Institutional Review Board

Research Involving Pregnant Women, Fetuses, & Neonates

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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:

  1. Identified potential or suspected risks the research may present to pregnant women or fetuses,
  2. Indication of whether, based on the research team's assessment of risks, pregnant women should be excluded,
  3. Indication of whether pregnancy tests will be required of or offered to female subjects of childbearing potential, and
  4. 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.


Applicability of Federal Regulations

Research Conducted or Supported by the DHHS

Including Pregnant Women in Research

Excluding Pregnant Women in Research

Definition of Childbearing Potential

Typical Requirements Based on Study Activity