If there is a chance that you could be pregnant at the time of your scheduled study participation, but you have not previously confirmed that you are pregnant, it is recommended that you consider using a home pregnancy test (available at pharmacies and other stores as an over-the-counter product) to assess whether you are or are not pregnant. Alternatively, you can request that the research team provide you with a pregnancy test stick, and you can check your urine in a private rest room at the research facility. Regardless of the outcome, you have the right to decide whether you want to participate. You do not need to tell the research team what the outcome is. If you are pregnant and you choose not to participate, you can simply tell the research team that you have decided that you do not want to participate. No further explanation is needed.
Note that the research team may elect to and/or the IRB may, based on the nature of the research activities, require that the research team have pregnancy test strips and a private location for females to complete the test available for convenience purposes.
The IRB is tasked with the anticipation and evaluation of a wide assortment of risks as they pertain to individuals, groups, and, for purposes of the involvement of pregnant women, fetuses. As part of risk assessment, the IRB regularly evaluates health-related exclusionary criteria, which includes a research protocol's potential to negatively impact the welfare of pregnant women and fetuses. As such, the IRB has the authority to approve protocols wherein pregnancy is listed as an exclusionary criterion and the exclusion is properly justified.
If pregnancy is established as an exclusionary criterion, then the following list of items should be incorporated into the Research Protocol and consent form.
- Specification that pregnancy is an exclusionary criterion
- Sufficient justification for the exclusion, such as a description of potential or suspected risks to pregnant women and/or fetuses
- The screening process, as described within the protocol, must ensure females are properly informed of the exclusionary conditions and must include pregnancy as an exclusionary factor
- Discussion whether all females of childbearing potential must have a negative pregnancy test before undergoing any study-related activities*
Consent Form (sample language provided below):
- Reminder that pregnancy is an exclusionary criterion
- Explanation of any potential or suspected risks to the pregnant women and fetuses
- If pregnancy testing is required before the study, a description of the requirement and process, and how privacy will be provided
- If pregnancy testing is not required but pregnant test strips will be made available, language explaining the option to take a pregnancy test
- Any other pregnancy-related considerations
*Note that the IRB, following evaluation of the protocol, may require that the research team provide pregnancy tests to all females of childbearing potential to confirm negative results before involvement in study-related activities. If relying on self-report, the research team may elect to and/or the IRB may, based on the nature of the research activities, require that the research team have pregnancy test strips and a private location for females to complete the test available for convenience purposes.
Sample language for the Risks section of the consent form:
Additional information for women who may be pregnant:
Federal regulations governing the protection of human subjects, specifically in a section outlining the limitations in use of pregnant women, state that if a research study provides no direct benefit to the woman, and poses a greater than minimal risk to the developing fetus, then pregnant women must not be included in that research study. The IRB, to ensure compliance with those federal regulations, has determined that pregnant women should not participate in this study.
If there is a chance that you could be pregnant at the time of your scheduled study participation, but you have not previously confirmed that you are pregnant, the IRB recommends that you consider using a home pregnancy test (available at pharmacies and other stores as an over-the counter product) to assess whether you are or are not pregnant. Alternatively, you can request that the research team provide you with a pregnancy test stick, and you can check your urine in a private rest room at the research facility. In either case, you do not have to tell anyone on the research team what the outcome is. If the test indicates that you are pregnant, you can simply tell the research team that you have decided that you do not want to participate. No further explanation is needed.
If you are pregnant, due to the risks identified above, you are ineligible to participate in this particular study.
Female subjects are considered of "childbearing potential" if they (a) are anatomically and physiologically capable of becoming pregnant and (b) they will be, or could possibly be, engaging in sexual activity with males while study interventions that pose the possibility of harm to a fetus are occurring.
Females who are postmenopausal or who have undergone a hysterectomy or bilateral oophorectomy are not considered of childbearing potential.
Although the IRB makes pregnancy-related decisions on a protocol-by-protocol basis, the following table represents what the IRB typically requires with regard to exclusion of pregnant women and pregnancy testing requirements based on study activities.
|Research Activity||Involvement Criteria||Pregnancy Testing Requirement|
|Non-physically invasive research (e.g., surveys, interviews, focus groups)||Women shall be included unless scientific justification is provided.||None|
|MRI/fMRI||Pregnant women may be included but advised to consult physician (view webpage for suggested language)||None|
|X-ray (DEXA, CT scans)||Pregnant women excluded||Required for females of childbearing potential|
|Alcohol administration||Pregnant women excluded||Pregnancy testing required by NIAAA|
|Driving research||View VTTI's guidance document.|
|Sensory evaluation (e.g., food tasting)||Pregnant women may be included. It may be appropriate to advise pregnant women to consult physician prior to participation.||None|
|Slip/fall research||Pregnant women may be included but advised to consult physician.||Pregnancy test strips made available.|
|Exclusion for scientific reasons only||N/A||Not required|