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# Including Pregnant Women in Trials Draft Guide
- URL: https://www.fdaweb.com/including-pregnant-women-in-trials-draft-guide/
- Published: 2018-04-06T12:00:00.000Z
- Updated: 2026-09-14T23:57:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141162

FDA has posted a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM603873.pdf?ref=fdaweb.com) entitled: “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” The document provides recommendations about how and when to include pregnant women in drug development clinical trials. It also discusses the scientific and ethical issues that should be addressed when considering the inclusion of pregnant women in clinical trials.

“Because of the complex ethical issues involved in designing clinical trials that include pregnant women, sponsors should consider including an ethicist in planning their drug development programs,” the guidance says. “Moreover, sponsors should consider meeting with the appropriate FDA review division early in the development phase to discuss when and how to include pregnant women in the drug development plan. These discussions should involve FDA experts in bioethics and maternal health.”

The guidance also addresses institutional review board (IRB) oversight. “Therefore, if an IRB regularly reviews research involving pregnant women, the IRB must consider including one or more individuals who are knowledgeable about and experienced in working with such subjects (21 CFR 56.107(a)),” it says. “Additionally, IRBs are required to determine that additional safeguards are included in the trial to protect the rights and welfare of subjects who are pregnant (21 CFR 56.111(b)).”