Do you think an inclusion mandate should be required for pregnant and lactating people in research?

March 17, 2021

Decades of effort including the development of guidance and implementation by individuals, groups, professional organizations, even the United States Congress, to address and facilitate inclusion of pregnant and lactating people in research and trials held no sway in the studies addressing the coronavirus disease 2019 (COVID-2019) pandemic.

"An inclusion mandate should be required for pregnant and lactating people in research. At present, pregnant people are excluded from research by default. Those governing, funding, and/or mandating trials should require an explanation of why pregnant and lactating people are excluded," Catherine Y. Spong, MD wrote in her March editorial for Contemporary OB/GYN®.

Do you agree that further expansion to include pregnant and lactating people is an attainable short-term goal?

"The 2000 U.S. Government Accountability Office Report on Women’s Health found significant progress in the representation of women in clinical trials because of the requirement of assessment of their inclusion as part of the scientific merit of the research grant. In the past several decades this has expanded and now all NIH grant applications include a section on inclusion on the basis of sex/gender, race, ethnicity, and age in clinical research. Further expansion to include pregnant and lactating people is an attainable short-term goal that will focus the inclusion by default," Spong wrote.

We want to hear from you. Do you agree with Spong, that expansion to include pregnant and lactating people is an attainable, short-term goal?