IRB Advocacy

Expanding Clinical Research during Pregnancy & Lactation: Advocacy Toolkit

Equipping obstetric care clinicians to advocate within their institutions for greater inclusion of pregnant and lactating people in clinical research. Those that achieve the toolkits three goals will become an Obstetric Research Champion.

Toolkit Goals

An institutional Obstetric Research Champion will achieve three goals or “Best Practices“ for their IRB or similar regulatory body:

  • Inclusion of a member with clinical expertise in obstetrics. This should be interpreted broadly to include researchers in the obstetric space, such as midwives, family medicine providers with obstetric expertise or individuals who study pregnancy within the context of their own fields; for example, a cardiologist who focuses on cardio-obstetrics.

  • Designation of pregnant participants as “scientifically complex” rather than “vulnerable.”

  • Default inclusion of pregnant and lactating individuals in clinical research with justification needed for exclusion, rather than a default of exclusion with justification needed for inclusion.

Steps for an Obstetric Research Champion

    • Locate and review your institution’s IRB membership and policies to determine:

      • Does your IRB include an individual with expertise in obstetrics as defined above?

      • Is the inclusion of pregnant and lactating people in clinical research the default?

      • Are pregnant research participants designated as “scientifically complex rather than “vulnerable”?

    • If all three are “yes,” you have completed the toolkit. Proceed to Step 4.

    • If not, proceed to step 2.

  • If any of the three best practices are not adopted, contact your IRB’s leadership and take the following steps:

    • Schedule a meeting with IRB leadership and professional staff.

    • Prior to the meeting circulate the FAQ factsheet and editorial included in the resources section.

    • Present to IRB on SMFM’s Best Practices using the slide deck and sample script in the resources section.

  • Follow up with IRB to determine if best practices are implemented.

    • If yes, congratulations! You have made a real difference for pregnant people! Proceed to Step 4.

    • If no, the Society for Maternal-Fetal Medicine is available for additional assistance. Contact them at SMFMadvocacy@smfm.org.

  • Let the SMFM advocacy team know you have completed the toolkit by emailing SMFMadvocacy@smfm.org.

    • You can elect to be publicly acknowledged, including a special ribbon on that 2027 SMFM Annual Meeting.

Toolkit Resources